White Label Leaf, LLC/Flying Monkey US, LLC – FDA Warning Letter, Jul 23, 2024

On July 11, 2024, the FDA issued a Warning Letter to Jonathan and Zachary Daye, owners of Flying Monkey, following a May 2024 review of their website, https://flyingmonkeyusa.com. The FDA determined that the company's Delta-8 THC products, specifically Flying Monkey Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies, are adulterated foods and unapproved new drugs.

The products are deemed adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) because they contain Delta-8 THC, an unsafe food additive. Delta-8 THC is not approved as a food additive, nor is it generally recognized as safe (GRAS) for use in conventional foods. Introducing adulterated food into interstate commerce is a prohibited act under section 301(a) of the Act.

Furthermore, the products are considered unapproved new drugs under section 201(g)(1)(B) of the Act, as evidenced by claims on the website suggesting their use for disease treatment or affecting body structure/function. These products are not generally recognized as safe and effective for their intended uses, making them "new drugs" under section 201(p) of the Act. Marketing unapproved new drugs violates sections 505(a) and