Last week, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued Industry Circular 2019-1 addressing the inclusion of hemp ingredients in alcoholic-beverage formulas. The Circular indicates that the TTB received a number of inquiries about whether it would approve the production of alcoholic beverages containing ingredients—like cannabidiol (CBD)—derived from hemp. For now, the answer is no, but that could change after the FDA holds its first public hearings on CBD on May 31.
The Circular states that per TTB policy, the TTB will not approve any formulas for alcoholic beverages that contain controlled substances under the CSA. But after the passage of the Farm Bill in December 2018, hemp (which contains a low percentage of THC) is no longer a controlled substance and neither is CBD derived from hemp. Nevertheless, the TTB is not green-lighting CBD-infused alcoholic beverages, relying on recent comments from former FDA Commissioner Scott Gottlieb where he stated that it remains unlawful under the Food, Drug, and Cosmetic Act to introduce or deliver for introduction into interstate commerce any food to which CBD or THC has been added. Instead, the “TTB has determined that, at this time, it will return for correction any applications for formulas containing ‘hemp’ ingredients (other than ingredients derived from hemp seeds or hemp seed oil). Applicants will have the option of resubmitting the formula to TTB upon receipt of a favorable individual determination from FDA on the regulatory status of their ingredients.”
A “favorable individual determination from the FDA on the regulatory status of their ingredients” could come soon. The FDA’s May 31 public hearing is expected to highlight the widespread use of CBD in food and beverage products and put increased pressure on the FDA to allow those products in some capacity. We will be monitoring the hearing and reporting on any significant events.
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