FDA has revised a guidance document to acknowledge that “Dietary Supplement” alone properly may be used as the statement of identity in labeling a dietary supplement. Announcement of this revision was published in a Federal Register notice on March 7th. The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended section 403 of the
“Dietary Supplement” is a Proper Statement of Identity Read More »
By Marshall Matz, as published in Agri-Pulse Q. Is there a connection between the Zika virus and global food security?A. Yes. Genetic engineering has an important role to play in meeting both challenges. The mosquito is the deadliest animal on earth. According to the World Health Organization, mosquitoes are the greatest menace spreading malaria, dengue, yellow fever
The Zika-Agriculture Connection Read More »
At the recent crop insurance industry conference in Indian Wells, California, Brandon Willis, administrator of USDA’s Risk Management Agency or RMA, surprised many and made some trade-press headlines by announcing a seemingly-obscure statistic: that RMA’s “improper payment” rate — a closely-watched standardized measure of waste and abuse required of all major Federal spending programs –
RMA’s 2.2 Percent “Improper Payment” Rate: Why this Matters. Read More »
USDA’s Food & Nutrition Service (FNS) is authorized to administer the Supplemental Nutrition Assistance Program (“SNAP”). This $80 billion program, formerly known as the food stamp program, provides monthly supplemental nutrition benefits to more than 45 million Americans. SNAP beneficiaries may redeem their monthly benefits at over 250,000 SNAP-authorized retailers across the country. To participate
Late last week, HHS’s Office for Civil Rights (OCR) and Office of the National Coordinator for Health IT (ONC) issued two Fact Sheets (or guidance documents) intended to assist regulated industry in Understanding Some of HIPAA’s Permitted Uses and Disclosures of protected health information (PHI): Permitted Uses and Disclosures: Exchange for Health Care Operations, 45
There is a need for an interstate structure to provide coordination and regulatory oversight of medical marijuana (cannabis) use in the 23 states that have approved its use by either referendum or legislation. Five jurisdictions — Colorado, Washington, Oregon, Alaska and the District of Columbia — have now also authorized the recreational use of cannabis.
Interstate Structure to Oversee and Regulate Medical Marijuana Read More »
On behalf of the Agriculture practice group at OFW Law, following is a copy of our Winter 2016 newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan.
Regulatory Round-Up Newsletter, Winter 2016 Read More »
By Marshall Matz, as published in Agri-Pulse. These comments were first presented to the National Association of Wheat Growers. The 150,000 to 180,000 wheat farmers in America are facing a double-barrel challenge: The declining role and power of agriculture generally; and The declining position of wheat farmers compared to both foreign competition and compared to other major
Wheat Faces a Double Challenge Read More »
Beginning in late 2009 and early 2010, attorneys Richard Hailey of Indianapolis, Charles Speer and Britt Bieri of Kansas City, and Richard Middleton brought five lawsuits based on negligence and nuisance in Randolph County, Indiana, on behalf of neighbors against Maxwell Farms of Indiana and several individual farmers. The complaints stated that the basis for
OFW Law Trial Team Wins Five Hog Nuisance Cases in Indiana Read More »
USDA’s Federal crop insurance program has benefited from a unique public-private partnership that is one of the most successful in government. USDA’s Risk Management Agency (RMA) and Federal Crop Insurance Corporation (FCIC) set the insurance policies, subsidize them and regulate them, but they rely on private agents and insurance companies (called Approved Insurance Providers or
For Crop Insurance AIPs, a New Financial Environment Read More »
By OFW Law and HACCP Consulting Group Under the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) made the decision that registered facilities would be required to implement food safety plans based on preventive controls rather than the principles of HACCP. Since HACCP is already mandatory for identified hazards in seafood, juice and foods
It’s Not What You Call It – It’s How You Manage It Read More »
This past year, USDA’s Risk Management Agency (RMA), which administers the Federal crop insurance program on behalf of USDA’s Federal Crop Insurance Corporation (FCIC), quietly issued three new regulatory interpretations with deep implications for the conduct of arbitration between FCIC farmer-customers and companies the sell them crop insurance (Approved Insurance Providers or AIPs). The impact,
Arbitration in Federal Crop Insurance AIP-Farmer Disputes Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block: Hello everybody out there in farm country. This is Rick Frank sitting in for John Block. This radio commentary is brought to you by John Deere and the National Corn Growers Association. They are all friends, supporters, and allies
John Block Reports: A Case Against Mandatory GMO Labeling Read More »
By Marshall Matz, as published in Agri-Pulse Earlier this month, I summarized the agriculture positions of the candidates for President on both sides of the aisle. You can read that column here. Since that time, Senator Bernie Sanders (I-VT) who is running for the Democratic nomination, (“Bernie” as he prefers) has released a position paper on agriculture entitled
Bernie on Agriculture Read More »
Dr. Doom and Ms. Gloom have been addressing the fact that both FSIS and FDA are paying more attention to Listeria control in ready-to-eat facilities. In previous blogs, they have discussed facility maintenance and repair as well as employee practices. Doom and Gloom also recommend that facilities that manufacture RTE foods maintain a Listeria Control
Doom and Gloom Suggest “Keeping Watch on Listeria” Read More »
They did it. Senate Agriculture, Nutrition and Forestry Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI) have completed their personal work on the Improving Child Nutrition Integrity and Access Act of 2016, and got it approved today with a unanimous vote of their Committee members. They did it. They crafted a bill
Last week the CPSC’s Office of Small Business Ombudsman unveiled a new tool to help businesses marketing new consumer products navigate the complex CPSC regulatory landscape. This useful new tool is called the Regulatory Robot. The program asks small businesses making new products a series of guided interview questions, and, based on the answers, produces
Take a Look at CPSC’s Regulatory Robot Read More »
By former USDA Secretary John R. Block I asked a couple of friends of mine in Illinois and Kansas – what do you think of the newly released Dietary Guidelines? Their answer – what Dietary Guidelines? The public is not paying much attention while the issue has had wide discussion here in Washington, D.C. Every five
John Block: Dietary Guidelines Read More »
In our last blog on medical privacy, we noted that HHS’s Office for Civil Rights (OCR) promised that a number of HIPAA guidances were forthcoming in the next several months. It appears that (at least so far) OCR is keeping its promise, issuing its long-awaited guidance addressing Individuals’ Right under HIPAA to Access their Health
Last year, Dr. Doom and Ms. Gloom offered tips for facility maintenance and repair to assist facilities in being prepared for the selection of targeted sampling by USDA’s Food Safety and Inspection Service (FSIS) and/or Food and Drug Administration (FDA). We hinted that the agencies would target sampling on areas of poor design or in
Flo and H’Jean (aka Doom and Gloom) Read More »
The Secretaries of Agriculture and Health and Human Services have released the 2015-2020 Dietary Guidelines for Americans (DGA) following what had been a captivating review of the Scientific Report of the Dietary Guidelines Advisory Committee, a process that began in 2013. In the end, the Guidelines continue many of the recommendations made by the 2010
MEDICAL PRIVACY UPDATE: New PHI Disclosures Permitted for Firearm Background Checks Earlier today, HHS published a Final Rule modifying the HIPAA Privacy Rule (45 C.F.R. § 164.512) to allow certain Covered Entities to disclose limited PHI to the FBI’s National Instant Criminal Background Check System (NICS) to help identify individuals subject to the “Federal mental
Medical Privacy Update and 2015 Retrospective Read More »
By Marshall Matz, as published in Agri-Pulse As far as politics goes, there is one and only one issue that will dominate 2016…who will be elected the next President of the United States on November 8. After the primaries and caucuses, and come the general election in the fall, all eyes will turn to swing states –
Agriculture Trumped in the Primaries Read More »
Happy New Year, readers! Yet another year has come and gone. I hope that 2015 was a good year for you, professionally and personally. As I look back on 2015, here are a few developments that caught my attention. In January, the House Energy and Commerce Committee released a long awaited discussion draft of the
2015 In Retrospect Read More »
Scientists from the Agricultural Research Service’s (ARS) Nutrient Data Laboratory, part of the Beltsville Human Nutrition Research Center, and the National Institutes of Health’s (NIH) Office of Dietary Supplements, in collaboration with other federal agencies, earlier this year updated and released a database that validates the content of popular dietary supplements — the Dietary Supplement
Database for Dietary Ingredient Content of Dietary Supplements Read More »
President Obama signed into law this week the Microbead-Free Waters Act of 2015 (H.R. 1321), which amends the Federal Food, Drug and Cosmetics Act to prohibit the manufacture and introduction into interstate commerce of rinse-off cosmetics containing intentionally-added plastic microbeads. The small plastic particles, often found in face washes, soaps and toothpaste, have become a
In the Federal Register of November 12, 2015, FDA published a notice announcing the establishment of a docket to receive information and comments on the use of the term “natural” in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering. See our
Comment Period Extended on “Natural” Read More »
FDA has created within CFSAN the Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition, Labeling and Dietary Supplements (ONLDS). Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation
CFSAN Office Restructuring Read More »
By former USDA Secretary John R. Block The U.S. Congress didn’t get much done this year until December. Agriculture had a long wish list that just sat on the table. But surprise! We came out better than I thought we would. First, the Congress passed a five-year, $305 billion dollar transportation bill. Our roads and bridges
John Block: What Did We Get Done In 2015? Read More »
America’s meat industry and our trading partners engaged in a collective sigh of relief on Friday. Prior to embarking on his annual Christmas retreat to Hawaii, President Obama signed the 2016 Consolidated Appropriations Act into law. Tucked into the 2,009-page bill was a measure that repeals USDA’s special country-of-origin labeling (COOL) requirements for fresh and
Beef and Pork are Now Un-COOL, and That’s a Good Thing Read More »
On September 17, 2015, the federal Food and Drug Administration (“FDA”) released a major final rule to implement the Food Safety Modernization Act (“FSMA”): Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (the “Final Rule”), 80 Fed. Reg. 56170 (Sept. 17, 2015). Additional information on the FSMA and the
Happy Holidays from OFW Law’s Dr. Barbara Masters, D.V.M., and Jolyda Swaim, A.K.A Dr. Doom and Ms. Gloom. As 2016 approaches, it is time for many of you to start considering the need to comply with the mandatory training requirements for Qualified Individuals as part of the FDA Hazard Analysis, Risk-Based Preventive Controls regulation. Dr. Doom and Ms. Gloom
By former USDA Secretary John R. Block The World Trade Organization ruled this week that Canada and Mexico can impose retaliatory tariffs on our exports to their countries to the tune of more than 1 billion dollars per year. This is serious. It can cost pork producers, cattlemen, and our whole ag industry a lot of
John Block: Repeal COOL Read More »
New House Speaker Paul Ryan (R-WI) is getting a lot of attention for a speech he made on December 3 outlining his 2016 goal for a pro-growth agenda – creating jobs, raising wages, fixing the tax code, trade agreements, and national security. In that speech, he also suggested that he would like to “…combine a
Speaker Ryan Suggests SNAP May Be On the 2016 Agenda Read More »
By former USDA Secretary John R. Block On the one hand, it makes me smile, and on the other, it makes me scratch my head. A lot of people are not sure if this Congress will get their business done without shutting down the government. I think they will avoid a shut down, but the process
John Block: This & That – The Politics of the Day Read More »
