FDA WARNING_LETTER - Capris Associates Inc. / BR Naturals - February 11, 2019

The FDA issued a Warning Letter to BR Naturals, specifically to CEO Boris Novosel, on February 5, 2019, following a review of their websites (www.brnaturals.com, www.amazon.ca/brnaturals), social media (www.facebook.com/BRNaturals, www.twitter.com/BRNaturals), and blog (www.brnaturals.blog) in October 2018.

The FDA determined that BR Naturals' products—Avocado Oil, Black Seed Oil, Moringa Powder, Premium Olive Oil D.O.P., Pumpkin Seed Oil, and Unrefined Coconut Oil—are promoted with claims that establish them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). These claims, found across their online platforms, suggest the products are intended for the cure, mitigation, treatment, or prevention of diseases such as Alzheimer's, Parkinson's, multiple sclerosis, colds, flu, intestinal parasites, epilepsy, high blood pressure, asthma, colon cancer, opiate addiction/withdrawal, Hashimoto’s disease, ulcers, leaky gut, colitis, atherosclerosis, and brain cancer.

Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act, requiring prior FDA approval.