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.
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. In April 2021, the FDA also provided an update to a federal court that it will only have reviewed a little over half of product applications by the end of 2022, and it will not finish reviewing all the applications for the most popular e-cigarette products until June 2023. That means products like Juul, Vuse Alto, Sourin, Smok and others may remain on the market yet another year without FDA authorization. Learn more about FDA pre-market review from the Public Health Law Center here. The FDA recently gained authority to regulate synthetic nicotine products 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.
- 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 until October 6, 2023.
- Health warnings on tobacco advertisements (including warnings for nicotine).
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 cigars. Public comment on the proposed rules will be open through July 5th. The FDA will also hold two public listening sessions on the proposed rules on June 13 and 15th. While this is a major step forward for public health, health equity, and the commercial tobacco endgame, the processes for finalizing and implementing these rules could take years, especially with delays from likely tobacco industry litigation. 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.
- Read the FDA’s full press release here.
- Read the proposed tobacco product standard for menthol in cigarettes and submit comments here.
- Read the proposed tobacco product standard for characterizing flavors in cigars and submit comments here.
- FDA Fact Sheet: Proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors (other than tobacco) in cigars
- 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. Learn more in the Public Health Law Center’s fact sheet Extension & An E-Cigarette Epidemic: The FDA’s Gatekeeping Authority for E-Cigarettes.
Future Regulations: Nicotine-levels
- 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. On 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 June 21, 2022, the FDA announced a their plan to issue a proposed rule limiting nicotine in cigarettes to minimally or non-addictive levels by May 2023.
- Learn more about the planned regulations on the FDA site on their new plan.
- The Public Health Law Center’s Federal Tobacco Action Center includes several helpful resources to learn more about FDA regulation, including:
- Commenting on Proposed FDA Regulations:
- Telling the Public Health Story to the FDA, Public Health Law Center
- Video: How to Submit a Comment to the FDA, Public Health Law Center
- “Getting Your Voice Heard – Commenting on FDA Regulations”, ChangeLab Solutions
- Participatory Rulemaking: A Guide to Locating and Commenting on Proposed Federal Regulations, Center for Public Health & Tobacco Policy
- POS Glossary