INSIDER Law
DEA Likely Decimates Kratoms Chances at Becoming Lawful Dietary Supplement

DEA Likely Decimates Kratoms Chances at Becoming Lawful Dietary Supplement

While many dietary supplement trade organizations welcomed DEA’s intent to schedule kratom as a Schedule 1 substance, a former FDA regulator said the status change would need to be followed up by strong enforcement.

A federal agency this week may have dealt a fatal blow to a controversial botanical’s potential future as a lawful dietary supplement in the United States.

The Drug Enforcement Administration (DEA) announced its intent in the Federal Register to place kratom’s primary active ingredients mitragynine and 7-hydroxymitragynine on the Schedule 1 list under the Controlled Substances Act (CSA). The agency stated kratom poses an imminent hazard to the public safety due to its high potential for abuse and lack of currently accepted medical use in the United States.

By exercising its authority to temporarily schedule kratom, DEA is outlawing these compounds, or products containing these compounds, for a period of at least two years. As such kratom would join other schedule 1 substances including marijuana, heroin, LSD and peyote.

“Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, and exportation of, and research and conduct of instructional activities of these opioids," DEA wrote, in its Notice of Intent.

The scheduling takes effect on Sept. 30 and runs for a period of two years, although DEA can extend this by one year.

Lawyers Skeptical on Kratom’s Future

Attorney Marc Ullman, of counsel to the law firm Rivkin Radler LLP, said he believes kratom as a dietary supplement is effectively dead or at the very least on its last breath.

“It is now or never for the kratom industry," he told INSIDER, meaning kratom proponents would need to prove the botanical can be safe and has medical benefits. “The kratom trade has always touted the botanical as ‘good for you,’ but I have not seen a serious effort to rebut the concerns on kratom that have been percolating for some time."

Given DEA’s intent to schedule kratom, someone would have to petition the agency claiming its move was arbitrary and capricious, and take the matter to court if DEA rejected the claim, Ullman noted.

“Only a groundswell of pressure on elected officials is likely to throw the brakes on this train," declared attorney Rick Collins, a partner with the law firm Collins Gann McCloskey & Barry PLLC. “Kratom’s future looks bleak."

Collins, who is well-known for his work on DEA-regulated compounds, especially as they relate to the dietary and sports supplement markets, said it might take a congressional hearing or similarly high-level move to change this new course for kratom.

“I don’t see that as probable," he said. “And, frankly, I don’t think even the most persuasive industry proponents will change the minds of the same DEA administrators who refuse to reclassify marijuana from Schedule I."

The temporary scheduling, Collins explained, is the administrative procedure process that leads to permanent scheduling. Permanent scheduling is a lengthy process that requires DEA to examine eight factors, including the drug’s actual or potential for abuse, scientific evidence of the drug’s pharmacological effect, if known, and the current state of scientific knowledge regarding the substance.

Death and Addiction

Kratom has a long history of use in Southeast Asia as a pain reliever and opium alternative. However, the botanical had been on the DEA’s radar for some time, and the administration previously designated kratom as a “Drug of Concern."

Kratom is popularly used in the United States to address chronic pain as well as to lessen the withdrawal symptoms when kicking an opioid addiction. The botanical is also popular with bodybuilders and athletes.

“Kratom is widely used and available in the sports nutrition world," said Anthony Roberts, a longtime sports nutrition insider and journalist, who noted athletes aren’t using the herb recreationally. “[it is used] primarily by those who suffer from chronic pain and wish to avoid opioids, which have themselves become an epidemic in the athletic world."

Roberts warned, “Removing this herb from the marketplace is a disservice to countless people who would otherwise be suffering and who will probably switch to using something more dangerous."

Despite the herb’s anecdotal benefits, DEA noted information from the Centers for Disease Control and Prevention (CDC), published literature, poison control centers and medical examiners indicated use of kratom containing the two primary active compounds have resulted in serious adverse events including deaths.

Kratom advocates aren’t throwing in the towel just yet. A petition to the White House is seeking to stop DEA from scheduling kratom as a Schedule I substance. As of press time, the petition had nearly 32,000 signatures and needed just over 68,000 additional signatures to get a response from the White House.

Kratom “has been shown numerous times in reports from users to help recovering opiate addicts, treat pain, combat depression and anxiety, and much more," the petition declares. “Deaths that involve kratom being [in] a persons' system have always been from the result of mixing kratom with other drugs, rather than kratom alone."

Kratom Import Alert Remains in Effect

FDA, which assisted with DEA’s efforts to schedule kratom, has previously cautioned the botanical has the potential for abuse and is a risk to public health. The agency warned consumers not to use any kratom products, highlighting serious concerns about the botanical’s toxicity in multiple organ systems. FDA issued an import alert in February 2014, advising that kratom shipments could be detained without physical examination, and U.S. Marshalls seized more than 25,000 pounds of raw kratom material in late 2014 and nearly 90,000 bottles of kratom supplements in early 2016. The agency issued another import alert in July 2016.

The import alert remains in effect, Marianna Naum, an FDA spokeswoman, said.

According to the import alert, FDA has no evidence that kratom was marketed as a dietary ingredient before October 15, 1994. Therefore, it cannot be sold in the United States as a dietary supplement without a new dietary ingredient notification (NDIN). Under the Dietary Supplement Health and Education Act (DSHEA), such a notification must demonstrate that kratom is “reasonably expected to be safe." As INSIDER reported, a lone one-page NDIN for a kratom finished product was submitted in August 2015. However, FDA sent the notifier a letter, listing several reasons why the notification was incomplete.

Naum confirmed no other NDINs have been submitted.

 “FDA is currently assessing the effect of the DEA’s action," she said in an emailed statement when asked about the effect of DEA’s decision on the ability to lawfully market kratom as a dietary supplement. “Any dietary supplement must comply with all applicable laws, including the laws administered by FDA as well as the laws administered by other agencies."

Supplement Industry Applauds DEA Decision

The move by DEA was welcomed by many supplement industry trade associations, many of whom formally asked FDA in 2013 to clarify kratom’s regulatory status.

In an emailed statement, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) noted in the past, CRN has raised concerns about an appropriate regulatory pathway for marketing kratom. “Although FDA has acknowledged that kratom, as a botanical, is a ‘dietary ingredient,’ the agency has also rightly indicated that it is a ‘new dietary ingredient,’ which means it was not marketed as a dietary supplement prior to 1994," he said. “To date, we are not aware that any [NDIN] has been filed that provides the necessary ingredient information and reasonably addresses the potential safety issues." Mister noted CRN does not have a position on the DEA’s intent to schedule kratom since no CRN member company markets a kratom-containing product.

Loren Israelsen, president of the United Natural Products Alliance (UNPA), said his organization is “pleased that DEA has used its authority to protect the public with this action."

“Its intention to place the active materials in kratom into Schedule I of the Controlled Substances Act is in line with UNPA’s policy against the sale of kratom by UNPA members, enacted by the organization in May 2014," Israelsen added in an emailed statement.

The Consumer Healthcare Products Association (CHPA) issued the following statement: “Consumers deserve to be protected from potentially dangerous and unlawful substances that are falsely promoted as ‘dietary supplements,’ so CHPA applauds DEA’s announcement to place the active constituents in kratom on Schedule I of the Controlled Substance Act. There is no current medical or healthful use for these ingredients and illegitimate products like these threaten to injure consumer confidence in legitimate, regulated and safe dietary supplements."

Daniel Fabricant, Ph.D., CEO and executive director of the Natural Products Association (NPA), welcomed the move by DEA, but he said the change on kratom will be for naught if it isn’t enforced. Fabricant was the director of FDA’s Division of Dietary Supplement Programs when CRN, UNPA and CHPA wrote to the agency, seeking clarification on kratom’s status.

“Kratom has been a public health target for almost five years, and its surging growth in use and availability is an unfortunate but real example of the federal government’s unwillingness to use existing authorities to enforce the law," Fabricant said in an emailed statement. “This is a necessary and welcome step, but unless it is followed with real enforcement and penalties for those who are selling it in coffee bars, on the internet, and elsewhere, it will be toothless."

Fabricant further said kratom is not an herbal supplement. He called the botanical addictive, harmful and a possible contributor to America’s opiate epidemic.

“We are eager to work with the authorities and our members to help turn the tide against kratom and ensure that it is seen as what the DEA says it is: a schedule I illegal narcotic that has no place in health or wellness," he said.

At press time, the American Herbal Products Association (AHPA) had not replied to INSIDER's request for comment, nor had the American Kratom Association, a non-profit group of kratom consumers focused on protecting usage rights for responsible consumers, and the Botanical Education Alliance, which describes itself as an organization dedicated to providing education on natural supplements including kratom.

More on Kratom:

Herb Kratom Faces Hurdles to Become Legal Dietary Supplement

Healthy INSIDER Podcast: The Return of Kratom

FDA, States Mount War on Kratom

Product Seizure Shows FDA Serious About Kratom

Hide comments

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish