FDA's Kratom Campaign Turns To Firms Destroying Inventory, Recalling Products

FDA announcement that Missouri firm Divinity Products will recall and destroy kratom was part of the agency's latest warning that ingredients derived from the herb are not safe for use in supplements or for therapeutic use to treat symptoms of withdrawal from opioid abuse. FDA doesn't get agreement from the kratom sector about the herb's status as a dietary ingredient as well as its safety profile.

One of the two latest strikes against marketing kratom in the US is a Missouri firm that previously touted the herb's safety and benefits agreeing with FDA to destroy its product inventory.

A second strike is reports of eight people hospitalized after using potentially salmonella-contaminated products containing the ingredient (see box below).

FDA's Feb. 21 announcement that Divinity Products LLC, of Oak Grove, Mo., will recall kratom products it has distributed in addition to destroying its inventory was part of the agency's latest warning that ingredients derived from the herb are not safe for use in dietary supplements or for therapeutic use to treat symptoms of withdrawal from opioid abuse.

Divinity brand capsules are among the kratom products that
Divinity Products  is recalling or has destroyed.

The announcement also continued FDA's argument that it considers kratum a new dietary ingredient that must been notified to the agency with substantiation that it is safe for its intended use in supplements. But the agency doesn't expect it would accept any NDI notifications for the herb, saying it "is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient."

FDA doesn't get agreement from the kratom sector, though, about its dietary ingredient status. They say it was available in the US before October 1994, the grandfather date for ingredients to used in supplements without an NDI notification, and is commonly used today, but substantiating its commercial history in the US to FDA's satisfaction appears untenable. (Also see "Kratom: All Questions On Pre-DSHEA Ingredient Evidence In One Package" - HBW Insight, 16 Oct, 2017.)

Divinity Changed Its View

Divinity Products agreed to destroy or recall its kratom products after FDA officials found the firm's inventory during an inspection. It manufactured and distributed nationwide kratom in crushed or powdered leaves, tea or capsules that were sold under the brands Botany Bay, Enhance Your Life and Divinity, the agency said.

While Divinity Products apparently agreed with FDA's findings about the product, a man identified in Missouri state business records as its owner, Philip Hackley, previously described the herb as a safe mood-enhancer.

According to an article about FDA's initial enforcement on kratom posted by the online publication Motherboard in April 2014, Hackley said he also makes and markets food products and holds his kratom products to the same quality standards. However, media reports about kratom that followed FDA's initial enforcements painted the herb as a dangerous drug, he said.

"The best way I can compare to it is kind of the feeling you get after you work out," said Hackley in the article "It wouldn't be so popular if it was a dangerous LSD-slash-heroin mixture of drugs that the media makes it out to be. It wouldn't be so popular throughout mainstream America," he added.

FDA Needs Science

Science, however, points to kratom problems rather than safety, FDA says in asking other firms to follow Divinity Products' lead.

"Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway," according to the agency's announcement.

Commissioner Scott Gottlieb, in statements included in the announcement, noted that FDA recently reported it found that some kratom compounds are opioids, making the herb unsafe as a remedy for opioid abuse withdrawal. The Feb. 6 report also discussed adverse events reports that identify 44 deaths of people who were found to have ingredients from the herbal in their systems. (Also see "FDA's Opioid Label For Kratom Called Misbranding By Marketers" - HBW Insight, 7 Feb, 2018.)

"Extensive scientific data" the agency evaluated "provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death," Gottlieb stated.

8 With Salmonella Infection Used Kratom

An additional element of the warning noted that FDA and the Centers for Disease Control and Prevention are monitoring an outbreak across 20 states of "a rare type of salmonella associated with kratom products".

In a Feb. 20 announcement, FDA said CDC reported that 28 people, from 6 to 67 years old, in 20 states are infected with salmonella; of the 11 hospitalized, eight reported consuming kratom in pills, capsules, powder or tea.  No common brands or suppliers of products reportedly used by those persons have been identified and no kratom products have been found as containing salmonella; no deaths have been reported.

The potential salmonella link to dietary supplements is the second FDA has reported in 2018. Firms in California and Massachusetts recalled supplement products due to potential salmonella contamination in early January, when FDA also was investigating reports of infections potentially linked to raw clover sprouts or frozen shredded coconut in meals served at restaurants around the country. (Also see "Latest Salmonella Contamination Reaches Dietary Supplements" - HBW Insight, 23 Jan, 2018.)

Noting that said no evidence supports kratom as safe or effective for any medical use, the commissioner said FDA will continue to study the ingredient, warn against its use and "take aggressive enforcement action against kratom-containing products."

Gottlieb also FDA has approved three drug products as safe and effective for the treatment of opioid use disorder and is making additional pathways available for drug firms to introduce more therapies. (Also see "Opioid Treatments Could Get Survival Claim As US FDA Develops Protocol" - Pink Sheet, 1 Dec, 2017.)

Solution Rather Problem?

The American Kratom Association, meanwhile, says no deaths have been determined to be caused by kratom and the chemical profile of its compounds as binding to opioid receptors in the brain does not support a conclusion that the herb is a dangerous substance.

Kratom binds to opioid receptors in the brain but does not suppress a user’s respiratory system, which opioid drug overdoses caused, the trade group says.

AKA also is lobbying Congress and the White House to intervene and prevent the Drug Enforcement Administration, based on FDA's conclusions, to complete a regulatory procedure it launched in 2017 to list kratom as a controlled substance.

Rather than preventing problems that DEA and FDA associate with kratom, scheduling the herb could increase the number of opioid-related deaths in the US because people using kratom as an alternative to opioids will be vulnerable to returning to using the drugs, whether their prior use was for pain or due to addiction.

In a Feb. 8 letter to President Trump aide Kellyanne Conway and acting DEA Administrator Robert  Patterson, AKA representatives said they expect that DEA has received FDA's recommendation place kratom compounds mitragynine and 7-hydroxymitagynine, into Schedule I of the Controlled Substances Act. (Also see "DEA Proposal To Schedule Kratom Stirs Wave Of Opposition" - HBW Insight, 8 Dec, 2016.)

"We believe strongly that the current body of credible research on the actual effects of kratom demonstrates that it is not dangerously addictive, nor is it similar to 'narcotics like opioids' with respect to 'addiction' and 'death' as stated by" FDA, said AKA research consultants Jack Henningfield, vice president of Research, Health Policy, and Abuse Liability at drug policy consultancy Pinney Associates, and Marc Swogger, of the University of Rochester Medical Center Department of Psychiatry.

Henningfield and Swogger, who both have conducted multiple studies on kratom with results published in scientific journals, said rather than ban marketing of the herb, federal agencies should support research into its therapeutic uses.

They said "publicly available research documents that kratom has a long history of acceptably safe consumer use, and, when used as an alternative pain management therapy, kratom provides a far more favorable safety profile for consumers compared to more dangerously addictive and potentially deadly classical opioid medications."

Additional research of kratom, its extracts and drugs or other substances similar to kratom’s active ingredients, they said in the letter, "might serve as breakthroughs in pain relieving medicines that are so desperately needed."

From the editors of the Tan Sheet. Our dietary supplement industry coverage now is published in the Rose Sheet, with articles emailed to readers daily and available on this page of the Rose Sheet website.