The Personal Care Products Council says talc-testing methods in the cosmetics industry must distinguish between carcinogenic asbestos and harmless non-asbestiform minerals, recalling its position against the FDA’s stab at rulemaking in 1973. However, the FDA is now arguing that elongate mineral particles of respirable dimensions are inherently dangerous, regardless of other considerations.
Methods for testing talc and talc-containing cosmetics for asbestos have advanced significantly since the 1970s, but renewed exchanges between industry and the US Food and Drug Administration suggest that their views on the matter are as divided as ever.
The FDA held a public meeting on 4 February to hear from scientific experts and leading stakeholders on testing methodologies,...
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.
