FDA WARNING_LETTER - Alternative Laboratories - June 10, 2019

The FDA issued a Warning Letter to a dietary supplement manufacturer in Naples, FL, following an inspection from May 29-31, June 3, and June 10, 2019. The letter addresses violations concerning several products, including Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa.

The primary violation involves the declared ingredient 2-amino-5 methylheptane and Octodrine (DMHA). The FDA states that DMHA is a "new dietary ingredient" for which no pre-market notification was submitted, rendering the products adulterated under sections 402(f) and 413(a) of the Federal Food, Drug, and Cosmetic Act (the Act). The FDA also notes a lack of evidence establishing DMHA's safety as a dietary ingredient. Furthermore, if DMHA is not a dietary ingredient, it would be considered an unsafe food additive, leading to adulteration under section 402(a)(2)(C)(i) of the Act.

Additionally, the "CBD oil" (550mg) distributed under the "Green Roads" brand is labeled as a dietary supplement but does not meet the definition, as CBD is an active ingredient in an approved drug product (Epidiolex) and has been authorized for investigation as a new drug,