FDA News Update
Tobacco Products Required Warnings
Among the key requirements of the FDA’s new Deeming Tobacco rule are that tobacco products bear the required warnings. This rule states advertising and packaging warnings…
FDA Enforcement and Recall Report Week of May 31
Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and…
FDA Enforcement and Recall Report Week of May 23
FDA Enforcement Report **This week’s FDA enforcement report is tardy due to meetings on FDA’s White Oak campus (read a post on the visit here.)**…
FDA Device Meetings
FDA Device Meetings Any meeting with the FDA on it’s White Oak campus can be intimidating, but a FDA device meeting to assess both pre-market…
FDA Enforcement and Recall Report Week of May 16
Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and…
E-Cig Rule Practical Guide
FDA E-Cig Rule Practical Guide Now that the shock of the new FDA E-Cig rule (Deeming Rule) is settling in it is time to get…
Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS)
FDA ENDS The FDA deeming rule extended authority over Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS). There are several key requirements that will go…
FDA Comments Deeming Regulation
FDA Comments Deeming Regulation This afternoon I attended a meeting with CTP Director Mitch Zeller regarding the deeming regulation (“FDA Comments on Deeming Regulation”). CTP Director…