FDA Deeming Rule

With the passage of the 2009 Family Smoking Prevention and Tobacco Control Act, also known as the Tobacco Control Act (TCA), the U.S. Food and Drug Administration (FDA) acquired the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. The NIH Tobacco Regulatory Science Program (TRSP) was established in 2013 within the Office of Disease Prevention (ODP) to partner with the FDA’s Center for Tobacco Products (CTP) in order to conduct research needed to inform FDA regulatory activities over tobacco products.

On May 5, 2016, the FDA issued its final deeming rule to extend its authorities to all categories of products that meet the statutory definition of "tobacco product" in the Federal Food, Drug, and Cosmetic Act, except accessories of such newly deemed tobacco products. In addition to products already regulated by the FDA (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), newly deemed products subject to regulation include cigars, pipe tobacco, hookah (waterpipe) tobacco, Electronic Nicotine Delivery Systems or ENDS (e.g., e-cigarettes, vape pens), gels, and certain dissolvable tobacco products. This final rule also prohibits the sale of "covered tobacco products" to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your-own tobacco, and covered tobacco product packages and in advertisements. The FDA is taking this action to reduce death and disease from tobacco products, and the NIH TRSP will continue to support the research base needed to meet this goal. The NIH TRSP provides the scientific evidence the FDA needs for the development and evaluation of its tobacco regulatory activities. The TRSP works with the FDA and participating NIH Institutes and Centers to develop and review new funding opportunities that can address gaps in research needed to make regulatory decisions regarding tobacco products. The TRSP also assists in monitoring progress of the FDA-funded tobacco regulatory science research portfolio at the NIH.

Tobacco use is the single largest preventable cause of disease and death in the United States. It is responsible for 480,000 deaths per year in the United States. Additionally, more than 16 million Americans live with a smoking-related disease, and treating these tobacco-related illnesses costs more than $170 billion annually. For decades, the federal government and the public health community have fought to protect people from the dangers of smoking. Since the first Surgeon General’s report on Smoking and Health in 1964, which warned Americans about the risks associated with tobacco use, significant progress has been made in reducing smoking rates among Americans.

While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, young people’s use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention (CDC) shows that current e-cigarette use among high school students has skyrocketed from 1.5% in 2011 to 16% in 2015 (more than a 1,000% increase) and hookah use has risen significantly, from 4.1% to 7.2% (more than a 175% increase) during the same time period. In 2015, 3 million middle- and high-school students were current e-cigarette users, and data showed that high-school boys smoked cigars at about the same rate as cigarettes. Additionally, a joint study by the FDA and the NIH shows that in 2013–2014, nearly 80% of current youth tobacco users reported using a flavored, non-cigarette tobacco product in the past 30 days—consistently citing the availability of appealing flavors as a reason for use.

Extending the FDA’s authority is a major milestone in public health and consumer protection. Moving forward, the FDA will be able to review all new tobacco products not yet on the market. The actions being taken also will help the FDA prevent misleading claims and provide consumers with better information about the risks of tobacco use. The rule also will allow the FDA to evaluate the ingredients of tobacco products, how those products are made, and their potential dangers. Additionally, it will subject all manufacturers, importers, and/or retailers of newly regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

Planned before the issuance of the deeming rule, the Tobacco Regulatory Science Grantees Conference was hosted by the TRSP on the NIH campus on May 16–18, 2016. There were over 400 attendees, including FDA- and NIH-funded investigators and NIH, FDA, and CDC scientific staff. Nearly 200 research projects and oral and poster presentations were showcased at the conference. All of the themed session topics featured current research relevant to the exercise of the FDA’s new authority. Key topics of particular interest to policy development included the appeal of flavors; harmful and potentially harmful constituents of tobacco products; use patterns; vulnerable populations (youth and young adults in particular); and communication and marketing strategies. The results of this research will help to ensure that future regulation of tobacco products is based on the best available scientific evidence.

David M. Murray, Ph.D.
Associate Director for Prevention
Director of the Office of Disease Prevention