Originally posted on MJBizDaily.
U.S. health regulators are taking their closest look in more than three years at the idea of incorporating cannabinoids into dietary supplements.
But hopes are dim that Tuesday’s daylong review by the U.S. Food and Drug Administration’s Science Board will finally deliver a path to treating CBD like other dietary supplements – regulated but sold without prescriptions.
“It’s hard to get too excited about anything anymore,” said Vince Sanders, a CBD manufacturer and retailer in Missouri who traveled to Maryland in 2019 to attend the FDA’s first CBD hearing and has since seen the agency take little action to guide how CBD can be made outside pharmaceutical channels.
Tuesday’s meeting is an informational discussion by the FDA’s Science Board, an advisory panel made up of outside nutrition and drug-safety experts.
The panel meets intermittently, and the virtual daylong discussion Tuesday focuses on “challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study.”
The hearing notice doesn’t mention CBD.
Still, several CBD manufacturers have submitted comments in hopes of seeing federal health regulators acknowledge that CBD is widely available and in need of guidelines.
“The majority of our industry either regulates itself with food and dietary supplement GMPs (Good Manufacturing Practices), or you have players that aren’t regulating themselves at all. It’s terrifying,” said Laura Eder, director of regulatory affairs and quality assurance for Vantage Hemp, which makes hemp-derived CBD in Greeley, Colorado.
How we got here
The FDA has been ostensibly considering CBD regulations ever since the agency was directed by Congress in 2018 to oversee how hemp products could be sold.
But the agency has repeatedly said it can’t set any regulations for over-the-counter hemp products because it doesn’t have enough data to say they’re safe.
The FDA also says that because CBD is an active ingredient in a prescription drug, Epidiolex, it can’t regulate nonpharmaceutical CBD.
Instead, the FDA has confined its cannabinoid enforcement activity to issuing warning letters to companies making egregious health claims.
At the same time, the agency has repeatedly discounted industry-funded research on the safety of CBD products as insufficient.
Last year, the FDA rejected efforts from two companies to market full-spectrum CBD as a new dietary ingredient.
So the fact that an advisory board is even talking about how to evaluate the safety of things such as cannabinoids in foods and dietary supplements could offer clues for companies trying to set themselves up for the day when FDA’s posture might change.
The Science Board meeting is “a peek behind the curtain,” said Emily Leongini, an attorney who specializes in FDA regulations for Arent Fox in Los Angeles.
“Is this meeting going to be the watershed moment where FDA announces that they’re going to allow a certain amount of CBD in food? No. But is it an important meeting in the grand scheme of things? I think so.”
Cynicism abounds
Leongini’s prediction that Tuesday’s meeting won’t immediately break FDA resistance to nonprescription CBD mirrors what several industry insiders told MJBizDaily.
In fact, many question why the Science Board is even taking up cannabinoid safety when the agency repeatedly says it isn’t safe without a prescription.
“I don’t view this as an attempt by FDA to try to move the needle. I just see this as them kind of building up their dossier of why they’re not going to be easing the burdens for industry,” said Jonathan Havens, a Washington DC-based cannabis attorney with Saul Ewing Arnstein & Lehr.
“It will probably result in more of the same, which is FDA saying, ‘We don’t have a sufficient basis or sufficient data to change our position that CBD is not a permissible dietary ingredient.’”
So far he FDA has dismissesed industry-funded safety research.
The silence exasperates manufacturers such as Sanders, president and founder of Kansas City, Missouri-based CBD American Shaman, a retail chain with more than 300 locations in 38 states.
“If you present (the FDA) with facts, they don’t pay any attention. … It just gets shelved.”
Next steps
The agency’s silence on over-the-counter CBD means companies are left to guess the best ways of making products.
“You just keep pounding away, doing it right every day, day in and day out, trying to raise the bar and do the best you can,” Sanders said.
“You just count on the fact that at some point in time, the opportunity is going to be there. You’re going to get the right people in the FDA, or the right situation, or Congress will pass a law where we can actually regulate this and move on with real business.”
For Vantage Hemp’s Eder, a 20-year pharmaceutical industry veteran who also made the trek to that 2019 hearing, skepticism about Tuesday’s hearing was overcome by her belief that consumers need better regulation of CBD.
“The common person who’s purchasing this has no idea if what they’re buying is safe,” Eder said.
She hopes the FDA will acknowledge that its opposition to CBD regulation hasn’t stopped folks from selling it.
“The cat is out of the bag. If you go to any store, any gas station, any salon, there are CBD products on the shelf, down to your local mom-and-pop store, not to mention the online presence,” Eder said.
“There is no way to pull back what is already there and try to enforce taking products off the shelf, when we all know that FDA does not have the manpower to enforce that.
“So the critical need right now is to implement a guidance for industry … because it’s critical for the safety of our consumers at this point.”
