Two members of Congress on Friday introduced a bill that would create a legal pathway for marketers of hemp-based CBD in dietary supplements, eliminating a monstrous hurdle that has stymied the sector’s growth in recent years.
The legislation would create an exception to a current provision in the law, which bars an article like CBD from being marketed in a dietary supplement if it was first the subject of substantial clinical investigations instituted and made public.
Under the bill, CBD and other ingredients from hemp would become lawful for use in supplements if the products comply with current legal requirements for new dietary ingredients, as well as all other requirements applicable to dietary supplements under federal law.
Subject to meeting the above provisions, hemp-based CBD would be lawful for use in a dietary supplement beginning 90 days after the legislation took effect.
Hemp, supplement trade groups weigh in
“Enabling CBD to be lawfully marketed as dietary supplements and mandating that manufacturers comply with the entire existing regulatory framework for dietary supplements, would create immense confidence in hemp and CBD products, and would provide great opportunity for hemp farmers across the nation,” Jonathan Miller, general counsel to the U.S. Hemp Roundtable, a coalition of companies and organizations, said in a press release.
The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 was introduced by Reps. Kurt Schrader, Democrat of Oregon, and Morgan Griffith, Republican of Virginia. Griffith and Schrader both sit on the House Committee on Energy and Commerce, which has jurisdiction over FDA.
“Hemp was historically an important crop for Virginia farmers, and dietary supplements made from it do not possess dangerous addictive qualities," Griffith said in an emailed statement through a spokesperson. "Nevertheless, the current state of regulation creates confusion about its legal uses. I joined this bipartisan bill to provide certainty for hemp farmers that their crop may find legal uses.”
Schrader hails from the same state as Sen. Ron Wyden, a Democrat who also has been a supporter of the hemp industry and recently expressed hope that FDA would release a sensible CBD guidance related to a policy of enforcement discretion.
In a joint press release, four dietary supplement trade groups applauded introduction of the bill in the House of Representatives. The release was issued by the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN) and United Natural Products Alliance (UNPA).
"While the 2018 Farm Bill changed the law to allow hemp farming, regulatory uncertainty remains about the inclusion of hemp and hemp-derived CBD in dietary supplements," the groups stated. "This lack of regulatory clarity along with insufficient oversight around hemp and hemp-derived CBD exposes consumers to potentially unsafe products and lack of consistency in product quality."
On May 31, 2019, FDA held a public meeting on cannabis-derived compounds largely devoted to CBD. While FDA has been exploring whether to issue regulations for the CBD market, the hemp and dietary supplement industries have grown inpatient with the lack of a national regulatory framework.
“Over one year has passed since FDA held its public meeting to better understand hemp-derived substances, and almost two years have passed since the Farm Bill was enacted, legalizing hemp-derived CBD,” said Julia Gustafson, vice president of government relations with CRN, in a separate news release. “During this time, the agency has taken no action to legalize this ingredient, facilitating an unregulated marketplace. CRN urges Congress to pass this critical legislation and open the marketplace to CBD dietary supplements, providing FDA enforcement authority over the category to assure consumers have access to safe and beneficial products to support their health and wellness.”
Unlike a bill introduced early in 2020 by Rep. Collin Peterson, who chairs the House Agriculture Committee, the new legislation does not create a lawful pathway to market for CBD in conventional food.
Criticism of bill
Among dietary supplement trade groups, the legislation did not receive unanimous support. Dan Fabricant, president and CEO of the Natural Products Association (NPA), who previously oversaw what was then known as FDA's Division of Dietary Supplement Programs, said the bill plays into the hands of industry critics who claim the industry doesn't want to be regulated.
He suggested marketers of so-called "hemp extracts" could argue that under the legislation, they have no obligation to file a new dietary ingredient notification (NDIN) with FDA, since hemp was in the market before passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). The NDIN requirement is a crucial provision in DSHEA intended to demonstrate the safety of new ingredients in supplements before they are sold on the market, but there's a consensus within industry that it's been underutilized.
The Secretary of the U.S. Department of Health and Human Services (HHS) already has authority to promulgate a regulation for CBD in supplements, Fabricant observed. He said he also wants to see CBD available in supplements, but added, “This isn’t the right way to do it.”
Pieter Cohen is a Massachusetts physician, whose research identifying potentially hazarous substances in products labeled as dietary supplements has been published in peer-reviewed journals and widely reported in the mainstream media and trade press. He expressed doubt that the CBD legislation would protect consumers.
“Because the FDA is not aggressively ensuring compliance with the law for dietary supplements, practically anything can be introduced into the market, including CBD products as a supplement," said Cohen, associate professor of medicine at Harvard Medical School, in a phone interview. The country needs “a functioning regulatory framework in place, so that would require reform of DSHEA, combined with the FDA enforcing DSHEA or the reform to DSHEA. Without those two things in place, the market’s going to remain confusing and potentially hazardous for consumers.”
Cohen identified problems with the way in which ingredients are introduced into supplements—a subject he tackled in research published in the New England Journal of Medicine, alongside a prominent attorney, Scott Bass, who helped negotiate DSHEA.
“There’s not just the NDI route,” but “back doors” are available, including GRAS (generally recognized as safe) self-affirmation, Cohen said in the interview. That's a process in which an expert panel makes a safety determination about an ingredient but does not notify FDA for its review. Some critics have argued the process is rife with conflicts of interest.
In a separate article published in The New England Journal of Medicine, Cohen and a former FDA official, Joshua Sharfstein, M.D., advocated for a CBD law that would incorporate several reforms of DSHEA, including strengthening safety requirements for NDIs.
"A new CBD law could require the FDA to strengthen its approach to safety requirements for new dietary ingredients, prohibit the risky practice of concentrating ingredients in supplements at levels much higher than those traditionally found in food or botanicals, and create an effective mandatory product listing for all dietary supplements," Cohen and Sharfstein wrote.
But they opposed legislation in which Congress would "make determinations about the safety of CBD or other individual chemicals." As the scientific agency responsible for protecting "the public from unacceptable risks," FDA should make such decisions, according to Cohen and Sharfstein.
The CBD legislation introduced Friday, Cohen concluded, “would give me no reassurance" that safety information would be produced to confirm "CBD supplements are safe."