Today the FDA officially denied requests to permit CBD in food or supplements. Action Alert!
The FDA just released a statement explaining that the “existing regulatory framework” for foods and supplements are not appropriate for CBD and that a new regulatory pathway is needed. The agency also denied three Citizens Petitions requesting the agency issue a regulation that would allow CBD to be sold as a supplement. Clearly the FDA is more interested in protecting Big Pharma profits than with promoting consumer access to a product that can benefit their health. We need Congress to take the issue out of the FDA’s hands to create a legal pathway for CBD supplements.
To be clear, CBD products will likely not be swept from the shelves by the FDA. But the agency is clearly stating that it does not believe that CBD should be allowed in food and supplements and that a separate regulatory category is needed. You will likely still be able to buy CBD products, but the FDA is signaling a changing landscape that could adversely affect consumer access.
In denying the Citizens Petitions, the FDA explained that “it is not apparent how CBD products could meet the applicable safety standard for dietary supplements.” In a Wall Street Journal interview earlier this week, an FDA official said the agency is looking at whether CBD can be safely eaten every day for a long period or during pregnancy. In November 2020, the FDA posted information to its website warning consumers of the harms that CBD can cause, including liver damage and male reproductive toxicity.
The FDA’s view on CBD’s safety is not supported by experts in the industry and elsewhere. A 2020 meta-analysis looked at human trials to assess CBD efficacy and safety. The authors concluded that most studies reported no adverse events with acute administration of CBD and mild to moderate effects with chronic administration, with the most common side effects being tiredness, diarrhea and changes of appetite/weight. Harvard Health Publishing, the publication of the Harvard Medical School, states simply that, for adults, “CBD appears to be very safe.” We believe that the safety question is a smokescreen to protect drug industry profits. Epidolex, the FDA-approved CBD drug, costs $32,500 a year. Allowing CBD supplements on the market would cut into these profits.
The FDA also said that they are interested in working with Congress to develop a new pathway for CBD products. To us, this means that the agency intends for CBD to become a more heavily regulated product, since it doesn’t believe CBD can be in food or supplements. This will bring CBD closer to the realm of drugs, alcohol, or perhaps even marijuana—the details are still unclear. But this move will increase prices for consumers and create more regulatory hurdles, which will decrease the available product options since not all companies will be able to comply with the regulations. As usual, consumers are the ones who lose.
How will this impact your access? It has long been the FDA’s position that CBD is not a legal supplement ingredient, but you can still buy CBD supplements. The FDA focused enforcement activities against CBD companies making illegal health claims. The agency has now doubled down on the determination that food and supplements cannot contain CBD. The agency’s statement says that they will continue to take action against CBD products to protect the public “when appropriate.” Does this mean they will continue to only take enforcement actions against products making illegal claims? Or will they now start pulling supplement versions from the market? And how long will it take to create a new regulatory pathway for CBD? We just don’t know, but it seems unlikely that CBD products will disappear overnight.
We said from the start that the FDA had no intention of allowing CBD to be sold as a supplement. According to FDA rules, CBD cannot be a supplement because it is a component of an approved drug. Allowing CBD to be sold as a supplement would, in the FDA’s view, undermine the integrity of the drug approval process, since GW Pharmaceuticals spent the astronomical sums for FDA approval. Because drug company user fees—the fees paid for FDA to review and approve new drugs—fund a substantial portion of the FDA’s budget, the FDA will look out for Big Pharma’s interest—which in this case means preventing CBD supplements from competing with the drug.
We need Congress to step in. Last year, we supported a number of bills in Congress that would have allowed CBD to be used in supplements despite FDA rules regarding prior approval of a drug. As of right now, these bills have not yet been reintroduced. We must urge Congress to move swiftly to introduce and pass this important legislation.
The Farm Bill offers another opportunity for reforming how the federal government treats CBD and other hemp-derived products. The 2018 Farm Bill legalized hemp and its derivatives at the federal level, removing hemp’s classification as a controlled substance. This is what initiated the FDA’s review of CBD in food, supplements, and other products. A new Farm Bill must be passed in 2023, and there have already been talks about hemp-related provisions to be included. But by and large, the issues that have been discussed do not address CBD’s status as a supplement. They relate to banking regulations to ease limitations for CBD companies, raising the allowable THC threshold in hemp products from 0.3% to 1%, and other technical issues.
Access to affordable CBD would help a wide variety of patients. We’re learning more and more about the benefits of CBD as more research gets conducted. There is research supporting its use for pain, anxiety, depression, certain cancers, and even heart health. We cannot let the FDA stand in the way of wider access to this naturally occurring compound.
Action Alert! Write to Congress and tell them to support a legal pathway for CBD supplements, either in the 2023 Farm Bill or by the reintroduction of bills like HR 841 and S 1698 from the last Congress. Please send your message immediately.