The Personal Care Products Council and Consumer Healthcare Products Association say FDA’s tentative final sunscreen monograph and related communications have given rise to confusion that could lead to reduced sunscreen use and negative public health consequences. The groups go one further: FDA should reissue a tentative final monograph proposing that the 12 chemical UV filters currently in question are GRASE.
Since the US Food and Drug Administration issued its tentative final monograph for OTC sunscreen drug products in February, designating 12 currently marketed chemical UV filters as Category III (additional data needed), the media has been awash with headlines reflecting various reads on the proposed rule’s significance.
Interpretations among public health advocates include “FDA Admits Most Sunscreens Are Probably Unsafe,” while the Environmental Working Group received...
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.
