November 24, 2020
FDA and members of Congress who introduced legislation to make CBD lawful as a dietary ingredient in supplements have starkly different visions of how such products should be regulated, an FDA document reveals.
H.R. 8179 would legalize CBD and other ingredients derived from hemp for use as a dietary ingredient in a supplement. That’s provided the dietary supplement complies with existing requirements of the Federal Food, Drug & Cosmetic Act (FDCA).
But in “technical comments” provided Oct. 30 to the House Committee on Energy and Commerce, FDA proposed several substantive amendments to H.R. 8179, otherwise known as the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020.
FDA’s proposal would limit the bill to hemp-derived CBD in supplements, require that manufacturers and distributors establish the safety of the compound through new dietary ingredient notifications (NDINs) and limit the amount of CBD per recommended daily serving, provided the secretary of the U.S. Department of Health and Human Services (HHS) established a threshold.
FDA also recommended language that would make it a “prohibited act” to introduce into commerce a product labeled as a dietary supplement that doesn’t meet the legal definition of a supplement. Agency officials in recent years have cited unique challenges dealing with products labeled in the U.S. as “dietary supplements” but tainted with active pharmaceutical ingredients. FDA doesn’t have jurisdiction to use its “food and supplement authorities” to target such products, which “creates challenges” for the agency, according to Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP), in a recent interview.
FDA’s proposed changes would allow the agency “to refuse admission to products that appear to be in violation of the new prohibited act, as well as to seize products that are in violation,” FDA stated in the technical comments. “This will help ensure that firms do not avoid the new requirements by simply developing their products with synthetic CBD rather than hemp-derived CBD, which we understand is not the intent of the sponsor. It would also help FDA to control the market against unlawful foreign imports.”
The beginning of the six-page document—"FDA/HHS Technical Comments on H.R. 8179"— cautioned the “comments are intended only to provide technical assistance and are by no means to be interpreted as any kind of approval or endorsement of the legislation by the Department of Health and Human Services and its agencies or the Administration.”
As currently written, H.R. 8179 would make lawful CBD and other hemp-derived ingredients in supplements. This is another area where FDA differs from the bill’s sponsors. The agency only wants the bill to apply to hemp-based CBD, not other ingredients derived from the plant.
Under the 2018 Farm Bill, hemp can contain a delta-9 THC concentration of up to 0.3 percent on a dry weight basis, but FDA stated that amount of THC in a dietary supplement poses "potential safety concerns."
FDA has "little safety data on the majority" of hundreds of compounds from hemp, including cannabinoids and terpenes, and the legislation could provide disincentives to study the substances as potential drugs, according to the agency's technical comments.
“We are concerned about this lack of safety data, and we are also concerned that by including these other hemp-derived compounds in the bill language, it could disincentivize potential drug development of these compounds and instead encourage the use of these compounds in dietary supplements," the agency stated.
FDA proposed requiring manufacturers demonstrate the safety of their CBD to FDA through an NDIN, a 75-day premarket notification to FDA that Congress adopted in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Based on FDA’s recommendations, CBD brands could not rely on the two exemptions to the notification requirement in the law.
FDA also suggested the bill’s sponsor consider providing the agency authority to establish or revise a threshold for the amount of a daily serving of CBD that a supplement could contain. Based on FDA’s proposal, the agency would not have discretion to accept NDINs exceeding such a limit.
The agency also touted its proposal in recent years for a change in the law to require listing of dietary supplement products with FDA. “We would be happy to work with the sponsor if there are questions regarding this proposal,” FDA stated in the technical comments.
Spokespersons for the co-sponsors of H.R. 8179—Reps. Morgan Griffith, Republican from Virginia, and Kurt Schrader, Democrat from Oregon—did not immediately respond to requests for comment on FDA’s technical comments to the bill. An FDA spokesperson had no comment on the document.
Reactions to FDA technical comments
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), agreed there were significant differences between the bill and what FDA proposed in its technical comments.
Certain members of Congress “are very eager to see something workable, and I’m hoping that those members of Congress will be able to bring both industry and FDA to the table to have some meaningful negotiations and see where we can meet in the middle,” Mister said in an interview. “But yes, as an opening bid, we are far apart.”
FDA has asserted CBD is excluded from the definition of a dietary supplement because it was previously the subject of substantial clinical investigations instituted and made public. GW Pharmaceuticals plc, which conducted the clinical investigations, markets an FDA-approved CBD drug, Epidiolex, for the treatment of seizures associated with two rare and severe forms of epilepsy.
Mister observed FDA has continued to raise safety concerns about whether CBD can be lawfully marketed in a supplement.
“And for us, that ignores the elephant in the room, which is that it’s not a safety question,” he said. “It’s the drug preclusion language. That’s the reason that FDA says it’s not a legal supplement because it was first marketed and studied as a drug.”
Without the broad language in H.R. 8179, hemp advocates fear FDA and industry will fight down the road over whether other hemp-derived compounds like CBN (cannabinol) and CBG (cannabigerol) were first studied as a drug. Rend Al-Mondhiry, an attorney who advises dietary supplement firms, said the legislation represents an opportunity to clarify that all hemp-derived cannabinoids are not subject to the drug exclusionary clause in the FDCA.
She disagreed with FDA that H.R. 8179 would disincentivize the development of drugs. Conventional food, supplements and drugs are all subject to distinct regulatory paths and are all “marketed for different purposes,” said Al-Mondhiry, a partner in Washington, D.C., with Amin Talati Wasserman LLP, in an interview.
“All three of these product categories can co-exist without disincentivizing drug development,” the lawyer added.
Al-Mondhiry also commented on FDA’s proposal to preclude marketers of CBD from relying on an exemption to the NDIN requirement in Section 413(a)(1) of DSHEA, which amended the FDCA.
Under Section 413(a)(1), a supplement containing a new dietary ingredient is not subject to the notification requirement if the product “contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.”
Several prominent brands marketing CBD in “food” and “dietary supplements” have announced demonstrating the safety of their hemp extracts through GRAS (generally recognized as safe) self-affirmations that FDA does not review. FDA officials have said many firms view the GRAS process as an alternative to an NDIN.
But FDA’s technical comments proposed amending Section 413(a)(1) so that the NDIN exemption would not apply to CBD. The agency also suggested Congress incorporate report language specifying hemp-derived CBD is an NDI. Such language would foreclose arguments that the compound is a “grandfathered” or “old” dietary ingredient under DSHEA presumed safe.
FDA’s proposal, several industry sources agreed, means only one regulatory pathway would be available to demonstrate the safety of CBD in a dietary supplement—through an NDIN.
“We’re sympathetic to what we’ve heard FDA say about the need for NDI notifications,” Al-Mondhiry said. “That it’s really the only opportunity FDA has to review the safety of the ingredient before it goes to market and that the self-affirmed GRAS pathway doesn’t give FDA that opportunity to review the data.
“On the other hand, there’s other ways FDA can obtain data about the safety of these ingredients,” she added.
Al-Mondhiry said she is not aware of safety concerns tied to CBD-containing products that have gone through GRAS self-affirmation.
“If you’re doing everything right through a self-affirmed GRAS, there’s no reason to think that those ingredients pose any more of a safety issue than ingredients that go through the NDI notification process,” she said.
Mister said many firms have turned to GRAS self-affirmation due to criticisms over FDA’s implementation and enforcement of the NDIN provision in the law.
Industry representatives “are willing to sit down with FDA and try to understand why they think the NDI notification route is the only route that should be available, but only if we have some confidence that the FDA is going to robustly enforce and implement the NDI notification process,” he said. “And what we’ve seen is it’s languished now for 10 years.”
Douglas (“Duffy”) MacKay previously worked at CRN and is currently senior vice president of scientific and regulatory affairs with CV Sciences Inc., a public company marketing hemp-based CBD in supplements. He expressed support for some of FDA’s recommendations in its technical comments.
“Full-FDA regulation of hemp-derived CBD will benefit consumers by increasing access to safe products that are tested to ensure they contain what’s on the label and nothing more,” MacKay said in an email. “From a public health and policy vantage point, it is hard to argue against requiring NDINs and mandatory product listing.”
In an article published Dec. 19, 2019 in the New England Journal of Medicine, attorney Scott Bass of Sidley Austin LLP proposed reforms to DSHEA, including that manufacturers of supplements submit the vast majority of new dietary ingredients to FDA for its review.
The proposal from Bass and his co-author—Dr. Pieter Cohen of Harvard Medical School—would largely gut the “food supply” exemption in Section 413(a)(1) to the NDIN requirement, or what the authors described as a “loophole” that has “swallowed the law.”
In a recent interview, Bass said he doesn’t believe the exemption applies to CBD because products containing the compound were neither commonly used as foods nor generally recognized as safe for their intended use. One year ago, FDA stated in a news release that it was unaware “of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food.”
Bass nonetheless opposes FDA tinkering with Section 413(a)(1) of DSHEA in CBD legislation.
“That provision needs to stay general and it needs to stay narrow,” he said in an interview. “There should be no implicit recognition that this game that people are playing with that exemption is valid.”
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