Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 5.8 - TOBACCO PRODUCTS

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 5.8.1 - DEFINITIONHighlighted to denote updated text

The term "tobacco product" is defined in FD&C Act Section 201 (rr) and means any product made or derived from tobacco that is intended for human consumption, including any component part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product.) The term "tobacco product" does not mean an article that is a drug under section 201(g)(1) of the FD&C Act, a device under section 201(h) of the FD&C Act, or a combination product described in section 503(g) of the FD&C Act.Highlighted to denote updated text

The term “cigarette” is defined in section 3(1) of the Federal Cigarette Labeling and Advertising Act and FD&C Act Section 900(3).

The term “cigarette tobacco” is defined in FD&C Act Section 900(4).

The term “roll-your-own tobacco” is defined in FD&C Act Section 900(15).Highlighted to denote updated text

The term “smokeless tobacco” is defined in FD&C Act Section 900(18).

 5.8.2 - TOBACCO INSPECTIONS

See IOM 2.2 for discussion of statutory authority.Highlighted to denote updated text

For the first few years, inspections involving tobacco product(s) at manufacturing facilities should be made pursuant to an assignment until a Compliance Program is developed. CTP’s office of Compliance and Enforcement and ORA’s Division of Medical Products and Tobacco Program Operations are Highlighted to denote updated text available to work with the field during inspections.

 5.8.3 - RETAIL COMPLIANCE CHECK INSPECTION CONTRACTS

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amended the FD&C Act to direct FDA to contract with States to inspect retailers within that State in connection with the enforcement of the Act and its implementing regulations related to tobacco products when feasible.

 5.8.4 - GUIDANCE, COMPLIANCE & REGULATORY INFORMATION

The Center for Tobacco Products website contains resources for legal, regulatory, and policy issues related to tobacco products and information for small business assistance.

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Page Last Updated: 08/20/2014
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