FDA CTP & NIH News

For the first time, FDA’s “The Real Cost” campaign will address teen e-cigarette use

The U.S. Food and Drug Administration is expanding “The Real Cost” public education campaign to educate teens about the dangers of using e-cigarettes and other electronic nicotine delivery systems (ENDS), specifically regarding how nicotine can rewire a teen’s developing brain to crave more nicotine. New campaign content, including online video and radio ads, will appear on platforms such as YouTube, Hulu, and Spotify, as well as on the campaign’s website. This is the first time FDA will explicitly address youth use of e-cigarettes through campaign advertising.

In addition to these new digital materials, FDA is planning to launch a full-scale campaign focused on youth use of e-cigarettes and other ENDS in fall of 2018. These efforts are part of the agency’s new, comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers of using tobacco products.

For more information on the FDA's "The Real Cost" campaign click here.

Just one e-cigarette might raise adrenaline in the heart

Research suggests smoking just one e-cigarette might expose users to enough nicotine to trigger an adrenaline surge in the heart that can contribute to high blood pressure and other health problems. Read the Reuters article for more information.

New ads accuse Big Tobacco of targeting soldiers and people with mental illness

Truth Initiative, a leading tobacco-control nonprofit, bought TV ads that accuse tobacco companies of purposely targeting mentally ill people and U.S. soldiers. Read the Washington Post article for more information.

A Nicotine-Focused Framework for Public Health

The attached editorial by Mitch Zeller and Scott Gottlieb explores the FDA's plan for a nicotine-focused framework for public health..

Big Tobacco’s new cigarette is sleek, smokeless — but is it any better for you?

Philip Morris International says it has created a less toxic cigarette, but is it any better for you? Read the Washington Post article for more information.

FDA to Expand Public Education Campaign to Focus on Prevention of Youth E-Cigarette Use

On Aug. 8, the FDA announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids.

The agency plans to expand its “The Real Cost” public education campaign to include messaging to teens about the dangers of using these products this fall while developing a full-scale campaign to launch in 2018. These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.

More than 2 million middle and high school students were current users of e-cigarettes and other ENDS in 2016. Data also show about half of all middle and high school students who were current tobacco users also used two or more tobacco products last year. This use by children and teens is especially concerning because of evidence that youth exposure to nicotine affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future.

For more information, read the FDA press annoucement.

FDA releases new webinar as part of the Tobacco Compliance Webinar series

The FDA invites you to watch the new webinar, “Required Warning Statements for Cigars.” This webinar provides further clarification on the required health warning statements for cigars sold in various sizes and types of packaging, including packaging too small to fit the required warning statements, which was not covered in the “Cigar Warnings and Warning Plan Requirements” webinar from November 2016. This webinar also provides information regarding retailers’ responsibilities when packaging and advertisements are received from a manufacturer, importer or distributor, and some options for complying when selling cigars that are not packaged.

Once the required warning statements in the deeming regulation take effect on August 10, 2018, it will be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United Sates any cigar unless the product packaging bears one of the required cigar warning statements. Manufacturers should note that warning plans are due to the FDA for review and approval no later than August 10, 2017, or 12 months before advertising or commercially marketing a product that is subject to the requirement, whichever is later.

To watch the FDA's other Tobacco Compliance webinars, visit the webinar page. For more information, read the draft guidance.

Tobacco use is the leading cause of preventable disease and death in the United States, and nearly all tobacco use begins during youth and young adulthood. View the full report from the CDC Tobacco Morbidity and Mortality Weekly Report.

This study explores the experiences of early career and senior scientists regarding mentorship and career trajectories in tobacco regulatory science (TRS). Find out more about effective mentorship in TRS requires that mentors possess an in-depth understanding of the scientific, regulatory, and legislative processes inherent to tobacco regulatory policy-making here.

In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel’s work to develop core TRS domains and competencies. Learn more here.

A bill is expected in the U.S. House of Representatives this week that would diminish FDA’s authority over e-cigarettes. The bill would exempt e-cigarettes from much of the Deeming Rule, including the requirement that new products be reviewed and authorized by the FDA before going to market. The bill is one of a series of legal and legislative efforts by tobacco and e-cigarette companies to thwart the Deeming Rule, but it is unclear how much support the bill will receive.

To read the full article, click here.

A recent study in JAMA Pediatrics found that 1 in 4 youths, or approximately 6.5 million youths, have reported exposure to secondhand smoke from e-cigarettes in the past 30 days. Using data from the 2015 National Youth Tobacco Survey, researchers found that of the nearly 6.5 million youths reporting exposure, 4.4 million youth were not e-cigarette users and that over 1 million youths reported secondhand exposure only from e-cigarettes. Exposure was greater among girls than boys (~27% vs. 22%) and among white students than black students (27% vs. 15%).

To read more on the study and the implications of its findings, click here.