FDA must ‘step up enforcement' against CBD products

FDA should boost its compliance and enforcement activities against products containing CBD, several trade and nonprofit groups said in interviews and public comments.

The agency must “step up enforcement” against CBD-containing products, said David Spangler, senior vice president of policy and general counsel with the Consumer Healthcare Products Association (CHPA), a trade association in Washington representing manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements.  

“To the best of my knowledge, they’ve not gone beyond warning letters,” Spangler said in an interview.

Spangler said FDA could take such actions as issue more consumer alerts tied to specific products and block products from entering the U.S.

Since 2014, FDA has opined—based on clinical studies of drugs—that CBD can’t be marketed as a dietary supplement, and it’s illegal to sell a food in interstate commerce to which the compound has been added. Similarly, FDA has declared THC can’t be marketed in a supplement or added to food.

However, agency officials have recognized wide support for CBD from the public and a Congress that removed hemp in 2018 from the Controlled Substances Act (CSA). The 2018 Farm Bill defined hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta- 9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”

FDA officials are working to identify a legal pathway to market for CBD-containing products in food and supplements. The agency hosted a May 31 hearing related to cannabis and cannabis-derived products, drawing more than 600 people who registered to attend the all-day event in person at FDA’s campus in Silver Spring, Maryland, as well as around 2,000 people online. FDA also opened a docket to solicit further public input through July 16, garnering nearly 4,500 written comments.

FDA intends to report its “progress around end of summer/early fall,” Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., revealed last week via Twitter.

While trade groups support FDA’s current undertaking, they want to ensure companies are meeting existing regulations, such as FDA’s cGMPs (current good manufacturing practices) for dietary supplements, incorporated in Title 21 of the Code of Federal Regulations (CFR), Part 111. Based on FDA warning letters and research into products containing CBD, it’s suspected many companies are flouting current regulations.

FDA, Spangler said, doesn’t need to change any rules or laws to increase its enforcement activities.

Over the past five years, FDA has issued warning letters to firms marketing CBD for making medical claims that suggest their unapproved products treat Alzheimer’s disease, cancer, clinical depression and other diseases. FDA also has cited discrepancies between labeled CBD content and testing results.

But the agency has done little to ensure manufacturers of CBD are meeting existing regulations, suggests data obtained through a Freedom of Information Act (FOIA) request by the Natural Products Association (NPA). A trade association in Washington, NPA represents various product categories in the natural products industry, including dietary supplements and medical and functional foods.

As of early June 2019, FDA had conducted only four inspections of CBD manufacturers, NPA disclosed in July 16 public comments filed with FDA, citing the agency’s response to its FOIA request. Of the four firms inspected, three received a document (Form 483) reflecting regulatory violations, according to the filing. NPA’s comments also suggested, based on its FOIA, that FDA has tested few products for THC.

A separate FOIA request previously obtained by Natural Products INSIDER in 2017 identified no FDA inspections of manufacturers of CBD-containing products. In response to requests for inspection reports over a 3.5-year period (from Jan. 1, 2014 through Aug. 15, 2017), FDA divulged it did not find any applicable records.

FDA must increase its inspections and testing “in a big, big way,” said Daniel Fabricant, Ph.D., president and CEO of NPA, who previously oversaw FDA’s Division of Dietary Supplement Programs from 2011 to 2014. “What do I say are the two best things the agency does? Inspect and test. That’s how they keep us safe.”

In an interview, he suggested fear of an FDA inspection—and the agency uncovering problems —motivates certain facilities to come into compliance with regulations.

While the legality of CBD is a “gray area,” companies running afoul of rudimentary requirements in the law shouldn’t be selling products, Fabricant suggested. “You have nowhere to hide if you’re not a [cGMP] product,” he said. “Similarly, if you’re a product that has a high level of THC, that’s a Schedule I substance. We don’t sell Schedule I substances in this industry.”

Michael McGuffin is president of the American Herbal Products Association (AHPA), a trade association in Silver Spring representing the herbal products industry. He concurred FDA should be conducting cGMP inspections of facilities manufacturing CBD-containing products. In a poll of some of its members selling such products, two members revealed that their contract manufacturers had been inspected for cGMPs, McGuffin revealed.

“I’m afraid that the agency thinks they can’t enforce the rules on a product that they’ve declared to not be lawful,” McGuffin said in an interview. “I’m afraid that’s their perception.”

AHPA in March adopted a guidance policy to foster compliance with existing federal regulations. The policy recommended any holder, labeler, manufacturer, marketer or packer of dietary supplements or foods containing hemp or CBD adhere to several different federal regulations, including cGMPs, registration of food facilities and safety-related ingredient notifications when applicable.

“We think the agency’s got to treat them like they’re selling anything else,” McGuffin said. “And you walk into the facility and you say, ‘Hey, we know when we walk in here you don’t have a food facility registration. You need to do that now. You need to get your registration in place. And we know you haven’t submitted any serious adverse event reports (AERs). We’d like to see your AER file.’”

Companies in the CBD market that label their products as “supplements” should be complying with all the requirements applicable to that product category, added Steve Mister, an attorney who is president and CEO of the Council for Responsible Nutrition (CRN), a trade association in Washington representing dietary supplement and functional food manufacturers and ingredient suppliers.

Mister expressed concern many companies selling CBD-containing products are entering the dietary supplement market without any prior experience or knowledge of the relevant requirements.

“And they just come into this and start operating from a point of ignorance because they don’t know what they are basically buying into by calling themselves a supplement,” he said in an interview.

Mister said he and other trade groups have “jointly urged FDA to enforce all of these requirements on these companies.”

During the May 31 public hearing hosted by FDA, several speakers pointed to studies showing products containing CBD are adulterated and mislabeled, defrauding consumers and possibly endangering their health.

“Now, I get it: If you’re FDA, you don’t necessarily want to stick a finger in the eye of Senator [Mitch] McConnell,” CHPA’s Spangler said, referring to the Senate majority leader who introduced the hemp legislation incorporated in the 2018 Farm Bill signed into law, “but that doesn’t mean that there isn’t lots of opportunity for [enforcement against] products that everybody would agree are egregious, and start there.”

What are the implications of not enforcing? “I think it sends a message to the marketplace—keep doing what you’re doing,” Spangler responded.

In comments filed with FDA, the nonprofit Center for Science in the Public Interest (CSPI) encouraged the agency to develop a letter eventually incorporated in guidance clarifying FDA “will take action against both CBD- and THC-containing products that pose the greatest public health risks.”

Such high-risk products include those containing high doses of CBD or THC, or displaying health claims, particularly those to treat serious or life-threatening diseases for which FDA-approved options are available, CSPI said.

The consumer advocacy group also flagged products marketed to children, falsely labeled products and products contaminated with various substances, such as FDA-approved drugs, synthetic cannabinoids and high levels of pesticide residues. Other high-risk products, CSPI said, include those that pose the risk of serious side effects and products that threaten vulnerable populations, including children and pregnant women.

“FDA should also issue and publicize warning letters to manufacturers of products that make clear that the agency will put these enforcement priorities into practice,” CSPI wrote.

In a recent article on FDA’s website, Abernethy and a colleague, Lowell Schiller—principal associate commissioner for policy—acknowledged speakers during the public hearing expressed support for proper regulatory oversight, including “clear safety standards and strong enforcement.”

“When dealing with complex questions like those posed by CBD, the FDA’s top priority is always our mission of protecting and promoting public health,” Abernethy and Schiller, co-chairs of a CBD working group, wrote.

Jonathan Miller, general counsel to the U.S. Hemp Roundtable, a nonprofit coalition of hemp companies in Lexington, Kentucky, expressed support for FDA enforcing its standards once it adopts rules governing CBD. He also confirmed members of the U.S. Hemp Roundtable are making efforts to comply with existing regulations based on the category for which they are marketing products containing CBD.

“Our U.S. Hemp Authority [a sister organization to U.S. Hemp Roundtable] will adjust our standards to meet what the FDA requirements are, if necessary,” Miller said in an interview. “But we encourage the FDA to go after the bad actors in the industry.”