Posts by Marc Sanchez
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 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…
Read MoreFDA Enforcement and Recall Report Week of May 9
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 a barrage of FDA food recall notices. This past week the recall notices spiked dramatically. A total of…
Read MoreFDA E-Cigarette Rule Finalized
The FDA e-cigaratte rule finalized. That is the breaking update from the FDA on Thursday May, 5 2016. The new rule known as the “deeming” regulation will go into effect August 8,2016. Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Now in the new e-cigarette rule – Deeming Tobacco Products To Be Subject…
Read MoreFDA Enforcement and Recall Report Week of May 2
Each week the FDA reports on its enforcement activities. To help capture and digest that information starting this week the FDA Atty blog will post FDA recalls and warning letters. FDA Recalls The end of the month proved busy for recalls. This past week the FDA posted 23 recall notices. Those notices are posted below. The…
Read MoreFDA Microneedling Presentation
FDA Microneedling This past month I joined the American Society for Aesthetic Plastic Surgery (ASAPS) for their annual conference. This year the ASAPS conference was held in Las Vegas Nevada. ASAPS invited me to speak on FDA regulation of microneedling. As I’ve addressed in previous posts and articles there are several questions about the FDA and…
Read MoreFDA Enforcement and Recall Report Week of April 26, 2016
FDA Enforcement and Recall Report Week of April 11 2016 Each week the FDA reports on its enforcement activities. To help capture and digest that information starting this week the FDA Atty blog will post FDA recalls and warning letters. FDA Recalls This past week the FDA posted 12 recall notices. That is two fewer…
Read MoreAmazon Registration Certificates and Seller Support
Amazon Registration Certificate A recent post on Amazon Registration Certificates generated a number of questions along with shared frustrations. In the previous post, I talked about selling on Amazon in an FDA regulated category, like health and beauty, where Amazon requires, among other hurdles, to be listed with a certificate from the FDA. The FDA…
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