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 Finalizes GRAS Rule

FDA has published a final rule (81 Fed. Reg. 54,959 (Aug. 17, 2016)), based on its 1997 proposed rule (62 Fed. Reg. 18,937 (Apr. 17, 1997); see also 75 Fed. Reg. 81,536 (Dec. 28, 2010) (reopening comment period)), which: Clarifies the criteria for w… Read More
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2015 In Retrospect

Happy New Year, readers!  Yet another year has come and gone.  I hope that 2015 was a good year for you, professionally and personally.  As I look back on 2015, here are a few developments that caught my attention. In January, the House Energy and… Read More
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Partially Hydrogenated Oils – GMA Petition to Allow Limited Uses Clears a Hurdle

FDA today announced that it has filed a petition submitted by the Grocery Manufacturers Association (GMA) to amend the food additive regulations to provide for the safe use of partially hydrogenated oils (PHOs) in limited food applications. Readers m… Read More
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FDA Notice Provides a “Backdoor” for Commenting on GRAS Notification Program

The U.S. Food and Drug Administration (FDA) today published a Federal Register Notice soliciting comments on its GRAS Notification (GRASN) Program.  “GRAS” is an acronym for the phrase “generally recognized as safe.” Under sections 201(s) an… Read More
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2014 And 2015

As we say goodbye to 2014 and welcome 2015, it’s time for a little backward and forward looking. Here’s what we saw in the 2014 rear view mirror in our little corner of the Universe devoted to the regulatory aspects of foods, drugs, medical devi… 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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OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team

Thirty-five (35) years ago, the Washington, DC law firm presently known as Olsson Frank Weeda Terman Matz PC, or simply “OFW Law,” originated as Olsson and Frank, P.C.  It was comprised of two (2) founding attorneys, Philip C. (Phil) Olsson and… Read More
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