FDA News Update
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…
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…
Cuban Cigars and the FDA
With the announcement today by US President Barack Obama that the United States will begin to normalize relations with Cuba a number of questions come-up….
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…
FDA, FSMA, and the USDA Budget Increases- Update from Latest Spending Bill
The latest reporting on the spending bill passed by the United States House of Representatives contains budget increases for the U.S. Food and Drug Administration…
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