What data will FDA consider as evidence that a substance is a pre-DSHEA dietary ingredient?

Published on October 10, 2017

On Oct.3, 2017, the Food and Drug Administration (FDA) held a public meeting to discuss…

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Consultancy Experience Key to Southeastern Reduction Company’s FDA GRAS for Pecan Shell Fiber as Food Ingredient in Amounts up to 10%

Published on October 10, 2017

When Southeastern Reduction Company (SRC) contracted with Burdock Group to submit a GRAS dossier to…

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Burdock Group’s Work With BioTech Startup Captozyme Results in Successful GRAS Determination of Oxalate-Reducing Enzyme As Food Ingredient

Published on September 7, 2017

After working with the Burdock Group to recently obtain a successful self-contained GRAS (Generally Recognized…

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Why Is 2017 a Better Year for Dietary Supplements Than 1997?

Published on September 7, 2017

Looking at industry, 2017 is a better year than 1997 for dietary supplements, as industry…

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Don’t Build Me a Cadillac: All I Want Is a Ford

Published on August 1, 2017

The title is synonymous with the expression, “Why should I pay you tens of thousands…

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“Clean” Labels Must Also Mean Safe Foods

Published on July 11, 2017

There has recently been an increased interest in cooking, as evidenced by the increase in…

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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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