Non-monetary settlements are more effective than litigation at changing consumer product companies’ advertising practices, says FTC Commissioner Christine Wilson. “We see non-monetary settlements curtail behavior and require sometimes fundamental changes in the way companies do business.”
Settlements that don’t impose monetary penalties against dietary supplement, personal care and other consumer products marketers in violation of Federal Trade Commission regulations are more effective than litigation in promoting compliance, says Commissioner Christine Wilson.
Non-monetary settlements in lieu of litigating complaints to impose financial penalties including consumer redress also are a better use of...
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.
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.
Dietary supplements containing unauthorized novel foods were reported to the European Commission by national regulators on around 40 occasions in the second quarter of 2024.
As it has every year since FSMA was passed in 2011, FDA doesn’t plan to impose reinspection fees until it publishes guidance for small businesses to request reductions. FY2025 budget proposal includes plan “to re-structure the fee programs to make it more administratively feasible to operate.”
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.
In this installment of HBW Insight’s “Inside Regulatory Affairs” series, we hear from Sharee Crumbey and Monica Sharda, regulatory affairs specialists at The Honest Company, about the mounting challenges and rewards of the job.
