Recently, the TTB expounded on its 2018 guidance regarding hemp derivatives (THC and CBD) to change the status for a few hemp derivatives while it works on an updated guidance. Since the Farm Bill from 2018 excluded “hemp” from the definition of marijuana under the Controlled Substances Act, the TTB wanted to address queries about producing alcoholic beverages with ingredients like CBDs derived from hemp.
In the 2018 guidance, the TTB informed brewers, distillers, vintners (everybody) that they would not approve formulas or labels for alcoholic beverages that contained controlled substances under Federal law.
In the new 2019-1 notice, the TTB states that it will not approve any formulas for alcohol beverages that contain ingredients that are controlled substances and even if a cannabis derived substance meets the updated Farm Bill definition of “hemp” the TTB will conslut with the FDA to determine whether its use violates the Food Drug and Cosmetic Act.
The update goes on to let industry members know that the TTB will return applications for formulas containing hemp ingredients other than those derived from hemp seeds or hemp seed oil. And that applicants for other derivatives will have the option to resubmit upon favorable approval (individual determination) from the FDA of their ingredients.
The notice reminds alcoholic beverage producers that even beverages sold exclusively in intrastate commerce require formula approval and that laboratory analysis of “hemp” ingredients is still required to ensure the ingredients are not controlled substances under Federal law.
With regard to testing and FDA approval which you can then take to the TTB – information about the recommended toxicological testing for ingredients used in food and contact information for general questions can be found on the FDA website. Applicants seeking to obtain an individual response on the regulatory status of their ingredient (e.g., via a GRAS notice) should contact FDA’s Office of Food Additive Safety directly at (240) 402-1200 before conducting studies or preparing documentation.