FDA WARNING_LETTER - Newhere Inc dba CBDFX - November 21, 2022

The FDA reviewed cbdfx.com and associated social media in October 2022, identifying multiple violations regarding CBD-containing human and animal products.

**Violations and Deficiencies:**

* **Adulterated Human Foods:** Flavored Chill Shots, Mixed Berry Gummies 1500mg, and CBD Cookies with Protein 20mg are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act because they contain CBD, an unsafe food additive. CBD is not approved as a food additive and is not generally recognized as safe (GRAS). * **Prohibited Act (301(ll)):** Introducing these human food products into interstate commerce is prohibited under section 301(ll) of the FD&C Act, as CBD is an active ingredient in an approved drug (Epidiolex) and has been subject to substantial clinical investigations. * **Unapproved New Drugs (Human):** Numerous CBD-containing human products (e.g., Chill Shots, Gummies, Vape Pens, Tinctures, Balms, Creams) are marketed with claims establishing their intended use as drugs (e.g., for sleep, pain relief, anxiety, COVID-19 protection, depression). These are unapproved new drugs under section 505(a) and 301(d) of the FD&C Act, as no FDA-approved