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  1. Rules, Regulations and Guidance

Family Smoking Prevention and Tobacco Control Act Table of Contents

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.


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

Table of Contents

(by Congress)

(summary of law)

(intended effect; authority of Secretary of Agriculture; authority of Secretary of Treasury)

(if one part is not valid, the other parts still are valid)

Title I – Authority of the Food and Drug Administration

Chapter IX of the FDCA — Tobacco Products

(limits of authority over tobacco leaf; establish the Center for Tobacco Products and establish an office to assist small tobacco product manufacturers)

(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)

(false, misleading, or incomplete labeling; manufactured in an unregistered establishment; prior approval of label statements; also relevant warnings)

(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)

(registration by owners and operators; biennial inspections; report required to introduce substantially equivalent products and exemptions from these requirements)

(restrictions on sale and marketing; limits on restrictions related to prescriptions, retail sales, and minimum age; matchbooks; remote sales; and Good Manufacturing Practices (GMPs))

(characterizing cigarette flavors; menthol; dissolvables; pesticides; tobacco product standards; reducing nicotine; cannot require zero nicotine; referral to Advisory Committee)

(recall authority)

(regulations to require certain records and reports, for example, about adverse experiences and removal from the market)

(pre-market review required; substantial equivalence; application process for new products; exemption for investigational use)

(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)

(advertising restrictions)

(small tobacco product manufacturers; testing, reporting, and disclosure)

(authorizes FDA to collect fees from manufacturers and importers of tobacco products)

(requirement for FDA to issue regulations regarding cigarettes and smokeless tobacco products, for example, restrictions on free samples)

(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)

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

(placement; typography; does not apply to foreign distribution; label statements on matchbooks; random display and quarterly rotation; graphics depicting negative health consequences)

TITLE III – Prevention of Illicit Trade in Tobacco Products

(use of statement "Sale only allowed in United States"; recordkeeping for tracking and tracing; illicit trade and illegal transactions)

(study on cross-border trade)

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