The Food and Drug Administration is getting serious about putting a stop to companies distributing unapproved kratom supplements which have unproven health claims.
FDA commissioner Scott Gottlieb issued a letter to three companies in different states on Tuesday, May 22. Gottlieb revealed that the companies were engaged in health scam frauds, which could pose serious health risks.
What Is Kratom?
Kratom is an opioid-like supplement derived from a plant in Southeast Asia. It can be sold as powder, tea, or pills. Advocates claim it can help people suffering from opioid withdrawal symptoms. Kratom is classified as a supplement, which means it has not been subjected to federal regulation and can easily be found in any store.
However, this has been linked to the recent outbreak of salmonella, which has affected at least 130 people in the United States. Forty-four deaths have been linked to this outbreak according to the FDA and the Center for Disease Control and Prevention.
Although kratom has not been confirmed as the reason for these illnesses and deaths, it does seem to be a factor in the salmonella outbreak. The CDC interviewed people who had salmonella and found that majority of those who were questioned used kratom.
Risks And Factors
The companies that have been named in the letter are Revibe, Inc. of Kansas City, Missouri; Front Range Kratom of Aurora, Colorado; and Kratom Spot of Irvine, California.
Revibe claimed to have destroyed several of the tainted products from their facility, however, it has yet to confirm that it recalled its products that have already been shipped to certain stores. The three companies are said to have stated that kratom would be very “effective” against cancer as part of their marketing strategy.
The FDA stated that there was very little evidence to support the claims. Research on the drug showed that it tapped into some of the brain defectors like opioids do, which led the FDA to classify it as an opioid. Other experts have stated that kratom has not been tested for safety by medical professionals, which makes it even more potentially unsafe.
“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,” Gottlieb stated in his letter.
Currently, kratom is banned in several states in America, including Indiana and Tennessee, and also in countries suh as Australia and Thailand.