By: Ryan Udell and William L. Doerler
In late 2018, President Trump formally signed the Agricultural Improvement Act of 2018 (2018 Farm Bill) into law, and in turn declassified hemp as a Schedule 1 substance under the Controlled Substances Act (CSA). Hemp is defined, in part, as the plant Cannabis sativa L. and any part of that plant, including the seeds thereof, with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis. Thus, cannabis plants and derivatives that contain no more than 0.3 percent THC – the ingredient attributed with marijuana’s psychoactive effects – are no longer controlled substances under Federal law. The change in the law renewed interest in developing and marketing products containing cannabis and cannabis-derived products, including products containing hemp and cannabidiol (CBD), another cannabis component.
FDA Announces a Public Hearing
Although the Food and Drug Administration (FDA) acknowledges that the regulatory oversight of products containing cannabis or cannabis-derived compounds is complex, involving multiple Federal and State agencies, the FDA recognizes that these products may be putting the health and safety of consumers at risk because manufacturers and sellers market these products in ways that violate the Food, Drug and Cosmetic Act. Thus, the FDA announced a public hearing, scheduled for May 31, 2019, to “obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds.” As stated by the FDA, the goal of the hearing is to inform the FDA’s regulatory path forward. Although the FDA does not expect this hearing to produce decisions or new positions on specific regulatory issues, it expects the hearing to be an important step in its continuing evaluation of cannabis and cannabis-derived components in FDA-regulatory products.
At the hearing, the FDA will ask stakeholders to share their experiences with products containing cannabis and cannabis-derived compounds. In addition, the FDA will solicit stakeholders’ views on the safety of these products and input relevant to the FDA’s strategy for regulating these products.
On the issue of the use of CBD in dietary supplements and other foods, the FDA is interested in obtaining information about, among other things: (1) particular safety concerns the FDA should consider regarding its regulatory oversight and monitoring of these products; (2) whether there are special human populations that should be considered when assessing the safety of products containing cannabis and cannabis-derived compounds; (3) the characteristics of a successful system to collect representative safety information at the national and state level; (4) the endpoints or outcomes that would define a maximal acceptable daily intake from all products; (5) data to support the safe use of cannabis and cannabis-related compounds in general food use; and (6) how the existing commercial availability of food products containing cannabis-derived compounds such as CBD affect the incentives for, and the feasibility of, drug-development programs involving such compounds.
The FDA will accept electronic or written comments related to the issues addressed at the hearing until July 2, 2019.
TTB Issues Industry Circular
On April 25, 2019, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an Industry Circular entitled Hemp Ingredients in Alcohol Beverage Formulas to the “[p]roprietors of Bonded Wineries, Bonded Wine Cellars, Taxpaid Wine Bottling Houses, Beverage Distilled Spirits Plants, Breweries, Importers, and [o]thers.” As noted in the circular, the “TTB is in the process of updating its guidance on the use of ingredients from hemp to reflect the recent changes to the law.” Thus, after consulting with the FDA, the TTB announced that it “will return for correction any applications for formulas containing ‘hemp’ ingredients (other than ingredients derived from hemp seeds or hemp seed oil)” and applicants will have the option of resubmitting the formula to the TTB “upon receipt of a favorable individual determination from [the] FDA on the regulatory status of their ingredients.” However, the TTB reminded winery owners and others that the TTB will continue its policy of not approving any alcoholic beverage formulas that contain ingredients that are controlled substances under the CSA.
Based on the forgoing, the government clearly has an interest in regulating food products and alcoholic beverages containing cannabis and cannabis-derived compounds including hemp and CBD. Thus, individuals and entities involved in the food and/or alcoholic beverage manufacturing or processing industry should closely monitor the cannabis-related announcements and guidance documents from governmental agencies such as the FDA and the TTB.