FDA has taken no significant regulatory action with regards to claims made for cosmetics for almost twenty five years. As a result, claims for cosmetics have become aggressive, as new science and ingredients have blurred the line between cosmetics and pharmaceuticals, leading to a class of products generally referred to as “cosmeceuticals”. There is, however, no regulatory definition of a cosmeceutical, and recent regulatory actions by the FDA suggests that they believe claims for such products are drug claims.

In four (4) recent “Warning Letters”, FDA has notified companies, including Avon Products, Inc. and Lancôme USA, that the claims for their products are drug claims, and that the products are new drugs requiring approval by FDA of a New Drug Application prior to marketing. FDA is alleging that these products are drugs, as they are intended – based on label and advertising claims (specifically on websites) – to affect the structure or any function of the human body rendering them drugs under the Federal Food Drug and Cosmetic Act (“FFDCA”). [1]

So what specific types of claims has the FDA targeted in these letters? The Agency has specifically cited claims relating to wrinkle reduction, face lifting, repair and regeneration products, and blemish reduction/elimination. They have focused not so much on the type of product, but how the product is claimed to work. For example, they have focused on claims such as:

“Rebuild collagen to help plump out lines and wrinkles”

“Stimulate elastin to help improve elasticity and resilience”

“…. helps reactivate the skin’s repair process……”

“…. help boost the production of collagen and elastin……”

“… boosts the activity of genes….”

“…. stimulate cell regeneration to reconstruct skin …..”

“…. immediate lifting, lasting repositioning.”

“….helping to repair structural damage to deeper layers of the skin.”

“… repair the structural damage that actually causes those wrinkles.”

“…. stimulate blood flow and cell metabolism to naturally dissolve fat deposits.”

They have also focused on claims that the cited products provide benefits equal to those of drug products, such as:

“…. provides all the muscle relaxing properties of BOTOX®.”

“…. provides all the benefit of BOTOX®.”

“…. provides BOTOX®-like results without needles.”

“…. a safe and effective alternative to BOTOX®.”

Last, they have objected to use of words that describe the method of activity, including:


“anti-microbial, antibacterial and antifungal”

“antiseptic and bactericide”

Whether this salvo of Warning Letters is just the beginning of a widening push of enforcement activity remains to be seen. FDA frequently takes such actions in the hope that other companies will note their actions and adjust their promotional activities accordingly, often referred to as “regulation by Warning Letter.” Whether this will lead to actual litigation over the legality of these claims remains to be seen. [2]

In the meantime, manufacturers and distributors of cosmetic products should note the types of claims FDA is objecting to, and review their advertising and promotional materials (in particular websites) in light of these actions. [3]

[1] Under Section 321(g)(1) of the FFDCA, the term “drug” means:

(A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

[2] FDA took action against “wrinkle removers” and “face lift” type claims in the late 60’s and early seventies. See, United States v. An Article… Line Away, 284 F. Supp. 107 (D. Del. 1968) aff’d, 415 F.2d 369 (3d Cir. 1979); United States v. An Article…Sudden Change, 288 F. Supp. 29 (E.D.N.Y. 1968), rev’d, 409 F.2d 734 (2d Cir. 1969); United States v. An Article … Magic Secret, 331 F. Supp. 912 (D. Md. 1971). In 1987, the Agency sent twenty three (23) regulatory letters pertaining to cosmetics products, alleging that claims such as “cell removal”, “cell recovery”, “cell-repair”, “anti-aging”, “increase collagen production” and similar claims were drug claims. But since then, there has been little or no enforcement action on these types of claims.

[3] The letters were all issued by the Office of Compliance, Center for Food Safety and Applied Nutrition of FDA. The letters are Warning Letter 262337 issued to Avon Products, Inc., on October 5, 2012; Warning Letter 273596 issued to Lancôme USA on September 7, 2012; Warning Letter 262375 issued to Bioque Technologies on October 5, 2012; and Warning Letter 262454, issued to Radcliff Consultants, LLC as agent for Greek Island Labs, on September 7, 2012. All can be found at www.fda.gov/ICE01/EnforcementActions/WarningLetters/2012.