Anti-aging products: companies should be familiar with FDA's and FTC's position before entering the anti-aging market.
Conventional Foods and Dietary Supplements
In the area of conventional foods there are several juices being introduced into the marketplace that are marketed with a "lifestyle" slant, promising to maintain and/or restore youth. For example, AlphaGenics, Inc., Rockville, MD, is a firm specializing in nutrigenomics, which is developing a new line of personalized lifestyle beverages that match a person's genetic chemistry. The beverages will be marketed under the name JeneJuice and contain ingredients that are adjusted based on how they interact with selected genes. According to AlphaGenics, adjusting food ingredients to match a person's genetic chemistry, physiology and metabolism provides the ultimate personalized consumer experience. Genetic personalization delivers what consumers want most today: to perform better physically, to control their weight, to look and feel younger, and to be sharper mentally. The product is planned for roll-out in the U.S. later this year.
Other examples of youth-promoting juices are pomegranate and acai juices. Both are marketed as containing high amounts of antioxidants that promote anti-aging.
In the dietary supplement industry, there has been a distinct increase in supplements specifically designed to help consumers fight the effects of aging. These products are typically marketed with claims of enhancing beauty from the inside out, including reducing visible lines and wrinkles, and increasing skin elasticity after a certain period of weeks. In the case of one product, the formula is patented and marketed as supplying essential amino acids, vitamins and minerals that aid in healthy collagen formation, helping the body defy the signs of aging associated with the thinning of the collagen layer.
Other products are marketed as unique therapeutic blends of vitamin, mineral and herbal extracts that promise to rejuvenate the skin's natural ability to protect itself against wrinkles and dryness.
Other supplement products contain collagen, human growth hormone precursors and little known ingredients such as red deer velvet, and promise to reduce wrinkles, clear age spots, combat cellulite, prevent hair loss, improve vision, mental clarity, skin elasticity and suppleness, and restore natural color to hair.
Now that conventional foods and dietary supplements are promising continued youth, the question is: what position have regulators such as FDA and FTC taken in regards to such claims?
FDA and FTC
While sales in this area appear to be on the rise, regulators such as FDA and FTC are skeptical about anti-aging products and claims. Indeed, they continue to question whether or not conventional foods, dietary supplements or cosmetics are really a fountain of youth. In this area of marketing, careful drafting of claims and recognizing the product category you are operating in are important to how anti-aging claims will be regulated. It is crucial to note that neither FDA nor FTC object to anti-aging claims. FDA is concerned whether certain claims could cause the product to be transformed into an unapproved new drug subject to FDA's drug approval process. FTC, on the other hand, questions whether the scientific evidence in support of the claims demonstrate that the products can deliver the promises of restored and/or maintained youth.
To date, FDA does not have a hard and fast rule against using "anti-aging" claims on product labels or in the labeling of conventional foods or dietary supplements. Using claims such as "anti-aging" or other promises of youth by itself on the label or labeling of food products is unlikely to raise any red flags with the FDA. However, the issue becomes more complex when claims about specific conditions associated with aging are used. FDA has explained that mild conditions commonly associated with particular stages of life or normal physiological processes will not be considered diseases. The key for FDA (and labeling) is that the claims must relate to conditions that are a normal result of aging and not to disease-related conditions that are associated with aging. For example, FDA has stated that "mild memory loss associated with aging" will not be considered a disease, but FDA has objected to claims that reference Alzheimer's disease or dementia. Similarly, FDA has permitted claims concerning presbyopia (the inability to change focus from near to far and vice versa) associated with aging, but the agency objects to claims relating to glaucoma or cataracts. Other examples of conditions about which structure/function claims can be made include wrinkles, other signs of aging on the skin (e.g., liver spots, spider veins), and hair loss associated with aging. The following conditions are considered diseases and discussion of them should be avoided: osteoporosis and arteriosclerotic diseases of coronary, cerebral, or peripheral blood vessels.
FTC, on the other hand, is concerned whether a company has competent and reliable scientific evidence to back up any claims it makes. For example, last year, FTC targeted companies claiming their pills and sprays would increase consumers' human growth hormone (hGH) levels and provide anti-aging benefits like reducing weight, fat, blood pressure, cholesterol, or wrinkles, and increasing muscle mass, cognition, memory, libido or skin quality. FTC objected to the claims because it believed that there was no scientific evidence to support the claims.
Claims of specific results also present a potential problem with FTC because they are often difficult to substantiate. For example, in order to substantiate a claim such as "take 5 years off the way you look," a company would need competent and reliable scientific evidence that most consumers will look five years younger after taking the product. That evidence must be in the form of well-designed, double-blind, placebo-controlled clinical trials on the products themselves. Unfortunately, such evidence is very expensive and thus rarely exists.
In general, it is unlikely that FDA and FTC will attack anti-aging claims in and of themselves. However, it is helpful to understand that the regulating agencies view such claims with a degree of skepticism.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004; 202-344-4724; E-mail: firstname.lastname@example.org.
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|Title Annotation:||CAPITOL COMMENTS; food and drug administration|
|Date:||Nov 1, 2006|
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