FDA warns three companies selling kratom and brands them as "Health fraud scams”

26 May 2018
FDA warns three companies selling kratom and brands them as

The US Food and Drug Administration (FDA) has sent out warning letters to three US companies for illegally selling “unapproved” kratom products, that had  claims that the product can treat opioid addiction and withdrawal and a whole host of other medical ailments.

Kratom Mitragyna speciosa

The letters were sent to Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California; and Revibe Inc of Kansas City, Missouri. The three companies were selling their products online and through social media. They requested responses from each of the companies within 15 working days and branded them as "Health fraud scams”.

FDA Commissioner Scott Gottlieb came out with the following statement :

“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there's no reliable scientific proof to support their use”

His “claim” quote that “there's no reliable scientific proof to support their use” is completely incorrect. There have been numerous scientific studies done in many countries around the world including the United States. The research has specifically concentrated on its two main active alkaloids Mitragynine and 7 Hydroxymitragynine, A lot of this research is published on the internet and is available for anyone to read.Kratom.comhas a fairly comprehensive list of research papers and scientific journals.

There are also given and pending medical patents too and so therefore it is very incorrect to say that there's no reliable scientific proof to support their use! Here are two US patents relating to Kratom extract and their specific alkaloids.

He went on to say "As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we've determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects," added Gottlieb.

Again this is simply just not true and real scientific research has shown that Mitragynine is a partialopioid agonist working with the same receptors but in a completely different and much safer way than opioids.

Gottlieb also criticized that these companies claimed their kratom products ease pain, lower blood pressure and blood sugar, treat cancer, and reduce stroke-related brain damage, among other things.

Kratom is a food supplement and therefore it is not legal to make medical claims. The FDA sent out the letters as part of their ongoing efforts to crackdown on kratom and stop the public from using it.

Responsible vendors now acknowledge this and just label their products with just the ingredients and no medicinal claims. People are already very familiar with Kratom and what it can do so there is also no need for companies to make such claims.

According to the FDA there are currently no approved uses for kratom, albeit all of the thousands of testimonials of people whom it has helped or even saved their life and all of the scientific literature available on the internet. The American Kratom Association (AKA)has published a list on its website of many relevant scientific studies.

Companies and vendors should be careful to make no medicinal claims online or through social media as it is against the law and the FDA are now starting to target such companies.

Speciosa.org supported by the Botanical Educational Alliancehas published important information for kratom vendors on how to become compliant with FDA labelling

 



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