FDA WARNING_LETTER - Nature Cast Products

The FDA issued a Warning Letter to Naturecast Products following a review of their website, www.naturecastproducts.com, in April 2013. The agency determined that the firm's products, Eradicator and Nature?s Gold, are illegally promoted for the treatment of diabetes, classifying them as unapproved drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Therapeutic claims, such as Eradicator's ability to "eradicate the causes of uncontrolled blood sugar" and Nature's Gold's role in "reducing inflammation" related to diabetes, establish their drug intent. Consequently, these products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their intended uses. Marketing these new drugs without prior FDA approval violates section 505(a) of the Act. Furthermore, the products are misbranded under section 502(f)(1) because diabetes is not amenable to self-diagnosis and treatment, meaning adequate directions for use cannot be provided for a layperson. The introduction of these misbranded drugs into interstate commerce also violates section 301(a). Naturecast Products must promptly correct these violations and notify the FDA in writing within fifteen working days, detailing corrective actions and preventive measures. Failure to comply may result in regulatory actions like seizure or injunction.