A two decade-long journey seeking US Food and Drug Administration approval of sunscreen UV filter BEMT is nearing its end, according to DSM-Firmenich’s Carl D’Ruiz. DSM-Firmenich’s experience speaks to the complexities and costs that sponsors face in the US in bringing new active ingredients to the OTC sunscreen products category.
DSM-Firmenich says UV filter bemotrizinol appears on track to reach the US after more than 20 years of working toward Food and Drug Administration approval and spending approximately $20m in the process.
That would make BEMT the first sunscreen active ingredient added to the agency’s OTC Sunscreen Drug Monograph in 25 years.
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.
In this episode of the Over the Counter podcast, HBW Insight speaks to Kerry's RDA senior manager of immune and joint health, Sonja Nodland, about the opportunity for innovation that postbiotics represent for the consumer health industry.
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.
Height of plaintiff attorney’s argument to present evidence which would prompt speculation by a jury was request to parse research by Kenvue’s lead expert, who coordinated the International Consensus Statement on ADHD by the World Federation of ADHD, where he’s president.
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