Note--Don't Cry Over Plant-Based Milk: Why The Use Of The Term "Milk" On Non-Dairy Beverages Does Not Constitute "Misbranded" Under The Federal Food, Drug, And Cosmetic Act.
In December of 2016, Congress launched an effort to prevent nondairy drink manufacturers from labeling their products as "milk." (3) Thirty-two members of the House signed a letter to the Commissioner of the U.S. Food and Drug Administration ("FDA") claiming that plant-based manufacturers are misleading consumers, and describing nondairy products as "unable to match the nutritional makeup of the product they mimic." (4) Though dairy consumption has long played a role in society, drinking dairy milk is a fairly new practice beginning in the late nineteenth century. (5) As demand dictates supply, dairy farms became industrial businesses with federal approval to increase milk production by extraordinary means, including injecting cows with various genetically engineered growth hormones such as bovine growth hormone ("rBST" or "rBGH"). (6) Researchers have conducted various studies on the links of these hormones to prostate, colorectal, and breast cancer but these links are still largely unexplored. (7) While the scientific community still lacks certain agreement on various growth hormones' effects on human health, the professional opinions on the necessity of dairy milk largely agree that plant-based products are often better sources of nutrients found in dairy milk. (8)
Due to vigorous advertising such as the "Got Milk?" marketing campaign including an advertisement featuring major league baseball player Cal Ripken Jr. with the caption, "[w]ith all the milk I drink, my name might as well be Calcium Ripken, Jr.," milk is perhaps best known for its association with bone health as a source of calcium and protein. (9) In clinical, longitudinal, retrospective, and cross-sectional studies, however, the consumption of dairy products has not shown "even a modestly consistent benefit" for young adult bone health. (10) Plant-based milks are free of animal fats, growth hormones, antibiotics, and lactose sugar, while also providing comparable levels of protein. (11) Nevertheless, in January of 2017, the Senate introduced the "Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese To Promote Regular Intake of Dairy Everyday Act" ("DAIRY PRIDE Act"), alleging that plant-based products "often do not provide the same nutrition content as real milk ... derived from dairy cows." (12) The Act cites data from the Dietary Guidelines, developed by a Committee that includes members with past or present ties to the dairy industry. (13) Further, the Senate introduced the Act only after a survey from Nielsen, a global information, data, and measurement company, revealed that plant-based product sales grew 250 percent, while dairy milk sales fell seven percent in 2015. (14) Despite these complaints of the dairy business suffering from the rise of plant-based manufacturers, milk giants are in fact investing in plant-based companies; for example, milk giant Dean Foods recently announced a minority stake and distribution deal in Good Karma Foods, a manufacturer of flaxseed-based milk alternatives. (15)
This note will explore the evolution of dairy milk production into the industry it is today, compared to the rise of the nondairy competition. (16) This note will first examine the nutritional makeup of dairy milk, the research on dairy milk and the influence of such research on its labeling regulations, and the effects of milk product labeling on human health and perception. This note will investigate various Congressional enactments promoting dairy milk consumption such as the Dairy Production Stabilization Act of 1983. (17) Next, this note will compare the rise of plant-based milk and its financial impact on the dairy industry. (18) In analyzing whether plant-based manufacturers are misleading consumers, this note will discuss the dairy industry's own mislabeling and whether plant-based milks really are comparable to dairy milk in their constitution. The conclusion advocates for the continued labeling of plant-based drinks as "milk," rather than the proposed requirement of labeling these drinks as "imitation milk."
II. The Evolution of Dairy Milk Production
A. The Promotion of Milk's Nutritional Makeup by the FDA and the Dairy Industry
The FDA regulates milk and is the main food safety inspection agency of the United States government. (19) The FDA began in 1862 as a scientific institution, but did not acquire regulatory functions until 1906 with the passage of the Pure Food and Drug Act prohibiting interstate commerce of misbranded food. (20) Since 1968, the FDA has been responsible for working with state and municipal milk control authorities to assure safe milk supplies. (21) The FDA currently defines "milk" as the "lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows." (22) Though humans have been consuming dairy since as early as the fifth millennium B.C., dairy milk consumption did not amplify in the United States until the nineteenth century, as infant mortality rose in cities. (23) As a growing interest in nutrition emerged, so did the consumption of milk as a convenient source of protein, calcium, and vitamin B12. (24) Pasteurization practices emerged in an attempt to make milk consumption safer, and in 1987, the FDA required the pasteurization of all milk to prevent the spread of dangerous bacteria in raw milk responsible for diseases such as tuberculosis. (25) Milk soon became known as a staple of the American diet, with the United States Department of Agriculture's ("USDA") Dietary Guidelines consistently advocating for two to three daily servings of milk, yogurt, and cheese. (26)
The USDA introduced the first Food Guide Pyramid in 1992, serving as the official guide for recommended daily serving sizes and recommending two to three daily servings of the milk, yogurt, and cheese group. (27) The USDA's protein foods group includes nuts, seeds, and "processed soy products." (28) Variously processed forms of dairy milk as well as "calcium-fortified soymilk (soy beverage)" are also included in this group. (29) For those with lactose intolerance who are unable to digest lactose, the natural sugar found in milk, the FDA suggests drinking milk anyway so long as it is "lactose-free," stating that otherwise it may be necessary to take a dietary supplement with calcium to maintain bone health. (30)
The dairy industry, like the FDA, is adamant about promoting the health benefits of dairy. (31) Dairy farmers created the National Dairy Council in 1915 for the purpose of promoting the consumption of milk. (32) The National Dairy Council describes milk's "unique nutrient package" of nine essential ingredients, including calcium, protein, and vitamins A, D, and B12. (33) California dairy processors created the California Milk Processor Board in 1993 to increase milk consumption, largely through advertising campaigns such as the "got milk?" campaign beginning in 1995. (34) The importance of milk has been especially emphasized as a source of nutrients for infants unable to chew or digest solid foods, through advertisements such as those by milk giant Borden Dairy showing the tag line, "why more mothers choose Borden's Milk." (35)
B. The FDA's Approval of the Use of Genetically Altered Bovine Growth Hormone ("rBST" or "rBGH") on Dairy Cows and Antibiotics to Mitigate Associated Health Problems Seen in Treated Cows
Milk's increasing popularity led to the FDA's 1993 approval of genetically altered bovine growth hormone ("rBST" or "rBGH"), an engineered growth hormone injected into a lactating dairy cow to increase her milk production. (36) Cows supplemented with rBST require less feed per unit of milk produced, which is one reason the dairy industry considers rBST an efficient production tool. (37) Cows administered rBST show a ten to twenty percent increase in milk production, which is why rBST is administered to approximately one-third of the United States' 9.39 million dairy cows. (38)
Dairy companies mitigate the health risks in cows treated with rBST, namely a twenty-five percent increase in the frequency of udder infections, with antibiotics. (39) American farm animals consume twenty-eight million pounds of antibiotics per year; by comparison, Americans consume approximately seven million pounds of antibiotics per year to combat infection. (40) Additionally, a majority of antimicrobials used on farm animals are used nontherapeutically. (41) Due to concerns of developing resistance to antibiotics, in 1996, the FDA, USDA, and Center for Disease Control and Prevention ("CDC") created a partnership called the National Antimicrobial Resistance Monitoring System to analyze drug-resistant pathogens and animal products, and publish its findings each year. (42)
The FDA's Pasteurized Milk Ordinance governs the requirements for determining antibiotic residues in milk. (43) Lactating cows are supposed to receive antibiotics only when they are sick, since antibiotic residues appear in the treated cow's milk. (44) However, antibiotics are given to cattle as a preventative measure. (45) Additionally, the FDA routinely tests milk for only around four of the eighty-two drugs used to treat dairy cows, including various antibiotics, so it is possible for dairy farmers to use antibiotics that routine tests do not detect. (46)
In response to growing concerns regarding the methodologies involved in the industrialization of dairy, the FDA investigated the effects of such methodologies on human health in an effort to assure consumer safety. (47) The FDA cited a study in which rBST was orally administered to rats at one hundred times the daily dose administered to dairy cows to investigate whether absorption occurred. (48) The study influenced the FDA's confirmation that humans do not absorb "biologically significant" amounts of growth hormones, such as rBST, after drinking milk from cows treated with the hormones. (49) The FDA also considered studies that analyzed potential links between cow's milk treated with rBST and elevated links of insulin-like growth factor I ("IGF-I"), a naturally-occurring protein linked to several types of cancers when consumed in high quantities, and concluded that IGF-I concentrations in milk are not increased after rBST treatment. (50) The National Dairy Council is a large funder of nutritional research, which raises a potential issue of systemic bias favoring products made by the company funding the research. (51) Industry-funded studies are concerning because in many instances, nutritional research reaches conclusions favorable to its sponsor, even if scientifically inaccurate. (52) Furthermore, the Beverage Guidance Panel cites concerns about circulating concentrations of IGF-1 as a reason for recommending zero ounces per day of whole milk. (53)
C. The Nutrition Labeling of Dairy Milk Products and Its Effect on Dairy Milk Consumption and Consumers' Perception of Dairy Milk
In addition to its regulation of milk products, the FDA regulates milk labeling, and its lenient requirements allow milk producers to publicize milk as a vital aspect of the human diet, offering a nutrient package that no other source can offer. (54) In 1973, the FDA required that nutrition labeling be used for all products shipped in interstate commerce, and required the implementation of "extensive data collection programs" to complete nutritional research on which these labels would rely. (55) Despite budding health concerns regarding the use of genetically altered bovine growth hormones, the FDA declines to require any special labeling on milk treated with rBST, citing its finding of "no significant difference" in the 1993 study of rBST-treated milk versus untreated milk. (56) The FDA also recommends that lactose intolerant individuals should just consume milk labeled lactose-free, rather than avoid milk; however, the FDA has no definition for the labels "lactose-free" or "lactose reduced." (57)
The Dairy Production Stabilization Act of 1983 encourages the sale of milk by allowing producer-financed advertising to promote milk as a necessary aspect of a person's diet. (58) The California Milk Processor Board's first major success was the 1993 "Got Milk?" campaign featuring public figures, such as actor Brandon Routh as Superman and professional soccer player David Beckham, with milk mustaches. (59) The campaign emphasized milk as a vital source of calcium, and suggested that milk can give its consumer "bones of steel." (60) The "Got Milk?" campaign continues today with the new tagline "milk life," and a television commercial aired for the 2018 Winter Olympics stating "nine out of ten U.S. Olympians grew up drinking milk," helping the Olympians "grow strong." (61)
As the "Got Milk?" campaign surprisingly did not achieve an increase in milk consumption, advertisements began shifting towards a more focused message of milk as a vital source of protein. (62) General Mills created the famous Yoplait Light Yogurt advertisement telling consumers that three servings per day of the protein-rich drink would help them fit into the "itsy bitsy, teeny weenie, yellow polka dot bikini." (63) In 2005, in response to the advertisement, the Physicians Committee for Responsible Medicine ("PCRM") filed a petition with the FDA against eleven dairy trade associations and dairy product manufacturers for false and misleading advertising, after studies showed a lack of association between dairy consumption and weight loss. (64) The PCRM also filed a complaint with the Federal Trade Commission in 2005 to prevent the corporations from advertising that drinking milk helps with weight loss. (65)
In 2012, the National Milk Producers Federation and Dairy Management Inc. met and declared "fluid milk is in crisis." (66) Health concerns and an increase in alternative beverages such as juices, sports beverages, and energy drinks that also provide calcium and vitamin D dealt a substantial hit to dairy milk. (67) Dairy milk sales decreased $17.8 billion in 2015, and are projected to drop through 2020. (68) Perhaps the biggest threat to the dairy industry is the availability of nondairy milks, with almond milk sales increasing by 250% over the past five years. (69)
III. The Rise of Plant-Based Milk as an Alternative to Dairy Milk
Nondairy milks go by a variety of names, such as "plant-based milks", "soymilk", and "milk alternatives." (70) Some of the most popular plant-based milks include soymilk, almond milk, and coconut milk; the protein content varies depending on the type of plant-based milk, and most plant-based milks usually have added calcium and vitamins. (71) In 1999, the FDA authorized a health claim that consumption of 6.25 grams of soy protein per serving may reduce the risk of heart disease by lowering cholesterol levels. (72) Soy food intake is also associated with lower mortality and recurrence among breast cancer patients, as soy foods have phytoestrogens, which are natural estrogen receptor modulators. (73) This claim generated public interest in a country whose leading cause of death is heart disease, and led to the creation of new plant-based products. (74) In the 1990s, producers of plant-based milks such as Rice Dream and Silk Soymilk began selling their product refrigerated in typical milk cartons. (75) Almond milk has surpassed soymilk as the leading plant-based milk alternative, and is offering an increase of flavors and blends in response to consumer interest in healthy lifestyle choices. (76) Comparisons between dairy milk and almond milk show that 100 ml of dairy milk has over double the calories as 100 ml of almond milk, and less calcium. (77) Scientific evidence of the comparable nutrient levels of plant-based milk, along with research on the effectiveness of plant-based protein on muscle building, is contributing to the rise of the plant-based milk industry. (78)
Changes in food consumption over the past fifty years have been referred to as the "nutrition transition", associated with rising rates of cancer, cardiovascular disease, and obesity, as well as with a greater concern for the health of the environment. (79) Many consumers are reducing or eliminating animal products such as dairy from their diets, and selecting alternatives due to personal preference as well as concerns over animal and environmental welfare and human health. (80) Dairy milk consumption is declining, and patterns suggest that it will continue to fall. (81) The overall consumption of animal fats has also declined, which mirrors the increased consumption of vegetable oil alternatives. (82) Plant-based milk sales have increased by 3.1% since 2016, while dairy milk sales have decreased by approximately 5%. (83) As awareness increases about the various benefits of plant-based nutrition sources, more consumers are supporting plant-based milks. (84)
Dairy milk has long been advertised as a primary source of calcium, protein, and vitamin B12, but the Beverage Guidance Panel states that milk products could be replaced with soy-based products and items from other food groups; particularly fruits and vegetables, some of which are also good sources of calcium. (85) The Panel also suggests that essential micronutrients in milk products could be replaced by daily multivitamin mineral and calcium supplements. (86) Calcium supplements may be warranted for consumers who cannot get enough dietary calcium, but dietitians do not recommend calcium supplements over dietary sources. (87) Rather, dietitians and the U.S. Department of Agriculture specifically recommend fruits and vegetables as "one of the best choices for better health," due to the presence of many essential nutrients in produce. (88) Studies show that adequate calcium intake can reduce the risk of bone fractures, irrespective of whether the calcium comes from animal or plant-based sources. (89) Research findings have also suggested that patients on plant-based diets are generally not at risk for protein deficiency, because essential amino acids can be obtained by eating brown rice, beans, and hummus. (90) Further, high animal protein intake is associated with higher mortality rates and increased weight gain. (91) On the other hand, a 2015 study of the effects of high-fat cheese diets on cardiovascular risk markers in overweight postmenopausal women concluded that diets with cheese were associated with higher levels of "good" cholesterol and lower levels of "bad" cholesterol, suggesting that dairy products may be a unique source of such health benefits. (92) Vitamin B12 is a nutrient that is most abundant in animal-based foods such as dairy, but many plant-based milks are now fortified with vitamin B12. (93) Plant-based milk manufacturers advertise these health benefits on their product labels with phrases such as "50% more calcium than milk" on Ripple Foods pea protein milk, and "10g pea protein per serving" on Bolthouse Farms dairy-free milks. (94)
In comparing their products to dairy milk, consumers consider not only what plant-based milks have, but also what they lack. (95) Many plant-based milk varieties have fewer calories than milk, and none have animal fat or genetically engineered growth hormones such as rBST. (96) Despite its prevalent use in the dairy industry, rBST has not been properly tested apart from one study performed by Monsanto, the agricultural biotechnology corporation that created the growth hormone. (97) Studies have shown that levels of IGF-I are "substantially elevated and more bioactive" in milk treated with rBST, which is of concern as a growing body of scientific research shows that IGF-1 is a potential risk factor for various cancers. (98)
Plant-based milks also do not cause the same severe environmental impact as dairy milks. (99) One 2009 study comparing the environmental effects of vegetarian versus nonvegetarians diets concluded that nonvegetarian diets exact a higher cost on the environment than vegetarian diets. (100) Another study focusing on the environmental effects of the production of animal-based protein compared to plant-based protein had a similar conclusion, finding that the production of one kilogram of kidney bean protein required twelve times less fertilizer and ten times less pesticide than producing one kilogram of beef protein. (101) Similarly, coconut farming requires little fertilizer or pesticide due to coconut's thick husks and giant root systems that help prevent soil erosion. (102) Growing concerns over dairy milk and its impacts on human, animal, and environmental health are affecting consumers' choices, and plant-based manufacturers are providing more varieties of dairy alternatives to meet the increased demand. (103)
The plant-based foods industry represents over $3.5 billion in sales. (104) The acquisitions of plant-based manufacturers by corporations, such as Hormel Foods, reflect a growing interest in the trend toward dairy alternatives. (105) Tyson CEO, Tom Hayes, stated that plant-based protein is growing "almost ... a little faster than animal-based." (106) In California, many dairy farmers are converting their dairies into almond groves, citing the "economics for the trees have been very good." (107) Concerns over dairy milk's negative health effects along with the major investments of meat and dairy corporations in the plant-based market have influenced the projections of the plant-based industry's lasting success. (108) The dairy industry remains under pressure as the global non-dairy milk market reached $5.8 billion in 2014 and is predicted to reach $10.9 billion by 2019. (109)
IV. Whether Plant-Based Manufacturers' Products are Misbranded and Therefore Misleading Consumers
A. The "Imitation" Label Requirement and the Congressional Effort to Require Plant-Based Manufacturers to Re-Label Their Products
Congress members Peter Welch and Mike Simpson, along with thirty other members of Congress, requested that the FDA investigate the labeling on various plant-based milks in a letter to FDA Commissioner Robert Califf, M.D., dated December 16, 2016. (110) The letter began by discussing the plunge of milk prices since 2014 and comparing the decline of milk sales to the growth of the plant-based market. (111) The members of Congress then expressed concern over the effect on consumers of plant-based companies labeling their product as "milk" by citing to the definition of "milk" as listed in 21 C.F.R. Section 131.110 and claiming that the plant-based products do not meet this standard. (112) Finally, the members of Congress requested that the FDA investigate and take action against the manufacturers of such labeled products. (113)
Sections 301 to 392 of the Federal Food, Drug, and Cosmetic Act establish penalties for the misbranding of food, with section 343 laying out what deems a food "misbranded." (114) Section 343(c) of the Act states that a food shall be deemed "misbranded" if it is an imitation of another food, unless its label bears the word "imitation" immediately before the name of the food imitated. (115) At the Act's passage, however, no provision defined the term "imitation." (116)
In determining whether a product is an "imitation" under section 343(c), courts have taken into account factors such as similarities in taste, smell, and texture, rather than simply similarities in appearance. (117) Courts and common usage are in agreement that the word "imitation" suggests an inferior quality, or "watered-down version of the imitated item." (118) In 1973, the FDA promulgated a regulation to define "imitation," codified at 21 C.F.R. Section 101.3(e). (119) Section 101.3(e)(1) provides that a food shall be deemed an "imitation," and thus subject to the requirements of 21 U.S.C.S. section 343(c), if it is a substitute for and resembles another food but is nutritionally inferior to that food. (120)
The Act also states that a food is misbranded "if it purports to be or is represented as a food for which a definition and standard of identity has been prescribed ... unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard...." (121) However, consumer expectations and food varieties are evolving, and many statutory standards of identity have fallen behind. (122) For example, the FDA's standards of identity define noodles as "the noodle product the units of which are ribbon-shaped" and require that they contain egg. (123) "Macaroni" is defined as the noodle product "the units of which are tube-shaped and more than 0.11 inch but not more than 0.27 inch in diameter." (124) Despite this standard of identity, many manufacturers still label their products as "pasta" because the term is more universally understood as a ribbon-shaped or tube-shaped noodle product than a "macaroni product." (125) These labels arguably violate FDA regulations, but since "pasta" is apparently a common and usual name of such products, whether the term constitutes "misbranded" is not so certain. (126)
The present congressional effort follows numerous past petitions to the FDA, as well as lawsuits against plant-based manufacturers, requesting enforcement of these sections that discuss standards of identity for milk products. (127) In 2010, the National Milk Producers Federation ("NMPF") filed a petition alleging that the FDA's failure to enforce various labeling provisions has led to the "misappropriation of dairy terminology on imitation milk products." (128) In the years surrounding the NMPF's petition, there have been numerous challenges to the plant-based manufacturers' use of the term "milk." (129) In 1981, the NMPF challenged the FDA's interpretation of the Act's "imitation" provision as "otherwise inconsistent with the Act." (130) NMPF challenged the interpretation because it allowed dairy-free cheeses to be labeled as cheese "substitutes" rather than "imitations." (131) NMPF's challenge was unsuccessful, as the court held that so long as an agency's construction "has a reasonable basis in law and does not frustrate congressional policy," it will be upheld. (132)
Similar lawsuits have demonstrated a continued interest in the topic of dairy and plant-based labeling. (133) A lawsuit against Trader Joe's for misleading consumers was dismissed because the court found that Trader Joe's did not, by calling its products soymilk, attempt to pass off those products as the food that the FDA has standardized within the meaning of section 343(g). (134) The judge explained that the existence of a federal standard of identity for "milk [would] not categorically preclude a company from giving any food product a name that includes the word 'milk.'" (135) Rather, the standardization of milk simply means that a company cannot pass off a product as milk if the product does not meet the regulatory definition of milk as listed in 21 C.F.R. Section 131.110. (136) Further, the judge stated that the "reasonable consumer ... does not think soymilk comes from a cow." (137)
A court used the "reasonable consumer" test in dismissing a lawsuit alleging misbranding against Whitewave Foods Co., sellers of Silk brand plant-based beverages. (138) The plaintiffs claimed that the use of
the word "milk" would lead a consumer to confuse plant-based products for dairy products, but the court found this "highly improbable" because that logic would lead a reasonable consumer to believe "veggie bacon contains pork, that flourless chocolate cake contains flour, or that e-books are made out of paper." (139) Similarly, a class-action suit filed against Blue Diamond Growers, the makers of plant-based milk, for failing to label its almond milk as "imitation milk," was dismissed after the court found the plaintiff s claim of customer confusion "patently implausible." (140)
While the FDA has not addressed concerns from either the plant-based manufacturers or the dairy industry in recent years, interest in the topic continues to grow. (141) Chris Galen, the Senior Vice President of NMPF, says that the use of the term "milk" on a plant-based product leads to customer confusion. (142) Dean Foods, the largest processor and distributor of fluid milk in the United States, however, takes the position recognizing soymilk "to be accurately descriptive, meaningful and widely understood." (143) The dairy and plant-based milk industries are advocating for different solutions by the FDA, but agree that consumers would benefit from the FDA taking action clarifying its labeling standards. (144)
B. Plant-Based Milk Manufacturers Should Not Be Required to Label Their Products "Imitation" Because Plant-Based Milk Is Not Nutritionally Inferior to Dairy Milk
Plant-based milk manufacturers should not be required to advertise using the term "imitation" as found in 21 C.F.R. Section 101.3(e) because plant-based milk products are not nutritionally inferior to dairy milk. (145) Under Section 101.3(e)(1), a food shall be deemed an imitation if it is a substitute for and resembles another food, but is nutritionally inferior to that food. (146) However, Section 101.3(e)(2) states that a food that is a substitute for and resembles another food shall not be deemed to be an imitation if it is not nutritionally inferior, and its label bears a name that is not false or misleading. (147)
1. Plant-Based Milk Has Similar Nutritional Makeup to Dairy Milk, Despite Prevalent Misleading Dairy Advertising Alleging Dairy Milk's Health Benefits
In its letter to the FDA, Congress reasons that plant-based milks should be prohibited from being advertised as "milks" because they are "unable to match the nutritional makeup of the product they mimic." (148) However, many varieties of plant-based milks contain comparable levels of calcium and protein, with fewer calories than many dairy milks. (149) For example, 100 milliliters of almond milk provides more calcium and fewer calories than 100 milliliters of dairy milk. (150) The Beverage Guidance Panel acknowledges that soy-based products are good sources of calcium. (151) Additionally, comparisons of nutritional contents between variants of dairy milk and plant-based milks show that plant-based milks have similar levels of protein. (152) The USDA's group of protein foods includes beans and peas, processed soy products, nuts, and seeds, showing that dairy milk is not the only whole food source capable of providing adequate levels of protein. (153) Former dairy companies like Elmhurst, which have re-branded towards exclusive production of plant-based milks with the changing market, have touted the nutrition benefits of nutmilks compared to dairy milk in marketing materials. (154)
One of the largest consumer concerns regarding plant-based milks is whether they provide adequate levels of calcium and protein. (155) This unease is largely due to the dairy industry's incessant advertising that implies milk is the exclusive source of nutrients such as protein and calcium, and exaggerates the association between these nutrients and the benefits advertised. (156) The Dairy Production Stabilization Act of 1983 declares that dairy milk production plays a significant role in the nation's economy, and that the expansion of existing markets for dairy products is vital. (157) The Act declared the Congressional policy of promoting dairy milk with a program "designed to strengthen the dairy industry's position in the marketplace." (158) The dairy industry spends hundreds of millions of dollars on advertising; $150 million goes toward its "Got Milk?" campaign annually. (159) Both the National Dairy Council and the California Milk Processor Board were created to promote milk consumption; the National Dairy Council describes milk's "unique" nutrient package, while the California Milk Processor Board is the creator of the "Got Milk?" advertising campaign. (160)
The "Got Milk?" campaign focuses on promoting the importance of dairy milk for strong bones, due to its calcium content. (161) Research concludes that, on the contrary, the specific source of calcium is not the factor associated with the risk of bone fracture, but the calcium itself. (162) The World Health Organization has suggested, "to date, the accumulated data indicate that the adverse effect of protein, in particular animal (but not vegetable) protein, might outweigh the positive effect of calcium intake on calcium balance." (163) As milk is high in animal protein, these findings may suggest that the concern is the source of calcium, rather than the amount of calcium. (164)
The dairy industry also advertises dairy products as a tool for weight loss despite scientific evidence to the contrary. (165) Perhaps the most famous example is the General Mills television commercial suggesting that eating three servings per day of Yoplait Lite Yogurt can help fit the consumer into that "itsy bitsy, teeny weeny, yellow polka dot bikini." (166) The advertisement is supported by one study, which found that dieters who ate three daily servings of dairy lost approximately twice the body weight as dieters who did not eat three daily servings of dairy. (167) Researchers, however, caution the attribution of milk to slimming properties, because no long-term studies or studies without calorie restriction saw beneficial effect of increasing dairy consumption on body weight and fat loss. (168) Other independent research has reached similar conclusions regarding dairy consumption and its lack of effect on weight loss. (169)
The research that General Mills cited in its yellow polka dot bikini advertisement was a study led by Michael Zemel, who received $1,680,000 in research grants from the National Dairy Council and $275,000 from General Mills for his research on yogurt. (170) This study reached conclusions that contradicted the majority of existing evidence, to the benefit of sponsors, and is just one example of industry-funded research being at a higher risk of bias. (171) In response to these misleading advertisements, the Federal Trade Commission met with the National Fluid Milk Processor Promotion Board and the National Dairy Promotion and Research Board to discontinue advertising involving weight-loss claims. (172)
The proposition that dairy is a source of bone strength and weight loss is also at a risk of bias because the industry funds the research. (173) In 2016, an article in the journal of the American Medical Association's Internal Medicine revealed that in the 1960s, the sugar industry paid Harvard scientists to produce research downplaying the link between sugar and heart disease, and to instead shift the blame to dietary fat. (174) The payment was not disclosed at the time of the study's publication, and the sugar industry continued to fund similar research for the next decade. (175) This practice of industry-funded research is prevalent in many areas of nutrition, including dairy. (176)
The National Dairy Council makes donations to a number of nutritional organizations and researchers, such as the Academy of Nutrition and Dietetics (formerly the American Dietetic Association), comprised primarily of registered dietitian nutritionists, researchers, nurses, physicians, and other nutritional professionals. (177) The National Dairy Council has been a "top level sponsor" in the Academy's corporate Sponsorship program since 2007, which has given it prominent access to key influencers in the nutrition marketplace. (178)
The 2015 study of the effects of high-fat cheese diets on cardiovascular risk markers in overweight postmenopausal women concluded that diets with cheese as the primary source of saturated fat caused higher levels of "good" cholesterol compared to diets without cheese as the primary source of saturated fat. (179) This study was comprised of only fourteen subjects, and was fully funded by the dairy industry, included the Dairy Research Institute. (180) Evidence also exists that the study's diets were designed to draw the desired conclusions; the diets had extremely high contents of fiber, indicating a very "peculiar" selection of plant foods, the cheese diets were enriched with foods known to lower "bad" cholesterol, and the non-cheese diets were enriched with fatty acids that raise "bad" cholesterol. (181) This study is yet another example of industry-funded research on dairy's effect on human health that reaches conclusions favorable to the sponsor. (182)
While the Dairy Production Stabilization Act announces the congressional mission to assist the dairy industry in promoting its products as vital aspects of the American diet, the evidence the dairy industry' references to support its findings is often misleading to consumers. (183) A spokesperson for the National Dairy Council has stated that "because 73% of the calcium available in the food supply is provided by milk and milk products ... it is difficult to get recommended levels of calcium by consuming nondairy sources." (184) To determine how much calcium is available in a food supply, however, which is in a constant state of flux, each and every one of its constituents would have to be tested. (185) Furthermore, obtaining recommended levels of calcium is actually fairly easy due to an increase in the variety of available dairy-alternative products and calcium-rich non-dairy foods. (186) Calcium and protein remain essential nutrients to the human diet, but dairy milk is not the sole source of such nutrients. (187)
2. Plant-Based Milk Does Not Contain Dangerous Growth Hormones rBST and Antibiotics That Treat Infections Associated with rBST Treatment
One of the major attractions to plant-based milks over dairy milk is the absence of potentially dangerous growth hormones such as rBST given to cows; these growth hormones have not been subjected to proper health and safety studies, are associated with elevated levels of IGF-I, and increase the instances of infections for which the cows are given various antibiotics. (188) After discovering that rBST is an effective production tool, the FDA approved the injection of the growth hormone into cows despite unexplored links to various aggressive cancers. (189) The FDA based this approval on a study that found "no significant difference" between milk derived from cows treated with rBST and untreated cows, and declined to even require special labels for milk treated with rBST. (190) The FDA misled the public about the purportedly unconcerning findings of this study. (191) Biotechnology corporation Monsanto, the developers of rBST, conducted the unpublished ninety-day study on adult rats and concluded that no toxicologically significant changes were seen in the rats treated with rBST. (192) An investigation of this study, conducted by Health Canada staff, revealed that twenty to thirty percent of rats in the high dose rBST group developed primary antibody responses to the hormone, which suggests that the hormone was actually absorbed into the bloodstream. (193) These findings, as well as the study's finding of cysts on the thyroid in some of the rats, are toxicologically significant changes that should have led the FDA to require the normal human safety toxicological assessment, which would have included assessment of potential carcinogenic and immunological effects. (194) Not only did the FDA decline to take this appropriate action, it also failed to even mention the existence of these findings in its article explaining its approval of rBST. (195)
The blood of rBST-treated cows contains ten times the levels of the hormone IGF-I than the blood of untreated cows. (196) Concentrations of IGF-I increased in the milk of cows after being treated with rBST. (197) Increased levels of IGF-I has been shown to be a risk factor for cancers such as breast cancer, prostate cancer, and gastrointestinal cancer. (198) For example, one study found that eating a plant-based diet can improve cancer defenses in just two weeks due to the decreased levels of IGF-I in plant-based diets as compared to diets containing animal protein. (199) Dr. Burroughs, the lead veterinary scientist for the FDA's Center for Veterinary Medicine, recommended further assessment of rBST after the Health Canada study found significant absorption of rBST and toxicity to the subject rats; Dr. Burroughs was fired by Center for Veterinary Medicine director Dr. Guest, who said that Dr. Burroughs was "slowing down his approval process". (200)
Another human health risk of dairy milk treated with rBST is that treated cows more frequently develop infections such as mastitis, an infection of the udder that requires antibiotic treatment. (201) The scientific community has expressed concerns that this treatment may lead to antibiotic residue in milk, which could ultimately lead to antibiotic resistance in humans. (202) The United States' estimated hospital and societal costs of antibiotic resistance are anywhere from $10.7-$15.0 million. (203) The CDC reports that over two million Americans develop antibiotic-resistant infections each year, and at least 23,000 die as a result of these infections. (204)
Although antibiotic resistance can occur naturally, it also occurs due to human actions such as the creation of industrialized animal agriculture. (205) Eighty percent of antibiotics sold in the United States are used on animals, and of those, eighty percent are administered to healthy animals as a preventive treatment and to promote growth. (206) The Institute of Medicine estimated that about half of the 31.9 million pounds of all antimicrobials consumed in the U.S. in 1989 were for nontherapeutic use in farm animals. (207) In fact, current standard recommended practice is to infuse antibiotics into dairy cows to help prevent mastitis, despite the CDC's recommendation that antibiotics be given to farm animals only to manage and treat infectious diseases, not to promote growth. (208) Antibiotics are administered to dairy cows to efficiently produce milk to keep up with a growing population, but research on the dangers and extent of associated risks of antibiotic resistance is still largely unexplored. (209)
Despite human health concerns, the FDA maintains that dairy milk is safe because of regulations that require the inspection of milk for antibiotic residues. (210) In the interest of preventing antibiotic resistance, the FDA or one of its regulatory agencies tests all milk shipments for six of the most widely used antibiotics, and products that test positive are rejected. (211) An FDA report from March 2015 reveals, however, that many farmers are using antibiotics that routine tests are not meant to detect. (212) Over one percent of the samples from the FDA's "targeted" group and 0.4 percent of the randomly collected samples contained drug residues; while these percentages seem small, these results are alarming because none of the drugs that the FDA detected are approved for use in lactating dairy cows. (213) The FDA only tests for six of the most widely used antibiotics. (214) Undetected contamination from antibiotics contributes to concern over the human health risks involved in consuming dairy milk. (215)
In their letter asking the FDA to prevent the plant-based milk industry from advertising with the term "milk," the members of Congress rely on the argument that plant-based milks are nutritionally inferior to dairy milk. (216) Plant-based milks, however, are nutritionally comparable to dairy milk because plant-based milks contain similar levels of calcium and protein, the major nutrients in dairy milk, and many plant-based milks offer fewer calories per serving. (217) Furthermore, the association between dairy milk and health benefits such as bone health and weight loss is grossly exaggerated by dairy advertisements that rely on potentially biased industry-funded research. (218) Additionally, plant-based milks are not treated with growth hormones or antibiotics and the absence of these chemicals contributes to the nutritional value of plant-based milks because they do not have increased levels of IGF-I or undetected antibiotic residues. (219)
C. Plant-Based Milk Manufacturers Should Not Be Required to Label Their Products "Imitation" Because Plant-Based Milks Are Not Purporting To Be Dairy Milk
Plant-based milk manufacturers should not be required to advertise using the term "imitation" as found in 21 C.F.R. [section] 101.3(e) because the plant-based milk products do not purport to be dairy milk. (220) Both the courts and common usage hold that "imitation" suggests a product with an inferior quality trying to pass itself off as another product; plant-based milks do not meet this definition because they have comparable nutritional makeups to dairy milks, without hormones and antibiotics and often with fewer calories, and the plant-based industry is not attempting to pass off its products as dairy milk. (221)
The purpose for the imitation requirement is not to protect industries, but to protect consumers from deception. (222) Voices from the dairy industry itself have admitted that the plant-based industry's use of the term "milk" is not misleading; George Muck, Vice President of Research and Development at milk giant Dean Foods, stated that as a dairy food processor, "[w]e have not found this term to be misleading to ourselves or our customers, [and we] have not received any complaints from customers or consumers regarding this issue." (223) Plant-based milk products do not use images of cows, goats or other exclusively dairy-related illustrations, and courts have already held that the "reasonable consumer" does not believe that soymilk comes from a cow. (224)
Furthermore, the plant-based milk products' various names alone alert consumers to the type of product they are purchasing; the products are not named "milk" or "dairy milk," but rather "Silk Soymilk," "Silk Almond," "Rice Dream," and "Almond Breeze," for example. (225) If the consumer is concerned about the specifics of a product's nutritious qualities, he or she can simply read the nutrition label. (226) Plant-based milks are not purporting to be a product for which they do not meet the statutory definition or nutritional makeup, nor are they hiding their actual composition. (227)
The dairy industry's past challenges to plant-based milks being called "substitutes" rather than "imitations" have been unsuccessful, as have its claims that plant-based milk labeling misleads consumers. (228) For example, the court in Coffee-Rich Inc. held that a product containing no milk ingredients and one that is a distinctive new product, with uses similar to milk products, need not be labeled as an imitation milk product. (229) Moreover, plant-based milk advertisements should be allowed to use the term "milk" because the existence of a federal standard of identity for a term does not categorically preclude a company from giving a product a name that includes such a term. (230) As consumer expectations and food choices evolve, many statutory standards of identity have become obsolete. (231) Standards of identity help prevent companies from attempting to pass off a product as something for which it does not meet the regulatory definition. (232) Since the manufacturers of plant-based milks are not trying to pass off their products as milk as defined in 21 C.F.R. Section 131.110, they should not be barred from simply using the word "milk" in various product names.
The FDA should not require plant-based milk producers to advertise using the term "imitation" as found in 21 C.F.R. Section 101.3(e) because these products are not nutritionally inferior to dairy milk and do not purport to be dairy milk. (233) While the congressional letter of December 2016 claims that plant-based milks are nutritionally inferior, they in fact contain comparable quantities of nutrients found in dairy milk without the antibiotic residues and growth hormones such as rBST, the safety testing of which remains largely incomplete and inconclusive. Additionally, plant-based milks do not purport to be dairy milk by including the word "milk" in many of their names; the plant-based manufacturers specifically advertise their products as healthy plant-based alternatives to animal-derived milks. (234)
The congressional letter to FDA Commissioner Califf begins with a plea to help dairy farmers experiencing a "serious financial crisis." (235) Though the dairy industry is experiencing cuts in income, its depressed prices cannot simply be attributed to the alleged mislabeling of plant-based milks; surveys show that primary reasons consumers are buying fewer dairy products are not because they are relying on an allegedly misleading plant-based label, but because of human health concerns such as the presence of artificial growth hormones. (236) The fact that consumers are seeking out dairy alternatives lends support to the argument against the congressmen's allegation that plant-based manufacturers are "profiting] from the 'milk' name." (237) Recent court holdings that no reasonable consumer could confuse plant-based milks with dairy milks also reflect the reality that buyers of plant-based milks are specifically choosing alternatives to dairy-based milks. (238) The members of Congress end their letter with a brief concern for human health, arguing that milk has a "unique" nutritional value that plant-based consumers may be missing. (239) In the current food market, however, there are many different adequate sources of vitamins and minerals, including calcium and protein, besides dairy milk. (240)
Much like the Congressional letter to the FDA Commissioner, the dairy industry puts economics first with human health as an afterthought. Independent scientific evidence has shown that the research the dairy industry relies on in marketing its products is misleading and at times, false. Investments of dairy corporations in plant-based milks are often accompanied with an acknowledgment of plant-based milks as "just as nutritious," showing conflicting opinions even within the dairy industry over whether plant-based milks are "imitations" under 21 C.F.R. Section 101.3(e). (241) Plant-based milks are not imitations under Section 101.3(e); they are not nutritionally inferior products purporting to be dairy milk. For these reasons, the FDA should allow plant-based milk producers to continue advertising their products using the word "milk" because their labels do not constitute "misbranded" under the Federal Food, Drug, and Cosmetic act [section] 343(c).
Giuliana D'Esopo (1)
(1) J.D. Candidate, Suffolk University Law School, May 2019; B.A., Roger Williams University, 2016. Ms. D'Esopo may be contacted at firstname.lastname@example.org.
(2) Michael Pollan, No Bar Code, MOTHERJONES (May 1, 2006), http://michaelpollan.com/articlesarchive/no-bar-code/. Virginia farmer, Joel Salatin, discussed how the "mainstream" of industrial food is starting to split into movements with focuses on organic, and sustainable foods, or in his words, "smaller groups of like-minded people." Id.
(3) Letter from Mike Simpson and Peter Welch, Members of Congress to The Hon. Robert M. Califf, Comm'r, FDA (Dec. 16, 2016) (on file with author). The members of Congress cite the standard of identity for milk found at 21 C.F.R. [section] 131.110 as "the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows." Id. The members of Congress allege that because plant-based products do not meet this standard of identity, they are unable to match the nutritional makeup of milk. Id.
(5) ALISSA HAMILTON, GOT MILKED? 135 (2015) (recounting the historical consumption of milk products as a "luxury").
(6) DAVID ROBINSON SIMON, MEATONOMICS: HOW THE RIGGED ECONOMICS OF MEAT AND DAIRY MAKE YOU CONSUME TOO MUCH 59 (2013). Recombinant bovine growth hormone ("rBGH") may commonly be known as recombinant bovine somatotropin ("rBST"). Id. The FDA declined to require special labeling on rBST-treated milk after finding "no significant difference" in treated versus untreated milk. Id.
(7) Susan E. Hankinson & Eva S. Schernhammer, Insulin-Like Growth factor and Breast Cancer Risk: Evidence from Observational Studies, 17 BREAST DISEASE 27, 37 (2003). Though there is an ample amount of published data regarding the links of various hormones to various cancers, such as prostate, colorectal, and breast cancer, some existing studies have limitations. Id. Limitations include study size and design. Id. The limitations to existing studies prevent the ability to draw firm conclusions from published data. Id.
(8) See Colleen De Bellefonds, 7 Foods with More Calcium than a Glass of Milk, WOMEN'S HEALTH (Nov. 23, 2016), https://www.womenshealthmag.com/food/foods-with-more-calcium-thanmilk. Milk contains three hundred milligrams of calcium per serving. Id. There are many calcium-rich foods that provide higher calcium contents, such as firm tofu (861 milligrams of calcium per cup), salmon (340 milligrams of calcium per six-ounce serving), sardines (370 milligrams of calcium per three-ounce serving), chickpeas (315 milligrams of calcium per one and a half cup serving), and dark leafy greens, such as a mixture of kale and turnip greens. Id.
(9) See generally MILK LIFE, https://www.milklife.com (last visited Apr. 10, 2019). Famous "Got Milk?" advertisements featuring athletes, actors, and other public figures wearing milk mustaches often included taglines associating dairy milk with strong bones. Id. Many of the "Got Milk?" advertisements also state that three glasses of milk per day will provide the calcium necessary for growing bones. Id.
(10) See Amy J. Lanou et al., Calcium, Dairy Products, and Bone Health in Children and Young Adults: A Reevaluation of the Evidence, 115 PEDIATRICS 115, 736, 739 (2005).
(11) See SIMON, supra note 6, at 198-99 (discussing the advantages of nondairy milk over dairy milk); see also Original Soymilk, SILK, http://www.silk.com/products/original-soymilk (last visited Apr. 10, 2019) (listing eight grams of soy protein and fifty percent more calcium than dairy milk); The future of Milk,, BOLTHOUSE FARMS, https://www.bolthouse.com/products/beverages/plantprotein-milk/ (last visited Apr. 10, 2019) (advertising its pea protein milks as containing 10 grams of protein per serving).
(12) The DAIRY PRIDE Act, S. 130, 115th Cong. (2017). The purpose of the DAIRY PRIDE Act is to "protect the integrity of dairy products by enforcing existing labeling requirements." Id. Specifically, the Act would prevent plant-based manufacturers from using terms such as "milk." Id.
(13) See id; see also Jeff Merman, Saving U.S. Dietary Advice from Conflicts of Interest, 65 FOOD & DRUG L.J. 285, 295 (2010). Members of the Committee can choose whether to rely on certain science in order to justify their desired outcomes. Id. at 297. In 2005, the Committee cited discussions of the health benefits of fruits and vegetables to justify the Committee's recommendations for those foods; however, the recommendations contained no discussion of research on the health consequences of eating raw meat. Id. at 291, 297. Since the research would show the association between meat consumption and risk of chronic diseases, by ignoring the research, the Committee may reach its desired conclusions. Id. at 291-92. Additionally, scientists conducting these clinical studies are more likely to favor the scientists' supporting industries. Id. at 296.
(14) See supra note 3; see also Americans Are Nuts for Almond Milk, NIELSEN COMPANY (Mar. 31, 2016), http://www.nielsen.com/us/en/insights/news/2016/americans-are-nuts-for-almondmilk.html.
(15) Press Release, Dean Foods Co., Dean Foods and Good Karma Foods Strike Investment and Distribution Deal to Accelerate Brand Growth (May 5, 2017) (on file with author). Dean Foods is the largest processor of dairy milk in the United States. Id. Its products include TruMoo, Friendly's, Garelick Farms, LAND O'LAKES, and Meadow Gold. Id. Good Karma is a Boulder-based independent company and the leading producer of flaxseed-based milk and yogurt alternatives. Id. In 2012, Good Karma created a flax-based dairy milk alternative and has since launched flax-based milks with added protein, as well as dairy-free yogurts. Id. Dean Foods CEO Ralph Scozzafava describes the opportunity as a way for Dean Foods to "build a platform for a larger plant-based portfolio." Press Release, Dean Foods Co. supra. Scozzafava refers to Good Karma as a fast-growing and high potential brand. Id. Scozzafava stated that Good Karma fit with Dean Foods' focus on "diversification both within and beyond dairy." Id. The partnership will give Dean Foods the opportunity to make flax-based non-dairy products more accessible. Id.
(16) See infra Part II. A. (discussing promotion of milk's nutritional makeup by FDA and dairy industry).
(17) See Dairy Production Stabilization Act of 1983, 7 U.S.C. [section][section] 4501-4514 (2006) (authorizing national producer program for dairy product promotion and research to increase consumption). The Act declares the congressional policy of promoting dairy products through the authorization of a procedure for financing a program of promotion "designed to strengthen the dairy industry's position in the marketplace." Id.
(18) See infra Part III.
(19) See Daniela Galarza, USDA vs. FDA: What's the Difference? eater (Mar. 24, 2017), https://www.eater.eom/2017/3/24/15041686/fda-usda-difference-regulation. The FDA regulates all processed foods created and sold in the United States. Id.
(20) See Wallace F. Janssen, The Story of the Laws Behind the labels, FDA CONSUMER 1, 4-5 (June 1981) [hereinafter Janssen Overviews], https://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm (explaining influence of chemist, Dr. Wiley, in crusading for truthful food labeling).
(21) See Wallace F. Janssen, The Story of the Laws Behind the Labels, FDA (June 1981), [hereinafter Janssen Evolving Powers], https://www.fda.gov/downloads/AboutFDA/History/FOrgsHistory/EvolvingPowers/UCM5 93437.pdf.
(22) 21 C.F.R. [section] 131.110 (2018).
(23) See Mark S. Copley et al., Direct Chemical Evidence for Widespread Dairying in Prehistoric Britain, 100 PN AS 1524, 1527 (2003). Evidence of the processing of dairy products has been found by studying absorbed organic residues from pottery from as early as the fifth millennium B.C. Id. See also DEBORAH V A LENZE, MILK: A LOCAL AND GLOBAL HISTORY 295 (2011). Even as milk consumption rose in the nineteenth century, it mainly occurred in the United States and Europe, and it was considered a luxury. See id.
(24) See generally USDA Food Composition Databases, U.S. DEP'T AGRIC, (Sept. 27, 2018) https://ndb.nal.usda.gov/ndb/search/list. The USDA's Food Composition Databases website allows consumers to enter terms such as "milk" and view the nutritional makeup of the product, such as approximate amounts of nutrients, including calcium, vitamins, lipids, and cholesterol per 100 grams. Id. One result that comes up after entering the term "milk" includes "[m]ilk, lowfat, fluid, one percent milkfat, with added nonfat milk solids, vitamin A and vitamin D." Id. A consumer can click on this product and obtain detailed information about its nutritional makeup, such as the fact that it has 3.48 grams of protein per 100 grams, 128 milligrams of calcium per 100 grams, and 0.38 micrograms of vitamin 1312 per 100 grams. Id.
(25) See 21 C.F.R. [section] 1240.61 (2018). Pasteurization requires that every particle of milk and milk product be heated in properly designed and operated equipment to one of the temperatures in the table provided by the statute, and held continuously at or above that temperature for at least the corresponding time specified in the table. Id. See, e.g., VALENZE, supra note 23; The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk, FDA (2012), https://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079516.htm.
(26) See U.S. DEP'T AGRICULTURE, DIETARY GUIDELINES ADVISORY COMMITTEE REPORT OF THE DIETARY GUIDELINES ADVISORY COMMITTEE ON THE DIETARY GUIDELINES FOR AMERICANS (1990); see also National Nutrition Monitoring and Related Research Act of 1990, Pub. L. No. 101-445 (codified at 7 U.S.C. [section][section] 5301-5342) (2009). The Act requires the U.S. Departments of Health and Human Services and the USDA to publish a report of nutritional and dietary guidelines every five years. See id. Study Explores Why Consumers Choose Dairy Milk or Plant-based Alternatives, KERRY HEALTH & NUTRITION INST., [hereinafter KERRY HEALTH & NUTRITION INST], https://khni.kerry.com/news/articles/study-explores-why-consumers-choose-dairy-milkor-plant-based-alternatives/ (last visited Apr. 10,2019). This study asked 999 participants questions to determine why consumers chose dairy milk or plant-based milks. Id. One reason for consuming plant-based milk was the goal of consuming fewer animal products. Id. A reason for consuming dairy milk included the perception of dairy milk as a staple food item. Id.
(27) See U.S. DEP'T AGRIC, Food Guide Pyramid (2005) [hereinafter Food Guide Pyramid], https://www.cnpp.usda.gov/FGP. The bottom layer of the Food Guide Pyramid suggests six to eleven daily servings of the bread, cereal, rice, and pasta group. Id. The next layer is split between the fruit group, with two to four recommended daily servings, and the vegetables group, with three to five recommended daily servings. Id. The Department of Agriculture recommends two to three daily servings from the milk, yogurt, and cheese group, as well as three daily servings from the meat, poultry, fish, dry beans, eggs, and nuts group. Id. Fats, oils, and sweets comprise the top of the Food Guide Pyramid, with the recommendation to "use sparingly." Id.
(28) HAMILTON, supra note 5, at 92-93.
(29) See id. (describing USDA's guidelines as heavily biased toward dairy consumption).
(30) See Problems Digesting Dairy Products?, FDA, https://www.fda.gov/forconsumers/consumerupdates/ucm094550.htm (last updated Apr. 10, 2019). A senior health promotion officer, in the FDA's Division of Drug Information, notes that lactose intolerance is not the same as a milk allergy. Id. Lactose intolerance, rather, is a discomfort, so the FDA suggests that people who experience trouble digesting lactose can "learn" which dairy products they can eat without discomfort. Id. The FDA recommends those with lactose intolerance should consume dairy products lower in lactose, consume dairy products in small amounts, or consume milk or other dairy products with other foods. Id.
(31) See infra notes 32-34 and accompanying text (reviewing two of the largest dairy industry organizations and how they promote dairy consumption). The National Dairy Council and the California Milk Processor Board are two large organizations that promote dairy consumption. See infra notes 32-34.
(32) See HAMILTON, supra note 5, at 11 (describing how National Dairy Council promoted health benefits despite foot-and-mouth disease outbreak).
(33) Id. at 3, 6 (exposing fallacy that milk is essential source of these nine nutrients).
(34) See History of Cow's Milk from the Ancient World to the Present, PROCON.ORG (last updated July 10, 2013, 4:53 P.M.), https://milk.procon.org/view.timeline.php?timelineID=000018.
(35) See Simon, supra note 6, at 193; see also Borden, BORDEN DAIRY COMPANY, https://www.bordendairy.com/ (last visited Apr. 10, 2019). The famous Borden's Milk advertisement features a baby holding a cup of milk, and states, "everybody knows that milk is good for children." Id.
(36) See Bovine Somatotropin, FDA, https://www.fda.gOv/AnimalVeterinaty/SafetyHealth/ProductSafetyInformation/ucm055435.h tm (last updated Aug. 21, 2018); see also SIMON, supra note 6, at 59.
(37) Dale Bauman, Facts About Recombinant Bovine Somatotropin, DEP'T ANIMAL SCI., CORNELL UNIV., https://ansci.cals.cornell.edu/sites/ansci.cals.cornell.edu/flles/shared/documents/Recombinant %20Bovine%20Somatotropin_v3.pdf (last visited Apr. 10, 2019) (attributing increased milk efficiency to additional feed nutrients).
(38) See Christina Cusimano, Comment, RBST, It Does a Body Good: RBST labeling and the Federal Denial of Consumers' Right to Know, 48 SANTA CLARA L. REV. 1095, 1099 (2008see also Number of Milk Cows in the United States 1999-2017, STATISTA, https://www.statista.com/statistics/194934/number-of-milk-cows-in-the-us-since-1999/ (last visited Apr. 10, 2019). There are an average number of around nine million dairy cows in the United States, the number of which has increased nearly each year since 2010. Id.
(39) See generally About rBGH, CTR. FOOD SAFETY, https://www.centerforfoodsafety.Org/issues/1044/rbgh/about-rbgh# (last visited Apr. 10, 2019) (describing significant health problems among cows treated with rBGH).
(40) See SIMON, supra note 6, at 104; see also Monica Wadsworth, Antibiotic Resistance--A Complex Issue and Serious Threat, MILKPRODUCTION.COM (Apr. 8, 2014), http://www.milkproduction.com/Library/Editorial-articles/Antibiotic-resistance--acomplexissue-and-serious-threat/ (discussing the causes of antibiotic resistance). Researchers anticipate that the number of antimicrobials fed to u.s. livestock will increase sixty-seven percent by the year 2030. See Lydia Zuraw, Scientists Model Global Trends in Animal Antibiotic Use, FOOD SAFETY NEWS (Mar. 23, 2015), http:// www.foodsafetynews.com/2015/03/ scientists-model-globaltrends-in-animal-antibiotic-use/#.WGPbv7YrLVo.
(41) See Timothy F. Landers et al., A Review of Antibiotic Use in Food Animals: Perspective, Policy, and Potential, 127(1) PUB. HEALTH REP. 4, 6 (2012). "[O]f 17.8 million pounds of antimicrobials used for animals, only 3.1 million pounds are used nontherapeutically." Id. There are twelve classes of antimicrobials that may be used at different times in the life cycle of poultry, cattle, and swine.
(42) See SIMON, supra note 6, at 105; see also The National Antimicrobial Resistance Monitoring System, FDA, https://www.fda.gov/animalveterinary/safetyhealth/antimicrobialresistance/nationalantimicrobi alresistancemonitoringsystem/ (last updated Sept. 14, 2018); U.S. DEP'T HEALTH & HUMAN SERVS., ANTIBIOTIC RESISTANCE THREATS IN THE UNITED STATES (2013), https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Each year in the U.S., at least two million people acquire antibiotic resistant bacterial infections. Id. at 11. At least 23,000 people die each year as a result of these infections. Id. Complete antibiotic resistance would cause once treatable infections and injuries to lead to death, and would render most surgeries "too dangerous to perform" due to likely post-operation infections. See Julia Belluz, Congress Could Help Solve Antibiotic Resistance. This Congresswoman Explains Why It Won't, Vox (Feb. 28, 2015), https://www.vox.com/2015/2/28/8122143/louise-slaughter-antibiotic-resistance. Representative Louise Slaughter, the only microbiologist in Congress, introduced the Preservation of Antibiotics for Medical Treatment Act, citing concerns of antibiotic-resistant infections in humans. Id. For new drugs, the bill would amend the Federal Food, Drug, and Cosmetic Act to require the approval of new "medically important" antimicrobials only where the applicants can demonstrate with reasonable certainty that the drug is not harmful to human health "via antimicrobial resistance resulting from its non-therapeutic use." Preservation of Antibiotics for Medical Treatment Act, H.R. 1552, 114th Cong. (2015).
(43) See "Grade A" Pasteurised Milk Ordinance, FDA 1, 28 (2015). The Ordinance provides model rules regarding the inspections of milk facilities to assure proper pasteurization. Id. In the case of a violation, the Regulator)' Agency is required to prevent further movement of such milk. Id.', see also Danny Hakim, At Hamburger Central, Antibiotics for Cattle That Aren't Sick, N. Y. TIMES (Mar. 23, 2018), https://www.nytimes.com/2018/03/23/business/cattle-antiobiotics.html. In addition to concerns of resistant disease strains, microbiologists are worried that the prolific use of antibiotics causes a "chaotic impact" on microbes in the human gut, as well as creating a problem of cross-resistance, involving other important drugs used in human medicine. Id.
(44) See Dan Charles, PDA Tests Turn Up Dairy Farmers Breaking the Law on Antibiotics, NAT'L. PUB. RADIO (Mar. 8, 2015, 3:02 ET), http://www.npr.org/ sections/thesalt/2015/03/08/391248045/ fda-tests-turn-up-dairy-farmersbreaking-the-law-on-antibiotics (finding that farmers using antibiotics to disguise illegal drug residues found in milk).
(45) See Hakim, supra note 43. The ways in which cattle are raised for human consumption cause them to develop health complications they would not likely see in other, less industrial settings. Id. Cattle are "fattened up" on corn and grain, but because they naturally eat grass, their time on feedlots causes them to develop liver abscesses and intestinal disease. Id. Antibiotics are regularly given to control such complications. Id.
(46) See Warren E. Leary, Report to Congress Opposes Synthetic Horn/one in Cows, N. Y. TIMES (Aug. 11, 1992), http://www.nytimes.com/1992/08/11/us/report-to-congress-opposes-synthetichormone-in-cows.html; see also Charles, supra note 44. It is possible for antibiotics to go undetected in milk shipments due to the use of antibiotics for which there are no tests, as they are not supposed to be used on dairy cows at all. Id.
(47) See Bovine Somatotropin, FDA, https://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055435.h tm (last updated Aug. 21, 2018) (stating Bovine Somatotropin is animal drug given to increase milk production tested before human consumption).
(48) See Report on the Food and Drug Administration '.r Review of the Safety of Recombinant Bovine Somatotropin, FDA, https://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetv'Information/ucm 130321.h tm (last updated Oct. 27, 2017) (determining that food products treated with hormones approved and considered safe for consumption by humans).
(49) See id. (stating there is essentially no risk for consumers who drink milk from rbG H-treated cows).
(50) See id.-, see also Int'l Dairy Foods Ass'n v. Boggs, 622 F.3d 628, 636 (6th Cir. 2010). The FDA approved the use of rBST after finding "no significant difference" between milk from cows given rBST and cows not given rBST. Id. at 633. However, a "compositional difference" does exist between milk from cows given rBST and cows not given rBST, as rBST has been associated with higher levels of a natural hormone that, in high levels, is linked to several types of cancers such as ovarian cancer and prostate cancer. Id. But see MICHAEL GREGER, HOW NOT To DIE 180 (2015). One study followed a group of approximately 30,000 women with no history of breast cancer over the course of seven years. Id. The study compared the blood cells of women on plant-based diets to the blood cells of women not on plant-based diets. Id. Researchers dripped the blood of the women before, and fourteen days after, beginning a plant-based diet. Id. The blood dripped after beginning the plant-based diets killed twenty to thirty percent more breast cancer cells than the blood dripped from the same women just fourteen days before. Id. The researchers attributed this difference to a decrease in IGF-I, likely due to the womens' reduced intake of animal protein. Id.; Cusimano, supra note 38; CG Prosser et al., Increased Secretion of Insulin-Like Growth Factor I into Milk of Cows Treated with Recombinantly Derived Bovine Growth Hormone, 56 J. dairy Res. 17, 20 (1989).
(51) See Joel Lexchin et al., Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review, 326 BMJ 1167, 1170 (2003) (showing industry-funded research more likely to reach conclusions favorable to sponsor).
(52) See Radio Interview with Michael Jacobson, Ph.D., CTR. FOR SCI. IN THE PUB. INTEREST (Sept. 17, 2016) (revealing sugar industry paid Harvard scientists to reach false favorable conclusions); see also Lenard Lesser et al., Relationship Between Funding Source and Conclusion Among Nutrition-Related Scientific Articles, 4 PLOS MED. 0041, 0042 (2007).
(53) See GREGER, supra note 50, at 379. Barry Popkin, Ph.D. assembled the Beverage Guidance Panel comprised of five nutritional scholars to provide nutritional recommendations for various beverages in response to unhealthy weight patterns developing in the United States. Id. Beverage categories are ranked on a six-tier scale from best to worst. Id. The Panel cites concerns about links between milk and various cancers such as prostate cancer and ovarian cancer. Id. See also Barry M. Popkin, et al., A New Proposed Guidance System for Beverage Consumption in the United States, 83 AM. J. CLINICAL NUTRITION 529, 535 (2006).
(54) See FDA, GUIDANCE FOR INDUSTRY: FOOD LABELING GUIDE (Jan. 2013), https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ LabelingNutrition/ucm2006828.htm. The Federal Food, Drug, and Cosmetic Act is one of the federal laws governing food products. Id.; see generally SIMON, supra note 6, at 21, 56. The FDA and the USDA split food labeling dudes in complicated ways. SIMON, supra note 6, at 21, 56. The FDA is responsible for seafood and the USDA is responsible for meat and poultry. Id. The FDA is also responsible for products containing three percent or less meat. Id.; see also MILK LIFE, supra note 9 (providing "Got Milk?" advertisements advocating for drinking three glasses of milk daily for adequate calcium).
(55) See Richard Farrow, Nutrition labeling 37 J. MILK, FOOD TECH. 17, 19 (1974) (considering data from compilations like USDA Handbook Number 8 unsatisfactory basis for nutrition labeling).
(56) See SIMON, supra note 6, at 59.
(57) See Problems Digesting Dairy Products?, FDA (Mar. 4,2009), https://www.fda.gov/forconsumers/consumerupdates/ucm094550.htm. Thirty to fifty million Americans are lactose intolerant, or unable to digest the natural sugar found in milk and other dairy products known as lactose. Id. The FDA's advice for these people is to learn which dairy products they can eat without discomfort, because lactose intolerance is not the same as a milk allergy. Id.
(58) See Dauy Production Stabilization Act of 1983, 7 U.S.C. [section][section] 4501-4514 (1983) (authorizing national producer program for dairy product promotion and research to increase dairy consumption); see also Food, Agriculture, Conservation, and Trade Act of 1990 [section] 2830, Title XIX, Subtitle H (1990) (citing milk as a primary source of required nutrients such as calcium).
(59) See Jeff Goodby, 20 Years of 'Got Milk?', AD WEEK (Oct. 25, 2013), https://www.adweek.com/creativity/20-years-got-milk-153399/; see also Stars Who've "Got Milk?", CBS NEWS, https://www.cbsnews.com/pictures/stars-whove-got-milk/ (last visited Apr. 10, 2019). The advertisements featuring David Beckham and singer Rihanna claim that teenagers who choose dairy milk "tend to be leaner." Id. The advertisement featuring Brandon Routh claims that the calcium in milk helps bones grow strong. Id.
(60) See Photo Advisory: Superman 'Got Milk?' Ad, market wired (Apr. 24, 2006), http://www.marketwired.corn/press-release/photo-advisoryT-superrnan-got-milk-ad-680988.htm (providing a Got Milk' advertisement stating that drinking milk can give you "bones of steel").
(61) MILK LIFE:, U.S. Olympian Maddie Bowman Milk Life TV Commercial, YOUTUBE (Nov. 13, 2017), https://www.youtube.com/watch?v=8cpF3AV0bZs.
(62) See Kirk Kardashian, The End of Got Milk?, NEW YORKER (Feb. 28, 2014), https://www.newyorker.com/business/currency/the-end-of-got-milk; see also E.J. Schultz, 'Got Milk' Dropped as National Milk Industry Changes Tactics, ADAGE (Feb. 24, 2014), http://adage.com/article/news/milk-dropped-national-milk-industty-tactics/291819/. Julia Kadison, CEO of MilkPEP, stated that while protein is on consumers' minds, many do not know that milk has protein. See Schultz, supra. The advertising strategy therefore became focused on plugging milk as providing a "very, very strong" protein benefit. Id.
(63) GEN. MILLS, Yoplait Yogurt: Itsy Bitsy Teeny Weenie, YOUTUBE (June 10, 2009), https://www.youtube.com/watch?v=vpr-OtKNT6E.
(64) See Citizen Petition submitted by The Physicians Committee for Responsible Medicine to the Food and Drug Administration (June 9, 2005); see also Mu Chen et al., Effects of Dairy Intake on Body Weight and Eat: A Meta-Analysis ofRandomized Controlled Trials, 96 AM. J. CLINICAL nutrition 735, 743 (2012) (finding no beneficial effect of increasing dairy consumption on body weight and fat loss). But see Michael Zemel et al., Dairy Augmentation of Total & Central Eat Loss in Obese Subjects, 29 INT'L J. OBESITY (LONDON) 391 (2005). Dr. Michael Zemel studied thirty-four healthy obese adults with one group of adults eating three servings of light yogurt per day. Id. Zemel found that participants who ate three servings of light yogurt per day lost twenty-two percent more weight and sixty-one percent more body fat than the other group of participants who merely reduced their caloric intake. Id.
(65) See Bill of Complaint, Physicians Comm. for Responsible Med. v. Kraft Foods, Inc. (2005), https://milk.procon.org/sourcefiles/PCRMlawsuit.pdf. In response to the PCRM's complaint, the FTC published a letter regarding the weight loss advertisements, stating that all advertising involving weight loss claims must be discontinued until further research provides stronger evidence of an association between dairy consumption and weight loss. Id; see also Letter from Lydia B. Parnes, Dir., Bureau of Consumer Prot., to Neal D. Barnard, M.D., President, Physicians Comm. for Responsible Med. (May 3, 2007).
(66) See HAMILTON, supra note 5, at 119 (referencing the continual drop of per capita consumption of milk).
(67) See Monika Evstatieva, Why Are Americans Drinking Less Cow's Milk? Its Appeal Has Curdled., NAT'L PUB. RADIO (May 16, 2017), http://www.npr.org/sections/thesalt/2017/05/16/528460207/ why-are-americans-drinkingless-cows-milk-its-appeal-has-curdled. Today, the average person drinks eighteen gallons of dairy milk per year. Id. In the 1970s, the amount was around thirty gallons per year. Id. In the early twentieth century, nutritionists conducted studies that showed the health benefits of dairy milk, and by the mid-twentieth century, Americans were told to drink two to three glasses of milk per day. Id. Milk, however, is no longer the only healthy beverage option; there are calcium and vitamin D-fortified drinks, for example. Id.
(68) See US Sales of Dairy Milk Turn Sour as Non-Dairy Milk Sales Grow 9% in 2015, MINTEL (Apr. 20, 2016), http://www.mintel.com/press-centre/food-and-drink/us-sales-of-dairy-milk-turn-souras-non-dairy-milk-sales-grow -9-in-2015. Dairy milk is most commonly used as an addition to other foods, such as an ingredient; fewer consumers drink dairy milk by itself. Id. According to Mintel's research, non-dairy milk is more likely to be consumed for heart health and weight loss than dairy milk. Id. The research concludes that consumers are connecting their diets with how they look and feel, which allows non-dairy manufacturers to promote the health of their products in many areas, such as wellness. Id.
(69) See Americans are Nuts for Almond Milk, NIELSEN (Mar. 31, 2016), https://www.nielsen.com/us/en/insights/news/2016/americans-are-nuts-for-almondmilk.html.
(70) William Shurtleff & Akiko Aoyagi, History of Soymilk and Other Non-Dairy Milks, SOYINFO CTR. (2013) http://www.soyinfocenter.com/pdf/166/Milk.pdf (describing different types of soymilks and non-diary milks).
(71) See Sarah-Jane Bedwell, Almond, Soy, Rice and Other Milks: The Nutrition Comparison, SELF (Feb. 26, 2015), https://www.self.com/story/almond-soy-rice-milks-nutrition-comparison.
(72) Shurtleff & Aoyagi, supra note 70, at 10.
(73) See Feng Chi et al., Post-diagnosis Soy Food Intake and Breast Cancer Survival: A Meta-Analysis of Cohort Studies, 14 ASIAN PAC. J. CANCER PREVENTION 2407, 2407 (2013) (discussing the safety of soy food intake); see also Michael Klaper, Q&A: This Doctor's Take on Dairy, MICHAEL KLAPER, M.D. (Aug. 18, 2013), http-J/doctorklaper.com/dairy-free. Dr. Klaper discusses milk as "brimming with estrogens," which are believed to have a central role in breast cancer development and progression. Id. Phytoestrogens possess both estrogen-like and anti-estrogenic properties, and are associated with blocking the effect of estrogen. Id.
(74) See Klaper, supra note 73; see also leading Causes of DEATH, CTRS. DISEASE CONTROL & PREVENTION, https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm (last updated Mar. 17, 2017) (citing heart disease as the leading cause of death with 633,842 deaths in 2016).
(75) Shurtleff & Aoyagi, supra note 70, at 9.
(76) See Global Plant Milk Market Set to Top a Staggering SI6 Billion in 2018, PLANT BASED NEWS (June 15, 2017, 3:35 p.M.), https://www.plantbasednews.org/post/ global-plant-milk-market-set-totop-a-staggering-16-billion-in-2018. The market of dairy alternatives is featuring a greater variety of ingredients, as well as products containing blended milks, such as almond and coconut. Id. Many consumers consider flavor the most important factor when deciding which dairy alternative to purchase. Id.
(77) See Head to Head: Cow's Milk vs. Almond Milk, SCI. FOCUS, https://www.sciencefocus.com/science/head-to-head-cows-milk-vs-almond-milk/ (last visited Apr. 10, 2019). While the difference between the amounts of calcium and protein in cow's milk and almond milk are too little to make a substantial difference in one's diet, the nutritional makeups of these two products are very similar. Id.
(78) See id.-, see also Kelsey M. Mangano et al., Dietary Protein is Associated with Musculoskeletal Health Independently of Dietary Pattern: The Tramingham Third Generation Study, 105 Am. j. clinical nutrition 714, 721 (2017). This study found no difference in muscle mass based on subjects' dietary patterns. Id. Subjects who ate mostly vegetables benefitted similarly to subjects who ate red meat. Id.
(79) See John Kearney, Food Consumption Trends and Drivers, 365 PHIL. TRANSACTIONS ROYAL SOC'Y. 2793, 2793 (2010); see also Joan Sabate et al., The Environmental Cost of Protein food Choices, 18 PUB. HEALTH NUTRITION 2067, 2067 (2014). Five billion pounds of pesticides are applied globally every year. Sabate et al., supra. Many dairy farmers express concerns over the use of chemical fertilizers, citing concerns about their own health, chemical exposure, and weed resistance to herbicides. Ann Galloway, Report: Herbicide, Chemical Fertilizer Use Doubled on Vermont Dairy Farms in a Decade, VT DIGGER (June 27, 2016), https://vtdiggenorg/2016/06/27/ report-herbicidechemical-fertiuzer-use-doubled-on-vt-dairy-farms-in-a-decade/. Pro-organic advocacy group, Regeneration Vermont, released a report showing that Vermont dairy farmers used 1.54 pounds of herbicide per acre in 2002, and by 2012, that number had increased to 3.01 pounds per acre. Id. In 2002, 8.9 million pounds of chemical nutrients were used on around 92,000 acres of farmland, and as of 2012, 16.5 million pounds of nitrogen fertilizer were used on the same size of farmland. Id. Increased use of chemical fertilizers in the production of dairy is a cause of a variety of human and environmental health concerns. Id.
(80) See AGRIC. RES. SERV., USD A National Nutrient Database for Standard Reference Dataset for What We Eat in America, N HAN ES (SURVEY-SR), https://www.ars.usda.gov/Services/docs.htm?docid=25662 (last modified Aug. 13, 2016). The "new foods" added to the 2013-2014 NHANES database include "several gluten-free products, milk substitutes ... low-sodium meat products ... and several beverages including bottled tea and coffee, coconut water, malt beverages, hard cider, fruit-flavored drinks, fortified fruit juices and fruit and/or vegetable smoothies." Id.; see also FDA, Problems Digesting Daily Products? (Mar. 4, 2009), https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094550.htm, (noting that percentage of adult lactose intolerant African, Native, and Asian Americans); Rick North, Consumer Demandfor rBGH--(rBST) Free Dairy Products Professional Survey Results, consumer Rep. NAT'I. RES. CTR., http://www.responsibletechnology.org/docs/153.pdf (last visited Apr. 10, 2019). Health concerns regarding dairy milk include concerns over artificial hormones. North, supra. Fifty-three percent of primary grocery shoppers say that they look for dairy products free of artificial hormones, and seventy-six percent say they were very concerned or somewhat concerned with dairy cows given synthetic growth hormones. Id.
(81) See Kearney, supra note 79 (showing how decreasing milk consumption has been mirrored by rising juice and carbonated beverage consumption).
(82) See id. at 2797. Animal fats often contain high proportions of saturated fatty acids, which are associated with cardiovascular disease. Id.
(83) Plant Based Food Sales Experience 8.1 Percent Growth Over Past Year., GISION PRWEB (Sept. 13, 2017), http://www.prweb.com/releases/2017/09/prweb14683840.htm (illustrating twenty percent growth of plant based dairy alternatives as a category in the last year).
(84) See Hannah Sentenac, Research Suggests 36% of Americans Open to Plant-Based Eating, latest vegan News, (May 27, 2015), http://latestvegannews.com/research-suggests-36-of-americansopen-to-plant-based-eating/# (referencing thirty-six percent of consumers reported preferring plant-based milks in 2014).
(85) See Barry M. Popkin et al., A New Proposed Guidance System for Beverage Consumption in the United States. 83(3) AM. J. CLINICAL NUTRITION 529, 533 (2006) (describing careful food selection required to combat nutrient decrease caused by eliminating dairy).
(86) See id. (describing alternatives to milk consumption, including increased fruit and vegetable intake).
(87) See Linda Antinoro, Calcium Controversy- Why Dietary Sources Trump Supplements, 15 TODAY'S DIETITIAN 50 (2013); see also Should You Get Y our Nutrients from Food or from Supplements? HARV. HEALTH PUBL'G (May 2015), [hereinafter HARY. HEALTH PUBL'G], https://www.health.harvard.edu/staying-healthy/should-you-get-your-nutrients-from-food-orfrom-supplements. Too many dietary supplements can be harmful. HARV. HEALTH PUBL'G, supra. Extra vitamin A supplements, for example, can lead to toxic levels if taken too frequently. Id. Nutrients are most potent when they come from food, because foods are accompanied by beneficial nutrients that are not included in most supplements, like minerals and antioxidants. Id.
(88) See id. (recommending dark, leafy greens as a primary source of calcium); see also Mary Beth Sodus, Opting for Fruits, Vegetables Over Vitamins Can Offer More Benefits, BALTIMORE SUN (Nov. 10, 2015), http://www.baltimoresun.com/health/blog/bs-fo-vitamins-20151110-story.html. The U.S. Department of Agriculture recommends each meal consist of half a plate of colorful fruits and vegetables, due to the presence of many essential nutrients in produce. Sodus, supra.
(89) P. Appleby et al., Comparative Fracture Risk in Vegetarians and Nonvegetarians in EPIC-Oxford, 61 EUR. J. CLINICAL NUTRITION 1400, 1404 (2007). The results of this study showed a similar risk of bone fractures among vegetarians and nonvegetarians. Id.
(90) Philip Tuso et al., Nutritional Update for Physicians: Plant-Based Diets, 17 permanente J. 61, 63 (2013) (describing replacement of usual meat-based amino acids with combinations of plant-based alternatives).
(91) Edward Mingyang Song et al., Association of Animal and Plant Protein Intake with All-Cause and Cause-Specific Mortality, 176 JAMA INTERNAL MED. 1453, 1454 (2016). This study analyzed over 36,000 deaths and found that the animal-protein-associated mortality risk applied mainly to meats, rather than fish or poultry. Id. at 1462. The researchers concluded that "substituting plant protein for animal protein was associated with a substantially lower ... mortality" suggesting that the protein source influences human health. Id. at 1460.
(92) See Tanja Thorning et al., Diets with High-Eat Cheese, High-Eat Meat, or Carbohydrate on Cardiovascular Risk Markers in Overweight Postmenopausal Women: A Ruindomized Crossover Trial, 102 AM. J. CLINICAL NUTRITION 573 (2015). But see Peter Marckmann, Misleading Conclusions on Health Effects of Cheese and Meat--Enriched Diets in Study Sponsored by Dairy Industry, 103 AM. J. CLINICAL NUTRITION 291, 292 (2016) (criticizing experimental diets in Thorning's study for its design intended to draw the desired conclusion).
(93) See Veronica Chavez, 14 Vegan Foods and Drinks Fortified with B12, ONE GREEN PLANET (Oct. 4, 2016), http://www.onegreenplanet.org/vegan-food/vegan-foods-and-drinks-fortified-with-bvitamins/. Plant-based milks that are fortified with vitamin B12 include Eden Foods EdenSov Extra (one serving provides fifty percent of the daily recommended vitamin B12 intake), Califia Farms Unsweetened Almond Milk (one serving provides sixty percent of the daily recommended vitamin B12 intake), and Cashew Dream Enriched Cashew Milk (one serving provides fifty percent of the daily recommended vitamin B12 intake). Id.
(94) See Products, ripple, [hereinafter Ripple Products] https://www.ripplefoods.com/products/ (last visited Apr. 10, 2019); Plant Protein Milk, BOLTHOUSE FARMS, https://www.bolthouse.com/products/beverages/plant-protein-milk/ (last visited Apr. 10, 2019).
(95) See Hassan Malekinejad et al., Horn/ones in Dai/y foods and Their Impact on Public Health--A Narrative Review Article, 44 I RAN J. PUB. HEALTH 742,742-43 (2015) (discussing concerns of hormones in dairy). There are effects of hormones in dairy on the endocrine system, possibly altering human development and reproduction. Id.
(96) See Brian Krans, Comparing Milks: Almond, Dairy, Soy, Rice and Coconut, HEALTHLINE (Mar. I 2017), https://www.healthline.com/health/milk-almond-cow-soy-rice. Regular dairy milk (one I percent fat) has 110 calories per eight-ounce serving, while unsweetened almond milk has only forty percent, unsweetened soy milk has eighty percent, and unsweetened coconut milk has fifty percent. Id. I
(97) See Report on the Food and D rug Administration's Review, supra note 48; see also Statement of Michael Hansen, Ph.D., Research Assoc., Consumer Policy Inst., Consumer's Union on FDA's Safety I Assessment of Recombinant Bovine Growth Hormone (Dec. 15, 1998) (on file with author). Dr. Hansen discussed the study of rBGH conducted on rats that showed "no toxicologically significant changes" in the rBGH-treated rats, which influenced the FDA to decline a normal human safety toxicological assessment. Statement of Hansen, supra. I le noted, however, that certain responses observed in the rats should have triggered a full human health review. Id.
(98) See SS Epstein, Unlabeled Milk from Cows Treated with Biosynthetic Growth Hormones: A Case of Regulatory Abdication, 26 INT'LJ. HEALTH SERV. 173, 173-74 (1996). IGF-1 is absorbed from the gastrointestinal tract, which is evidenced by growth-promoting effects, even in short-term tests. Id. See also David Gunnell et al., Are Diet-Prostate Cancer Associations Mediated by the IGF Axis? A Cross-Sectional Analysis of Diet, IGF-1 and IGFBP-3 in Healthy Middle-Aged Men, 88 brit. J. cancer 1682, 1684 (2003). Numerous studies have shown associations between high circulating levels of IGF-1 and an increased risk of prostate and other cancers. Id. Dairy products, milk intake, and calcium intake were all associated with raised IGF-1 levels, while high intakes of vegetables and tomato-containing products were associated with lower IGF-1 levels. Id. See generally Rudolf Kaaks, Nutrition, Insulin, IGF-I Metabolism and Cancer Risk: A Summary of Epidemiological Evidence, 262 NOVARTIS FOUND. SYMP. 247 (2004). Low physical activity and high intake of animal protein, saturated fats, and rapidly digestible carbohydrates are associated with increased risks of various cancers. Id. These increases in risks may be affected by alterations in the metabolism of I IGF-I. Id. IGF-I stimulates anabolic processes, and the anabolic signals by IGF-I can promote tumor development by stimulating cell proliferation. Id.
(99) See Harold J. Marlow et al., Diet and the Environment: Does What You Eat Matter? 85 AM. J. CLINICAL NUTRITION 1699, 1700-1702 (2009) (comparing environmental effects of nonvegetarian versus vegetarian diets using agricultural production used to produce commodities).
(100) See id. Omnivorous diets use 2.9 times more water, 2.5 times more energy, 13 times more fertilizer, and 1.4 times more pesticides than vegetarian diets. Id. at 1699. The greatest contribution to the differences came from the consumption of beef. Id. While this study did not focus on the differences between the production of plant-based milk versus dairy milk, its findings show that a greater amount of inputs are used in the production of diets that include animal products. Id. at 1700. A greater number and amount of inputs are associated with a greater environmental effect. Id. at 1701. But see Eric Brodwin & Samantha Lee, Chart Shows how some of Your Favorite Foods Could Be Making California's Drought Worse, BUS. INSIDER (Apr. 8, 2015), http://www.businessinsider.com/amount-of-water-needed-to-grow-one-almond-orange-tomato2015-4. Central Valley, California, where the country gets almost all of its almonds and a variety of other foods, has been suffering a severe drought. Id. One almond requires over one gallon of water to grow. Id. However, this may be a small amount when considering the amount of water required to grow other produce, such as oranges, broccoli, and tomatoes. Id.
(101) See Sabate et al., supra note 79. The production of kidney bean protein also requires less land, water, and fuel than the production of beef protein. Id. The researchers advocate for the substitution of beef with beans in meal patterns as a significant way to reduce the worldwide environmental footprint. Id.
(102) See Kiera Buder, Is Coconut Water Really Better than Sports Drinks, MOTHER JONES (Aug. 2, 2010, 9:30 A.M.), https://www.motherjones.com/politics/2010/08/coconut-water~sports-drinks/. Severino Magat, a former senior scientist with the Philippines' Department of Agriculture, says that coconuts also support beneficial bacteria and fungus that nourish the land and sandy beaches on which they grow. Id.
(103) See Mary Beth Quirk, Move Over, Almonds: New Non-Dairy Milk Product Is Made Out of Peas, consumerist (Apr. 19,2016), https://consumerist.com/2016/04/19/ move-over-almondsnew-non-dairy-milk-product-is-made-out-of-peas/ (promoting new brand of dairy-free milk from Ripple Foods company, made out of peas).
(104) Maggie McGrath, Soy Milk Money: The $3.5 Billion Food Business WhiteWave and Others are Drooling Over; FORBES (June 22, 2016, 6:06 P.M.), https://www.forbes.com/sites/maggiemcgrath/2016/06/22/ plant-power-how-the-3-5-billiondairy-alternative-industry-could-help-whitewave-hormel-and-other-food- giants/#7bb6969e125f. Plant-based products have become popular, particularly over the last ten years. Id. Health concerns regarding cancer risk and environmental degradation have influenced this consumer interest in plant-based products, which leads to better food innovation and a greater variety of available products. Id.
(105) See id. Hormel Foods' purchase of Justin's, whose products include various almond butters, shows an interest in diversifying a company's products. Id. General Mills has invested in Kite Hill, which is a company who makes yogurt, cheese, and cream cheese using nutmilks rather than dairy milk. Id.
(106) Jade Scipioni, Tyson Foods CEO: The Future of Food Might Be Meatless, FOX BUS. (Mar. 7, 2017), http://www. foxbusiness.com/features/2017/03/07/tyson-foods-ceo-future-food-might-bemeatless.html. Tyson invested $150 million in startups that develop meat substitutes, and Hayes believes that the migration away from animal-based protein may continue. Id.
(107) Kat Smith, See It's Finally Happening ... Dairy Farmers Are Converting Land to Almond Groves, ONE GREEN PLANET (Sept. 16, 2016) [hereinafter Smith Converting Land], http://www.onegreenplanet.org/news/dairy-farmers-are-converting-land-to-almond-groves/; see also Kat Smith, 92-Year-O/d Daily Plant That Switched to All-Plant Based I Munches Line of Minimally Processed Milks, ONE GREEN PLANET (Apr. 28, 2017) [hereinafter Smith Minimally Processed Milks], http://www.onegreenplanet.org/news/dairy-farm-in-queens-switches-to-plant-basedmilks/. Henry Schwarz, son of the co-founder of Elmhurst Dairy, stated, "pasteurized fluid milk has sort of gone out of style." Smith Minimally Processed Milks, supra.
(108) See Got Plant-Based Milk? Milk-Alternatives Market Booming, Reports BCC Research, BCC RESEARCH (Apr. 6, 2016, 5:30 ET), http://www.marketwired.com/press-release/ got-plantbased-milk-milk-alternatives-market-booming-reports-bcc-research-2112301.htm.
(109) Id. (describing market growth of various milk alternatives).
(110) Letter from Simpson & Welch, supra note 3.
(111) See id.
(112) See id.; see also 21 C.F.R. [section] 131.110 (2018) ("milk [is] ... lacteal secretion, practically free from colostrum, obtained by ... complete[ly] milking ... healthy cows").
(113) Letter from Simpson & Welch, supra note 3.
(114) See 21 U.S.C.S. [section][section] 301-392 (2018).
(115) See 21 U.S.C.S. [section] 343(c) (2018).
(116) See 21 U.S.C.S. [section] 343(c) (2018).
(117) See Coffee-Rich, Inc. v. Kan. State Bd. Health, 388 P.2d 582, 586 (Kan. 1964). The court held that a vegetable oil substitute for cream, which does not have the same aroma, texture, or taste as cow's cream, is not an "imitation cream" but rather a separate and distinct product that should bear its own common or usual name. Id. at 584.
(118) See id.
(119) 21 C.F.R. [section] 101.3(e) (2018). The regulation was enacted pursuant to 21 U.S.C. [section] 371(a) (1976), which authorizes the promulgation of regulations in order to efficiently enforce the Act. [section] 101.3(e); see Nat'l Milk Producer Fed'n v. Harris, 653 F.2d 339, 342 (8th Cir. 1981) (holding that agency's construction of its operational statute is entitled to deference).
(120) 21 C.F.R. [section] 101.3(e)(1).
(121) 21 U.S.C.S. [section] 343(g) (West, Wesdaw through Pub. L. No. 116-5, also includes Pub. L. No 1168 tit. 26 current through 116-12).
(122) See infra notes 123-126 (discussing manufacturers' use of "pasta" despite products often meeting standard identity for "noodles" or "macaroni").
(123) See 21 C.F.R. [section] 139.150(a)-(b) (2018) (adding that noodle product must contain at least "87 percent of total solids").
(124) 21 C.F.R. [section] 139.150(c) (2018).
(125) See Products, KRAFT, [hereinafter Kraft Products], http://www.kraftrecipes.com/products/kraft-5-5-oz-macaroni-and-chees-3.aspx (last visited Apr. 10, 2019); see also Products, BARILLA, [hereinafter Barilla Products], https://www.barilla.com/en-us (referring to the majority of its products as "pasta") (last visited Apr. 10, 2019).
(126) See 21 U.S.C.S. [section] 343(i) (requiring label that includes common name of food, where no representation to definition and identity). The FDA acknowledges that many foods have common or usual names that are different from or not included in the Agency's statutory identity standards. [section] 343(i).
(127) See generally Painter v. Blue Diamond Growers, No. 17-55901, 2018 WL 6720560, at *1 (9th Cir. 2018) (affirming motion to dismiss putative class action against producer of almond beverages deceptive labelling); Nat'l Milk Producer Fed'n v. Harris, 653 F.2d 339 (8th Cir. 1981) (dismissing dairy producer's complaint about qualifying dairy substitutes for exemption from imitation requirement); Ang v. Whitewave Foods Co., No. 13-cv-1953, 2013 WL 6492353 (N.D. Cal. Oct. 4, 2013) (granting motion to dismiss on putative class action for misbranding of evaporated can juice products); Gitson v. Trader Joe's Co., No. 13-Cv-O1333-WHO, 2013 U.S. Dist. LEXIS 144917 (N.D. Cal. Oct. 4, 2013) (finding organic soy milk label not misleading); Press Release, Nat'l Milk Producers Fed'n, I DA Should Stop Imitation Products from Milking Dairy Terms [hereinafter Press Release Imitation] (Apr. 29, 2010) (on file with author).
(128) See Press Release Imitation, supra note 127.
(129) See generally Harris, 653 F.2d 339; Painter, 2018 WL 6720560; Gitson, 2015 U.S. Dist. LEXIS 170401 (dismissing third complaint, which alleged using "soymilk" label violated Food, Drug, & Cosmetic Act);Ang, 2013 WL 6492353.
(130) See Nat'l Milk Producers bed., 653 F.2d at 340. NMPF, representatives of dairy producers brought suit against the FDA Commissioner alleging the invalidity of an FDA regulation that authorized the labeling of products with the term "substitute" rather than "imitation." Id. at 342. NMPF alleged that various products labeled as cheese substitutes were misbranded. Id. The district court held that NMPF failed to state a claim upon which relief could be granted, because the FDA had discretion to decide whether to initiate such enforcement proceedings. Id. at 343. The court found no provision to narrow or limit the FDA's wide discretion to investigate, enforce, or prosecute alleged violations of the Act or its regulations. Id. at 344.
(131) See id. at 343. NMPF sought revocation of 21 C.F.R. [section] 101.3(e) and withdrawal of the proposed regulations adopting standards of identity for cheese substitutes, seeking enforcement action "against producers of cheese substitutes for misbranding." Nat'l Milk Producers Fed'n, 653 F.2d at 342.
(132) Id. at 342-43 (citing Med. Ctr. Of Indep. v. Harris, 628 F.2d 1113, 1118 (8th Cir. 1980)).
(133) See e.g., Gitson, 2015 U.S. Dist. LEXIS 170401, at *2 (alleging that various products are mislabeled); Aug, 2013 WL 6492353, at *1 (alleging misbranding of products); Painter v. Blue Diamond Growers, CV 17-02235-SVW-AJW, 2017 U.S. Dist. LEXIS 215086, at *2 (C.D. Cal. May 24, 2017) (alleging advertising misleads consumers to believe they are buying dairy products).
(134) See Gitson, 2015 U.S. Dist. LEXIS 170401, at *7-9. The plaintiffs alleged that Trader Joe's Organic Soy Milk and Organic Chocolate Soy Milk were improperly labeled "milk" and that the plaintiffs were misled by the defendant's use of the term milk in connection with its soy products. See id. at *1, 3-5.
(135) See id. at *6.
(136) See id. at *5-6.
(137) Id. at *4. Trader Joe's argued that a reasonable consumer could not have been misled to believe that its Organic Soy Milk actually contains "lacteal secretions from healthy cows," particularly because the label explicitly states that soy milk "has become a very popular alternative to dairy milk." Id. at *4-6.
(138) See Ang v. Whitewave Foods Co., No. 13-cv-1953, 2013 WL 6492353, at *3-4 (N.D. Cal. Oct. 4, 2013). The plaintiffs claim that Whitewave Foods misbranded the Silk products with names such as "soymilk," "almond milk," and "coconut milk." Id. at *1. The district court held that because the FDA has yet to proscribe a name for the Silk products, the court may consider the "common or usual name[s] ... [for those] food[s]" under 21 U.S.C. [section] 343(i). Id. at *3. The court agreed with Whitewave Foods that the names accurately describe the products, as they convey the products' basic nature and content, and distinguish them from characteristics of dairy from cows. Id. at *4.
(139) Id. at *4.
(140) See Painter v. Blue Diamond Growers, No. 17-55901, 2018 WL 6720560, at *1 (9th Cir. 2018). The plaintiff alleged that the use of the term "milk" in the name of Blue Diamond's plant-based beverages misled her and other consumers into thinking that these products were as nutritious as dairy milk. Id. at *1-2. The plaintiff alleged that Blue Diamond's marketing strategy' portraying its almond beverages as nutritionally superior to dairy milk, by calling its products "milk," was misleading consumers. Id. at *2-3. Plaintiff argued that Blue Diamond should have been mandated to either label its products as "imitation milk" or cease using the term "milk." Id. at *3. The district court held that the plaintiff s false advertising claims were "governed by the reasonable consumer standard, whereby a plaintiff must show that members of the public are likely to be deceived." Id. at *5 (quoting Aug, 2015 U.S. Dist. LEXIS 170401, at *4). The court held that no reasonable consumer could be misled by Blue Diamond's unambiguous labeling. Id. at *6.
(141) See Press Release, Nat'l Milk Producers Fed'n, NMPI Urges PDA: Enforce U.S. Standards for Dairy Food Labeling (July 25, 2017) (on file with author). NMPF food policy staff met with the FDA to discuss the FDA's lack of enforcement of labeling identity standards. Id. NMPF expressed concern over potential customer confusion, and claims it is deceptive to allow plant-based manufacturers to continue using milk's "hard-won reputation to their advantage." Id.
(142) Brad Aver)', Identity Crisis Brews for Alt-Milks as Congress Pushes FDA Scrutiny, BEVNET (Jan. 5, 2017), https://www.bevnet.com/news/2017/identity-crisis-brews-alt-milks-congress-pushesfda-scrutiny. Galen says he does not worry that shoppers confuse dairy milk for non-dairy alternatives, but that they think they are getting the same amount of nutrition from dairy-alternatives as they would from dairy milk. Id.
(143) Letter from George Muck, Ph.D., Vice President of Dean Foods Co., to Virginia Wilkening, Div. of Standards & Labeling Regs. (Mar. 8, 2000), https://www.regulations.gov/document?D=FDA-1997-P-0016-0024. The letter explains that the term "soymilk" has been "widely recognized" in the industry as the commonly-used name for natural beverages made out of soybeans, water and other vegetable-based ingredients. Id.
(144) State Regulators Chime in on Plant-Based Milk Labeling Debate, DAILY INTAKE (May 19, 2017), https://www.dailyintakeblog.com/2017/05/state-regulators-chime-in-on-plant-based-milklabeling-debate/. State milk regulators voted in favor of a resolution to address customer confusion about nondairy products' use of the word "milk," which was dismissed as "unhelpful" by the Plant Based Foods Association. Id.
(145) 21 C.F.R. [section] 101.3(e) (2018). A food shall be deemed misbranded if it is an imitation of another food unless it bears the word "imitation" and, immediately thereafter, the name of the food imitated. Id. The label must be prominent. Id.
(146) [section] 101.3(e)(1). A food is an imitation if it is being used as a substitute and resembles another food but lacks the nutrition of the food it is imitating. [section] 101.3(e)(1)
(147) [section] 101.3(e)(2). In the absence of an existing common or usual name, the label shall bear an appropriately descriptive term that is not false or misleading, or a fanciful name that is not false or misleading. [section] 101.3(e)(2)
(148) See Letter from Simpson & Welch, supra note 3.
(149) See The Future of Milk, supra note 11. A new line of plant-based milks has more protein per serving than dairy milk. Id. See also Bedwell, supra note 71. Sugar content and number of calories are also important factors when considering the nutritional value of a beverage. Id. Many plant-based milks contain fewer calories per cup than dairy milk. Id. One cup of 1 % fat dairy milk contains 103 calories, which is more than one cup of almond milk (30 calories), soy milk (100 calories), coconut milk (45 calories), and hemp milk (70 calories). Id. Many plant-based milks contain seemingly high amounts of sugar, with, for example, rice milk containing twelve grams per cup. Id. However, one cup of 1 % fat dairy milk is high in sugar content as well, containing thirteen grams of sugar per cup. Id. Additionally, many plant-based milks have unsweetened varieties that contain even fewer grams of sugar. Bedwell, supra note 71.
(150) Head to Head: Cow's Milk vs. Almond Milk, supra note 77.
(151) Barr)' M. Popkin et al., supra note 85 (stating fortified soy milk provides important source of protein, calcium, and other essential micronutrients).
(152) See The Future of Milk, supra note 11. Bolthouse Farms launched a line of plant-based milks that contain ten grams of pea protein per serving. Id. The company compared its products to almond milk, which often contains only one gram of protein. Id. See also Bedwell, supra note 71. Soy milks contain six grams of protein per cup, compared to dairy milk's eight grams per cup. Id.
(153) See Food Guide Pyramid, supra note 27. The Food Guide Pyramid divides two groups of foods that are important for protein and calcium, as well as iron and zinc. Id. These foods include not only milk and meat, but also nuts, of which plant-based milks are made. Id. The USDA replaced the Food Guide Pyramid with MyPlate, which similarly includes a variety of foods as adequate protein sources. See All About the Protein Foods Group, USDA, https://www.choosemyplate.gov/protein-foods.
(154) See All About Almonds--Nutrition, Benefits & More, ELMHURST, https://elmhurst1925.com/news/all-about-almonds-benefits.html/. Elmhurst's cold milling technique retains nutrients found in nuts, generating a product "packed with satisfying protein," along with vitamin E, calcium, and potassium.
(155) See K.S. McCarthy et al., Drivers of Choice for Fluid Milk Versus Plant-Based Alternatives: What Are Consumer Perceptions of Fluid Milk?, 100j. DAIRY SCI. 6125, 6137 (2017) (providing insight as to which fluid milk attributes are most appealing to consumers); KERRY HEALTH & NUTRITION INST., supra note 26. Researchers asked 999 participants questions in order to determine why consumers choose dairy or plant-based milk. Id. The answers showed that maintaining a healthy lifestyle was an important consideration for both consumers of dairy milk and plant-based milks, and dairy milk consumers perceived dairy milk as a staple food item. Id.
(156) See HAMILTON, supra note 5, at 56, 61 (referencing the National Dairy Council's description of milk's "unique nutrient package"); see also History of Cow's Milk from the Ancient World to the Present, PROCON.ORG, https://milk.procon.org/view.timeline.php?timelineID=000018 (last updated July 10, 2013). The "Got Milk?" and subsequent "Milk Life" advertising campaigns have emphasized milk as a major source of body growth and strength due to its calcium and protein contents. Id.
(157) See Dairy Production Stabilization Act of 1983, 7 U.S.C. [section][section] 4501-4514 (2018). The Act states five major Congressional findings:
(1) [D]airy products are basic foods that are a valuable part of the human diet; (2) the production of dairy products plays a significant role in the Nation's economy, the milk from which dairy products are manufactured is produced by thousands of milk producers, and dairy products are consumed by millions of people throughout the United States; (3) dairy products must be readily available and marketed efficiently to ensure that the people of the United States receive adequate nourishment; (4) the maintenance and expansion of existing markets for dairy products are vital to the welfare of milk producers and those concerned with marketing, using, and producing dairy products, as well as to the general economy of the Nation; and (5) dairy products move in interstate and foreign commerce, and dairy products that do not move in such channels of commerce directly burden or affect interstate commerce of dairy products.
(158) [section] 4501(b).
(159) See HAMILTON, supra note 5, at 69-70. "Got Milk?" is now called the "Milk Life" campaign and emphasizes milk's nutritional benefits, including its protein content. Id. The transition occurred in February 2014 as part of a national campaign launched to help increase consumption of dairy milk products. Id.
(160) See id. at 11-13 (discussing creation of the National Dairy Council and California Milk Processor Board).
(161) See id. at 14; supra notes 59-61 and accompanying text. The campaign has featured public figures such as actors, athletes, and models, with messages focusing on how drinking milk keeps their bones healthy and strong, and assists their performance. Id. During the 2018 Olympics, campaign advertisements were dedicated to milk's role in "fueling team U.S.A.," and featured athletes participating in the 2018 Olympics. Id. See also hamilton, supra note 5, at 99-100. The World Health Organization's "Disease-specific Recommendations" recommend a minimum of four hundred to five hundred milligrams of calcium intake to prevent osteoporosis. Id. Despite the fact that the World Health Organization does not discuss any need for a higher calcium intake than its recommended four hundred to five hundred milligrams, the USDA recommends three glasses of milk per day, which is almost one thousand milligrams. Id.
(162) Appleby et al., supra note 89. The study found that vegetarians, fish eaters, and meat eaters all had similar fracture rates, but vegans had considerably higher fracture rates. Id. at 1402. Vegans consume considerably less calcium than any of the other groups included in the study, so the results show that calcium intake in general is important for bone health. Id. at 1403.
(163) See hamilton, supra note 5, at 121. The World Health Organization announced the paradox developed countries, where calcium intake is higher, experience higher hip-fracture rates than developing countries where calcium intake is lower. Id.
(164) See id. at 123. Dairy milk has a high content of animal protein. Id. It is suggested that America's high rate of bone fractures may be related to the source of calcium, rather than the amount of calcium, that Americans consume. Id.
(165) See Mu Chen et al., supra note 64. Researchers examining effects of dairy intake on body weight found that dairy consumption did not result in a significant weight reduction. Id. Researchers examined twenty-nine randomized controlled trials with a total of 2,101 participants. Id. See also Bill of Complaint, supra note 65. The FTC' banned advertisement of the link between dairy consumption and weight loss due to a lack of scientific evidence. Id.
(166) See GEN. MILLS YOUTUBE, supra note 63. The commercial shows a woman trying to avoid attention at the beach, wearing an "itsy bitsy, teeny weenie, yellow polka dot bikini." Id. The woman begins to eat a Yoplait light yogurt, containing "just 100 itsy bitsy calories." Id. The commercial ends with an image of the yogurt with the tagline: "Lose the weight. Find the confidence." Id.
(167) See Zemel et al., supra note 64 (study of obese subjects showed that substituting yogurt for food can lead to fat loss).
(168) See Francesco Visioli & Andrea Strata, Milk, Dairy Products, and Their Functional Effects in Humans: A Narrative Review of Recent Evidence, 8 ADVANCES NUTRITION 131, 137-38 (2014) (milk is good for a balanced diet unless there is clear contraindication to exclude it).
(169) See Mu Chen et al., supra note 64 (finding dairy consumption did not result in a significant reduction in weight).
(170) See Citizen Petition, supra note 64. Since no studies showed a correlation between dairy consumption and weight loss, General Mills as well as the National Dairy Council contributed funding towards the research Michael Zemel did regarding eating yogurt and losing weight. Id.
(171) See Joel Lexchin, Sponsorship Bias in Clinical Research, 24 int. J. RISK safety med. 233 (2012). Pharmaceutical companies fund a majority of the research undertaken on medications. Id. This paper investigated bias in various areas, such as choice of doses, control over trial design and changes in protocols, and reporting to regulatory authorities. Id. at 234-36. The studies found bias in favor of industry in every one of the examined areas, resulting in industry-funded research undermining confidence in medical knowledge. Id. at 239-40.
(172) See supra note 65 and accompanying text (discussing the FTC's ban on dairy advertising involving weight loss claims from lack of scientific evidence).
(173) See Lexchin, supra note 171 (discussing bias in research on tobacco and pharmaceuticals funded by the tobacco and pharmaceutical industries); see also supra note 167 and accompanying text; Visioli & Strata, supra note 168 (refuting industry-funded research claims linking dairy consumption to weight loss).
(174) See supra note 52. The sugar industry paid Harvard scientists for research downplaying sugar's role in heart disease 50 years ago, but many present-day nutrition studies remain funded by the food industry. Interview with Jacobson, supra note 52. Nutrition scholar Marion Nestle spent a year tracking industry-funded studies on food and found that approximately ninety percent of the 170 studies favored the sponsor's interest. Id.
(175) See Radio Interview with Jacobson, supra note 52.
(176) See supra note 171 and accompanying text (discussing conflicts of interest and funding bias apparent in the tobacco industry and pharmaceutical industry).
(177) See e.g., Am. dietetic ASS'N, American Dietetic Association, https://www.diet.eom/g/americandietetic-association (last visited Apr. 10, 2019); HATRIGHT, ACAO. NUTRITION & DIETETICS, http://www.eatright.org (last visited Apr. 10, 2019).
(178) See SIMON, supra note 6, at 9-10; see also Press Release, Am. Dietetic Ass'n, American Dietetic Association Welcomes National Dairy Council as an ADA Partner in the Association's New Corporate Relations Sponsorship Program, (Mar. 6, 2007) (on file with author).
(179) See Thorning et al., supra note 92. The study examined fourteen overweight postmenopausal women and found that the diets with cheese and meat as primary sources of saturated fatty acids appear to be less atherogenic than the nondairy, low-fat, high-carbohydrate diets. Id.
(180) See Marckmann, supra note 92. The study criticizes the experimental diets in Thorning's study for appearing designed to draw the desired conclusion. Id.
(181) See id. The cheese and meat diets were enriched with foods rich in polyunsaturated fats that are known to lower LDL cholesterol, such as nuts, canola oil, and sunflower oil. Id. The nondairy, low-fat diet, on the other hand, was enriched with coconut milk and fat, which are rich in palmitic acid, a highly LDL-raising fatty acid. Id.
(182) See Lesser et al., supra note 52. A 2007 study of publications about the health effects of commonly consumed beverages, including milk, found that articles funded by the dairy industry were four to eight times more likely to be favorable to the sponsors than articles without funding. Id.
(183) See Visioli & Strata, supra note 168 (finding no relation between dairy consumption and weight loss, contrary to dairy industry funded study); see also Statement of Hansen, supra note 97. The main study finding "no significant difference" between milk treated with growth hormone rBST and untreated milk has flaws that the dairy industry did not disclose to consumers. Id.
(184) HAMILTON, supra note 5, at 83-84.
(186) See Bedwell, supra note 71 (holding almond milk as good as forty-five percent daily value per cup calcium-containing milk alternative); Head to Head: Cow's Milk vs. Almond Milk, supra note 77 (showing 100 mL almond versus dairy milk contains 124 and 120 mg of calcium respectively); see also supra note 88 and accompanying text. Dietitians recommend leafy greens as a primary source of calcium. Id. The U.S. Department of Agriculture recommends incorporating fruits and vegetables into each meal as "one of the best" choices for health, due to the amount of essential nutrients found in produce. Id.
(187) See The Future of Milk, supra note 11 (Bolthouse Farms' new line of pea milks contains more grams of protein per serving than dairy milk); see also Bedwell, supra note 71 (comparing the nutrients in various plant-based milks versus dairy milk).
(188) See North, supra note 80. Seventy six percent of respondents said they were very concerned or somewhat concerned with dairy cows given synthetic growth hormones. Id. Consumers were willing to pay a dollar per gallon more for milk that did not come from cows treated with synthetic growth hormones. Id. Sixty one percent of consumers said their main reason for buying organic foods was to avoid products that relied on antibiotics or growth hormones. Id.
(189) See SIMON, supra note 6, at 59-60 (discussing the PDA declining to require special labels for rBST-treated milk); see also Hankinson & Schernhammer, supra note 7. Studies on links of rBST to prostate, colorectal, and breast cancer are still largely unexplored and inconclusive, and current studies have limitations such as study size and design that prevent the ability to draw firm conclusions from published data. Id.
(190) See SIMON, supra note 6, at 59-60.
(191) See Statement of Hansen, supra note 97.
(192) Id. (discussing how rBGH study on rats should have triggered a full human health review by FDA).
(193) See id. Health Canada is Canada's equivalent of the United States' Food and Drug Administration. Id.
(194) See id.; see also HEALTH CANADA, REPORT OF THF ROYAL COLLEGE OF PHYSICIANS AND SURGEONS OF CANADA--EXPERT PANEL ON HUMAN SAFETY OF RBST (Jan. 1999), https://www.canada.ca/en/health-canada/services/drugs-health-products/veterinarydrugs/other-issues/ recombinant-bovine-somatotropin-rbst/ report-royal-college-physicians-surgeons-canada-expert-panel-human-safety-rbst-health-canada-1999.html#pts.
(195) See HEALTH CANADA, supra note 194; D. Richard, et al., Three Month (90-day) Oral Toxicity Study of Sometribove in the Rat: Determination of Sometribove Immunoglobulin in Rat Serum, in MONSANTO TECHNICAL REPORT 1989 (SA-88-353).
(196) See Cusimano, supra note 38 (discussing concerns of increased levels of IGF-I in humans who consume rBST-treated milk). Increased levels of IGF-1 are seen in cows who are injected with rBST. Id.
(197) See Prosser et al., supra note 50 (noting increase of IGF-1 in six cows' milk who received rBST for seven days).
(198) See Kaaks, supra note 98. IGF-I stimulates anabolic processes. Id. at 247. The anabolic signals by IGF-I can promote tumor development by inhibiting apoptosis and stimulating cell proliferation. Id.
(199) See GREGER, supra note 50, at 49. Conducting a study of 30,000 women with no history of breast cancer, researchers dripped the blood of women before, and fourteen days after, beginning a plant-based diet. Id. Researchers found that the blood dripped after beginning the plant-based diets killed twenty to thirty percent more cancer cells than the blood dripped from the same women just fourteen days before. Id.
(200) See id.
(201) See generally About rBGH, supra note 39. Dairy cows treated with growth hormones such as rBST often develop many significant health problems. Id. Treated cows experience a fifty percent increase in the risk of leg and hoof problems such as lameness, and over a twenty five percent increase in the frequency of mastitis, which is infection of the udder. Id. Dairy farmers use antibiotics to combat these infections. Id.
(202) See Landers et al., supra note 41. Concern over residues in animals is largely due to the large amount of antimicrobials given to farm animals, with a majority of these antimicrobials being used nontherapeutically. Id.; see generally The National Antimicrobial Resistance Monitoring System, supra note 42 (analyzing drug-resistant pathogens in U.S. food products).
(203) See SIMON, supra note 6, at 254; see also Rebecca R. Roberts et al., Hospital and Societal Costs of Antimicrobial-Resistant Infections in a Chicago Teaching Hospital: Implications for Antibiotic Stewardship, 49 CLINICAL INFECTIOUS DISEASES 1175,1176 (2009); BIOMERIEUX & ALL. PRUDENT USE OF MED., ANTIBIOTIC-RESISTANT INFECTIONS COST THE U.S. HEALTHCARE SYSTEM IN EXCESS OF $20 BILLION ANNUALLY (2009), http://emerald.tufts.edu/med/apua/news/aam_report.pdf.
(204) See U.S. DEP'T HEALTH & HUMAN SERVS., supra note 42, at 12. The CDC admits that there is concern over the use of antibiotics in food-producing animals because it contributes to antibiotic-resistant bacteria in the animals, who serve as carriers. Id. Resistant bacteria can contaminate the food produced by these animals, and consumers can develop antibiotic-resistant infections. Id. at 36. The CDC encourages efforts to minimize inappropriate use of antibiotics in animals, such as only using antibiotics under veterinary oversight, and only to manage and treat infectious diseases, rather than to promote growth. Id.
(205) See Landers et al., supra note 41. Antibiotic resistance can be an "inherent consequence" of exposure to antibiotic compounds. Id. at 6. Due to genetic variation, individual organisms can carry mutations that make antibiotics ineffective. Id. Historically, hospitals and similar healthcare facilities are known to promote antibiotic resistance. Id. However, the excessive use of antibiotics in farm animals in the industrialized animal agriculture setting may also contribute to the nationwide problem of antibiotic resistance. Id.
(206) Id. (examining the impact of antibiotic-fed animals on human health and resistance).
(207) See supra note 41 and accompanying text (evaluating patterns and quantity of antibiotic use in animals).
(208) See Landers et al., supra note 41. Sixteen percent of lactating dairy cows in the U.S. receive antibiotics for mastitis each year. Id. at 6. Nevertheless, nearly all dairy cows, receive antibiotic doses following each lactation to prevent and control future mastitis. Id:, see also supra note 204 and accompanying text
(209) See supra note 204 and accompanying text (exploring how antibiotic use in farm animals contributes to human antibiotic resistance).
(210) See Grade A Pasteurised Milk Ordinance, supra note 43. The Grade A Pasteurized Milk Ordinance includes regulations that require inspection of milk for antibiotic residues. Id. at 21. Farmers must discard milk that contains residue in excess of standard levels. Id. The purpose of the inspection requirement is to protect consumers from consuming antibiotic residues. Id.
(211) See Charles, supra note 44. After cows are treated with antibiotics, farmers discard the cows' milk for several days until the antibiotic residues disappear. Id.
(212) See Charles, supra note 44 (citing FDA, MILK DRUG RESIDUE SAMPLING SURVEY (2015), https://www.fda.gov/downloads/AnimalVeterinary/ComplianceEnforcement/UCM435759.pdf. The FDA looked for thirty-one drugs in samples of milk from almost 2,000 dairy farms. Id. Approximately half of these farms, the "targeted" group were under suspicion for sending cows to slaughter with drug residues in their meat. Id. The other group of farms consisted of a random sample of milk producers. Id.
(213) See id.
(214) See Charles, supra note 44. Many antibiotics are not approved for use on dairy cows, such as ciprofloxacin and sulfamethazine, but were used anyways. Id. Other drugs are illegal for farmers to use on their own, but may be authorized by veterinarians under certain conditions. Id. This survey shows that this veterinary safeguard does not always work. Id.
(215) See id.
(216) See supra note 3 and accompanying text.
(217) See supra notes 95-98 and accompanying text (explaining plant-based milks have fewer calories and lack dangerous growth hormones found in dairy milk).
(218) See supra notes 51-52 (describing industry-funded research as leading to cherry-picked results favoring dairy over non-dairy); see also supra note 171 and accompanying text (discussing conflicts of interest and funding bias apparent in the tobacco industry and pharmaceutical industry).
(219) See supra notes 95-98 and accompanying text (discussing the presence of r-BST and IGF-1 in dairy milk).
(220) See 21 U.S.C. [section] 343(g). A product is mislabeled if it purports to be a food but does not conform to said food's definition and standard of identity. [section] 343(g).
(221) See Coffee-Rich Inc. v. Kan. State Bd. Health, 388 P.2d 582 (Kan. 1964). Members of the Kansas State Board of Health alleged Coffee-Rich coffee creamer was misbranded because the vegetable oil substitute was not labeled "imitation cream." Id. at 585. The district court held that the product was not misbranded because the product is a vegetable product, containing no cream or other dairy products. Id. at 585. The court held that the product is an original development that did not intend to imitate a dairy product but rather to create a product different from dairy. Id. at 584. The court took into consideration the product's taste, aroma, texture, and color; all different from dairy cream. Id. at 584-85.
(222) See id. at 587.
(223) Letter from Muck, supra note 143.
(224) See Gitson v. Trader Joe's Co, 2015 U.S. Dist. LEXIS 170401, at *3-4 (N.D. Cal. Dec. 1, 2015). Under the "reasonable consumer test," in order to state a claim of misrepresentation, a plaintiff must show that consumers are "likely to be deceived" by a product's label. Id. at *4; see also supra notes 138-140 and accompanying text.
(225) See Ang v. Whitewave Foods Co, No. 13-cv-1953, 2013 WL 6492353, at *3-4 (N.D. Cal. Dec. 10, 2013). The names "soymilk," "almond milk," and "coconut milk," accurately describe plant-based products because as set forth in the regulations, the names "clearly convey" the beverages' nature and content, and "clearly distinguish" the products from dairy milk. Id. at *4. "The first words in the products' names should be obvious enough to even the least discerning of consumers." Id.; see also supra note 138 and accompanying text.
(226) See Painter v. Blue Diamond Growers, No. 17-55901, 2018 WL 6720560, at *1 (9th Cir. 2018). The plaintiff alleged the use of the term "milk" in the name of Blue Diamond's plant-based beverages misled consumers. Id. at *6. The district court held that the plaintiff failed to meet her burden under the "reasonable consumer" standard because members of the public were not likely to be deceived by Blue Diamond's unambiguous labeling. Id.; see also supra note 140 and accompanying text.
(227) See sing, 2013 WL 6492353, at *4. Claiming that a reasonable consumer would confuse plant-based milks, such as "soy" or "almond" milk, from cow milk, "stretches the bounds of credulity." Id. at *4.
(228) See Nat'l Milk Producer Fed'n v. Harris, 653 F.2d 339, 343 (8th Cir. 1981); 2013 WL 6492353, at *4; Painter., 2018 WL 6720560, at *5-6 (holding no reasonable consumer misled by "unambiguous" labeling of Blue Diamond's plant-based beverages); see also supra notes 130, 137 and accompanying text (stating court's holding that a reasonable consumer does not think soymilk comes from a cow).
(229) See Coffee-Rich Inc. v. Kan. State Bd. Health, 388 P.2d 582, 586 (Kan. 1964).
(230) See Gitson v. Trader Joe's Co, 2015 U.S. Dist. LEXIS 170401, at *4 (N.D. Cal. Dec. 1,-2015).
(231) See supra notes 123-126 (discussing that despite statutory standard regarding macaroni, companies advertise product as "pasta").
(232) See Gitson, 2015 U.S. Dist. LEXIS 170401, at *6.
(233) See 21 C.F.R. [section] 101.3(e) (1980).
(234) See supra note 228 and accompanying text. The Painter Court, for example, held that the plant-based milk label was "unambiguous." Id. at *5-6. Similarly, the Gitson Court noted the plant-based milk label that explicitly stated that soy milk "has become a very popular alternative to dairy milk." See supra note 137 and accompanying text.
(235) See Letter from Simpson & Welch, supra note 3.
(236) See North, supra note 80 and accompanying text (noting 76% of primary grocery shoppers reported concerns about synthetic growth hormones in dairy cows).
(237) See Letter from Simpson & Welch, supra note 3.
(238) See, e.g., Nat'l Milk Producer Fed'n v. Harris, 653 F.2d 339, 343 (8th Cir. 1981); Ang v. Whitewave Foods Co, No. 13-cv-1953, 2013 WL 6492353, at *4 (N.D. Cal. Dec. 10, 2013); Painter v. Blue Diamond Growers, No. 17-55901, 2018 WL 6720560, at *5-6 (9th Cir. 2018). All three aforementioned cases are recent examples of courts holding that a reasonable consumer could not be confused or misled by the unambiguous labeling of plant-based beverages using terms such as "soymilk" or "almond milk." See also supra note 228 and accompanying text.
(239) See Letter from Simpson & Welch, supra note 3.
(240) See supra note 8 and accompanying text (listing various calcium-rich foods besides dairy milk); supra note 11 and accompanying text (comparing protein contents of various plant-based and dairy milks).
(241) See Smith Minimally Processed Milks, supra note 107; All About Almonds--Nutrition, Benefits & More, supra note 154 (quoting Elmhurst Dairy's description of its new line of nutmilks).
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|Publication:||Journal of Health & Biomedical Law|
|Date:||Dec 22, 2018|
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