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
- Regulation of menthol in cigarettes:
- In July 2013, the FDA released an advance notice of proposed rulemaking (ANPRM) of the potential regulation of menthol in cigarettes. While the 2009 Act banned most flavored cigarettes, it excluded menthol from this ban. Review the FDA’s “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol versus Nonmenthol Cigarettes” and read more about the proposed rulemaking. After a tobacco industry challenge to the Tobacco Products Scientific Advisory Committee’s report on menthol as a public health issue, a January 15, 2016 court decision allows the FDA to use the report as evidence and take action on menthol. Read more in the Public Health Law Center’s Federal Regulation of Menthol Tobacco Products.
- The FDA originally included language in the 2016 deeming regulations that would prohibit the sale of any tobacco product in a flavor other than tobacco, but the agency was overruled by the Office of Management and Budget. Read more. However. the FDA has announced their intention to issue a follow-up rule that prohibits the use of characterizing flavors in cigars as well, but has not announced a timeline for this action.
- On March 20th, 2018 the agency issued an ANPRM on the regulation of flavors in tobacco products, “calling upon all stakeholders to share data, research and information that can inform our process for examining the role that flavors – including menthol – play in initiation, use and cessation of tobacco products.”
- On November 15, 2018, FDA Commissioner Scott Gottlieb announced that the FDA would
- issue a Notice of Proposed Rulemaking to ban menthol in cigarettes and any other combustible products
- issue a product standard to ban flavored cigars
- limit the sale of flavored e-cigarettes other than mint, menthol, and tobacco flavors to age-restricted (18+) locations
- On March 13, 2019, the FDA issued a draft compliance policy for flavored e-cigarettes and flavored cigars.
- 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.
- In June 2020, the African-American Tobacco Control Leadership Council (AATCLC) and Action on Smoking & Health (ASH) sued the FDA over their failure to act on menthol, and the FDA has committed to responding by April 30, 2021.
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