OFW Law is pleased to announce that Mason Weeda, Chair of the firm’s FDA Food Practice, was recently featured on the FDA Watch podcast in an episode focused on the evolving landscape of food safety. In the episode, Mason discusses key issues shaping food safety regulation and enforcement, including thoughts on FDA’s GRAS proposed rule,
Mason Weeda Featured on FDA Watch Podcast: Food Safety in the Spotlight Read More »
Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition. GCNF’s Annual Gala has become a signature Washington event, bringing together executives from industry as well as high-level officials from both government and NGO’s. It will take place tonight, from 5:30-7:30 PM, at the
Tonight: Global Child Nutrition Foundation Honors USDA Secretary Vilsack Read More »
The 2015 Dietary Guidelines Advisory Committee (DGAC) submitted its report to the Secretaries of Agriculture and Health and Human Services last month and disbanded. It is now up to the USDA and HHS to take the DGAC’s conclusions and recommendations and issue a revised edition of the Dietary Guidelines for Americans. Interested persons may submit
2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy Read More »
Climate change is real and GM technology is safe, but those in denial want to undermine the public understanding of science with misinformation and pseudo-debate By Nina Fedoroff, Peter Raven and Phillip Sharp, as published in The Guardian The authors are former presidents of the American Association for the Advancement of Science (AAAS) Barely a week goes
GM Opponents are Science Deniers Read More »
The White House (via the Department of Commerce) has released a “discussion draft” of consumer privacy legislation intended to codify President Obama’s 2012 Consumer Data Privacy In A Networked World: A Framework For Protecting Privacy And Promoting Innovation In The Global Digital Economy. The 2012 Framework included a Consumer Privacy Bill of Rights and called
Privacy Update: White House Drops Draft Consumer Privacy Bill . . . Splat! Read More »
FDA will hold a “National Kick-Off Meeting on Implementation of the Food Safety Modernization Act (FSMA)” on April 23-24, 2015, in Washington, D.C. The agency has sent out a save-the-date notice to subscribers to its FSMA webpage, but the notice contains few details. FDA says that meeting specifics, including registration information, will be made available
FDA Announces National Kick-Off Meeting on FSMA Implementation Read More »
The Global Child Nutrition Foundation is proud to announce Secretary of Agriculture Tom Vilsack as the recipient of the 2015 Gene White Lifetime Achievement Award for Child Nutrition. Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition at GCNF’s Annual Gala Reception. Now
Global Child Nutrition Foundation to Honor Secretary Vilsack on April 16th Read More »
There is good news for certain sectors of the medical device industry. FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applications (apps). In a pre-published Federal Register notice (available here, which should issue in the Federal Register on Monday), FDA
We are pleased to announce that Dr. Nina Fedoroff, a renowned plant molecular biologist, has joined OFW Law as Senior Science Advisor focusing on agriculture policy, global food security and government affairs. The former Science and Technology Adviser to the Secretary of State, Dr. Fedoroff has long been involved in regulatory issues surrounding genetic modification of organisms (GMOs)
Dr. Nina Fedoroff Joins OFW Law as Senior Science Advisor Read More »
As the 114th Congress begins in earnest, there is rough sledding ahead this winter over the gulf between the governing philosophies of the President and the new Congress. Not to belabor the obvious, but early indications are that Republican victories have altered the President’s willingness to deal only very modestly, if at all. With just
114th Congress – What to Expect in Ag and Food Read More »
In what seemed like a bit of end-of-year housekeeping, FDA issued a series of minor guidance documents, notices, and other regulatory paraphernalia related to food. Coming in under the wire in 2014 were: A notice requesting nominations for non-voting industry representatives to the Food Advisory Committee. Nominations are due by January 7, 2015. FDA is
A Flurry of End-of-Year Activity from FDA on Food Read More »
FDA has published notices announcing that, over the next 10 years, it plans to conduct surveys on the occurrence of foodborne illness risk factors in restaurants, retail food stores, and foodservice institutions (e.g., hospitals, schools). Pursuant to the Paperwork Reduction Act, FDA is required to provide a 60-day notice of a proposed collection of information
Getting ready for holiday “get togethers”, one often finds themselves in a rush or behind on preparing the food for the party. Don’t let tardiness be the reason the party attendees end up with a case of foodborne illness. Don’t rush cooking of product; I am certain the guests would rather wait a few minutes
Don’t Rush the Holiday Preparations – Make Certain the Meat is Properly Cooked Read More »
Yesterday, the House Energy and Commerce Subcommittee on Health held a hearing to examine FDA’s role in the regulation of genetically engineered foods (commonly, but inaccurately, referred to as “genetically modified organisms” or “GMOs”). Congressman Mike Pompeo’s (R-KS) Safe and Affordable Food Act (H.R. 4432), which would preempt state GMO labeling laws and require labeling only
Seasons greetings from the Federal Trade Commission (FTC). Yesterday, the FTC published its Agreement Containing Consent Order and attendant press release regarding its settlement with a medical billing company (PaymentsMD) and the company CEO for alleged failure to adequately inform patients regarding the company’s collection of their medical records. Although not arising under HIPAA (which
FTC Reminds Us That HHS’s Office for Civil Rights Not Only One Watching Medical Privacy Read More »
Citing the obesity epidemic and the fact that Americans consume about one-third of total calories in the form of foods prepared outside the home, FDA yesterday issued two sweeping final rules on nutrition labeling of foods sold in chain restaurants and similar retail food establishments and vending machines. There had been considerable controversy over how
FDA Shares the Pain in Final Rules on Menu Labeling and Vending Machine Food Labeling Read More »
It is that time of year again. I don’t cook –and I continue to provide food safety advice for those of you that do. Ah, it must be Thanksgiving. Last year I provided some tips on thawing and cooking your Thanksgiving turkey. I encourage you to review those tips if you have any questions on
In our prior posting, we provided a brief overview of the notification and adverse event reporting requirements that will apply to the vast majority of a subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs), most likely in the not so distant future. These requirements were detailed in the draft guidance documents published on October 3 of this year, outlining
Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part II) Read More »
FDA has released a revised guidance document on food facility registration: Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition). The revised guidance adds only one new question and answer to the 34-page guidance: 1.3 Q: [Added November 2014] Under the supplemental notice of proposed rulemaking for preventive controls for human food,
FDA Tweaks Its Guidance on Food Facility Registration Read More »
OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part V) By Neil P. Di Spirito In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, III, and IV focused on
GMPs Have Long History That Precedes Application In Medical Products Read More »
Phil: Rick, it’s hard to believe that 35 years have passed since we started this firm as a two-lawyer shop in 1979. Rick: It sure is. I remember working with you at the law firm I joined fresh out of the University of Michigan Law School, and which you had joined several years earlier out
Phil Olsson and Rick Frank on 35 Years of Life at OFW Read More »
What now? The answer is quite a lot. It remains to be seen whether the change-over in the U.S. Senate, putting both chambers of Congress in the hands of Republicans, will do anything to alter the modus operandi of the Obama presidency — which means the President’s willingness, or unwillingness, to roll up his sleeves,
U.S. Congress — Both Chambers are controlled by Republicans: What now? Read More »
By Mark L. Itzkoff In the October 30 Federal Register, FDA that it will hold a public meeting to receive public input on updating its commonly known as “the Redbook.” The meeting will be held on December 9. Requests to make oral comments during the meeting must be submitted to FDA by November 21, 2014.
FDA Public Meeting Will Consider Fundamental Changes to, and Expansion of, the Redbook Read More »
OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part II) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights from throughout the years. Part I focused on Hatch-Waxman. Today’s blog focuses on the development
HIPAA Comes of Age… Thanks to HITECH, D.D.S. Read More »
A Webinar Presented by OFW Law and Davis, LLP November 12, 2014, 1:00 p.m. EST During this webinar, attendees will learn about additional regulatory requirements placed on medical devices, pharmaceuticals, and food products as consumer products in the U.S. and Canada. Topics will include, among others: A general understanding of the interplay of obligations at
OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part I) Since its inception in 1979, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practices have focused on myriad regulatory issues arising under FDA and broader HHS jurisdiction. We advise clients on matters ranging from Hatch-Waxman and generic drug marketing exclusivity
Thirty Years of Hatch Waxman Read More »
When asked to visit an establishment to assess compliance, my first step is always to ask for data. Establishment food safety data, laboratory results, regulatory data, audits…. What story is being told? Is there a trend in the making? Upward trend? Downward trend? It is important for establishments that are regulated by the Food Safety
Data Driven Decision Making by Dr. Doom Read More »
A Webinar Presented by OFW Law and Davis, LLP October 29, 2014, 1:00 p.m. EST During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Canada. Topics for each country will include, among others: A general understanding of the regulatory
How to Legally Import and Market Foods and Beverages in the U.S. and Canada Read More »
On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will mark a “game changer” for clinical laboratories. Specifically, these guidances call for the active regulation of a subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs) and the firms that produce them.
Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part I) Read More »
The Food and Drug Administration (FDA) has announced a public meeting to be held on November 13, 2014 to discuss its four supplemental proposed rules under the Food Safety Modernization Act (FSMA). On September 29, FDA published supplemental proposed rules for four of its “foundational” FSMA rulemakings: Produce Safety Preventive Controls for Human Food Preventive
FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules Read More »
By Mark L. Itzkoff On October 20, 2014, FDA and the consumer group called the Center for Food Safety (CFS) filed a consent decree in the U.S. District Court for the District of Columbia that requires FDA to promulgate a final rule regarding the GRAS Notification (GRASN) Program by August 31, 2016. The decree resolves a
Settlement Agreement Reached on GRAS Notification Program Final Rule Read More »
FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA). Those four rules are: Produce Safety; Preventive Controls for Human Food; Preventive Controls for Animal Food; and Foreign Supplier Verification Programs (FSVP). Comments on the supplemental proposed rules are due December 15, 2014. The “Supplementals”
FDA Tweaks Its Four Foundational FSMA Proposed Rules Read More »
A Webinar Presented by OFW Law and Davis, LLP October 29, 2014, 1:00 p.m. EST During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Canada. Topics for each country will include, among others: A general understanding of the regulatory
How to Legally Import and Market Foods and Beverages in the U.S. and Canada Read More »
A Webinar Presented by OFW Law and Davis, LLP October 1, 2014, 1:00 p.m. EST During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market a medical device in the U.S. and Canada. Topics
How to Legally Import and Market Medical Devices in the U.S. and Canada Read More »
By Mark L. Itzkoff We have previously reported on criticism of the so-called “GRAS Exemption” and FDA’s GRAS Notification Program by the Pew Charitable Trusts, the Natural Resources Defense Council, and the Center for Science in the Public Interest. In response to these criticisms, the Grocery Manufacturers Association (GMA) recently announced a 5-part initiative to improve
GMA Announces Initiative to Address Criticisms of GRAS Exemption Read More »
