FDA Announces Intent to Regulate OTP

FDA expects to issue a deeming regulation in summer 2012 to cover other tobacco products.

Cigars, e-cigs and cigarillos are among tobacco products about to meet with U.S. Food and Drug Administration (FDA) scrutiny. The agency has announced its intent to issue a “deeming regulation” sometime during the summer of 2012 to cover other tobacco products. 

The announcement was posted on the Federal Business Opportunities Website (www.fbo.gov). The statement by the FDA was included as a part of a solicitation announcement in which the agency is seeking a contractor to identify a list of all tobacco product advertisements in the U.S., the National Association of Tobacco Outlets (NATO) reported.

In the “Background” section of the solicitation announcement, the FDA states as follows:

“On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law (Public Law 111-31).  The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (Act) and granted the Food and Drug Administration (FDA) authority to regulate the manufacture, marketing, and distribution of tobacco products.  Currently, FDA regulates the following tobacco products: cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. See Section 901(b) of the Act.  The Act allows FDA to issue regulations asserting jurisdiction over other tobacco products, such as cigars, cigarillos, e-cigarettes, and hookahs, among others.  FDA expects to issue a deeming regulation in summer 2012 to cover other tobacco products.”

A deeming regulation is a proposed regulation that would include products meeting the definition of a “tobacco product” under the Tobacco Control Act to be subject to the FDA’s jurisdiction.  The Tobacco Control Act defines a “tobacco product” as meaning “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”

In other words, the FDA plans to issue sometime this summer a proposed regulation covering other tobacco products such as cigars, cigarillos, e-cigarettes, hookahs and possibly other tobacco products.  The extent of the proposed regulation is not known at this time, but will be published in the Federal Register when released by the FDA’s Center for Tobacco Products, NATO reported.

As described in the announcement, the purpose of the tobacco advertisement surveillance project is as follows:

“The overall objective of this project is to identify, collect, record, and track information on tobacco advertisements in electronic and hard copy publications (i.e., newspapers, magazines, alternative weekly papers, periodicals, trade journals, direct mails, and emails) to aid in our routine surveillance of promotional materials by tobacco industry. Tobacco advertisements include those for cigarettes, smokeless tobacco products, cigarette tobacco, and roll-your-own tobacco that are currently regulated by FDA, and other tobacco products that will be deemed under FDA jurisdiction once regulations are issued.”






  1. Cstorevisionllc says:

    Quit regulating!!! The American people are sick of it!!

  2. Anonymous says:

    It’s nice that the FDA continues to pile on the rules/regulations for ‘Big Tobacco’ yet still won’t approve any new products since March 2011.  Great job! 

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