Two businesses that claimed an interest in kratom products seized by the U.S. government agreed last month to destroy the articles under FDA’s supervision.
On Oct. 26, U.S. District Judge Sheri Polster Chappell in Fort Myers, Fla. entered a consent decree as a final judgment.
The seized products that BioBotanical LLC and MT Brands LLC must destroy are worth about $1.3 million, according to FDA.
In May, U.S. Marshals—at FDA’s request—seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including more than 34,000 kilograms of bulk kratom.
Atofil LLC, a subsidiary of Premier Manufacturing Products, produced the seized kratom products marketed under such names as Bio Botanical, Boosted Kratom, The Devil’s Kratom and Terra Kratom.
BioBotanical and MT Brands—a wholly owned subsidiary of Premier Manufacturing Products and producer of herbal supplements—claimed an interest in the seized articles.
The U.S. Department of Justice (DOJ) alleged Atofil’s articles are “adulterated” because “they contain or are a new dietary ingredient [NDI], kratom, for which there is inadequate information to provide reasonable assurance that this ingredient does not present a significant or unreasonable risk of illness or injury.”
For several years, FDA has raised concerns over kratom, a botanical from Southeast Asia which has long been the subject of an import alert.
“There is substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse,” Judy McMeekin, FDA’s associate commissioner for regulatory affairs, said in a May 21 press release announcing the seizure. “The FDA will continue to exercise our full authority under the law to take action against these adulterated dietary supplements as part of our ongoing commitment to protect the health of the American people.”
Several marketers of supplements have submitted to FDA premarket ingredient notifications to satisfy a requirement in the law to establish NDIs are reasonably expected to be safe. But the agency has essentially rejected all of them, citing safety concerns and other considerations.
Kratom advocates have maintained FDA harbors a bias against the botanical and that its efforts to ban it could result in more drug overdoses and related deaths. Kratom was recently the subject of a pre-review by an expert committee of the World Health Organization (WHO)—the first step in what could lead to scheduling of the plant, restricting consumers’ access to it.
Mac Haddow, senior fellow on public policy with the American Kratom Association (AKA), said in an email that his organization “fully supports responsible enforcement actions by the FDA when the safety of the American people is put at risk.”
However, the above case’s disposition “raises serious questions” about the legitimacy of FDA’s claims presented to the court regarding kratom’s safety, according to Haddow.
He said a review by a former official under the Trump administration—then-Assistant Secretary for Health Brett Giroir, M.D.—“directly” contradicted FDA’s concerns about kratom’s potential for abuse and its potential risk to public health.
In a 2018 letter to then-DEA Acting Administrator Uttam Dhillon, Giroir recommended two constituents of kratom, mitragynine and 7-hydroxmitragynine, not be controlled either temporarily or permanently until such action is supported by scientific research.
“In addition, Dr. Giroir concluded that there is an ‘unknown and potentially substantial risk to public health’ if kratom were scheduled,” Haddow added. “On balance, with a lack of evidence that kratom is unsafe, combined with the harm reduction kratom offers to those attempting to wean off of opioids, then properly manufactured kratom should be available to consumers.”
Asked for comment concerning the consent decree, an FDA spokesperson pointed to the agency's May 2021 news release that expressed concerns about kratom's risk to public health and potential for abuse. McMeekin, the FDA official, also noted in the release that kratom had not been approved by FDA for any use.
DOJ and Robert Becerra, an attorney representing BioBotanical and MT Brands, did not immediately respond to requests for comment about the consent decree.