Posts by Marc Sanchez
FDA New Tobacco Deadlines
As is well known by now the FDA Deeming Regulation is effective as of August 8, 2016. What is less well understood are the various new tobacco deadlines from the regulation. As a reminder the new tobacco deadlines apply to any new tobacco product (electronic nicotine delivery systems (such as e-cigarettes and vape pens), all…
Read MoreFDA Vaping
The FDA vaping regulation (a/k/a Deeming Regulation) currently requires companies to register and list their products. Previous posts discussed the FDA vaping regulation and provided updates on the registration process. After two weeks interacting with the FDA’s Center for Tobacco Products registration system it appears there is a design flaw. The system is formally known…
Read MoreFDA Enforcement and Recall Report Week of July 18
FDA Recalls 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. This week continues the slow roll out of recalls. The biggest burst coming from the continued E. Coli concern with…
Read MoreFDA Enforcement and Recall Report Week of July 11
FDA Recalls 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. This week is both late and light due to the Independence Day holiday, but the FDA’s response to the General…
Read MoreFDA New Tobacco
FDA new tobacco regulation also known as the Deeming Regulation takes effect in 30-days (August 8, 2016). The regulations are broad, complex and impact every part of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others. This has created a great deal…
Read MoreFDA Enforcement and Recall Report Week of July 4
FDA Recalls – General Mills and Raw Cookie Dough 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. This week is both late and light due to the Independence Day…
Read MoreFDA 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…
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