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Email to a FriendCompanies who want to make CBD are increasingly frustrated that the Food and Drug Administration hasn’t yet given them clear regulations for their work. So, too, are consumer advocates, who want the agency to rein in the wildly popular marijuana-adjacent product.
Dr. Amy Abernethy, the FDA official leading that effort, has a simple but less than satisfying message: We’re trying. The FDA set out in earnest in April to figure out how to regulate CBD supplements. But following a closely watched public meeting in May, the agency has largely gone silent on when it will release a blueprint for how it plans to regulate the product — even blowing past self-imposed deadlines.
In a brief interview on the sidelines of the STAT Summit in Boston on Thursday, Abernethy, who serves as the principal deputy commissioner of the FDA and the head of the agency’s CBD working group, acknowledged those frustrations, but insisted the agency is going as fast as possible.
“My commitment is to work as quickly as possible and I’ve made that commitment quite vocally,” Abernethy said. “There is a great sense of urgency internally to get this out.”
Read more: Dude, where’s my regulatory framework? As CBD gains popularity, Washington struggles to keep up
At the same time, Abernethy declined to telegraph any significant action from the agency any time soon — particularly on a long-awaited report that would outline the FDA’s current thinking on the issue, which Abernethy previously tweeted would be released by “end of summer/early fall.”
“I’d love to give you an exact time frame,” Abernethy said. “I will say that it is not because we’re not trying. And actually, this is not about needing to get something written. Think about all the different agreements you’ve gotta get.”
In response to the agency’s inaction, industry and consumer groups have launched pressure campaigns against the agency, even threatening to get Congress involved.
“Something has to change,” said David Spangler, the top policy official for the Consumer Healthcare Products Association. “I’m at a loss for why they have not [acted faster].”
The FDA, to be fair, faces an unenviable task. Under current FDA rules, CBD supplements are technically illegal, because CBD is marketed as a prescription drug. Therefore, like other prescriptions, it can’t be sold over the counter. But the widespread enthusiasm about CBD both from consumers, industry, and increasingly, members of Congress, makes a wide-scale FDA crackdown on CBD unlikely.
Read more: The company behind the first-ever CBD-based drug is now eyeing everything from multiple sclerosis to autism
Writing an exemption in the rules, however, could have sweeping implications for the way FDA both regulates drugs and supplements. And the agency has insisted it doesn’t have enough data to give the agency’s blessing for putting CBD in everything from breakfast cereals to traditional supplements.
“There’s a huge gap in the data,” Abernethy said. “We don’t know what happens if you take CBD every day for a year or we don’t know what happens if you’re pregnant or breastfeeding. We don’t know about CBD for people who are older in life or have other medical conditions.”
Abernethy’s CBD working group co-chair, Lowell Schiller, struck a similar tone in recent comments at a supplement industry public meeting.
“There’s still much we don’t know — about the consequences of long-term use, about the risks to vulnerable populations, and lots more,” he said. “As we continue to work as rapidly as possible to figure out how to address this popular ingredient that until very recently was a controlled substance, it’s important to remember that there are no special rules for CBD.”
Abernethy said Thursday that the FDA is finally figuring out what it doesn’t know about CBD and where it needs to facilitate new research.
“We’ve really learned a lot about the data gaps,” Abernethy said. “We are identifying a research plan that needs to be done.”
Read more: ‘The industry has earned it’: Three CEOs own up to biopharma’s bad reputation
But industry doesn’t seem to be hearing it.
“I was not optimistic from hearing Mr. Schiller’s remarks at our conference because it doesn’t sound like the conversation is evolving at the FDA,” said Steve Mister, president and CEO of the Council for Responsible Nutrition. “It feels like they’re kicking the can down the road in hopes that somebody else will solve it.”
Increasingly they’re pushing the FDA to move faster, and saying that if the FDA doesn’t act, Congress should force the agency’s hand. Four of the largest supplement makers wrote to Congress in October making such a request.
“Since it appears FDA is unlikely to provide a timely and effective resolution to this challenge, Congress must act,” the letter, signed by the Council for Responsible Nutrition, American Herbal Products Association, Consumer Healthcare Products Association, and the United Natural Products Alliance.
Consumer advocates, too, have begun to publicly grouse about the FDA’s pace.
The National Consumers League and the Consumer Federation of America launched a new advocacy campaign Tuesday that has called on the FDA to more closely regulate the industry and highlighted new polling that showed a vast majority of Americans — roughly 80% — support strict enforcement by the FDA in the CBD market.
“We’re urging [the FDA] to at least get started in this process,” said Sally Greenberg, executive director of National Consumers League. “I think our polling data is going to really light a fire under the agency.”
Read more: These four companies are betting big on CBD-based prescription drugs
Abernethy demurred when asked whether she’s concerned the issue could be taken out of the FDA’s hands. Supplement makers have asked Congress to pass a bill that would declare CBD supplements can be sold legally. Under that plan, CBD makers would still have to ask FDA for permission to market their products.
“The way to get things done is to focus,” said Abernethy. “When people say, ‘I’m worried,’ I’m like, ‘No, no, focus. Get things done.’”
But all of this makes it so Abernethy, a doctor known more for her futuristic thinking on data and medicine than her opinions on dietary supplements, can’t escape questions about CBD — even from her own family.
“I walk into my mall in North Carolina and there’s a pop-up store that’s every CBD product available,” she said. “And my son is always taking selfies in front of the store and sending them to me.”
Copyright 2019. Boston Globe Life Sciences Media, LLC - Terms of Use
Dr. Amy Abernethy, the FDA official leading that effort, has a simple but less than satisfying message: We’re trying. The FDA set out in earnest in April to figure out how to regulate CBD supplements. But following a closely watched public meeting in May, the agency has largely gone silent on when it will release a blueprint for how it plans to regulate the product — even blowing past self-imposed deadlines.
In a brief interview on the sidelines of the STAT Summit in Boston on Thursday, Abernethy, who serves as the principal deputy commissioner of the FDA and the head of the agency’s CBD working group, acknowledged those frustrations, but insisted the agency is going as fast as possible.
“My commitment is to work as quickly as possible and I’ve made that commitment quite vocally,” Abernethy said. “There is a great sense of urgency internally to get this out.”
Read more: Dude, where’s my regulatory framework? As CBD gains popularity, Washington struggles to keep up
At the same time, Abernethy declined to telegraph any significant action from the agency any time soon — particularly on a long-awaited report that would outline the FDA’s current thinking on the issue, which Abernethy previously tweeted would be released by “end of summer/early fall.”
“I’d love to give you an exact time frame,” Abernethy said. “I will say that it is not because we’re not trying. And actually, this is not about needing to get something written. Think about all the different agreements you’ve gotta get.”
In response to the agency’s inaction, industry and consumer groups have launched pressure campaigns against the agency, even threatening to get Congress involved.
“Something has to change,” said David Spangler, the top policy official for the Consumer Healthcare Products Association. “I’m at a loss for why they have not [acted faster].”
The FDA, to be fair, faces an unenviable task. Under current FDA rules, CBD supplements are technically illegal, because CBD is marketed as a prescription drug. Therefore, like other prescriptions, it can’t be sold over the counter. But the widespread enthusiasm about CBD both from consumers, industry, and increasingly, members of Congress, makes a wide-scale FDA crackdown on CBD unlikely.
Read more: The company behind the first-ever CBD-based drug is now eyeing everything from multiple sclerosis to autism
Writing an exemption in the rules, however, could have sweeping implications for the way FDA both regulates drugs and supplements. And the agency has insisted it doesn’t have enough data to give the agency’s blessing for putting CBD in everything from breakfast cereals to traditional supplements.
“There’s a huge gap in the data,” Abernethy said. “We don’t know what happens if you take CBD every day for a year or we don’t know what happens if you’re pregnant or breastfeeding. We don’t know about CBD for people who are older in life or have other medical conditions.”
Abernethy’s CBD working group co-chair, Lowell Schiller, struck a similar tone in recent comments at a supplement industry public meeting.
“There’s still much we don’t know — about the consequences of long-term use, about the risks to vulnerable populations, and lots more,” he said. “As we continue to work as rapidly as possible to figure out how to address this popular ingredient that until very recently was a controlled substance, it’s important to remember that there are no special rules for CBD.”
Abernethy said Thursday that the FDA is finally figuring out what it doesn’t know about CBD and where it needs to facilitate new research.
“We’ve really learned a lot about the data gaps,” Abernethy said. “We are identifying a research plan that needs to be done.”
Read more: ‘The industry has earned it’: Three CEOs own up to biopharma’s bad reputation
But industry doesn’t seem to be hearing it.
“I was not optimistic from hearing Mr. Schiller’s remarks at our conference because it doesn’t sound like the conversation is evolving at the FDA,” said Steve Mister, president and CEO of the Council for Responsible Nutrition. “It feels like they’re kicking the can down the road in hopes that somebody else will solve it.”
Increasingly they’re pushing the FDA to move faster, and saying that if the FDA doesn’t act, Congress should force the agency’s hand. Four of the largest supplement makers wrote to Congress in October making such a request.
“Since it appears FDA is unlikely to provide a timely and effective resolution to this challenge, Congress must act,” the letter, signed by the Council for Responsible Nutrition, American Herbal Products Association, Consumer Healthcare Products Association, and the United Natural Products Alliance.
Consumer advocates, too, have begun to publicly grouse about the FDA’s pace.
The National Consumers League and the Consumer Federation of America launched a new advocacy campaign Tuesday that has called on the FDA to more closely regulate the industry and highlighted new polling that showed a vast majority of Americans — roughly 80% — support strict enforcement by the FDA in the CBD market.
“We’re urging [the FDA] to at least get started in this process,” said Sally Greenberg, executive director of National Consumers League. “I think our polling data is going to really light a fire under the agency.”
Read more: These four companies are betting big on CBD-based prescription drugs
Abernethy demurred when asked whether she’s concerned the issue could be taken out of the FDA’s hands. Supplement makers have asked Congress to pass a bill that would declare CBD supplements can be sold legally. Under that plan, CBD makers would still have to ask FDA for permission to market their products.
“The way to get things done is to focus,” said Abernethy. “When people say, ‘I’m worried,’ I’m like, ‘No, no, focus. Get things done.’”
But all of this makes it so Abernethy, a doctor known more for her futuristic thinking on data and medicine than her opinions on dietary supplements, can’t escape questions about CBD — even from her own family.
“I walk into my mall in North Carolina and there’s a pop-up store that’s every CBD product available,” she said. “And my son is always taking selfies in front of the store and sending them to me.”
Copyright 2019. Boston Globe Life Sciences Media, LLC - Terms of Use