New York City and National Public Health Organizations Petition FDA on “Track-andTrace”

Citizen Petition Calling on FDA to Implement the Track & Trace Tobacco System Required by the Family Smoking Prevention and Tobacco Control Act

Section 920(b)(3) of the Federal Food, Drug, and Cosmetic Act (as added by section 301 of the Family Smoking Prevention and Control Act, or “the Tobacco Control Act”) mandates that the FDA implement a national track-and-trace system to monitor the manufacture and flow of tobacco products from production through distribution to retail outlets. We request that the FDA fulfill this statutory obligation by issuing proposed rules on track-and-trace by June 1, 2013. A track-and-trace system would promote the public health objectives of the Tobacco Control Act by ensuring compliance with tobacco product standards and other regulations issued by the FDA. It will also disrupt the illicit trade, trafficking and counterfeiting of cigarettes. Finally, it will increase revenue for federal, state, and local governments that tax tobacco products, while helping to maintain high tobacco prices with their downward impact on smoking rates.


Issue regulations requiring counterfeit-resistant identifying codes on the labels of the tobacco products, or other designs or devices for the purpose of tracking and tracing tobacco products from the point of manufacture, through the distribution chain to the point of retail sale.

  • Require that any implemented track-and-trace system have the capacity to determine the date of manufacture, payment records, and shipping information on the smallest unit of tobacco offered for retail sale (i.e. the level of the pack for cigarettes).
  • Partner with state and local governments to provide them with shipping, receiving, and sales information which can help identify illicit activity.
  • Hold manufacturers, distributors, wholesalers and retailers accountable for maintaining complete records of their transactions and ensuring legal sales of their products.


A track-and-trace system ensures that every participant in the legal market for tobacco products—from manufacturer to wholesaler to retailer—is accountable for every product produced, received, maintained, and transferred, and that law enforcement can identify where in the distribution chain a contraband tobacco product was diverted into the illegal market.

  • Implementing this regulation would assist FDA in ensuring timely compliance with numerous provisions of the Tobacco Control Act, as well as other federal tobacco laws.
  • A track-and-trace system will disrupt the trafficking of cigarettes that are untaxed or taxed in one jurisdiction and sold illicitly in another jurisdiction. The Department of Justice estimates that illegal tobacco sales cost federal and state governments $5 billion annually.

Improving the enforcement against cigarette trafficking will generate much needed government revenue, and some of the recouped tax revenue could be directed towards tobacco cessation and other health programs. Improving the enforcement against cigarette trafficking will also disgorge large, illicit profits from organized criminal actors. Worldwide, cigarette trafficking is a multibillion dollar enterprise, and some cigarette smugglers have been linked to terrorist groups. 2,3,4,5

By reducing illicit sales, a track-and-trace system will increase the public health benefits of the Tobacco Control Act.

1 U.S. Department of Justice’s Office of the Inspector General. The Bureau of Alcohol, Tobacco, Firearms and Explosives’ Efforts to Prevent the Diversion of Tobacco. 2009. Available

2 U.S. GAO Report, (March 2011) (citing U.S. General Accounting Office), Terrorist Financing: U.S. Agencies Should Systematically Assess Terrorists’ Use of Alternative Financing Mechanisms, GAO-04-163 (Nov. 2003); William Billingslea, Bureau of Alcohol, Tobacco, Firearms, and Explosives, Illicit Cigarette Trafficking and the Funding of Terrorism, Jul. 22, 2003)).

3 U.S. GAO Report, (March 2011) at 14.

4 Michael Beebe, Cigarette Smuggling Conspiracy Nets Prison for 2 Seneca Women, Buffalo News, Apr. 14, 2004 at B2.

5 Republican Staff of the U.S. House Committee on Homeland Security, U.S. Representative Peter T. King, Tobacco and Terror: How Cigarette Smuggling is Funding our Enemies Abroad, at 9 (Apr. 2008)