This freedom is denied to drug companies, who must endure a prolonged and often exhaustive process--in terms of both time and money--in order to clear the hurdles placed in front of their product before they can market it to the public.

Cosmetics have largely been considered to be beyond the purview of the FFD&C because while Congress intended to use the Act to safeguard the health and economic interests of consumers, there was also a Congressional concern that manufacturers be allowed to market a legal product with a minimum of government regulation. In an industry that, as Charles Revson once phrased it, sells "hope in a bottle" along with images of beauty and sex appeal, to rein in a cosmetic manufacturer's assertions as the FDA routinely does with drug claims would unduly harm the company's marketing ability. Beyond the regulations that would require a "wrinkle" to be called a wrinkle and not a "dermatologic corrugation," this chilling effect might make many claims for beauty enhancement as blase as the aphoristic "beauty is only a lightswitch away" and could drastically impact an industry that amassed approximately $40 billion dollars in retail sales in 1998.

An increasing number of consumer and health activists have asserted, however, that the result of the careful eye toward drugs and hands-off toward cosmetics has been that cosmetic manufacturers and marketers have been able to blur the distinction between the two. Jurist Vincent A. Kleinfeld called this wrinkling of the cosmetic/drug boundaries "the Minotaur's labyrinth" thirty-two years ago, and the passing of a generation seems only to have increased the ambiguity and confusion. As one may have predicted, in recent years, there has been a building of momentum for the regulation of cosmetics that seem to do more than "cleanse, beautify, promote attractiveness, or alter the appearance." The director of the Cosmetic division of the Food and Drug Administration, Dr. John E. Bailey, has called for "cosmeceuticals," as they have come to be called, to be regulated as "cosmetic therapeutics," and to be subject to pre-market safety and effectiveness review--just as drugs have traditionally been. The charge is increasingly leveled that the producers and promoters of cosmetics have gone beyond touting their products as capable of "cleansing, beautifying, promoting attractiveness, or altering the appearance," and have begun to make drug-like claims in which "cosmeceuticals" are promoted as having the ability to, as it were, "affect the structure or function of the body."

Among cosmetics that have proven to be the most controversial in this regard are the Alpha-Hydroxy Acids, an ingredient in many skin-cream products produced and marketed today. Touted as having the seemingly miraculous ability to reverse the damage of over-exposure of the sun, AHAs have been the focus of many clinical studies this decade, including one performed by the Massachusetts General Hospital and the Beth Israel Hospital, which concluded that AHAs resulted in "modest but real benefits" for women who had experienced mild to moderate damage from ultra-violet rays from over-exposure to the sun when younger. At the other end of the spectrum, there are other studies that have concluded that the use of products containing AHAs actually may make users more sensitive to sunlight and especially to the ultraviolet radiation component of sunlight, ironically making the user more susceptible to the very damage the products are used to counteract.

Researchers have not determined definitively how AHAs work, but it is believed that they have two primary effects on the skin. First, the acids loosen the bonds in the stratum corneum (within the epidermis) that hold dead skin cells together, which allows for a more rapid process of the shedding of old tissue and the production of new skin cells. Second, the acids are believed to thicken underlying layers of the skin and increase the amount of hyaluronic acid, a gelatinous substance that holds cells together. However, it is unclear exactly what effect AHAs have on deeper levels of the skin, a question that may become crucial to the issue of FDA regulation. If it is scientifically determined that AHAs do possess the ability to "affect the function and structure of the body," it seems clear that the FDA will move toward tighter regulation of "cosmeceuticals."

Adding to the mix that may drive regulators into the cosmetic industry is the notion of the safety of products. Restricted to products with AHAs, since 1989, the FDA has received over 100 reports of adverse reactions from the use of products containing AHAs. The adverse reactions include severe redness of the skin, swelling (most frequently around the eyes), burning, blistering, bleeding, rash outbreaks, itching, and skin discoloration. Bailey believes the instances of adverse reactions could be much higher, noting that, generally, for every adverse report FDA receives, the manufacterer of a product receives between 50 to 100. Accordingly, in 1997, the FDA began a study of the safety of AHAs; a full report is expected next year.

To find out if a cosmetic contains an AHA look at the list of ingredients all cosmetics must, by law, have on their outer packaging. AHA ingredients may be listed as:

AHAs are not the only cosmetic ingredient that has come under scrutiny in recent years due to safety concerns. The potential toxicity of a few ingredients have also been seen as troubling. For instance, an article in a recent issue of Pediatrics explored the issue of accidental poisonings from the ingestion of methacrylic acid, a common ingredient in fingernail care products. The authors note that in 1996, more than 28,000 reports of poison exposures were traceable to fingernail products, 77 per cent of which involved children six years old and younger. However, as is the case with reports of adverse reactions to the FDA, it is believed there are many more instances than those actually reported to regional poison centers. While only twelve cases of the 28,000 were characterized as constituting "major effects," the lack of ingredient and toxicity information on the packages and the absence of child-resistant caps--not required of cosmetic products as they are for drugs--are seen to represent a health threat.

The authors recommend safety packaging and appropriate labeling of the toxicity dangers and appropriate suggested action upon accidental ingestion. However, to do so creates economic dangers for the industry. To require the industry to label their products to signify possible hazards of the product, first aid measures, a list of ingredients and a "keep out of reach of children" statement, for instance, would be counterproductive to the spirit of the FFD& C, which sought to allow the cosmetic industry a freer hand than the pharmaceutical industry. Not only would such language intrude upon the space strictures in packaging for many cosmetic products, particularly fingernail products, but the presence of "negative" comments would surely negate many of the positive claims of which cosmetic manufacturers rely on in the marketing of their products.

Obviously much uncertainty remains regarding both cosmeceuticals and more conventional cosmetic products and how they may be affected by either governmental oversight, litigation, or legislative action. As both industry and activists await the FDA's findings on AHAs, the fine line between drugs and cosmetics promises to become even more wrinkled.

Return to Table of Contents

Selected Bibliography