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OCR Page 1 of 44TITLE III: Penalties and Enforcement; Consent Decrees;
Non-Participating Companies
A.
Penalties and Enforcement
This legislation will be enforceable both by the federal government,
including FDA and civil and criminal divisions of the Department of
Justice, and by the several States. FDA will also have the
authority to contract directly with state agencies to assist with
enforcement. If conduct is subject to a particular State's consumer
protection law or similar statute, such state may proceed under that
law.
State enforcement actions -- whether brought under the Act or a
State's consumer protection law -- could not impose obligations or
requirements beyond those imposed by the legislation (except
where the legislation does not specifically preempt additional state-
law obligations), and would be limited to the civil and criminal
penalties established by the legislation and by the prohibition on
duplicative penalties. State enforcement proceedings under the
Act (or predicated on conduct violating the Act), except those
exclusively local in nature, would be removable to federal court.
Nothing in the Act precludes a State from enforcing its laws in the
ordinary fashion as to matters not covered by the Act or Protocol.
Civil and criminal penalties for violations of the legislation based on
those governing other drugs or devices regulated under the Food,
Drug and Cosmetic Act and, where applicable, under Title 18 of the
U.S. Code.
In addition, the industry faces civil penalties of up to $10 million per
violation for any violations of the obligations to disclose to the FDA
research about tobacco-product health effects and information
regarding the toxicity of non-tobacco ingredients and constituents
used in their products. This penalty is ten times the largest penalty
faced by other drug or device manufacturers for similar violations.
To reflect the fact that not all States have filed lawsuits against the
tobacco industry, but that the intent of the negotiators is to provide
the benefits of the settlement to all States, the industry also will
enter into a binding and enforceable national tobacco control
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