FDA WARNING_LETTER - GCHNC LLC dba Hemp XR/Gate City Hemp dba Hemp XR/Allaziya Enterprises, LLC dba Hemp XR - September 28, 2023

The FDA issued a Warning Letter to Alaa Odeh Mahmoud Hamed and Abdulraouf B. Allamandani, operating hemp-xr.com, after reviewing their website in September 2023. The letter identifies several Delta-8 THC and CBD-containing products as adulterated foods and subject to prohibited acts under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, multiple Delta-8 THC products, including cookies, crispy bites, gummies, and honey, are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act because Delta-8 THC is considered an unsafe food additive, lacking FDA approval and not generally recognized as safe (GRAS). Introducing these adulterated foods into interstate commerce is prohibited under section 301(a). FDA expressed serious public health concerns regarding Delta-8 THC's unapproved status, adverse event reports, psychoactive effects, manufacturing processes, and potential appeal to children.

Similarly, the Hemp XR CBD Honey 500 MG product is adulterated under section 402(a)(2)(C)(i) as CBD is also an unsafe food additive, not GRAS, and not FDA-approved. Its introduction into interstate commerce is prohibited under section 301(a). Furthermore, introducing this CBD product is a prohibited act under section 301(ll) because CBD is an active ingredient in an approved drug and has been subject to substantial clinical investigations. FDA highlighted potential harms from CBD, including liver injury, drug interactions, and reproductive issues.

The firm must respond in writing within fifteen working days, outlining corrective actions and preventative measures, with supporting documentation. Failure to comply may lead to legal action, including seizure and injunction.