FDA commissioner gives fresh details on CBD review

In two separate meetings over the past two days, the U.S. Food and Drug Administration offered a glimpse of potential CBD regulations to come and promised an April hearing to start work.

FDA Commissioner Dr. Scott Gottlieb told state agriculture regulators that products not approved by the FDA and marketed with unproven claims about therapeutic benefits could cause patients to forego necessary medical care for those ailments.

“We’ll continue to warn consumers and take enforcement action to protect public health,” Gottlieb told the National Association of State Departments of Agriculture (NASDA).

CBD food still a no-no

Gottlieb said CBD in food and dietary supplements remains unlawful.

That’s because CBD is an active ingredient in an FDA-approved drug (Epidiolex) and continues to be evaluated as a pharmaceutical substance, he said.

The FDA must issue new regulations to change that policy. The agency plans to open a forum for public comment on the topic.

But it’s not a “straightforward process,” Gottlieb told the U.S. House Appropriations Committee on Wednesday.

The FDA may need to reconvene with Congress if the process becomes too complicated.

The 2018 Farm Bill took regulatory oversight of hemp away from the U.S. Drug Enforcement Administration, but it says the FDA retains authority over its use in foods, drugs and cosmetics.

“We’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches, to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products,” Gottlieb said.

Congress wants action

A letter from several members of Congress sent to Gottlieb last week called for the FDA to provide direction on CBD.

“We’ve got to work through what that regulation would look like,” Gottlieb said. The exact date for an April public meeting is expected to be announced soon.

He said the agency will solicit comments to establish a framework to allow CBD to be put into the food supply and laid out “theoretical frameworks” for CBD regulations.

As an example, he suggested concentration limits on CBD in foods and dietary supplements, while purer forms of CBD would need FDA approval.

“We want to preserve the incentive to study CBD as a pharmaceutical product,” he said.

Not soon enough

Rep. Chellie Pingree of Maine, who was part of the group that sent the letter asking for answers, asked for a faster process.

“The timing [is urgent] because so many of our states have legalized hemp and have hemp growers going on it.” Pingree said.

“And as you know CBD is being sold in a lot of places and the role of FDA confuses everyone, I think.”

Gottlieb assured her that CBD regulation is a high priority for FDA.

“We have taken on other hard challenges before. I think we have a good track record of trying to come to resolution on other challenges, and you have my commitment that I am going to focus on this one,” he said.

A working group led by senior FDA officials will be assigned shortly to lead the effort, and if the process finds there is a need for a multiyear regulatory process, FDA will work with Congress to address it.

Laura Drotleff can be reached at [email protected].

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13 comments on “FDA commissioner gives fresh details on CBD review
    • Martin on

      I hear you but in fact it is now exactly that, prior to Farm Bill being signed (which is no coincidence) GW Pharmas Epolidiex was granted market authorisation as exactly that a ‘drug’ to treat rare forms of epilepsy. Scary thing is, as they are only company with authorisation for this ‘medicine’ in theory they can ask FDA to remove all mine market authorised forms of CBD from the market (which is every other CBD product).

      Reply
  1. William Arterburn on

    Well, I guess that explains why so called CBD Drug Epidiolex, or whatever it’s called, was approved. Now that its an active ingredient in a prescription drug, FDA can regulate it. Slick trick. But CBD, unlike its brother THC, has less health and well being threat than a sugar loaded candy bar, and might actually be beneficial over and above its placebo value, so by all means let’s get out the sirens and ring up the alarm bells and be out there protecting the public. Cant you just hear the dollars rolling, Dinah! This is all so freaking phony.

    Reply
  2. Steve on

    why is the FDA giving pharma cover on this… money? of course it is…
    CBD helps people for a fraction of what it would be if pharmaceutical companies get involved. The FDA is slow because they look to pharma for the solution.

    Reply
  3. JERI STEWART on

    The sooner the legislation is enacted, the sooner the government can rake in more taxes. What better reason to light fires under the right butts to get this done?

    Reply
  4. Dr. Run on

    I will like to see FDA clearance (to add low level CBD in food) very quickly (within a month ideally). Farm bill is passed, and the intent (for low level CBD) is already passed. So, time line for FDA clearence should be very short. Pharma may like to stretch the time as long as they can. The intent already cleared (with Farm Bill) so clearance time should be very short. I will like to thank 12 Congressman for their efforts. Will also request Congress to make sure timing is very short. Low level CBD saves life from Opoids.Thanks

    Reply
  5. The Mad Yooper on

    SURPRISE SURPRISE SURPRISE Sargent Carter.
    We still have the best government money can buy!
    From Illegal drug to a Pharmaceutical, which one is worse?
    From the DEA to the FDA and we haven’t even gotten to the FTC yet We have alphabet soup.
    If we want this we are going to have to fight like hell to get it.

    Reply
  6. Ray on

    The FDA already knows they were/are on the wrong side of history with CBD, now they are stalling for as long as they can to make the most money in profits for their pharmaceutical pals.

    Reply
  7. The Mad Yooper on

    Genncanna OC-00. Certified Zero THC and they are working on raising its cbd levels. We can eat it and smoke and use it in anyway we see fit.
    Can the fda produce any data that supports CBD overdosing?
    If not it is and should be a dietary supplement.
    The law says ALL legally grown hemp by products are legal.
    We are going to have to fight for this if we want it.

    Reply
  8. Jim Boynton on

    Let’s face it this and other congress’ are strictly for show and to line their own pockets. This is where a true plebiscite action on the part of Americans could, would and should be used to determine our logical course of action where there is ZERO evidence to the contrary.
    If you want to feel like an orphan just say the word ‘plebiscite’ in presence of congressional pocket liners; they want hard money to pass any bill.

    Reply

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