A note on the economic rationale for regulating health claims on functional foods and nutraceuticals: the case of Canada.Introduction Regulating health claims continues to be among the highly contentious regulatory challenges involving functional foods, nutraceuticals and, more broadly, natural health products. (1) The potential effects of regulations on health claims are multifaceted mul·ti·fac·et·ed adj. Having many facets or aspects. See Synonyms at versatile. Adj. 1. multifaceted - having many aspects; "a many-sided subject"; "a multifaceted undertaking"; "multifarious interests"; "the multifarious , and a substantial body of literature has recently emerged examining impacts on innovation/product commercialization, marketing/advertising, promotion of healthy consumption patterns and international competitiveness. (2) We aim here to give an overview of the economic rationale for regulation of health claims, hopefully in a manner that is accessible to both an audience of economists and non-economists. The premise of regulating health claims is to remedy market failures arising from imperfect information in food markets. (3) Proponents of health claim regulations solicit greater regulatory intervention and, at the extreme, near prohibition of health claims. They argue that incentives are rampant for manufacturers to deceive TO DECEIVE. To induce another either by words or actions, to take that for true which is not so. Wolff, Inst. Nat. Sec. 356. and/or mislead consumers because claimed health effects cannot be easily verified by consumers, (4) providing scope for 'false' product differentiation Product Differentiation A source of competitive advantage that depends on producing some item that is regarded to have unique and valuable characteristics. . In contrast, opponents of such restrictive regulations on health claims have argued that direct information provision through product labels is an effective approach to informing consumers about potential positive health effects that could not be acquired through pre-consumption information-seeking or post-consumption experience. (5) Further, opponents of regulations argue that, by restricting the provision of information through health claims, consumers are 'kept in the dark' and that the consequent welfare losses to consumers are typically much greater than the potential costs associated with deception. (6) Indeed, there is a substantial body of evidence supporting the notion that provision of information on health effects through product labels not only brings about positive changes in consumer dietary choices, (7) but also intensifies market competition among manufacturers for the supply and disclosure of valued product attributes, in turn enhancing consumer choices. (8) We contend that both sides of the debate on regulating health claims are centered around, to a large extent, the degree of consumer verifiability of the claimed deliverables, in terms of health effects of product consumption, and that the extant literature Extant literature refers to texts that have survived from the past to the present time. Extant literature can be divided into extant original manuscripts, copies of original manuscripts, quotations and paraphrases of passages of non-extant texts contained in other works, tends to gloss over Verb 1. gloss over - treat hurriedly or avoid dealing with properly skate over, skimp over, slur over, smooth over do by, treat, handle - interact in a certain way; "Do right by her"; "Treat him with caution, please"; "Handle the press reporters gently" this important aspect. (9) The purpose of this conceptual note is to bridge this gap in the health claim regulations literature. Our arguments and reasoning are borrowed from the literature on the economics of advertisements as information, (10) where claims on product attributes have been examined in terms of their ability to provide truthful and verifiable information to consumers, and in terms of the role of market forces when information verifiability varies across product attributes. We tailor our analysis to view health claims through the lens of information economics and conclude by outlining the potential remedies for certain information failures through the regulation of health claims. In particular, we highlight the potential role of biomarkers that are used to assess disease risk reductions as a remedy for informational failures. Verifiable and authenticated au·then·ti·cate tr.v. au·then·ti·cat·ed, au·then·ti·cat·ing, au·then·ti·cates To establish the authenticity of; prove genuine: a specialist who authenticated the antique samovar. information on such biomarkers related to long term health effects of functional foods and nutraceuticals could be used to remedy the informational failures. The information requirements The information needed to support a business or other activity. Systems analysts turn information requirements (the what and when) into functional specifications (the how) of an information system. for this transformation can be considered a public good and, thus, public provision and authentication (1) Verifying the integrity of a transmitted message. See message integrity, e-mail authentication and MAC. (2) Verifying the identity of a user logging into a network. of such information becomes the prima facie case prima facie case n. a plaintiff's lawsuit or a criminal charge which appears at first blush to be "open and shut." (See: prima facie) for regulation of health claims. Regulation of Health Claims (11) The Codex Alimentarius Codex Alimentarius a document entitled 'Recommended International Codes of Hygienic Practice for Fresh Meat, for Ante-Mortem and Post-Mortem Inspection of Slaughter Animals and for Processed Meat Products' published by FAO/WHO in 1976. Commission has proposed a health claim as "any claim establishing a relation between a food or a constituent of that food and health, (whether it is good health or a condition related to health (or disease)) ... or ... any claim which suggests that food has an impact on health." (12) In most countries such claims are highly regulated and closely associated with controls on advertising. (13) The general premise of regulating health claims is to prevent the public from being misled through communication of erroneous information. (14) In 1984, the Kellog Company in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. initiated the modern era of food product health claims, (15) soon followed by the rapid proliferation proliferation /pro·lif·er·a·tion/ (pro-lif?er-a´shun) the reproduction or multiplication of similar forms, especially of cells.prolif´erativeprolif´erous pro·lif·er·a·tion n. of health claims by food manufacturers. In due course this led to the promulgation PROMULGATION. The order given to cause a law to be executed, and to make it public it differs from publication. (q.v.) 1 Bl. Com. 45; Stat. 6 H. VI., c. 4. 2. of the Nutrition Labelling and Education Act of 1990, (16) mandating regulatory approval for health claims through the US Food and Drugs Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). (17) Other countries and regions have subsequently implemented regulations of health claims, including the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community and Canada. Until relatively recently, regulation of health claims in Canada was undertaken under more general provisions related to advertising of foods. Section 2 of the Food and Drugs Act Food and Drugs Act (formal title An Act respecting food, drugs, cosmetics and therapeutic devices) is an Act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics (18) defines advertisement as "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device." The definition of a label is "any legend, word, or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic or device or package." (19) Sections 3 and 5 of the Food and Drugs Act establish requirements for food advertising. For example, section 5 (1) declares that no person shall advertise "any food in a manner that is false, misleading, or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety." Canadian courts have interpreted this provision as imposing a strict liability offence which is subject to a defence of due diligence Research; analysis; your homework. This term has caught on in all industries, because it sounds so "wired." Who would want to do analysis or research when they can do due diligence. See wired. . (20) Section 3 of the Act prohibits product-specific disease risk reduction claims: "no person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A." (21) Moves towards specific regulation of health claims in Canada began in 1998 when Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. published a Policy Paper on Nutraceuticals/Functional Foods and Health Claims on Food, (22) proposing the use of generic health claims similar to those allowed in the United States. The Food and Drugs Act was subsequently amended in 2003 to permit five generic health claims. (23) Generic health claims are applied to specific food groups (for example fruits and vegetables) or particular foods that have a specific compositional characteristic (such as fibre) and/or a specific nutrition (such as potassium). (24) These claims, once authorized, can be used on any food product that fits the specified conditions and has the required composition without further scrutiny by Health Canada. However, such claims cannot make reference to a specific food product. (25) Currently, product-specific disease risk reduction claims or product-specific biological role claims are allowed only as "therapeutic claims" that do not make references to any diseases or physiological states Noun 1. physiological state - the condition or state of the body or bodily functions physical condition, physiological condition wakefulness - a periodic state during which you are conscious and aware of the world; "consciousness during wakefulness in a sane listed in Schedule A of the Food and Drug Act, including the majority of diet-related diseases. Economic Rationale for Regulating Health Claims In a fundamental sense, health claims represent information provided to consumers via product labels and advertising by sellers whose primary objective is to sell more of their product. (26) In general, economists are in agreement that the free flow of truthful and verifiable information facilitates the convergence of the value of resources used in the production process to the value placed by consumers on the benefits of consuming the associated product In the context of fuels and lubricants, a petroleum or chemical product used as a hydraulic fluid, corrosion preventive, liquid propellant, or specialized product, required for the operation, maintenance, or storage of military equipment. , leading to efficient resource allocation resource allocation Managed care The constellation of activities and decisions which form the basis for prioritizing health care needs in an economy. (27) However, economists are also attentive to the fact that the free flow of truthful and verifiable information is neither the norm nor the likely objective of sellers who are looking for Looking for In the context of general equities, this describing a buy interest in which a dealer is asked to offer stock, often involving a capital commitment. Antithesis of in touch with. ways to sell more of their product. Economists carefully examine situations in which the sellers' desire to sell more of their product may jeopardize the free flow of truthful and verifiable information, in extreme cases leading to the notorious market for "lemons" whereby poor quality products drive out good quality products. (28) Economists have asserted that the origin of early food regulations was closely linked to this "lemons" problem due to the adulteration Mixing something impure with something genuine, or an inferior article with a superior one of the same kind. Adulteration usually refers to mixing other matter of an inferior and sometimes harmful quality with food or drink intended to be sold. and misbranding of food products. (29) The possibility of misleading consumers by claiming benefits that are, at best, doubtful and, at worst, simply non-existent provides a prima facie case for regulatory intervention to control the information that is permitted in advertisements and/or on labels. However, the role of market forces, manifested through consumers' ability to assimilate information from commercial sources (e.g., advertising and labels) and word of mouth, as well as their own experiences with the product, must be carefully examined to identify whether the provision of misleading information is economically sustainable, and thus a major concern for regulators, or a short-term phenomenon that will naturally correct itself over time. Economics of Advertising as Information--Attributes of Goods and Information Food manufacturers have little or no incentives to innovate and commercialize products with health benefits that are potentially attractive to consumers unless they are able to communicate such benefits to consumers in an effective manner. Misleading consumers about a product to promote sales will not be sustainable if consumers can easily detect the characteristics of the product and thus are able to discipline sellers who indulge in misinformation mis·in·form tr.v. mis·in·formed, mis·in·form·ing, mis·in·forms To provide with incorrect information. mis . Information economists, especially those who study advertising as information, have categorized cat·e·go·rize tr.v. cat·e·go·rized, cat·e·go·riz·ing, cat·e·go·riz·es To put into a category or categories; classify. cat product attributes (or claims on product attributes) based on the degree of verifiability by buyers, (30) namely search, experience and credence characteristics. Search attributes are claimed deliverables for which full information is acquired prior to purchase of the product; the colour of a product is a simple example. Consumers can accurately assess whether a good possesses the level of an attribute claimed in advertising or on labels with relatively little effort. Experience attributes are claimed deliverables that cannot be verified until after purchase and use of the product; for example, taste or some acute health effects. After consumers "experience" the attribute they can verify whether the claim is true. Finally, credence attributes are claimed deliverables that cannot be easily verified even after purchase and consumption; long-term health effects are an example. Consumers exercise market power by withholding initial purchase when they detect a search attribute claim is untrue or by withholding repeat purchase when an experience attribute claim is discovered to be false. (31) The ability of consumers to verify such claims is arguably ar·gu·a·ble adj. 1. Open to argument: an arguable question, still unresolved. 2. That can be argued plausibly; defensible in argument: three arguable points of law. a more important disciplinary tool for firms to not make misleading or untrue claims than regulatory compulsion. (32) Indulgence in misleading claims is more likely in the case of credence attributes, including long-term health effects, where verification imposes the greatest effort and/or cost on consumers. (33) The cost and/or effort for consumers of verifying and assimilating a claim increases from search through experience to credence characteristics. At the same time, however, the cost for sellers of supplying information is lowest for search characteristics and greatest for credence characteristics. For example, manufacturers typically face the greatest difficulty in conveying truthful and easily understandable information about credence attributes, which are not susceptible to consumer verification by pre- or post-consumption search. Indeed, manufacturers may seek to transform experience or credence characteristics such as long-term health benefits, into search attributes, thereby lowering the consumer's effort/cost in verifying the claim and encouraging purchase. For example, Phillip Nelson asserts that manufacturers tend to advertise experience attributes in order to educate consumers about the existence of the functions of a product, which is a more cost-effective way for consumers to compare brands than their own individual search efforts. (34) Indeed, mandatory disclosure of nutrient information (35) acts to transform largely credence attributes into search attributes, thereby lowering the otherwise great cost to consumers of information assimilation. It is evident, therefore, that regulation of health claims may provide benefits for both consumers and producers as described in Box 1. Consumers make efforts to establish a desired level of information accuracy for the claims on experience and credence attributes that could directly affect the probability of expected health outcomes. There are corresponding costs and benefits for such verification efforts as given in Figure 1 (see Box 1 for more details). The marginal cost Marginal cost The increase or decrease in a firm's total cost of production as a result of changing production by one unit. marginal cost The additional cost needed to produce or purchase one more unit of a good or service. and the marginal benefit lines indicate the addition or increment To add a number to another number. Incrementing a counter means adding 1 to its current value. to the total costs and total benefits as effort level increases. For example, successive units of effort add a successively smaller increment to the total benefits as indicated by downward sloping marginal benefit lines. At the effort level of [E.sub.max] no incremental Additional or increased growth, bulk, quantity, number, or value; enlarged. Incremental cost is additional or increased cost of an item or service apart from its actual cost. benefit is accruable to the total benefits, thus verification efforts exceeding the point [E.sub.max] are futile. In contrast, as indicated by the upward sloping marginal cost lines, successive units of effort add a successively higher increment to the total costs. If the marginal benefit is greater than the marginal cost at a given level of effort, by increasing the efforts consumers could gain since their incremental benefits would be greater than incremental costs Costs which are additional costs to the Service appropriations that would not have been incurred absent support of the contingency operation. See also financial management. . The reverse holds if the marginal cost is greater than the marginal benefit at a given level of effort and by decreasing the efforts a consumer could gain. It is evident therefore that a rational consumer makes verification efforts up to a point where the incremental (marginal) cost is equal to the incremental (marginal) benefit from the last unit of verification effort. These optimal levels of verification effort for an experience attribute ([E*.sub.E]) and credence attribute ([E*.sub.C]) are shown in Figure 1. At this optimal level of verification efforts, the total benefits of verifying the credence attribute is the summation summation n. the final argument of an attorney at the close of a trial in which he/she attempts to convince the judge and/or jury of the virtues of the client's case. (See: closing argument) of incremental benefits as the verification effort increases from zero units of effort to [E*.sub.C] units of effort. This summation is represented by the area of OAB OAB Ordem dos Advogados do Brasil (Brazil) OAB Offline Address Book OAB Over-Active Bladder (urology) OAB Outlook Address Book (Microsoft) OAB Ocean Affairs Board [E*.sub.C]. Likewise, the total cost of verifying the credence attribute is the area of OB [E*.sub.C]. Thus the net benefit (total benefit minus total cost) of verifying the credence attribute is the triangle of OAB. If the consumer holds [E*.sub.C] constant, any reduction in the cost of verifying a credence attribute (that reduces the slope of the line [delta][C.sub.C]/[delta]E), for example through the action of the manufacturer in terms of product claims that transform a credence attribute into an experience attribute, would increase this net gain ([DELTA]OAB) to the incremental maximum of [DELTA]OBC OBC Other Backward Classes OBC Ontario Building Code OBC On Board Computer OBC Organization for Bat Conservation OBC Outline Business Case (UK government procurement) OBC Oriental Bank of Commerce (India) . If the cost to the manufacturer of providing this information, including verification and supply, is less than the consumer's gain, the action is socially desirable. There is only a case for government regulation here if sellers are not able to capture enough of the benefit to consumers (e.g., through higher prices) to cover their costs and thus have an economic incentive to provide such information. One of the crucial steps in the transformation of credence attributes to experience or search attributes is the provision of reliable information that is verifiable, such that there is protection against misleading claims. While there may be a role for government here in establishing criteria that govern health claims, there may also be other market-based mechanisms that can verify if claims are reliable. For example, if a product's credence attribute is the potential lowering of blood cholesterol, a manufacturer may provide the results of independent scientific research or offer blood cholesterol testing Cholesterol Test Definition The cholesterol test is a quantitative analysis of the cholesterol levels in a sample of the patient's blood. Total serum cholesterol (TC) is the measurement routinely taken. services to consumers. Indeed, if the credence attribute relates to changes in any biomarker, such as blood pressure, bone density or body weight, the impact of the product is ultimately verifiable, everything else being equal, and thus would become an experience characteristic. This then returns to an issue of the costs of verification and to whom these accrue. [FIGURE 1 OMITTED] The informational remedy for converting a credence attribute to an experience attribute, for example through testing services is, a priori a priori In epistemology, knowledge that is independent of all particular experiences, as opposed to a posteriori (or empirical) knowledge, which derives from experience. , plausible. If the health effects related to a particular credence attribute are applicable to the general public rather than a relatively small 'at risk' group, the information needed to transform that attribute into an experience attribute becomes a public good. In such situations, provision of information is most cost effective through public modes of health claim substantiation and verification than by individual sellers and/or buyers. This perhaps supports current approaches to the substantiation of health claims through significant scientific agreement. However, from an economics of information perspective, if the public good nature of the information needed to transform a credence attribute to an experience attribute is relatively small (e.g., with a relatively small group of consumers who stand to benefit) and/or where individual consumer verification is relatively straightforward (e.g., weight control claims), public authentication of health claims may not be warranted. Conclusions This paper has described how health claims can be conceptualized as a credence attribute associated with the longer term health outcomes from consuming functional foods, nutraceuticals and/or natural health products. The desire for manufacturers to promote sales of their products by informing consumers about such credence attributes is confounded by regulatory controls on advertising and products labelling, including the scope to make health claims, and by the inability of consumers to verify claims that are made through either pre- or post-consumption search. A plausible market-based mechanism is the transformation of credence attributes to experience or search attributes at the level of the individual consumer, for example through monitoring of biomarkers. Indeed, developments in scientific understanding of biomarkers is, at least in principle, making the longer term health effects of functional foods, nutraceuticals and/or natural health products into experience attributes. However, if the associated potential health benefits are applicable to the wider population rather than relatively small 'at risk' groups, such information can be considered a public good that is more efficiently provided in a collective manner through government action. This suggests, perhaps, a new role for government in this sphere, in providing verified information on the potential health effects of products that are applicable to the wider population rather than simply regulating the claims made by manufacturers. Deepananda Herath, Postdoctoral post·doc·tor·al also post·doc·tor·ate adj. Of, relating to, or engaged in academic study beyond the level of a doctoral degree. Noun 1. Research Fellow, Spencer Henson, Professor and John Cranfield, Associate Professor, Department of Food, Agricultural and Resource Economics, University of Guelph The University of Guelph is a medium-sized university located in Guelph, Ontario, established in 1964. While the U of G offers degrees in many different disciplines, the university is best known for its focus on life sciences, based in part on a long-standing history of , Guelph, Ontario Guelph (IPA: gwɛlf) (population 114,943[1]) is a city located in the Southwestern region of Ontario, Canada. . 1. See e.g. Paul F. Hopper, "To Claim or Not To Claim--That is the Question" (1986) 41 Food, Drug, Cosmetic Law Journal 80; A. L. Forbes, "Dimensions of the issue of explicit health claims on food labels Health claims on food labels are claims by manufacturers of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of " (1986) 43 American Journal of Clinical Nutrition Clinical nutrition The use of diet and nutritional supplements as a way to enhance health prevent disease. Mentioned in: Naturopathic Medicine 629; John E. Calfee & Janis K. Pappalardo, "Public Policy Issues in Health Claims for Foods" (1991) 10:1 Journal of Public Policy & Marketing 33 [Public Policy Issues]; Constance J. Geiger, "Health claims: history, current regulatory status, and consumer research" (1998) 98 Journal of the American Diabetic Association 1312; Mark Lawrence Mark H. Lawrence, is the principal trombonist of the San Francisco Symphony Orchestra. He was appointed to this position in 1974. Lawrence was educated at the University of Michigan and the Curtis Intitute of Music. His teachers have included Carlos Rivera, Allen H. & Mike Rayner, "Functional foods and health claims: A public health policy perspective" (1998) 1 Public Health Nutrition 75; Corinna Hawkes, Nutrition labels and health claims: the global regulatory environment (Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. : World Health Organization, 2004) [Hawkes]; Ilene Ringel Heller, "Functional Foods: Regulatory and Marketing Developments" (2001) 56 Food & Drug L.J. 197; Martijn B. Katan & Nicole M. De Roos, "Promises and Problems of Functional Foods" (2004) 44 Critical Reviews in Food Science and Nutrition 369. 2. On innovation and product commercialization, see A.M. Stephen, "Regulatory Aspects of Functional Products" in G. Mazza, ed., Functional Foods, Biochemical and Processing Aspects (Lancaster, Penn.: Technomic Publishing Company, 1998) 403; Kathie L. Wrick, "The Impact of Regulation on the Business of Nutraceuticals in the United States: Yesterday, Today and Tomorrow" in Clare M. Hasler, ed., Regulation of Functional Foods and Nutraceuticals: A Global Perspective (Ames, Iowa Ames is a city located in the central part of the U.S. state of Iowa, about 30 miles north of Des Moines in Story County. It is the principal city of the 'Ames, Iowa Metropolitan Statistical Area' which encompasses all of Story County, Iowa and which, when combined with the : Blackwell Publishing, 2005) 3; D. Richardson, "Scientific and regulatory issues about foods which claim to have a positive effect on health" in Michele J. Sadler & Michael Saltmarsh, eds., Functional Foods. The Consumer, The Products, The Evidence (London: Royal Society of Chemistry, 1998); Gary Gnirss, "Innovation versus regulation" (October 2004) Food in Canada 20; Ronald L. Doering, "A Duty to Do it Well: Regulations and Food Industry Competitiveness and Innovation Under the Food and Drugs Act" (2005) [unpublished, archived at Gowling Lafleur Henderson LLP LLP - Lower Layer Protocol , Ottawa]. On marketing and advertising, see Alison M. Stephen et al., "Regulation of foods with health claims: A proposal" (2002) 93 Canadian Journal of Public Health 328; D. Gorman, "Health Canada's regulatory initiative regarding foods with health claims" (2002) 93 Canadian Journal of Public Health 325; Kelley Fitzpatrick, "Regulatory Issues Related to Functional Foods and Natural Health Products in Canada" in Clare M. Hasler, ed., Regulation of Functional Foods and Nutraceuticals: A Global Perspective (Ames, Iowa: Blackwell Publishing, 2005) 213; Health Canada, Product-Specific Athorization of Health Claims for Foods: A Proposed Regulatory Framework (Ottawa: Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system. , 2001); P.H. Jones & C. Bourque, "Health claims on foods in Canada: Toward successful implementation" (2003) 94 Canadian Journal of Public Health 260; Michele Veeman, "Policy Development for Novel Foods: Issues and Challenges for Functional Food" (2002) Canadian Journal of Agricultural Economics Agricultural economics originally applied the principles of economics to the production of crops and livestock - a discipline known as agronomics. Agronomics was a branch of economics that specifically dealt with land usage. 527 [Veeman]; Cynthia Ramsay, "A Cure Worse than the Illness: Canada's Proposed Regulatory Framework for Natural Health Products in Light of International Evidence" (2002) 55 Public Policy Sources 1, online: Fraser Institute The Fraser Institute is a moderate libertarian think tank based in Canada. Though it contains some socially conservative and neo-conservative elements, it is mostly libertarian. <http://www.fraserinstitute.ca/admin/books/files/CureWorsethanthelllness.pdf>. 3. See e.g. Alan Schwartz Alan Schwartz is the President and Co-Chief Operating Officer of The Bear Stearns Companies, Inc. He assumed that position on June 25, 2001. Schwartz has worked at Bear Stearns since 1976, and is a 1972 graduate of Duke University. & Louis L. Wilde, "Intervening in Markets on the Basis of Imperfect Information: A Legal and Economic Analysis" (1979) 127 U. Pa. L. Rev. 630; John E. Calfee & Janis K. Pappalardo, How Should Health Claims For Foods Be Regulated? An Economic Perspective, Bureau of Economics Issues Paper, Federal Trade Commission, United States (1989) [Calfee & Pappalardo, How Should Health Claims For Foods Be Regulated]; Paul H. Rubin, "Information Regulation (Including Regulation of Advertisisng)" in Boudewijn Bouckaert Boudewijn Bouckaert is a Belgian liberal thinker and politician, adhering to more radical-liberal views than the vast majority of Flemish liberals . He is chairman of the classical liberal Nova Civitas think tank and a member of List Dedecker. & Gerrit De Geerst, eds., Encyclopedia of Law and Economics, vol. 3 (Cheltenham: Edward Elger, 2000) 271. 4. See e.g. W.T. Jarvis, "Food Faddism Food faddism and fad diet refer to idiosyncratic diets and eating patterns.
barber-surgeon inferior doctor; formerly a barber performing dentistry and surgery. [Medicine: Misc.] Dulcamara, Dr. " (1983) 3 Annual Review of Nutrition 35; Vicki S. Freimuth, Sharon L. Hammond & Judith A. Stein, "Health Advertising: Prevention for Profit" (1988) 78 American Journal of Public Health The American Journal of Public Health (AJPH) is a peer reviewed monthly journal of the American Public Health Association (APHA). The Journal also regularly publishes authoritative editorials and commentaries and serves as a forum for the analysis of health policy. 577; Bruce A. Silverglade, "A Comment on 'Public Policy Issues in Health Claims for Foods'" (1991) 10:1 Journal of Public Policy and Marketing 54; Bruce A. Silverglade & Ilene Ringel Heller, "Are Functional Foods the Solution to Dysfunctional Diets--A Review of U.S. Regulatory Requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. and Lessons From Abroad" (1997) 52 Food & Drug L.J. 313; International Association of Consumer Food Organizations, "Functional Foods: Public Health Boon or 21st Century Quackery? (1999), online: Center for Science in the Public Interest <http://www.cspinet.org/reports/functional_foods/index.html>; Chester S Chester, city and district, England Chester, city (1991 pop. 80,154) and district, Cheshire, W central England, on a sandstone height above the Dee River. It is a railroad junction. Manufactures include electrical equipment, paint, and window panes. . Galloway, "The First Amendment and FTC FTC See Federal Trade Commission (FTC). Weight-loss Advertising Regulation" (2003) 37 The Journal of Consumer Affairs 413. 5. See e.g. Public Policy Issues, supra A relational DBMS from Cincom Systems, Inc., Cincinnati, OH (www.cincom.com) that runs on IBM mainframes and VAXs. It includes a query language and a program that automates the database design process. note 1; Pauline M. Ippolito & Alan D. Mathios, "Information, Advertising and Health Choices: A Study of the Cereal Market" (1990) 21 Rand Journal of Economics 459 [Information, Advertising and Health Choices]; Pauline M. Ippolito & Alan D. Mathios, "The Regulation of Science-Based Claims in Advertising" (1990) 13 Journal of Consumer Policy 413 [The Regulation of Science-Based Claims]; Pauline M. Ippolito & Alan D. Mathios, "Health Claims in Food Marketing: Evidence on Knowledge and Behaviour in the Cereal Market" (1991) 10 Journal of Public Policy and Marketing 15 [Health Claims in Food Marketing]; Alison Keith, "Regulating Information About Aspirin and the Prevention of Heart Attack" (1995) 85:2 American Economic Review 96 [Keith]. 6. See Calfee & Pappalardo, How Should Health Claims For Foods Be Regulated, supra note 3. 7. See e.g. Pauline M. Ippolito & Alan D. Mathios, "Information and Advertising: The Case of Fat Consumption in the United States" (1995) 85:2 American Economic Review 91, on the removal of the ban on health claims by the US Food and Drugs Administration in 1985, and the impact this had on changes in fat and saturated fat saturated fat, any solid fat that is an ester of glycerol and a saturated fatty acid. The molecules of a saturated fat have only single bonds between carbon atoms; if double bonds are present in the fatty acid portion of the molecule, the fat is said to be consumption. See also Information, Advertising and Health Choices, supra note 5 and Health Claims in Food Marketing, supra note 5, on the impact of allowing health claims on changes in the high fibre breakfast cereal breakfast cereal, a food made from grain, commonly eaten in the morning. The oldest type of cereal, known as porridge or gruel, requires cooking in water or milk. The modern breakfast cereals, however, are entirely precooked and eaten in cold milk. consumption. See John C. Kozup, Elizabeth H. Creyer & Scot Burton, "Making Healthful health·ful adj. 1. Conducive to good health; salutary. 2. Healthy. health ful·ness n. Food Choices: The Influence of
Health Claims and Nutrition Information on Consumers' Evaluation of
Packaged Food Products and Restaurant Menu Items" (2003) 67:2
Journal of Marketing 19, on information provision and prepared meal
purchasing behaviour in restaurants. See Keith, supra note 5, on the
loss of opportunity for Aspirin to help prevent heart attacks due to
prohibitions on direct information provision to consumers. See also Gary
T. Ford et al., "Can Consumers Interpret Nutrition Information in
the Presence of a Health Claim? A Laboratory Investigation" (1996)
15 Journal of Public Policy and Marketing 16.
8. In "The Informational Role of Warranties and Private Disclosure about Product Quality" (1981) 24 J.L. & Econ. 461 [Informational Role], Sanford J. Grossman Sanford Jay "Sandy" Grossman (born July 21, 1953) is an American economist specializing in quantitative finance. He earned his A.B. in 1973, his A.M. in 1974 and Ph.D. in 1975, all from the University of Chicago. demonstrates that firms with a superior product characteristic which is valued by customers are likely to voluntarily highlight that attribute. If there is adequate competition among manufacturers of this particular characteristic along with some other beneficial characteristics, there will be a voluntary "unfolding" of information on such characteristics by competitors. Richard Posner Richard Allen Posner (born January 11, 1939, in New York City) is currently a judge on the United States Court of Appeals for the Seventh Circuit. He is one of the most influential living legal theorists and a major voice in the law and economics movement, which he helped start has noted that manufacturers can improve their market share by highlighting and calling attention to negative attributes, and prompting that their own brand is a lesser evil. See Richard A. Posner, "The Federal Trade Commission's Mandated-Disclosure Program: A Critical Analysis" in Harvey Goldschmidt, ed., Business Disclosure: Government's Need to Know (New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of : McGraw-Hill, 1979) 331. For an explanation of how this unfolding theory is manifest in the context of food health claims, see The Regulation of Science-Based Claims, supra note 5. See also Public Policy Issues, supra note 1. 9. Some discussion is provided on this aspect by Julie A. Caswell & Eliza M. Mojduszka, "Using Informational Labelling to Influence the Market for Quality in Food Products" (1996) 78 American Journal of Agricultural Economics 1248 [Caswell & Mojduszka]; Lorna Aldrich, Consumer Use of Information: Implications for Food Policy, Agricultural Handbook No. 715 (Washington D.C.: Food and Rural Economics Division, Economic Research Services, U.S. Department of Agriculture, 1999); Veeman, supra note 2. 10. For an accessible introduction, see Phillip Nelson, "The Economic Value of Advertising" in Yale Brozen, ed., Advertising and Society (New York: New York University Press New York University Press (or NYU Press), founded in 1916, is a university press that is part of New York University. External link
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11. A claim can be a much broader representation than a mere statement. The Study on Nutritional, Health and Ethical Claims in the European Union (New York: Hill and Knowlton, 2000) at 25 provides a broader definition on claims: A claim is any direct or indirect statement, symbol, suggestion, implication or any other form of communication (including the brand name) that a good has particular characteristics relating to its origin, properties, effect, nature, method of production, processing, composition or any other quality. Different types of claims related to foods, nutritional supplements Nutritional Supplements Definition Nutritional supplements include vitamins, minerals, herbs, meal supplements, sports nutrition products, natural food supplements, and other related products used to boost the nutritional content of the diet. and natural health products can be broadly grouped into nutrition claims and health claims, albeit there are grey areas in-between these two groups. Nutrition claims in general deal with either nutrient content and/or their role in general body functions. In contrast, health claims deal with disease risk reductions and improvements in general health or managing or controlling specific disease conditions. In the literature, one finds two important sub-groups of nutrition claims, namely nutrient content claims and nutrient-related structure/function or biological role claims. Two important sub-groups of health claims are "generic" and "product-specific" disease risk reduction claims. 12. Joint FAO/WHO FAO/WHO Food and Agriculture Organization of the United Nations and the World Health Organisation Food Standards Programme, Codex Alimentarius Commission, Report of the Twenty-Seventh Session of the Codex codex Manuscript book, especially of Scripture, early literature, or ancient mythological or historical annals. The earliest type of manuscript in the form of a modern book (i.e. Committee on Food Labelling, ALINORM 99/22A, online: Food and Agriculture Organisation of the United Nations World Health Organization <ftp://ftp.fao.org/docrep/fao/meeting/005/X1919e/X1919e.pdf> at 48 (accessed 21 July 2006). 13. For instance, the Codex Alimentarius Commission prohibits claims "as to the suitability of a food for use in the prevention, alleviation, treatment or cure of a disease, disorder, or particular physiological condition Noun 1. physiological condition - the condition or state of the body or bodily functions physical condition, physiological state wakefulness - a periodic state during which you are conscious and aware of the world; "consciousness during wakefulness in a sane unless they are: (a) in accordance with the provisions of Codex standards or guidelines for foods under jurisdiction of the Committee on Foods for Special Dietary Uses and follow the principles set forth in these guidelines, or (b) in the absence of an applicable Codex standard or guideline, permitted under the laws of the country in which the food is distributed." FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Codex Alimentarius: Food Labelling Complete Texts, rev. ed rev. abbr. 1. revenue 2. reverse 3. reversed 4. review 5. revision 6. revolution rev. 1. revise(d) 2. ., (2001), online: Food and Agriculture Organisation of the United Nations World Health Organization <ftp://ftp.fao.org/docrep/fao/005/Y2770E/Y2770E00.pdf> at 26 (accessed 21 July 2006) [Codex, 2001]. Sec also Hawkes, supra note 1. 14. Codex General Guidelines on Claims assert that "The principle on which the guidelines are based is that no food should be described or presented in a manner that is false, misleading, or deceptive or is likely to create an erroneous impression regarding its character in any respect" (Codex, 2001, supra note 13 at 25). See also Anthony Ogus, Regulation. Legal Form and Economic Theory (Oxford: Clarendon Press, 1994) (see especially Chapter 7, "Information Regulation"); Elizabeth McNaughton & Jeffrey Symons, "Canada" in Jocelyn Kellam & Elizabeth Toni Guarino, eds., International Food Law (Norwich: The Stationary Office, 2000) [McNaughton & Symons]. 15. The message on their All-Bran cereal boxes claiming a "low fat, high fibre diet may reduce the risk of certain cancers" with the endorsement of the National Institute of Cancer. See Pauline M. Ippolito & Janis K. Pappalardo, Nutrition and Health Advertising: Evidence From Food Advertising 1977-1997 (New York: Novinka Books, 2003). 16. Nutrition Labelling and Education Act of 1990, Pub. L. No. 101-535. 17. See Victor Fulgoni, "Health Claims: A U.S. Perspective" in Clare M. Hasler, ed., Regulation of Functional Foods and Nutraceuticals: A Global Perspective (Ames, Iowa: Blackwell Publishing, 2005) 79; John E. Calfee, Fear of Persuasion: A New Perspective on Advertising Regulation (La Vergne La Vergne is the name of several places:
18. Food and Drugs Act, R.S.C. 1985, c. F-27. 19. Ibid, s. 2. 20. See McNaughton & Symons, supra note 14 at 95. 21. Schedule A covers 40 diseases and conditions, including arthritis, asthma, cancer, diabetes, heart disease, hypertension, obesity, ulcer of the gastro-intestinal tract, etc. 22. Health Canada, Policy Paper on Nutraceuticals/Functional Foods and Health Claims on Food, online: Health Canada <http://www.hc-se.gc.ca/fn-an/label-etiquet/nutrition/claims-reclam/nutra-funct_foods-nutra-fonct_aliment al·i·ment n. 1. Something that nourishes; food. 2. Something that supports or sustains. v. To supply with sustenance, such as food. aliment food; nutritive material. _e.html> [Policy Paper]. 23. Namely, (1) A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease; (2) A healthy diet with adequate calcium and vitamin D vitamin D Any of a group of fat-soluble alcohols important in calcium metabolism in animals to form strong bones and teeth and prevent rickets and osteoporosis. It is formed by ultraviolet radiation (sunlight) of sterols (see steroid) present in the skin. , and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis; (3) A healthy diet low in saturated and trans fats trans fat n. 1. A trans fatty acid. 2. Trans fatty acids considered as a group. trans fat A fat containing trans fatty acids. may reduce the risk of heart disease; (4) A healthy diet rich in a variety of vegetables and fruits may help reduce the risk of some types of cancer; (5) Won't cause cavities / Does not promote tooth decay Tooth Decay Definition Tooth decay, which is also called dental cavities or dental caries, is the destruction of the outer surface (enamel) of a tooth. / Does not promote dental caries caries or tooth decay Localized disease that causes decay and cavities in teeth. It begins at the tooth's surface and may penetrate the dentin and the pulp cavity. / Noncarcinogenic. See Food and Drug Regulations, C.R.C., c.870, s. B.01.603. 24. See Michael Heasman. "The Regulatory Context for the Use of Health Claims and the Marketing of Functional Foods: Global Principles" in Clare M. Hasler, ed., Regulation of Functional Foods and Nutraceuticals: A Global Perspective (Ames, Iowa: Blackwell Publishing, 2005). 25. See Policy Paper, supra note 22. 26. The perceived impact of the ability to make a health claim is directly related to that objective through product differentiation where a "health claim will persuade consumers that a particular product is preferable to consuming competing or similar products which don't carry health claims." Michael Heasman & Julian Mellentin, The Functional Foods Revolution: Healthy People, Healthy Profits? (London: Earthscan, 2001). 27. For an accessible introduction, see Ejan Mackaay, Economics of Information and Law (Boston: Kluwer Nijhoff Publishing, 1980). 28. See George A. Akerlof, "The Market for 'Lemons': Quality Uncertainty and the Market Mechanism" (1970) 84 Quarterly Journal of Economics The Quarterly Journal of Economics, or QJE, is an economics journal published by the Massachusetts Institute of Technology and edited at Harvard University's Department of Economics. Its current editors are Robert J. Barro, Edward L. Glaeser and Lawrence F. Katz. 488. Akerlof demonstrates that, in a market where information is absent and hence detecting quality differences among low and high quality products is impossible, the low quality product will chase away the high quality products, sometimes leading to complete breakdown of the market. This information aberration is established in the economics lexicon as the "lemon" problem. 29. See Peter Barton
Peter Thomas Barton (born July 19, 1956) is an American actor. A graduate of Valley Stream Central High School, he also attended Nassau Community College. Hutt & Peter Barton Hutt II, "A History of Government Regulation of Adulteration and Misbranding of Food" (1984) 39 Food, Drug, Cosmetic Law Journal 2; Marc T. Law, "The Origins of State Pure Food Regulation" (2003) 63 Journal of Economic History 1103. 30. See Philip Nelson Phillip Nelson is an emeritus professor in economics at SUNY Binghamton. He is noted for having been the first to observe the distinction between an experience good and a search good. References
31. See Advertising as Information, supra note 10. 32. See Informational Role, supra note 8; Paul A. Rubin & Ellen R. Jordan, "An Economic Analysis of the Law of the False Advertising" (1979) 8 J. Legal Stud. 527; Richard A. Posner, "Truth in Advertising: The Role of Government" in Yale Brozen, ed., Advertising and Society (New York: New York University Press, 1974) 111. 33. See Gary T. Ford, Darlene B. Smith & John L. Swasy, "Consumer Scepticism scep·ti·cism n. Variant of skepticism. skepticism, scepticism a personal disposition toward doubt or incredulity of facts, persons, or institutions. See also 312. PHILOSOPHY. — skeptic, n. of Advertising Claims: Testing Hypotheses from Economics of Information" (1990) 16 Journal of Consumer Information 433. 34. See Advertising as Information, supra note 10. 35. See e.g. Caswell & Mojduszka, supra note 9. 36. For example, maintaining a healthy level of triglycerides Triglycerides Fatty compounds synthesized from carbohydrates during the process of digestion and stored in the body's adipose (fat) tissues. High levels of triglycerides in the blood are associated with insulin resistance. and maintaining a normal blood pressure, etc. For the analytical ease, we confine ourselves here to only one such accomplishment: a healthy level of blood cholesterol denoted by H. Further, we assume that V could be realized by accomplishing H alone (i.e. maintaining a healthy blood cholesterol level would be the only accomplishment that determines a life with a lower risk of coronary heart disease coronary heart disease: see coronary artery disease. coronary heart disease or ischemic heart disease Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis). ). Note that the realization of H is a probabilistic (probability) probabilistic - Relating to, or governed by, probability. The behaviour of a probabilistic system cannot be predicted exactly but the probability of certain behaviours is known. Such systems may be simulated using pseudorandom numbers. outcome which is based on a multitude of factors, including genetic predisposition genetic predisposition Molecular medicine The tendency to suffer from certain genetic diseases–eg, Huntington's disease, or inherit certain skills–eg, musical talent , diet, lifestyle, etc. 37. For example, the consumer's effort in verifying product attributes such as trans-fat and unsaturated fat unsaturated fat: see saturated fat. that are directly associated with H would condition the probability of accomplishing H. 38. Further, we also assume that, in a Lancastrian sense, the consumer derives value from both these attributes and these attributes are not substitutable such that consumers verify both. 39. See Paul N. Bloom & James E. Pailin Jr., "Using information situations to guide marketing strategy" (1995) 12:2 Journal of Consumer Marketing 19. 40. The assumption of a greater marginal cost of verification efforts for credence attributes relative to experience attributes is realistic given the typical amount of information available to consumers on credence attributes relative to experience attributes. 41. See e.g. supra note 33. 42. See George J. Stigler, "The Economics of Information" (1961) 69 Journal of Political Economy 213. Suppose a consumer has a value of V for a desirable health outcome (e.g., a lower risk of coronary heart disease). To realize V, the consumer must achieve various lifelong accomplishments such as maintaining a healthy level of blood cholesterol (H). (36) All else being equal (including all other risk factors), the probability of accomplishing H [denoted by P(H)], depends on food consumption choices based on the awareness of associations between particular nutrients and health. No doubt this awareness is manifested through the consumer's efforts to verify the various product attributes in their consumption basket. (37) Assume a product with one credence attribute (for example potential impacts on levels of blood cholesterol) and one experience attribute (for example certain elements of fat content) that are directly related to H; (38) for model simplicity we ignore any search attributes of the product. The consumer exerts [E.sub.c] level of verification effort for credence attributes and [E.sub.e] level of verification effort for experience attributes. Such efforts condition P(H). Thus, P(H| [E.sub.c], [E.sub.e]) corresponds to the conditional probability conditional probability the probability that event A occurs, given that event B has occurred. Written P(AB). of accomplishing H with a given level of [E.sub.c] and [E.sub.e], and everything else being equal, the expected value Expected value The weighted average of a probability distribution. Also known as the mean value. of life with a specific lower risk of coronary heart disease would be V* P(H| [E.sub.c], [E.sub.e]). We assume that increasing efforts directed at the verification of credence and experience attributes will increase this expected value at a decreasing rate, that is increasing the level of verification effort has a diminishing return in terms of the level of the conditional probability. Health claims are almost invariably in·var·i·a·ble adj. Not changing or subject to change; constant. in·var i·a·bil applied where the most
important attribute that consumers are striving to verify is a credence
characteristic. (39) Thus, we assume that increases in [E.sub.e]
correspond to a monotonously mo·not·o·nous adj. 1. Sounded or spoken in an unvarying tone. 2. Tediously repetitious or lacking in variety. See Synonyms at boring. greater increase in V* P(H| [E.sub.c], [E.sub.e]) relative to an increase in [E.sub.e]. That is, the marginal benefits of verification efforts for credence attributes are monotonously greater than those of experience attributes across all effort levels. Suppose the costs of verifying credence and experience attributes are given by [C.sub.C]([E.sub.c]) and [C.sub.E]([E.sub.e]) respectively, where both cost functions increase at an increasing rate with the level of effort and the marginal costs of verifying credence attributes are monotonously greater than those of verifying experience attributes across all effort levels. (40) That is, [delta][C.sub.C]([E.sub.c])/[delta][E.sub.C]>[delta][C.sub.E]([E.sub.e])/[delta][E.sub.e]. (41) The optimal level of verification effort for an experience attribute ([E*.sub.e]) and credence attribute ([E*.sub.C]) is determined by maximizing the expected value of V subject to the costs of verification efforts where the marginal benefit of verification equals the marginal cost of verification, (42) as shown in Figure 1. At the equilibrium level In meteorology, the equilibrium level (EL), or level of neutral buoyancy (LNB), is the height at which a rising parcel of air is at a temperature of equal warmth to it. of verification effort, the total net gain to the consumer from verifying credence attribute is [DELTA]OAB. |
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