FDA’s most recent safety alert is clearly an unfortunate repeat of the exact mistakes the FDA has made for years on kratom

WASHINGTON, DC, July 29, 2024 (EZ Newswire) -- The FDA’s most recent mistaken and misguided safety alert which warns consumers to not use OPMS Black Liquid Kratom is clearly an unfortunate repeat of the exact mistakes that former HHS Assistant Secretary of Health, Dr. Brett Giroir, previously condemned when he correctly noted that the FDA has been relying upon "embarrassingly poor evidence and data" on kratom.

The American Kratom Association (AKA) calls upon the FDA Commissioner, Robert Califf, to immediately remove the July 26, 2024, consumer warning statement regarding OPMS Black Liquid Kratom until the agency has independently verified the alleged claims regarding the death that they have not conclusively proven to be attributed to this product.

"The FDA safety alert on a kratom product appears to be a new rehash of previously debunked FDA claims that kratom killed nine people in Sweden in 2009, that the FDA cited in their Federal Register Notice in 2016 to justify its recommendation to classify kratom as a Schedule I substance that researchers eventually determined were actually caused by the mixing of a toxic adulterant, O-desmethyltramadol, into the kratom product that actually caused those deaths," stated Mac Haddow, Senior Fellow on Public Policy at the AKA. "The HHS Assistant Secretary of Health wrote a scathing withdrawal letter on the FDA’s scheduling recommendation, and publicly called out the FDA for using 'embarrassingly poor evidence and data' in trying to schedule kratom."

The most recent FDA safety alert vaguely references a reported kratom death but provides no details or credible evidence that would link that death to the kratom product referenced by the FDA. That safety warning stands in stark contrast to a July 25, 2024, FDA public health alert on elevated levels of lead in a ground cinnamon product where the product was tested by the New York State Department of Agriculture, and then "confirmed by the FDA", with their own testing. 

No such information on the verification of this claim is available in the FDA safety alert for the alleged kratom product issue.

"The consistently unreliable and often false statements about kratom issued by the FDA over the past decade, which is a part of its relentless and misguided pursuit of banning kratom products that is not supported by reliable science, are wrong and Commissioner Califf should hold his agency fully accountable," Haddow stated. "The various autopsy reports that have claimed that kratom is the sole cause of deaths have been thoroughly refuted as incomplete, poorly documented, hastily concluded, or demonstrably incorrect."

The FDA safety alert claims that it is based upon an adverse event report relating to a "person who died after using OPMS Black Liquid Kratom," and stated that it was among many such reports. Yet, in a review of the current data available on the FDA Adverse Events Reporting System (FAERS) Public Dashboard (https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis) those claims cannot be validated.

Plaintiff’s trial attorneys have been openly encouraging clients and other anti-kratom advocates to submit complaints to the FDA on alleged deaths over the past few months and have taken to social media platforms to solicit others to do so. The FDA "safety alert on kratom" appears to be the result of a coordinated effort by those trial attorneys who have a financial interest in litigation against the very company the FDA’s safety alert identifies. Those cases should be tried in the courts, where they belong, and not involve the power of a federal agency to prosecute private claims.

The FDA staff is undermining Commissioner Califf’s own initiative to eliminate health misinformation, which the commissioner himself said "poses the most serious threats to public health today.” The FDA is not exempt from the solemn duty to accurately convey information only after it that has been fully and credibly vetted and proven.

"Commissioner Califf must direct that this current safety warning be immediately and completely removed until the report can be fully evaluated and meaningful discussions with the manufacturer have taken place," concluded Haddow. “Until then, the prior ominous warning by Dr. Giroir remains accurate: the FDA continues to rely on 'embarrassingly poor evidence and data' in relation to kratom issues."

Sources

About American Kratom Association (AKA)

The American Kratom Association (AKA), a consumer-based non-profit organization, advocates to protect the freedom of consumers to safely consume natural kratom as a part of their personal health and well-being regimen. AKA represents the nearly 20 million Americans who consume kratom safely each year. www.americankratom.org

Media Contact

Mac Haddow
+1 571-294-5978

SOURCE: American Kratom Association (AKA)

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