FDA recently notified its field personnel who are responsible for imports that it may detain certain products containing kratom (Mitragyna speciosa), an herb that comes from a tree in Southeast Asia, without physical inspection because the agency determined the substance is a botanical that qualifies as a new dietary ingredient (NDI) and poses adverse health effects ranging from aggression to nervousness, hallucinations and sleeplessness.
Twenty seven companies based in Canada, Indonesia and Malaysia are subject to the Feb. 28 import alert, which prompted at least one company, SNI National, to recall kratom from distributors and retail locations.
The alert did not come out of the blue. Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), which represents dietary supplement manufacturers and ingredient suppliers, said FDA raised concerns over kratom at trade shows beginning last year. Eight months ago, CRN, the United Natural Products Alliance (UNPA) and the Consumer Healthcare Products Association (CHPA) asked FDA to clarify its safety concerns over kratom and its position that the botanical is not a legitimate dietary ingredient.
"Given the widespread availability of kratom, the dietary supplement industry is concerned about the potential dangers to consumers who may believe that they are consuming a safe, regulated product when they are not," the trade groups wrote in a July 18, 2013 letter to Daniel Fabricant, Ph.D., FDA's director of the division of dietary supplement programs.
Mister said the import alert constitutes "another message to industry FDA means business that supplements should contain only legitimate supplement ingredients and that there is a safety standard in the statute."
FDA's alert was a blow to kratom users, cutting off supply to the botanical, though it's possible FDA is unaware of all the firms that ship kratom to the United States. Kratom has a number of different names, and shipments have come in a variety of forms including capsules, whole leaves, processed leaves, leaf resins, leaf extracts, powdered leaves and bulk liquids made from leaf extracts, according to the agency.
"Because kratom is not grown in the U.S., FDA's import alert effectively cuts off U.S. access to this plant and products that include this ingredient," said Michael McGuffin, president of the American Herbal Products Association (AHPA). "Any company interested in selling kratom or products with kratom would have to overcome significant challenges to bring this plant to the U.S. market. FDA has made it clear that it considers this plant a health risk for consumers and changing the agency's stance would likely require a significant investment."
Theoretically, a kratom ingredient supplier or finished product maker could change FDA's mind by submitting an NDI notification to the agency, demonstrating pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA) that the NDI (kratom) "when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe."
Mister expressed doubt that such a notification would persuade FDA that kratom is safe.
"It would very hard for a company to try to demonstrate this product is reasonably expected to be safe," he said. "It seems to have addictive properties to it, and there doesn't seem to be any legitimate medical use."
In fact, DEA recognizes no legitimate medical use for kratom, which is in the same family tree as coffee and contains more than 25 alkaloids. DEA contends high doses of the substance can produce opiate effects and lead to addiction. The agency cited cases in which addicts exhibit psychotic symptoms, such as delusions and hallucinations. According to DEA, national drug abuse surveys have not monitored kratom abuse in the United States.
Rob Henderson, owner of the Leaping Leaf, an Internet retailer that has sold kratom, disputed FDA's claim that kratom causes hallucinations.
"That is laughable, do you hallucinate when you drink your morning cup of Joe? It's not much different," Henderson said.
But the feds are not the only ones who have raised concerns over the botanical.
A number of states have proposed to effectively ban kratom. In Louisiana, Rep. Kevin Pearson (R) introduced a bill that would classify certain alkaloids in kratom as controlled dangerous substances.
"Crime lab and hospitals [are] seeing numerous cases attributed to kratom," Pearson said in an email to Natural Products Insider.
As reported by local media outlets, Iowa and Illinois also have introduced bills targeting kratom. State lawmakers who introduced the bills, Rep. Clel Baudler (R-IA) and Rep. Dennis Reboletti (R-IL), did not respond to requests for comment.
Authorities have expressed concerns that youngsters are buying kratom at head shops to get high—similar to purchases of synthetic marijuana and bath salts that produced amphetamine-like effects. In 2012, Congress amended the Controlled Substances Act (CSA) to include 26 synthetic drugs as Schedule I drugs, joining the likes of marijuana, heroine and LSD. Kratom did not make the list.
Congress is not the only body that could classify other substances such as kratom as a drug. DEA, working in conjunction with the U.S. Department of Health and Human Services (HHS), also has authority to schedule kratom as a controlled substance. If the agencies regulated kratom, and the botanical was not deemed to have an acceptable medical use, kratom also would be classified as a Schedule I drug, rendering it illegal for all purposes.
"We are monitoring kratom, but so far, it has not been a big enough problem in the U.S. to control," said Barbara Carreno, a DEA spokeswoman. "But we are monitoring it closely."
In the recall by SNI National, the company said it was unaware of any adverse effects associated with the kratom products, which were sold to wholesale distributors in Alabama, California, Colorado, Florida, Idaho, Illinois, Kentucky, Massachusetts, Missouri, Ohio, Oklahoma and Wisconsin.
Supporters of kratom tout its benefits and are fighting back to preserve access to the herb.
The non-profit Botanical Legal Defense is working with lawyers and lobbyists to "ensure kratom isn't being regulated at the state level," said Angela Watson, a board member.
Thanks in part to those efforts, some states including Arizona and Oklahoma withdrew legislation that would have banned alkaloids in kratom, according to news reports.
But Watson said three states—Indiana, Tennessee and Vermont—presently ban alkaloids in kratom. A bill introduced last year by Indiana State Sen. Dennis Kruse (R) proposed removing mitragynine and 7-hydroxymitragynine from the definition of a "synthetic drug." Kruse was not available for an interview.
In Oklahoma, legislation was withdrawn after a lobbyist cited legitimate uses for the herb, said Mark Woodward, a spokesman for the Oklahoma Bureau of Narcotics.
"If this bill is allowed to pass with these two compounds included, it will effectively undermine the legitimate medical usage sought after by people all across the state of Oklahoma, and will throw Kratom into a grey area," warned a petition on change.org that urged the Oklahoma State House to remove mitragynine and 7-hydrxoymitragynine from legislation that would have effectively banned kratom.
According to the petition, kratom has been used as "treatment for depression, stress and mitigating pain" as well as for its "antioxidant, anti-inflammatory and anxiety-reducing properties."
Woodward said the agency has received calls from parents who reported their kids were buying kratom over the Internet and at gas stations. He also referenced YouTube videos showing viewers how to get high on kratom. In one video, a young woman claims kratom can give a person a "happy euphoric feeling" and help an individual get over an addiction to such opiates as heroine and Vicodin.
"We do have some concerns about it," Woodward said. "It's not epidemic by any means in Oklahoma, but we don't want to wait" until a child dies or is hospitalized before the state intervenes.
Woodward said his agency will reevaluate kratom in another year, and future legislation could include a prohibition on selling the herb at gas stations and a requirement that kratom is sold over the counter (OTC) at pharmacies. Or the Sooner State could move to ban kratom altogether.
Henderson said many customers who take kratom suffer from chronic pain and are seeking to improve their life by weaning off opiates such as heroin.
"Kratom is an all-natural solution and just because the headshops sell it, it automatically gets a bad name because of those very dangerous bath salts and synthetic marijuana the headshops sold," he said. "Kratom is very different from those."
Christopher McCurdy, a School of Pharmacy faculty member at the University of Mississippi, and his colleagues performed research that indicated kratom may provide an alternative to methadone in treating addictions to opiates, according to a Jan. 25, 2013 news release.
“Mitragynine completely blocked all withdrawal symptoms and could provide a remarkable step-down-like treatment for people addicted to hardcore narcotics such as morphine, oxycodone or heroin," McCurdy said in a statement. “The compound has been known for years, but we’re working to come up with an improved synthetic analog or a better formulation of the tea for testing in humans."
But kratom couldn't be marketed to treat heroine addiction unless kratom obtained approval of a new drug application (NDA), said Marc Ullman, a food and dietary supplement lawyer in New York.
And even if FDA considered kratom to be safe as a botanical, marketers of kratom would be precluded by the Federal Food, Drug & Cosmetic Act (FD&C) from making claims that such products are intended to treat diseases. Such disease claims render a product an unapproved drug, Ullman said.
Beyond helping addicts quit hardcore drugs, kratom supporters have used it to reduce other diseases. Only a couple of years ago, Mary Leonhardt said she could sleep just a few hours due to her restless leg syndrome. Nervous about taking a prescribed dopamine agonist drug, she found relief in kratom.
"It's been wonderful for me," said Leonhardt, a 70-year-old grandmother who noted she is now getting between six and seven hours a night of sleep. "I take about a gram at a time, mixed in orange juice, and it completely quiets the squirmy feelings in my legs."
Paul Kemp, a 65-year-old Oregon resident and business owner, said he occasionally uses kratom to ease his back pain, relax him and provide energy. "It is ludicrous for the FDA to be stopping importation of kratom on the grounds it may be dangerous, when there are many FDA-approved products on the U.S. market that have killed tens of thousands of Americans," he said. "What is the FDA doing about OxyContin, which has been turned loose on people with back pain and it causing addiction and accidental overdoses?"
Kratom, when taken in large quantities, produces similar effects to coffee such as diarrhea, said representatives of Botanical Legal Defense.
Board member David Derian, a regular kratom user, denied that kratom makes a person hallucinate. And Watson said research does not support claims that kratom causes other adverse effects such as nervousness.
"You can't put something that has pretty amazing potential and just lie to us and ban it," Derian said.
Josh Whitson, a structural engineer and small business owner from Boise, ID, said he began taking kratom to give him energy and relieve pain after suffering a severe work injury.
"I've never felt a loss of control or experienced serious side effects," he said. "I am so thankful for this natural herb that has allowed me to live pain free while continuing down the straight and narrow, sober path."
But Patty Smith told CBS Boston last year that her adult daughter became increasingly addicted to kratom and shelled out nearly $1,600 in just a few weeks. "My main concern was not only her health, but financially what it was doing to her," she said.
Watson said it is important to educate the public on kratom and work with FDA to make the herb safe, although she said her organization has not contacted the agency about the import alert.
"People are finding an affordable safer alternative, and it is being stripped from them," Henderson said. "Oh well, I will find something new to do as a business. It was fun while it lasted."