FDA Issues Final Regulations for Nutrition Facts Labeling and Serving Size Changes

FDA has issued final regulations changing the requirements for the Nutrition Facts label required on almost all foods since 1994. A picture tells a thousand words, or in this case, more than 1000 pages of typewritten text detailing the new regulation… Read More
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Are Your Employees Still Exempt From Overtime Under the New Department of Labor Regulation?

The Department of Labor this week announced a final regulation that changes the tests for determining whether executive, administrative, and professional employees are exempt from federal overtime requirements.  Now is the time to evaluate whether y… Read More
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FDA Finalizes Guidance Document about Medical Foods

FDA has updated and published its Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition (05/12/2016).  The guidance document is consistent with the agency’s good guidance practices regulation, 21 C.F.R. § 10.115. F… Read More
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John Block: Peanuts

By former USDA Secretary John R. Block As a farmer, I would not like it if Europe shipped subsidized beef into our market. That would undercut our prices. What if Brazil shipped subsidized soybeans to us? We would be furious. Did you know that the U… Read More
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Final Menu Labeling Guidance Issues: Setting Effective Date for Menu Labeling Final Rule

FDA has published a Level 1 guidance document, entitled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu  Labeling Requirements in Accordance with 21 CFR 101.11).”  81 Fed. Reg. 27… Read More
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$380 Million Keepseagle II Settlement Reached

As published in Agri-Pulse The landmark civil rights lawsuit by Indian farmers and ranchers against the Department of Agriculture for discriminatory lending practices has come to a conclusion (barring any unexpected turn of events on appeal). U. S. D… Read More
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EU-US Regulatory Cooperation: Strides Made, but More Can Be Done

Earlier this week, the George Washington University Regulatory Studies Center released a significant report, “International Regulatory Cooperation:  Benefits, Limitations, and Best Practices.”  This report builds on earlier work done by the Cen… Read More
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In Memoriam: Robert A. Hahn

Our dear colleague, partner and friend, Robert A. (Bob) Hahn passed away on April 20, 2016, at the age of 57.  Bob’s incredible intellect and exceptionally kind heart made him OFW Law’s gentle giant.  His quiet tenacity garnered him great resp… Read More
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Categories: Uncategorized

NYT: Mosquito vs. Mosquito in the Battle Over the Zika Virus

Please see Dr. Nina Fedoroff and former USDA Secretary John Block’s op-ed featured in the New York Times on April 6, 2016 – Mosquito vs. Mosquito in the Battle Over the Zika Virus. Read More
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Medical Privacy Update: OCR Issues Revised Audit Protocol For Phase II

As a foundation for moving forward with Phase II of its Audit Program of Covered Entities (CEs) and their Business Associates (BAs), HHS’s Office for Civil Rights (OCR) has quietly released its beefed-up Audit Protocol (Protocol). Significantly, th… Read More
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