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While U.S. officials have not disclosed the substance of an FDA policy of enforcement discretion related to CBD, they have been meeting with industry representatives to solicit their feedback.
August 6, 2020
A prominent advocate for U.S. CBD brands said Thursday he was “very encouraged” after meeting last week with FDA and White House officials.
Jonathan Miller, general counsel to the U.S Hemp Roundtable and member-in-charge of the Lexington, Kentucky office of the law firm Frost Brown Todd LLC, expressed optimism that a formal FDA policy of enforcement discretion related to CBD would be announced soon.
A document, “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” is currently before the White House’s Office of Management and Budget (OMB).
While U.S. officials have not disclosed the substance of the document, they have been meeting with industry representatives to solicit their feedback on a host of issues, from recommendations for a daily serving amount of CBD to drug testing.
The meetings have been conducted via teleconference amid a pandemic and a year fraught with challenges for the hemp and CBD industries, including an oversupply of hemp and cutthroat competition in the retail market.
FDA’s long-held position—that CBD cannot be lawfully marketed in food or dietary supplements because, essentially, the cannabis-derived compound was first studied as a drug—has dissuaded many U.S. corporate behemoths from entering the category, stemming demand.
A formal policy of enforcement discretion, industry advocates said, would provide comfort to CBD companies who follow various FDA regulations, bolstering a U.S. economy reeling from the effects of the coronavirus. Industry's hope is that under a formal policy, FDA would target for enforcement action only those companies that are endangering the public or flouting agency regulations—such as the requirement to manufacture dietary supplements in accordance with cGMPs (current Good Manufacturing Practices).
“It certainly won’t solve all the problems that we’re facing, but I’m real hopeful that we do get something like an enforcement discretion policy that will allow those who are playing by the rules to sell products in the marketplace without fear of being prosecuted,” Miller said in an interview.
He added later, “This would be a great way to help the economy without spending trillions of dollars on stimulus.”
During the July 30 meeting, Miller also highlighted FDA’s mission to protect public health. An enforcement discretion policy “should authorize the sale of products that meet FDA’s other regulations,” he said.
Nathan Arnold, an FDA spokesman, said the draft guidance document was entered July 22 into OMB’s system.
“This is part of the standard OMB review of regulatory documents,” he said via email, declining further “comment on the guidance until it is published.”
Miller said he met last week for around 45 minutes with about a dozen officials from FDA, U.S. Department of Health and Human Services (HHS) and the White House.
Joining him was Rend Al-Mondhiry, FDA counsel for the U.S. Hemp Roundtable. The meeting included representatives from several different White House offices, including the Domestic Policy Council, Office of National Drug Control Policy and National Economic Council, Miller reported.
Al-Mondhiry said someone from the government inquired whether companies were submitting food additive petitions to FDA.
“I don’t know whether they were using the term ‘food additive’ as a form of art, meaning specifically food additive petitions, as opposed to a GRAS (generally recognized as safe) notification or something like that," noted Al-Mondhiry, a partner in Washington, D.C., with the law firm Amin Talati Wasserman LLP, in an interview.
During the teleconference with government officials, Al-Mondhiry explained FDA's position—that CBD is not a legal food or dietary ingredient—poses a barrier to companies investing in a safety-related notification to FDA, "if there’s a possibility those would be rejected because the agency would say, ‘Well, these aren’t legal ingredients so we’re not going to review the data,'" the lawyer said.
The U.S. Hemp Roundtable is among those entities that have supported the continued availability of multiple regulatory pathways for demonstrating the safety of an ingredient, such as GRAS self-affirmation, a GRAS notice or a new dietary ingredient notification to FDA.
"We made that point as well, that there are different legal pathways that the law allows, and guidance should permit companies to provide safety evidence in any one of those available pathways," Al-Mondhiry said.
Miller said he advocated for a formal policy of enforcement discretion “that would provide a safe harbor for companies who sell CBD, according to all other FDA guidelines—whether that’s good manufacturing practices or truth in labeling.”
He said officials asked several questions, such as what constituted a proper daily serving limit for CBD. Miller referenced daily limits announced in Australia, as well as the UK, where the Food Standards Agency in February recommended healthy adults consume no more than 70 mg a day.
“I thought that would be appropriate to use here,” he said. “It’s based on good science.”
On July 31, a few days after sharing its perspective on regulations with FDA’s CBD policy working group, the National Industrial Hemp Council (NIHC) met with OMB.
“OMB listened to our experts in the industry and we pressed our case for enforcement discretion and sensible regulations,” Patrick Atagi, chairman of the board of directors for NIHC, said in a statement. “We stressed to OMB that with no regulatory framework in place right now, it leaves room in the market for bad actors.”
“We’re all on the same page,” Barroso said in an interview. “We want rules and regulations—some kind of standards that can help the industry and really get rid of the bad actors that are just not doing it right.”
OMB did not disclose details of the proposed policy or a timeline for when a draft policy might be announced, NIHC said.
In a separate teleconference Aug. 3, officials from FDA, HHS and the White House met with four representatives of Ziese Farms, a farmer and producer of hemp leaf foods.
David Heldreth, founder and CEO of Ziese Farms in Washington State, said he asked officials for clarification whether the guidance would be specific to CBD or hemp more generally.
“They couldn’t even answer that,” he said in an interview.
Heldreth expressed hope that any guidance would apply as well to parts of the hemp plant beyond CBD, such as cannabinol (CBN), terpenes and delta-8 THC—which he described as an isomer of delta-9 THC, yet legal to be marketed based on the 2018 Farm Bill.
He wants all substances in the hemp plant to be treated equally. “If we’re going to create this new gameboard of what the legal standing is … all of it should be allowed to play,” Heldreth said.
Heldreth said he also requested U.S. officials mandate testing for such things as pesticides and heavy metals. He also supports a requirement that constituents of the hemp plant are declared on the product label—or if such information is proprietary, a mandate that the information is shared with the government.
While U.S. officials did not disclose their timing for the release of an enforcement discretion policy, Miller’s optimistic. The day OMB announced FDA’s policy was under review, he requested a meeting.
“Within a couple of hours, they scheduled a meeting for a couple days later,” he said. “That does not sound like something that they’re dragging out. To me, that indicates that this is on the fast track as opposed to something that’s going to take months.”
Still, the notion that the feds will move swiftly is far from a unanimous one. “Some people are thinking we are going to hear something in a few weeks,” Jessica Mulligan, the founder of CBD brand Winged, said last week during the NBJ Summit. “But I’ve heard that for a few years now.”
Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition
Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.
Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.
Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.
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