FDA has reiterated that it will continue to take enforcement action against CBD and hemp companies making disease claims, but is otherwise committed to finding “an appropriate, efficient and predictable regulatory framework” for the legal marketing of these products. This view was outlined both in a press announcement and an updated Q&A posted by the agency on Tuesday.
Gottlieb: We’ve heard the market
In the press statement, outgoing FDA Commissioner Scott Gottlieb said the agency is aware that states and other jurisdictions are seeking clarity on what to do about the hundreds of products containing CBD or hemp derivatives now for sale in their jurisdictions.
“We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products,” he wrote.
Along with Gottlieb’s press statement, FDA also revamped its Q&A on cannabis products. This document has been extensively revised from its previous form and is now titled “FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers.” It was previously titled as a Q&A on marijuana.
Whereas the previous document contained several paragraphs on CBD products, the updated version is mostly about CBD. It includes sections devoted specifically to what changed under the 2018 Farm Bill.
What hasn’t changed is FDA’s stance that as current federal law stands, it it illegal to market dietary supplements contained CBD, becuase of the prior drug development by GW Pharma of its pharmaceutical product Epidiolex, which FDA approved in mid 2018. This drug is intended to treat two forms of childhood epilepsy that are not easily treated with existing antiseizure medications.
So while the many CBD products on the market are strictly speaking in violation of this provision, the agency has reiterated its position that its primary concern is the safety of consumers, not plugging this particular gap in the regulatory fence. So companies marketing CBD products that are not making disease claims have little to fear from the agency at the moment.
Information sought on safety questions
In a document announcing the opening of a federal docket for the upcoming CBD meeting, which is set for May 31, FDA did say there are potential safety concerns. GW’s drug testing did reveal a risk of liver injury at dosages of 20 milligrams per kilogram of body weight per day. FDA said it is seeking input from the scientific community and the industry to answer such questions as:
- What levels of cannabis and cannabis-derived compounds cause safety concerns?
- How does the mode of delivery (e.g., ingestion, absorption, inhalation) affect the safety and exposure to cannabis and cannabis-derived compounds?
- How do cannabis and cannabis-derived compounds interact with other substances (e.g., drug ingredients)?
Actions bring welcome clarity
Andrew Shao, PhD, acting senior vice president of scientific and regulatory affairs for the Council for Responsible Nutrition said the events of the past couple of months and the communications posted yesterday have brought some welcome clarity to a market that was threatening to run out of control.
“This couldn’t have come sooner, because the industry and other stakeholders, consumer groups and members of Congress have all been looking to the agency for direction on this,” Shao told NutraIngredients-USA.
“It is now crystal clear what the agency’s position on CBD is. Technically speaking products that contain added CBD are not legal. For some reason there had been debate about that in the industry, and in our view any doubts along those lines have been been thoroughly dispelled,” he said.
With that being said, it’s also clear that the agency is committed to finding a way to make this market work, given all of the burgeoning interest in it.
“We see now the agency is actively looking to pursue a regulatory pathway. I think, though, that FDA is trying to manage everyone’s expectations as they had down this pathway because it is something that they have never done before,” he said.
Prochnow: Genie’s not going back into bottle
Attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, said its seems FDA’s moves are to some degree a recognition of the facts on the ground.
“I think it just demonstrates how the FDA has realized how big of an issue this is and is clearly something that is not going away. For an ingredient that is allegedly not permissible there is certainly a lot of discussion about it. We don’t have public hearings on piracetam, for example,” he said.
“I think they realize that the best way to deal with this is to come up with a clear way to regulate it at the federal level,” he said.
Prochnow said that in the absence up to now of clear direction from FDA, the regulatory picture on CBD has become increasingly convoluted. In Maine for example, products containing CBD were seized from shelves earlier this year but now have been specifically approved via a law signed by Gov. Janet Mills a week ago.
And Prochnow noted that in Texas, the county attorney in Tarrant County had announced that he would vigorously prosecute cases involving CBD products whereas neighboring Denton County has said it will not pursue CBD-only cases.
“So now it’s not only state by state, but also county by county,” Prochnow said.