News & Insights

FDA Issues Guidance on Labeling of Honey

April 8, 2014

The Food and Drug Administration (FDA) has issued a draft guidance document on labeling of honey and honey products. According...

FDA

FDA Final Rule and Guidance on Emergency Records Access

April 4, 2014

The Food and Drug Administration (FDA) has issued a final rule expanding its emergency records access authority, as provided by...

Health Care

HHS Releases HIPAA Security Rule Risk Assessment Tool

April 2, 2014

The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), Office of the National Coordinator for Health...

USDA

Steps to Prevent Allergen Recalls – A Practice Tip from Ms. Gloom

April 2, 2014

Anyone who is remotely involved in the food arena knows that the number one reason for a recall of meat...

Public Policy

Global Food Security

April 1, 2014

By Marshall L. Matz, as published in Agri-Pulse Agriculture is a business, a very big business. Whether you look at...

FDA

FDA Updates Its Guidance on Prior Notice of Imported Foods

March 31, 2014

The Food and Drug Administration (FDA) has published an updated guidance document, Draft Guidance for Industry: Prior Notice of Imported...

FDA

Draft Methodological Approach for Designating High-Risk Foods — Comment Period Extended

March 28, 2014

The Food and Drug Administration (FDA) has published notice of a 45-day extension, until May 22, 2014, of the comment...

FDA

Intentional Adulteration – Comment Period Extended

March 28, 2014

The Food and Drug Administration (FDA) has published notice of a 90-day extension, until June 30, 2014, of the comment...

Miscellaneous

John Block Reports: FDA’s New Nutrition Label—Proposal to Demonize Sugar

March 27, 2014

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports....

Public Policy

Food Security from the Tractor Seat

March 24, 2014

Last week’s headlines announced the arrival of higher food prices with more increases to come because of widespread drought in...

USDA

“Time”-ly Tip from Dr. Doom

March 21, 2014

There has been a great deal of noise in the media recently about “plants running without inspection” and the significance...

FDA

FDA denies Remodulin® Citizen Petition; Treprostinil Injection ANDAs can proceed with labeling carve-out

March 19, 2014

Last week, FDA announced the latest in a line of decisions demonstrating the agency’s continued support for approval of generic...

FDA

FDA Issues Statement on GRAS Determination of Senomyx

March 17, 2014

By Mark L. Itzkoff On March 12, 2014, FDA issued an unusual statement regarding the GRAS status of a new...

Public Policy

U.S. Supreme Court Extends Sarbanes-Oxley Whistleblower Protection to Employees of Privately-Held Companies

March 10, 2014

On March 4, 2014, the U.S. Supreme Court ruled in Lawson v. FMR LLC, No. 12-3 that “whistleblower” protection under...

FDA

Good Reprint Practices Revamped

March 7, 2014

By Casper E. Uldriks The Food and Drug Administration (FDA) issued a revised draft guidance document in February 2014 entitled,...

FDA

“Evaporated Cane Juice” — Comment Period Reopened

March 6, 2014

“Evaporated cane juice” is an ingredient name for a sweetener often seen in food labeling. In October 2009, FDA issued...

USDA

Tune up and Be Ready – A Practice Tip from Dr. Doom

March 5, 2014

FSIS has indicated that based on some recent “negative events;” they will be increasing verification activities. Increased verification should not...

USDA

Federal Crop Insurance Sets Prices for Corn, Wheat, Cotton, and Soybeans

March 5, 2014

This week, USDA’s Federal Crop Insurance Corporation (FCIC) announced its projected prices for all FCIC crop insurance policies with March...

Public Policy

GE To The Rescue

March 4, 2014

It’s not new news to report that genetically engineered (GE) products are under assault. We are in free trade talks...

EPA

Environmentalists, Glyphosate and Butterflies

February 28, 2014

The Natural Resource Defense Council (NRDC) has petitioned EPA to restrict the use of glyphosate herbicide to protect the dwindling...

FDA

FDA Proposes Major Changes to the “Nutrition Facts” Label – Price Tag $2 Billion

February 27, 2014

Two billion dollars – That is what FDA estimates the food industry will spend to comply with proposed changes to...

FDA

A Consumer Group Files Suit to Vacate FDA’s GRAS Notification Program

February 27, 2014

By Mark L. Itzkoff In a formal challenge to FDA’s GRAS Notification Program, a consumer group called the Center for...

Public Policy

FNS Seeks Comments on Proposed Rule Establishing Stronger Requirements for Local School Wellness Policies; Rule Also Proposes to Limit Marketing of Foods in Schools

February 26, 2014

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FDA

Wide-Reaching FDA Proposed Rule on Sanitary Transportation Could Have Greatest Impact on Food Carriers

February 26, 2014

On February 5, 2014, the Food and Drug Administration (FDA) published in the Federal Register its proposed rule on “Sanitary...

News & Insights

FDA Issues Guidance on Labeling of Honey

FDA Final Rule and Guidance on Emergency Records Access

HHS Releases HIPAA Security Rule Risk Assessment Tool

Steps to Prevent Allergen Recalls – A Practice Tip from Ms. Gloom

Global Food Security

FDA Updates Its Guidance on Prior Notice of Imported Foods

Draft Methodological Approach for Designating High-Risk Foods — Comment Period Extended

Intentional Adulteration – Comment Period Extended

John Block Reports: FDA’s New Nutrition Label—Proposal to Demonize Sugar

Food Security from the Tractor Seat

“Time”-ly Tip from Dr. Doom

FDA denies Remodulin® Citizen Petition; Treprostinil Injection ANDAs can proceed with labeling carve-out

FDA Issues Statement on GRAS Determination of Senomyx

U.S. Supreme Court Extends Sarbanes-Oxley Whistleblower Protection to Employees of Privately-Held Companies

Good Reprint Practices Revamped

“Evaporated Cane Juice” — Comment Period Reopened

Tune up and Be Ready – A Practice Tip from Dr. Doom

Federal Crop Insurance Sets Prices for Corn, Wheat, Cotton, and Soybeans

GE To The Rescue

Environmentalists, Glyphosate and Butterflies

FDA Proposes Major Changes to the “Nutrition Facts” Label – Price Tag $2 Billion

A Consumer Group Files Suit to Vacate FDA’s GRAS Notification Program

FNS Seeks Comments on Proposed Rule Establishing Stronger Requirements for Local School Wellness Policies; Rule Also Proposes to Limit Marketing of Foods in Schools

Wide-Reaching FDA Proposed Rule on Sanitary Transportation Could Have Greatest Impact on Food Carriers

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