Kratom Suspected In 35-State Salmonella Outbreak: Health And Wellness Industry News

Kratom suspected in 35-state salmonella outbreak; FTC mails refunds for false weight loss ads; Spear at tip of Nutrition 21 sales; and BioCell Collagen halal certified.

An outbreak of salmonella infections that FDA suspects is linked to products containing kratom has spread to 35 states and 40 of 55 infected people who were asked about the botanical reported consuming it before getting sick. According to FDA's March 15 update to its ongoing monitoring of the salmonella outbreak potentially linked to kratom, the investigation by the agency, Centers for Disease Control and Prevention and state and local officials includes four outbreak strains. Salmonella Javiana, Okatie and Thompson were identified after the outbreak was detected and linked to a single strain, salmonella I 4,[5],12:b:-, FDA says.

The agency also reported that Portland, Ore., firm PDX Aromatics LLC on March 9 recalled kratom-containing powder products it marketed under the brands Kraken Kratom, Phytoextractum and Soul Speciosa after testing by California's Department of Public Health identified salmonella in an open sample its products. Separate testing by FDA confirmed salmonella in products purchased from PDX. Through March 14, CDC reported 87 people infected with one of the four outbreak strains of salmonella and 27 have been hospitalized. FDA investigates this salmonella outbreak as it advises firms marketing kratum products that it consider the botanical a new dietary ingredient that must be notified to the agency with substantiation that it is safe for its intended use in supplements. But the agency also says it is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient." Also see "FDA's Kratom Campaign Turns To Firms Destroying Inventory, Recalling Products" - HBW Insight, 21 February, 2018

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

Some Laid Off Employees Called Back At US FDA

 

Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

 

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

 

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

 

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.