With FDA’s Tightening Stance on Food Claims, What Should Manufacturers Do?

Published on January 10, 2017

In the past year, FDA has made considerable progress (in most cases), fine-tuning the regulations…

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New FDA Dietary Supplement Guidance: Unnecessarily High Requirements for Safety Factors Based on Animal Studies

Published on December 2, 2016

The FDA’s new guidance document on new dietary ingredient notifications (NDINs) and related issues (1)…

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The GRAS Process Under the Final Rule (Part 2): Increased Emphasis on Exposure

Published on October 1, 2016

The finalized GRAS rule and associated Federal Register Notice1 emphasizes the FDA’s opinion that dietary…

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The Strictest Regulation on Infant Formula in Chinese History: How does it compare to the U.S. registration process?

Published on October 1, 2016

On June 6th 2016, the China Food and Drug Administration (CFDA) published the final rule…

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New Draft Guidance on Allergy Assessment of Genetically Modified Plants from EFSA: More Tests to Ensure Safety for Everyone

Published on September 1, 2016

The European Food Safety Authority (EFSA) has issued a new draft guidance on allergenicity testing…

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Dietary Supplements in the U.S. and Abroad: Similarities and Differences

Published on September 1, 2016

Demand for dietary and nutritional supplements worldwide continues to increase, with steady growth in the…

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The GRAS Process and Notifying FDA under the Final Rule (Part 1)

Published on August 1, 2016

What makes for a successful Generally Recognized as Safe (GRAS) determination?  In the recent past…

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Some Speculation on Forthcoming Dietary Supplement Guidelines

Published on August 1, 2016

If you liked the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and…

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The Elements for a Successful Generally Recognized as Safe (GRAS)

Published on August 1, 2016

What makes for a successful Generally Recognized as Safe (GRAS) determination?  In the recent past…

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Safety Assessment Considerations When Testing Food Ingredients or Food Related Nanomaterials

Published on July 1, 2016

Nanomaterials (NM) are substances that have at least one dimension in the nanoscale (1-100 nm)….

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