, ,

FDA Seeks Public Reporting of Tobacco Product Safety Issues

April 14, 2017 at 4:36 pm

The Food and Drug Administration Center for Tobacco Products has recently launched a website seeking public reporting of unexpected health or safety issues with all tobacco products.  Public reporting can be done on the FDA CTP reporting portal here.

While the media has noted battery issues with e-cigarettes leading to burns and accidental poisoning from e-cigarette solutions, the FDA is seeking to collect more comprehensive national data on unexpected adverse health effects resulting from use of all tobacco products.  The FDA is particularly interested in physician input because physicians are likely to treat patients who have been affected.

Reports can be submitted on any tobacco product, including cigarettes, roll-your-own cigarettes, cigars, smokeless tobacco, electronic cigarettes and waterpipe tobacco. Reports can be submitted on components and parts of tobacco products.

What to Report

The FDA is interested in reports from consumers, manufacturers, clinical investigators, and health professionals about tobacco products that:

  • are damaged
  • are defective
  • are contaminated
  • smell or taste wrong

Health and safety issues could include:

  • fire, burns, and other injuries
  • accidental or unintended tobacco product exposures in children
  • allergic reactions
  • poisonings and other toxicities
  • an unusual reaction in a long-time user

What FDA Does with Reports

The FDA is building a comprehensive tobacco regulation program to make sure all tobacco products have an appropriate level of regulatory oversight. All reports submitted to the Safety Reporting Portal will be reviewed and evaluated by the FDA; when appropriate the reports will be addressed.

Advertisement

ATS 2016 Full Registration