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, 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, a… 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 marketing… 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 during t… Read More
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