Advocates hopeful that Gottlieb’s departure won’t derail drive toward new CBD rules

05-Mar-2019 - Last updated on 06-Mar-2019 at 15:19 GMT

FDA Commissioner DR Scott Gottlieb, MD testifying before Congress. Photo courtesy of FDA.

The advocates for the reformation of the regulation of hemp derivatives in nutritional products were clinging to the hope that the abrupt resignation of FDA Commissioner Dr Scott Gottlieb will not mean the initiative will be stillborn.

Gottlieb, who announced his plan to resign on Tuesday, March 5, had only announced the plan to look at new CBD regulations a week prior. Gottlieb signaled the move during testimony before Congress, where he said a public meeting on the issue as the start of a formal rule making procedure would be held sometime in April.

Gottlieb told Rep. Mark Pocan, D-WI, and other members of the House Appropriations Committee that the goal was to create “an appropriately efficient and predictable regulatory framework for regulating CBD products.”

“We heard Congress loud and clear with respect to that legislation,” Gottlieb said in response to a question from Rep. Pocan. “I understand Congress wants there to be a pathway for CBD to be available.”

Rule making procedure might be too protracted

Gottlieb he could ‘speculate’ on a possible future framework in which CBD could exist as a high concentration, high purity pharmaceutical form while at the same time be a dietary ingredient for supplements at lower concentrations. But he said the issue is complicated enough that a rule making procedure might last longer than Congress saw fit (more than two to three years), so new legislation on CBD might be necessary.

“This is not a straightforward process. There is not a good proxy for us doing this through regulation, and if we get comments back and find this is sufficiently complicated for the agency, we will come back and have a conversation with Congress on with how we might be able to work together on this,” Gottlieb said.

Where the process goes from here

Mark Ullman, an attorney at counsel in the firm Rivkin Radler, said it’s too early to tell where the CBD initiative will now go.

“We don’t know how much of the initiative in working on CBD was institutional in nature and how much was the result of the personal initiative of the now former commissioner,” he told NutraIngredients-USA.

Steve Hoffman, a consultant and principal in the firm Compass Natural Marketing who has worked many natural products and hemp brands, said he believes there is too much momentum behind the CBD question for it to be more than momentarily delayed by Gottlieb’s resignation.

“Congress wants FDA to arrive at a resolution regarding CBD in food and supplements. I believe this is a larger agenda item than the commissioner’s resignation. While it might delay FDA’s focus, I believe CBD will remain a priority item for FDA.”

Issue of precedent

Jonathan Havens, an attorney with the Washington, DC law firm Saul Ewing Arnstein & Lehr, said the hard work of crafting new CBD regulations that don’t set an unwanted precedent will remain, no matter who takes up the reins.

CBD is for the moment a drug ingredient, according to FDA’s reading of federal law. It was first researched as a drug for anti seizure indications before marketers started to sell it in supplements. If a new rule is written in such way as to allow subsequent supplement development, say in a less purified (read: full spectrum) extract form, the trick will be to not open the door for companies to try the same with other drug ingredients.

“FDA is being pressured right now by Congress to come up with something. I don’t think they want to be obstinate or unhelpful; but they want to avoid the situation where people think, now they can take all drug ingredients and water them down somehow and put them into a supplement,” he said.

While the FDA may “ultimately choose to undertake rulemaking to authorize the use of CBD in foods and dietary supplements,” said Wiley Rein special counsel Brian Sylvester, “As an interim action—to facilitate the immediate commercialization of CBD-added products nationwide—FDA could choose to issue a formal policy statement indicating that it will not enforce the prohibition on foods and dietary supplements containing CBD."

Asked about companies that are currently using broad or full spectrum hemp extracts rather than isolated CBD as a way of navigating the regulatory minefield, he said: “The marketing of broad or full spectrum ‘hemp extracts’ rather than isolated CBD does not necessarily insulate a company from FDA enforcement action.

"This is especially the case if the CBD present in the product exceeds the naturally occurring levels in the hemp plant as a result of the manufacturing process.”