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FDA Sets Up Portal for Unsafe Tobacco Products

SILVER SPRING, Md. -- The Food and Drug Administration (FDA) established a new online tool that allows consumers to report problems with tobacco products.

The Department of Health and Human Services' Safety Reporting Portal (SRP) has been revised to add a new category for tobacco products. This update provides a standardized way for consumers and health care professionals to let the FDA know when they suspect there's an unexpected health or safety issue with a specific tobacco product.

Prior to launching this new tool, consumers reported problems with tobacco products to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program, a system that does not ask questions specific to tobacco products, according to the agency.

"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," said Dr. Ii-Lun Chen, medical branch chief in the Office of Science at FDA's Center for Tobacco Products.

According to the FDA, consumers should report tobacco products that are damaged, defective or contaminated, such as cigarettes containing mold. They can also report tobacco products that smell or taste wrong.

The agency also wants to know if tobacco product users have experienced any unexpected health or safety problem that they believe has been caused by use of a particular tobacco product. This 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 long-time user.

Reports may be submitted for cigarettes, tobacco used for roll-your-own cigarettes, other smoking tobacco, cigars, smokeless tobacco, electronic cigarettes or any other product made or derived from tobacco that is intended for human consumption and is not regulated by FDA as a drug or medical device, the agency said.

The FDA will use the reports to help build a comprehensive tobacco regulation program that ensures all tobacco products have an appropriate level of regulatory oversight.

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