News and Announcements

The FDA’s New Stance On Cannabidiol (CBD)

Marguerite Arnold
Written by Marguerite Arnold

The American Food and Drug Administration is slowly but surely changing its stance on CBD. While its latest information page (current as of March 11, 2020) is quick to point out the problems of a still vastly under if not unregulated national market, it is refreshing to see an American federal agency express genuine interest in learning more about the general topic.

The General Information Available
The new site is broken down broadly into consumer information, FDA communications about CBD and regulatory resources and questions and answers. Underneath are valuable links to a range of topics from the Federal Register to public docket information. However with titles like “What You Need To Know (And What We’re Working To Find Out)” it is clear that a new day has dawned on the CBD front at a major American regulatory body.

Blame It On the 2018 Farm Bill

The Agriculture Improvement Act of 2018 (aka the Farm Bill) changed everything. Namely, the bill establishes a state-USDA process for the regulation of hemp as a crop, and gives the federal Department of Agriculture (USDA) the authority to issue federal regulations and guidelines. The bill also defined the federal level of tetrahydrocannabinol (THC) allowed in cannabis derivatives – namely not more than 0.3% on a dry weight basis.

The Farm Bill also removed hemp from the definition of “marijuana” in the Controlled Substances Act. This is also clearly an attempt to differentiate hemp from cannabis strains with higher concentrations of THC.

FDA Support For Cannabis Drug Development
The FDA will, as a result of this interaction, of course now be directly involved in the development of cannabinoids as medicine. The FDA is already providing digital guidance via its new updated webpages on how to initiate research studies.

Cannabinoids And Food
CBD and THC are still banned from being food additives. That change of course will only come with more widespread studies, which will of course, from now on, directly have to involve the FDA.

A Strange Little Deviation On Hemp Seeds
The FDA will not interfere in the production and selling of products derived from hemp seeds (including hemp seed oil) if the products are properly labelled and in other ways comply with FDA food safety guidelines (no use of toxic chemicals, for example).

Just as on other CBD products, however, hemp-seed derived extracts, edibles and other products must not make unscientifically-based claims about curing any type of disease.

The New Guidance On Cosmetics

The FDA is refusing to give premarket approval for cosmetic products (with the exception of colour additives). Further all “cosmetics” with any kind of hemp derivative must also be topical products that are not marketed as “drugs” or “cures” without being specifically approved by the FDA as such.

Labelling
This is of course a place where the entire industry has suffered from a lack of federal guidance. The FDA will of course play a role in all cannabis labelling on a federal level (even for state markets). This includes things like how much of each cannabinoid, if not other ingredients are marked clearly on the outside of packaging.

A New Day For Cannabis At The FDA?

It is clear from both their redesigned website as well as presentations they have increasingly made over the last year that the FDA intends to play an ongoing and developing role in the regulation of the hemp (and beyond that cannabis) market in the United States.

Sources:

FDA Role in Regulation of Cannabis Products, Presentation to NIDA, February 2019

Photo credit: The Food and Drug Administration (FDA Lab at Building 64 in Silver Spring)

About the author

Marguerite Arnold

Marguerite Arnold

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