CBD Rejected as a Dietary Supplement by the FDA

The US Food and Drug Administration (FDA) recently elected not to regulate cannabidiol (CBD) products as a dietary supplement.

The Background

The market for CBD products continues to grow at an exceptionally high rate; because of this, the hemp industry and several members of congress have pushed for the FDA to begin regulating CBD products as dietary supplements as far back as 2018.

The Decision

After careful review, the FDA determined that there was not substantial evidence to show that CBD products would meet the safety standards for dietary supplements or food additives, and thus would not be regulated as such. The agency’s reasoning was as follows:

“Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)].

Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.”

To this day, there are only three FDA-approved cannabis/CBD products, and they are only available via a prescription from a licensed healthcare provider. The agency remains adamant that all other cannabis and CBD products may not be marketed as being able to treat diseases or having any other therapeutic use.

Tighter Regulations

The FDA also announced that CBD products require a “new regulatory pathway”, and that the agency is prepared to work with congress in order to develop these new regulations. Among the new requirements would be clear labeling, prevention of contaminants, limits on CBD content, and measures to prevent youths from using or ingesting the products.

Further details and FAQ’s about the regulation of hemp, cannabis, and CBD products can be found on the FDA’s website.

Moving Forward

DOT contractors and employees should continue to be wary of CBD products to ensure DOT compliance; some CBD products have been found to contain THC as well, which will elicit a positive result on any drug test.

TEAM will continue to monitor new movements in regards to CBD and THC products, and share any new developments on our Industry News page.