FDA’s Center for Tobacco Products: 10 Years of Protecting Public Health through Regulation
Just 10 years ago, in June 2009, Congress passed the Tobacco Control Act granting FDA regulatory oversight of tobacco products. Prior to this historic action, tobacco companies were mostly exempt from federal product regulation. There was no federal law preventing tobacco companies from selling their products to children, though states were required to enact such laws to receive some federal grants. There was no pre-market scientific review of the health effects of new tobacco products coming onto the market. Tobacco companies were free to make unproven claims of reduced risk or harm.
In 2009, when the Tobacco Control Act was signed, everything changed. FDA was given powerful tools to help reduce the disease and death caused by the use of tobacco products. One way FDA accomplishes this is through regulation: rules that tobacco manufacturers, retailers, distributors, and importers must follow, and guidances that provide the tobacco industry with the most current thinking from FDA to help ensure they are in compliance with the law.
In August 2009, FDA established the Center for Tobacco Products and in September 2009, just three months after the Tobacco Control Act was signed into law, FDA implemented a statutory ban on cigarettes with characterizing flavors other than menthol, such as fruit, candy or clove, which Congress had recognized as appealing to kids. Six months later, FDA carried out another Congressional directive by publishing its first finalized regulation—or final rule—prohibiting the sale and distribution of cigarettes and smokeless tobacco to anyone under the age of 18. The rule also required a photo ID for tobacco sales, prohibited free samples and vending machine sales (with some exceptions), prohibited tobacco company promotional items such as hats and tee shirts, and prohibited tobacco company sponsorship of sporting events.
In the following years, FDA continued to issue other rules related to the manufacture, distribution, and marketing of tobacco products, such as establishing a methodology to assess user fees that the statute requires tobacco companies to pay to fund FDA’s work.
In 2016, FDA finalized the historic “Deeming Rule,” which extended the agency’s regulatory authority to all tobacco products (other than accessories), including electronic nicotine delivery systems (ENDS) like e-cigarettes. Thanks to this regulation, retailers can no longer sell e-cigarettes, or any other product made or derived from tobacco, to anyone under 18. In addition, manufacturers must now provide FDA with information about what these previously unregulated products contain and how they impact public health, which, in turn, informs future regulatory decision-making.
Finalizing a regulation is an involved, well-considered process that can sometimes take several years. Before publishing a final rule, FDA first publishes a proposed rule, soliciting comments from the public. As an additional step, FDA sometimes chooses to solicit comment even earlier in the process by issuing an Advance Notice of Proposed Rulemaking (ANPRM).
In March 2018, three ANPRMs were issued, including one to obtain information about a potential tobacco product standard that would lower the nicotine in cigarettes to a minimally or non-addictive level. Such a standard could drastically help addicted adult smokers in their efforts to quit and, importantly, prevent children from ever becoming addicted to cigarettes. The other two ANPRMs sought information to help inform FDA’s regulation of certain flavors in tobacco products—including flavors in e-cigarettes—and premium cigars, respectively.
FDA is committed to issuing foundational rules to make the science-based product review process more efficient, predictable, and transparent for manufacturers, while advancing the agency’s public health mission. Earlier this year, FDA issued a proposed rule that details the content and format for submitting a Substantial Equivalence report to the Agency. FDA is also continuing to work on other foundational rules and guidances, including regulations outlining what should be included in Premarket Tobacco Product Applications (PMTA) and Modified Risk Tobacco Product (MRTP) applications.
Since its inception, FDA’s Center for Tobacco Products has finalized 11 rules, issued 11 proposed rules, and published 29 final guidances. FDA regulations are science-based and intended to support the Agency’s mission of reducing the negative impact of tobacco use on the nation’s health. Grounded in scientific research, and with public input taken into consideration, each regulation put forth by FDA is intended to help protect the American public from the harms of tobacco with the goal that one day future generations will not know the burden of tobacco-related disease and death.
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