Dietary Supplements

Mandatory Product Listing For Dietary Supplements

Mandatory Product Listing For Dietary Supplements

The Food and Drug Administration (FDA) is getting closer to requiring manufacturers and distributors of dietary supplements to list their products on a public FDA electronic database. On Tuesday, June 14, 2022, the US Senate Committee on Health, Education, Labor, and...

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Kratom-Navigating the Murky Regulatory Waters

Kratom-Navigating the Murky Regulatory Waters

On March 29, 2021, the Food and Drug Administration (FDA) updated and republished Import Alert 54-15, which allows for the detention without physical examination of dietary supplements containing Mitragyna Speciosa, otherwise known as  Kratom. Kratom is a botanical...

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Trump to Pharma CEOs — 75-80% less FDA regulations…

Recent headline: Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated Our take... Yeah...not so fast. I expect the Trump-team follow up to be, "we meant 75-80% of the really bad regulations will disappear -- and most likely only in...

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FDA Registration Renewal – Get Ahead of the Curve

Between October 1 and December 31 this year, all FDA-registered facilities must renew their registrations. Our team has handled registration renewal for hundreds of facilities. Here are some of our best tips for ensuring the renewal season goes smoothly. Medical...

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