FDA WARNING_LETTER - Infusionz, LLC - November 21, 2022

The FDA issued a Warning Letter to CBD Infusionz on November 16, 2022, following a review of their website and social media in October 2022. The letter states that the company sells various human and animal products containing cannabidiol (CBD).

The primary violation cited is that all strengths, varieties, and flavors of CBD gummies, fruit snacks, gum, candy, oil/tinctures, and lollipops are adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. 342(a)(2)(C)(i)] because they contain an unsafe food additive (CBD). The FDA asserts that CBD is not a generally recognized as safe (GRAS) substance for use in conventional foods and lacks premarket approval as a food additive. Introducing these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. 331(a)].

Furthermore, the letter highlights that it is a prohibited act under section 301(ll) of the FD&C Act [21 U.S.C. 331(ll)] to introduce into interstate commerce any food to which a drug approved under section 505 of the FD&C Act, or for which substantial clinical investigations have been instituted