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|FDA Issues Guidance for Dispensers to Explain Compliance Policy on Product Tracing Requirements and Notes Limited Exemptions|
Scott S. Liebman; Loeb & Loeb LLP;
August 5, 2015, previously published on July 2015Section 202 of the DSCSA, which was signed into law in 2013 and added new sections to the FDCA, laid out new product tracing definitions and requirements. Beginning in 2015, trading partners must provide subsequent purchasers with product tracing information when it comes to transactions that...
|Food Court Report: Consumer Claims Targeting Trans Fat In Instant Noodles Case Survive Motion To Dismiss|
Eric P. Gotting; Keller and Heckman LLP;
August 4, 2015, previously published on July 29, 2015Last month we wrote about FDA's determination that trans fat will no longer be generally recognized as safe ("GRAS") and that the agency's decision could open the door for consumers wishing to attack food products containing trans fat.1 Perhaps in a sign of things to come, the "Food...
|Employer in the Restaurant Industry Beware: Employees have a Private Right of Action for Violation of the Tennessee "Tip Statute"|
Christen C. Blackburn, J. Gregory Grisham; Leitner, Williams, Dooley & Napolitan, PLLC;
July 31, 2015, previously published on Summer 2015The Tennessee Court of Appeals recently determined that tipped employees may file a lawsuit against their employer for violations of Tennessee Code Annotated Section 50-2-107 (¿Section 107¿), commonly known as the ¿Tip Statute.¿ Kim Hardy v. Tournament Players Club, Inc. d/b/a ¿TPC Southwind¿ et...
|FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial|
Linda D. Bentley; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
July 30, 2015, previously published on July 21, 2015The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company with offices in France and New Jersey, regarding the company’s...
|GMOs in the Hotseat: White House to Overhaul Regulatory Framework on Biotechnology|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 15, 2015, previously published on July 10, 2015Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation.
|FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 3, 2015, previously published on June 30, 2015On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until November 1, 2015 (Compliance Policy). As we previously discussed, pursuant...
|Supreme Court Upholds Affordable Care Act Rule Authorizing Health Subsidies in States with Federal Exchanges|
Robert P. Charrow; Greenberg Traurig, LLP;
June 29, 2015, previously published on June 25, 2015Today, in King v. Burwell, the Supreme Court in a 6-3 decision authored by the Chief Justice upheld the IRS Regulation (“the Regulation”) that provided subsidies under the Affordable Care Act (ACA) to individuals in States with only federally established - as opposed to State...
|China Regulatory Affairs: China Notifies WTO of Draft General Safety Standard for Food-Contact Materials|
Yun Chen, David J. Ettinger, Mark Thompson; Keller and Heckman LLP;
June 26, 2015, previously published on June 24, 2015On May 22, 2015, China notified to the World Trade Organization (WTO) Committee on Sanitary and Phytosanitary Measures its draft Standard on the General safety requirements for food contact materials and articles for public comment. The Standard was developed by the National Health and Family...
|Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA's Hackles if They Do Not Meet Basic Requirements for Promotional Communications|
Joanne S. Hawana; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 26, 2015, previously published on June 23, 2015For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s...
|Distributor of Heineken Beer Entitled to Use 'Green' Nickname|
Henning Voelkel; Dr. Helen Papaconstantinou, John Filias & Associates;
June 25, 2015, previously published by “This article first appeared
in WTR Daily, part of World Trademark Review, in May 14, 2015.
For further information, please go to www.worldtrademarkreview.com.” on May 2015In Panathinakes Editions SA v Athenian Brewery SA (Decision No 1208/2015, February 19 2015, notified only recently), the Athens District Court, in preliminary proceedings, has held that Athenian Brewery SA was entitled to continue to use the word 'Prasini' in Greek characters (meaning 'green' in...