Warning and Untitled Letters

View PDF of Warning and Untitled Letters Section (26 KB)

Background

If a person or firm violates the Federal Food, Drug and Cosmetic Act (FD&C Act), FDA may give them an opportunity to take voluntary and prompt action to correct the violation before FDA initiates an enforcement action.  FDA will issue either a Warning Letter or an Untitled Letter, depending upon the nature of the violation.

FDA uses Warning Letters for violations that may lead to enforcement action if they are not promptly and adequately corrected.  FDA uses Untitled Letters for violations that are not as significant as those that trigger warning letters.  Unlike a Warning Letter, an Untitled Letter does not include a statement warning that failure to promptly correct a violation may result in an enforcement action.

See: FDA Warning Letters

Previously, only some Centers posted Untitled Letters on FDA’s website.  As a result of the Agency’s Transparency Initiative, the Centers are working to disclose more Untitled Letters on FDA’s website.  The Agency believes that posting additional Untitled Letters may increase public accountability of firms, which may deter future violations and increase compliance with the law.  However, due to limited resources, the Agency is not able to post all Untitled Letters at this time.

Interested parties may access the available Untitled Letters and similar correspondence below.

CFSAN

• Cyber Letters (Issued before December 1, 2011) – CFSAN Cyber letters are sent to Internet Website Operators promoting dietary supplement products that claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.
• CFSAN Untitled Letters/Cyber Letters (Issued on/after December 1, 2011) – Untitled letters issued by CFSAN (but not by the Office of Regulatory Affairs field offices), on and after December 1, 2011, related to manufacturing controls and labeling requirements, as well as cyber letters, may be found at this link.
• Warning Letters and Untitled Letters for Color Additive Violations

CBER

• Untitled Letters for Advertising and Promotional Labeling

CDRH

• Promotion and Advertising Untitled Letters (and Other Letters to Industry) 

CDER

• Cyber Letters - CDER sends cyber letters electronically to web sites whose online sales of prescription drugs may be illegal.  The letters warn these website operators that they may be engaged in illegal activities and informs them of the laws that govern prescription drug sales.

• Untitled Letters Issued by the Office of Prescription Drug Promotion – The Untitled Letters issued by the Office of Prescription Drug Promotion (formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC)) are mixed in with the Warning Letters Issued by CDER, and they are organized according to the year they were issued.

CTP
To date, CTP has not yet issued any Untitled Letters.  Warning Letters issued by CTP may be accessed below.

• Tobacco Retailer Warning Letters - Warning Letters issued by CTP to tobacco retailers for violations observed during a compliance check inspection.
• Other Tobacco-Related Warning Letters

CVM

• Advisory Action Letters (Warning Letters and Untitled Letters) - CVM's Advisory Action Letters website includes all Untitled Letters issued by the Center, but not those issued by the field offices.