All posts by Marian Boardley

FDA’s Current Warning Letter Focus

The above chart is based on the past 90 days of Warning Letters published on FDA.gov issued to firms that are FDA-regulated (some data may be redacted*) Their focus on regulatory actions against tobacco products that are aimed primarily at children and teenagers continues, along with enforcement aimed at curbing illegally marketed products claiming to prevent or cure diseases associated with the novel coronavirus outbreak (in co-operation with FTC).

The FDA website states “To date, the FDA has worked with online retailers to remove more than 90 fraudulent products with claims related to COVID19, and has issued more than 30 health fraud warning letters to sellers of bogus COVID-19 products.” 

Additionally, in mid-March 2020, FDA temporarily postponed all domestic routine surveillance facility inspections, and most foreign facility inspections, due to travel restrictions, social distancing, and other advisories associated with the COVID-19 outbreak.  However, FDA continues to monitor FSMA Foreign Supplier Verification Program compliance using remote inspections [see this article  for more information on this process] requesting that importers send records electronically.

*  “Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.”