Some industry trade groups in the nation’s capital differ on the appropriate path forward in FDA establishing a framework authorizing CBD in dietary supplements.
Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), said FDA must first establish a level at which CBD can be safely sold in supplements and doesn’t produce drug-like side effects.
“For foods, we shouldn’t have side effects,” he noted in an interview.
In July 16 comments filed with FDA, Fabricant stated the agency “has resources and personnel to establish a daily exposure level for a healthy population using CBD.”
He described such a measure as a form of “enforcement discretion” that FDA has used when a natural product containing an active pharmaceutical ingredient is sold as a food or dietary supplement.
Typically, FDA uses such discretion by establishing a level of an ingredient or daily amount through a health hazard evaluation (HHE), Fabricant wrote to FDA. He cited as an example red yeast rice products marketed as dietary supplements and containing a drug known as monacolin K or lovastatin.
“While it does not appear that the agency has established a level in foods or dietary supplements regarding CBD that would be considered a hazard at this time, the World Health Organization (WHO) has established such a level,” Fabricant stated in his written comments. “Regarding abuse potential, WHO established a limit of 600 mg per day in healthy subjects.”
Another trade association in Washington—the Council for Responsible Nutrition (CRN)—asserted FDA must first address a definitional issue identified by FDA: namely that CBD is excluded from the definition of a dietary supplement because, in essence, the compound or “article” was first studied as a drug by GW Pharmaceuticals plc.
“Sequentially, you can’t talk about safety levels of something if you’re not going to let it be sold as a supplement in the first place,” said Steve Mister, president and CEO of CRN, in an interview. “You’ve got to solve the definitional problem before you can talk about safe levels.”
The secretary of the U.S. Department of Health and Human Services (HHS)—FDA is an agency within HHS—has authority to create an exception to the definitional problem above and make CBD lawful in food and dietary supplements by issuing a rulemaking following notice and comment.
“Nowhere in the statutory language or the legislative history of these provisions did Congress require or intend FDA to address the safety of dietary supplements or food when determining whether it should invoke its notice and comment rulemaking authority,” representatives of CRN wrote in July 16 comments to FDA. “The regulatory framework already exists to ensure the safety of a dietary supplement or food through other statutory provisions and regulations.”
Mister acknowledged FDA wants marketers to demonstrate the safety of CBD at the levels in which the hemp-derived compound is sold as a dietary supplement. However, he said companies aren’t “willing to invest money to do that kind of safety research if they can’t see a light at the end of the tunnel.”
In creating a legal pathway for CBD in dietary supplements, FDA doesn’t need to craft an exception to the clause in the law that excludes an article studied as a drug from the definition of a dietary supplement, said David Spangler, senior vice president of policy and general counsel with the Consumer Healthcare Products Association (CHPA).
FDA, he suggested, could distinguish the “article” studied by GW Pharmaceuticals from the CBD-containing dietary supplement products on the market. According to marketers of CBD-containing products in dietary supplements, “hemp extracts” contain a “broad” or “full” spectrum of cannabinoids and are distinguishable from GW’s CBD medicine—Epidiolex—approved by FDA.
Spangler cited examples in which a pharmaceutical drug like fish oil co-exists with other product categories, including conventional food and dietary supplements. Even within the drug industry, Ibuprofen can be an over-the-counter (OTC) or medical prescription drug depending on the dosage, he pointed out.
“Epidiolex is a highly isolated, highly refined CBD product,” Spangler said in an interview. “That doesn’t necessarily mean that ‘CBD’ has to be the article. Highly isolated refined CBD could be the article.”
Lawmakers in Washington are showing an increasing interest in FDA’s prospective oversight of CBD.
For instance, an appropriations bill that passed last month in the U.S. House of Representatives incorporated a provision that would earmark “$100,000 for FDA to undertake a process to make lawful a safe level for conventional foods and dietary supplements containing Cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations.”
The directive, which NPA supported, was introduced by Rep. Jerry McNerney, a Democrat from California. H.R. 3055 would provide funding in fiscal year 2020 for various agencies. According to a Washington insider who closely tracks legislation in Congress, the Senate has not yet considered a companion appropriations bill.
“Consumer safety and confidence is of the utmost importance, and it was the driving factor behind my introduction of the CBD amendment,” McNerney said last month in a statement. “By directing the Food & Drug Administration to set safe CBD consumption levels, we will be giving consumers peace of mind and outlining standards for producers to ensure a safe and reliable market for these products.”
Asked about the appropriations language, Mister responded: “We don’t believe there is a single safe level for CBD.”
“Each product needs to demonstrate that that product is reasonably expected to be safe because certain dosage formats might be able to go higher than others,” he explained.
He noted, for example, a consumer might be more likely to abuse CBD in a food like a CBD-infused sweet rather than a supplement capsule.
“It’s much more likely that somebody could unintentionally end up eating five or six cookies a day that are all laced with CBD because they taste so good and kind of forget that, ‘Oh yah, every time I’m eating one of these, I’m getting a daily dosage of CBD,’ and then pretty soon you’ve taken too much,” he said.
Establishing the safety requirements, he added, depends on the product category in which CBD is being marketed, such as a conventional food, supplement or pharmaceutical drug.
“Safety is intended to be addressed on a product-specific basis in the framework already carefully laid out by Congress and FDA,” CRN representatives wrote to FDA. “This framework permits FDA to address safety in the context of each regulatory channel (e.g., dietary supplements versus food), unique delivery form, ingredient matrix (e.g., CBD isolate versus hemp extract), dosage, and other unique considerations for each product.”
But FDA cannot reach the safety question unless it creates a regulatory pathway for supplements, according to CRN. If a company submits to FDA a new dietary ingredient (NDI) or generally recognized as safe (GRAS) notification for CBD, the agency will reject the notice because it doesn’t consider the substance a legitimate dietary or food ingredient, the trade group said.
Fabricant, however, reiterated safety is the overriding concern that must be addressed first—not the issue related to CBD’s legality in supplements.
“Why would we as an organization look in the camera of NBC, CNN, whoever, and say, ‘We don’t want FDA to establish a safe level of CBD,’” asked Fabricant, who led FDA’s Division of Dietary Supplement Programs from 2011 until 2014 before rejoining NPA. “Can you think of a worst position to be in?”
“When safety’s on the line, who cares about the definitional issues,” he added.
Fabricant suggested a company could exceed a safe level established by FDA if it subsequently provided documentation to the agency, demonstrating a new limit in a product did not pose a safety concern or produce a drug-like side effect.
In a news release Tuesday, FDA’s acting commissioner, Ned Sharpless, M.D., said “there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD.”
Michael McGuffin is president of the American Herbal Products Association (AHPA). Although AHPA hasn’t “called on FDA to set a quantitative limit” for CBD, McGuffin acknowledged the likelihood the agency will do so rather than simply declaring the compound lawful in products and trusting marketers to notify FDA about their ingredient-related safety assessments for their individual products.
“FDA can’t take any position that even sounds like ‘safety second,’” he explained in an interview. “They have to take the position that says …, ‘Our first priority’—they say this all the time—'is to protect the public health.’”
Jonathan Miller is general counsel to the U.S. Hemp Roundtable, a nonprofit coalition of hemp companies in Lexington, Kentucky. Based on his contacts at the agency, he expressed his understanding that FDA will seek to establish a ceiling under which CBD can be sold as a dietary supplement and above which it could only be marketed as a drug provided it is subject to FDA approval.
“The available scientific evidence demonstrates that CBD is generally well tolerated, even at high doses, in healthy and non-healthy populations,” the U.S. Hemp Roundtable wrote to FDA in July 16 comments.
Vote Hemp, a grassroots nonprofit organization in Washington, said FDA should treat hemp-derived extracts as any other herb.
“Thus, existing federal regulations for food and dietary supplements must apply to hemp-derived extract products, including those containing CBD, to assure consumers of the same production safety and integrity of ingredients met by other FDA-regulated supplements,” Vote Hemp wrote to FDA in July 16 comments.
Finally, McGuffin noted all the supplement trade groups are in agreement that the CBD product category should be “well regulated.”
“We want the regulations to be properly enforced across the category,” he said. “And by proper enforcement, we mean just like any other dietary supplement.”
Editor's note: For a deep dive into the CBD market, download this report.