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Tonight: Global Child Nutrition Foundation Honors USDA Secretary Vilsack

Public Policy, USDA /

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 […]

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2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy

FDA, Health Care, Public Policy, USDA /

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

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Privacy Update: White House Drops Draft Consumer Privacy Bill . . . Splat!

Health Care, Public Policy /

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 Announces National Kick-Off Meeting on FSMA Implementation

FDA /

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

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Global Child Nutrition Foundation to Honor Secretary Vilsack on April 16th

Public Policy, USDA /

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

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FDA Decides Not to Actively Regulate Medical Device Data Systems, Medical Image Storage Devices, Medical Image Communication Devices and Similar Mobile Medical Apps

FDA /

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

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Dr. Nina Fedoroff Joins OFW Law as Senior Science Advisor

FDA, OFW Law News, Public Policy, USDA /

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)

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A Flurry of End-of-Year Activity from FDA on Food

FDA, Public Policy /

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

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FDA Announces New Surveys of Foodborne Illness Risk Factors in Restaurants, Retail Food Stores, and Foodservice Institutions

FDA /

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

FDA Announces New Surveys of Foodborne Illness Risk Factors in Restaurants, Retail Food Stores, and Foodservice Institutions Read More »

Don’t Rush the Holiday Preparations – Make Certain the Meat is Properly Cooked

Miscellaneous, USDA /

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

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GMO Hearing

FDA, Public Policy /

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

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FTC Reminds Us That HHS’s Office for Civil Rights Not Only One Watching Medical Privacy

Health Care /

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

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FDA Shares the Pain in Final Rules on Menu Labeling and Vending Machine Food Labeling

1 Comment / FDA, Public Policy /

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

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Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part II)

FDA /

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 Tweaks Its Guidance on Food Facility Registration

FDA /

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,

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GMPs Have Long History That Precedes Application In Medical Products

1 Comment / FDA, Health Care, OFW Law News, Public Policy /

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

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U.S. Congress — Both Chambers are controlled by Republicans: What now?

Public Policy /

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 »

FDA Public Meeting Will Consider Fundamental Changes to, and Expansion of, the Redbook

FDA /

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,

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HIPAA Comes of Age… Thanks to HITECH, D.D.S.

4 Comments / FDA, Health Care, OFW Law News, Public Policy /

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

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Medical Devices, Pharmaceuticals and Food Products as Consumer Products – Additional U.S. and Canadian Regulatory Considerations

FDA, OFW Law News /

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

Medical Devices, Pharmaceuticals and Food Products as Consumer Products – Additional U.S. and Canadian Regulatory Considerations Read More »

Thirty Years of Hatch Waxman

4 Comments / FDA, Health Care, OFW Law News, Public Policy /

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 »

Darren Webb headshot

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

FDA, OFW Law News /

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 »

Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part I)

FDA /

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 »

Roger Szemraj headshot

FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules

FDA /

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

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David Durkin headshot

FDA Tweaks Its Four Foundational FSMA Proposed Rules

1 Comment / FDA /

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 »

Ladd Wiley headshot

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

FDA, OFW Law News /

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 »

Darren Webb headshot

How to Legally Import and Market Medical Devices in the U.S. and Canada

FDA, OFW Law News /

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 »

John G. Dillard headshot

GMA Announces Initiative to Address Criticisms of GRAS Exemption

FDA /

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

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Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

FDA, OFW Law News /

Announcing OFW Law and Davis LLP’s New Four-Part Webinar Series: REGULATORY REQUIREMENTS FOR THE IMPORT OF MEDICAL PRODUCTS AND FOODS INTO THE U.S. AND CANADA OFW Law and Davis LLP have joined together to present a new webinar series to provide attendees with an overview of laws with which a firm must comply when importing

Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada Read More »

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