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Editorial |

FDA Encourages Reporting of Tobacco Product Adverse Experiences

Sandra S. Retzky, DO, JD, RPh, MPH
Author and Funding Information

FINANCIAL/NONFINANCIAL DISCLOSURES: None declared.

Center for Tobacco Products, US Food and Drug Administration, Silver Spring, MD

CORRESPONDENCE TO: Sandra S. Retzky, DO, JD, RPh, MPH, Office of Science, Center for Tobacco Products, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993


Copyright 2016, . All Rights Reserved.


Chest. 2016;150(6):1169-1170. doi:10.1016/j.chest.2016.08.1452
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Reporting adverse health experiences resulting from tobacco product use is an important public health initiative. The US Food and Drug Administration (FDA) has a Safety Reporting Portal (SRP) for reporting issues involving tobacco products, in addition to human or animal drug products, foods, and dietary supplements. Although most health-care professionals are familiar with reporting drug-related adverse events, they may be unaware that unexpected health or safety concerns arising from tobacco product use can also be reported. “Tobacco products” means any product made or derived from tobacco and not approved by the FDA for therapeutic use. This includes but is not limited to cigarettes, roll-your-own tobacco, cigars, smokeless tobacco, e-cigarettes, water pipe tobacco, pipe tobacco, and delivery devices and components such as e-cigarette devices and water pipe equipment. Anyone—health-care professionals, researchers, manufacturers, or the public—can submit a report to the SRP.

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