Congress questions FDA policy regarding the publication of Untitled Letters.

  • FDA has the authority to issue two types of letters to regulated entities:  Warning Letters and Untitled Letters.  FDA issues Warning Letters to highlight alleged violations of the Federal Food, Drug, and Cosmetic Act that — if not appropriately resolved by the entity — may trigger enforcement action.  FDA issues Untitled Letters to highlight violative conduct that does not necessarily warrant enforcement action.  In practice, FDA posts Warning Letters on its website once redacted versions are available.  In contrast, FDA posts some — but not all — Untitled Letters on the web.
  • The U.S. House Committee on Energy and Commerce has sent a letter to FDA, indicating its intent to investigate the Agency’s policies regarding the “use and publication of untitled letters, including whether such policies and practices are consistently fair, effective, and efficient in gaining compliance.”  The letter cites the case of an unnamed company that was the recipient of an Untitled Letter that FDA posted in a manner that had a significant impact on the company’s stock price.  Congress appears to question both the timing and the nature of FDA’s release of information in that case.  Congress also seems concerned that FDA may be using Untitled Letters to advance new policies or interpretations without giving adequate notice to industry.  FDA has been asked to respond to Congress’ letter in writing by June 10, 2015.
  • According to FDA’s website, the Center for Food Safety and Nutrition (CFSAN) posts Untitled Letters related to violations from manufacturing controls or labeling that do not meet the threshold of significance for a Warning Letter, or that are issued to Internet websites (“Cyber Letters”).  Assuming that FDA is willing to engage with Congress on this issue, the Agency’s response may clarify the “publicity policy” with respect to Untitled Letters issued to food companies and could give the food industry more predictability with respect to the timing and nature of the release of information.