Delta 8 Hemp

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your website establish that your products, some of which are available in multiple varieties, “Delta 8 THC Distillate Oil," “Delta 8 THC Vape Cartridge,” “Delta 8 THC Disposable Vape Pen,” “Delta 8 THC Tincture,” “Delta 8 Infused Gummies,” and “Delta 8 Infused Sour Gummies” (hereinafter referred to as “Delta-8 THC products for humans”), are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

Passage 2

Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).

Passage 3

FDA has also determined that your “Delta 8 Infused Gummies” and “Delta 8 Infused Sour Gummies” products 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 bear or contain an unsafe food additive.