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FDA issues warning letter to Strivectin

The FDA has issued a letter to Strivectin regarding two products that were found to be in violation of section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act.

The products, Potent Wrinkle-Reducing Treatment and TL Advanced Tightening Neck Cream, were indicated by claims on the company’s website as being intended to affect the structure or a function of the human body, thus classifying them as drugs under FDA regulations.

According to the letter, introducing or delivering these products for introduction into interstate commerce for such purposes violates the Act. The products are at fault with the FDA because they are not recognized among qualified experts as safe and effective for such purposes.

Strivectin will have 15 working days to respond to the letter and must list the steps that will be taken to correct the violations.

Reference: www.fda.gov.