Key Takeaways:

  • The 2018 Farm Bill created the possibility that hemp-derived products, such as cannabidiol (CBD), could legally be used in food, beverages, and dietary supplements, but the Food and Drug Administration (FDA or Agency) has not yet promulgated regulations governing the use of CBD in these products.
  • In January 2023, the FDA denied industry petitions for CBD to be included in products marketed as dietary supplements under the current regulatory regime but signaled a willingness to work with Congress on creating a different regulatory pathway.
  • On March 17, 2023, two CBD-related bills were reintroduced in the House to regulate CBD products as dietary supplements and to regulate the use of CBD in food and beverage products.
  • As the Farm Bill reauthorization looms, stakeholders should monitor these and other forthcoming legislative proposals and engage with Congress accordingly.

On the heels of a January 2023 statement released by the FDA expressing the need for a new regulatory pathway for cannabidiol products, two CBD-related bills were reintroduced in the House of Representatives on March 17, 2023. The first bill, H.R. 1629, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023, seeks to make hemp, CBD derived from hemp, and other hemp-derived products lawful for use in dietary supplements, while a second bill, H.R. 1628, the CBD Product Safety and Standardization Act, seeks to regulate CBD products like food or beverage additives.

The 2018 Farm Bill and Prior History of Related Bills to Regulate CBD

In the Agriculture Improvement Act of 2018, ("Farm Bill"), Congress modified the definition of marijuana under the Controlled Substances Act (CSA), thereby removing restrictions on the cultivation of hemp. The legislation also expanded the statutory definition of hemp to include cannabinoids, so long as it meets certain conditions. However, the Farm Bill maintained the FDA's authority to establish regulatory guidelines for hemp-derived products, like CBD.

Following passage of the Farm Bill, the market for CBD products increased dramatically, but the FDA has yet to issue regulations governing the use of CBD and has refused to accept CBD as a new dietary ingredient or food additive. The FDA has instead maintained a policy of enforcement discretion, choosing to prioritize its enforcement activities on companies that make egregious and unsubstantiated claims about their CBD products, make their products appealing to children, or sell products that may be mistaken for traditional foods or that are otherwise unsafe. The FDA has also issued public statements explaining its concern regarding the safety of CBD as a food additive or dietary ingredient. As a result of the lack of a clear regulatory pathway, and concern that the market was overrun with unsafe and underregulated products, lawmakers introduced these bills during the 117th Congress to establish standards for the use of CBD in food, beverage, and dietary supplements products. Lawmakers championing these initiatives have previously expressed frustration that the Agency was reluctant to engage with lawmakers or initiate federal rulemaking to regulate such products.

Since both lead sponsors retired last Congress, these bills are now being led by Rep. Morgan Griffith (R-VA) and Rep. Angie Craig (D-MN). Griffith was the lead Republican sponsor last Congress, and he and Craig both sit on the Energy and Commerce Health Subcommittee, which has oversight over FDA issues. Notably, Craig is from Minnesota, which has one of the most liberal hemp-derived cannabinoid laws nationally. With the Farm Bill due for reauthorization this year, it is likely there will be a bipartisan push to tackle these and other issues —such as clarifying the definition of "hemp"— that have been left unaddressed since passage of the 2018 law.

The FDA's Position on CBD

Notwithstanding the reintroduction of these bills, the FDA's position with respect to the inclusion of CBD in dietary supplements and food (as explained in the January 2023 statement and our prior alert) remain unchanged. Based on a review of published scientific literature, information submitted to a public docket, as well as studies conducted and commissioned by the Agency, the FDA does not believe that CBD products could meet safety standards for dietary supplements or food additives. According to the FDA, certain questions revolving around how much CBD can safely be consumed, and, for how long without causing harm, remain scientifically unaddressed. Because of this, the FDA has chosen not to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods through the traditional pathways.

However, per the January 2023 statement, the FDA is prepared to work with Congress on a new, non-dietary supplement/non-conventional foods regulatory pathway for CBD products. According to the statement, the Agency envisions that the new regulatory pathway would provide additional safeguards and oversight to manage the risks associated with CBD products. Such safeguards may include CBD content limits, procedures to prevent contaminants, modified labeling requirements, and measures such as minimum age requirements to mitigate the risk of ingestion by children. The Agency most likely will advocate for authorities to regulate CBD products and, most likely, other cannabis-derived products recreationally and/or for general purpose use—potentially through the creation of another FDA Products Center.

The Industry's View on the FDA's Position and Moving Forward

The CBD industry has been actively requesting that the FDA provide more guidance and flexibilities for CBD to be included in dietary supplements. In January, the FDA denied the request in three petitions from various groups requesting that the FDA allow for legal marketing of dietary supplements containing CBD derived from hemp based on the lack of available scientific evidence. The effect of the FDA's decision has taken the air out of some parts of the CBD industry due to continued uncertainty. Many companies and individuals who were initially excited to invest in an up-and-coming industry are now taking steps back financially. The lack of regulations is also affecting farmers who have seen little benefit from their production of hemp. The "gray market" is still likely to survive though as many CBD stores are continuing with their sale and marketing of CBD products. Those who would prefer the legal route are hoping for legislation or some type of regulation to come soon, as many see the gray market as having deceptive practices that maybe causing more harm.

The legislative path forward for CBD products is not clear, but the Farm Bill reauthorization is a viable and logical pathway for considering these issues. A legislative proposal establishing a new regulatory pathway consistent with the FDA's planned approach has not yet been introduced but may be imminent. (The bills mentioned above have instead centered on the FDA's existing authorities.) A broader bill that may resurface is the Cannabis Administration and Opportunity Act (CAOA), which was introduced by Sens. Cory Booker (D-NJ), Chuck Schumer (D-NY), and Ron Wyden (D-OR) last year. CAOA is a comprehensive bill that would decriminalize, regulate, and tax cannabis (i.e. not just CBD). Among other provisions, CAOA would establish a Center for Cannabis Products within the FDA to regulate the production, manufacturing, labeling, distribution, sales, and promotion of cannabis products. The Marijuana Opportunity Reinvestment and Expungement Act (the MORE Act), an even broader decriminalization bill that did not establish a separate cannabis center at the FDA, narrowly passed the House on April 1, 2022.

Stakeholders should monitor the Farm Bill reauthorization closely and consider engaging directly with the champions of these and other cannabis-related bills that may be forthcoming, key members of the House and Senate Agriculture committees, as well as Senate offices engaged on CBD issues. Bipartisan, bicameral support for any proposals involving the regulation of CBD is critical if they are to be seriously considered for inclusion in the Farm Bill. Both the House and Senate Agriculture committees are accepting comments and ideas related to the 2023 Farm Bill.

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