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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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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Settlement Agreement Reached on GRAS Notification Program Final Rule

By Mark L. Itzkoff On October 20, 2014, FDA and the consumer group called the Center for Food Safety (CFS) filed a consent decree in the U.S. District Court for the District of Columbia that requires FDA to promulgate a final rule regarding the GRAS… Read More
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GMA Announces Initiative to Address Criticisms of GRAS Exemption

By Mark L. Itzkoff We have previously reported on criticism of the so-called “GRAS Exemption” and FDA’s GRAS Notification Program by the Pew Charitable Trusts, the Natural Resources Defense Council, and the Center for Science in the Public Int… Read More
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Bill Introduced to Ban the Use of Bis-Phenol A in Food Packaging

By Mark L. Itzkoff On July 10, 2014, Senator Ed Markey (D-MA) introduced a bill (S. 2572) to ban the use of Bis-phenol A (BPA) in food packaging.  The bill was also introduced in the House of Representatives (H.R. 5033) by Reps. Lois Capps (D-CA) a… Read More
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FDA Issues Guidance Documents on the Use of Nanotechnology in FDA-Regulated Materials

By Mark L. Itzkoff On June 24, 2014, the Food and Drug Administration (FDA) released three final and one draft guidance document regarding the use of nanotechnology in the manufacture of FDA-regulated products.  Specifically, the agency issued the… Read More
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NRDC Issues Report Critical of GRAS Self-Determinations and CSPI Joins in Criticism

By Mark L. Itzkoff On April 7, 2014, the Natural Resources Defense Council (NRDC) issued its latest report on GRAS self-determinations, entitled Generally Recognized as Secret: Chemicals Added to Food in the United States.  We previously reported o… Read More
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FDA Issues Statement on GRAS Determination of Senomyx

By Mark L. Itzkoff On March 12, 2014, FDA issued an unusual statement regarding the GRAS status of a new flavor ingredient.  FDA issued the statement in response to a March 11 press release from Senomyx regarding the GRAS status of a new flavor ing… Read More
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A Consumer Group Files Suit to Vacate FDA’s GRAS Notification Program

By Mark L. Itzkoff In a formal challenge to FDA’s GRAS Notification Program, a consumer group called the Center for Food Safety (CFS) filed a lawsuit on Thursday alleging that FDA’s operation of the program under a proposed rule since 1997 and i… Read More
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Consumers Union Testing Raises New Questions Re: Safety of Caramel Coloring

By Mark L. Itzkoff In an article published January 23, 2014, Caramel Color: The health risk that may be in your soda, Consumer Reports (CR) announced the results of analytical tests conducted on 81 cans and bottles of 12 different soft drinks.  The… Read More
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