Bioque Technology – FDA Warning Letter, Aug 31, 2012

On October 5, 2012, the FDA issued a Warning Letter to Bioque Technologies after reviewing their website, bioque.com, in August 2012. The FDA determined that Bioque's products, including Serum XL, Serum Rejuvenate, C-Plus Moisturizing Cream, and others, are promoted with claims that cause them to be classified as drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the FFDCA.

The claims, such as "Argireline provides all the muscle-relaxing properties of BOTOX®" for Serum XL and "Damaged skin cells repair themselves" for Serum Rejuvenate, indicate the products are intended for disease treatment, prevention, or to affect body structure/function. These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Marketing these new drugs without prior FDA approval via an approved New Drug Application (NDA) violates section 505(a) of the Act.

Bioque Technologies is required to take prompt action to correct all violations. Failure to do so may result in enforcement actions, including injunctions and product seizure. The company must respond in writing within 15 working days, detailing corrective steps, an explanation of how similar violations will be prevented, or provide