The agency on July 14, 2016 published FDA Foods and Veterinary Medicine Program (FVM) – Strategic Plan — Fiscal Years 2016–2025. This FVM Program outlines goals and objectives for the next 10 years: GOAL 1: Food Safety Hazards — Protect America’s Consumers and Animals from Foreseeable Hazards 1.1: Establish and gain high rates of […]
FDA’s Strategic Plan for Foods and Veterinary Medicine Read More »
By former USDA Secretary John R. Block How long have we been listening to the relentless insinuations that genetically engineered crops may not be safe? The environmental activists have chosen to ignore science and use every trick to frighten consumers into not eating GMO food. Most scientists, 70% or 80%, stand up for the safety of
John Block: Nobel Laureates Read More »
Voters in the UK sent shockwaves rippling through the marketplace when they voted to leave the European Union. Markets don’t appreciate uncertainty and no one knows exactly how or when the “Brexit” will be executed or what trade environment will emerge in the post-split EU and UK. The Brexit is expected to have a sizeable
How “Brexit” Will Impact Agriculture and Trade Read More »
By former USDA Secretary John R. Block The Brits jump ship and the UK is on its way out of the European Union. I understand the UK getting sick of the regulations and rules written in Brussels, not London. European agriculture is heavily subsidized and regulated – much more than ours. I would expect UK –
John Block: Brexit and Trade Read More »
Yesterday, Senate Agriculture Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI) released their long-awaited bill that would establish a federal GMO labeling regime and preempt any state laws, such as Vermont’s Act 120. This legislation, unlike earlier attempts, is expected to garner enough support to gain enough support to pass in the
Senate Ag Leaders Unveil Compromise GMO Labeling Bill Read More »
With the CPSC’s blessing, a large furniture company recently sent out wall anchors for its children’s dressers to address a tipping hazard and the accompanying CPSC press release did not refer to the activity as a recall. Subsequently a child was killed when one of the dressers fell. Chaffing under criticism from its decision to
Saying It’s a Recall Doesn’t Make It So Read More »
By former USDA Secretary John R. Block Today, I want to concentrate on trade. We are in the process of negotiating a trade agreement with the European Union. We have just completed an agreement with 11 other countries (the Trans Pacific Partnership – TPP). That agreement now needs to be approved by the countries involved. Let’s
By former USDA Secretary John R. Block We hear a lot of talk about the economy. It’s not growing as fast as it should. Two percent growth is just too slow. It has taken forever to recover from the 2008 recession. There are a lot of opinions about why growth has been slow. I think one
John Block: Regulations and Licensing Read More »
Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share patient-specific information recorded, stored, processed, retrieved, and/or derived from a medical device with the patient who is either treated or diagnosed with
The Department of Labor (DOL) released the final rule updating the overtime regulations, which will automatically extend overtime pay protections to over 4 million workers within the first year of implementation. Starting on Dec. 1, 2016, the initial increases to the standard salary level and highly compensated employee total annual compensation requirement will go into
Upcoming Webinar: Understanding the New DOL Overtime Rules Read More »
Commissioner Mohorovic has just issued a thoughtful statement discussing the black hole that the Consumer Product Safety Commission calls its civil penalty policy. This statement follows another he filed this week discussing the $4.5 million penalty lodged against Sunbeam for a single-brew coffee maker that squirted out hot water when not used properly. The Commissioner’s most recent
CPSC: Let’s Play Penalty Roulette Read More »
By former USDA Secretary John R. Block Another week goes by – Donald Trump and Hillary Clinton look to be our Presidential candidates. It’s quite a contrast. Polls indicate that they are in a dead heat, but it’s a long time until November. Today, I’m going to put a series of issues on the table. The
John Block: A Lot Going On Read More »
The Food and Drug Administration (FDA) has published in the Federal Register a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration, 81 Fed. Reg. 34,165 (May 27, 2016), 21 C.F.R. Part 121 (Final Rule). The proposed rule was issued on December 24, 2013. The revisions in the Final Rule are largely designed
By former USDA Secretary John R. Block Agriculture is an industry that depends heavily on exports with some 30% of our production sold to other countries. That explains the reason why the Ag industry has so much interest in the Trans-Pacific Partnership (TPP) trade agreement that has been negotiated with 12 nations representing 40% of the
John Block: Trans-Pacific Partnership 2016 Read More »
Last week, Commissioners Buerkle and Mohorovic each issued a statement on a civil penalty settlement involving glass tumblers manufactured by Teavana. Each is a thoughtful statement and both should be read by anyone interested in how the Consumer Product Safety Commission does its work. They can be found here and here. Both Commissioners address, in somewhat different ways,
CPSC: Navigating an Unmarked Channel Read More »
FDA yesterday released so-called “voluntary” targets for sodium reduction for 150 categories of foods. A spreadsheet issued by the agency details baseline sodium content for each of the categories and lists short-term and long-term targets. In its draft guidance, the agency says it “recognizes the important role of sodium in food for microbial safety, stability,
“Voluntary” FDA Sodium Targets May Bind Food Companies Read More »
FDA has finalized a new food safety rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent wide-scale public health harm by requiring companies in the U.S. and abroad to take steps to prevent intentional adulteration of the food supply, including acts of terrorism targeting the food supply. While such insidious
Peat miners, golfers, and landowners with real property containing or adjacent to Waters of the United States will benefit greatly from the Supreme Court’s May 31st decision in U.S. Army Corps of Engineers v. Hawkes Co., Inc. Hawkes resolved whether an approved jurisdictional determination by the Army Corps of Engineers (“Approved JD”) involving wetlands owned
By former USDA Secretary John R. Block Hopefully, we are beginning to set the record straight. We have heard so much misleading information criticizing biotechnology that we could go down the European road. In Europe, GE food is not on the plate. The National Academy of Sciences, Engineering, and Medicine, with more than 60 experts, has
John Block: GMOs Are Safe Read More »
Every election year, former Senator George McGovern (SD), the 1972 Democratic Nominee for President, seems to find his way back into the news, and this one, 2016, more than most. Comparisons come up routinely between McGovern’s 1972 campaign against the Vietnam war and the Democratic Party’s then-exclusionary nominating rules, a movement that inspired a generation
George McGovern: My Turn Read More »
Pursuant to consideration of public comments submitted on its October 2009 draft guidance document (see our prior article here), FDA today announced (81 Fed. Reg. 33,538) the availability of its finalized guidance document, Guidance for Industry: Ingredients Declared as Evaporated Cane Juice (May 2016). The guidance document essentially conveys FDA’s view that sweeteners derived from
FDA Nixes “Evaporated Cane Juice” as Ingredient Name Read More »
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 regulations that will appear in the Federal Register on May 27, 2016. The following is
FDA Issues Final Regulations for Nutrition Facts Labeling and Serving Size Changes Read More »
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 your employees qualify as exempt. The Final Rule focuses primarily on updating the salary and compensation levels needed for Executive,
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. FDA published earlier versions of the guidance document in May 1997 and May 2007. This guidance is a second edition of
FDA Finalizes Guidance Document about Medical Foods Read More »
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.S. government does this all of the time? Think about it
John Block: Peanuts Read More »
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. 27,067 (May 5, 2016). The guidance document is issued consistent with the agency’s good guidance practices regulation (21 C.F.R. § 10.115), and
Final Menu Labeling Guidance Issues: Setting Effective Date for Menu Labeling Final Rule Read More »
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 Center and examines opportunities to improve regulatory cooperation between the European Union and the United States. The report is timely because negotiators from the
EU-US Regulatory Cooperation: Strides Made, but More Can Be Done Read More »
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 respect from clients and colleagues within the food and nutrition community. He contributed greatly to
In Memoriam: Robert A. Hahn Read More »
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.
NYT: Mosquito vs. Mosquito in the Battle Over the Zika Virus Read More »
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, this revised, more robust, Protocol more closely ties the audit “checklist” to the respective provisions of the implementing
Medical Privacy Update: OCR Issues Revised Audit Protocol For Phase II Read More »
FDA has issued a final rule on Sanitary Transportation of Human and Animal Food. The rule creates new requirements for shippers, loaders, carriers, and receivers of food transported by rail or motor vehicle in the United States. A fact sheet and other information about the final rule are available here and here. FDA will hold
Another FSMA Final Rule: Sanitary Transportation of Food Read More »
Anyone who has spent time around political circles in Washington, D.C., knows that, by this point in a presidential campaign, leading candidates have usually gathered around them a network of advisors connecting them to key issues and constituent groups. And agriculture is usually at the forefront. Since at least the 1990s when I worked as
Where are the “Farmers and Ranchers for Donald J. Trump”? Let alone for Ted Cruz? Read More »
The U.S. Consumer Product Safety Commission (CPSC) announced today that Gree Electric Appliances Inc., of Zhuhai, China; Hong Kong Gree Electric Appliances Sales Co. Ltd., of Hong Kong; and Gree USA Sales Ltd., of City of Industry, Calif., has agreed to pay a $15.45 million civil penalty – the maximum penalty provided for under the
CPSC Issues Record $15.45 Million Civil Penalty Read More »
FDA is scheduled to issue regulations finalizing its proposed Nutrition Facts label soon according to the US Regulatory Agenda. Many food companies and trade associations are eagerly awaiting the final rules to see how the agency will handle the most controversial provisions. One part of the proposed rules would require the disclosure of added sugars,
By former USDA Secretary John R. Block Last week was Ag Day. In fact, it was an Ag Week. Agri-Pulse had a panel of speakers talking about one of our industry’s biggest challenges – how do we communicate about our industry today? Very few people know anything about the business of producing food. We can’t produce
John Block: Ag Day Read More »
