Helen Meissner, Ph.D., Sc.M. is the director of the Tobacco Regulatory Science Program (TRSP). TRSP is an interagency partnership between the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) to foster tobacco regulatory research.
On August 15 the FDA issued a proposed new rule to require color graphic health warnings for cigarette packaging and advertisements. The agency says these warnings represent the most “significant change” to cigarette labels in 35 years.
Tell us more about these new warning labels. How are they an improvement over the current text labels?
Even though smoking rates have declined in the United States over the last several decades, tobacco use is still the leading cause of preventable disease and death. Research tells us that people aren’t always fully aware of the impact that cigarettes and smoking have on their health. The proposed new rule is an opportunity to better educate the public about some of the lesser known health risks of smoking like bladder cancer, diabetes, erectile dysfunction, and conditions that can cause blindness.
Cigarette warning labels were last updated in 1984. The text is small and located on the sides of the package, meaning that the warning is often invisible to consumers.
The new warning labels are the result of extensive research done by the FDA to make sure the text and images promote a greater understanding of the health risks of smoking. The labels will be colorful and easy to spot. They will cover the top half of the front and back of cigarette packs and at least 20% of the area at the top of advertisements.
You mentioned that these warning labels were based on a lengthy research process. I know that your office works with the FDA to promote tobacco regulatory research. Can you explain what that is and why it’s important?
The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health. In 2013, the NIH and the FDA formed our program, the Tobacco Regulatory Science Program (TRSP), to establish a comprehensive research agenda in tobacco regulatory science.
TRSP funds research that is critical to helping the FDA develop science-based policies and standards. This research helps the FDA better understand how new and existing tobacco products are used (and by whom), how their labeling and advertising affects their use, and the impact of these products on both individual health and the health of the whole population.
How did tobacco regulatory science help inform the FDA’s new cigarette warning labels?
After a review of research on cigarette packaging and warning labels, the FDA found that text warnings paired with photographs (or images that resemble photographs) of specific health conditions were most likely to help consumers better understand the impact that smoking has on their health.
The FDA then ran a large consumer study to select distinct and clear messages about the risks associated with cigarette smoking. Researchers also tested images to find out which ones did the best job of painting a picture of those risks.
After pairing the images with the text statements, the FDA conducted focus groups across the United States to evaluate their effectiveness. Based on feedback received in these focus groups, the agency further refined the images and statements and conducted a final study that compared 16 potential cigarette warnings to the current 1984 Surgeon General’s warnings. The FDA then selected 13 cigarette health warnings for the proposed rule.
What are the next steps in order to implement the new rule?
The FDA is currently looking for feedback about the proposed labels and is particularly interested in discussion about the number of warnings that should be selected. The agency is also interested in evidence-based ideas for alternative text and images to help the public better understand the negative health impacts of smoking.
The comment period for the proposed rule has closed. You can read submitted comments at regulations.gov.
Anyone who is interested can submit comments on the proposed rule until October 15.