The idea is one that has been suggested in the recent past by the American Herbal Products Association, said AHPA president Michael McGuffin. The notion was also put forward by a letter sent last week to FDA by Sen. Ron Wyden, D-OR. McGuffin said there was a lot to like in Wyden’s proposals.
McGuffin said that Wyden was pushing the agency to move promptly on CBD. But he said that priority remains safety, and a push to resolve the issue cannot compromise this.
“In no way is he proposing the agency abandon its mission to protect the public health. He’s saying the agency has his support in making decisions that ensure a reasonable expectation of safety for hemp and CBD products in the marketplace,” McGuffin told NutraIngredients-USA.
“That’s something we also value. FDA’s priority is exactly the same as AHPA’s priority on this,” he added.
Number of products mounts while deliberations continue
But the issue remains that CBD products continue to flood the marketplace while FDA deliberates the matter. It’s an open question whether the public health has been therefore compromised. But recent studies have shown that there is wide variability in the quality of the products that are currently for sale.
The agency took the unusual step of convening a public meeting on CBD on May 31 to take public input on the matter. The 10-hour meeting featured more than 100 speakers.
That’s a lot to sort through and include in a draft of a proposed rule on CBD, McGuffin said. And rule making procedures are lengthy affairs, subject to rounds of public comment and possible court challenges. A three-to five-year window has been proposed as a likely timeline (and some in the industry say even that might optimistic).
“The problem with taking all that time is it leaves all those same products in the marketplace without any regulatory oversight,” McGuffin said. “That in and of itself is a disservice to the public.”
McGuffin said issuing an interim final rule on how CBDs can be legally marketed would forestall many of these issues, even if that interim form might have to be substantially amended before it became final.
“It enables you to establish a regulatory framework much more quickly than a formal rule making. By imposing an interim final rule FDA could issue something yet this year. It doesn’t mean they would not take more information and they could modify that interim rule,” McGuffin said.
Expectation of regulatory compliance
Among the things McGuffin said any interim rule should include are:
- Facilities making CBD products should be registered with FDA;
- Companies manufacturing CBD products would comply with cGMP regulations, and;
- CBD ingredients would be subject to New Dietary Ingredient Notification requirements.
On the NDI issue, McGuffin said there might need to be some sort of grace period built into an interim final rule to allow the marketplace to catch up. And then there is the potentially thorny issue of how to draw a dividing line between the drug forms of CBD already on the market and what an acceptable supplement form might look like.
“As soon as they issue a rule they can begin to inspect those companies. If there are companies out there that are not willing to comply, then FDA will put them out of business. I think it’s important to get these companies on the train of an expectation of regulatory compliance. It might not be perfect, but I think it’s important to get something done now that could protect public health in the short term,” McGuffin said.
