FDA affirms in draft guidance that a maximum lead level of 10 parts per million in cosmetic products does not pose a health risk to consumers, establishing a position consistent with the Personal Care Products Council’s recommendation in 2011. The formal stance from FDA could take some heat off of manufacturers, though the Environmental Working Group says it will continue pushing for tighter restrictions.
In a notable win for the cosmetics industry, FDA issues draft guidance regarding trace lead levels in lipstick and other cosmetic products after sitting on the issue for more than half a decade.
Published in the Dec. 22 Federal Register, the document advises a maximum 10 parts per million limit for lead 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.
