Thème
Tobacco
Toutes les réglementations du corpus Vantage taguées avec tobacco. Les éléments sont tagués par le cron d'enrichissement dès leur arrivée, plus toute attribution thématique pré-renseignée par le connecteur.
Derniers éléments
Ouvrir dans le navigateur →Regulatory Hearing Before the Food and Drug Administration
21 CFR Part 16 establishes procedures for regulatory hearings before the FDA when the Commissioner considers regulatory actions affecting drugs, devices, food, cosmetics, and tobacco products. Hearings are available under specific statutory provisions including premarket approval withdrawals, device bans, mandatory recalls, investigational device exemptions, and tobacco product orders. The procedures apply when the Commissioner discretionarily offers a hearing or when statutory provisions mandate one, but exclude informal presentations and certain admission refusals.
Enforcement Policy
FDA enforcement policy governing regulatory actions under the Federal Food, Drug, and Cosmetic Act. Establishes procedures for recalls, corrections, and voluntary removals of violative products including foods, drugs, devices, cosmetics, biologics, and tobacco. Defines recall classifications based on health hazard severity and clarifies distinctions between recalls, market withdrawals, and stock recoveries.
Civil Money Penalties Hearings
21 CFR Part 17 establishes procedures for FDA administrative hearings on civil money penalties for violations of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Penalties apply to violations involving prescription drug marketing, medical devices, pesticide residues, clinical trials, direct-to-consumer drug advertising, biologics, electronic products, mammography standards, vaccine record falsification, and tobacco products.
General
21 CFR Part 1105 establishes FDA's premarket submission requirements for tobacco products. The regulation specifies grounds for refusing to accept applications, including submissions that lack required contact information, English translation, proper FDA forms, product identification details, environmental assessments, or a U.S. agent signature for foreign applicants. Accepted submissions receive a tracking number and processing acknowledgement.
Premarket Tobacco Product Applications
21 CFR Part 1114 establishes procedures and requirements for submitting premarket tobacco product applications (PMTAs) to the FDA, including evaluation procedures and postmarket reporting obligations. The regulation defines key terms such as tobacco product accessories, additives, adverse experiences, brand characteristics, and composition, and specifies the scope of applicability, excluding premium cigars and modified risk tobacco product applications unless they seek dual marketing orders.
Exemption Requests and Substantial Equivalence Reports
21 CFR Part 1107 establishes the FDA's process for granting exemptions from substantial equivalence reporting requirements for minor modifications to legally marketed tobacco products involving changes to tobacco additives. Manufacturers must submit detailed requests to the Center for Tobacco Products demonstrating that the modification is minor, does not require a substantial equivalence report to protect public health, and does not increase appeal to minors, toxicity, addictiveness, or abuse liability.
General
21 CFR Part 1100 establishes FDA authority over tobacco products, defining the scope of regulations under the Federal Food, Drug, and Cosmetic Act. It covers cigarettes, smokeless tobacco, roll-your-own tobacco, and nicotine-containing products, while clarifying definitions of accessories, components, and packaging. Products intended for drug purposes (smoking cessation, disease treatment) are excluded from tobacco regulation.
Cigarettes, Smokeless Tobacco, and Covered Tobacco Products
21 CFR Part 1140 establishes federal restrictions on the sale, distribution, and use of cigarettes, smokeless tobacco, and covered tobacco products under the Federal Food, Drug, and Cosmetic Act. The regulation defines key terms including cigarettes, smokeless tobacco, covered tobacco products, accessories, components, manufacturers, distributors, and importers. The primary purpose is to reduce youth access and use of tobacco products and mitigate health consequences from tobacco consumption.
Minimum Required Warning Statements
21 CFR Part 1143 establishes definitions and minimum required warning statements for tobacco products subject to federal regulation. It defines key terms including cigars, cigarettes, roll-your-own tobacco, accessories, and components, and specifies packaging and point-of-sale requirements. The regulation mandates warning statements on packaging and advertisements for cigarette tobacco, roll-your-own tobacco, cigars, and other covered tobacco products, including warnings regarding nicotine addictiveness.
Required Warnings for Cigarette Packages and Advertisements
This regulation establishes requirements for warning labels on cigarette packages and advertisements sold in the United States. It defines key terms including cigarette, manufacturer, distributor, and retailer, and clarifies that retailers are not liable for compliant packaging supplied by licensed manufacturers, though they remain responsible for advertisements they display or alter.
User Fees
21 CFR Part 1150 establishes user fee requirements for tobacco product manufacturers and importers under the Federal Food, Drug, and Cosmetic Act. Domestic manufacturers and importers must pay their proportional share of annual FDA user fees based on product removals. Monthly reporting to FDA is required by the 20th of each month, including identification information, units of product removed by class (cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, roll-your-own tobacco), and Federal excise taxes paid.