Despite the U.S. Food and Drug Administration’s (FDA or Agency) aggressive action against CBD products late last year, recent information from FDA leadership demonstrates a renewed vision for potential products and enforcement policies.
In November 2019, after the FDA simultaneously issued a record number of Warning Letters to companies selling CBD products and also publicly announced some very serious safety concerns associated with the use of CBD, it seemed like the Agency was moving toward an aggressive, hardline position against the sale of CBD products. This change in enforcement policy represented a major development with serious implications for the industry, and companies selling CBD products were warned to proceed with caution.
However, based on recent statements by FDA Commissioner Dr. Stephen Hahn as well as FDA’s report to Congress, it appears that FDA’s intentions for enforcement in this space have diminished and they are not going to be as expansive or aggressive as previously thought. Therefore, in the short term it looks like CBD consumer products will be here to stay.
FDA to Take a Risk-Based Approach to Enforcement
In its March 2020 report to Congress, FDA reiterated its belief that CBD is not a risk-free substance, noting that CBD is associated with liver injury, drug-drug interactions, drowsiness that may affect driving and the possibility of male reproductive toxicity. However, the Agency is working to gather additional data to learn more about the safety profile of CBD and determine whether there are safe conditions of use that could allow for broader access to CBD in other FDA-regulated consumer products. In particular, given the high level of interest in dietary supplements as a potential pathway for products containing CBD, FDA stated that it was actively evaluating potential rulemaking to allow CBD in such products.
Regarding enforcement, FDA noted that it is most concerned about products that pose the greatest risk to consumers, and intends to prioritize enforcement decisions on a risk-based approach. Specific areas of concern include the following:
- Products with contaminants (e.g., heavy metals, high levels of THC or other potentially harmful substances)
- Products marketed with false claims or statements (e.g., omitted ingredients, incorrect statements about the amount of CBD)
- Products marketed for use by vulnerable populations (e.g., children or infants)
- Products that otherwise put the public health at risk
Of note, FDA is currently evaluating issuance of a risk-based enforcement policy to provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.
FDA Will Not Try to Shut Down CBD Markets
Despite FDA’s ongoing concerns regarding the safety of CBD use, the Agency does not appear to be in any hurry to wholly remove such products form the market, as many have feared. In a speech before the National Association of State Departments of Agriculture on February 26, 2020, Commissioner Hahn stated that the Agency has no plans to try and shut down the CBD markets. Noting how large the CBD market has grown, Dr. Hahn said: “We know one thing, the American people are using CBD products . . . We’re not going to be able to say you can’t use these products. It’s a fool’s game to try and even approach that.”
Nevertheless, Dr. Hahn emphasized that there is “still much we don’t know about the effects of sustained, long-term exposure to these products,” and noted that information gaps still need to be filled.
This sentiment was echoed by FDA in its report to Congress, and again a public statement by the Commissioner on March 5, 2020. In particular, FDA is seeking reliable and high-quality data on the following:
- Sedative effect of CBD
- Impacts of long-term sustained or cumulative exposure to CBD
- Transdermal penetration and pharmacokinetics of CBD
- Effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile
- Safety of CBD for use in pets and food-producing animals
- Processes by which “full spectrum” and “broad spectrum” hemp products are derived, what the content of such extracts is and how these products may compare to CBD-isolate products
In order to facilitate the collection of such data from the industry, FDA has reopened the public docket established for its prior May 2019 public hearing. The docket will remain open indefinitely. Additionally, FDA has allowed for anonymous submissions in order to facilitate a more open dialogue.
Taken together, it is clear that FDA is signaling that it is still resolving how best to deal with CBD consumer products. Any company or individual that has useful data to share with the Agency regarding CBD should submit their information to the FDA in the re-opened docket. Additionally, any company that sells products containing CBD should continue to monitor FDA’s actions for further updates.