FDA Enforcement
FDA 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 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…
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…
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…
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 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….
Nutrient Content Claims + KIND Warning Letter
What is a Nutrient Content Claim? The US Food and Drug Administration appears to have riled fans of the KIND snack bar with a recent…
FDA Warning Letters
The Significance of Warning Letters FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters are common food,…
FDA Regulatory Status Call
Managing Engagement with the US FDA to Avoid Penalties One of the most challenging aspects of working with the FDA is engaging directly with the…
GNC to Strengthen Supplement Quality Controls – Implications for Suppliers
The New York Times reported that the GNC will institute “sweeping new testing procedures” on its herbal supplements following an investigation and accusations from the…