FDA WARNING_LETTER - Pharmaterra, Inc. - July 31, 2013

The FDA reviewed PharmaTerra.com in July 2013 and determined that the product "ProBeta" is promoted for conditions that classify it as a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). The website makes therapeutic claims, including "Natural Blood Sugar Balancer," and references research and testimonials indicating its use for the cure, mitigation, treatment, or prevention of diseases like Type I and Type II diabetes, and pre-diabetes. Specific claims include reductions in fasting blood glucose, HbA1c, and insulin requirements, and increases in endogenous insulin production.

Because ProBeta is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act. Introducing a new drug into interstate commerce without prior FDA approval violates section 505(a) and 301(d) of the Act. Furthermore, ProBeta is misbranded under section 502(f)(1) of the Act because adequate directions for use cannot be written for self-diagnosis and treatment by laypersons.

Even if not classified as a drug, ProBeta is misbranded as a dietary supplement under section 403(q)(1)(A)(i) and 403(q)(1)(B) of the Act because its label fails to list the serving size and servings per container as