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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.

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.”

In late August, the Department of Health and Human Services recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substance Act. Meanwhile Congress is weighing a bill that would create federal safe harbors for financial institutions to accept deposits from state-sanctioned marijuana business operators. Read on for details

Gov. Gavin Newsom recently signed into law the California Food Safety Act and amendments to the 2020 Toxic-Free Cosmetics Act. Together, they ban four additives commonly used in popular snacks and beverages, and an additional 26 chemicals found in many personal care products.

Read on for details about these developments impacting food and personal care