The FDA Is Forcing This Supplement Off Store Shelves

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Update April 4, 2018:

For the first time ever, the FDA has issued a mandatory recall order against a contaminated food product, namely, kratom-containing supplements. “This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said FDA Commissioner Scott Gottlieb, MD in a press release.

After a voluntary recall of kratom products due to a salmonella outbreak was ignored by companies, the FDA filed a mandatory recall against Triangle Pharmaceuticals, a consultant and packager of supplement products. As a result, kratom-derived items will be pulled from store shelves.

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"The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession," continues the statement in the press release. "The FDA is working with the U.S. Centers for Disease Control and Prevention to continue to investigate the ongoing [salmonella] outbreak."

Update February 22, 2018:

The FDA has just announced the voluntary destruction and recall of kratom-containing dietary supplements nationwide. The recall affects three major brands—Botany Bay, Enhance Your Life and Divinity—all of which are manufactured and sold nationwide by Divinity Products Distribution of Missouri.

“The company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market,” the FDA wrote in a press release.

This additional news seems to indicate the beginning of the end for kratom-based products. We’ll be sure to update if more information is released.

Update February 21, 2018:

Kratom—an herbal supplement to treat pain, anxiety and depression—has been under major scrutiny by the FDA for the last few weeks, and now, new findings have put the supplement into even more hot water. The Centers for Disease Control and Prevention (CDC) has just reported that Kratom has been linked to an outbreak of salmonella.

Although it's unknown how Kratom became contaminated with salmonella in the first place, 28 people in 20 states are believed to have gotten the illness from the supplement. So, considering all the controversy surrounding this popular product right now, it's best to err on the side of safety and skip your dosage until the FDA and CDC release more information—you'll be happy you did.

Original Post February 7, 2018:

New evidence has surfaced regarding a controversial supplement and its association with 44 deaths, the Washington Post reports. The Food and Drug Administration announced on Tuesday that Kratom, an herbal supplement, contains chemical compounds that mimic “opioid properties” and put consumers at risk for negative side effects.

The supplement—it’s traditionally crushed and made into tea, or consumed as a powder, pill or capsule—is used to treat pain, anxiety, depression, and interestingly enough, opioid-withdrawal symptoms. Advocates of Kratom claim it’s a safe and effective way to deal with painful conditions, but FDA commissioner, Dr. Scott Gottlieb, warns “there is no evidence to indicate that Kratom is safe or effective for any medical use.”

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“We feel confident in calling compounds found in kratom, opioids,” said Dr. Gottlieb in a statement, adding that these new findings add to the agencies already growing concerns that Kratom’s “potential for abuse, addiction and serious health consequences, including death,” are severe.

Currently, the FDA is aware of 44 kratom-related deaths between April 2011 and last December. Because Kratom has obviously become a drug of concern, the FDA recommends steering clear of it until further research has been done.

  • ID
    Posted on

    Deaths between April 2011 and last December...

  • LLC
    Posted on

    This article is somewhat misleading. The 44 deaths have occurred over 20 years. It is a shame that our government does not see the medical value in kratom. As someone who has excruciating debilitating chronic pain Kratom has its purpose and has helped me tremendously. There is medicinal value. It is not an opioid however it works on the opioid receptors in the brain that every human has. Again very misleading.

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