FDA WARNING_LETTER - Strivectin Operating Company

The FDA issued a Warning Letter to StriVectin Corporate Headquarters after reviewing their website, strivectin.com, in December 2014. The FDA determined that two products, "Potent Wrinkle Reducing Treatment" and "TL Advanced Tightening Neck Cream," are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because their website claims indicate they are intended to affect the structure or function of the human body. Examples of such claims include "Clinically proven to change the anatomy of a wrinkle," "Potent elastin-stimulating peptides help enhance skin structure," and "[F]eatures breakthrough Gravitite-CF Lifting Complex to restore the elastin fiber architecture, providing noticeable lift and improving resistance to gravity."

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses. Under Section 505(a) of the Act, new drugs cannot be legally marketed in the U.S. without prior FDA approval via a New Drug Application (NDA).

StriVectin was requested to take prompt action to correct the violations and notify the FDA in writing within fifteen working days of receipt of the letter, detailing the specific steps taken to correct the violations and prevent recurrence. Failure to comply could result in enforcement actions such as injunctions or product seizure.