Another federal agency has weighed in on the rules governing hemp-derived products in the food supply. Specifically, a division of the Treasury Department clarified lat last month that CBD from hemp cannot be added to alcoholic beverages at this time.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) said in an industry circular released on April 25 that it had received “many inquiries from industry members” asking whether they can add ingredients derived from hemp, which was federally legalized under the 2018 Farm Bill, to alcohol.
While the agency said it is in the process of revising its guidelines, for now it is deferring to the Food and Drug Administration (FDA) with respect to adding CBD to beer, wine and liquor. The FDA has stated numerous times that hemp-derived CBD currently cannot be lawfully marketed, though it is also investigating alternative regulatory pathways to change that rule.
“After consultation with FDA, as set forth in more detail below, 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),” TTB wrote. “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. TTB will continue to process applications for formulas for alcohol beverages that contain ingredients derived from hemp seeds or hemp seed oil.”
The National Law Review first reported on the TTB memo.
— National Law Review (@natlawreview) May 6, 2019
Before hemp was federally legalized—and regulatory responsibility for the crop shifted from the Justice Department to the U.S. Department of Agriculture—TTB issued earlier guidance stipulating that hemp ingredients (except hemp seed or hemp seed oil) couldn’t be added to alcoholic drinks because the prior version of the Farm Bill prohibited hemp from being used “for the purpose of general commercial activity.”
TTB left open the possibility that formulas containing hemp-derived CBD could be approved down the line if FDA determined that it could be lawfully marketed in food products. Companies would still have to submit formula applications to TTB before selling the products, though.
For companies that want to market alcoholic beverages containing hemp seeds or hemp seed oil, which is permissible, they must first “submit laboratory analyses of ‘hemp’ ingredients to ensure that the ingredients are not controlled substances.”
“TTB will not approve any formulas or labels for alcohol beverage products that contain a controlled substance under federal law, including marijuana,” the agency wrote. “In determining whether an ingredient is a controlled substance, TTB will continue to consult with the Drug Enforcement Administration where appropriate.”
Further, “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 [Food, Drug, and Cosmetic Act].”
The agency made clear that it will be following FDA actions and guidance on CBD closely as it continues to review its existing policies. That includes monitoring what comes out of a May 31 public hearing the FDA announced that it will be holding to gather input from industry stakeholders.
It should be noted that while FDA currently prohibits hemp-derived CBD products from being added to the food supply, and TTB said it also won’t allow CBD-infused alcohol, multiple companies continue to market such products. The FDA explained that it was prioritizing enforcement in cases where companies make exaggerated and unsanctioned claims about the health benefits of their products.
Photo courtesy of Marilyn Acosta.