With strong, bipartisan support, Congress in 2009 enacted the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which gave the U.S. Food and Drug Administration the authority to regulate the manufacturing, marketing, and distribution of tobacco products.
This landmark law sought to end the special protection from comprehensive federal regulation that the tobacco industry had enjoyed for decades. It represented a milestone in protecting America’s children and health from the devastating consequences of tobacco use, but its full life-saving potential has yet to be realized.
Key Provisions
The Tobacco Control Act:
Bans candy and fruit-flavored cigarettes that appeal to kids.
Sets a federal minimum legal sales age (now 21) and cracks down on industry marketing and sales tactics to kids (e.g., free samples, self-service displays, and brand sponsorships of athletic and music events).
Prohibits companies from deceiving the public by making false or misleading claims that a tobacco product is less harmful than others (e.g., using terms such as “light” and “low-tar” or making unsubstantiated claims that a product has lower levels of a substance or presents a lower risk of disease).
Requires tobacco companies to disclose to FDA information about their products, including harmful ingredients.
Requires that new tobacco products receive marketing authorization from FDA to prevent the introduction of products that are more harmful, addictive, or appealing.
Allows FDA to order the reduction or elimination of harmful ingredients and additives in tobacco products to protect public health.
Requires bigger, bolder graphic health warnings on cigarettes.
As of 2022, gives FDA clear authority to regulate products containing nicotine from any source, including those containing so-called synthetic nicotine, as tobacco products.
Key FDA Actions
Deeming Rule
The Tobacco Control Act gave the FDA immediate regulatory authority over cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco and authorized the agency to extend its jurisdiction to all other tobacco products. In May 2016, the FDA issued a final “deeming rule” extending its authority to other tobacco products, including electronic cigarettes, cigars and hookah.
This rule subjected all newly deemed products to the requirements of the Tobacco Control Act, including manufacturer registration, ingredient reporting, and premarket review of both new tobacco products (those marketed or modified as of February 15, 2007) and claims of reduced risk or exposure. The rule also banned free samples, established a national minimum sales age for all tobacco products, with required age verification in face-to-face transactions; restricted vending machine sales; and required health warnings.
The rule has been a critical first step toward comprehensive regulation of all tobacco products, but it—and FDA actions resulting from it—has also been the subject of continuing litigation.
Product Standards
Three product standards to reduce or eliminate harmful ingredients in tobacco products have been proposed, and another is highly anticipated:
In January 2017, FDA initiated a rulemaking to limit the carcinogen N-nitrosonornicotine (NNN) in smokeless tobacco products. The public comment period on the proposed rule closed in April 2017, but the rule has yet to be issued in final form.
On April 28, 2022, FDA announced two proposed rules that would significantly reduce tobacco-related death, disease, and disparities: one to prohibit menthol as a characterizing flavor in cigarettes and another to prohibit all characterizing flavors in cigars. The public comment period on the proposed rules closed on August 2, 2022, and they remain a high priority for the agency.
On June 21, 2022, FDA announced plans to propose a rule to establish a maximum nicotine level in cigarettes and other combusted tobacco products to reduce the addictiveness of such products.
Flavored E-Cigarette Decisions
On August 26, 2021, FDA issued its first marketing denial orders (MDOs) for flavored e-cigarettes, finding that the applications “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
Similarly, on October 26, 2022, FDA issued its first denials of menthol-flavored e-cigarettes, finding that “[t]he evidence provided within the application does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.”
The MDOs for flavored e-cigarettes appropriately recognize the massive youth vaping crisis kickstarted by flavored e-cigarettes and the lack of product-specific evidence demonstrating a countervailing public health benefit to justify continued marketing. Despite this, many e-cigarette manufacturers have filed lawsuits challenging the MDOs.
Unfinished Business
In several significant ways, the FDA has not been able to exercise the full scope of its authority to regulate tobacco products.
Graphic Health Warnings for Cigarettes
The Tobacco Control Act required FDA to issue a regulation mandating large, graphic health warnings for cigarettes. After FDA’s initial rule was struck down by the U.S. Court of Appeals for the D.C. Circuit in 2012 and the rulemaking was remanded to FDA, FDA did not issue a second graphic warnings rule until a federal court in Boston, pursuant to a lawsuit filed by the Campaign for Tobacco-Free Kids, other public health groups, and several pediatricians, ordered FDA to issue a second rule. The court found that FDA had “unlawfully withheld and unreasonably delayed” issuance of the rule. Pursuant to that court order, FDA issued a final rule on March 18, 2020, which was later vacated by the U.S. District Court for the Eastern District of Texas following yet another challenge by the tobacco industry.
Enforcement of the Tobacco Control Act’s Premarket Review Requiremen
The Tobacco Control Act is clear that before any new tobacco products (those marketed or modified as of February 15, 2007) may be introduced into commerce, it must undergo premarket review and receive FDA marketing authorization. Despite the clear statutory mandate, FDA and its enforcement partner, DOJ, have for years allowed unauthorized new tobacco products, including cigarettes, smokeless tobacco products, cigars and e-cigarettes, to be introduced on the market apparently free from FDA scientific review or enforcement. It is critical for public health that FDA clear the market of these illegal products and ensure that only FDA-authorized products are permitted on the market.
Last updated Jan. 13, 2023