# FDA WARNING_LETTER - Dr. Smoke, LLC aka Dr. S, LLC - July 05, 2023

Source: https://www.keypedia.com/records/warning_letter/dr-smoke-llc-aka-dr-s-llc/e2ba08b7-8317-4324-981f-371d9d3a84c4

> FDA WARNING_LETTER for Dr. Smoke, LLC aka Dr. S, LLC on July 05, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dr. Smoke, LLC aka Dr. S, LLC
- Inspection Date: 2023-07-05
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA and FTC issued a Warning Letter to DrSmoke.com after reviewing their website in December 2022 and June 2023, identifying the sale of human products containing Delta-8 THC, specifically "Cheetos Crunchy Flamin’ Hot THC Infused Chips" and "Doritos Nacho Cheese THC Infused Chips."

The FDA determined these 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 Delta-8 THC is an unsafe food additive. It is not approved, nor is there a basis for it to be Generally Recognized As Safe (GRAS) for use in conventional foods. Introducing adulterated food into interstate commerce is prohibited by section 301(a) of the FD&C Act, 21 U.S.C. 331(a). The FDA expressed serious concerns about Delta-8 THC products, including lack of evaluation/approval, adverse event reports, psychoactive effects, manufacturing processes, and appeal to children.

The FTC cited Section 5 of the FTC Act, prohibiting unfair or deceptive marketing practices. The products' packaging mimics well-known snack brands, making them appealing to children and increasing the risk of accidental ingestion, which has led to numerous adverse events.

DrSmoke.com must notify the FDA within fifteen

## Related Officers

- [Director](https://www.keypedia.com/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)
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Company: https://www.keypedia.com/companies/dr-smoke-llc-aka-dr-s-llc/43a77c97-cb3b-4a63-81fa-2d0e7924f32c

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2