Frustrated over FDA's inaction, supplement sector eyes Congress for CBD fix

The dietary supplement industry is growing increasingly frustrated with FDA’s lack of action to create a legal pathway for CBD as supports mounts for Congress to step in with a legislative fix, several sources close to the issue said.

Industry sources in Washington expressed growing frustration with the agency’s reluctance to allow CBD to be lawfully sold in a supplement. FDA for years has insisted the cannabis-derived compound—known formally as cannabidiol—cannot be marketed in a supplement or added to food because, in essence, it was first studied as a drug.

FDA is “dragging its feet” on the issue and insisting it must first have safety data before it can address the legality of CBD in supplements, said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in an interview. Through its inaction, the agency is “overlooking a huge potential health problem” that it “helped to create,” he added.

“There are senior leaders in Congress who are feeling very concerned about the FDA’s inaction and FDA’s statements, and [they] are pledging to try to fix this as soon as they are able to,” said Jonathan Miller, general counsel to the U.S. Hemp Roundtable, a coalition of hemp companies.

That FDA could reasonably and swiftly determine appropriate safety thresholds for CBD, which is already present in thousands of products on the U.S. market, is facing growing skepticism. Even if FDA established a safety dosage limit, at least some people in the industry remain concerned that the agency would set an artificially low limit, threatening to stymie clinical research and product innovation.

Asked about FDA’s reluctance to act quickly, the president and CEO of the Natural Products Association (NPA), Daniel Fabricant, Ph.D., said, “They’re worried they’re going to get it wrong, but I think they know that’s the only pathway forward.”

He has maintained the only path forward is for FDA to establish a safe level in CBD.

At a conference last week hosted by CRN, an FDA official, Lowell Schiller, expressed reservations about creating a legal pathway for CBD in supplements without fully understanding the ingredient’s safety profile.

“If we are unable to conclude that CBD is safe for use in foods or dietary supplements, and yet we were to make an exception to allow for such uses, what would that mean for the next substance to come along with similar known safety risks?” asked Schiller, principal associate commissioner for policy in FDA’s Office of Policy, during his Nov. 7 speech.

While Schiller said FDA is “trying to learn as much as we can about CBD, as quickly as we can,” he pointed out FDA still doesn’t know such things as “the consequences of long-term use” and “risks to vulnerable populations.”

Through the secretary of the U.S. Department of Health and Human Services (HHS), Schiller’s agency has discretion to create an exception to a provision in the law that FDA has interpreted as barring the sale of CBD in dietary supplements. FDA could authorize a pathway for CBD in conventional food and supplements through a rulemaking, though the agency has warned the process could take several years to complete.

“As we consider this issue, safety is front of mind,” Schiller said. “If we don’t think we’ll have the data to say that some level of CBD can be safely added to a food or dietary supplement, then we wouldn’t want to create an exception for CBD.”

During a Q&A with Mister at CRN’s conference, Schiller said the agency would not exercise such discretion unless it first determined “there is a safe viable supplement that could go to market,” Mister recalled.

“That creates an untenable position for industry,” Mister said in an interview with Natural Products INSIDER, “because why would you do the safety data until there’s a guarantee that you can go to market with it?”

Many large supplement companies haven’t entered the CBD market yet due to the legal risks, he added.

“They’re not going to go to market with a CBD product because their culture says, ‘Do not take a product into the marketplace unless you know it’s legal,’” Mister said. “But they’re the ones that have the most resources to go out and do this kind of safety research that FDA wants done.”

Many supplement trade groups are in favor of lawmakers crafting a legislative solution that would authorize the sale of CBD in supplements. In October, CRN and three other trade groups urged Congress to pass legislation clarifying hemp-derived CBD is a lawful dietary ingredient if a dietary supplement meets established product safety and quality criteria.

David Spangler directs legal and international affairs for the Consumer Healthcare Products Association (CHPA), one of the supplement groups that wrote the letter to Congress. He acknowledged FDA today can’t answer all the questions related to the safety of CBD.

The only way FDA is going to obtain such information, he said, is if the agency develops a pathway for supplement companies to provide new dietary ingredient (NDI) notifications, demonstrating the safety of the CBD in their products.

Mister said FDA could insist CBD products meet relevant safety requirements—including the NDI notification provision in the Dietary Supplement Health and Education Act of 1994 (DSHEA)—and enforce those regulations if Congress determined CBD could be lawfully sold in supplements.

“Even if you go to FDA now with an NDI notification, and even if you have safety data appended to it, that NDI notification will be rejected because of 321ff,” he said, referencing the provision of DSHEA upon which FDA has concluded CBD cannot be lawfully marketed as a dietary supplement because it was first investigated as a drug.

A Washington insider close to the industry, who meets with congressional offices and agreed to talk on background to speak more frankly, noted lawmakers in recent weeks have become more receptive to Congress stepping in.

“FDA actions have not given confidence to folks on the Hill that they [FDA officials] really are going to take some action in a timely manner that would be satisfactory,” the source said.

“There’s a general reluctance in Congress to take the role of the FDA and say, ‘This stuff is safe,’ in whatever … quantities,” another Washington insider noted. “That said, when the agency isn’t moving forward with any guidance, and there are still products on the market, Congress gets increasingly concerned.”

Among the congressional staff members meeting with industry representatives: the office of Sen. Majority Leader Mitch McConnell, a Republican from Kentucky who championed passage of the 2018 Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act (CSA).

McConnell in October inserted report language accompanying a Senate Agricultural Appropriations bill, directing FDA to issue a CBD enforcement discretion policy within 120 days that meets the definition of hemp in federal law. The bill would fund the operations of FDA, among other agencies, in fiscal year (FY) 2020.

On Oct. 31, the Senate voted to adopt a "minibus," which includes bills that fund FDA and several other agencies, according to the Alliance for a Stronger FDA, a nonprofit corporation.

But McConnell's CBD-related report language doesn’t go far enough for many in the supplement industry. For starters, even if the bill passed, report language is not binding on government agencies like FDA. Secondly, it would not directly address the legal conundrum facing industry: FDA’s conclusion that CBD is barred from being added to food or marketed in supplements because it was first the subject of substantial drug clinical investigations made public.

Congress faces a looming deadline for passing an appropriations bill or continuing resolution to fund FDA and other agencies.

“President [Donald] Trump has hinted several times that he might not sign a new continuing resolution when the current one expires on Nov. 21,” Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, wrote in a Nov. 11 analysis. “That would lead to a government shutdown.”

But he added, “The threat has diminished to the point where a shutdown seems quite unlikely.”

Potentially complicating the chance of an agreement between the House and Senate, Democrats have launched a probe into whether President Trump should be impeached.

“The biggest challenge now is not the consensus in Congress to move forward” on CBD, Miller of the U.S. Hemp Roundtable said in an interview. “It’s impeachment, and will we have a government shutdown, or will there be continuing resolutions for appropriations, which would make it impossible to have bill language? We’re really kind of held hostage to the much bigger issues going on in Washington right now.”

The House of Representatives in July passed an appropriations bill that would fund FDA in FY2020. It incorporated an amendment from Rep. Jerry McNerney (D-California) that would earmark US$100,000 for FDA to establish a safe level for CBD-containing food and supplements.

On Nov. 7, two state senators from New Jersey introduced a resolution urging Congress and President Trump to “enact legislation establishing a safe daily level of cannabidiol consumption.”

“Within the past three years, more than 1,500 cannabidiol products have come to the market without a clear approach for regulation or any plan from the FDA to balance consumer access and protect consumer health,” the resolution stated.

Fabricant, who previously oversaw what was then known as FDA’s Division of Dietary Supplement Programs, remains supportive of the language in the House. Asked for this article whether McNerney’s amendment is “essentially dead,” he responded, “I don’t think it’s dead at all. Again, that’s got to get worked out in conference—what amendments stay in on conference [and] what amendments come out if we can get an appropriations.”

He was nonetheless skeptical that the House and Senate can reconcile massive differences in their proposed budgets by next week. “With all this impeachment talk, good luck getting that gulf crossed,” Fabricant said.

Another wildcard: Each of the 12 appropriations subcommittees in the House and Senate don't yet know how much money will be earmarked to them for so-called 302(b) allocations. Until the House and Senate appropriations committees decide how to allocate overall spending to each of the subcommittees, the two chambers of Congress can't reconcile differences in their spending bills.

Ultimately, the cloud of uncertainty over CBD could finally dissipate if Congress agrees on an amount to fund FDA and other government agencies, and the legislation incorporates a CBD amendment. Of course, the substance of any such spending bill, and its chances of passing through Congress anytime soon, remain anyone’s guess.

“There’s no way to know,” said a Washington veteran close to the supplement industry with vast experience on Capitol Hill. “We’re talking about 535 moving pieces.”

Editor's note: This story was updated Nov. 13 with additional commentary on the appropriations process.