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The FDA strikes again... in matters of misleading claims

By Michelle Yeomans , 04-Oct-2012
Last updated on 19-Dec-2012 at 23:57 GMT

Two more cosmetic brands have been rapped by the FDA for violating its regulation laws, bringing the number of companies to be pulled up on the matter in recent weeks to four.

‘Janson Beckett' and ‘Andes Natural Skin Care’ are the latest to have received warning letters from the administration, after it had only rapped L’Oreal and 'Greek Island Labs’ on misleading marketing claims less than a month ago.

The complaint

In regards to Janson Beckett, the FDA found claims for its ‘Vitamin C&C Facial Serum’ and ‘Vitamin C Ester’ amongst various other products as intending to affect the structure or function of the body, rendering them as drugs under the Food, Drug and Cosmetic Act.

"Vitamin C Ester... boosts protective antioxidant action and helps repair past damage by aiding new collagen production." 

Overall, the FDA found the description and marketing of the company's products to have violated the Act, and that they were not generally recognized amongst qualified experts as “safe and effective and, therefore, deemed as new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)].”

On reviewing the website of the second company, 'Andes Natural Skin Care', the administration found its ‘Bio Skin Rejuvenation’ and ‘BioSkinrepair’ amongst others to be promoted for uses that cause the products to be drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act.

"BioSkinRepair... helps to prevent and reduce all types of scars, because it orchestrates an orderly repair of damaged skin, scarless healing & enhanced skin regeneration."

Here, the FDA found this company as claiming its products for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs and thus violating its Act.

Advice

As a result of its findings in both cases, the FDA has requested that the cosmetic companies contact it to outline the specific action they intend to take to ensure that their products comply with the Federal Food Drug and Cosmetic Act within 15 days.

Before concluding that they must also; “take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice.”

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