The 2009 Family Smoking Prevention and Tobacco Control Act gave the United States Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution and marketing of tobacco products to protect public health. Products included under this regulatory authority included cigarettes, smokeless tobacco, roll-your-own tobacco, and any other product the FDA deemed subject to the law. The Tobacco Control Act has dramatically changed how tobacco products are sold and marketed in stores. 

On May 5, 2016, the FDA finalized additional deeming regulations on tobacco products. This expands products under FDA regulatory authority to also include electronic nicotine delivery systems (e.g. e-cigarettes, vape pens, e-hookah, advanced refillable personal vaporizers, electronic pipes), all cigars (including little cigars, cigarillos, and premium cigars), hookah (water pipe) tobacco, pipe tobacco, nicotine gels, dissolvables, and any novel and future tobacco products. 

FinalDeeming_TCLC Table
Table created by the Tobacco Control Legal Consortium, originally published in their document “The Deeming Regulation: FDA Authority Over E-Cigarettes, Cigars, and Other Tobacco Products”

The act also prohibits:

  • Tobacco products marketed with modified risk health descriptors such as “light,” “mild,’ or low tar, unless specifically approved by the FDA.
  • Non-tobacco gifts with purchase, such as free t-shirts, baseball caps, key chains, lighters, etc.

The act also requires:

  • Pre-market review and authorization of new tobacco products by the FDA. Any product that was not on the market prior to February 15, 2007 must undergo review through one of three pathways: substantial equivalence (SE), exemption from SE, or pre-market tobacco application (PTMA). This tobacco product review process allows the FDA to evaluate the ingredients, product design, health risks, and youth appeal of tobacco products before allowing them to be marketed.
  • Health warnings on advertisements (including warnings for nicotine).
POS HW on ads at
Required health warnings on advertisements, located on the side of a retailer.

Future regulations: flavors

While cigarette with characterizing flavors (left) were banned in 2009, flavored little cigars and cigarillos have grown in prevalence, and menthol cigarettes (right) are excluded from then ban.
While cigarette with characterizing flavors (left) were banned in 2009, flavored little cigars and cigarillos (middle) have grown in prevalence, and menthol cigarettes (right) are currently excluded from then ban.

Future Regulations: Nicotine-levels

  • July 28, 2017, the U.S. Food and Drug Administration announced its plan to lower the burden of tobacco-related disease and death by pursuing regulations to lower nicotine levels in cigarettes to non-addictive levels, while encouraging the development of innovative tobacco products that may be less dangerous to public health than cigarettes. 
  • On March 15th, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced an ANPRM aimed at reducing nicotine in cigarettes to non-addictive levels. FDA-funded research published in the New England Journal of Medicine shows that this type of nicotine reduction could result 5 million more adults quitting within a year of implementation, and by 2100, could result in 33 fewer people becoming smokers, a drop in the smoking rate to as low as 1.4%, and could prevent 8 million tobacco-related deaths.See more here. However, advocacy groups like ACSCAN are also calling for a maximum nicotine level for all combustible products, not just for cigarettes. See the ANPRM summary and submit comments here
  • In order to allow the FDA to encourage innovation that has the potential to make a notable public health difference—and to inform future policies and efforts that will protect kids and help smokers quit cigarettes—the agency intends to extend timelines to submit tobacco product review applications for newly-regulated products that were on the market as of August 8, 2016. Under the expected revised timelines:
    • Applications to market newly-regulated combustible products, such as cigars, pipe tobacco, and hookah tobacco, would be submitted by August 8, 2021.
    • Applications to market newly-regulated non-combustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, would be submitted by August 8, 2022.
  • Learn more about the planned regulations on the FDA site on their new plan. 


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