FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products — including youth-appealing e-cigarettes — and conduct on-site inspections abroad.
Domestic tobacco product manufacturers are currently required under federal law to register their establishments and list their products with the FDA. In contrast, foreign tobacco product manufacturers are not subject to these requirements unless and until the FDA mandates their registration and product listing through regulation. This proposed regulation would implement this requirement, closing this regulatory gap. With a more complete picture of the products manufactured for sale to American consumers and where they come from, the FDA can better protect public health and more efficiently identify and take action on unauthorized tobacco products such as e-cigarettes that are imported and illegally sold in the U.S.
Under the proposed rule, titled “Establishment Registration and Product Listing for Tobacco Products,” the FDA would prescribe the format, content, and procedures for establishment registration and tobacco product listing. This would include both foreign and domestic establishments that manufacture, prepare, compound, or process tobacco products.
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