FDA
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…
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 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
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…
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…
FDA SEC Reporting – Regulatory Reviews for SEC Forms
FDA SEC Reporting Regulatory Reviews in Form 8-K FDA SEC Reporting does not readily come to mind when considering foods, dietary supplements, drugs, cosmetics (so…
FDA Regulation of Homeopathic Drugs – Meeting Foreshadows Changes
FDA Regulation of Homeopathic Drugs Current Regulation of Homeopathy The FDA currently regulates homeopathic drugs under a 1988 Policy Guide. The Policy Guide is detailed…
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…