Companies 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.”
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.
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.”
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.”
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.”
Once again the FDA under the influence of non scientists, propagandists and industry insiders has failed the American people. Like all of the other supplements, herbs and quack cure, there is no legal requirement that these even contain the ingredients listed. The FDA and the FTC have failed to regulate the false health claims contained in the marketing of CBD or marijuana. Once again American patients and sick people, are being exploited by an industry with only one agenda, massive profits.
The FDA and the FTC failed with JUUL, and helped introduce millions of American children to nicotine addiction, and a few to an early death. In the US anything goes in the profit driven system. Most of the health claims made by the Marijuana and CBD peddlers are outright lies or misleading. The FDA and FTC failed to acknowledge the fact that states that legalized these products were incapable of regulating the advertising.
The huge lag in knowledge about CBD’s short or long-term effects is caused by the criminal stigma that still widely applies, with ancient outdated laws.
CBD (in marijuana and hemp) has been used by humans for milennia, for all sorts of afflictions. It obviously works, hemp CBD is approved, and it is not a killer substance. Governing bodies need to relax (have some !) and the FDA needs to speed up, show some backbone. There are far too many people missing out on the benefits of CBD, and yes also THC (replace opioids !).
The republican party must be removed, The prohibitionists are far too ignorant and poorly educated to hold any position of responsibility. A few greedy despots and greedy corporate parasites are hold up in the Republican Party. The Democrats have done just as much to destroy democracy than the authoritarians. The two-party divide and conquer must end.
Having worked on some of the “safe” issues of CBD etc., here are a few things to consider.
1: First and foremost a Certified Testing facility like the lab in AZ must be consulted.
Desert Valley testing (www.desertvalleytesting.com is a testing facility that could be a model for other testing facilities.
Each state does NOT have the capability or the know how to create and support testing facilities.
They want to generate the revenue for the state, coming from a state testing facility. when the real issue should be safety. MA is a prime example of what not to do.
At the NCIA, there is a scientific committee trying to recommend basic testing standards for all of these derivatives.
It is tough because no one is willing disclose how they test product etc.
2: all derivatives, vaping, tinctures, orals, oils etc. SHOULD and MUST be tested prior to being released into the market and labeled as such.
Once it is known they are safe, they get released. They should be spot tested randomly. Fines should be high.
Too many of these products are not regulated and people are creating them in their kitchens. This is downright dangerous which is what happened to the vaping with someone using
Vit. E synthetic oil. Oil does not “work” with the lungs. Duh
The pharmaceutical industry wants to own the cannabis business. Like they did the opioid business.
I hope you continue to report why this is NOT ok. We are not in need of Big Pharma monopolies.
Last thing: FDA should ask for categorized specific papers (short) to get feedback from industry experts.
People like Steve DeAngelo and Leonard Leinow/Juliana Birnbaum, have been studying the Cannabinoid system for years. Great books.
Smart intelligent people need to be in on the decision making process.
SUGGEST F.D.A. REFORM.
Big Foods ‘for greedy profit’ has killed more people with processed and counterfeit food items than both world wars and all worldwide terrorist attacks combined. Just Google ‘the Swiss milk study’ or the ‘Harvard milk study’, you will find that drinking more than three cups of PASTEURIZED milk has the mortality rate comparable to smoking three packs of cigarettes a day and with a hip-replacement thrown in.Even a cow would not drink that swill. All pastured foods and juices have been sterilized to prolong shelf life. This denatures the protein and destroys nearly all nutrition. You do not even want to know (but you should) what those nuggets are really made from.They no longer qualify as food. Everyone except an uneducated, retarded and ignorant person knows what fried foods do. Drive-throughs are responsible for more deaths than drive by’s. If a terrorist wishes to maim kill and hurt Americans all they need do is open a fast food restaurant. The F.D.A. may have started out as an competent research establishment but is now an obsolete deep state throwback to the cold-war era and should redirect their priorities away from politics and promoting the marijuana war and before they allow big foods to kill everyone off.
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