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Last month the Food and Drug Administration (FDA) released draft guidance for industry with instructions on how to obtain a food allergen labeling exemption through submission of a petition or notification to FDA.[1] The Food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