The U.S. Food and Drug Administration holds its position with respect to the newly legalized compound – CBD which is known to have healing properties that can reduce anxiety, stress, inflammation, swelling, improve sleep patterns and also treat severe ailments like cancer, epilepsy and Alzheimer’s. The agency is yet to announce its regulatory framework for CBD infused food and beverages. A public meeting will be held on May 31 where lawmakers, consumers and the FDA representatives would decide on cannabis-based edibles.
In the meantime, another federal agency has weighed in on the rules that govern hemp-derived cannabinoid-based edibles. A division of the Treasury Department clarified last month that CBD from hemp can not be added or infused to alcoholic beverages at this time.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) revealed in an industry circular released on April 25 that the agency has been receiving numerous inquiries from industry members about whether they can add hemp derived CBD, which was federally legalized under the Farm Bill 2018, to alcohol-based beverages.
The agency said that while the process for determining a safe method to infuse cannabinoid in alcoholic beverages is on its way, for now it defers from the Food and Drug Administration (FDA) with respect to adding CBD to beer, liquor or wine. The FDA has been quite stringent about its regulations regarding CBD infused edibles, it has stated several times that using hemp-derived CBD in edibles cannot be lawfully marketed currently. It is finding out an alternative regulatory model to change the rule.
TTB wrote,“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).”
It further added that applicants will have the option for resubmitting the formula to the agency upon receipt of a favourable individual from the FDA on the regulatory quotient of their ingredients. TTB will continue to process applications for formulas for alcoholic beverages that contain even traces of the hemp-derived cannabinoid.
Companies that produce cannabidiol infused alcoholic beverages need to comply with the rules set by TTB and submit laboratory analysis of the hemp ingredients in their products to ensure that they align with the regulatory limits set by the agency. Even for marketing purposes of their product, they have to go through this process to avoid any prosecution or legal charges.
The TTB will not approve any formulas or labels for alcohol beverage products that contain a controlled substance under the federal law, including marijuana. Only hemp-derived CBD with limited amounts of other chemicals that are legal and comply with the federal law would be permitted to be marketed and sold in the consumer market. In order to ensure the concentration of the ingredients in the products, TTB will consult will the Drug Enforcement Administration whenever needed.
Further, TTB would require companies to bring in documentation approved and signed by the 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 it quite clear that it will be following FDA actions and guidelines on CBD based edibles as it continues to review the existing policies.
The FDA will decide on the regulatory framework for CBD after the much awaited public hearing on May 31, where it will gather input from the industry stakeholders. Despite of the FDA and TTB’s strict rules against using CBD in edibles, many companies are using the ingredient in their product and marketing it.
From alcoholic beverages to tincture oils, CBD is being infused in a gamut of products without the permission from FDA. Till now, the FDA has issued warning letters to 3 different companies for marketing their CBD infused products as an alternative cure to Cancer.