The Food and Drug Administration (FDA) recently issued a warning letter to a cosmetics company, citing marketing claims that allegedly violate the Federal Food, Drug, and Cosmetic Act (the Act). According to FDA, “Greek Island Labs” makes several statements on its Websites indicating that its products are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body, rendering them drugs under the Act.” The statements highlighted by FDA as violations of the Act include claims about the use of organic essential oils and herbal remedies as antimicrobials and as treatments for hair loss and alopecia, scarring, inflammation, “plague and fevers,” and other infections.

“Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)],” states the warning letter. “Under section 505(a) of the Act (21 U.S.C. § 355(a)) a new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application (NDA).”

FDA has given the company or its agent, Radcliff Consultants, LLC, 15 days to address all violations and respond to the warning letter. “Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products,” concludes FDA. “If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented.”