U.S. FDA Updates Safety Reporting Portal for Tobacco

The U.S. Food and Drug Administration has made several updates to the desktop Safety Reporting Portal (SRP) tobacco questionnaire to improve the clarity, internal consistency and utility of the information being collected, according to the regulatory agency. The move will enhance the agency’s Center for Tobacco Products’ (CTP) public health surveillance for new and existing safety signals.

Some of the updates include:

• Questions have been edited for inclusiveness and clarity that FDA is interested in health and product problems arising both from direct use of (by users) or exposure to (in nonusers) tobacco products
• Questions about a tobacco product’s manufacturer are now designed with a search/select response list that provides submitters who know the manufacturer’s name with the full contact information for many of the manufacturers
• The optional health questions now include questions about use of alcohol and other substances of abuse, and ask more details about diagnostic testing, treatment settings, and final health outcomes

Additionally, when manufacturers register an account in the SRP, they are asked to specify the type of manufacturer.

“FDA encourages anyone who has had a reaction to, or was hurt by, a tobacco product – or knows someone who experienced such effects – to visit the SRP and provide as much information as possible,” according to an FDA statement. “Reports from consumers/concerned citizens and healthcare professionals may be submitted anonymously, but including contact information allows FDA the option to find out more about the adverse experience. FDA reviews all tobacco-related SRP reports to identify new or concerning trends.”