INSIGHTS BLOG > The FDA’s Refusal to Provide Clear Guidelines for CBD Activity is Unconscionable

The FDA’s Refusal to Provide Clear Guidelines for CBD Activity is Unconscionable

Written on 22 December 2022

by Ruth Fisher, PhD

Image Source: https://www.tasnimnews.com/en/news/2020/10/20/2372978/cbd-oil-may-protect-against-covid-19-lung-damage-research

2021 CBD sales surpassed $5B.^[1]

Since CBD was initially legalized under the 2018 Farm Bill, the FDA has reserved the right to enforce prohibitions on CBD in supplements and food products.^[2] The FDA has continually delayed release of guidelines for industry participants to help clarify the FDA's position/intentions.^[3] The most recent refusal to clarify its position on CBD (April 2022) elicited the following comment by Steve Mister, president and CEO of the Council for Responsible Nutrition:

We know some companies have gone in and presented safety data to the agency, but there just doesn’t seem to be any forward movement there ... We’ve really put our focus on Congress. We think we’re going to have to change the statute because there just doesn’t seem to be any interest at FDA in trying to find a pathway forward.^[4]

Personally, I think it's criminal that the FDA can force this type of uncertainty on such a substantial industry.

The FDA laid out its concerns about CBD in testimony before the Senate in July 2019 then subsequently in March 2020. The FDA noted several concerns, including:

1. The fact that CBD is an active ingredient in Epidioliex, which has been extensively studied, precludes it from being included in food or supplements, unless CBD had been marketed in food and supplement products before Epidiolex was approved. FDA claims that CBD had not been previously marketed in food/supplements, so the exception does not apply.^[5] So then by allowing CBD in food or supplements, the FDA sets a precedent that dilutes its ability to regulate other future substances that appear in FDA-approved drugs.

2. “FDA has learned that CBD is not a risk-free substance.” ^[6] During the clinical trials for Epidiolex, a nontrivial portion of children with epilepsy in the trials who were also taking valproate and/or clobazam experienced large elevations in liver transaminases. On the other hand, in 2/3 of cases the elevations resolved after discontinuing or decreasing doses of either Epidiolex and/or valproate, and in the remaining 1/3 of patients the elevations resolved on their own. At the same time, CBD also affects the rate of metabolism of other medications.^[7]

3. Many CBD products are not accurately labeled: Many products contain either less CBD than indicated and/or they contain other cannabinoids (e.g., THC) or pesticides.^[8]

Of course, there’s an ocean of difference between controlling CBD as a pharma substance and allowing untested CBD sales at the corner gas station. Surely the FDA can address many of these concerns by requiring product testing, accuracy in labeling, and product warnings, while limiting unestablished claims.

The CBD market has been a multi-billion dollar market for several years now, that is, a lot of people have used the substance. Surely any major acute problems would have been reported by now. Of course, this isn’t to say that no problems will be found. However, the risks associated with the general use of CBD are surely no greater than those for many other commonly used substances, such as Tylenol, peanuts, or even household cleaners.

As for losing its power to regulate APIs in food or supplements, I’d say FDA has forfeited its rights for CBD by steadfastly refusing to enforce its power from the outset. Legal doctrine (“laches”) prevents a party from enforcing a claim after “unreasonable delay in seeking a remedy”.^[9] It seems to me the FDA should be covered by this same doctrine.