The Alcohol and Tobacco Tax and Trade Bureau (TTB) recently issued an industry circular which makes clear that cannabidiol (CBD), a product derived from hemp, is not permitted in alcohol beverages.
TTB generally consults with the U.S. Food and Drug Administration (FDA) when establishing whether an ingredient for use in an alcoholic beverage is safe. Last December, the Agriculture Improvement Act of 2018, which is commonly referred to as the 2018 Farm Bill, was enacted. The 2018 Farm Bill amended the definition of marijuana under the Controlled Substances Act to exempt “hemp”, which is defined as:
the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9-tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. Source: 7 U.S.C. 1639 o(1).
Following passage of the 2018 Farm Bill, FDA Commissioner Scott Gottlieb, MD, issued a statement in December noting that the use of CBD and delta-9-tetrahydrocannabinol (THC) in food is still prohibited. As explained in Commissioner Gottlieb’s statement and an accompanying FDA guidance document, Sections 301(ll) and 201(ff)(3)(B) of the Federal Food, Drug and Cosmetic Act prohibit foods and dietary supplements from containing CBD and THC because they are active ingredients in approved drugs. FDA has recently approved Epidiolex, a drug that contains purified form of CBD for the treatment of seizures for certain conditions, as well as Marinol and Syndros, drugs which include the active ingredient dronabinol, a synthetic form of THC.
TTB previously issued guidance in May 2018 that allowed the use of hemp ingredients, such as hemp, hemp seed, and hemp oil in approved alcoholic beverage formulas. This guidance was issued prior to both the enactment of the 2018 Farm Bill and FDA’s December 2018 announcement that it had no questions regarding the generally recognized as safe (GRAS) notices submitted by Fresh Hemp Foods Ltd. for the use of hulled hemp seed, hemp seed oil, and hemp seed protein powder in foods.
According to the industry circular, TTB will not approve any formulas that contain ingredients that are controlled substances under the CSA, even if the ingredient meets the new definition for hemp. However, certain alcohol beverages may still be legally marketed as containing hemp according to the circular, so long as those products contain only hemp seeds or hemp oil as both TTB and FDA have approved those ingredients as permitted food additives. For any formulas that contain hemp ingredients other than hemp seeds or hemp seed oil, TTB will return those applications for correction.
While TTB generally takes a conservative approach to labeling, TTB generally will permit graphics and terminology on the label that accurately and specifically identify the use of a hemp derived ingredient. TTB will generally not approve labels that create a misleading impression that the product contains marijuana or has similar effects to those of a controlled substance.
The FDA is holding a public hearing on May 31, 2019, where it is seeking data and information regarding the safety of products containing CBD. Because TTB closely consults with FDA regarding the safety of ingredients, alcoholic beverage manufacturers interested in using CBD and hemp ingredients in their products should seriously consider monitoring this meeting and possibly testifying or submitting comments to FDA.
Husch Blackwell has experience working with alcoholic beverage companies on these types of regulatory matters. Our Cannabis, Alcohol and Beverage, and FDA lawyers are available to discuss the TTB announcement and upcoming meeting. Contact Adena Santiago, Seth Mailhot, Emily Lyons or your Husch Blackwell attorney.