A29: Will TTB approve any formulas or labels for alcohol beverage products that contain a controlled substance under Federal law, including marijuana?
TTB will not approve any formulas or labels for alcohol beverage products that contain a controlled substance under Federal law, including marijuana. The Controlled Substances Act (CSA), 21 U.S.C. § 802(16), defines marijuana as all parts of the Cannabis sativa L. plant (and its derivatives) with certain specific exclusions. Substances (such as tetrahydrocannabinols (THC), cannabidiols (CBD), or terpenes) that are derived from any part of the cannabis plant that is not excluded from the CSA definition of marijuana are controlled substances, regardless of whether such substances are lawful under State law. See Drug Enforcement Administration (DEA), Clarification of the New Drug Code (7350) for Marijuana Extract for more information about DEA's position on cannabis derivatives. The parts of the cannabis plant that are excluded from the definition of marijuana in the CSA (referred to here as "hemp" ingredients) include hemp seed oil, sterilized hemp seeds, and non-resinous, mature hemp stalks.
Formula approval from TTB is required before a hemp ingredient may be used in the production of an alcohol beverage product. In determining whether a hemp ingredient is allowable for use in an alcohol beverage, TTB will consult with the DEA where appropriate and defers to the DEA in its interpretation of the CSA.
TTB also consults with the U.S. Food and Drug Administration (FDA) on ingredient safety issues where appropriate. In some cases, TTB may require formula applicants to obtain documentation from FDA indicating that the proposed use of an ingredient in an alcohol beverage would not violate the Federal Food, Drug and Cosmetic Act. For more information, see TTB Industry Circular 2019-1, Hemp Ingredients in Alcohol Beverage Formulas.
For alcohol beverage products containing a hemp ingredient, the product label must accurately and specifically identify the ingredient in a manner that makes it clear that the ingredient is not a controlled substance (e.g., "hemp seed oil" rather than "hemp oil"). Additionally, labeling statements for alcohol beverage products may not create the misleading impression that the product contains a controlled substance or has effects similar to those of a controlled substance.
For more information, including requirements for lab analysis of hemp components, please refer to the "Hemp Policy" published by our predecessor agency in 2000.
TTB notes that section 7606 of the Agricultural Act of 2014, commonly referred to as the Farm Bill, defines "industrial hemp." See 7 U.S.C. 5940. Subject to certain restrictions, this law allows an institution of higher education or a State department of agriculture to grow or cultivate industrial hemp for purposes of research where allowed under State law. As explained by the Statement of Principles on Industrial Hemp which was issued by USDA, in consultation with DEA and FDA, and published in the Federal Register on August 12, 2016, section 7606 does not authorize the sale of industrial hemp "for the purpose of general commercial activity." Accordingly, it is TTB's understanding that the Farm Bill does not authorize the use of industrial hemp in the production of alcohol beverage products for sale beyond limited State-sanctioned pilot projects by authorized entities.