FDA WARNING_LETTER - Amafruits

On July 21, 2017, the FDA issued a Warning Letter to Amafruits LLC, following a May 2017 review of their website (www.amafruits.com), Facebook page (https://www.facebook.com/amafruits/), and Twitter page (www.twitter.com/amafruits). The FDA determined that Amafruits' products—Acai Fruit Puree, Acerola Fruit Puree, Cupuacu Fruit Puree, Goiaba Fruit Puree, and Graviola Fruit Puree—are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because of therapeutic claims made on the company's website, social media, and a document collected at the 2017 Natural Products Expo West trade show. Examples of claims include "protecting against some chronic diseases, including cancer, cardio- and cerebro-vascular, atherosclerosis and diabetes," "natural remedy for fever and dystentery," "lowering of blood pressure," and "can kill over 12 types of cancer!"

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses, lacking prior FDA approval. Their introduction into interstate commerce without approval violates sections 301(d) and 505(a). Furthermore, the products are misbranded under section 5