The U.S. Alcohol and Tobacco Tax and Trade Bureau (“TTB“) has joined the discussion regarding the legality of hemp and hemp-derived additives in consumable items. In a bureau-wide bulletin, the agency addressed wineries, distilleries, breweries, and importers hoping to add ingredients like cannabidiol (“CBD“) into their products. While the TTB is currently updating their own guidelines on the inclusion of hemp, they reinforce some of the regulatory concerns issued in previous notices from state and federal authorities with respect to the Controlled Substances Act (“CSA“).
“It remains TTB’s policy that it will not approve any formulas for alcohol beverages that contain ingredients that are controlled substances under the CSA,” agency administrator John Manfreda explains. “Even if an ingredient derived from cannabis is not a controlled substance because it meets the new definition of ‘hemp,’ TTB continues to consult with the U.S. Food and Drug Administration (‘FDA‘), to determine if the use of hemp ingredients would violate the Federal Food, Drug, and Cosmetic Act (‘FD&C Act’).”
The TTB will continue to process formula applications for alcohol beverages specifically infused with hemp seed or hemp seed oil, however, the agency announced they will return applications with all other hemp ingredients for correction. These returned applications may be resubmitted if granted FDA approval through obtaining a notice of Generally Recognized as Safe (“GRAS“) status. As Manfreda explains, “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.”
Following the Agriculture Improvement Act of 2018’s passing, the TTB has continued to require that all alcohol beverages containing hemp derivatives undergo formula approval in accordance with agency regulations, such as laboratory testing. Consulting with the FDA on current drug scheduling, TTB formula approval is withheld if a controlled substance is present in the lab analyses. Noting federal acknowledgment of the additional chemicals present in cannabis, Manfreda goes on to say, “ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of section 301(ll) of the FD&C Act, and therefore might be able to be added to food.”
With TTB guidance referring further regulatory supervision to the FDA, industry participants and consumers again look towards the FDA’s scheduled meeting on the safety of products laced with cannabis or cannabis-derived compounds. The public hearing is currently scheduled for May 31 at the FDA’s White Oak Campus in Maryland.
For information on the TTB’s rules for alcohol beverage formulas and labels, click here.
For more information on the FDA’s current cannabis or cannabis-derived product guidelines, click here.