LexisNexis® Legal Newsroom
Split 6th Circuit: Michigan Drug Shield Law Does Not Apply To Fentanyl Patch

CINCINNATI — (Mealey’s) A split Sixth Circuit U.S. Court of Appeals on Jan. 21 reversed dismissal of a fentanyl patch overdose lawsuit, saying the trial court needs to determine whether the patch is a combination product that is not preempted by Michigan’s drug preemption law ( Beth...

FDA Issues Guidance on Submission of Petitions and Notifications for Exemption from Allergen Labeling

Last month the Food and Drug Administration (FDA) released draft guidance for industry with instructions on how to obtain a food allergen labeling exemption through submission of a petition or notification to FDA.[1] The Food Allergen Labeling and Consumer Protection Act of 2004 (FACLPA) amended the...

FDA Issues Two Final Rules to Help Consumers Keep Track of Calories

The U.S. Food and Drug Administration (FDA) recently finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments, as well as on certain vending machines. In announcing the finalization of the two rules, FDA Commissioner...

Navigating FDA and USDA Reporting/Notification Requirements for Adulterated and Misbranded Food

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 (FDA) and the U.S. Department of Agriculture, Food...

FDA Announces Plan to Streamline Animal Food Regulation

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. Currently, ingredients used in animal feed and...

Keller And Heckman LLP: Consumer Claims Targeting Trans Fat In Instant Noodles Case Survive Motion To Dismiss

Last 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...