Duffy MacKay, senior VP of scientific and regulatory affairs at CV Sciences, offers his predictions regarding the FDA’s likely course in regulating CBD’s use in dietary supplements – action that is sorely needed as the market continues to crowd with CBD products “with who-knows-what in them.”
CV Sciences, Inc. is confident that the US Food and Drug Administration will establish a regulatory framework for cannabidiol’s lawful use in dietary supplements, which it believes will be a crucial accelerator for its already market-leading PlusCBD brand.
In recent years, the San Diego-based company has been working to grow US distribution for the PlusCBD line, including moves...
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.
