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December 12, 2019

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Bill Introduced to Protect State Cannabis Programs from Federal Interference

As previously reported on this blog, while the 2018 Farm Bill removed hemp from the Controlled Substances Act, its passage did not affect FDA’s authority to regulate cannabidiol (CBD) or other hemp products in FDA-regulated products. In December 2018, FDA released a statement clarifying that it is illegal to sell a food or dietary supplement that contains added CBD or THC in interstate commerce. Five months later, during a public hearing on products containing cannabis or cannabis-derived compounds, Acting FDA Commissioner Ned Sharpless, MD, reiterated that under current federal law, CBD cannot lawfully be added to a food or marketed as a dietary supplement. He also expressed concern about the lack of research to support CBD’s use in FDA-regulated products. (See our June 4, 2019 blog for more details.)

On June 27, 2019, U.S. Senator Ron Wyden (D-OR) and U.S. Representative Earl Blumenauer (OR-03) introduced the State Cannabis Commerce Act, which would permanently protect all state cannabis programs from federal interference and allow for interstate cannabis commerce between states. The legislators point out in a press release that since 2014, “federal law has prohibited the Department of Justice (DOJ) from using taxpayer funds to prevent states from implementing their own state laws that authorize the use, distribution, possession or cultivation of medical marijuana.” The State Cannabis Commerce Act would expand that law to include all cannabis producers or consumers who transport cannabis between states that have legal cannabis programs and where the states agree to the transportation.

Concerning the bill, Sen. Wyden stated: “As more and more states legalize cannabis, the gap between state and federal laws will only grow more confusing for both legal businesses and consumers. He added that, “the federal government needs to end its senseless and out of touch prohibition.”

Two days prior to issuing the legislation, on June 25, Sen. Wyden urged FDA in a letter to “immediately issue enforcement discretion guidance not later than August 1, 2019…to ensure a regulatory pathway for lawful use of CBD in a food additive and as a dietary ingredient in a dietary supplement.” However, as previously reported on this blog, FDA’s Principal Associate Commissioner for Policy, Dr. Amy Abernethy, reiterated in a June 14 2019 statement that outstanding questions related to the safety of CBD products must be addressed before a regulatory framework can be established for lawfully marketing foods and dietary supplements containing CBD. Responses to FDA’s request for information on safety (including whether there is a threshold level that could appropriately be considered safe), manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds are due by July 16, 2019 (See docket, FDA-2019-N-1482).

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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...

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