August 2006 - Legal File

Selling Youth

By Jeffrey D. Knowles and Claudia Lewis-Eng

If you survey the consumer products industry, particularly the direct marketing sector, you will see that anti-aging products-those promising continued youth or even turning back the hands of time-are on the rise. In the past, anti-aging products were typically limited to cosmetic products. We are all familiar with brands, such as Oil of Olay, Neutragena and Ponds, promising to maintain youth or shave years off. Today, however, the anti-aging products have found new outlets in the form of dietary supplements and foods. Large companies such as Nature Made and Solgar are selling supplements formulated specifically to combat wrinkles, cellulite, memory loss and other conditions associated with aging. Following in the footsteps of its cosmetic predecessors, the food industry is now beginning to offer new and innovative ways to combat aging.

In the area of conventional foods, there are a number of juices being introduced into the marketplace that are marketed as lifestyle beverages that are promising to maintain and/or restore youth. For example, AlphaGenics Inc., a Rockville Md., firm specializing in NutriGenomics, is developing a new line of personalized lifestyle beverages that match a person’s genetic chemistry. The beverages are to be marketed under the name JeneJuice and contain ingredients that are adjusted based on how the ingredients 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 chemistry 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 rollout in the U.S. in late fall 2006. Other examples of youth promoting juices are pomegranate and Acai juices. Both are promoted 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 promote anti-aging. Products such as New Chapter’s Anti-Aging formula promises restored energy and a youthful appearance. Murad’s Youth Builder supplement promises to reduce visible lines and wrinkles and increase skin elasticity after four weeks. The formula is patented and is marketed as supplying essential amino acids, vitamins and minerals that aid in healthy collagen formation, helping the body to defy the signs of aging associated with the thinning of the collagen layer.

Nutraceuticals markets its MSM Plus as a therapeutic blend of 20 percent MSM (an organic sulfur supplement), vitamin C, aloe vera, vitamin E, essential oils and herbal extracts that rejuvenate skin’s natural ability to protect itself against wrinkles and dryness. Vitalfan Antichute markets its products for thin hair to combat various imbalances of the scalp, hair and skin. The formula includes dry extract of Cardamine, amino acids to promote keratin production and stimulates the scalp circulation. Other supplement products contain collagen, human growth hormone precursors and little known ingredients, such as red deer velvet, promise to reduce wrinkles, clear age spots, combat cellulite, prevent hair loss, improve vision, mental clarity, improve 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 has regulators-such as the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC)-taken in regards to such claims?

While sales in this area appear to be on the rise, regulators such as the FDA and FTC are skeptical about anti-aging products and anti-aging claims. Both the FDA and FTC question whether conventional foods, dietary supplements or cosmetics are really a fountain of youth. In this area of marketing, careful drafting of claims and the product category are important to how anti-aging claims will be regulated. It is important to note that neither the FDA nor FTC object to anti-aging claims. The FDA is concerned whether certain claims could cause the product to be transformed into an unapproved new drug subject to the FDA’s drug approval process. The FTC on the other hand, questions whether the scientific evidence in support of the claims demonstrates that the products can deliver the promises of restored and/or maintains youth.

To date, the FDA does not have a hard and fast rule against using “anti-aging” claims on the labels and 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. The 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 the 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, the FDA has stated that “mild memory loss associated with aging” will not be considered a disease, but the FDA has objected to claims that reference Alzheimer’s disease or dementia. Similarly, the 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 may 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.

The FTC, the agency responsible for advertising, is concerned whether a company has competent and reliable scientific evidence to back up any claims it makes. For example, last year, the FTC targeted companies that claimed that their pills and sprays would increase consumers’ human growth hormone (HGH) levels and provide anti-aging benefits, including reduced weight, fat, blood pressure, cholesterol or wrinkles and increased muscle mass, cognition, memory, libido or skin quality. The FTC objected to the claims, because it believed that there was no scientific evidence in support of the claims.

Claims of specific results also present a potential problem with the FTC, because they are often difficult to substantiate. For example, in order to substantiate a claim such as “take five 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 the 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 some skepticism. To avoid regulatory pitfalls, it is best to avoid promising unrealistic results.

Jeffrey D. Knowles is a partner and chair of the Advertising, Marketing and New Media Practice Group at Venable LLP, a law firm based in Washington, D.C. Knowles is the chairman of ERA’s board of directors. He can be reached at (202) 344-4860. Claudia Lewis-Eng is a partner at Venable. She can be reached at (202) 344-4359, or via [email protected].


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