FDA Declares A Popular Herbal Supplement A Dangerous Opioid, Warns Against Its Use

February 14, 2018
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FDA Declares A Popular Herbal Supplement A Dangerous Opioid, Warns Against Its Use

“The Food and Drug Administration has taken the unusual step of labeling a popular herbal supplement an opioid.

This past week, FDA commissioner Dr. Scott Gottlieb issued a statement warning Americans to stop using the herbal supplement kratom, saying the plant-based stimulant acts just like an opioid. He points out that there are 44 documented cases in which people have died using kratom, many of them healthy young people.

Gootlieb says the FDA’s research into kratom proves it affects the brain just like an opioid, and is just as dangerous. “Taken in total, the scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance,” he wrote. “Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use.”

The American Kratom Association disputes the FDA’s findings. “This is an unprecedented abuse of science to create a new computer program that is clearly garbage in garbage out avoiding the rules of the Controlled Substances Act and making unproven claims that have been proven to be untrue,” they said in a statement.

Here is the complete statement issued by the FDA.

Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body. Today, we’re providing details of some of the important scientific tools, data and research that have contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.

Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties. These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body. We also have learned more about deaths that involved kratom use, and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom.

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.

The FDA’s PHASE model used to assess kratom

Federal agencies need to act quickly to evaluate the abuse potential of newly identified designer street drugs for which limited or no pharmacological data are yet available. This is why the FDA developed the Public Health Assessment via Structural Evaluation (PHASE) methodology – a tool to help us simulate, using 3-D computer technology, how the chemical constituents of a substance (such as the compounds/alkaloids found in kratom) are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain. In effect, PHASE uses the molecular structure of a substance to predict its biological function in the body. For example, the modelling platform can simulate how a substance will affect various receptors in the brain based on a product’s chemical structure and its similarity to controlled substances for which data are already available.”

Article link: https://silenceisconsent.net/fda-declares-popular-herbal-supplement-dangerous-opioid-warns-use/

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FDA Declares A Popular Herbal Supplement A Dangerous Opioid, Warns Against Its Use
FDA Declares A Popular Herbal Supplement A Dangerous Opioid, Warns Against Its Use
FDA Declares A Popular Herbal Supplement A Dangerous Opioid, Warns Against Its Use
FDA Declares A Popular Herbal Supplement A Dangerous Opioid, Warns Against Its Use

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