What happened
Original notice title
Mary Jane's Bakery Co. LLC MARCS-CMS 678010, July 15, 2024
From the archived source record
FDA has determined that your Stoney Sour Gummy Bears: 1,000mg Delta-8 THC, Stoney Ranchers Hard Candy: 1,000mg Delta-8 THC, Dank Ropes: 1,000mg Delta-8 THC, Stoney Patch Sour Watermelon Slices: 1,000 mg Delta-8 THC, Slizzles: 1,000mg Delta-8 THC, Flaming Hot Weedos: 1,000mg Delta-8 THC, and Trips Ahoy Chocolate Chip Cookies: 1,000mg Delta-8 THC products 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. 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). This letter is to inform you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers. FDA is particularly concerned that your products are in forms (candy, chips, and cookies) that are appealing to children, that mimic well-known snack food brands by using similar brand names, logos, or pictures on packaging, and that consumers may confuse with traditional foods. Therefore, with these products there is a risk of unintended consumption of the Delta-8 THC ingredient by consumers. In June 2022, FDA warned consumers about the accidental ingestion by children of food products containing THC. 1 From January 1, 2021, through December 31, 2023, FDA received over 300 adverse event reports describing children and adults who consumed Delta-8 THC products. Nearly half of the reports involved hospitalization or emergency department visits, and approximately two-thirds described adverse events after ingestion of Delta-8 THC-containing food products such as candy or brownies. Adulterated Human Foods According to your product labeling, your Stoney Sour Gummy Bears: 1,000mg Delta-8 THC, Stoney Ranchers Hard Candy: 1,000mg Delta-8 THC, Dank Ropes: 1,000mg Delta-8 THC, Stoney Patch Sour Watermelon Slices: 1,000 mg Delta-8 THC, Slizzles: 1,000mg Delta-8 THC, Flaming Hot Weedos: 1,000mg Delta-8 THC, and Trips Ahoy Chocolate Chip Cookies: 1,000 mg Delta-8 THC are products to which Delta-8 THC has been added.
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
- 69dc76eb38ff
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 →