The USDA’s National Organic Program, which sets requirements for “100% Organic,” “Organic” and “Made with Organic” products, should be the model on which natural regulation is based at FDA, according to the Natural Products Association, which has administered its own natural personal-care standard and certification program for almost a decade. Legislation likely would be needed, and the FDA burden would be considerable.
The Natural Products Association believes a multi-tiered framework for natural product labeling and regulation – differentiating between items that are “100% Natural,” “Natural” or “Made with Natural Ingredients” – is the best course forward in the US to provide clarity to consumers and minimize burdens on industry.
Such a system, administered by FDA, would closely parallel aspects of the National Organic Program overseen by the US Department...
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.
