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                Rules, Regulations and Guidance

Rules, Regulations and Guidance

                        Rules and Regulations
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          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview Home
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Section 104(2) Report to Congress: Study on Raising the Minimum Age to Purchase Tobacco Products
	Section 106(a) Report to Congress: Progress and Effectiveness of the Implementation of the Family Smoking Prevention and Tobacco Control Act
	Section 801(p)(1) Report to Congress: Tobacco Product Exports That Do Not Conform to Tobacco Product Standards Required by Section 801(p)(1) of the Federal Food, Drug, and Cosmetic Act
	Section 918 Report to Congress: Innovative Products and Treatments to Achieve Abstinence from Tobacco Use, Reductions in Consumption of Tobacco, and Reductions in the Harm Associated with Continued Use
	Report to the House Committee on Appropriations on Tobacco Product User Fees
	The Consolidated Appropriations Act of 2022Section 104(2) Report to Congress: Study on Raising the Minimum Age to Purchase Tobacco Products

Section 104(1) of the Tobacco Control Act requires FDA to convene an expert panel to conduct a study of the public health implications of raising the minimum age to purchase tobacco products and to submit a report to Congress on the results of such study.

The Agency contracted with the Institute of Medicine (IOM) in 2013 to convene a committee to:

examine existing literature on tobacco use initiation
	use modeling and other methods, as appropriate, to predict the likely public health outcomes of raising the minimum age for purchase of tobacco products to 21 years and 25 years.IOM published a report of its study in 2015: Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products.

In 2016, the Agency submitted its report to Congress: Section 104(2) Report to Congress on the Study on Raising the Minimum Age to Purchase Tobacco.

Section 106(a) Report to Congress: Progress and Effectiveness of the Implementation of the Family Smoking Prevention and Tobacco Control Act

Section 106(a) of the Tobacco Control Act requires the Secretary of the Department of Health and Human Services to submit a Report to Congress on the Progress and Effectiveness of the Implementation of the Family Smoking Prevention and Tobacco Control Act.

This report provides an assessment of FDA’s effort to implement the Tobacco Control Act since it was signed into law on June 22, 2009, including:

key accomplishments
	objective measures of progress
	impediments to progressSection 801(p)(1) Report to Congress: Tobacco Product Exports That Do Not Conform to Tobacco Product Standards Required by Section 801(P)(1) of the Federal Food, Drug, and Cosmetic Act

Section 801(p)(1) of the Tobacco Control Act requires the Secretary to submit to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce a report regarding:

**A.** the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act; **B**. the public health implications of such exports, including any evidence of a negative public health impact; and**C.** recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports.
FDA has concluded annually, since the initial report in 2013, that there are currently no documented instances of the export of tobacco products that do not conform to current U.S. tobacco product standards.

**Annual Report to Congress on United States Tobacco Product Exports that Do Not Conform to Tobacco Product Standards Required by Section 801(p)(1) of the Federal Food, Drug, and Cosmetic Act**

2023
	2022
	2021
	2020
	2019
	2018
	2017
	2016
	2015
	2014
	2013Section 918 Report to Congress: Innovative Products and Treatments to Achieve Abstinence from Tobacco Use, Reductions in Consumption of Tobacco, and Reductions in the Harm Associated with Continued Use

Section 918 of the Tobacco Control Act requires the Secretary to submit a report to Congress, after consultation with recognized scientific, medical, and public health experts, that "examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine based products and treatments) to better achieve, in a manner that best protects and promotes the public health –

**A**. total abstinence from tobacco use;**B**. reductions in consumption of tobacco; and**C.** reductions in the harm associated with continued tobacco use."

On December 17, 2012, FDA held a public hearing, under 21 CFR Part 15, to gather input from all interested stakeholders on the full range of issues raised by Section 918. The input received at that hearing (including comments submitted to the associated docket) was taken into account in the development of the report to Congress.

FDA submitted the Section 918 Report to Congress on April 22, 2013. The report discusses FDA’s actions and current policies relating to fast track processes and new indications for nicotine replacement therapy (NRT) products, in addition to the regulation of “innovative products and treatments” for achieving abstinence, reductions in consumption, and reductions in harm.

Report to the House Committee on Appropriations on Tobacco Product User Fees

On December 27, 2020, the Consolidated Appropriations Act, 2021 (P.L. 116-260) was enacted into law, which provided appropriations under Division A, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021 for the fiscal year ending September 30, 2021. The accompanying Joint Explanatory Statement directed the Food and Drug Administration (FDA or the Agency) to report on tobacco product user fees (PDF).
	On February 15, 2019, the Consolidated Appropriations Act, 2019 (P.L. 116-6), was enacted into law, which provided appropriations under the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill for the fiscal year ending September 30, 2019.  The accompanying House Report 115-706 directed the Food and Drug Administration (FDA or the Agency) to report on tobacco product user fees (PDF).
	On March 23, 2018, the Consolidated Appropriations Act, 2018 (P.L.115-141), was enacted into law, which provided appropriations under the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018, for the fiscal year ending September 30, 2018. The accompanying House Report 115-232 directed the Food and Drug Administration (FDA or the Agency) to report on tobacco product user fees (PDF).The Consolidated Appropriations Act of 2022

The Consolidated Appropriations Act of 2022 (Public Law 117-103), signed into law on March 15, 2022, (1) provided appropriations to federal agencies, (2) modified or established various programs to address a wide range of policy areas, and (3) requires yearly reporting by FDA on specific information and data related to its tobacco regulation activities. This report to Congress satisfies this annual reporting requirement by providing information and data about the funding, application review, regulatory work, and compliance and enforcement efforts of FDA in fiscal year 2022.

Additional Resources

Understanding the U.S. Illicit Tobacco Market: Characteristics, Policy Context, and Lessons from International Experiences
	Tobacco Control Act

                                                                                  Content current as of:
      07/06/2022
              
              
Regulated Product(s)
		 TobaccoRules, Regulations and Guidance

          
                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview
 
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