Amarin's petition to the Federal Circuit Court to direct ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs leans on Supreme Court decisions that compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information rendered a product an unapproved drug or represented false advertising.
FDA has no authority to waylay an International Trade Commission investigation into whether products marketed as dietary supplements unfairly compete with Amarin Corp. PLC's ethyl-ester eicosapentaenoic acid omega-3 drug, the firm argues in a federal court appeal.
Amarin's petition submitted Dec. 1 to the US Circuit Court for the Federal Circuit for an order directing ITC to...
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The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.
Whether called “dark patterns,” “shady” online marketing practices, or simply deception on the internet, the issue has taken on high importance at the US Federal Trade Commission and is being tackled by new laws in a growing number of states. Amin Talati Wasserman partner Lauren Aronson discusses in this interview with HBW Insight.
BBB National Programs found FTC’s proposed Trade Regulation Rule on the Use of Consumer Reviews and Testimonials largely effective with some certainty on whether product reviews or customer testimonials are violations of its false advertising standards. But it =expects some clarifications may come in final rule.
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.
