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  6. Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age (Final Rule)
  1. Economic Impact Analyses of FDA Regulations

Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age (Final Rule)

The final rule makes conforming changes as required by the Further Consolidated Appropriations Act, 2020 (Appropriations Act), which established a new Federal minimum age of sale for tobacco products. These conforming changes include increasing the minimum age of sale for cigarettes, smokeless tobacco, and covered tobacco products from 18 to 21 years of age; increasing the minimum age for age verification by means of photographic identification for cigarettes, smokeless tobacco, and covered tobacco products from under the age of 27 to under the age of 30; increasing the minimum age of individuals who may be present or permitted to enter facilities that maintain vending machines to sell cigarettes, smokeless tobacco, or covered tobacco products from 18 to 21 years of age; and increasing the minimum age of individuals who may be present or permitted to enter facilities that maintain self-service displays that sell cigarettes or smokeless tobacco from 18 to 21 years of age. In cases where the relevant statutory provisions are entirely self-implementing even in the absence of the regulation, or the regulatory action is one “over which an agency clearly has essentially no regulatory discretion”, OMB's Circular A-4 allows for the use of a “with-statute” baseline. A with-statute baseline means that an Agency is only tasked to assess the impacts of the rule that are up to its discretion. Section 603(b) of the Appropriation Act charges FDA with publishing “in the Federal Register a final rule to update the regulations issued under chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 et seq.)” to make edits to conform the regulations to the statutory changes. As FDA “clearly has essentially no regulatory discretion” over any of the provisions of this rule, we do not assess costs, benefits, or transfers for this final rule.

Regulatory Impact Analysis

Federal Register: 89 FR 70483 
Publication Date: 08.30.2024
Docket: FDA-2020-N-1395 

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