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Proposition 65 Regulatory Changes Being Contemplated

Products (e.g., food, dietary supplements, cosmetics) distributed in California are subject to Proposition 65, a voter initiative that became the...

FDA Extends Comment Period on Nutrition Labeling Reforms

In tomorrow’s Federal Register, FDA will publish a notice extending until October 13, 2015, the comment period on its proposed...

Doom and Gloom Challenges for Success Under FSMA

Are you set up to succeed under the Food and Drug Administration’s (FDA) preventive controls final rules for human and...

EPA Hazardous Waste Pharmaceuticals Rule Begins Circulating: Proposal Applies To Dietary Supplements, 503B Outsourcing Facilities, And Any OTC Retailers

On Tuesday, the Environmental Protection Agency (EPA) announced that its Administrator signed the proposed rule: Management Standards for Hazardous Waste...

John Block: EPA Overreach

By former USDA Secretary John R. Block There they go again. The EPA has threatened to impose a fine of...

National Forests on the Brink

By Marshall Matz and Bill Imbergamo, as published in Agri-Pulse It’s another hot, dry summer, and another several million acres...

John Block: Back to Illinois

By former USDA Secretary John R. Block Last week, I flew to Illinois – drove down to Springfield to attend...

OFW’s Bruce Silverglade to Participate at FDLI Food Advertising and Litigation Conference

OFW Law’s Bruce Silverglade will be a featured speaker at that Food and Drug Law Institute’s annual “Food Advertising and...

John Block: Raw Milk

By John R. Block “Got raw milk? Well, don’t drink it! …Too many people are risking their health and the...

Five Unresolved Questions the Food Industry Should Be Looking for Answers to in FDA’s Final FSMA Regulations

It’s August, which in Washington means Congress recesses, the President and much of the bureaucracy go on vacation and the...

FDA Drug Promotion Enforcement Update

It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we...

Whole Genome Sequencing Part 2: Regulatory and Public Health Uses

In Part 1 of this blog series, I went back to Genetics 101 to provide a brief crash course on...

Whole Genome Sequencing Part 1: What is It?

In the last few years, we have seen the regulatory agencies begin to utilize a new detection method that will...

The Dietary Guidelines and Moderate Alcohol Consumption

Officials at the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) have an opportunity to...

The Agriculture Biotechnology Riddle

The debate over agriculture biotechnology (aka genetic engineering (GE), genetic modification (GM), and GM organisms (GMOs)) was front and center...

Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels

Your product is ready. The formulation is finalized, packaging is designed, and your launch date is set. Then a labeling...

“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...

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...

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...

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...

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...

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...

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...

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...