Why Your Brewery Shouldn’t Make CBD-Infused Beer
August 20, 2019
“Hemp” was exempted from the definition of marijuana in the federal 2018 Farm Bill. Since then, the Alcohol and Tobacco Tax and Trade Bureau (TTB) has received inquiries on whether breweries can produce alcoholic beverages containing hemp-derived ingredients, including cannabidiol (CBD).
Hemp is now legal under state and federal law, but the TTB has determined that CBD currently is not a permitted ingredient in beverages.
There are two separate wheels turning here. While the TTB regulates the use of hemp in alcoholic beverages, the U.S. Food and Drug Administration (FDA) has broader regulatory authority over hemp- and cannabis-derived products
The FDA has determined that hulled hemp, hemp seed protein powder and hemp seed oil are generally recognized as safe. But the agency also maintains that CBD is not a permitted ingredient in food or dietary supplements under federal law.
The FDA is in the process of reevaluating this position. Meanwhile, the TTB has said it will not approve alcohol beverage formulas that contain certain hemp ingredients, including CBD.
The TTB regulates alcohol beverage formulas, including those containing non-traditional ingredients such as hemp-derived products, for products sold exclusively intrastate. The FDA regulates interstate commerce, which means food, beverages and dietary supplements produced and sold in a single state may go beyond the agency’s regulation. Hence, the TTB has indicated that it will not likely approve formulas containing any other hemp derived ingredients — such as CBD — pending a determination by the FDA that such products are safe as food additives.
In April, the TTB said it would look to the FDA’s determinations on whether hemp ingredients such as CBD can be included in food or alcohol. The FDA has determined that three hemp derivatives (hulled hemp, hemp seed protein powder and hemp seed oil) are generally recognized as safe and can be legally marketed in human foods. But current FDA laws prohibit the introduction or delivery of CBD-infused products into interstate commerce.
Does the FDA govern your local brewery?
Many New York State breweries sell and distribute beer at a local level, conducting most, if not all, of their business within the state. Does this mean that FDA laws and regulations don’t apply to those businesses? The law in this area is rather ambiguous and has yet to be litigated in the specific realm of CBD-infused beer. But what remains clear is that the FDA’s regulatory reach is expansive.
Historically, the FDA has obtained jurisdiction over businesses solely engaged in intrastate commerce where one ingredient or product was shipped to the company across state lines. There have also been cases where the FDA obtained jurisdiction over a business because its product was sold to a consumer who then transported the product across state lines.
The bottom line is that the FDA has broad authority to regulate and breweries conducting business solely within New York State are not free from its grasp. Arguably, any New York brewer pouring a pint for an out-of-state consumer or brewing beer with hops grown outside the state is engaged in interstate commerce and subject to FDA governance.
The FDA has issued warning letters to companies selling CBD products and the FDA’s laws and regulations prohibiting the interstate transport of drug-infused foods provide for civil and criminal penalties.
The FDA’s Position on CBD
The FDA is responsible for making sure that what we eat and drink is safe. Therefore, it’s understandable that the FDA is trying to slow down the CBD craze across the country to make sure that CBD products don’t put consumers at risk. As the law stands now, it is unlawful to add CBD to a food (or beverage).
Currently, the FDA is taking a science-based approach to CBD in assessing whether to approve it as a safe food additive. It is compiling clinical research regarding the effects of CBD and continuing to address aspects of CBD use that remain uncertain and need to be studied further.
The FDA recently opened the CBD conversation up to public comment, where it received input from stakeholders in all industries regarding topics such as new scientific research and suggestions for regulatory approval. The public comment period closed on July 16.
The Future of CBD-Infused Beer
It is unlikely the TTB will approve CBD-infused beer formulas until it receives guidance or approval from the FDA. And while we know that the FDA’s process for approving drugs can take years — if not decades — the FDA has suggested that it is committed to evaluating the use of CBD as a food or dietary supplement, which requires more relaxed approval procedures. It will continue to gather data and conduct research regarding the safety of CBD, but in the meantime, it holds firm to its position that it is unlawful to add CBD as a drug or dietary supplement to any food — including beer.