Commissioner Scott Gottlieb says prior to investigating a "large outbreak of salmonellosis," FDA determined there are no proven medical uses for kratom and that it is inherently addictive and can cause harm. "The subsequent findings of this investigation only strengthen that public health recommendation. … Now, in addition to those risks, we can conclude that there may be a high proportion of kratom and kratom-containing products contaminated with salmonella," he says.
The link between kratom and salmonella is more widespread than FDA previously suspected, prompting the agency to warn that consumers using the botanical in dietary supplements or other products "may be placing themselves at a significant risk of being exposed to" the contaminant.
When FDA on July 2 announced it has ended its investigation of a "large outbreak of salmonellosis" linked to kratom,...
Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.
Week after publishing safety alert about OPMS Black Liquid Kratom “linked to serious adverse health effects, including death,” FDA announced market research “to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” But it withdrew the study 10 days later.
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to Kenvue's Kevin Whelan.
Court order dismisses claims against Perrigo and Joseph Papa, its former CEO, with prejudice. Settlement also bars any claim against plaintiffs and class members, “whether arising under state, federal, common or foreign law,” alleging liability for losses.
In this episode of the Over the Counter podcast, HBW Insight speaks to Kerry's RDA senior manager of immune and joint health, Sonja Nodland, about the opportunity for innovation that postbiotics represent for the consumer health industry.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
