In the past year, so many skin creams have hit the market containing dietary supplements or food ingredients, such as actual whipped cream and yogurt, that seem good enough to eat. But can they make skin young again? And if they can actually accomplish anti-aging (beyond the mere appearance of it), then would these topical creams still be cosmetics, or would they cross the line into pharmaceuticals?

Seekers of beauty want oral products that work from the inside out. The market for nutricosmetics, also called beauty supplements, was born in Europe in 2003. Its rapid growth is fueled by baby boomers who want to look young and attractive. The first tradeshow dedicated to dietary supplements for skin health, Inside Beauty, debuted in September 2005. Kline & Co.'s research, reported in Nutricosmetics 2006: Japan, United States and Western Europe, indicates that the global market for nutricosmetics is $1 billion, and estimated to grow rapidly in the next five years. Datamonitor agrees that the "beauty-from-within" category is growing fast, but it estimated that as of July 2006, the European market was already worth $4.4 billion.

Newer ingredients in face cream and beauty supplements are alfalfa extract, alpha tocopherol, beta-carotene, cellulose, chocolate, cotton (specifically, non-GMO cotton linters), ginseng (Korean, American and Siberian), hot pepper, lycopene, rice extracts, saffron, selenium, shiitake mushrooms, succory dock-cress and white tea. Even nail polish has a nutraceutical component, with additions of antioxidant vitamins A, C and E for hydration and conditioning, and soy protein to fortify the nails. Most outrageous are some ventures beyond the "functional food" of a bronzing water drink into "cosmetic confectionery," such as collagen marshmallows, in three different fruit flavors, each containing 300 milligrams of collagen that promises to provide plumper lips and cheeks.

The claims for topicals are becoming even more aggressive in offering alternatives to invasive procedures such as eye-lifts, collagen injections, chemical peels, bust shapers and cellulite removers. These claims are all metaphorical and figurative rather than literal, of course. Just as dramatic (and equally illegal) are ingredients that promise photo-protective effects, claiming not just to promote skin health but also to defend the skin against the sun's ultraviolet damage.

There are also newer techniques of formulation and manufacturing, including use of nanoparticles, a neuron-cosmetic technology with an anti-pollution complex, and a patented dial technology for color-enhancing moisturizer (to get that glow for summer). And delayed-release antioxidants in moisturizing creams have borrowed a delivery system from supplements that, in turn, borrowed the technology from drugs.

The newest techniques—and their promotional themes—seem derived from environmental law: There are now "green salons" that beautify the human system while protecting the ecosystem by not increasing the consumer's "carbon footprint." There are "eco-chic" initiatives when companies partner with Carbonfund.org, to plant one tree for each of the first X thousands of bottles sold. One product name suggests a primordial rain forest and claims to defend the skin against damage from pollution, UV exposure and even high temperatures. The consumer may wonder if she is fighting dry skin or global warming.

Simultaneously, the beauty supplements niche, especially for healthy nails and hair, has been increasing. For women, many of these supplements provide a two-for-one in terms of efficacy: The calcium and zinc in nail supplements, the silicon for better hair and vitamin D for healthier skin all are equally important for strong and healthy bones. The legal "beauty" of marketing a product as a dietary supplement—to nourish and rejuvenate from within—is that supplement labels and advertisements may include structure/function claims, which would essentially be drug claims if made for a topical, such as a cream or lotion.

In the past year, we have seen new ingredients, innovative techniques and contemporary themes, but the law on cosmetics is well established and has not changed in at least 20 years. In advertising and labeling, terms such as cosmeceutical, dermal health, nutracosmetics and cosmedicine, creams are blurring the lines between the official categories of cosmetic and drug, as defined by Congress. Other descriptors such as aromatherapy have been in the personal care marketplace for several years—though none of these terms is found in the Federal Food, Drug, and Cosmetic Act. According to the FFDCA and FDA regulations, skin creams are either cosmetics or drugs, with only a few products in the cosmetic drug category—most notably sunscreens, which prevent skin cancer as well as moisturize the skin. Cosmetic drugs are governed by specific over-the-counter regulations, called monographs, such as the sunscreen monograph. There are also topical OTC drug creams, as well as prescription drugs, for common conditions such as acne, eczema and rosacea.

There are strict boundaries between these two main FDA categories. Drugs are defined as ". . . articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; articles (other than food) intended to affect the structure or any function of the body of man or other animals; articles intended for use as a component of any of the articles listed above." Cosmetics are defined as "?articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied onto the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; articles intended for use as a component of any such articles," except soap. My italicizing in the definitions above shows the key distinction: physiological or chemical change versus cosmetic or surface improvement.

If your product treats a disease (e.g., cystic acne or eczema), works transdermally by going beyond surface effects and reaches layers under the skin, or changes the body at the cellular level (thickens the skin, increases collagen production), then it is a drug. The only completely conservative claims for cosmetics are those by which the product purports to have an effect merely on the surface of the skin, such as creating a youthful appearance. Even then, these claims must be supported by competent and reliable scientific evidence to be valid under Federal Trade Commission regulations—unless they are purely sales puffery. Any research that manufacturers rely on must have scientific conclusions equal to the strength of their claim.

A recent FDA Warning Letter cites seemingly innocuous claims such as "reduces redness." However, the same company elsewhere states a product is "intended for individuals with skin redness ? often associated with conditions like eczema and rosacea," which is a disease claim about treating abnormal conditions. Another FDA warning letter objected to a claim on a skin cream label that said it "helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin;" and, in addition, "cell repair" claims are routinely, repeatedly cited.

However, the cosmetic industry is less likely to face enforcement by the FDA than the drug, medical device or food industries simply because the agency's budget is finite, and cosmetics are lower priority. In fact, with bioterrorism threats, malfunctioning pacemakers, E. coli in produce and post-market problems with approved drugs, I used to say that cosmetics are second-lowest priority, followed only by pet foods and pet supplements. But now with the recently contaminated pet foods, even that safety risk is a more important focus. The FDA does not invest as many resources in enforcing cosmetic labeling regulations; it focuses instead on unsafe cosmetic ingredients and the most egregious drug claims.

Susan Brienza practices in the area of regu?latory compliance, specifically FDA (including DSHEA) and FTC law. Her e-mail address is [email protected].

Natural Foods Merchandiser volume XXVIII/number 7/p. 33