This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts.
In This Issue…
Kids are back in school, a place where many youth vape or see their peers using vapes. And FDA is committed to ensuring that no tobacco product is marketed to, sold to, or used by kids. Education is a cornerstone of FDA’s efforts to stop the epidemic of youth e-cigarette use. This is an especially timely opportunity to educate teens about potential vaping-associated health consequences, given the ongoing investigations of vaping-related lung injuries, as well as reports of seizures and other neurological symptoms following the use of e-cigarettes.
Along with education, FDA undertakes a broad range of additional efforts to protect youth and all Americans from the dangers of tobacco use. Among its current regulatory actions are:
- A plan to prioritize enforcement of the premarket authorization requirements for non-tobacco-flavored electronic nicotine delivery systems (ENDS), such as e-cigarettes
- A proposed rule to set forth requirements for “premarket tobacco product applications” (PMTAs), one type of application for FDA authorization to market a tobacco product.
In this issue of CTP Connect, catch up on CTP’s efforts, in these and other areas, to protect the public and especially youth from tobacco-related harms. Specifically, in this issue, read about…
FDA’s Continuing Steps on E-Cigarettes: Protecting Youth, Studying Health Effects, Providing Current Information
- FDA’s Compliance Policy for Unauthorized, Non-Tobacco-Flavored ENDS
- Messages to Change the Youth Mindset on Tobacco: “The Real Cost” and Beyond
- While Investigating Vaping-Associated Lung Injuries, FDA Provides Information, Recommendations
- FDA Issues Warning Letter to JUUL Labs for Marketing Unauthorized “Modified Risk Tobacco Products”
- "How FDA Is Regulating E-Cigarettes” by Acting FDA Commissioner Ned Sharpless, M.D.
- Proposed Rule on “Premarket Tobacco Product Application” Requirements
- Proposed New Health Warnings for Cigarette Packs, Ads
Additional CTP Actions
- Companies Warned About 44 Illegally Marketed E-Liquid and Hookah Tobacco Products
- Public Meeting on Deemed Tobacco Product Applications—Oct. 28–29
Did You Know…?
New CTP Resources
- Resources Especially for Small Businesses: Webpage, Feature Article
- Exchange Lab: Offering Free Print Materials and Web Content
FDA’s Continuing Steps on E-Cigarettes: Protecting Youth, Studying Health Effects, Providing Current Information
The Trump Administration announced that FDA plans to finalize a compliance policy that would prioritize enforcement of the premarket authorization requirements for non-tobacco-flavored ENDS. FDA will share more soon on specific details of the plan and its implementation.
“We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth,” said Secretary of Health and Human Services Alex Azar.
Acting FDA Commissioner Ned Sharpless, M.D., said in an FDA news release:
“We appreciate President Trump and Secretary Azar’s continued support of the agency’s efforts to prevent youth use of e-cigarettes, including the bold approach we’re announcing today. Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use. We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products. The tremendous progress we’ve made in reducing youth tobacco use in the U.S. is jeopardized by this onslaught of e-cigarette use. Nobody wants to see children becoming addicted to nicotine, and we will continue to use the full scope of our regulatory authority thoughtfully and thoroughly to tackle this mounting public health crisis.”
As part of its commitment to doing everything possible to protect kids from the harms of tobacco, FDA develops a wide range of public health education resources to inform youth and others about tobacco-related risks. The agency has:
- Expanded its award-winning “The Real Cost” campaign to inform youth about the dangers of using e-cigarettes
- Joined forces with publishing, education, and media company Scholastic to provide resources on youth e-cigarette use to middle and high school students, as well as high school educators
- Made additional free information available through the CTP Exchange Lab for use by churches, doctors’ offices, coaches, and others who work with youth.
“The Real Cost”: Impact and Expansion
FDA’s “The Real Cost” campaign, originally created to inform youth about the dangers of cigarettes, began to educate teens about the dangers of e-cigarette use in 2018, and has become especially important in light of the surge in e-cigarette youth among teens shown in the 2018 National Youth Tobacco Survey. “The Real Cost” Youth E-Cigarette Prevention Campaign, which was started as primarily a digital campaign, broadened this year to include its first TV ads emphasizing the emerging scientific understanding that teens who use e-cigarettes are more likely to start smoking cigarettes. Also, the campaign’s first e-cigarette ad highlighting the fact that e-cigarettes can contain dangerous chemicals has begun airing on TV.
Campaigns like “The Real Cost” can play an important role in reducing tobacco-related disease and death and protecting youth from a lifetime of addiction, as shown by findings published recently in the American Journal of Preventive Medicine (AJPM). “The Real Cost” campaign prevented up to 587,000 youth from trying cigarettes between February 2014 and November 2016—half of whom might have gone on to become established smokers— according to this research, which builds on previous impact results published in the Morbidity and Mortality Weekly Report and demonstrates the continuing influence of “The Real Cost” campaign on youth cigarette smoking behaviors. “The results from our work demonstrate that ‘The Real Cost’ will have lasting benefits to public health by convincing these teens not to smoke,” Acting FDA Commissioner Sharpless remarked in a statement. “It’s imperative that public health campaigns like ours continue in order to reduce the individual and collective burden of tobacco-related disease and death among current and future generations.”
According to additional research published in AJPM, “The Real Cost” youth smoking prevention campaign will save youth, their families, and the country more than $53 billion by reducing smoking-related costs such as medical care, lost wages, lower productivity, and increased disability. By preventing youth from becoming established smokers, the campaign saved $180 for every dollar of the nearly $250 million invested.
CTP Joins Forces with Scholastic to Deliver Youth E-Cigarette Prevention Resources
In a continuing collaboration with Scholastic to increase awareness of youth e-cigarette prevention, FDA has mailed new “The Real Cost” campaign posters to all U.S. high schools. The posters for display in high school bathrooms, where teens are often faced with the decision to use e-cigarettes, deliver messages such as:
- “You might as well flush your lungs while you’re at it. Vaping can deliver toxic metal particles, like nickel, lead and chromium directly into your lungs.”
- “When you find out what’s in a vape, you won’t be relieved. Vaping can expose you to some of the same cancer-causing chemicals as those found in cigarette smoke.”
FDA and Scholastic also developed free resources for high school educators to help them talk with students about the harms of e-cigarette use. And new lesson plans and resources for middle and high schools are in development and are expected to become available throughout the 2019–2020 school year.
Additional Resources to Change How Teens View E-Cigarettes
In addition, FDA has developed new posters and social media assets for use by doctors, youth groups, churches, public health agencies, and others who may find them helpful in educating youth on the dangers of e-cigarette use. The materials are available to order or download for free through the CTP Exchange Lab. For teens in need of help quitting e-cigarettes, free resources are available through the National Cancer Institute’s Smokefree Teen program.
As of Oct. 8, 2019, 1,299 cases of lung injury associated with the use of e-cigarette or vaping products have been reported to the Centers for Disease Control and Prevention (CDC), and 26 deaths have been confirmed. Most patients reported using THC-containing products or both THC-containing products and nicotine-containing products. Some of the patients reported using only nicotine-containing products. FDA and the CDC are working closely with state and local health officials to investigate.
While federal and state health officials continue to investigate recent illnesses following the use of vaping products—including gathering information about the products used, where they have been obtained, and what substances they have contained—FDA is providing information related to the incidents and the ongoing investigation by the agency and its public health partners. For example, the agency’s Lung Illnesses Associated with Use of Vaping Products webpage provides an overview of incidents and FDA’s actions to date, as well as recommendations for consumers, health care providers, and state health departments. The page also contains links to additional FDA and CDC information, such as a Consumer Update about steps consumers can take to help protect themselves, including not using THC-containing vaping products or any vaping products obtained off the street.
FDA Encourages Continued Submission of Reports About Seizures After E-Cigarette Use
FDA is also continuing to investigate reports of e-cigarette users having seizures, and is pursuing additional information to help evaluate the possible association between e-cigarette use and seizures or similar neurological events. FDA encourages people to submit reports to the Safety Reporting Portal to help the agency identify concerning trends and clear patterns or causes for particular incidents. An FDA “In Brief” provides additional information about the investigation and how to report an adverse experience.
FDA issued a warning letter to JUUL Labs Inc. on Sept. 9 for marketing unauthorized modified risk tobacco products (MRTPs) through activities directed to consumers, including a presentation given to youth at a school. The agency also sent the company a letter expressing concern about, and requesting more information related to, issues raised during a recent Congressional hearing about JUUL’s outreach and marketing practices, including those targeted to students, tribes, health insurers, and employers.
An FDA news release contains more information about the warning letter and about the additional letter requesting information from the company about issues including its outreach and marketing practices.
Modified risk tobacco products are tobacco products sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Marketing products as MRTPs requires an appropriate FDA order. “Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” said Acting FDA Commissioner Sharpless. “JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
When I was Director of the National Cancer Institute (NCI), I would be frequently asked “What topic in cancer research and cancer care keeps you up at night?” I always answered this question the same way: “tobacco control in the era of e-cigarettes.”
Read this article by Acting FDA Commissioner Sharpless, in which he discusses CTP’s enduring efforts to protect the public health in the context of e-cigarettes.
Also, read his prepared remarks for a House Subcommittee hearing on FDA’s regulation of electronic nicotine delivery system products and the investigation of vaping illnesses.
Proposed Rules: Premarket Tobacco Product Applications, Cigarette Health Warnings
Before a new tobacco product can be legally marketed, FDA must issue an order permitting marketing of that product. Tobacco product manufacturers or importers seeking authorization to market under a “premarket tobacco product application” (PMTA) must demonstrate to the agency, among other things, that marketing of the new tobacco product would be “appropriate for the protection of the public health.” Under this standard, FDA must consider risks and benefits of the product to the population as a whole, including tobacco product users as well as non-users.
FDA has issued a proposed rule to set forth requirements related to PMTA content, format, and FDA review procedures. This regulatory action, along with the announcement of the compliance policy being finalized for unauthorized, non-tobacco-flavored ENDS, is “part of our ongoing oversight of e-cigarettes and other tobacco products that is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine addiction and tobacco-related disease and death,” Acting FDA Commissioner Sharpless said in a news release. The release contains more information, including links to the proposed rule and related documents.
To promote greater public understanding of smoking’s negative health consequences, FDA has issued a proposed rule to require new cigarette health warnings for cigarette packages and advertisements. The proposed warnings, which feature photo-realistic color images (images resembling photographs) depicting some of the lesser-known, but serious, health risks of cigarette smoking—when finalized—would represent the most significant change to cigarette labels in 35 years. As a complement to the additional important work FDA is undertaking to advance the health of America’s families, the proposed warnings represent an enormous public health opportunity to address substantial gaps in the public’s knowledge of the health risks of cigarette smoking.
The 13 proposed warnings cover a number of health conditions and include text statements such as:
- WARNING: Tobacco smoke can harm your children.
- WARNING: Smoking can cause heart disease and strokes by clogging arteries.
- WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
Wonder what these warnings would look like on a cigarette package? On our online Exchange Lab, you can sign in to see a 3D image.
Additional CTP Actions
FDA issued warning letters notifying four companies that 44 flavored e-liquid and hookah tobacco products do not have the required marketing authorization, and therefore cannot be legally sold in the United States. As detailed in an FDA news release, these new actions are part of FDA’s ongoing, aggressive effort to investigate and take action against illegally marketed tobacco products amid the epidemic of youth e-cigarette use in America. “Today’s actions make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found,” Acting FDA Commissioner Sharpless stated.
FDA is holding a public meeting to provide information about the agency’s expectations for tobacco product applications, with a focus on deemed tobacco products such as cigars, waterpipes, and e-cigarettes and other electronic nicotine delivery systems. The meeting will address topics such as product review policies, procedures, and general scientific principles to improve public understanding and assist those considering submission of marketing applications for tobacco products. For those who have not registered online by the Sept. 30 deadline to attend the workshop in person or by webcast, FDA will be posting the webcast and complete transcripts.
Did You Know…?
Smoking cigarettes increases the risk for heart disease and cancer, the leading causes of death for Hispanics in the United States. Help lower your risk by staying smoke-free. For tips, visit http://smokefree.gov.
Es el Mes de la Herencia Hispana. El tabaquismo aumenta el riesgo de enfermedades cardíacas y cáncer, las causas principales de muerte entre hispanos en los Estados Unidos. Ayude a reducir su riesgo manteniéndose libre de humo. Para consejos, visite http://espanol.smokefree.gov.
Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS (short for “sudden infant death syndrome”). Learn more about smoking and pregnancy on FDA’s website.
Octubre es Mes de Concientización del Síndrome de Muerte Súbita del Lactante (SMSL). Fumar durante el embarazo puede causarle complicacion, visite es, parto prematuro, peso al nacer, muerte fetal, y SMSL. Aprenda más sobre el tabaquismo y el embarazo en el sitio web de la FDA.
New CTP Resources
A new webpage introduces CTP’s Office of Small Business Assistance (OSBA) and the resources it offers to help businesses comply with FDA’s tobacco laws and regulations. And a feature article provides additional details about the resources offered by OSBA and how businesses can reach out for help with specific questions.
CTP’s Exchange Lab provides free resources aimed at communicating the dangers of tobacco use. Newly available resources include:
- “Chemicals in Vaping” posters. These five posters—focused on chromium, lead, nickel, formaldehyde, and nicotine—help educate youth about the potential dangers of e-cigarette use.
- Digital age verification calendar. This tool helps retailers determine if a customer is old enough to legally purchase tobacco products.
- Loosies decal and fact sheet. A 5"x7" double-sided window sticker informs retailers and their customers about the federal rules prohibiting the sale of single cigarettes known as "loosies." A Spanish version is available.
- “Every Try Counts” posters, coasters, and car air fresheners. These new resources from CTP are part of the “Every Try Counts” campaign designed to encourage adult cigarette smokers to quit through messages of support underscoring the health benefits of quitting.
Social Media Content
- 11 short vaping videos, designed to educate youth that vapes can contain chemicals that could be harmful to the body, are available for download to share on Instagram and Facebook.