May 26, 2020

Update on the Regulation of CBD-Infused Products

  • As previously reported on this blog, state regulators want a role in the regulation of CBD-infused food, beverages, and supplements. And while industry has been pressuring Food Drug Administration (FDA) to create a pathway for the lawful use of CBD in food and dietary supplements, currently, under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD (or cannabidiol) cannot lawfully be added to a food or marketed as a dietary supplement.

  • Washington State Department of Agriculture (WSDA) updated its website this month to clarify that hemp-derived CBD is not permitted as a food ingredient or additive. WSDA points out that while food processors licensed in the state of Washington may currently use certain hemp products in foods—such as hulled hemp seeds, hemp seed protein power, and hemp seed oil—”[o]ther parts of the hemp plant, including CBD, cannot be used as a food ingredient under a Washington State Food Processor License.” The department further states, “Recognizing that these recent changes in law may have caused some confusion in the manufactured-food industry, WSDA has been reaching out to the industry so they can take appropriate actions, such as removing CBD ingredients from their products or discontinuing distribution of CBD-containing food products in the state.”

  • As recently as last week, Cara Welch, FDA’s Acting Special Assistant to the Deputy Commissioner for Policy Legislation & International Affairs, reminded attendees at the American Herbal Products Association Hemp-CBD Supplement Congress that it is prohibited to add CBD to food. Noting that, “There is still a significant amount of missing data to better understand the effects on human exposure and the long-term effects of regular consumption,” Welch pointed out that some studies show some toxic effects on the liver in high doses, and there is inadequate research about the use of CBD by pregnant or nursing mothers or people with low immunity (see U.S. News). She added, “We’re trying to be as transparent and informative as possible on these issues, and to resolve open questions quickly, efficiently, but also thoughtfully.”

  • Preliminary data on the growth of hemp-derived CBD was presented during the AHPA Congress. AHPA reports in a press release on the Hemp-CBD Congress that, hemp-derived CBD sales ballooned to $238 million, an increase of 57% in 2018 over the previous year, according to Nutrition Business Journal. Additionally, hemp acreage under license across the U.S. increased nearly five-fold in the past year from 112,000 acres in 2018 to 480,000 acres in 2019, according to data gathered by advocacy group We will continue to report on developments in the regulation of CBD-infused food, beverages, and supplements.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...