Cosmeceutical? An Overview of FDA’s Regulation

by Linda M. Dougherty, Esq.

The term cosmeceutical may be assumed by many to refer to a cosmetic product that does more than perform the purely cosmetic functions of cleansing, beautifying, promoting attractiveness or temporarily altering the appearance. It is, after all, a portmanteau of the words “cosmetic" and “pharmaceutical." However, it is crucial for manufacturers, importers and distributors of products being marketed as cosmeceuticals in the United States to understand FDA’s very clear position on the term cosmeceuticals—namely, that this word has no meaning under the law, and that any product that purports to do more than function solely as a cosmetic is actually a drug and will be regulated as such.

The FDA website includes a page titled “Cosmeceuticals" that sets forth this position as follows:

“While the [Federal Food, Drug and Cosmetic Act (FDCA)] does not recognize the term ‘cosmeceutical,’ the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits.  The FDCA defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body.  While drugs are subject to a review and approval process by FDA, cosmetics are not approved by FDA prior to sale.  If a product has drug properties, it must be approved as a drug."¹

In a separate guidance document, FDA makes the following statement about cosmeceuticals:

“The [FDCA] does not recognize any such category as ‘cosmeceuticals.’ A product can be a drug, a cosmetic, or a combination of both, but the term ‘cosmeceutical’ has no meaning under the law."²

Generally speaking, most cosmetic companies want to avoid having their products regulated as drugs because FDA’s regulation of drugs is substantially stricter than its regulation of cosmetics (of course, some manufacturers intend to sell a product that is both a cosmetic and a drug, such as a moisturizer with sunscreen or a deodorant that is also an antiperspirant, in which case, it must comply with the regulatory requirements for both categories). Whereas cosmetic products are not subject to premarket approval by FDA, drug products must either apply for and receive premarket approval through the lengthy and costly process of filing a New Drug Application with FDA or conform to a pre-existing over-the-counter (OTC) monograph. In addition, while there is no FDA regulation setting forth special good manufacturing practice requirements (GMPs) for cosmetic products, drug products must be manufactured in strict compliance with FDA’s drug GMPs. 

Assuming the maker or distributor of a product marketed as a cosmeceutical wishes to avoid it being regulated as a drug, the following basic principles should be kept in mind:

• Cosmetics are defined under the FDCA 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."³ Permissible claims for cosmetics are therefore limited to claims that the product will cleanse, beautify, promote attractiveness or (temporarily) alter the appearance. The claimed effects of using such products may only be superficial and temporary.
• Drugs are defined under the FDCA as, among other things, “articles intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease" and “articles (other than food) intended to affect the structure or any function of the body."⁴
• Thus, whether or not a particular product is viewed by FDA as a cosmetic or a drug is most often determined by FDA’s perception of that product’s intended purpose. In determining what a product’s intended purpose is, FDA will consider the express and implied claims made for that product in labeling and advertising (including websites, social media and customer testimonials).

The following are examples of regulatory action taken by FDA against companies marketing products as cosmetics, which FDA found to actually be illegal drug products under the law due to the claims being made:

• Warning Letter issued April 18, 2011, against the manufacturer of an eyelash and eyebrow serum product, citing several drug claims, including: “designed to lengthen and thicken lashes in 30 days"; “induced a significant increase in the length of eyelashes"; “helps accelerate the length of the hair shaft, while promoting fuller, thicker, and healthier looking brows"; and “effectively renews and regenerates skin cells."⁵
• Warning Letter issued March 1, 2011, against the marketer of a wrinkle serum product, citing several drug claims, including: “reduce expression lines & deep furrows"; “decrease wrinkle volume [and] density"; and “increase skin firmness."⁶
• Warning Letter issued March 29, 2007, against the marketer of a topical skin product, citing several drug claims, including: “good for reestablishing new collagen growth … helps keep the skin from sagging"; “protects skin against harm caused by exposure to sunlight"; “helps skin to produce new skin cells and rejuvenate damaged cells"; and “a strong weapon against thinning … slow growing and depleted hair."⁷

In addition to FDA considerations, marketers of cosmetics must ensure their product claims made in advertising (including websites, social media and customer testimonials) comply with FTC’s regulations, which prohibit false or misleading advertising.  Any express or implied structure/function or disease claim made by a cosmetic product would be subject to FTC’s requirement that the claim be supported by competent and reliable scientific evidence, such as multiple well-controlled human clinical trials.

It is important for manufacturers and marketers of cosmetic products and/or products marketed as cosmeceuticals to understand whether the product claims they are making may be viewed as drug claims, and to seek the assistance of legal counsel if they are unsure.

Linda M. Dougherty, Esq. (ld[at]usulaw.com), is an associate at the law firm of Ullman, Shapiro & Ullman, LLP, which concentrates in legal issues affecting marketers of food, cosmetic, and dietary supplement products and the natural products industry.

References:

1. "Cosmeceutical", FDA, February 24, 2000, http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm127064.htm
2. “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)", FDA, July 8, 2002, http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
3. FDCA § 201(i)
4. FDCA § 201(g)(1)
5. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm251951.htm
6. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm246086.htm
7. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076343.htm