News & Insights

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PEW Report’s Mischaracterization of GRAS Process Leads to Questionable Conclusions

By Mark L. Itzkoff As someone who has worked with numerous food companies on food additive and GRAS issues for...

“Gluten-Free” Now Has an Official FDA Definition

FDA has published a final rule defining the term “gluten-free” for voluntary use in food labeling. Food labels will have...

FDA Tells Food Importers How It Wants Them To Verify the Safety of the Foods They Import

FDA has published two proposed rules to implement to provisions of the Food Safety Modernization Act (FSMA) related to the...

Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?

On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act...

John Block Reports: How Lucky We Are

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports....

EPA Steps Up Criminal Enforcement Efforts Against Livestock Farmers

Ignorance of the law excuses no man. Not that all men know the law, but because ‘tis an excuse every...

Not Dead Yet – The Paper PI Lives On

In the 1984 film Ghostbusters, Dr. Egon Spengler declared to Janine Melnitz, “Print is dead.” A quick search of print...

Hot Dogs on the Hill

Former Congressman and OFW Law Senior Policy Advisor Charlie Stenholm (D-TX) greets six-time Major League Baseball Gold Glove Award winning...

Will FSMA Court-ordered Deadlines Set a Precedent?

The Obama Administration recently announced that it will delay the employer health insurance mandate under the Affordable Care Act (aka...

USDA’s National Appeals Division: A Checklist for Farmers

Farm producer and USDA program customers increasingly are turning to USDA’s National Appeals Division (NAD) as the best option when...

Reviewing Regulatory Noncompliance – It is Good For Your Business

Based on our experience reviewing a number of noncompliance records, we recommend that when USDA’s Food Safety and Inspection Service...

A Farm Bill by the Boot Straps

After two years of not passing a Farm Bill out of the House, it should be obvious to everyone that...

Dealing With FDA Warning Letters

By Casper E. Uldriks The FDA issues Warning Letters to provide firms notice that unless they achieve voluntary correction of...

Supreme Court Draws the Line on Genes and Patentability

The discovery and isolation of a naturally-occurring gene is not eligible for patent protection. Such was the holding issued by...

AMS Issues Final COOL Amendment

On May 23, 2013, the United States Department of Agriculture’s (USDA) Agriculture Marketing Service (AMS) issued a final rule to...

FSIS Notification Rule – One year later

A little over a year ago, the Food Safety and Inspection Service (FSIS) issued a final rule requiring inspected meat...

The Development of the 2015 Dietary Guidelines for Americans Begins

The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), announced today that the...

John Block Reports: Bowman v. Monsanto—The Decision

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports....

“Serving Facts” for Alcohol Beverages—FINALLY!

Yesterday, a 9-year effort by consumer and public health groups, and beer, wine and spirits maker Diageo, succeeded when a...

USDA is Right on Carrageenan

Kudos to Secretary Vilsack and USDA for basing their regulatory decisions on sound science. Another recent example is the Proposed...

Bowman v. Monsanto: Supreme Court Confirms That Soybeans Do Not Grow Themselves, Affirms Seed Biotech Patent Rights

In a unanimous decision, the U.S. Supreme Court held that a patent holder’s rights in biotech seeds extend to subsequent...

New HHS Privacy Rule Conflicts With Congressional Support for Refill Reminder Programs

The Obama Administration (HHS’s Office for Civil Rights) promulgated its new HIPAA Privacy Rule ostensibly to strengthen consumers’ medical privacy...

First Son: The Biography of Richard M. Daley

Reviewed by Kenneth D. Ackerman, as published by the Washington Independent Review of Books History and public opinion rarely turn...

Warning: FDA Tightens Up Regulations for Tanning Beds

You have probably heard that on May 6, 2013, FDA issued a proposed rule requiring warning labels to be affixed...