The legal difference between a cosmetic and a drug is determined by a product’s intended use. Different laws and regulations apply to drugs and to cosmetics. Firms sometimes violate the law by marketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs. Thus a cosmeceutical’s “intended use” — gleaned from the labeling, advertising, promotional materials — determines the regulatory fate of a cosmeceutical as a cosmetic or drug. The actual physical effect of the product has no bearing on its intended use.Therefore, cosmeceuticals might indeed have skin altering properties, but as long as the manufacturers are careful in their advertising claims, they will not have to worry about FDA oversight. This article is the first in a three-part series on the definitions of cosmetics, drugs, cosmeceuticals, and soaps and other products. These articles will discuss the claims regarding these product categories that can be made and FDA enforcement of the Food, Drug, and Cosmetic Act (FD&C Act) and specific enforcement actions of the FD&C Act by the FDA and claims of false representations by the Federal Trade Commission. (FTC).Knowing What is in the BoxThe Fair Packaging and Labeling Act and passed in 1966, requires ingredients to be listed in descending order of amount, according to guidelines established by the United States Food and Drug Administration.1 This does not mean that all ingredients are listed — just those that are above a set percentage get listed. Those who are experts in contact dermatitis know that doctors testing for contact allergies can get a list of all of the ingredients in a preparation (although not their percentages), which is not be shared commercially.Definition of Cosmetic1FD&C Act defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.Definition of a Drug1The FD&C Act defines drugs by their intended use, as:“(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease“(B) articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].1 How Can a Product be Both a Cosmetic and a Drug?Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug.Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs. What About Cosmeceuticals?The term “cosmeceutical” was coined around 1980 by Dr. Albert Kligman, of the University of Pennsylvania and the inventor of tretinoin. By 2004, Americans bought $6.4 billion worth of cosmeceutical skincare products.2 Another $6 billions of other cosmeceuticals, mostly vitamins, or related products were sold in 2004. Despite these sales, no “cosmeceuticals” category is recognized by the FD&C Act. A product can be a drug, a cosmetic, or a combination of both, but the term “cosmeceutical” has no meaning under the law. Promises of skin rejuvenation do not mean a product is a drug. Examples of cosmeceuticals include: alpha hydroxy acids, ester-c, and copper peptides.A large class action is ongoing in the area of the sale of cosmeceuticals. This class action litigation involves Debra C. Scheufler who is the lead plaintiff against Estee Lauder, Inc.3 in a purported class action suit. The suit challenges “anti-aging” cosmetic claims as false advertising, unfair competition, and fraudulent due to the fact that Crème de la Mer, the $110-per-ounce anti-aging face cream, claims it is effective as an antiaging treatment of the skin and is fact composed in large part of petrolatum (essentially Vaseline), mineral oil, seaweed extract, and a handful of antioxidants, vitamins, and minerals that do not work.3,4Expansive claims by cosmeceuticals have caught the attention of the Federal Trade Commission. In 2000, the FTC filed suit against Rexall Sundown for marketing a product that claimed to eliminate cellulite.5 In 2004, Basic Research, the maker of StriVectin, was charged with making false and unsubstantiated claims for weight-loss and fat-loss gels and supplements, including Dermalin, Cutting Gel, Tummy Flattening Gel, Leptoprin, Anorex, and PediaLean.6 In January of 2005, the FDA issued a Warning Letter to Basic Research/Klein Becker regarding StriVectin.6,7 The FDA noted:This letter is in reference to your firm’s marketing and distribution of StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-APg, Mamralin-ARa, and TestroGel. The Food and Drug Administration (FDA) has reviewed the labeling for these products, including your Web sites at www.kleinbecker.com and www.strivectin.com. FDA has determined that your products StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-APg, Mamralin-ARa, and TestroGel are promoted with claims that cause the products to be drugs under section 201(g)(l)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC 321(g)(l)(C)). As defined in section 201(g)(l)(C) of the Act, the term “drug” means articles (other than food) intended to affect the structure or function of the body. The labeling for your products includes several claims that demonstrate that these products are intended to affect the structure or function the body (structure/function claims). Still, it seems that StriVectin is on sale. Despite such suits, consumers remain unaware that some cosmeceuticals do not work. An April 2004 survey conducted by the National Consumers League revealed that 6 out of 10 adults think that the FDA tests anti-aging products for safety and efficacy. It does no such thing.A No-Man’s-Land CategoryIt is clear that cosmeceuticals occupy a peculiar place in the world of products to enhance health and beauty. In fact, cosmeceuticals are not really a category at all; they are either cosmetics or drugs — not some third recognized category.As such, if you as a dermatologist sell or brand products, then consult a lawyer to ensure that you market, sell and make claims within the bounds of the law. Although the FDA cannot prosecute everyone who sells a product with inappropriate and illegal claims, it advisable to stay within the bounds of the law.