“Hide No Harm” Channels Public’s Safety Concerns

Last week, the Senate Commerce Committee marked up legislation reauthorizing the National Highway Safety Administration (NHTSA).  Why should a food company, a company that makes medical devices or a one that sells consumer products have this on its… Read More
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Are You Ready for Electronic MDR Reporting?

Paper medical device reports (MDR) will soon be a thing of the past.  On August 14, 2015, the electronic MDR final rule goes into effect, requiring manufacturers, importers and other firms responsible for reporting to submit MDRs to the FDA e… Read More
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SURPRISE: FDA Proposes a Daily Value for Added Sugars

In an unexpected move, FDA this coming Monday, July 27th, will publish a supplemental proposed rule that would establish a Daily Reference Value (DRV) for added sugars.  This DRV would be utilized in calculating the percent Daily Value (%DV) that wo… Read More
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Inclusion in the TPP May Come at a Cost for Canada

As President Obama signed Trade Promotion Authority into law he removed a major stumbling block to completion of the Trans-Pacific Partnership (TPP) trade negotiation when chief negotiators, and then Ministers, meet in Maui July 24-31.  However, a s… Read More
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House to Vote on GMO-Labeling Preemption Bill Tomorrow

On Thursday, the full U.S. House of Representatives will vote on H.R. 1599, which is officially titled “The Safe and Accurate Food Labeling Act of 2015.” The bill (full text here) would establish a federal standard for when foods containing genet… Read More
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Regulatory Round-Up Newsletter, Summer 2015

On behalf of the Agriculture practice group at OFW Law, following is a copy of our Summer newsletter.  We hope you find it useful.  To receive this periodic newsletter by e-mail, please contact Carrie Morgan at Read More
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John Block Reports: Let’s Keep A Strong Alcohol Section in the 2015 Dietary Guidelines

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block: Today’s Quiz: What has more alcohol – a 12 oz can of beer? A 5 oz glass of wine? Or, a mixed drink with 1.5 oz of spirits? Answer – they all have t… Read More
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Privacy Update: Refill Reminders Expressly Permitted In California – The State Finally Catches Up to the Feds

Although HIPAA-compliant sponsored “refill reminders” have always been legally permissible for a host of treatments under California’s Confidentiality of Medical Information Act (CMIA), Cal. Civ. Code §§ 56-56.37, the state finally came right… Read More
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USDA Announces New Operating Margin Protection Crop Insurance Option

The U.S. Department of Agriculture’s (USDA) Risk Management Agency (RMA) announced this week the availability of a new crop insurance coverage option that provides producers with coverage against an unexpected decrease in their operating margin… Read More
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The White House Announces Plans to Update the U.S. Regulatory Framework for Biotechnology

On July 2nd, the White House issued an executive memorandum on “Modernizing the Regulatory System for Biotechnology Products.”  The modernization effort will apply to “biotechnology products” defined as “products developed through genetic… Read More
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