M&A; Caribbean Traders, Inc – FDA Warning Letter, Mar 31, 2014

The FDA issued a Warning Letter to M&A Caribbean Traders, Inc. on March 28, 2014, following a review of their website, www.MegaGraviola.com, in March 2014. The FDA determined that the company was promoting the product MegaGraviola for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the website, such as "lowers blood pressure," "anti-bacterial," and claims of killing various cancer cells (e.g., ovarian, colon, breast), treating fever, flu, skin disease, diarrhea, dyspepsia, influenza, herpes, rheumatism, diabetes, arthritis, and reducing tumor size, establish the product's intent for use in the cure, mitigation, treatment, or prevention of disease. The website also featured testimonials claiming the product caused tumors to disappear and helped with chemotherapy side effects.

These claims render MegaGraviola a "new drug" under section 201(p) of the Act, as it is not generally recognized as safe and effective for these uses. Introducing a new drug into interstate commerce without prior FDA approval violates sections 505(a) and 301(d) of the Act. Furthermore, the product is deemed misbranded under section 502(f)(1) of the Act because