Posts by Marc Sanchez
FDA Enforcement and Recall Report Week of June 27
Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters. FDA Recalls This past week brought one of the more diverse series of recalls since in several weeks. It may be a…
Read MoreFDA Enforcement and Recall Report Week of June 23
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 warning letters. FDA Recalls Signs that listeria related recalls may be trending downward emerge this week. A total of 20 new recall postings were posted.From this only 9 were related to Listeria.…
Read MoreFDA 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 Zeller made the following comments on the deeming regulation: Flavors of e-liquids – concern about health benefits for adults versus the appeal to youth; Flavors and PMTAs – questions on…
Read MoreFDA Enforcement and Recall Report Week of June 13
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 warning letters. FDA Recalls – Allergen Recalls Listeria continues to dominate the recall postings. A total of 15 new recall postings were posted. A full 10 of those were related to…
Read MoreTobacco 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 for newly deemed covered tobacco products must contain one of two required warnings. The required warnings will be one of the first requirements of the rule to go into effect.…
Read MoreFDA Enforcement and Recall Report Week of June 6
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 warning letters. FDA Recalls – Allergen Recalls Recall postings picked up steam again this past week. After only three new recall postings preceding the Memorial Day holiday a full 23 recall…
Read MoreFDA 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 warning letters. FDA Recalls – Allergen Recalls Recall postings can be slow following a holiday. This week is no exception with the recent Memorial Day holiday. Only three new recall…
Read MoreFDA 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.)** 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 warning letters. FDA Recalls It…
Read MoreFDA 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 approval and enforcement action adds particular pressure. That is exactly the meeting I’ve been engaged in over the past two days. This post contains a few reflections on FDA device…
Read MoreFDA 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 warning letters. FDA Recalls Anyone subscribing to the FDA recall e-mail list received saw only a small slow down in the barrage of FDA food recall notices related to the frozen…
Read MoreE-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 practical about compliance. This post is meant to be a practical guide to the e-cig rule. Below are key dates to keep in mind. One of the big keys in…
Read MoreVaporizers, 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 into effect for the first time for FDA ENDS. The effective dates are staggered. It is important NOT to see the staggered dates as extra time to wait. The FDA…
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