Five things CBD insiders are looking for from the FDA

The hemp industry cheered when the plant was legalized last year. But the promise of hassle-free commerce from hemp’s most valuable product – the cannabinoids in its flowers – has remained elusive.

That’s because the U.S. Food and Drug Administration waited less than 24 hours after hemp was legalized to extinguish hopes that cannabinoids, especially CBD, would be allowed in food, drugs and dietary supplements.

The FDA said the only legal use for CBD in the United States is in an approved prescription drug.

But the agency has left that position largely unenforced – aside from a few warning letters to CBD manufacturers – leading to a confusing patchwork of availability in dietary supplements and foods.

The fear of an FDA crackdown has limited the market to those businesses willing to flout federal warnings.

FDA action on CBD will likely take years.

Hemp Industry Daily, which will be covering the FDA’s first hearing on CBD on May 31, sat down with some industry leaders to find out what they’re looking for in the review – and what to expect in the meantime.

Here are five takeaways from those conversations:


Emily Leongini

Emily Leongini, attorney in Arent Fox law firm’s FDA practice

“What the FDA is really focused on, and what will inform the agency’s policy approach to regulating in this space, is the science. Where are the data? And so that’s what I’m going to be looking for.

“I’m not going to hold my breath, though, because I’m not sure how much will be brought to the table. But I am excited to hear what’s out there that might be outside the public scientific literature.”

New opinions on CBD

Andrew Kline

Andrew Kline, director of public policy, National Cannabis Industry Association

“There is a consensus that – at least in lower doses and at least when you’re not mixing medications – CBD is relatively harmless. And so the elephant in the room is going to be, are there going to be other groups or entities testifying that would give us a different impression?

“That seems to me to be what the FDA is going to be focused on: How safe are these products?”

Labeling guidance

Chris Husong

Chris Husong, vice president of marketing and communications, Elixinol Global

“There does need to be direction around (labeling), and what’s beneficial and what’s not on a label, what’s a pharmaceutical product and what’s not. Those are answers that are going to come out of it, for sure.

“Hopefully, we’ll have some good conversation around (labeling) country of origin. Where does your hemp come from? I think that’s an important thing. Just like we’re starting to ask the FDA to tell us where our meat and chicken come from. We need to be saying that, too.”

What’s already out there

Corey Cox

Corey Cox, attorney in Vicente Sederberg hemp practice

“One thing we really want the FDA to understand is that CBD and cannabis products are already subject to a very high degree of regulation, typically at the state level. And there are also industry organizations that have really tried to self-regulate their products over the last few years.

“I think there’s this misunderstanding or assumption that a lot of these products are totally unregulated, that no one knows who’s making these products or what’s in them or there’s no safety standards in place. And one thing we want to educate the FDA on is, there may be strict quality control or manufacturing requirements these businesses already follow.”

Next steps

Douglas Mackay

Douglas Mackay, senior vice president, CV Sciences

“It can take several years to get to the final rule. In the meantime, I think the FDA is going to be well aware that they’re going to have to flex their regulatory muscle to show the industry that it needs to behave responsibly in the interim period until it’s able to get a final rule.

“They’re going to have to set examples of companies that go way over the line so that they show that, if you want an industry to exist in the future, you’re going to have to show us that you’re prepared to behave responsibly.”

Answers have been edited for length and clarity. Expect continuing coverage from Hemp Industry Daily about the FDA’s CBD review – and how the industry is preparing for changes to the CBD market.

How is your hemp company getting ready for FDA oversight? We invite your company to share its story by emailing [email protected].

3 comments on “Five things CBD insiders are looking for from the FDA
  1. Patrick on

    Listen to Mr. Mackay. He knows what he’s talking about having worked in the dietary supplement industry and interacted with the FDA for years.

  2. John on

    As the owner of a modern plant tissue culture lab facility working to assure a consistent quality plant product, I’m very interested in where this goes. As a user of CBD that found it was the only thing short of opioids or possibly surgery that provided significant relief to a rotator cuff injury that I suffered from for two years I have a personal health vested interest in this. As far as data is concerned the medical community is very reluctant to “prescribe” it or officially recommend it. But I was told by a physician that “many patients report good results”, another said, “I can’t recommend it but I use it”. I was amazed with the results. I do agree that sourcing and quality control is highly warranted.

  3. Jill on

    My Dr’s and surgeons as well as my pain Dr know I use full spectrum CBD and what company with ingredients on the bottle. I got cut off half my meds and I had started CBD due to sciatica, leg pain neuropathy in my toes starting, but within less than a year I took myself off morphine! What a ride and all the opiods cut back so far that I’m unable to even be part of life. Now my sciatica pain and neuropathy is gone!!!!! Thats what CBD from a reputable company can do. Its my way to live. Still have to keep my pain pills for traveling purposes and hardware and 6 slipped discs…but unable to purchase Arkansas cannabis due to the amount of money I get on disability. I think it should be covered by insurance, but they (BIG PHARMA) want to keep us sick..not healthy! Unless they can replicate it…which I would never take. The patients NEED our medicine!!!! Without fear. We the People have spoken…


Leave a Reply

Your email address will not be published. Required fields are marked *