SUBCHAPTER 5.8 - TOBACCO PRODUCTS

5.8 - TOBACCO PRODUCTS
5.8.1 - TOBACCO INSPECTIONS
5.8.2 - TECHNICAL ASSISTANCE
5.8.3 - RETAIL COMPLIANCE CHECK INSPECTION CONTRACTS
5.8.4 - GUIDANCE, COMPLIANCE & REGULATORY INFORMATION

5.8 - TOBACCO

 5.8.1 - TOBACCO INSPECTIONS

See IOM 2.2 for discussion of statutory authority.

The term “cigarette” is defined in section 3(1) of the Federal Cigarette Labeling and Advertising Act Section 1332(1) 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(4). The term “smokeless tobacco” is defined in FD&C Act Section 900(18). 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. FD&C Act Section 201(rr).

 5.8.2 - TECHNICAL ASSISTANCE

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 is 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 it’s implementing regulations related to tobacco products when feasible.

 5.8.4 - GUIDANCE, COMPLIANCE & REGULATORY INFORMATION

Resources for legal, regulatory, and policy issues related to tobacco products are available on the internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm