Several consumer groups are urging lawmakers on Capitol Hill to reject a bill that would legalize CBD in dietary supplements, warning the move would bypass the expert regulatory agency—FDA—and create an unsafe market.
“We strongly oppose any bill to force the FDA to allow cannabidiol (CBD) and any other ingredient derived from hemp to be used in dietary supplements as a dietary ingredient within [a] set period of time from enactment,” the organizations wrote in a March 10 letter addressed to members of Congress. “Such a measure would cut short the FDA’s current efforts, create an unsafe CBD market and irreparably politicize the FDA’s scientific oversight of the food and drug supply.”
CBD-containing products labeled as dietary supplements have proliferated in the U.S., despite repeated assertions for years by FDA that CBD cannot be lawfully marketed as a dietary supplement because the cannabis-derived compound was first studied as a drug.
H.R. 841 would expressly allow CBD and other hemp-derived compounds to be marketed in dietary supplements, subjecting the products to FDA oversight and the same provisions of law that apply to all other supplements. Critics of the bill said it would circumvent FDA’s ongoing efforts to assess conditions under which CBD could be safely consumed in a dietary supplement.
The Center for Science in the Public Interest (CSPI), Consumer Reports, Consumer Federation of America, National Consumers League and Dr. Pieter Cohen of Harvard Medical School criticized H.R. 841 in the seven-page letter to lawmakers that also called for sweeping reforms to how dietary supplements are regulated.
Joining the March 10 letter in opposition to H.R. 841 “was an easy call for me because it’s putting Congress in the position of evaluating the safety of … a dietary supplement and something that’s going into the food and drug supply,” said Thomas Gremillion, director of food policy at the Consumer Federation of America, in an interview. “And it’s a really important principle that we have experts at the Food and Drug Administration and other places that make those decisions and not elected leaders.”
FDA’s enforcement against CBD products to date has been focused largely on firms making claims that their products treat diseases. But just because FDA hasn’t taken steps to remove all the CBD products from the market doesn’t mean Congress should order FDA to “rubber-stamp” CBD as safe, Gremillion said.
Consumer groups warned lawmakers that passage of H.R. 841 would set a terrible precedent.
“If these types of bills are enacted, more well-funded profiteers would inevitably barrage Congress with requests for their chosen products to be given carte blanche,” the organizations wrote in the letter. “For their part, consumers would wrongly believe that these products have been evaluated while potentially being put at risk.”
Jonathan Miller, general counsel to the U.S. Hemp Roundtable, said the consumer groups that oppose H.R. 841 “have gotten it precisely backwards.”
“They’re arguing that if this bill passes that there would be unsafe CBD products in the marketplace,” he said in an interview. “And it’s just the opposite. There are currently unsafe products in the marketplace because there is no regulation. And that’s why we so desperately need 841, which would provide for an existing regulatory regime for dietary supplements to govern the manufacture of CBD products.”
Laura MacCleery, policy director of CSPI, doesn’t find such an explanation persuasive.
“That argument is hard to support given that the people making that argument know full well that the baseline assurances for any supplement are really shoddy,” she said in an interview. “Supplements are among the most poorly regulated of consumer products sold…We need to rethink the whole approach to supplement regulation. This shows exactly why.”
The consumer groups’ letter opposing H.R. 841 “strikes me as inappropriately focused on what we should not do. ‘We should not let the Congress fix this,’” said Michael McGuffin, president of the American Herbal Products Association (AHPA), in an interview. “And yet, I have not heard any of these organizations take strong positions to encourage the Food and Drug Administration to complete its task to establish a clear regulatory pathway for these products.”
FDA has been studying CBD for years, but it has yet to commence a notice-and-comment rulemaking to regulate CBD in conventional food and supplements.
Such a process could take several years to complete, FDA officials have warned, and ultimately rulemaking authority for a substance like CBD that was first studied as a drug is vested in the secretary of the Department of Health and Human Services (HHS). Xavier Becerra, California’s former attorney general, was recently confirmed by the U.S. Senate as HHS’s new leader.
Dietary supplement companies that want to act responsibly today and provide FDA evidence that their CBD is safe through a new dietary ingredient notification (NDIN) are precluded from doing so, due to FDA’s position that CBD can’t be lawfully marketed in a dietary supplement, observed David Spangler, senior vice president of legal, government affairs and policy with the Consumer Healthcare Products Association (CHPA).
“Until we can get that roadblock removed, we’re stuck,” he commented in an interview.
Removing the legal impediment, via passage of H.R. 841, would give supplement firms the ability to notify FDA, providing the agency the basis upon which they have concluded their CBD is reasonably expected to be safe.
“And FDA [officials] can then say why they disagree,” Spangler added. “The company could introduce it anyway, but then get sued to kingdom come.”
Although the consumer groups have argued H.R. 841 would usurp FDA’s role, it demonstrates a lack of understanding of the bill, according to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).
Even if H.R. 841 is passed into law, CBD and other hemp-derived ingredients marketed in supplements would be subject to the NDIN provision in the Dietary Supplement Health and Education Act of 1994 (DSHEA), as well as all other requirements pertaining to dietary supplements under federal law. The bill expressly says as much.
All H.R. 841 does, advocates of the bill said, is overcome an obstacle in the law, which prevents an article like CBD from being marketed in a supplement if it was first authorized for investigation as a new drug and the subject of substantial clinical investigations made public.
The consumer groups “don’t understand the legal problem facing CBD, and secondly, they don’t understand that the safety concerns that they raise can be addressed through the NDI process,” Mister said.
MacCleery responded the NDIN process doesn’t provide adequate assurances of safety, supplement manufacturers are plagued with “notorious quality control problems,” and false and misleading claims proliferate in the market. Among the consumer groups’ proposals to Congress: gutting an exemption to the NDIN requirement in DSHEA, what the consumer groups described as a “GRAS (generally recognized as safe) loophole to secretly self-affirm that new ingredients and uses are safe without FDA review.”
H.R. 841 “would just add to an already chaotic marketplace—another risky, poorly regulated, questionable quality category alongside sexual enhancement and weight loss and workout drugs,” MacCleery declared. “Enough is enough. At some point, you actually have to fix the system and make sure that consumers are protected.”
Critics of H.R. 841 are making some “patently false” statements regarding the regulatory system governing dietary supplements, according to Dan Fabricant, Ph.D., a former FDA official who leads the Natural Products Association (NPA).
On the other hand, he’s not a champion of H.R. 841.
The legislation “plays right into our critics’ hands,” said Fabricant, who led the Division of Dietary Supplement Programs from February 2011 until April 2014, when he departed the agency to rejoin NPA. “Our critics say that industry doesn’t want to be regulated, and effectively, this bill is taking it out of FDA’s hands for rendering an opinion.”
He firmly believes FDA should establish limits—based on a safety evaluation—at which CBD can be sold in a dietary supplement, distinguishing it from Epidiolex, an FDA-approved CBD medicine to treat seizures associated with rare forms of epilepsy.
Fabricant argued H.R. 841 is the equivalent of him advising lawmakers that his family member has developed a vaccine that should be legalized tomorrow.
“That—long term for consumer confidence—is not good,” he said in an interview.
While McGuffin would prefer FDA act rather than Congress, industry groups have grown impatient with FDA.
“It’s not my favorite route for a solution, but the Food and Drug Administration has not to date addressed the issue,” McGuffin remarked. If FDA won’t move to actively regulate the CBD market, “we need to protect consumers, and this [bill] would do that.”