FDA WARNING_LETTER - Alfa Vitamins Laboratories, Inc. - May 31, 2012

The FDA issued a Warning Letter to Alfa Vitamins Laboratories, Inc. on July 12, 2012, following a May 2012 review of their websites (www.alfavitaminsonlinestore.com and www.amazon.com). The FDA determined that 15 of their products, including Alfa's Sugar Control, Aloe Vera, and Noni capsules, were 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 therapeutic claims made in English and Spanish on their website, such as "May help those who suffer [sic] AIDS, arthritis, rheumatism, diabetes, tumors, ulcers and cancers" for Cat's Claw, and "It is recommended to patients with diabetes" for Alfa's Sugar Control, establish their intended use in the cure, mitigation, treatment, or prevention of disease. These claims, along with metatags like "diabetes relief" and "anti-cancer herbs," violate the Act.

The FDA states that these products are "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for the claimed uses and lack prior FDA approval. Furthermore, the products are deemed "misbranded" under section 502(f)(1) of the Act because adequate directions for use cannot be provided for self-diagnosis