FDA Should Take A Fresh Look At Kratom Science
Published: Aug 21, 2018
WASHINGTON, /PRNewswire/ -- Referencing millions of people who depend on natural kratom for pain management and to assist in withdrawal from dangerous opioids, scientific and legal experts joined the American Kratom Association (AKA) in demanding that the U.S. Food and Drug Administration (FDA) move beyond politics to focus on the science and enforcing laws already on the books to police those who adulterate the natural botanical with other substances.
In an online press conference today, Dr. Jane Babin--author of a recent white paper disclosing numerous errors, omission, and misstatements committed by the FDA in analyzing deaths it erroneously associates with kratom--called upon FDA to "take a fresh look as scientists." Dr. Babin provided a litany of FDA mistakes and missteps related to its data and conclusions, including miscounting deaths, failure to cite deadly toxic substances that had been used to contaminate kratom and was found in decedents' bodies, and even cases of suicide and homicide that FDA attributed to kratom.
Dr. Oliver Grundmann from the College of Pharmacy and Department of Medicinal Chemistry at the University of Florida criticized FDA's representation that kratom is an opioid and may lead to addiction. "Mitragynine (the active ingredient in kratom) is unlikely to reach blood levels in unadulterated kratom products that would create adverse effects," he said, explaining that while mitragynine binds to opioid receptors, the effects are "quite different" from classic opioids. Those who use kratom are not inclined to use more, and research demonstrates that "those who have been using drugs before kratom seek out kratom to mitigate their dependence on drugs." According to Dr. Grundmann, "Kratom is used as a harm reduction agent--an important step that speaks against (the FDA's claim) that kratom is a gateway drug."
"You should be able to trust a government agency," said C. McClain Haddow, Senior Fellow on Public Policy at AKA. "Their information must be accurate, but in the 8-Factor Analysis that the FDA is using to persuade the U.S. Drug Enforcement Agency (DEA) to schedule kratom, their cases are discredited. The FDA won't say that the kratom was adulterated."
AKA released its recommendations for good manufacturing practices (GMP) for kratom, which includes maintaining purity from contaminating substances. "FDA already has regulatory authority to require vendors to adhere to the law, and to take action against those who adulterate kratom with other substances," Haddow said, adding that if FDA forces the scheduling of kratom "it will force people into more dangerous alternatives."
Dr. Grundmann concluded that "if FDA or any regulatory agency tries to regulate kratom by equating it to opioids" the action "would significantly hinder any current and engaging research, and any progress being made on a potentially new drug."
The American Kratom Association (AKA), a consumer-based non-profit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom. AKA represents millions of Americans, each of whom has a unique story to tell about the virtues of kratom and its positive effects on their lives. www.americankratom.org
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SOURCE American Kratom Association