AG/FDA Blog

FDA’s Proposed Guidance on Convening a GRAS Panel May Result in Higher Costs for GRAS Notifiers

Contributor: Mark L. Itzkoff Principal, The Law Office of Mark Itzkoff, mark@itzkofflaw.com On November 15, 2017, FDA released a proposed guidance document, Best Practices for Convening a GRAS Panel: Guidance for Industry.  The Guidance is, in part,… Read More
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“Grandfathered” Dietary Ingredients – It’s About Time

The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 – almost a quarter century ago.  It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) in a number of significant ways that set the stage for present marketin… Read More
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FDA Seeks Input on the Meaning of “Natural” for Foods -- First Impact of FDA Action Will Be on Class Action Cases

For over two decades, when assessing the propriety of a “natural”-type claim (e.g., “natural,” “all natural,” “100% natural,” “from nature,” “naturally grown,” or “naturally sourced”) made in food labeling, FDA has applied… Read More
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FDA Public Meeting Will Consider Fundamental Changes to, and Expansion of, the Redbook

By Mark L. Itzkoff   In the October 30 Federal Register, FDA that it will hold a public meeting to receive public input on updating its commonly known as “the Redbook.” The meeting will be held on December 9. Requests to make oral comments d… Read More
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