Jessica O’Connell, partner at Covington & Burling, is getting questions from clients about the electronic system the FDA plans to launch in coming weeks for cosmetics manufacturers to register facilities and list products as required by new cosmetics regulations. It remains to be seen how hard the 29 December 2023 deadline will be for companies to get their information submitted.
Stakeholders are generally pleased with the “relatively user-friendly” interface of Cosmetics Direct, the facility registration and product listing portal that the US Food and Drug Administration plans to roll out this month, according to Jessica O’Connell, partner in the Washington DC office of Covington & Burling LLP.
However, most have gotten just limited looks at the electronic system in the form of screenshots the agency released...
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.
