Since the passage of the 2018 Farm Bill, the hemp CBD industry has been eagerly awaiting FDA CBD regulations. In that time, FDA convened a working group to study how the agency would regulate CBD foods and dietary supplements. As of January 26, 2023, the FDA concluded that it will NOT regulate CBD foods or dietary supplements.
FDA and the States on CBD since the Farm Bill
Before jumping into the post, it bears noting that the FDA has taken the position, literally since the day the 2018 Farm Bill was passed, that CBD foods and dietary supplements violate the Food, Drug & Cosmetic Act. Nevertheless, it has issued only periodic warning letters and taken minimal actions against the CBD industry beyond these letters. The agency has also tended to focus more on egregious misconduct.
In the face of the FDA’s limited responses, states have filled the void with their own regulations, though we always knew the FDA was considering CBD food and dietary supplement regulations.
Now, the FDA is declining to move forward with regulations but has indicated that it would work with Congress if it passes separate CBD legislation. This is because the FDA concluded that its existing regulatory framework was insufficient for CBD and that it would need a new legislative framework through which to introduce regulations.
What FDA said today
Something that should give hope to the industry is that the FDA seems to have put a lot of thought into what CBD legislation should look like:
A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.
The FDA used the word “regulatory framework,” but again, this would need to come through congressional legislation in light of the FDA’s refusal to move forward.
So why did the FDA conclude that it couldn’t regulate CBD foods or dietary supplements? Here’s what it said:
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.
The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency. 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.
CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.
The status of CBD regulation won’t change anytime soon
It’s frustrating that after more than four years of waiting, the FDA is still in the same spot of claiming more information is needed. But this shouldn’t be shocking to anyone familiar with the FDA in general. It can take years – even decades – to get approval of new drugs. And in the FDA’s view, CBD doesn’t fit neatly into any of the categories of things it regulates.
For this reason, the FDA isn’t moving forward with CBD regulations and denied “three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”
One final thing that the FDA said that’s worth noting is:
The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.
I’m not sure if there’s any “there” there. As mentioned, the FDA’s enforcement priorities to date have been relatively minor compared to what they could be if the FDA really wanted to swing the hammer. It may pick up the pace, but then again, it may not.
While Congress is unlikely to do anything anytime soon (because, well, it’s Congress in 2023), there are definitely some CBD champions in Congress on both sides of the aisle. Hopefully the FDA’s new position spurs them to reach across the aisle and figure this mess out.
In the meantime, and as always, stay tuned to the Canna Law Blog for more FDA updates.
The post Breaking: FDA Says “No” to CBD Foods and Dietary Supplements appeared first on Harris Bricken Sliwoski LLP.
