AG/FDA Blog

Data Driven Decision Making by Dr. Doom

When asked to visit an establishment to assess compliance, my first step is always to ask for data.  Establishment food safety data, laboratory results, regulatory data, audits…. What story is being told?  Is there a trend in the making?  Upward… Read More
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John Block Reports: Dietary Guidelines for Americans 2015 Edition – Losing It’s Way on Caffeine (Part I)

This week, OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block. There are a variety of disturbing questions surrounding the Dietary Guidelines for Americans now being drafted for release in 2015. The questi… Read More
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How to Legally Import and Market Foods and Beverages in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 29, 2014, 1:00 p.m. EST During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Cana… Read More
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Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part I)

On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will mark a “game changer” for clinical laboratories. Specifically, these guidances call for the active regulation of a sub… Read More
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FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules

The Food and Drug Administration (FDA) has announced a public meeting to be held on November 13, 2014 to discuss its four supplemental proposed rules under the Food Safety Modernization Act (FSMA). On September 29, FDA published supplemental proposed… 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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FDA Tweaks Its Four Foundational FSMA Proposed Rules

FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA).  Those four rules are: Produce Safety; Preventive Controls for Human Food; Preventive Controls for Ani… Read More
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How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 15, 2014, 1:00 p.m. EST During this webinar, the second of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to succes… Read More
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Consumers are Misled About Organic Safety

By John R. Block, as published in the Des Moines Register Every day millions of shoppers are paying out as much as 50 or 100 percent more to buy organic foods for themselves and their families. I have friends who make these choices because they have… Read More
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What to Do After I Filed My Comment on FDA’s Proposed “Nutrition Facts” Labeling Regulations

Don’t sit back and wait: Be proactive! The comment period for FDA’s proposed regulations revising the “Nutrition Facts” label has closed.  The comment period has also closed for FDA’s proposed rule that would lead to more than 30 new servi… Read More
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