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
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
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
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
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
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
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
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
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
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
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
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
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
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
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