Hello, FDA? The Industrial Hemp Industry Would Like to have a Word with You!

Background: 2018 Farm Bill Legalizes Industrial Hemp Cultivation

In December of 2018, the 2018 Farm Bill (the “Farm Bill”) was signed into law by the Federal government. Among other things, the Farm Bill legalized the production of industrial hemp as an agricultural commodity and removed hemp and derivatives of cannabis with extremely low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (“THC”), such as cannabidiol (“CBD”), from the definition of marijuana in the Controlled Substances Act (“CSA”). 

Prior to the enactment of the Farm Bill, the CSA did not differentiate between marijuana and hemp, and therefore, all cannabis (with certain exceptions) was a Schedule I substance. Pursuant to the passage of the Farm Bill, hemp and certain hemp derivatives like CBD are no longer classified as Schedule 1 substances under Federal law and therefore the criminal laws that once applied to the sale of industrial hemp and hemp derivatives like CBD are no longer applicable. 

At the Federal level, industrial hemp cultivation now falls under the purview of the United States Department of Agriculture (“USDA”), while the inclusion of hemp and hemp derivatives like CBD in food products, drugs, dietary supplements, and cosmetics now falls under the purview of the Food and Drug Administration (the “FDA”). 

The FDA Fails to Issue Regulations for Processed Industrial Hemp Products

Even though the Farm Bill preserved the FDA’s authority to regulate processed industrial hemp products under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), the FDA has been slow to act and has NOT adopted any formal regulations about the inclusion of industrial hemp or hemp derivatives in food products, drugs, cosmetics, or dietary supplements. In response to the FDA’s lack of action, many States have passed regulations and issued guidance to those wishing to engage in the manufacture and sale of products containing hemp derived cannabinoids. 

The Reason for the FDA’s Lack of Industrial Hemp Product Regulations

Although the FDA’s work related to COVID-19 vaccines is likely one of the reasons that the FDA has been slow to adopt industrial hemp product regulations, it does not account for the entirety of the nearly four (4) years that have passed since industrial hemp and certain industrial hemp derivatives were de-scheduled under the CSA. This fact is not lost on the FDA’s new Commissioner, Robert M. Califf, M.D. who was sworn into office on February 17, 2022. 

While speaking before a subcommittee of the United States House of Representatives Appropriations Committee (the “Committee”) on May 19, 2022, Commissioner Califf noted that the FDA has made little progress with regard to regulating industrial hemp products since the signing of the 2018 Farm Bill. Commissioner Califf stated that the FDA has spent much of the time that has elapsed since the Farm Bill was signed on sampling and researching the numerous “derivatives of the cannabis plant” that exist to determine what risks are associated with the use of the “material” in its “various forms”. Commissioner Califf, who also served as FDA Commissioner from February 2016 to February January 2017, acknowledged that his office worked on the issue of industrial hemp regulation in 2016 and that upon his return to the FDA earlier this year, things “look pretty much the same” as they did in 2016. 

A New Regulatory Process?

Many had hoped that the nomination and confirmation of an FDA Commissioner after over a year without one would spark movement with regard to the FDA’s regulations of industrial hemp products, unfortunately that does not appear to be the case. While Commissioner Califf noted that he is very committed to “taking a path” on industrial hemp product regulation, he also stated that he does not think that the “current authorities [the FDA] ha[s] on the food side or drug side necessarily give us what we need to have to get the right pathways forward. We are going to have to come up with something new and I’m very committed to do that.” When questioned by Representative Mark Pocan, a Democrat from Wisconsin, about whether or not the FDA anticipates that it will regulate CBD infused edible products as “food” or “food additives”, he responded “the research so far has shown that there are some risks with CBD, so we’re going to need a different pathway than just the standard food pathway.

It is unclear if Commissioner Califf’s comments were meant to signal a need for Congress to expand the role of the FDA, however, it’s clear that Commissioner Califf believes a new regulatory process will be needed for the FDA to regulate industrial hemp products and cannabinoids like CBD. With so many Americans already buying, selling, and consuming industrial hemp products like CBD infused candy and tinctures, members of the Committee expressed frustration and concern over the FDA’s lack of progress. 

Conclusion: The Hemp Industry Must Hold the FDA Accountable

Though Commissioner Califf could not provide a plan or timeline for the adoption of hemp or CBD regulations, he did express a strong desire to work with Congress on the subject moving forward.  Given Commissioner Califf’s comments about his willingness and desire to make real progress on the FDA’s industrial hemp product and derivative regulations, now is the time for the industrial hemp community to apply pressure to ensure that he actually does so.

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