On May 31, the FDA held its first hearing on CBD. After the meeting, the same questions remain as before: will the federal agency continue to maintain its current regulation and prohibition of hemp-derived cannabinoids? Or will it give in to market forces and open the door for the general sale and use of CBD?
Despite removing industrial hemp from the list of controlled substances late last year, the federal government still prohibits the general sale of CBD products and the addition of CBD to food and beverages under FDA rules. The hearing did not result in any kind of policy change but is widely seen as the first step toward a comprehensive regulatory scheme for CBD. What that will look like remains to be seen.
More than 100 people testified before a panel of FDA officials. According to a Forbes article, most speakers agreed on “the need for federal CBD oversight for production quality, more testing and research and better product labeling and dosing guidance.”
Acting FDA Commissioner Ned Sharpless opened the hearing with comments about the safety of CBD that doesn’t bode well if you hope the feds will adopt a more hands-off approach.
“There are real risks associated with [THC and CBD] and critical questions remain about the safety of their widespread use in foods and dietary supplements … While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know. What if someone applies a topical CBD lotion, consumes a CBD beverage or candy and consumes some CBD oil? How much is too much?”
FDA principal deputy commissioner Amy Abernethy echoed her boss’s sentiments, saying 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.”
2018 Farm Bill and CBD
With the passage of the farm bill, the federal government now treats industrial hemp as an agricultural commodity instead of a controlled substance. While the DEA no longer has the authority to regulate hemp, the provisions of the farm bill have no bearing on FDA rules and regulations regarding CBD. 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.”
Practically speaking, the passage of the farm bill does not mean CBD is federally-legal in all 50 states, as some hemp supporters claim. In fact, the FDA still maintains a strict prohibition on the sale of CBD in the U.S.
To date, the FDA has only approved one medication with cannabidiol as an active ingredient – Epidiolex for the treatment of seizures – and 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.
At this time, the agency hasn’t changed its position on CBD. During a congressional hearing in March, then-FDA Commissioner Scott Gottlieb said he understands that Congress wants a pathway to CBD availability, but said “it is not a straightforward issue” due to the fact that the agency has approved CBD for treatment of epilepsy and it is “subject of substantial clinical investigation.” Both of these factors prohibit CBD from being sold as a “health supplement” and from being added to food.
Gottlieb said, “the law does allow us to go through a regulatory process and go through a notice and comment rule-making to establish a framework to allow it to be put into the food supply.”
The May 31 meeting was the first step in that process.
In effect, while farmers can now legally grow hemp for commercial purposes, including the production of fiber, biofuel, building products, paper, clothes and even food products that don’t contain CBD, the sale of cannabinol or food products containing CBD remain federally-illegal, as it has been all along, unless the FDA changes its policy or Congress passes legislation specifically legalizing CBD.
LOOKING AHEAD
FDA acting commissioner of food and drugs, Dr. Norman Sharpless, encouraged interested parties to submit comments to the FDA’s Docket. It will remain open until July 2.
“Docket comments will help inform the FDA as we consider the important policy options related to the regulation of products containing cannabis or cannabis-derived compounds.”
Even if the FDA elects to maintain strict regulation of CBD, it will have a hard time enforcing its will if states don’t cooperate. Despite past and ongoing federal prohibition, CBD is everywhere. A 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. The FDA can’t effectively enforce prohibition without the assistance of state and local officials.
According to the FDA, the agency prioritizes enforcement based on a number of factors, including “agency resources and the threat to public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.”
Even with both the FDA and DEA theoretically enforcing federal laws and regulations banning CBD, state and local action have already nullified federal prohibition in practice and effect. There’s no reason to think that won’t continue as long as states maintain the same stance on CBD as they did under the 2014 farm bill. Simply put, the federal government lacks the personnel and resources to crack down on CBD – even if the FDA wants to.
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