Now that FDA has completed its evaluations of two compounds in kratom – mitragynine and 7-hydroxymitragynine – that DEA has proposed to schedule as controlled substances, researchers who attest to the ingredient's safety and its value in helping opioid abusers through withdrawal or as a natural pain reliever or mood enhancer say time could be running short to convince federal officials against ending consumer access to kratom products due to fear that the ingredient is an opioid.
FDA should regulate kratom as a dietary ingredient rather than the health threat the agency claims it is, not only due to its history of safe use similar to other botanicals but also because like other supplement ingredients, some products labeled as kratom are adulterated and should be removed from the market, experts say.
Now that FDA has completed its evaluations of two compounds in kratom – mitragynine and 7-hydroxymitragynine – that the Drug...
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.
Global beauty giant is working to adapt its approach to the prestige market to meet escalating competition, increased points of sale, and more knowledgeable consumers with new shopping habits, CFO Tracey Travis said at the Barclays Global Consumer Staples Conference.
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.
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.
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.
