A ruling in Maine federal court questions whether FTC could show firms made claims a product labeled as a supplement “cures, mitigates, or treats any disease." But agency's administrative complaint includes the same phrase as a stipulation among the penalties it would order.
The Federal Trade Commission pivots to an administrative proceeding in its litigation against a dietary supplement firm after a court ruled that terms US regulators commonly use to define noncompliant claims are vague and unenforceable as a stipulation in a settlement the FTC allowed the firm to enter.
After the FTC allowed Maine businesses Health Research Laboratories LLC and Whole Body Supplements LLC and their owner, Kramer Duhon,...
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.
