FDA WARNING_LETTER - Synticare Corp - February 28, 2013

The FDA reviewed Synticare Corp.'s website, www.macularvitamin.com, in February 2013 and determined that their macular degeneration products (Maximum Lutein, AREDS 1, AREDS 1 Smokers, AREDS 2, Combo AREDS 1 and 2, and Combo Smokers AREDS 1 and 2) are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The website's therapeutic claims, such as "proven supplement (AREDS) for age related macular degeneration" and "treatment of choice by eye doctors," establish the products' drug intent for cure, mitigation, treatment, or prevention of disease.

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 and lack prior FDA approval, violating section 505(a). Furthermore, the products are misbranded under section 502(f)(1) because macular degeneration is not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided. The introduction of misbranded drugs into interstate commerce violates section 301(a).

Synticare Corp. must take prompt action to correct these violations and notify the FDA in writing within fifteen working days of receipt of the letter,