US Kratom Warnings Note Opioid Withdrawal Claims, Omit Unlawful Ingredient Reference

FDA and FTC joint warnings to four kratom firms as well as an essential oil marketer explain they're acting under Department of Health and Human Services’ declaration of a public health emergency involving the opioid crisis.

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Recent warning letters to four US firms didn’t say regulatory agencies deem sales of any kratom-containing products unlawful but that making disease claims including treatment of opioid abuse withdrawals made them noncompliant.

The joint warnings the Food and Drug Administration and the Federal Trade Commission submitted on 30 June to kratom product marketers Herbsens Botanicals in Plant City, FL, Klarity Kratom in Los Angeles, Kratom Exchange in Wilmington, NC, and Omni Consumer Products LLC, dba YoKratom, in Myrtle Beach, SC, along with essential oil firm MONQ LLC in Goodlettsville, TN, explain that the agencies are acting under the Department of Health and Human Services’ declaration that a public health emergency exists nationwide involving the opioid crisis.

Each firm markets multiple products “for the treatment or cure of opioid addiction and withdrawal symptoms” but the products haven’t been approved by the FDA as “safe and effective for these (or any other) uses,” the letters state.

The documents sent with the signatures of the director of the FDA Center for Drug Evaluation and Research Office of Compliance and the associate director of the FTC’s Division of Advertising Practices also note enforcement is needed because “unproven treatments could cause patients to forego or delay FDA-approved treatment for opioid addiction or withdrawal,” making sales of unlawful products a “potentially significant threat to the public health.”

The two agencies agree the five firms’ claims are noncompliant, but not on the urgency for compliance with its regulations.

While the FDA allows its standard 15 days for each warned firm to submit a response detailing specific steps it has have taken to correct the violations, the FTC instructs the firms to “immediately cease making all such claims and [it] strongly suggests that you review all health-related claims that you or any of your affiliates are making in any medium to ensure that they are properly substantiated and do not violate the FTC Act.”

Not A Controlled Substance In US

The letters show no disagreement between the agencies about whether kratom sales should be considered lawful in the US. None of the warnings mentions the FDA’s initiative to stop imports of the herb, known for its mild caffeine-like effects and typically is used to relieve stress and enhance mood, and to move its constituent ingredients into the Drug Enforcement Administration’s schedule of controlled substances.

The FDA doesn’t acknowledge any evidence showing kratom can help people stop abusing opioids or other narcotic drugs; it contends kratom is used together with narcotics to enhance the drugs’ effects.

The agency contends kratom is excluded from being eligible for use in supplements through the new dietary ingredient notification process or in food through the generally regarded as safe process because of its abuse potential, particularly by people reportedly using it to enhance the effect of opioid drugs.

The FDA’s concerns about kratom, available in formats including dried/crushed leaves, powder, capsules, tablets, liquids and gum/resin, emerged in 2009 after report on deaths in Sweden reportedly linked to the botanical and imposed an import alert in 2014. Its concerns in 2016 reached the DEA, which in August that year published a Federal Register notice stating it would temporarily place mitragynine and 7-hydroxymitragynine into Schedule I under the CSA to avoid an imminent hazard to public safety. (Also see "FDA Turns Kratom's Future In US Dietary Supplement Market Into History" - HBW Insight, 14 Nov, 2017.)

But a wave of opposition, including by member of Congress, led the DEA in October to withdraw the notice of temporary scheduling while continuing to consider listing the ingredients as controlled substances.

Analysis provided for the American Kratom Association trade group and included with its comments on the DEA proposal showed kratom has a low potential for abuse and a low dependence liability and evidence of personal harm, adverse health effects or detriment to the public health is insufficient to warrant control under the CSA.

Instead, the AKA promotes regulation of kratom as a dietary ingredient under FDA regulations as the most effective way to protect public health by ensuring appropriate access along with regulatory oversight.

But when former FDA Commissioner Scott Gottlieb took the helm in 2017, the agency moved to stop all sales of the botanical’s ingredients due to growing concerns about safety and claims of treating narcotic addictions. In November that year, Gottlieb said the FDA is concerned that some consumers use kratom to ease withdrawal symptoms from opioid or opiate addiction, or use it in addition to the drugs. (Also see "FDA Turns Kratom's Future In US Dietary Supplement Market Into History" - HBW Insight, 14 Nov, 2017.)

However, the FDA’s recommendation to the DEA to schedule mitragynine and 7-hydroxymitragynine as controlled substances in the US was rescinded on direction of the HHS deputy secretary for health because it was based on incomplete data and faulty science. (Also see "US HHS Pulled Recommendation To Make Kratom A Controlled Substance, But Kept Mum On Change" - HBW Insight, 28 Jan, 2021.)

More recently, the FDA made its position on kratom known more emphatically.

In May 2021, it made kratom an NDI unfit for use in any supplement rather than an ingredient some marketers were promoting with noncompliant claims. It seized more than 207,000 units of supplements kratom and ingredients containing kratom, including more than 34,000 kg of bulk kratom with a complaint for forfeiture against a Fort Myers, FL, firm. (Also see "With Seizure in Florida, FDA Targets Kratom As Unsafe For Any Use" - HBW Insight, 24 May, 2021.)

In August, it submitted a proposal to the World Health Organization’s request for information on whether the kratom constituent ingredients should be deemed controlled substances under the UN’s s 1971 Convention on Psychotropic Substances. (Also see "US Kratom Industry Chafes At FDA’s Short Leash On Science Showing Botanical’s Safety, Benefits" - HBW Insight, 12 Aug, 2021.)