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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

Own-Labeler Let's Talk Health Hears It From FDA About GMPs, Claims

For all but one of nine GMP violations found by FDA officials, warning letter states: "These are repeat violations from the previous inspection of your firm in 2016."
Dietary Supplements FDA

Anheuser-Busch, Molson Coors Tap Into CBD Market With Canadian Cultivators

Brewers are working with firms on launching in Canada beverages with cannabis-based ingredients before potentially distributing products in US. Alkaline Water Co. expects lawful sales of CBD supplements and foods in US early in 2020, when it plans to launch Alkaline88 CBD-infused waters.

North America Canada

Canada Is Large Firms' CBD Test Market While US Weighs Allowing Sales

Large beer and beverage firms partner with hemp cultivators to compete in fledgling US CBD-infused beverage market, which is estimated to reach $1.4bn sales by 2023. Many firms are working on R&D or have completed products and are waiting for a clear regulatory pathway from FDA before launch.

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