Warning letter · FDA Warning Letters

Dr. Smoke, LLC aka Dr. S, LLC: FDA Warning Letter 648825 (Jun 29, 2023)

Agency action: Jun 29, 2023Record ID: fda_warning_-497e908d985f5964
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What happened

Original notice title

Dr. Smoke, LLC aka Dr. S, LLC MARCS-CMS 648825, June 29, 2023

From the archived source record

FDA has determined that your Cheetos Crunchy Flamin’ Hot THC Infused Chips and Doritos Nacho Cheese THC Infused Chips are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 FD&C 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 (e.g., candy, chips, and beverages) 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 As noted in the warning, the agency received over 125 adverse event reports from January 1, 2021, through May 31, 2022, related to children and adults who consumed edible products containing THC. Adulterated Human Foods According to your product labeling, your Cheetos Crunchy Flamin’ Hot THC Infused Chips and Doritos Nacho Cheese THC Infused Chips 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 FD&C Act (21 U.S.C. 348(a)) and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under 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.

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Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
14c6b2f0e81d

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 →

What is affected

Product
Delta-8 THC-containing products; Cheetos Crunchy Flamin’ Hot THC Infused Chips; Doritos Nacho Cheese THC Infused Chips
Company
Dr. Smoke, LLC aka Dr. S, LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.