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FDA Warning Letter Declares Delta-8 and CBD Gummies ‘Adulterated Foods’

By Allyson M. Maur & Royce DuBiner on December 15, 2023
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On Dec. 6, the U.S. Food and Drug Administration sent a warning letter to the owners of online hemp, tetrahydrocannabinol and cannabidiol retailer Hemp-xr.com for introducing adulterated foods into interstate commerce. FDA took issue with certain cookies, edibles, gummies and honey containing delta-8 THC and CBD because they “bear or contain an unsafe food additive.” Read on for details about this development and implications for the cannabis and marijuana industries.

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Photo of Allyson M. Maur Allyson M. Maur

Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more.

Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more. Allyson’s healthcare regulatory work ranges from clinical bioethics and informed consent issues to counseling on compliance with U.S. federal fraud, waste, and abuse laws such as the Anti-Kickback Statute, Stark Law, Sunshine Act, and their state law equivalents, as well as HIPAA, state healthcare privacy laws, change of ownership and state licensing requirements for various healthcare and healthcare adjacent entities.

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Photo of Royce DuBiner Royce DuBiner

Royce practices food and drug law with a focus on advising pharmaceutical, medical device, cannabis, dietary supplement, tobacco, food and beverage companies as well as investment firms on a range of regulatory matters. He is presently the lead of the Cannabis, Hemp, and…

Royce practices food and drug law with a focus on advising pharmaceutical, medical device, cannabis, dietary supplement, tobacco, food and beverage companies as well as investment firms on a range of regulatory matters. He is presently the lead of the Cannabis, Hemp, and CBD industry team.

Read more about Royce DuBinerEmail
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  • Posted in:
    Corporate & Commercial
  • Blog:
    One-Stop Shop
  • Organization:
    McGuireWoods LLP
  • Article: View Original Source

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