AG/FDA Blog

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

November 28th, 2017
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, a… Read More
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Categories: FDA
Tags: Food, Generally Recognized As Safe, GRAS, Guidance, Honoraria, Ingredient, Mark Itzkoff, Panel

“Grandfathered” Dietary Ingredients – It’s About Time

September 6th, 2017
Contributor: Michael J. O'Flaherty
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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Categories: FDA, For Export
Tags: Attorney, Dietary Supplement Health and Education Act, DSHEA, Food, Ingredient, Law Firm, Lawyer, Michael J. O'Flaherty, Pre-DSHEA, Supplement

FDA Seeks Input on the Meaning of “Natural” for Foods -- First Impact of FDA Action Will Be on Class Action Cases

November 24th, 2015
Contributors: Michael J. O'Flaherty, Bruce A. Silverglade
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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Categories: FDA, Public Policy
Tags: Agriculture, Bruce A. Silverglade, CFSAN, Class Action, Define, FDA, Food, Food Drug and Cosmetic Act, Food Label, FSMA, Healthy, Ingredient, Labeling, Michael J. O'Flaherty, Natural, Nutrition, Organic, USDA

FDA Public Meeting Will Consider Fundamental Changes to, and Expansion of, the Redbook

November 5th, 2014
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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Categories: FDA
Tags: Additive, Caffeine, CFSAN, Food, Food Safety, GRAS, Ingredient, Mark Itzkoff, Nutrition, Partially Hydrogenated Oils, Public Meeting, Redbook, Safety Assesment, Toxicity Testing, Toxicology, Trans Fat

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