FDA WARNING_LETTER - Glytain

On July 15, 2013, the FDA issued a Warning Letter to Internal Remedies, Inc. dba Glytain, following a January 2013 review of their website, www.glytain.com. The FDA determined that the product "Glytain" was promoted for the prevention and treatment of diabetes, both on its label and website.

The FDA cited that these claims establish "Glytain" as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], as it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of "Glytain" with these claims violates the Act.

Examples of claims included "Control your Diabetes Naturally," "Glytain is an all natural treatment for diabetes that...can help to naturally reduce blood sugar levels," and "Glytain is an all natural dietary supplement that works with your body to lower your blood sugar naturally." The letter also noted the commercial use of scientific publications and metatags like "Natural diabetes treatment" as evidence of the product's intended drug use.

"Glytain" is considered a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it