Designating new “critical habitats” off US shores, as proposed by the National Marine Fisheries Service, would require federal agencies “to ensure that actions they plan to undertake, fund, or authorize do not destroy or adversely modify that habitat.” That could factor in the US FDA’s OTC sunscreen review program and potential follow-up on a 2018 citizen petition calling for a ban on "coral-killing" UV filters.
Proposed rulemaking from the US National Marine Fisheries Service would designate areas of the Caribbean, Florida and the Indo-Pacific region as “critical habitats” to help protect coral reefs, movement that could resurface concerns about sunscreen ingredients.
It also could complicate the US Food and Drug Administration’s consideration of UV filters that it already has flagged as...
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.
