The Food and Drug Administration (FDA) has conceded it cannot regulate CBD under its current congressional authority. That means theoretically, CBD and cannabinol will remain illegal at the federal level for the foreseeable future. In practice, it means the status quo will continue with CBD being widely available and most regulation occurring at the state level.
Many people think CBD is totally legal now due to the fact that it’s available on virtually every street corner and the 2018 farm bill legalized industrial hemp. But this is not the case.
While the Drug Enforcement Administration (DEA) no longer has the authority to regulate or prohibit hemp, the provisions of the farm bill don’t limit the FDA. Farmers can legally grow hemp for commercial purposes, but the sale of cannabinol or food products containing CBD remains illegal at the federal level per FDA regulations. In fact, a section in the farm bill makes this explicit.
Section 297D, paragraph (c)(1) “Regulations and Guidelines; Effect on Other Law” states “nothing in this subtitle shall affect or modify the Federal Food, Drug, and Cosmetic Act.”
Under the Food Drug and Cosmetic Act, the FDA claims the authority to regulate CBD as a medication, and as a supplement in food and beverages.
The FDA classifies CBD as “a drug for which substantial clinical investigations have been instituted.” Under federal law, that designation means the FDA maintains full control over the substance and it cannot be marketed as a “dietary supplement.” The agency also maintains that the sale of CBD or any food products containing the substance is illegal. To date, the FDA has only approved one medication with cannabidiol as an active ingredient – Epidiolex for the treatment of seizures.
Under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)], THC and CBD products are excluded from the dietary supplement definition. …
Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which 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 a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. …
The FDA further declares, “It is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.” Under the federal definition of “interstate commerce,” this includes virtually all CBD products.
But things aren’t as cut and dry as FDA proclamations may sound.
While the agency declares to this day that CBD in food or beverages is illegal, it recognizes that there is no way to enforce an outright ban with CBD products already widely available throughout the United States, its rules and proclamations notwithstanding. That genie left the bottle long ago and there is no way to stuff it back in.
As a result, the FDA has been trying to find a way to practically regulate CBD and cannabinol for several years. In effect, the agency wants more power and more regulations, but it can’t figure out how to achieve the goal given the market dynamics.
The FDA held its first public meeting relating to CBD in May 2019. FDA principal deputy commissioner Amy Abernethy said there is a need to “further clarify the regulatory framework to reduce confusion in the market,” and “Key questions about product safety need to be addressed. Data are needed to determine safety thresholds for CBD.”
In March 2020, FDA Commissioner Dr. Stephen Hahn delivered a report to Congress on CBD.
“FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway.”
A January 2021 FDA report shows the FDA had made little headway in promulgating a new policy.
Now it appears the FDA has given up completely and punted the issue to Congress in hopes it can get more control.
In January 2023, the FDA issued a statement saying the agency couldn’t regulate CBD as foods or supplements under its current regulatory structure. In effect, that means the agency can’t figure out a workable rulemaking scheme without Congress granting it new authority.
“Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter.”
At the same time, the FDA denied three citizen petitions asking the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
The FDA couched its claim in concerns about safety.
“The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive. … Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
Nevertheless, the FDA asserted that in the meantime, it will maintain the status quo and continue to “take action against CBD and other cannabis-derived products to protect the public in coordination with state regulatory partners when appropriate.” [Emphasis added]
WHAT THEY DIDN’T SAY
If you take the rhetoric at face value, it’s difficult to understand exactly what the FDA is trying to do. On the one hand, the agency claims it can’t adequately regulate CBD because it doesn’t fit under the current authority delegated to it by Congress. On the other hand, it has asserted “full control” over CBD due to approving it as a drug.
What exactly is going on? If it has “full control,” why does it need more authority from Congress?
You have to read between the lines to understand what actually happened.
The reality is, from a practical standpoint, the FDA can’t regulate CBD. But it wants to.
Despite a lot of talk over the last several years, there has been no meaningful federal regulation of CBD. The market is too big. I think this is why the FDA refused the citizen petition to promulgate rules. The agency knew that no matter what rules it laid out, there was no way they were going to be able to enforce them.
While nobody will say this out loud, I think the FDA hopes that more concrete regulatory authority from Congress will allow it to crack down on the market and bring it back under federal control.
With or without congressional intervention, the FDA faces two fundamental problems.
In the first place, CBD is everywhere. You can likely walk into your local gas station or grocery store and buy CBD products.
A 2018 New York Times article asserted that “with CBD popping up in nearly everything — bath bombs, ice cream, dog treats — it is hard to overstate the speed at which CBD has moved from the Burning Man margins to the cultural center.”
This was happening when both the DEA and FDA prohibited CBD. It will undoubtedly continue as long as market demand remains and states don’t interfere.
In 2022, the CBD market generated $9.7 billion in the U.S.
Secondly, the FDA can’t effectively enforce prohibition without the assistance of state and local authorities. The FDA alluded to this fact in its most recent statement when it mentioned it will continue enforcement “in coordination with state regulatory partners.”
The problem for the FDA is in most cases, state regulatory partners aren’t enforcing CBD regulations at all. In fact, many states have explicitly legalized CBD by declaring it a “food additive” or clarifying that is not an “adulterant” under state law. As we’ve seen with marijuana, when states and localities stop enforcing laws banning a substance, the federal government finds it virtually impossible to maintain prohibition.
This is why the FDA wants Congress to step in. It hopes that with more authority, it can rein in the CBD market.
Trying to “crack down” on CBD now would create a political minefield for Congress that it won’t likely want to navigate. In all likelihood, the status quo will continue. That means CBD will be available everywhere that states allow it. And even if Congress were to hand the FDA more authority, it would still find it nearly impossible to regulate the industry without state and local cooperation.
This reveals the fecklessness of federal prohibition when states, localities and most importantly, individuals in the marketplace, refuse to cooperate.
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