FDA Enforcement Actions: Warning Letters and Untitled Letters

Fuerst Ittleman David & Joseph, PL represents a wide array of FDA-regulated businesses, including those engaged in the manufacture, distribution, import and export of foods, drugs, biological products, medicines, cosmetics, anti-aging products and a host of others. FDA keeps a close watch over the industries it regulates, and has many options when launching enforcement actions against any particular company or individual. The FDA’s most frequently used enforcement mechanisms are advisory communications that are issued in one of two forms: Warning Letters and Untitled Letters.

A Warning Letter identifies a perceived violation, indicates that correction is necessary, specifies if there are any specific actions FDA wishes the firm or individual to take, and provides a number of days (typically 15 days) for the firm or individual to take corrective action and respond to the letter. More severe enforcement action can be imposed if no response is submitted to FDA. However, if FDA finds that a company or individual adequately responds to a Warning Letter and takes appropriate corrective action, FDA may issue a Close-Out Letter stating the Warning Letter violations have been addressed. However, FDA is not required to issue a Close-Out Letter and does not do so in every situation.

An Untitled Letter is initial FDA correspondence to a regulated party citing infractions of federal food and drug law that FDA deems to be less severe and not warranting a Warning Letter. An Untitled Letter is different from a Warning Letter in that an Untitled Letter will not include a caution from FDA that failure to take corrective action could result in enforcement action. Further, an Untitled Letter requests, rather than requires, a response. Failure to take action or respond to an Untitled Letter, however, could eventually lead to further enforcement action by the agency.

In many cases, FDA publishes Warning Letters and Untitled Letters to the World Wide Web even before they are received by the targeted firm, making the firm’s timely response all the more critical. Responding to Warning Letters and Untitled Letters are unquestionably daunting, but Fuerst Ittleman David and Joseph’s FDA attorneys have years of experience guiding clients through FDA enforcement actions and responding to Warning Letters and Untitled Letters under even the most pressing of circumstances.

FIDJ Services

FIDJ’s legal and regulatory services regarding FDA, FTC, and USDA enforcement actions and litigation include:

  • Assisting clients in responding to and complying with FDA Warning Letter and Untitled Letters.
  • Handling FDA inspections and responding to 483s.
  • Litigating, as necessary, against the FDA, FTC, and USDA.
  • Assisting clients with product recalls or agency injunctions.
  • Responding to FTC complaints.