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.
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.
More from United States
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.
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.
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.
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
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.”
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.
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.