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Some Regulatory Updates

by | May 13, 2019 | alcohol beverage law, cannabis, Tied House, Trade Practice, Wholesalers

Post 2018 Farm Bill, TTB Addresses Hemp Ingredients in Alcohol Beverage Formulas

Recently, the TTB added to its on its 2018 guidance regarding hemp derivatives (THC and CBD) in light of the Farm Bill from 2018 which excluded “hemp” from the definition of marijuana under the Controlled Substances Act.

Since the 2018 Farm Bill excluded “hemp” from the definition of marijuana under the Controlled Substances Act (CSA), TTB has received many inquiries from industry members about whether they may produce alcohol beverages containing ingredients, such as cannabidiol (CBD), derived from “hemp.” TTB is in the process of updating its guidance on the use of ingredients from hemp to reflect the recent changes to the law.

In the interim, 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. Even if an ingredient derived from cannabis is not a controlled substance because it meets the new definition of “hemp,” TTB will continue to consult with the FDA to determine if the use of hemp ingredients would violate the Federal Food, Drug, and Cosmetic Act (FD&C 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. TTB will continue to process applications for formulas for alcohol beverages that contain ingredients derived from hemp seeds or hemp seed oil.

Recent Amendment to Law

The 2018 Farm Bill amended the definition of marijuana under the Controlled Substances Act (CSA), 21 U.S.C. § 802(16), to exempt “hemp,” which is defined in section 10113 as follows:

“The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”

The law explicitly reserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act.

Existing TTB Guidance on Hemp Ingredients

Prior to the enactment of the 2018 Farm Bill, TTB issued guidance on the use of “hemp” ingredients in alcohol beverages. While TTB updates their guidance on the use of hemp in alcohol, they remind industry members that alcohol beverages containing “hemp” ingredients (including alcohol beverages sold exclusively in intrastate commerce) continue to require formula approval under TTB regulations.

TTB will continue to require formula applicants to submit laboratory analyses of “hemp” ingredients to ensure that the ingredients are not controlled substances under Federal law. TTB will not approve any formulas or labels for alcohol beverage products that contain a controlled substance under Federal law, including marijuana. In determining whether an ingredient is a controlled substance, TTB will continue to consult with the Drug Enforcement Administration where appropriate.

Consultation with FDA

As TTB noted in its guidance, TTB also consults with 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 FD&C Act.

After enactment of the 2018 Farm Bill, FDA Commissioner Scott Gottlieb, M.D., issued a statement noting that it remains unlawful under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any food to which CBD or THC has been added. On April 2, 2019, Dr. Gottlieb announced that FDA will hold a public hearing on May 31, 2019, in part to obtain scientific data and information about the safety of products containing cannabis or cannabis-derived compounds.FDA also updated its website to include FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers. Among other things, the updated Questions and Answers note that 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. However, FDA stressed that food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the requirements for food additive approval and substantiation of evidence for Generally Recognized as Safe (GRAS) status.

FDA has advised us that, in evaluating the safety of any food ingredient, the agency applies the rigorous, science-based food safety standards in the FD&C Act and implementing regulations. 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.

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The foregoing was prepared as general information. It is not meant to provide legal advice granting any specific matter and should not be acted upon without professional counsel. If you have questions or require additional information regarding these or other related matters, please contact Malkin Law, P.A. This material may be considered attorney advertising under certain rules of professional conduct.