Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for ...

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Rule Summary: This proposed rule will extend the FDA's tobacco product regulatory authority to either "all other categories of products, except accessories of a proposed deemed tobacco product, that meet the statutory definition of 'tobacco product' in the FD&C Act," or all those indicated here with the exception of premium cigars. This will subject certain products such as electronic cigarettes, nicotine gels, and certain dissolvable tobacco products to the FD&C Act.

RIN: 0910-AG38

Agency: Department of Health and Human Services Food and Drug Administration 

Date Proposed by Agency: 04/25/2014
Stage: Closed Comment Period

Top Industry: Beverage and Tobacco Product Manufacturing

Restrictions: 349

 Word Count: 73149

Costs Monetized: Yes 

Benefits Monetized: No



  1. Regulation Title: The official title of the rulemaking used by the issuing agency.
  2. RIN: Regulation Identifier Number—a unique tracking number assigned by the Regulatory Information Service Center to each regulation under development or review by an agency.
  3. Stage: Shows where the rulemaking is in the regulatory process. Stages include:
     a. Open comment period: the proposed rule has been published in the Federal Register and the agency is taking public comments.
    b. Closed comment period: the public comment period for a rulemaking is closed.
    c. Pending final review: OIRA is reviewing what the agency intends to publish as the final regulation.
  4. Restrictions: The number of binding constraints or “restrictions” in the proposed regulation’s text. These are words that indicate an obligation to comply such as “shall” or “must.” Given the difficulty of measuring regulations, counting restrictions is one of the best ways to measure the size and scope of regulations. These numbers are obtained from using RegData
  5. Top Industry: The industry likely to be most affected by the regulation. Obtained using RegData.
  6. Costs Monetized: Shows whether the agency provides a quantitative estimate of the costs associated with the rule.
  7. Benefits Monetized: Shows whether the agency provides a quantitative estimate of the benefits associated with the rule.