Bundled within the draft FDA Safety and Landmark Enhancements Act are federal cosmetics reform provisions that would require facility registration and product listings with the US FDA, adverse event reporting and good manufacturing practices, while empowering the agency to order product recalls, access company records, and suspend dangerous operations.
A discussion draft bill released by the US Senate Health, Education, Labor and Pensions Committee on 17 May to reauthorize drug and medical device user fee programs also would modernize federal cosmetics oversight, reigniting movement in Congress that’s been underway for more than a decade.
The Personal Care Products Council and Independent Beauty Association said they are assessing the draft FDA Safety and Landmark...
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.
