On October 27, 2016, OFW Law founding principal Richard L. Frank filled in for former USDA Secretary John R. Block on his weekly radio broadcast: Tuesday, November 8, is Election Day. A free and fair election is what separates the U.S. from many of our toughest competitors – for example, China, Russia, and Iran. And – make
John Block Reports: Election Day 2016 & the Need for a Balanced Government Read More »
As previously reported, at an upcoming, November 15, 2016, public meeting of the Proposition 65 Carcinogen Identification Committee (CIC), aspartame will be discussed prior to the CIC sending advice to the Office of Environmental Health Hazard Assessment (OEHHA) relative to the prioritization of aspartame for possible preparation of hazard identification materials and prospective inclusion on
Aspartame Potentially Subject to California Prop 65 Listing – Update Read More »
The Food and Drug Administration (FDA) is showing a willingness to modify its recently finalized rule establishing Reference Amounts Customarily Consumed (RACCs) used to set serving sizes on the Nutrition Facts label. The agency announced two requests for information (RFI) inviting comments on 1) the appropriate RACC and product category for flavored nut butter spreads
Danny Hakim’s attempt to skewer biotech crops in his recent article on the front page Sunday’s New York Times (Doubts About the Promised Bounty of Genetically Modified Crops, Oct. 29, 2016) is skewed from beginning to end. His insight – what he says the debate has missed – is that genetic modification has not accelerated
Hakim’s Effort to Skewer Biotech Crops in Sunday’s NY Times Read More »
The U.S. Food and Nutrition Service (“FNS”) administers the Supplemental Nutrition Assistance Program (“SNAP”). Formerly known as “food stamps,” this important federal nutrition benefit program serves over 45 million Americans by increasing “food purchasing power for all eligible households who apply for participation.” 7 U.S.C. §2011. FNS licenses eligible supermarkets and convenience stores to participate
Oh, SNAP! Connecticut Judge Affirms Permanent Disqualification of New Haven Grocery Read More »
FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act. See generally Food for Animals Small Entity Compliance Guide Availability; Human Food Small Entity Compliance Guide Availability. The final rules
FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include a disclosure statement, in documents accompanying a food, that certain hazards requiring a control have not been controlled by that entity.
By Marshall Matz, as published in Agri-Pulse While agriculture, like many other issues, has been overshadowed in the presidential campaign this year, if you look closely there is evidence on how Secretary Clinton would approach agriculture policy and rural America: Senator Clinton had a strong record in support of agriculture while serving in the Senate and consistently
Hillary on Agriculture Read More »
A fundamental principle of administrative law is that federal agencies must provide the public with reasonable notice and the opportunity to comment on proposed administrative issuances that impose substantive obligations that did not previously exist. Not every agency issuance, including guidance and policy interpretations, rise to that level. Whether agency action requires notice and comment
By former USDA Secretary John R. Block I will cover a list of issues today. I am encouraged to note that Secretary Vilsack made a wise suggestion to the House and Senate Ag Committees. He said they should change the “Farm Bill’s” name. He is right. We need to broaden support. I would go even further.
John Block: This and That Read More »
By Marshall Matz, as published in The Des Moines Register Norman Borlaug, the father of the World Food Prize and the winner of the 1970 Nobel Peace Prize, had a dream. His dream was to extend the Green Revolution to Africa. His work introducing high-yielding wheat and modern seed breeding started in Mexico and then spread to Asia.
Borlaug’s Dream is Within Reach in Africa Read More »
Five OFW Law Attorneys Named to 2017 Best Lawyers in America for FDA Law One of OFW Law’s Founding Principals, Richard L. Frank, was recognized as the Health Care Lawyer of the Year in the 2017 Washington, D.C., edition of The Best Lawyers in America. Only a single attorney in each practice area and designated metropolitan
OFW Founder Rick Frank Named Best Lawyers® Washington DC Health Care Lawyer of the Year Read More »
By former USDA Secretary John R. Block In these times of low farm prices, it is encouraging to see farm associations and leaders stepping up to protect our farmers and ranchers. The CEOs of CropLife America, the National Corn Growers Association, and the American Soybean Association became a powerful agriculture industry leadership team, including the American
John Block: Ag Industry United Read More »
Today, FDA’s Center for Devices and Radiological Health published a proposed rule that would require manufacturers to electronically submit the device label and package insert for Class II and Class III devices labeled for “home-use.” The proposed rule is intended to implement the listing requirement for the submission of labels and package inserts for home-use
CDRH Proposes Submission Requirements of Labeling for Certain Home-Use Devices Read More »
FDA has issued a revised guidance that explains the necessity of having food product categories in food facility registrations submitted to FDA under section 415 of the FD&C Act (21 U.S.C. 350d), and that updates the food product categories to be used in food facility registrations. See generally Necessity of the Use of Food Product
FDA Revises Food Product Categories for Food Facility Registrations Read More »
FDA has defined the term, “healthy” (and related terms, including “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”), when used as an implied nutrient content claim in labeling human food products, at 21 C.F.R. § 101.65(d)(2). Today, FDA published a Federal Register notice announcing that the agency has established a docket to receive information
“Healthy” Regulatory Definition To Be Revised? Read More »
By Marshall Matz, as published in Agri-Pulse For almost thirty years, August has meant returning to Jackson, Wyoming, the Grand Teton National Park, the Bridger-Teton National Forest and the Yellowstone ecosystem. It is fishing, hiking, photography, reading under the aspens, the Grand Teton Music Festival….and more fishing. Most importantly, it is quality family time. The Bridger-Teton National
The Bridger-Teton National Forest Read More »
We are pleased to announce that Dr. Betsy L. Booren, who specializes in food safety policy development and analysis, has joined OFW Law as Senior Policy Advisor. Most recently, Dr. Booren served as Vice President of Scientific Affairs for the North American Meat Institute, where she represented and provided informed analysis for the majority of
Dr. Betsy Booren Joins OFW Law as Senior Policy Advisor Read More »
By former USDA Secretary John R. Block My agenda for this post will be Labor Day and Tough Times. I want to begin by saying how much respect I have for the hard-working men and women that labor in the trenches day in and day out. I’m not talking about big corporation executives, not talking about Wall
John Block: Labor Day and Tough Times Read More »
The Carcinogen Identification Committee (CIC) – California’s qualified experts on carcinogenicity for purposes of Proposition 65 (Prop 65)) – pursuant to a meeting scheduled for November 15, 2016, will be providing the state’s Office of Environmental Health Hazard Assessment (OEHHA) with advice on the prioritization of aspartame for possible preparation of hazard identification materials. While
Aspartame Potentially Subject to Prop 65 Listing Read More »
FDA has published Federal Register notice of an extension of the comment periods for issues pertaining to its draft guidance, entitled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.” The agency is taking this action in response to requests to extend the two comment
FDA Extends Comment Periods on “Voluntary” Sodium Reduction Goals for Foods Read More »
You thought FDA was the only agency implementing the Food Safety Modernization Act (FSMA), well think again. The Occupational Safety and Health Administration (OSHA) promulgated a final rule that defines whistleblower protections for employees that disclose information about alleged food safety issues in violation of the Federal Food Drug and Cosmetic Act (FDCA). FSMA
OSHA and FSMA (No, Not FDA This Time) Read More »
By former USDA Secretary John R. Block We are looking at record crops of corn, soybeans, and wheat this year. Dairy farmers are suffering with the lowest prices since 2009. We have too much milk – not just here in the U.S. but in Europe also. Members of Congress from farm districts and states want the
John Block: Farm Problems Read More »
FDA issued today a new draft guidance to help industry comply with certain requirements in the final rule on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food. The new draft guidance was issued only in part because the agency is still working on additional chapters. See generally Hazard Analysis
FDA has published seven foundational rules to implement FSMA, and compliance dates are quickly approaching: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Earliest compliance date: September 19, 2016 Current Good Manufacturing Practice [CGMP], Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Earliest compliance date: September 18,
FDA Extends Certain FSMA Compliance Dates Read More »
This week, Counterpoint Press announced the release of the newest book by OFW Law’s own Ken Ackerman called TROTSKY IN NEW YORK, 1917: A Radical on the Eve of Revolution. Far afield from agriculture and crop insurance — Ken’s usual specialties at OFW Law — this is Ken’s latest entry in a prolific writing career
Ken Ackerman’s Newest Book, TROTSKY IN NEW YORK, 1917, Set for Release in September 2016 Read More »
By former USDA Secretary John R. Block Yes – We now have legislation to deal with the GMO labeling question. Without the legislation, all the states could have required different labels on their food products. A patchwork national plan like that would have cost consumers a lot more money for their food. However, the battle is
John Block: GMO Labeling Read More »
FDA has published a final rule (81 Fed. Reg. 54,959 (Aug. 17, 2016)), based on its 1997 proposed rule (62 Fed. Reg. 18,937 (Apr. 17, 1997); see also 75 Fed. Reg. 81,536 (Dec. 28, 2010) (reopening comment period)), which: Clarifies the criteria for when the use of a substance in a food for humans or
FDA Finalizes GRAS Rule Read More »
As published in Agri-Pulse “I have sometimes thought it might be well to establish an office of insurance for farms against the damage that may occur to them from storms, blights, insects, etc. A small sum paid by a number would repair such losses and prevent much poverty and distress.” – Benjamin Franklin, October 24,
Crop Insurance: Priority # 1 Read More »
Today, the Food and Drug Administration (FDA) published in the Federal Register a final rule that amends relevant FDA regulations in Title 21 of the C.F.R. to change the address of the Center for Food Safety and Applied Nutrition (CFSAN). 81 Fed. Reg. 49894 (Jul. 29, 2016). CFSAN did not actually move its physical location
CFSAN Changes Address Read More »
On behalf of the Agriculture practice group at OFW Law, following is a copy of our Summer 2016 newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan.
Regulatory Round-Up Newsletter, Summer 2016 Read More »
Contributor: Rachel Rosenberg As of July 16, 2016, FDA’s amendment to expand the safe uses of vitamin D2 and D3 as nutrient supplements in food for human consumption became effective. This amendment stems from a food additive petition (FAP 3A4801) filed by Dean Foods Company and WhiteWave Foods Company. Vitamin D2 may now be used
FDA Amends Food Additive Regulations to Expand Permitted Uses of Vitamin D in Food Read More »
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 »
