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.
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. The timeline for this process has shifted numerous times with changes in administration and lawsuits, but all tobacco companies must submit their applications for all products going through pre-market review by September 9, 2020. The FDA will have one year to review those applications, during which time the products can stay on the market unless ordered otherwise by the FDA. Learn more about FDA pre-market review from the Public Health Law Center here. The FDA also published a page on Tobacco Product Applications: Metrics & Reporting detailing the breakdown of product applications they have received and processed so far.
- Health warnings on advertisements (including warnings for nicotine).
Future regulations: flavors
- Menthol cigarettes and flavored cigars: In April 2021, the FDA announced their intention to issue a rule prohibiting menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. However, it is likely to take years for the agency to finalize and implement a rule. Learn more here about menthol’s initial exclusion from the 2009 FSPTCA’s ban on characterizing flavors in cigarettes, tobacco industry litigation, and other federal delays in action.
- E-cigarettes: 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. Learn more in the Public Health Law Center’s facthsheet Extension & An E-Cigarette Epidemic: The FDA’s Gatekeeping Authority for E-Cigarettes.
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.
- Learn more about the planned regulations on the FDA site on their new plan.
- Public Health Law Center’s
- FDA Tobacco Action Center
- The FDA’s New Tobacco Regulatory Plan: What You Need to Know
- The Deeming Regulation: FDA Authority Over E-Cigarettes, Cigars, and Other Tobacco Products
- State and Local Tobacco Regulation in a Post-Deeming World
- FDA Act Litigation Update
- “Federal Regulation of Tobacco and its Impact on the Retail Environment” Fact Sheet
- “Telling the Public Health Story to the FDA: How the FDA Regulates Tobacco through the Rulemaking Process” Fact Sheet
- ChangeLab Solutions’
- Center for Public Health & Tobacco Policy’s “Participatory Rulemaking: A Guide to Locating and Commenting on Proposed Federal Regulations”
- POS Glossary