The U.S. Food and Drug Administration (FDA) recently flexed its regulatory muscles in the cosmetics and personal care products industry by identifying numerous marketing claims that the agency says violate the Food, Drug and Cosmetics Act (FDCA). In July 2016, FDA sent nine warning letters to cosmetics manufacturers identifying alleged FDCA violations and threatening enforcement action if these companies do not take immediate corrective action.
These letters interpret certain marketing claims as evidence that such cosmetic products are intended for use as drugs, rendering them unapproved and “misbranded” drugs under FDCA. FDA has sent a total of 14 warning letters this year, making 2016 the agency’s most active year for this type of regulatory enforcement against cosmetics and personal care product companies.
In these letters, FDA has cited alleged violations in marketing claims related to:
- promotion of regeneration of tissue or collagen production;
- safe alternatives to surgery;
- “age defying” properties;
- minimization of the appearance of wrinkles, spots or lines; and
- anti-inflammatory or healing properties.
The focus on these marketing claims is a departure to some extent from previous warning letters, which centered on claims relating to skin discoloration and dark circles; reduced wrinkling and skin tightening; anti-inflammatory and anti-bacterial properties; and regeneration, repair and surgical alternatives.
FDA’s Authority to Regulate Cosmetics
While FDA has limited authority to regulate cosmetic non-deceptive labeling related to “cleansing, beautifying, promoting attractiveness, or altering the appearance,” the agency has interpreted its drug-regulating authority to extend to any cosmetic product purported to diagnose, cure, mitigate, treat or prevent disease, or “affect the structure or any function of the body.” If FDA determines that a product has made an unapproved drug claim, it can take any number of regulatory actions, including removal from the market, injunctive relief or seizure. However, the regulatory action du jour has typically been in the form of warning letters like those issued over the past several months.
Intended Use: Is it a Cosmetic or a Drug?
FDCA defines drugs and cosmetics by their “intended use.” Cosmetics are “articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” (21 U.S.C. § 321(i)). Drugs are “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” or “articles (other than food) intended to affect the structure or any function of the body”—even if these products also alter the appearance. (21 U.S.C. § 321(g)(1)).
In regulatory language, FDA has defined intended use as “the objective intent of the persons legally responsible for the labeling of drugs” (i.e., the manufacturer); objective intent is “determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.” (21 C.F.R. 201.128). These “expressions” may include any “labeling claims, advertising matter, or oral or written statements by such persons or their representatives.” (21 C.F.R. 201.128).
What Increased Scrutiny Means for Cosmetic Manufacturers
The spike in warning letters indicates that FDA has departed from its previous approach of issuing a few warning letters and expecting the industry to self-regulate and fall in line with FDA regulations. Full and complete compliance is expected, and drug-like claims will garner the attention—and enforcement arm—of the agency. Cosmetics and personal care product manufacturers should carefully review their current marketing materials and be mindful when creating new materials in light of FDA’s recent attention.