FDA News Update
Amazon 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…
FDA Enforcement and Recall Report Week of April 11
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 Tanning Bed Rule
The FDA is issuing a new tanning bed rule. The FDA tanning bed rule is actually a set of two proposed rules simultaneously released on…
FDA Exemption to E-Cigarette Deeming Rule
***UPDATE December 16, 2016*** The draft text of the Omnibus Bill does not include the FDA exemption to e-cigarette deeming rule. If this is confirmed,…
FDA Picamilon Status
In the FDA’s most recent set of warning letters Picamilon noticeably stood out with five (5) firms receiving a FDA Warning Letter on the same…
Criminal Charges USPlabs LLC
Breaking News – Criminal Charges USPlabs LLC The US Department of Justice and the Food and Drug Administration announced criminal charges and other civil charges. The…
FDA Holiday Imports
The time is fast approaching where US shoppers will begin their holiday shopping. FDA holiday imports are a common feature of the holiday season in…
New FDA Automatic Destruction Rule
Under New Authority Re-Export Option May be Removed An ominous sounding new rule goes into effect tomorrow (October 15, 2015). The rule is titled, “Administrative…
FDA Criminal Liability – PCA and the DOJ Yates’ Memo
Peanut Corporation of America executives Stewart Parnell and Michael Parnell were sentenced yesterday following a conviction last year for their role in the salmonella outbreak linked…
FDA Shutdown – Preparing for the Likely Government Shutdown
***UPDATE: Congress approved a short term budget deal that will fund the government through December 11th. There remains a liklihood that a FDA shutdown could…
FDA Warning for Kim Kardashian
A Lesson in paid and un-paid user testimonials It is a bit of a surprise to write about Kim Kardashian on a FDA regulatory blog….
Regulatory Planning for FDA FY 2016
The FDA operates on a Federal Fiscal Year rather than a calendar year. The FY runs from October 1 through September 30. The new FY brings…