Tobacco Products

Reports to Congress


Section 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 disclaimer icon.

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 progress 

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 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. 

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

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.


Page Last Updated: 09/08/2016
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