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Court Tosses Amarin Fair Trade Complaint Against Omega-3 Imports
Majority opinion by Federal Circuit upheld International Trade Commission's decision and denied as moot Amarin's petition for order to compel a judicial or government officer or agency to perform a duty. Dissenting opinion not only agrees ITC acted correctly denying the firm's complaint, but also says the commission's decision wasn't appealable. Ropes & Gray attorneys suggest ruling provides guidance for additional fair trade complaints about FDA-regulated products.
Latest OTC Homeopathic Firm Using Rx Indications Also A Repeat GMP Offender
FDA says Newton Laboratories sells unapproved Rx homeopathics because its products are labeled to treat diseases and conditions including allergies, chicken pox and “suicidal tendency.” Warning letter says firm also has repeatedly violated same GMPs across more than a decade of inspections.
Regulation
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Latest From Wellness & Regulation
Health And Wellness Trademark Review 14 January, 2020
CBD Safety And Hemp Farming Have Equal Space In Rep. Harris’ Concerns
“We ought to deal with this. There are questions on long-term safety and questions on efficacy claims that are just not proven,” says the Maryland Republican. “The biggest threat hanging over, in my mind, the farmers who want to grow hemp, is what if the FDA comes out tomorrow and says, ‘You can't sell any product’? The market collapses,”he said at a CBD policy conference.
FDA Gets Message In Congress' First Cannabis Policy Hearing: Deliver CBD Regulation
During first-ever congressional hearing on federal policies for lawful use of cannabis, House Energy and Commerce Health Subcommittee Chairwoman Anna Eschoo says with $2m appropriated to develop a regulation on CBD’s use in non-drug products during, FDA should deliver.
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