Wyden, a Democrat who was first elected as Senator in 1996, sent the letter earlier this week in which he is requesting something he called a “formal enforcement discretionary policy” on products containing CBD. Wyden said he wants FDA to issue the policy no later than August 1, 2019.
Recognizing the intent of Congress
In the letter Wyden noted that the intent of Congress is for there to be a legal pathway for this ingredient to come to market. He said he was pleased with FDA’s apparent flexibility on the matter.
“I have been pleased to hear statements from FDA leadership that acknowledge Congress’s intent for the agency to take action and provide a legal pathway for the production and sale of hemp-derived products containing CBD. I also applaud the agency’s appointment of an internal Cannabis Working Group as well as its convening of a public stakeholder meeting on May31, 2019 to discuss hemp-derived CBD,” he wrote.
But Wyden said there are grave concerns with the time frame that FDA has put forth for the resolution of the matter. He noted that the United States Department of Agriculture is preparing to issue an interim final rule on hemp production by August, but action at FDA is falling behind.
“The FDA’s current inaction with respect to regulating hemp-derived CBD in manufactured products has caused confusion and uncertainty for hemp producers,” he said.
Call for formal acknowledgment of enforcement discretion
“I, and many in the CBD industry, find FDA’s indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements fully unacceptable. The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time,” Wyden added.
“Given these strong concerns, I urge FDA to immediately issue enforcement discretion guidance not later than August 1, 2019, and promptly issue an interim final rule, pending issuance of a permanent final rule, to ensure a regulatory pathway for lawful use of CBD as a food additive and as a dietary ingredient in a dietary supplement. Additionally, the agency must initiate permanent final rulemaking to allow manufacturing and sale of products containing hemp-derived CBD under the existing statutory and regulatory frameworks applicable to food and dietary supplements. I further urge you to streamline processes for submitting and prioritizing review of resulting new dietary ingredient and GRAS notifications for hemp-derived CBD ingredients, including, without limitation, dedicating necessary agency staff to the process,” Wyden concluded.
The need for speed
The three-to five-year time frame for a final rule on CBD put forward for former FDA Commissioner Dr Scott MD, had not been seen as foot dragging by industry sources. Rather, it was viewed as a realistic—even optimistic—assessment of how long such a process usually takes.
Steve Mister, president and CEO of the Council for Responsible Nutrition did agree with Wyden that time is of the essence.
“We are working through a lot of different avenues on the Hill to keep the pressure on the agency to move forward on CBD. We believe that there is a legal pathway for these products to come to market and we believe FDA has the authority to do it,” Mister told NutraIngredients-USA.
“The marketplace has gotten away from the agency with very little enforcement and you cannot put that toothpaste back into the tube. They need to move quickly to prevent the unregulated marketplace from getting any worse,” he said.
It will be difficult to move quickly, because the problems to be hashed out are numerous and complex, said Loren Israelsen, president of the United Natural Products Alliance.
“Most everyone feels that the consumer CBD market is so embedded now that there is no way FDA could remove it,” Israelsen told NutraIngredients-USA is a conversation following the May 31 public meeting on the matter in Washington, DC.
Where does CBD fit in drug/supplement divide?
In Israelsen’s view, among the questions to be solved are: How are the supplement forms of CBD different from the drug that is on the market? What is CBD being used for, and where does that fit into the drug vs supplement question? And what are the specifications of the forms of CBD that is already on the market?
“It seems to me that there is a combination of the disaster of the opiod crisis and a huge unmet need for the management of pain. CBD seems to me to be filling a gap there. If that’s true, that’s a really big consideration,” Israelsen said.
“But other important considerations are, how much THC is in the finished dose of the product? And FDA seems to be asking, too, for companies to please explain what ‘full spectrum’ and ‘broad spectrum’ means in the description of products,” he added.
Questions about discretionary policy
Dan Fabricant, PhD, president and CEO of the Natural Products Association, and also a former FDA official, said he was a bit confused by Wyden’s approach. In his view, the goal should be to engage other lawmakers in the crafting of new legislation, rather than trying to compress the time frame on an FDA rule making procedure.
“I was at the agency, and I’ve never heard of a ‘formal enforcement discretionary policy,’” he said.
“I think anyone who wants to see a real market for CBD, they want to see a law,” Fabricant said.