StriVectin Hit with Warning Letter

The Food and Drug Administration (FDA) has sent a warning letter to StriVectin after reviewing the company’s website in December 2014. Based on the review, FDA says the company takes orders for “Potent Wrinkle Reducing Treatment” and “TL Advanced Tightening Neck Cream,” which appear to be  drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1) (C)].
 
According to the FDA letter, which is dated Feb. 12, 2015, examples of some of the claims on the website include:
 
Potent Wrinkle Reducing Treatment:
•  “Clinically proven to change the anatomy of a wrinkle”
•  “This superb age-fighting serum is super charged with …potent elastin stimulating peptides….”
•  “Potent elastin-stimulating peptides help enhance skin structure ….”
 
TL Advanced Tightening Neck Cream:
•  “#1 Selling Neck Cream. Now even more tightening, lifting…”
•  “[F]eatures breakthrough Gravitite-CF Lifting Complex to restore the elastin fiber architecture, providing noticeable lift and improving resistance to gravity.”
•  “Breakthrough Gravitite-CF Lifting Complex [an ingredient in your product] contains a  powerful blend of active ingredients that stimulate elastin synthesis…”
 
FDA says the compnay's “Potent Wrinkle Reducing Treatment” and “TL Advanced Tightening Neck Cream” 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)], according to the FDA letter.