During April and May 2016, the U.S. Food and Drug Administration (FDA) issued three warning letters to cosmetics companies addressing “drug claims made for products marketed as cosmetics.”
In its May warning letter to Reviva Labs, FDA identified a number of claims it viewed as problematic, including: “ingredients that can help increase fatty tissue volume to . . . plump up . . . ,” “new peptides and additional ingredients can help increase the volume of fatty tissue,” “can help . . . reduce inflammation . . . “ “reduces blemish-causing bacteria,” and “fade dark spots.”
FDA acknowledged that Reviva had responded, but was unable to evaluate the response due to “lack of documentation.” The letter set a 15-day response period for the company to identify the “specific steps it has taken to correct violations.”
FDA has not issued a close-out date for this letter, but sources indicate that Reviva Labs will eliminate all drug-like marketing claims from its products as a result of the warning letter. “I believe you will see that we are going beyond your Warning Letter to comply with FDA cosmetic directives for all Reviva products,” owner Stephen Strassler was quoted as saying. See New Jersey.com, July 1, 2016.
Similarly, FDA’s warning letter to Crescent Health Center, Inc., identified as problematic product label claims for the Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream and Ageless Derma Anti-Aging Skin Brightener Cream. The labels indicated the products were “proven to reduce all types of hyperpigmentation” and “improve the firmness and elasticity of the skin, removes crows feet.” Claims on the company’s websites relating to these products were also deemed problematic. Additionally, the agency found the products were misbranded. The 15-day response period has passed, and no further updates are yet available. FDA has not issued a close-out date for this letter.
In mid-April, FDA issued a warning letter to Hollywood Skincare International, Inc., finding that the claims on its website relating to the product DermaSet™ Stem Cell 3d Renewal Treatment established the product as a drug, and the introduction or delivery of the product into interstate commerce violated the Federal Food, Drug, and Cosmetic Act (FDCA). Unapproved claims found on the website included assertions that the product “Removes Wrinkles Instantly.” In addition, claims regarding the product ingredients included statements such as “This marine ingredient…offer[s] protection against UVB induced free radicals,” and “provides amazing benefits to our skin by . . . stimulating regeneration of cell tissues. . . ”
FDA sent Hollywood Skincare a close out letter on June 1 to inform the company that its (unspecified) corrective actions taken in response to the warning letter sufficiently addressed the violations cited in the letter.
The agency cautioned, however, that it expects the company to maintain compliance with the FDCA and its implementing regulations and will continue to monitor Hollywood Skincare’s compliance in the future.