Public Policy

Recent Posts

Food and Beverage News and Trends: Labeling of GMOs, Honey, Sugar, Cane Juice
Posted on 21 Apr 2014 by DLA Piper

By Stefanie Jill Fogel , Mary B. Langowski , and Tiffani V. Williams • Federal GMO labeling legislation introduced . On April 9, Representative Mike Pompeo (R-KS) introduced The Safe and Accurate Food Labeling Act of 2014 (H.R. 4432) [ enhanced... Read More

Tags: school , FDA , GMO , labeling

Navigating FDA and USDA Reporting/Notification Requirements for Adulterated and Misbranded Food
Posted on 3 Mar 2015 by Keller and Heckman LLP

When incidents of adulterated or misbranded food arise that trigger a need to report to or notify a federal agency, food companies face a number of somewhat confusing, and not always congruent, requirements. Both the U.S. Food and Drug Administration... Read More

FSMA Update: FDA Seeks Input on Reportable Food Registry Requirements
Posted on 22 Apr 2014 by Keller and Heckman LLP

FDA has issued an Advanced Notice of Proposed Rulemaking (ANPRM) to seek comments, data, and information from stakeholders that will assist the Agency with implementing amendments to the Reportable Food Registry (RFR) requirements that were enacted as... Read More

FDA Gives Guidance on Compounding for Human Use
Posted on 13 Aug 2014 by Duane Morris LLP

Last month, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use. These documents are: ... Read More

Fungal Meningitis Outbreak Spurs FDA Oversight Of Drug Compounders
Posted on 2 Dec 2013 by William A. Ruskin

In 2012, a major outbreak of fungal meningitis was traced to drugs compounded by New England Compounding Centers . The outbreak included approximately 750 confirmed cases and has resulted in 64 deaths to date. Tragedies of this scale have often been the... Read More

Twenty-Nine States Urge FDA To Strengthen Proposed Regulation Of E-Cigarettes To Protect Kids
Posted on 20 Aug 2014 by LexisNexis Legal Newsroom Staff

States Propose Restrictions On Advertising To Youth, Bans On Flavored E-Cigarettes Current FDA Proposal Falls Far Short Of What Is Needed To Protect Our Youth The attorneys general of Illinois, Indiana, Massachussetts, and New York, have co-sponsored... Read More

FDA Issues Final Guidance Distinguishing Liquid Dietary Supplements from Beverages
Posted on 3 Mar 2014 by GreenbergTraurig

The Food and Drug Administration (FDA) has issued a long-awaited and much anticipated, revised and now, final Guidance for Industry entitled, “Distinguishing Liquid Dietary Supplements from Beverages.” The FDA had previously issued a Draft... Read More

FDA Seeks Information for Implementation of Drug Supply Chain Security Act
Posted on 23 Apr 2014 by Duane Morris LLP

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To accomplish this... Read More

Keller and Heckman: N.J. District Court Refuses to Dismiss False Advertising Suit
Posted on 12 Aug 2013 by Keller and Heckman LLP

On June 12, 2013, the U.S. District Court for the District of New Jersey denied Tropicana’s motion to dismiss a false advertising suit. In Lynch v. Tropicana Products, Inc. , the plaintiffs alleged that the juice’s label falsely claimed that... Read More

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
Posted on 1 Jul 2014 by Duane Morris LLP

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers , which provides answers to questions from public comments received on the... Read More

FDA Opens Plan to Let Generic Drug Manufacturers Update Labels to Debate
Posted on 23 Apr 2015 by Duane Morris LLP

In response to the U.S. Supreme Court's holding in Pliva v. Mensing , 131 S. Ct. 2567 (2011), [ enhanced version available to lexis.com subscribers ], that federal laws and regulations preempted state failure-to-warn claims, the U.S. Food and Drug... Read More

Tags: drugs , generic , warn , FDA , labeling

No Decision by FDA Until Next Year On Whether Evaporated Cane Juice is Misleading
Posted on 17 Aug 2015 by DLA Piper

By Stefanie Jill Fogel , Kathleen Smith Ruhland , and Maggie Craig FDA will not issue further guidance on evaporated cane juice until 2016. In a July 8, 2015 letter response to a Northern District of California federal judge (filed July 13, 2015),... Read More

FDA Declines to Define "Natural"
Posted on 5 Feb 2014 by DLA Piper

In a much anticipated letter response, FDA has officially declined the opportunity to administratively determine whether foods containing bioengineered ingredients may be labeled as “Natural,” “All Natural” or “100% Natural... Read More

FDA Issues Draft Guidance for Identification and Notification of Suspect Products
Posted on 10 Jul 2014 by Duane Morris LLP

As discussed in our April 11, 2014 Alert , the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States."... Read More

FDA Announces Plan to Streamline Animal Food Regulation
Posted on 7 May 2015 by Keller and Heckman LLP

On March 27, 2015, FDA announced a strategy to establish ingredient definitions and standards for animal food. The goal of FDA’s strategy is to promote consistency in the Agency’s regulatory review and clearance of animal food ingredients... Read More

Tags: Food , animal , pet , FDA , additive , safety , feed