December 11, 2024

FDA Warns Consumers Again About Dangers of Kratom

The FDA is again warning consumers about the dangers of kratom. This compound has not been approved for the treatment or cure of opiod use disorder and withdrawal symptoms. And the agency has received "concerning reports" about the use of kratom. Kratom is an extract from the leaves of an evergreen tree that grows in Southeast Asia. The FDA is actively evaluating all scientific information about this compound and is warning consumers not to use kratom or essential oils. The agency recently sent five warning letters to companies that are selling this product: Herbsens Botanicals, Klarity Kratom, Kratom Exchange, Omni Consumer Products LLC d/b/a/ YoKratom, and MONQ, LLC. The warning letters state that the kratom products are unapproved new drugs under the FD&C Act, because they … [Read more...]

Sunstone Organics Kratom Recalled For Possible Salmonella

Sunstone Organics is recalling two lots of Sunstone Organics Kratom, including White Vein Kratom Lot 119 and Maeng Da Kratom Lot 124A. The recall covers both capsules and powder form, in all sizes. These products may be contaminated with Salmonella bacteria. No reports of illness have been received to date in connection with this recall. The product is used as a tea or a supplement and is packaged in Kraft stand-up pouches, in three different size bags. The package sizes in the powder type are 25 grams, 50 grams, and 100 grams. The package sizes in the capsule form are 20 count, 60 count, and 150 count. You can see the UPC numbers for these recalled products at the FDA web site. All six kratom sizes pertain to the same lot number. These kratom products do not have an expiration … [Read more...]

Heavy Metals Found in Some Kratom Products

There have been several warnings issued in the past year about kratom, a dietary supplement that was recalled for Salmonella contamination. Now, the FDA states that they have found "disturbingly high levels of heavy metals in kratom products." Kratom is not legally marketed in the U.S. as a drug or dietary supplement. The FDA states that some substances in kratom have opioid properties that suggest the potential for abuse. FDA scientists tested 26 separate kratom products obtained by field investigators. These products were originally collected as part of the efforts related to the multistate Salmonella outbreak linked to those products. Officials found lead and nickel in the kratom, at levels that are not safe for human consumption. The levels of heavy metals found are not … [Read more...]

New Warnings About Kratom With Unproven Medical Claims

The FDA has been warning consumers about dietary supplements containing kratom, a plant native to Southeast Asia, that contains opioids. The plant mitragyna speciosa contains substances that react in the body in a way similar to opioids. This compound is illegal and controlled in several other countries, including Denmark, Germany, and Australia. Several states and cities in the U.S. also ban it. The FDA states that "there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in humans. Nor have there been studies on how this compound, when combined with other substances, may impact the body, its dangers, potential side effects, or interactions with other drugs." The FDA has sent warning … [Read more...]

Zakah Life Recalls Kratom For Possible Salmonella Contamination

Zakah Life of Iowa is recalling Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules for possible Salmonella contamination. No illnesses have been reported as of today in connection with this issue. The recalled products were sold nationwide through mail order and in retail stores. They all have expiration dates before 01/01/2023. These recalled items include Super Green Maeng Da Premium Kratom Powder in 4 ounce black and clear organic rice paper bag that contains 100 grams of kratom with lot number BSG010118; Powerful Red Vein Bali Premium Kratom Powder in 4 ounce black and clear organic rice paper bags containing 100 grams, with lot number BPR010118; … [Read more...]

FDA Says Kratom Not Worth the Risk

The FDA released a statement on July 2, 2018, about the risks of kratom, a dietary supplement, and a Salmonella I 4,[5],12:b:- outbreak that has sickened 199 people in 41 states and hospitalized 38. Officials have stated before that there is no proven medical use for kratom and the FDA "strongly discourages the public from consuming kratom." Public health officials believe that the issue with this product and Salmonella has been occurring for some time and is ongoing. Their conclusion from the investigation of this outbreak is "anyone consuming kratom may be placing themselves at significant risk of being exposed to Salmonella." Kratom is not legally marketed as a drug or dietary supplement in the United States. It is an opioid, addictive, and has been "linked to severe health … [Read more...]

Salmonella Outbreak Linked to Kratom Products Ends With 199 Sick

The Salmonella outbreak that is linked to kratom containing products is over, according to the Centers for Disease Control and Prevention (CDC), with 199 sick in 41 states. People should be aware that kratom could be contaminated with Salmonella bacteria and contaminated products may still be available for purchase. The investigation did not identify a single, contaminated source of kratom. Several companies did recall kratom products because they may be contaminated. The list of products is available on the FDA website. The patient case count by state is: Alabama (1), Alaska (2), Arizona (7), California (13), Colorado (4), Connecticut (2), Delaware (1), Florida (8), Georgia (3), Iowa (2), Idaho (10), Illinois (5), Indiana (2), Kansas (2), Kentucky (6), Louisiana (3), … [Read more...]

FDA Sends Warning Letter To Three Companies Selling Unapproved Kratom Products

The FDA is warning companies that sell illegal, unapproved kratom products marketed for opioid cessation, pain treatment, and other medical uses to stop. Three corporations were issued warning letters on May 22, 2018: Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California, and Revibe, Inc., of Kansas City, Missouri. The government states that those companies are illegally selling unapproved kratom-containing drug products and making unproven claims about their ability to help in the treatment of opioid addition and withdrawal. Other unproven claims the FDA alleges the companies are making including treating pain, lowering blood pressure, treating cancer, and reducing neuron damage caused by strokes. The FDA has repeatedly warned consumers that no kratom product … [Read more...]

Two Manufacturers Recall Kratom Supplements for Possible Salmonella

Two manufacturers are recalling kratom-containing dietary supplements for possible Salmonella contamination. Illness have been reported tied to these recalled products. Badger Botanicals of Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements that were sold directly to consumers through the company website from January 1, 2018 to April 12, 2018 because it has the potential to be contaminated with Salmonella. One potential illness has been reported in connection with this issue. There is a multistate Salmonella outbreak linked to some kratom containing products in the U.S. right now. At least 132 people are sick in this outbreak as of April 5, 2018, according to the FDA. We don't know whether or not the illness reported in this recall is … [Read more...]

More Kratom Products Recalled for Possible Salmonella Contamination

Several more kratom products have been recalled for possible Salmonella contamination. These four recalls have been listed by the FDA. The first recall is for products made by Viable Solutions for Herbal Salvation Dietary Supplements. You can see the list of products, along with the product name and net weight at the FDA site. These are the lot numbers of the recalled products; RVS1380182301, RVB1380182201, GVH1380171512, and MD13120181601. They were sold directly to consumers nationwide in January and February 2018 through company websites. The company was notified by the Michigan Department of Health that certain lots tested positive for Salmonella. The second recall is for products from Triangle Pharmanaturals of Las Vegas, Nevada. All of its kratom products the company … [Read more...]

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