FDA Commissioner Marty Makary Asked Point Blank If Kratom Is Safe To Use

Forbes Breaking News

At a press briefing on Tuesday, FDA Commissioner Marty Makary was asked if kratom was safe to use.

Transcript

00:00Thank you, Secretary Kennedy.

00:02We're now going to take questions from the press.

00:05If you can please keep your questions to the reason we're here today and also give your

00:09first name, last name, and outlet.

00:14We have a microphone for you.

00:17David Lin with Politico.

00:19Thanks for taking my question.

00:21In 2018, former FDA Commissioner Scott Gottlieb said FDA scientists conducted an analysis

00:27suggesting that Kratom compounds had opioid-like properties.

00:31And he said that there was, quote, no evidence to indicate Kratom is safe or effective for

00:35any medical use.

00:36I know the FDA's warning letters and the actions today are concentrated on concentrated 7OH products,

00:42but does the government today believe Kratom itself is safe to consume?

00:48And then secondly, the DEA previously attempted to temporarily schedule 7OH in 2016 before

00:54backing off after receiving public blowback.

00:58Is the Trump administration prepared to finalize the scheduling process, even if it receives

01:02similar concern now?

01:05So first of all, we're not prepared to say anything is 100 percent safe, especially when

01:10it has psychoactive properties.

01:13But what we are saying is that our focus is on synthetic concentrated Kratom.

01:18You point out a good point, and that is that if we talk about all 7OH, then we're not distinguishing

01:27to the public the risk stratification of the synthetic concentrated from the trace amounts

01:33of 7OH that naturally appear in the Kratom leaf and have for centuries and have been used

01:38in teas and other things.

01:40So our scheduling recommendation will delineate trace amounts from synthetic concentrated amounts.

01:47Great question.

01:50Hi.

01:51Lizzie Lawrence, reporter with STAT.

01:56I'm curious how many, if there are any, known cases there are of 7OH being recorded as the

02:03sole cause of a fatal overdose?

02:07We have terrible statistics because if somebody comes in with 7OH overdose, I'm not even sure

02:14a doctor would know to ask about 7OH.

02:17Very few doctors I've spoken with know what's in these vape stores or know what 7OH is.

02:22I've had to explain it to the dozen or so doctors I've talked to.

02:26So I think we're just starting to understand.

02:29It's very, very reminiscent of when we prescribed opioids to patients who didn't need them after

02:35minor surgical procedures or too many opioids for those who did need an opioid.

02:41And we would notice some people were coming back for refills at a very high rate.

02:46But we hadn't put the two together because we hadn't recognized the addictive nature.

02:50So we need better statistics.

02:53There is a commitment from NIH to do some research to try to understand this.

02:57But this is not something where, you know, after 50,000 Americans have died from it, we

03:02want to start that process.

03:04Thank you, Lizzie.

03:05Hi, Sarah of MALL-CNN.

03:10To David's question, what kind of regulation and guidance or scientific evaluation could

03:15we see in the future about natural kratom?

03:18Look, I think there have been physicians who have had concerns about some claims around natural

03:27kratom.

03:28We have to prioritize what we work on.

03:31So we are going after the killer first, which is the synthetic concentrated kratom.

03:36And then we can look into that other question.

03:39But we think it's night and day in terms of the public health risk.

03:43Hey, thank you.

03:49I'm Scott with CBS.

03:52You mentioned the doctors need to become more familiar with the danger here.

03:56And you've issued a letter, I think, today to doctors.

03:59But what, in fact, changes today, I'm sorry, are you issuing a new regulation?

04:05Are you going to do the scheduling?

04:06What actual change is HHS affecting today?

04:09Yeah.

04:10So, great question.

04:12Thank you for that.

04:13So a couple things.

04:14We're issuing a report, an FDA report on 7OH, explaining it.

04:21We are putting that out there.

04:22We are, and we'd love for you to let Americans know about that report so they can learn.

04:28It has both a deep science component and a section for laypeople so they can understand

04:35the issue.

04:37We think every school board should be talking about this.

04:40We are, number two, issuing a letter today to the DEA to recommend scheduling above a concentration

04:47threshold as a controlled substance.

04:51Number three, we are sending a dear doctor letter to every physician in the United States

04:55warning them about this.

04:58And we're going to continue to try to educate the public.

05:01So a couple very definitive actions today.

05:03And of course, we announced a couple weeks ago that we have let distributors to the retail

05:09stores know that we have serious safety concerns and specified those concerns.

05:14Yeah.

05:15We should talk about the request to DEA to reschedule this.

05:18Oh, yeah.

05:19Okay.

05:20Right here.

05:21Right here.

05:22Hi.

05:23Margaret Manta with Notice.

05:26You said that you're thinking about this in terms of concentration where it's like trace

05:31amounts of 7-OH and Kratom versus, you know, the much more concentrated product.

05:37Is this a framework that you think the FDA could use for other dietary supplements?

05:42I think it's a good idea.

05:44Thank you for suggesting it.

05:46You know, we do something called an eight-factor analysis.

05:50So our scientific team and the scientific team at the DEA independently try to evaluate,

05:57is there a threshold?

05:58And they look at animal studies and a whole bunch of other criteria to look at dependence

06:02and addictive thresholds.

06:04So we have a threshold that is calculated in two different mathematical ways to try to

06:11distinguish what we're talking about with concentrated Kratom from the trace amounts

06:15that appear in the Kratom leaf.

06:24Ketron Asaf, Gray Media.

06:25I know you said this process is just beginning, but of course that takes time.

06:29So in the meantime, can you tell us how quickly can we see these products removed from shelves

06:33or at least made harder to obtain?

06:36And then what message do you want to give to Americans who are seeing this and saying,

06:41oh, I thought it was totally safe and maybe still today can actually go and get it?

06:46So effective immediately, the letters are out to the distributors and we've actually gotten

06:52some positive feedback from some of those distributors.

06:55So we're sounding the alarm with the distributors of the synthetic concentrated Kratom.

07:01We also want to create a national conversation where parents talk to their children.

07:07Kids are sometimes using these substances and the parents don't know.

07:11And sometimes the kids are using it and they don't actually know what's in these substances.

07:15So this is a time, as with other new addictive substances that enter the United States, for us to have these conversations.

07:25And I hope school boards, places of worship, all talk about the illegal substances in these vape and smoke shops and gas stations.

07:35Hi, Liz White with the Wall Street Journal.

07:41Also very present in smoke shops and vape shops are high potency cannabis products and synthetic cannabis products,

07:49such as Delta 9, Delta 8, THCA, high THC products.

07:53And these have been linked in the medical literature already to psychosis.

07:57Is there a reason that this kind of well-established smoke shop problem is not something you're going after?

08:03So I personally, in my writings as a physician, in my statements, and also the Department of Health and Human Services,

08:17have expressed serious concerns about people using these cannabis products.

08:23We don't want kids to use them.

08:26Cannabis use disorder is a real thing.

08:29And as you appropriately mentioned, there are now studies linking it to psychosis and even cardiovascular problems.

08:37So that is an entirely separate public health campaign, and it's an important issue.

08:43Last question right here.

08:47Amanda Seitz with the Associated Press.

08:49I was wondering if you could say what class you're recommending that it be scheduled

08:54and how quickly you're expecting the DEA to act.

08:57Yeah.

08:58Class one, it is an opioid by definition.

09:02It will be ultimately up to the DEA to decide.

09:07Thank you so much.

09:09Thank you very much.

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