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COWEN
COLLABORATIVE INSIGHTS

February 25, 2019

supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug."

In response to Gottlieb’s statement, Sens. Ron Wyden (D-Ore.) and Jeff Merkley (D-Ore.) sent a letter to the FDA on Jan. 15 urging the agency to update federal regulations governing the use and interstate sale of certain hemp-derived ingredients in food, beverages or dietary supplements. The two senators, who authored the 2018 Farm Bill’s Hemp Farming Act provision, indicated that it was "Congress’ intent to ensure that both U.S. producers and consumers have access to a full range of hemp-derived products, including hemp-derived cannabinoids." They requested feedback from FDA within 30 days on the agency’s specific plans regarding implementation of the 2018 Farm Bill.

Sample Of FDA Warning Letters On CBD Products:

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm616278.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm583192.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm583197.htm

Notable State-Level Events

California

California has historically been more aligned with the FDA’s stance that industrial hemp-derived CBD cannot be used in food or dietary supplements. However, that state does permit the sale of food products with cannabis-derived CBD in licensed dispensaries. The Food and Drug Branch of California Department of Public Health (CDPH) issued an updated FAQ on CBD in food products in July 2018 indicating that its definition of "food" does not include cannabis products like edibles, which are legal in California. CDPH also technically bans the sale of CBD oil outside of licensed cannabis retailers, though it isn’t always enforced.

Separately, California Governor Jerry Brown signed a law in late September 2018 (Assembly Bill 2914) that bans the addition of CBD or THC to any cocktail at a public establishment. The new law "prohibit[s] an alcoholic beverage licensee from, at its licensed premises, selling, offering, or providing cannabis or cannabis products, including an alcoholic beverage that contains cannabis or cannabis products, and would provide that no alcoholic beverage shall be manufactured, sold, or offered for sale if it contains tetrahydrocannabinol or cannabinoids, regardless of source."

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