What happened
Original notice title
TKO Distribution, LLC MARCS-CMS 696557, April 17, 2025
From the archived source record
FDA has determined that your Trippy Smak’d Fuk’d Blend Watermelon 1500 mg Gummies, Trippy Smak’d Fuk’d Blend Pineapple 1500 mg Gummies, and Trippy Smak’d Fuk’d Blend Grape 1500 mg Gummies are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the Act, 21 U.S.C. 331(a). FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has expressed serious concerns about products containing Delta-8 THC. Our concerns include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. This letter is to inform you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers. Adulterated Human Foods According to your product labeling, your Trippy Smak’d Fuk’d Blend Gummy 1500 mg Delta-8 gummy products in pineapple, grape and watermelon flavors are foods to which Delta-8 THC has been added. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the Act (21 U.S.C. 348(a)) and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act, 21 U.S.C. 342(a)(2)(C)(i).
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
- 50775b988ff7
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.
Sources, dates, and coverage →