According to the United States Food and Drug Administration (FDA), personal care products can be classified as a drug, or as a cosmetic, or as both. Moisturizers with skin protection factor (SPF) and antidandruff shampoos are examples of dermatologic products classified as both a drug and a cosmetic. There is actually not a category called “cosmeceuticals”. This is actually a made up term that companies use to imply that their products really work, although they are regulated as cosmetics which are not supposed to have biologic activity.
The term cosmeceutical was introduced approximately 25 years ago by Albert Kligman at a meeting of the Society of Cosmetic Chemists because he felt that a new category of regulation should exist1. Although this topic has been debated for decades, the category “cosmeceutical” has still not been codified or officially recognized. In other words, it has no legal meaning. The term, however, is increasingly part of the mainstream vernacular and frequently used to describe products that are known to have a biologic action but are regulated as cosmetics (e.g., products containing retinol). Although it is well known that retinol stimulates retinoic acid receptors resulting in biologic activity, retinol is a popular ingredient in products labeled as cosmetics. Companies list retinol as an inactive ingredient on product labels to avoid regulatory action by the FDA.
The stage for this regulatory, unforeseen loophole in which “cosmeceuticals” reside was set in 1938 when the U.S. Congress passed a statute known as The Federal Food, Drug, and Cosmetic Act (FD&C Act), which outlined formal criteria for classification of drugs and cosmetics. In this document, cosmetics were defined as: “…articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance…” In contrast, a drug is defined as a substance “intended to affect the structure and function of the body.” Based on this definition, it is actually the intent of the product and not the actions of the product that govern its classification. This allows for the classification of retinol as a cosmetic because it is listed as an inactive ingredient on product labels; therefore, it is not intended to serve a biologic purpose.
In other words, it is not what the product does that determines whether it is a drug or not, it is what the company claims it does that determines the classification.
As in many other areas of society during our era of rapidly propagating technology, there are several implications of law not anticipating future developments. The first is that the current regulations discourage companies from publishing supportive scientific clinical trials to evaluate the efficacy of their products. For example, if a manufacturer proves in a study that an ingredient increases collagen synthesis, they are proving that their product affects the “function of the body.” If they were then to market or sell that product as a cosmetic intended to increase collagen synthesis, as would be desirable in an anti-aging product or a wrinkle cream, they would be violating the 1938 statute. The only legal option for the manufacturer would be, instead, to market its product as a drug.
Every new drug must be clinically tested in accordance with FDA guidelines for a new drug application (NDA). The FDA process of drug approval can take over 10 years and cost hundreds of millions of dollars. Obviously, the cosmetic companies are left with compelling incentives to avoid such long delays and exorbitant costs by following the guidelines to keep their products classified as cosmetics. In such cases, even though the companies perform extensive research on such products, their findings are considered proprietary and are not published. This, too, has several implications. The first is that dermatologists and other physicians do not have access to this scientific evidence and are rendered poorly equipped to evaluate the efficacy of the numerous and varied products making it to market. Physicians are taught to practice evidence-based medicine, but without evidence, have little reason to believe that any of these products are efficacious. Consequently, the medical establishment dismisses these products as useless when such formulations may, in fact, offer potential benefits to patients. The second problem is that consumers may often become confused by all of the sleek, glitzy marketing. They rarely know how to tell the difference between a reputable company that conducts scientific research and a company of charlatans seeking to capitalize on consumers’ dreams of younger and healthier skin. With little guidance given the medical community’s lack of information regarding these OTC products, consumers try products and likely feel disappointed with the lack of results. This can lead to a general distrust of the entire cosmetic dermatology field. The third problem with cosmetic companies performing internal research and not publishing the results for general review is the circumvention of the peer review process. Peer review has long been considered essential to validate the research findings of scientists. It is difficult to believe or have confidence in the results of a study that has not been subjected to the peer review process.
(To find peer reviewed research studies visit www.pubmed.gov - I only trust studies published here. You must be a very reputable medical journal to make it on Pubmed.)
A legal category called “cosmeceuticals,” products shown to have a biologic function but not subjected to the expensive drug approval process, would be ideal. However, many companies and individuals oppose such an enactment because it would likely lead to the regulation of most cosmetic products. It would make all skin care products more expensive and likely would not give us better products. For example, in Europe, under the European Economic Cosmetic Directive of 1993, the requirements for cosmetic product labeling became formidable and complex.2 Many great skin care products are no longer available in Europe now for this reason. In contrast, companies in the U.S. do not have to demonstrate either efficacy or safety prior to marketing their products. Of course, all reputable companies ensure the safety of their products before distributing them; however, astonishingly, they are technically not required to do so.
What should cosmetic professionals, whether dermatologists, aestheticians, or others should do to protect patients, clients and themselves in an atmosphere in which companies are not required to research, or to release their research, on the efficacy and safety of cosmetic products? Fortunately, many individuals are beginning to independently investigate these products and their claims and to publish the findings in peer reviewed journals. Poster presentations at meetings are also a helpful source of information. Companies seem more likely to present their findings in a poster format; however, it is important to remember that these posters are often not peer reviewed. Some companies will provide unpublished research data on request to interested physicians. The CTFA (Cosmetic Toiletry and Fragrance Association) publishes a helpful guide called the Cosmetic Ingredient Review. It is designed to review and document the safety of cosmetic ingredients. An expert scientific panel examines worldwide published and unpublished safety data in an independent and unbiased manner. For 5 years I have written a column in the journal Skin and Allergy News on individual cosmetic ingredients in which I review the data on these skin care ingredients. This column can be found at www.eskinandallergynews.com (click on Archives of “Cosmeceutical Critique” on the home page). Finally, all cosmetic physicians and aestheticians who hope to preserve and enhance the integrity of the field should insist that manufacturers of cosmetic products and procedures supply well-controlled published studies to support their claims. If these dermatologists and, later, consumers refuse to buy products lacking an evidence-based medicine approach, the studies will eventually be performed and certainly lead to exciting new developments in the field of “cosmeceuticals.”
Finally - if you don’t know what to believe…ask me. If I don’t know I will do my best to find out. That is what the forums at www.DrBaumann.com are for. Lets all work together to provide educated and unbiased information to our patients and clients!
Thanks for joining me,
Leslie Baumann MD
1 Kligman A. Cosmeceuticals: Do we need a new category? In: Cosmeceuticals, Elsner P, Maibach H (eds.). Marcel Dekker Inc., New York, 2000, p. 1.
2 Rogiers V. Efficacy claims of cosmetics in Europe must be scientifically substantiated from 1997 on. Skin Res Technol 1995;1:44.
