Family Smoking Prevention and Tobacco Control Act Table of Contents

Family Smoking Prevention and Tobacco Control Act

Note: We have put short descriptions in parentheses next to the names of some sections. These descriptions list some of the topics covered in the sections that might not be readily apparent just by looking at the section title. These descriptions are not intended to be a comprehensive guide or to reflect FDA’s interpretation of the Tobacco Control Act. The descriptions may not include every point in each section. For complete information you must read the entire law.

Key:

* = Refers to section of Family Smoking Prevention and Tobacco Control Act
^# = Refers to section of Federal Food, Drug, and Cosmetic Act

Section 1* - Public Law 111-31 [H.R. 1256]; table of contents
Section 2* - Findings
(by Congress)
Section 3* - Purpose
(summary of law)
Section 4* - Scope and Effect
(intended effect; authority of Secretary of Agriculture; authority of Secretary of Treasury)
Section 5* - Severability
(if one part is not valid, the other parts still are valid)
Section 6* - Modification of Deadlines for Secretarial Action

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Title I – Authority of the Food and Drug Administration

Section 101* - Amendment of Federal Food, Drug, and Cosmetic Act (FDCA)

Chapter IX of the FDCA — Tobacco Products

Section 900# - Definitions
Section 901# - FDA Authority over Tobacco Products
(limits of authority over tobacco leaf; establish the Center for Tobacco Products and establish an office to assist small tobacco product manufacturers)
Section 902# - Adulterated Tobacco Products
(filthy, putrid or decomposed; prepared under insanitary conditions; user fees not paid; not conforming to tobacco product standards; required premarket review and no Sec 910 order; violates Sec 910 or 911)
Section 903# - Misbranded Tobacco Products
(false, misleading, or incomplete labeling; manufactured in an unregistered establishment; prior approval of label statements; also relevant warnings)
Section 904# - Submission of Health Information to the Secretary
(listing all ingredients added to the tobacco product; description of the nicotine; listing all constituents identified as harmful or potentially harmful to health; documents related to research on health, toxicological, behavioral, or physiologic effects of tobacco products; documents on research on risk reduction; new additives and changes to additive amounts; must publish understandable list of harmful and potentially harmful constituents; and do consumer research to ensure list is not misleading)
Section 905# - Annual Registration
(registration by owners and operators; biennial inspections; report required to introduce substantially equivalent products and exemptions from these requirements)
Section 906# - General Provisions Respecting Control of Tobacco Products
(restrictions on sale and marketing; limits on restrictions related to prescriptions, retail sales, and minimum age; matchbooks; remote sales; and Good Manufacturing Practices (GMPs))
Section 907# - Tobacco Product Standards
(characterizing cigarette flavors; menthol; dissolvables; pesticides; tobacco product standards; reducing nicotine; cannot require zero nicotine; referral to Advisory Committee)
Section 908# - Notification and Other Remedies
(recall authority)
Section 909# - Records and Reports on Tobacco Products
(regulations to require certain records and reports, for example, about adverse experiences and removal from the market)
Section 910# - Application for Review of Certain Tobacco Products
(pre-market review required; substantial equivalence; application process for new products; exemption for investigational use)
Section 911# - Modified Risk Tobacco Products
(marketing a modified risk tobacco product, such as those using the descriptors "light," "mild," or "low"; postmarket surveillance and studies required to determine the impact on consumer perception; tobacco dependence products)
Section 912# - Judicial Review
Section 913# - Equal Treatment of Retail Outlets
(advertising restrictions)
Section 914# - Jurisdiction of and Coordination with the Federal Trade Commission
Section 915# - Regulation Requirement
(small tobacco product manufacturers; testing, reporting, and disclosure)
Section 916# - Preservation of State and Local Authority
Section 917# - Tobacco Products Scientific Advisory Committee
Section 918# - Drug Products Used to Treat Tobacco Dependence
Section 919# - User Fees
(authorizes FDA to collect fees from manufacturers and importers of tobacco products)
Section 102* - Final Rule
(requirement for FDA to issue regulations regarding cigarettes and smokeless tobacco products, for example, restrictions on free samples)
Section 103* - Conforming and other Amendments to General Provisions
(prohibited acts: counterfeit tobacco product; failure to notify about knowledge of illicit trade; misleading consumers that FDA approves the tobacco product; no-tobacco-sale orders; civil money penalties; state contracts to inspect retailers; report on exports to Congress; effective dates of certain package label requirements; effective dates of certain advertising requirements)
Section 104* - Study on Raising the Minimum Age to Purchase Tobacco Products
Section 105* - Enforcement Action Plan for Advertising and Promotion Restrictions
Section 106* - Studies of Progress and Effectiveness

Title II – Tobacco Product Warnings; Constituent and Smoke Constituent Discloser

Section 201* - Cigarette Label and Advertising Warnings
(placement; typography; does not apply to foreign distribution; label statements on matchbooks; random display and quarterly rotation; graphics depicting negative health consequences)
Section 202* - Authority to Revise Cigarette Warning Label Statements
Section 203* - State Regulation of Cigarette Advertising and Promotion
Section 204* - Smokeless Tobacco Labels and Advertising Warnings
Section 205* - Authority to Revise Smokeless Tobacco Product Warning Label Statements
Section 206* - Tar, Nicotine, and Other Smoke Constituent Disclosure to the Public

TITLE III – Prevention of Illicit Trade in Tobacco Products

Section 301* - Labeling, Recordkeeping, Records Inspection
(use of statement "Sale only allowed in United States"; recordkeeping for tracking and tracing; illicit trade and illegal transactions)
Section 302* - Study and Report
(study on cross-border trade)