Florida Cosmetics Company Receives FDA Warning Letter about Product Claims

The Food and Drug Administration (FDA) sent a warning letter to Hollywood Skincare International about a number of product claims on the company’s web site. The FDA these claims amounted to selling unapproved new drugs.

The letter, addressed to company president Nick Manas, cited Hollywood Skincare’s DermaSet Stem Cell 3D Renewal Treatment. The letter said that claims on Hollywood Skincare’s web site “establish that the product is a drug under section 201(g)(1)(B)/(C) of the Federal Food, Drug, and Cosmetic Act . . . because it is intended for use in the cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.”

The FDA objected to a number of claims the company made for the stem cell renewal treatment, including the use of such terms as “removes wrinkles instantly,” “stem cells,” “skin lightening,” “skin healing,” “eliminates age spots,” “offering protection against UVB induced free radicals,” and “boosts collagen synthesis.” Under the Food, Drug and Cosmetic Act, such claims put the product in the category of a drug. Because the product was not generally recognized as safe and effective for the uses promoted on the web site, under the FD&C, it is an unapproved new drug.

The letter writer, Susan M. Turcovski, director of the FDA’s Florida district told Manas that new drugs “may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.” Cosmetics do not require approval. Under the FD&C, cosmetics are defined 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” (FD&C Act, sec. 201(i)). Cosmetics include products such as deodorants, skin moisturizers, perfumes, lipstick, nail polish, shampoos, and hair colors, as well as substances used as ingredients in a cosmetic product. But, a product intended for therapeutic use is a drug and must have FDA approval.

The FDA advised Hollywood Skincare to examine its web site and product labels to ensure that they complied with FDA regulations and the letter warned “Failure to promptly correct these violations may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products,” Turcovski wrote.

Any company that receives a warning has 15 working days from receipt the letter to reply in writing about “specific steps” taken to correct the violations and to “ensure that similar violations will not recur.” If the company believes the product(s) named are not in violation of the FD&C, the company may explain its position and provide supporting information. If the company cannot complete corrective action within 15 working days, it must “state the reason for the delay and the time frame within which the corrections will be implemented.”

In a June 1 follow-up letter, the FDA said Hollywood Skincare seemed to have addressed the violations. But the FDA cautioned the company that it is responsible for “sustained compliance with the Federal Food, Drug, and Cosmetic Act.” Future action is possible if the FDA finds violations “during a subsequent inspection or through other means.”

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