FDA Will Regulate Tobacco Under New Law
Calling it a bill that “will save American lives,” President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, which grants the Food and Drug Administration (FDA) the authority to regulate tobacco products. Under the law, the FDA now has sweeping new authorities related to the manufacture, marketing, and sale of tobacco products—authorities covered by a more expansive public health standard than has traditionally been granted to the agency.
President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act on June 22.
Enactment of the law was met with praise by members of Congress and many officials from the nation’s top public health and medical organizations, hundreds of which had endorsed the legislation.
“Today is a day for special celebration as President Obama signs into law this long-overdue authority for FDA to regulate tobacco products,” stated Senator Edward Kennedy (D-MA), the primary sponsor of the bill in the Senate and an ardent backer of efforts to regulate tobacco.
The push by some lawmakers and public health organizations to grant the FDA legal authority over tobacco products began in earnest in the mid-1990s. It took on renewed vigor, however, following a 5-4 decision by the U.S. Supreme Court in the spring of 2000, in which the court ruled that the FDA did not have the authority to regulate tobacco and that Congressional action would be required to grant the agency that power.
The new law does just that, providing the FDA with a comprehensive array of legal authorities. For example, it requires:
- New, larger, more prominent warning labels on tobacco products about potential harms and ingredients, and a prohibition on the use of misleading terms such as “light” or “mild”
- Significant restrictions on marketing geared toward teenagers and children, including restricting advertising to black-and-white text in stores and in magazines with high teen readership, and a complete ban on tobacco sponsorship of sports and entertainment events
- Tobacco product manufacturers to register with the agency every 2 years and submit to the agency comprehensive information about the manufacture and composition of all tobacco products they wish to market, including pre-market review of any new products
- A ban on candy-like flavorings and certain other additives to cigarettes
Under the new law, the agency’s approach to regulation would not follow the “safe and effective” standard employed for drugs and other items over which the FDA has regulatory control, explained Mitch Zeller, vice president for policy and strategic communications at Pinney Associates in Washington, DC, who directed the FDA’s Office of Tobacco Programs in the 1990s. Rather, its regulatory activities for tobacco will be guided by a standard of what is appropriate for the protection of the public's health.
“It’s a very broad standard,” Zeller continued. “Congress elucidates what that standard means when it comes to regulatory functions such as … proposed product standards that the agency would issue.”
That legal flexibility is very important, said Vince Willmore from the Campaign for Tobacco Free Kids. It means the FDA “won’t have to go to Congress every time it needs to take additional steps to protect public health” with regard to tobacco, he added.
“We think this is the strongest tobacco control measure that Congress has ever approved,” Willmore said.
The law also establishes a mechanism to fund the FDA’s tobacco regulation activities by levying fees on manufacturers and importers of tobacco products. It also mandates the formation of a new Center for Tobacco Products within the FDA, as well as a Tobacco Products Scientific Advisory Committee to, among other things, help guide the implementation of the new law.
There's a New Law—Now What?
The FDA will now begin the process of hiring staff and creating the infrastructure for the Center for Tobacco Products at FDA, which, said Zeller, will likely be as large as the agency’s centers for biologics and devices. As far as regulatory actions are concerned, explained Willmore, the law contains specific deadlines for certain actions.
They include issuing regulations that will:
- Within 3 months, ban candy, fruit, and other flavors from cigarettes
- Within 12 months, ban product labels using terms such as “light” and “low tar”
- Within 15 months, restrict the marketing and sale of tobacco products to teens and children; this includes restricting advertising to black-and-white text in stores and in magazines with high teen readership
- Within 24 months, require larger, graphic warning labels
In the case of nicotine, Zeller noted, although the FDA is prohibited under the law from requiring that nicotine be eliminated from tobacco products, there is nothing in the law that prevents the agency from requiring nicotine levels that fall below the threshold for addiction—something, he added, that is currently the topic of ongoing research.
Zeller said that the first FDA actions under the new law will focus on restrictions on sales and marketing of tobacco products to teenagers and children. (See box above.) The agency may also look to a guidance document issued last year by the World Health Organization that identifies priority areas for tobacco regulation.
While FDA regulation is expected to help make dramatic strides in reducing the nation’s prevalence of tobacco use, it is not a panacea, said Dr. Cathy Backinger, chief of NCI’s Tobacco Control Research Branch. “Regulation is a critical component of a comprehensive tobacco control agenda, but it is not the only thing we need to do to make progress,” she said. “We also need to implement evidence-based programs and policies and continue research efforts to understand how to drive down both youth and adult tobacco-use prevalence.”
ALSO OF INTEREST
Research Supporting Regulation
An important component of the FDA’s regulation of tobacco products will be research into a number of important scientific issues that affect how the agency conducts its work, said NCI officials. “Research supported by NCI and other NIH and federal health agencies will be very important to inform the agency’s efforts with regard to tobacco,” explained Dr. Backinger. “We look forward to working with the FDA to ensure that the science base for regulation expands to meet their needs.”
NCI-funded tobacco control research includes multidisciplinary studies of potential reduced-exposure tobacco products, both smoked and smokeless; research to analyze tobacco industry documents to better understand the industry’s knowledge, strategies, and tactics; research on the determinants of tobacco use and addiction; and studies to identify strategies to prevent and reduce tobacco use. To learn more about NCI-funded research supporting tobacco regulation, visit: http://dccps.nci.nih.gov/tcrb/research_topic-tob_products.html and http://dccps.nci.nih.gov/tcrb/research_topic-tob_industry.html.