The Department of Health and Human Services' Safety Reporting Portal was revised to add a new category for tobacco products. It provides a standardized way for consumers and healthcare professionals to let the FDA know when they suspect that there is an unexpected health or safety issue with a specific tobacco product, officials said.
Dr. Ii-Lun Chen, medical branch chief in the Office of Science at FDA's Center for Tobacco Products, said a new online tool can help report a problem.
Until now, consumers reported problems with tobacco products to FDA via MedWatch, the FDA Safety Information and Adverse Event Reporting Program, a system that does not ask questions specific to tobacco products.
"There is no known safe tobacco product, but FDA can play a role in helping prevent certain unexpected health consequences from tobacco products, such as those that occur from defective tobacco products, or health or safety problems beyond those normally associated with tobacco product use," Chen said in a statement.
The FDA is interested in reports from consumers about tobacco products that are damaged, defective or contaminated, such as cigarettes containing mold. It could also be that a tobacco product just smells or tastes wrong Chen said.
FDA also wants to know if tobacco product users have experienced an unexpected health or other safety problem that they believe has been caused by use of a particular tobacco product. These could include reports of fire caused by tobacco product use, burns or other injuries, accidental or unintended exposure of children, allergic reactions, poisonings and other toxicities, or an unusual reaction in a longtime user.
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