The FDA continues to show that it is not interested in regulating hemp-derived products

Last week, the Food and Drug Administration (the “FDA”) maintained its strict and narrow stance on the legality of cannabidiol (“CBD”) by rejecting two new dietary ingredient (“NDI”) notifications from Charlotte’s Web and Irwin Naturals. Both companies applied for approval from a government agency to market their full-spectrum hemp extract as a “dietary supplement”.

In their letters to these two big brands, the FDA pointed out two main reasons for their rejection:

1. Drug exclusion rule: Since CBD is an active ingredient in an approved drug (e.g. Epidiolex), CBD is exempt from the definition of “dietary supplement” according to the Federal Law on Food, Drugs and Cosmetics (the “FDCA”); and therefore cannot be marketed as a dietary supplement.
2. Insufficient data: The FDA raised safety concerns about the adequacy of the evidence presented by both companies. In particular, the Agency noted: (a) the “vagueness” of the preclinical and clinical studies submitted which, in its view, did not allow a sufficient comparison of the history of use with the proposed conditions of use for the companies’ hemp extracts; and (b) failure to adequately address certain toxicity endpoints, including reproductive toxicity.

Photo by BATCH of Wisconsin Hemp Scientific via Unsplash

The FDA’s conclusions are disappointing because both companies:

1. The distinction between full-spectrum products such as their extracts from CBD isolate, the substance contained in Epidiolex, was addressed.
2. They provided ample evidence, including published peer-reviewed toxicological studies and years of practical safety evidence, that their products can be marketed in ways that are reasonably expected to be safe.

The FDA’s objections seem to suggest that the agency is sticking to hemp-based CBD companies to a higher standard for NDIs. This dynamic reinforces the need for Congress to participate in paving a legal path for the sale and marketing of CBD products made from hemp. Laws like HR 841 that would exempt hemp CBD from the drug exclusion rule would also play a critical role in advancing the amount of data needed to support successful NDI for these products.

RELATED: Congress Denies the DEA (Horrible) Hemp Rule

As suggested by several stakeholders, the FDA’s objection to Charlotte’s Web and Irwin Naturals’ NDI reports shows once again that the agency does not intend to create a regulated market for CBD products. Additionally, by rejecting the NDI notifications from these two reputable companies, the FDA is deterring the industry from requiring compliance and filing their own NDI notifications.

Photo by Iryna Veklich / Getty Images

Ironically, by delaying its rulemaking process and failing to implement meaningful reforms around CBD products, the FDA has created the very problem it points to in justifying its position: the proliferation of mislabeled and unsafe products.

The FDA’s continued reluctance to find a legitimate legal route for CBD products is unsustainable. By failing to perform its administrative duties quickly, the FDA continues to deny the CBD industry the ability to succeed and jeopardize the very task the agency is responsible for: protecting public health and safety.

Nathalie Bougenies is an attorney with Harris Bricken. This article was originally published on the Canna Law Blog and is republished with permission.