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Regulation/Legislation (Wellness)

Set Alert for Regulation {Wellness}

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.

Wellness Advertising, Marketing & Sales Business Strategies

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.

FDA Regulation OTC Drugs

Regulation

Set Alert for Regulation {Wellness}

Latest From Wellness & Regulation

US COVID-19 Fraud: Tincture, Sanitizer Warnings, Criminal Contempt Charges And Civil Settlement

FDA’s latest COVID-19 warnings note fewer violative claims than identified in previous warnings to consumer health firms. One had a single noncompliant claim on its website, while another’s violations included identifying potential symptoms of COVID-19. Four men associated with a Florida church face counts of conspiracy to defraud the US and of contempt of court stemming from COVID-1 claims for a bleach solution.

Dietary Supplements Enforcement

P&G Given Green Light To Offload Haliborange Supplements

P&G's decision to offload its Haliborange children's supplement line will not lead to reduced competition in the UK market, according to the regulator.

Deals Regulation

US FDA Restarting Domestic Inspections, Prioritizing Areas With Low Covid-19 Rates

The agency is resuming domestic inspections using a pandemic rating system to identify localities where inspections will be safest for investigators and plant workers. Another safety factor: all inspections will be pre-announced.

FDA Manufacturing
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