Grecian Formula marketer Combe likens the process and calculations that informed FDA’s final rule against lead acetate to “a child’s game of telephone.” Environmental Defense Fund warns that if FDA grants Combe’s request – which the NGO suspects is unavoidable – it intends to cross-examine the company’s witnesses about consumer complaints and their handling in the firm’s past.
Combe Inc. has discontinued use of lead acetate in its Grecian Formula products, but it clearly still has a stake in FDA’s October 2018 final rule striking the substance’s use in hair dyes from the agency’s approved color-additives list.
In a request filed Nov. 30 and published online Dec. 12, Combe demands an evidentiary public hearing to go over...
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.
