FDA Tobacco Control Act and POS

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. 

Final Deeming Regulations Provisions. Minimum sales age of 18 and age verification under 27 applies to cigarettes, smokeless tobacco, cigars, e-cigarettes & others. Prohibition on vending machine sales anywhere except adult-only facilities applies to cigarettes, smokeless tobacco, cigars, e-cigarettes and other products. Prohibition on self-service displays in anywhere other than adult-only facilities applies only to cigarettes and smokeless tobacco. Minimum package size requirements apply only to cigarettes. Prohibition on breaking packages by retailers (e.g., sales of looses) applies only to cigarettes. Prohibition on free samples applies to cigarettes, cigars, e-cigarettes & other products. Free samples are allowed for smokeless tobacco in qualified adults-only facilities. Prohibition on characterizing flavors applies to cigarettes only (menthol and tobacco flavors are still allowed). For mandatory warning labels on packages and advertisements, there are 9 rotating warnings for cigarettes, 4 rotating warnings for smokeless tobacco, 6 rotating warnings for cigars, and 1 static warning for e-cigarettes and other products. The prohibition on brand names on non-tobacco products and brand name sponsorship of sporting and cultural events applies to cigarettes and smokeless tobacco. Required notice of advertising in any non-traditional medium applies to cigarettes and smokeless tobacco.
Table created by the Public Health Law Center, originally published in their document “The Deeming Regulation: FDA Authority Over E-Cigarettes, Cigars, and Other Tobacco Products”

As of April 14th, 2022 the FDA ‘s authority was expanded to include regulation of tobacco products containing nicotine derived from any source, including synthetic nicotine, rather than just tobacco products containing nicotine derived from tobacco. This closed a previous loophole that allowed tobacco companies to skirt regulation. For example, Puff Bar, the most popular brand of e-cigarettes among youth, had recently reintroduced their flavored disposable e-cigarette products to the market with claims of “tobacco-free nicotine,” and many oral nicotine pouch manufacturers had also started marketing products as tobacco-free.  Learn more about synthetic nicotine from the Truth Initiative here.

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 “new” product that was not on the market prior to February 15, 2007 and any newly “deemed” product not on the market prior to August 8, 2016 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. The timeline for this process has shifted numerous times with changes in administration and lawsuits, but all tobacco companies were required to submit their applications for all products going through pre-market review by September 9, 2020. The FDA then had one year to review those applications before they could take enforcement action to remove products without an affirmative marketing order from the marketplace. However, the FDA still has not finished reviewing and making decisions on all applications. Learn more about FDA pre-market review from the Public Health Law Center here. The FDA gained authority to regulate synthetic nicotine products on April 14, 2022 and required manufacturers of tobacco products containing synthetic nicotine to submit applications for their products to the FDA for premarket review by May 14th, 2022. FDA has published a page on Tobacco Product Applications: Metrics & Reporting detailing the breakdown of product applications they have received and processed so far. They also a Searchable Tobacco Products Database that lists all the tobacco products that are legally authorized for marketing in the United States. 
  • Graphic health warnings on cigarette packs. However, implementation of these requirement of the 2009 FSPTCA has faced years of litigation and delay (learn more here). In March 2020, the FDA issued a final rule, requiring new text and graphic health warnings that showing some of the serious but lesser known health risks of cigarette smoking, such as heart disease, type 2 diabetes, cataracts, erectile dysfunction and bladder cancer. The eleven new graphic warnings will cover the top 50% of the front and back of cigarette packages, as well as 20% of the top of cigarette advertisements. The warnings, which are not required for any other tobacco product, will be randomly distributed across cigarette packages and rotated multiple times per year in cigarette advertisements. However, enforcement of these warning labels has been delayed several times due to tobacco industry litigation and the FDA currently plans to begin enforcement in January 2026.
  • Health warnings on tobacco advertisements (including warnings for nicotine).
Advertisements for smokeless tobacco and cigarettes with the required health warnings
Required health warnings on advertisements, located on the side of a retailer.

Future regulations: flavors

  • Menthol cigarettes and flavored cigars: On April 28, 2022, the FDA announced a proposed rule to prohibit menthol as a characterizing flavor in cigarettes, as well as prohibit menthol and all other characterizing flavors in cigar, and the finalized rule was sent to the White House in October 2023. While this was a major step forward for public health, health equity, and the commercial tobacco endgame, in April 2024, the Biden Administration announced they were delaying implementation of the rules indefinitely, and in January 2025, the Trump administration withdrew the rule. State and local action to prohibit the sale of menthol cigarettes and all other tobacco products remains critical and can save lives and prevent addiction now. 
  • E-cigarette flavors: On September 11, 2019, the Trump administration announced a future ban on the sale of flavored e-cigarettes, but final guidance from the FDA, issued January 2, 2020, only prohibits the sale of flavored cartridge-based (closed system) e-cigarette products other than menthol or tobacco flavor. However, additional flavored e-cigarettes could be removed from the market after September 9, 2021 if they are not granted marketing authorization through the FDA’s premarket review process. To date, only four menthol-flavored e-cigarettes have been granted authorization, and no other flavored e-cigarette products have been authorized.  Learn more in the Public Health Law Center’s fact sheet Extension & An E-Cigarette Epidemic: The FDA’s Gatekeeping Authority for E-Cigarettes.
cigarettes with a variety of flavors, flavored little cigars/cigarillos, and menthol-flavored cigarettes
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

  • On January 15, 2025, the FDA issued a proposed rule to limit nicotine in cigarettes; cigarette, roll-your-own, and pipe tobacco; and most cigars to minimally or non-addictive levels (0.7 milligrams per gram of tobacco). A comment period on the rule runs through September 15, 2025. 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. The FDA’s press release noted that the agency’s population health model predicts this proposed standard would result in 12.9 people who smoke cigarettes quitting within a year of implementation and 19.5 million within 5 years of implementation, prevent 48 million youth and young adults from starting smoking, and save 4.3 million lives by 2100.

Resources:

Next Steps:

Last updated January 29, 2025

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