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Will FDA crackdown harder on kratom – The Fix.com

Why Does the FDA Care About Kratom?
By Dorri Olds 05/17/16
It’s caused no overdose deaths. It feels like coffee and a light painkiller. Is there any reason for the FDA to crack down on kratom?
Will the FDA Crack Down Harder on Kratom?
The FDA makes vague disclosures about their lack of available resources to determine the level of safety with the plant Mitragyna speciosa (kratom). But it seems that some individual states are opting for a tougher guilty-until-proven-innocent approach. The most recent legislation came on May 5. Alabama added kratom to the state’s list of Schedule 1 controlled substances.

The process of determining the legality of a substance—in this case kratom—is not something most laypeople are familiar with. The FDA says they need information from the DEA. The DEA says scientific tests take time and money but if and when they have anything, they’ll surely send it along to the FDA.

Each state is independent. Last February in Georgia, Rep. Bruce Broadrick brought a proposal for House Bill 783 to include plants which have no medical use and thus cannot be legally prescribed by a doctor. Travis Lowin, a member of the board of directors for the Botanical Legal Defense (BLD), was in attendance to testify in favor of keeping kratom legal.

The Fix spoke with Lowin via telephone. He said, “I’ve been in the botanical industry for a decade specializing in analytics and plant pharmacology.” He further explained that during his presentation to the committee, he brought to their attention that the Georgia Poison Control from the Georgia Health and Public Safety Department has no relevant information, or any data, on kratom being an issue in the state of Georgia. “None whatsoever,” Lowin stressed. He felt his job was to make it clear that kratom is not dangerous and therefore not a threat.

“According to the Georgia Drugs and Narcotics Agency (GDNA),” Lowin said, “kratom was referred to as a drug because it had been brought to the agency’s attention by the Georgia Bureau of Investigation Division of Forensic Sciences Crime Lab as a problem. Georgia government agencies are aware that kratom is currently illegal in Indiana, Tennessee, Vermont and Wisconsin and of the pending legislation in other states.”

The three sponsors for the Georgia Bill are Lee Hawkins, Buddy Hardin and Bruce Broadrick. Said Lowin, “One of the issues that we had with Bruce Broadrick in Georgia was that he’d said in a TV interview that young kids can become addicted to kratom and then they’ll overdose on it. I let Broadrick know there are no deaths from kratom alone. For any supposed deaths from kratom, I’ve obtained death certificates and coroner’s reports. In every case it has always been in correlation with other substances. The overdoses were from polydrug use, and often included legal prescription medications.”

At the Georgia meeting Lowin said, “The Georgia Poison Control had nothing concrete to offer. The head of the Georgia Crimes Unit even said, ‘This is a natural compound, not a synthetic,’ and when he was asked if he’d found kratom at any Georgia crime scenes, he was like, ‘No, ma’am.’”

Lowin said, “We were all scratching our heads wondering why is kratom even in question. There is no logic. It’s like we’ve all entered the Twilight Zone.”

Susan Ash, the director of the American Kratom Association (AKA) told us via telephone, “I was at the Georgia committee meeting and GDNA Director Rick Allen testified that there is no synthetic version of kratom that could be labeled as a drug.”

Ash shared her excitement about the new addition to the kratom legality cause. “Paul Pelosi, Jr. is the son of former Speaker of the House Nancy Pelosi,” said Ash, “and he’s AKA’s new executive director. We’re so excited to have him on board to help with our mission to keep kratom legal. With his strong political background, he knows what’s up with Big Pharma.”

On that topic Lowin told us, “At every committee meeting I always point out that the pharmaceutical industry is a for-profit industry. That’s the bottom line. That’s a for-profit business and obviously cured patients aren’t returning customers. A patient requiring constant medication is, from a business standpoint, preferable to people getting pain relief from a plant.”

Lowin’s mother uses kratom. “She’s 63 years old,” Lowin said, “and she’s had two knee surgeries. My mom uses kratom to go walk the dogs in the morning and to mitigate pain.” When asked if he uses kratom Lowin responded, “I suffered an injury in college playing basketball where I had torn all the ligaments in my left ankle. I had fractured the back end of it in a motorcycle accident and bruised my hip badly. I can’t run because of that injury so now I bike a lot and use it for that. Within an hour of taking a capsule, I notice a stimulating effect similar to coffee. It also gives a pain relieving effect similar to Motrin.”

Lowin said, “In Georgia, based on what we all presented, they tabled the bill and were obviously going to strike kratom off the list of dangerous drugs. Kratom isn’t a drug—there’s a lack of information. News agencies are running sensational news stories and that’s where people are getting their information. For news organizations like USA Today and the New York Times to write articles which blatantly leave out easy-to-find scientific evidence it just boggles my mind.”

AKA’s Ash shared, “All this traveling to states that are trying to ban kratom makes my Lyme Disease symptoms all the more terrible but I am compelled to fight. It always takes me a few days to recover physically from these trips.”

When The Fix contacted the FDA, Linda Meyer who covers dietary supplement issues for the agency replied to our queries via email. She would not openly discuss any scientific evidence that proves kratom is any more dangerous than the more familiar plant in its species: caffeine. Meyer stuck to quoting the FDA’s official statement.

“[The] FDA has limited … data [on adverse effects associated with kratom] but believes the … population using these … products would not necessarily see the effects as being adverse … and therefore would not report them to the agency or a healthcare professional.”

That seems worrisome. Of course addicts don’t complain to organizations that can ban the drugs they’re addicted to. When we asked Meyer why kratom is illegal in four states, Meyer quoted the FDA’s official statement again, “[We have] identified kratom as a botanical substance that poses a risk to public health and has the potential for abuse.”

She added that the FDA attempts “to coordinate with its regulatory partners at DEA, which has identified kratom as a drug of concern.”

We went to the DEA for answers. DEA headquarters spokesperson Barbara Carreno said, “There’s a process we go through in determining whether to control something. You can read the DEA’s enforcement of the Controlled Substances Act. If we determine from our 8-factor analysis that [a substance] is a big enough problem to merit taking it off the free market we have to justify that—we can’t do it all willy-nilly.”

Carreno said, “We send a request along with our analysis to the U.S. Department of Health & Human Services (HHS) which will have the FDA or the National Institute on Drug Abuse (NIDA) do research, usually using animal studies.”

That’s where I became confused. If the FDA and the DEA are not willing to state definitively that kratom is harmful and addicting, then how were four states able to make it illegal?

“Each state has its own standards for making something controlled,” Carreno explained. “If the DEA controls something and the state does also, whoever is the strictest prevails. The DEA has five schedules for controlled substances. Kratom is interesting because, as with any plant, it’s not a pill made in a factory that has x micrograms of ingredients. There’s no quality control with plants and you don’t know about contaminants. We’re looking at kratom and the states are doing the same. For states, a bill can be introduced to make something illegal. There’s a vote. If the bill passes the state legislature says ‘Okay, now this is illegal’ or ‘this is controlled.’ It’s not so easy for the DEA. It’s a more involved process….The standards and priorities vary and states take different approaches on how they regulate. With synthetics, everybody agrees on bath salts and fake pot because they’re harmful with no redeeming qualities. But states can still regulate differently.”

To understand more about state legislatures it is helpful to visit NCSL.org. Regarding the DEA’s research Carreno said, “We are in the process of studying kratom and we haven’t come to a conclusion yet. After we do our 8-factor analysis, it’ll go to the FDA and they’ll do animal studies. Then they’ll come back to the DEA with their recommendation and we’ll make our determination. We study many things simultaneously so it’s not something we can do in a month, or even a year.”

This leads me to believe that unless definitive studies suddenly become available, the FDA will not be making dramatic decisions any time soon.

The DEA’s 8-Factor Analysis to Determine the Control of a Substance:

1. Its actual or relative potential for abuse

2. Scientific evidence of its pharmacologic effect, if known

3. The state of current scientific knowledge regarding the drug or other substance

4. Its history and current pattern of abuse

5. The scope, duration and significance of abuse

6. What, if any, risk there is to public health

7. Its psychic or physiological dependence liability

8. Whether the substance is an immediate precursor of a substance already controlled under this subchapter

AKA’s Ash said that recently, “Vice and Alternet articles included some good info, as did an article called ‘Kratom, legal in Texas, seized in Illinois’ which reported on kratom-related issues in the DEA drug database.” She seconded what Lowin said—that every death that implicated kratom has been a result of a polydrug combo. For those fighting to keep kratom legal, what they all have in common is a desire to get all of the hype out of the way. It’s a sane suggestion: let’s lower hysteria and deal only with facts.

Clearly, more research needs to be done before we’ll know if kratom is any worse than the world’s most celebrated addiction—caffeine. In the meantime, if you’d like to get involved and have your voice heard, visit the first impartial real-time legislative tracking service, LegiScan.

Breakdown of current legislation in the U.S.

Florida—Legal except for Sarasota County. Legislation (HB 73 and SB 11) that would criminalize kratom is now moving through the legislative process.

Alabama—Legislation passed making Kratom a Schedule 1 controlled substance. Change.org is requesting signatures on a petition to fight the bill.

Georgia—(HB 783) was tabled at the Feb. 2, 2016 meeting.

Illinois—Legal to adults. Legislation (HB 5526) during the 2014 legislative session make the sale of kratom to minors under 18 of age banned.

Indiana—Banned. Indiana incorrectly identifies kratom as a synthetic drug and thus scheduled kratom as part of synthetic controlled substances legislation. Advocacy and education efforts are underway with the regulators and legislators of jurisdiction.

Iowa—Legal. Legislation that would have criminalized kratom (HB 640 / HF 2355) was introduced and referred to the Iowa House Public Safety Committee, however, the bill was not passed.

Kentucky—Legal. No known active or pending legislative action, although given its proximity to Tennessee where kratom is currently banned, advocacy and education efforts are underway with the regulators and legislators of jurisdiction to promote the continued legality in the state of Kentucky.

Louisiana—Legal. that would have scheduled kratom (HB 174) was amended and specifically removed language that would have banned one of the primary alkaloids in kratom, 7-OH (hydroxymitragynine). This amendment ultimately ensured kratom’s continued legality in the state of Louisiana as of July 23. This amendment was born out of advocacy and education efforts of AKA members and kratom users across the state of Louisiana. Advocacy and education continue with the regulators and legislators of jurisdiction to thwart future legislation.

Michigan—Legal. Legislation that would have scheduled kratom (HB 5707) was not passed during the 2014 legislative session.

New Jersey—Legal. Assemblyman Ron Dancer introduced legislation (AB 4431) in May 2015 that would criminalize the manufacture, sale and possession of substances containing kratom. Since the bill was introduced, it was referred to the Law and Public Safety Committee. The Committee has not taken any action yet. Advocacy and education efforts are underway with the regulators and legislators of jurisdiction.

New York—Legal. Assembly Member Aileen Gunther introduced legislation (A8670 and S6345) which prohibits the sale or distribution of kratom. New York is the latest state to introduce legislation that would ban kratom at a state level. Assembly Bill A8670 is sponsored by Assembly Member Aileen Gunther, and its Senate Companion Bill S6345 is sponsored by Senator David Carlucci, were introduced in January, 2016.

Oklahoma —Legal. Legislation that would have scheduled kratom (HB 2666) was not passed during the 2014 legislative session.

Tennessee—Banned. Tennessee defines kratom, Mitragyna speciose, as a controlled substance (Pub. Ch. No. 161). Advocacy and education efforts are underway with the regulators and legislators of jurisdiction.

Vermont—Banned. Vermont classifies one of the primary alkaloids in kratom, 7-OH (hydroxymitragynine), as a regulated drug (Title 18 V.S.A. § 4205), effectively banning kratom in the state of Vermont. Advocacy and education efforts are underway with the regulators and legislators of jurisdiction.

Wisconsin—Banned. Wisconsin classified the primary alkaloids in kratom, mitragynine and 7-OH (hydroxymitragynine), as Schedule I (Wis. Stat. § 961.14), effectively banning kratom in the state of Wisconsin. Advocacy and education efforts are underway with the regulators and legislators of jurisdiction.

Please read our comment policy. – The Fix

TAGS: Kratom DEA FDA drug policy Regulation controlled substances opioid Features Dorri Olds
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