FDA Enforcement and Recall Report Week of April 11

FDA FFY16 Renew Renewal

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 14 recall notices. Those notices are posted below. The FDA recall notices continue to show undeclared allergens…

Read More

FDA Tanning Bed Rule

FDA Tanning Bed Rule New Restrictions

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 December 18, 2015. The first FDA tanning bed rule proposes a restriction on the use of sunlamp products to individuals 18 and older. This FDA tanning bed rule would require, before their…

Read More

FDA Exemption to E-Cigarette Deeming Rule

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, then the rule will go into effect as originally planned. A potential FDA exemption to the E-Cigarette Deeming Rule may pass Congress before the end of 2015. A rider has…

Read More

FDA Picamilon Status

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 day. The FDA Picamilon status is now clear – it is not an approved dietary ingredient. In each FDA Warning Letter the ingredient is described as: This ingredient is also…

Read More

Criminal Charges USPlabs LLC

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 criminal charges will be against USPlabs and its corporate officers – a stinging reminder of the broad personal liability under the Food Drug and Cosmetic Act. The announcement highlights an intensified…

Read More

FDA Holiday Imports

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 particular speciality foods imported from across the globe. FDA holiday imports are unique because the timing is absolutely crucial. An import delay or refusal could lead to a costly missed…

Read More

New FDA Automatic Destruction Rule

FDA Exemption to E-Cigarette Deeming 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 Destruction of Certain Drugs Refused Admission to the United States. Final rule.” This may be one scenario where the rule is as ominous as the title suggests. Under the new…

Read More

FDA Criminal Liability – PCA and the DOJ Yates’ Memo

FDA PCA Yates Criminal Liability Personal

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 to their tainted plant (click here for media coverage). Stewart Parnell will spend 28 years in jail while his brother Michael will spend 20 years. The family owned company based…

Read More

FDA Shutdown – Preparing for the Likely Government Shutdown

FDA FFY16 Renew Renewal

***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 occur if a deal is not reached before then. The final quarter of the year will likely experience a rush to submit filings to the FDA in anticipation of a…

Read More

FDA Warning for Kim Kardashian

Kim Kardashian FDA Morning Sickness

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. For clients it is often equally surprising to discover the FDA monitors and enforces social media posts among other mediums of marketing. If you are one of Mrs. Kardashian’s 42…

Read More

Regulatory Planning for FDA FY 2016

FDA FFY16 Renew Renewal

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 fee increases, expiration of registrations and statuses like the Small Business Decision, and a call for registration renewals. Regulatory Planning for FDA FY 2016 varies depending on if you are…

Read More

FDA Microneedling Regulations Status Update

Befuddled and Confused – Microneedling and the FDA One of the most common questions received in our office is whether a product is “FDA Approved.” As microneedling grows in popularity this question is being asked about manual and motorized derma rollers as well. The question comes amid a confusing backdrop of events where Warning Letters…

Read More