What happened
Original notice title
Delta 8 Hemp MARCS-CMS 618368, May 04, 2022
From the archived source record
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). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). 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. Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. This letter is to inform you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers. Unapproved New Human Drugs Based on a review of your websites, your Delta-8 THC products for humans are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Misbranded Human Drugs Your Delta-8 THC products for humans are misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- c1e65a93685f
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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