FDA Enforcement
FDA Enforcement and Recall Report Week of April 11
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…
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…
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
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…
Nutrient Content Claims + KIND Warning Letter
Nutrient Content Claims + Kind Warning Letter What is a Nutrient Content Claim? The US Food and Drug Administration appears to have riled fans of…
FDA Warning Letters
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…
FDA Regulatory Status Call
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…
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…
Review: FY 2014 Inspectional Observation Summaries
At the end of each fiscal year the US FDA posts a summary of the Inspectional Observations from Form 483. The fiscal year for the…
FTC Sues Gerber Over Unapproved Health Claim
The US Federal Trade Commission announced today its intent to sue Gerber for unapproved and unsubstantiated health claims made on its
Tips for Appeals and FDA Meetings: Reflections from Recent Visit to FDA HQ
An enforcement meeting with the US FDA, whether in person or over the phone, can become an intimidating task. There are number of variables to…