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.  The Agency contracted with the Institute of Medicine in 2013 to convene a committee to: examine existing literature on tobacco use initiation, and; to 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.

Section 104(2) requires the Agency to submit a report to Congress on the results of such study.

A copy of the report is available here: Section 104(2) Report to Congress


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

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products and protect the public from the harmful effects of tobacco product use. 

Section 106(a) of the Tobacco Control Act requires the Secretary of the Department of Health and Human Services to submit to Congress a report detailing 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, including key accomplishments, objective measures of progress, and impediments to progress since it was signed into law on June 22, 2009.

A copy of the report is available here: Report to Congress on the Progress and Effectiveness of the Implementation of the Family Smoking Prevention and Tobacco Control Act, as Required by Section 106(a) 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 801(p)(1) of the Food, Drug and Cosmetic Act, as amended by 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 concluded in the initial report that there are currently no documented instances of the export of tobacco products that do not conform to current U.S. tobacco product standards.  The Report was submitted to Congress on April 25, 2013 and contains FDA’s findings, along with supporting data and information.

FDA submitted its second Report to Congress on Tobacco Product Exports That Do Not Conform to Tobacco Product Standards Required by Section 801(P)(1) on November 3, 2014. FDA’s conclusions in this report are the same as those issued in the 2013 report.

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 Food, Drug & Cosmetic 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.”
 
The Section 918 report was submitted to Congress on April 22nd, 2013. The report discusses FDA’s actions and current policies relating to fast track processes and new indications for NRT products, in addition to the regulation of “innovative products and treatments” for achieving abstinence, reductions in consumption, and reductions in harm. 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, and the input received at that hearing (including comments submitted to the associated docket) has been taken into account in the development of the report to Congress.  

A copy of the report is available here: Section 918 Report to Congress

Page Last Updated: 03/24/2016
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