CTP Connect—December 2018
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…
As e-cigarettes’ popularity has been surging among youth, FDA has translated its resolve to turn around this dangerous trajectory into strong actions related to prevention and enforcement, as well as an unprecedented public health education campaign. Some of the agency’s strongest steps yet to protect kids from tobacco’s harms were announced Nov. 15 by FDA’s commissioner, Scott Gottlieb, M.D. Meanwhile, the agency is making additional important headway in areas related to tobacco regulation—working to improve the tobacco product application and review process, for example.
These and other FDA actions in the tobacco regulatory arena are guided by the agency’s “Comprehensive Plan for Tobacco and Nicotine Regulation,” a framework announced by Commissioner Gottlieb in 2017 and updated in his Nov. 15 statement. Information about major tobacco regulatory actions is available on our Comprehensive Plan webpage, as well as our Youth Tobacco Prevention Plan webpage focusing on actions to protect minors from tobacco products’ dangers.
Here, we provide highlights of current FDA initiatives. Specifically, in this CTP Connect, read about…
- FDA Plans Strong Prevention Steps, as Study Shows Alarming Surge in Youth E-Cig Use
- Additional Recent Steps to Stem ENDS Sales to Youth
- FDA to Seek Public Input on Research, Strategies to Help Addicted Kids Quit Using E-Cigarettes
- Educating Kids About E-Cigs’ Dangers: The Real Cost Campaign, Educator Resources
- Application Submission and Review: Bettering Processes
- FDA Issues First Marketing Orders for Non-Combusted Cigarettes
- Warning Statement Requirement: New Guidance, Webinar
- Ingredient Listing Deadline: Extension for Small-Scale Manufacturers, Importers Impacted by Recent Natural Disasters
FDA Plans Strong Prevention Steps, as Study Shows Alarming Surge in Youth E-Cig Use
FDA has announced new steps to protect kids from tobacco’s harms by helping to prevent youth appeal and youth access. The steps, announced in a Nov. 15 statement by FDA’s commissioner, are being taken in response to a troubling recent surge in youth use of e-cigarettes and other electronic nicotine delivery systems (ENDS). Commissioner Gottlieb also announced the agency’s plans to ban menthol in cigarettes and to ban all flavors, including menthol, in cigars.
The last year has seen an extremely concerning spike in youth use of e-cigarettes. According to new findings from the 2018 National Youth Tobacco Survey, released in November by FDA and the Centers for Disease Control and Prevention (CDC), from 2017 to 2018 there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. The total number of middle and high school students currently using e-cigarettes rose to 3.6 million, which is 1.5 million more than the previous year.
This alarming surge has caused FDA to revisit certain deadlines for deemed products that were extended in 2017, in part to allow for the potential benefits of innovative new products to be studied further. The deadlines were extended under the condition that youth e-cigarette use numbers did not change for the worse. But these numbers have worsened—and to a startling extent.
The new policy framework seeks to address youth appeal of, and access to, tobacco products and especially flavored tobacco products, which appear to be at the heart of the youth tobacco use problem. The proposed changes would affect these product categories:
- Flavored ENDS products (other than those with tobacco, mint, or menthol flavors) that are not sold in an age-restricted, in-person location;
- Flavored ENDS products (other than those with tobacco, mint, or menthol flavors) that are sold online without heightened age verification processes;
- Flavored cigars;
- ENDS products that are marketed to kids; and
- Menthol-flavored combustible tobacco products, including cigarettes and cigars.
The actions were announced with strong support from the Department of Health and Human Services. “The new data show that America faces an epidemic of youth e-cigarette use, which threatens to engulf a new generation in nicotine addiction,” said HHS Secretary Alex Azar in a statement.
FDA intends to issue more information soon on subjects such as “age-restricted” location, “heightened” age-verification online, and timelines for FDA implementation of these policies. Commissioner Gottlieb has stated his hope that, within 90 days of his November announcement, manufacturers will choose to remove flavored ENDS products from stores where kids can access them and from online sites that lack sufficient age-verification procedures. He also expressed his hope that manufacturers of ENDS products will soon prepare, with FDA input as appropriate, premarket tobacco product applications (PMTAs) to demonstrate that their products meet the public health standard in the Tobacco Control Act.
These plans have taken shape as FDA continues to pursue a balance between the availability of potentially less harmful non-combustible products as an alternative to smoking for adults and FDA’s resolve to make nicotine products less accessible and appealing to children. In his Nov. 15 statement, Commissioner Gottlieb stressed that innovative alternatives for adults “cannot, and will not, come at the expense of addicting a generation of children to nicotine.”
FDA is also moving forward with proposed rulemaking to ban menthol in combustible tobacco products, including cigarettes. “I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes,” Commissioner Gottlieb stated. Unlike menthol-flavored ENDS, the commissioner pointed out, there is no evidence suggesting that menthol-flavored cigarettes may play a role in harm reduction for adult smokers. The agency also plans to propose a product standard to ban flavors, including menthol, in cigars, which data indicate would likely help prevent cigar initiation and use by youth and adults.
Emphasizing that FDA’s actions will continue to be based on the best available science, Commissioner Gottlieb said of FDA’s ongoing commitment to protect youth by pursuing a wide range of prevention and enforcement actions, “We will leave no stone unturned. This is one of our highest priorities.”
For more information about how FDA is addressing youth e-cigarette use, read Commissioner Gottlieb’s Nov. 15 statement:
Additional Recent Steps to Stem ENDS Sales to Youth
The steps announced by FDA’s commissioner in November follow a series of escalating steps the agency has already taken recently to help stem the sale and marketing of ENDS to youth.
Based on a nationwide undercover inspection effort focusing on both brick-and-mortar and online stores selling tobacco—the largest coordinated enforcement effort in FDA’s history—the agency issued more than 1,300 warning letters and fines known as civil money penalty complaints to retailers found to be selling JUUL and other e-cigarette products to minors. The agency has already taken additional significant steps, including:
- Warning companies to stop selling e-liquids resembling kid-friendly food products;
- Investigating whether more than 40 e-cigarette products are being illegally marketed; and
- Warning an e-liquid company of violations of the Food, Drug, and Cosmetic Act, including selling unapproved new drugs.
Warning companies to stop selling e-liquids resembling kid-friendly food products.
As part of its efforts to protect youth from the dangers of nicotine and tobacco products, FDA—in some cases, in collaboration with the Federal Trade Commission—has warned manufacturers, distributors, and retailers to stop selling e-liquids whose labeling or advertising cause the products to resemble kid-friendly food products. All 17 companies warned in May have stopped selling the identified products.
FDA has continued to monitor tobacco product labeling and advertising for potential violations and has issued warning letters to additional online retailers selling products resembling kid-friendly foods. FDA Commissioner Gottlieb said about these products that could entice and endanger kids, “When companies market these products using imagery that misleads a child into thinking they’re things they’ve consumed before, like a juice box or candy, that can create an imminent risk of harm to a child who may confuse the product for something safe and familiar.”
Investigating whether more than 40 e-cigarette products are being illegally marketed.
FDA sent 21 letters to e-cigarette companies, including the manufacturers and importers of Vuse Alto, myblu, Myle, Rubi, and STIG, seeking information about whether more than 40 products—including some flavored e-cigarette products—are being marketed outside the agency’s current compliance policy. FDA has received complaints that some companies may be marketing new products that were introduced or modified after the deeming rule’s Aug. 8, 2016, effective date.
Commissioner Gottlieb stated, “We will take swift action when companies are skirting the law.” To enforce legal requirements for tobacco products, the agency can pursue a variety of actions, which include administrative actions such as civil money penalty complaints and judicial actions such as seizures or injunctions.
Warning an e-liquid company of violations of the Food, Drug, and Cosmetic Act, including selling unapproved new drugs.
FDA issued a warning letter to HelloCig Electronic Technology Co., Ltd., for violations of the Federal Food, Drug and Cosmetic Act, including selling two e-liquids containing or purporting to contain the prescription drugs tadalafil and/or sildenafil, leading the agency to determine the products are unapproved new drugs. Sildenafil and tadalafil are the active pharmaceutical ingredients in FDA-approved prescription drugs used to treat erectile dysfunction. These FDA-approved prescription drugs are not approved for use in e-liquid products. The company is also marketing other e-liquids used in e-cigarettes in ways that mislead consumers into believing that FDA has approved these tobacco products when it has not. “There are no e-liquid products approved to contain prescription drugs or any other medications that require a doctor’s supervision,” FDA Commissioner Gottlieb said. “Prescription drugs are carefully evaluated and labeled to reflect the risks of the medications and their potential interactions with other medicines, and vaping active drug ingredients is an ineffective route of delivery and can be dangerous.”
FDA to Seek Public Input on Research, Strategies to Help Addicted Kids Quit Using E-Cigarettes
FDA is concerned about rising numbers of youth becoming addicted to e-cigarettes and the current lack of adequate research or approved treatments to help kids quit using e-cigarettes or other tobacco products. To help address these issues, the agency has planned a public hearing to hear perspectives on the available scientific evidence related to drug therapies for e-cigarette cessation as it relates to youth users and how FDA may support further research in this area. The hearing, originally planned for Dec. 5, will be rescheduled, as the federal government was closed that day as a mark of respect for former President George H.W. Bush. You can find more information, as it becomes available, by visiting the meeting webpage.
Educating Kids About E-Cigs’ Dangers: The Real Cost Campaign, Educator Resources
FDA wants kids to understand that using e-cigarettes puts them at risk for addiction and other health consequences. Recently, the agency launched “The Real Cost” Youth E-Cigarette Prevention Campaign to educate youth about the dangers of these products, and has also partnered with publishing and education company Scholastic to provide free educator resources designed to help get students talking about the risks e-cigarettes pose.
“The Real Cost” e-cigarette prevention campaign for youth, a part of FDA’s “The Real Cost” public health education effort, targets nearly 10.7 million youth aged 12 to 17 who have used e-cigarettes or are open to trying them. This campaign features hard-hitting advertising on digital and social media sites popular among teens, and places posters with e-cigarette prevention messages in high schools across the nation. Some messages highlight that nicotine can rewire the brain to crave more nicotine, especially among adolescents, while others highlight that e-cigarettes can contain dangerous chemicals such as acrolein (which can cause irreversible lung damage); formaldehyde (a cancer-causing chemical); and toxic metal particles such as chromium, lead, and nickel (which can be inhaled into the lungs).
In another initiative to educate youth about the dangers of e-cigarette use, FDA joined forces with Scholastic to provide resources to help educators inform youth in grades 9 to 12 about the health risks of vaping. Through the partnership, FDA and Scholastic provided resources to 350,000 educators on Nov. 15, and another 350,000 educators will receive the materials in January 2019.
Many teens don’t view e-cigarettes as harmful and some are not even aware that most e-cigarettes contain nicotine, the commissioner highlighted in a letter to school administrators and teachers about these materials. While “The Real Cost” reaches kids online, the commissioner wrote to these educators, “You’re on the front lines of another location where we all know they face the decision about whether to use e-cigarettes: in school.”
For more information about “The Real Cost” and the expansion of the campaign to educate youth about e-cigarettes, visit CTP’s “The Real Cost” webpage. Also, learn more online about the resources available from FDA and Scholastic to help educators engage their students in discussions about e-cigarettes’ dangers.
Application Submission and Review: Bettering Processes
With respect to FDA’s critical responsibility to assess new products and their potential public health impact, the agency is working to help industry better understand product application requirements, and to improve the transparency and efficiency of the tobacco product application review process. An FDA Voice article co-authored by FDA Commissioner Gottlieb and CTP Director Mitch Zeller reviews milestones under the plan and outlines several new efforts, which include inviting public input on premarket review.
In one example of FDA’s steps taken to improve the tobacco product application review process, the agency has made the approach for review of products known as “provisional substantial equivalence tobacco products” more transparent. As part of this improvement, copies of certain relevant reviews that guide the “not substantially equivalent” (NSE) decision are now being made available to the applicant that receives an NSE order. An FDA statement provides additional information.
FDA held a public meeting in October related to tobacco product application submission and review processes. Relevant resources, including a meeting webcast and complete transcripts, are posted on CTP’s “Tobacco Product Application Review—A Public Meeting” webpage. A dedicated docket, Federal Register docket FDA-2018-N-3504, was established for related public comments.
FDA Issues First Marketing Orders for Non-Combusted Cigarettes
For the first time, FDA has issued substantial equivalence (SE) orders on regular SE reports for non-combusted cigarette products. (If you are not familiar with the concept of substantial equivalence for new tobacco products, CTP’s “Substantial Equivalence” webpage provides information.) The SE orders were for two R.J. Reynolds Company tobacco products, Eclipse and Eclipse Menthol. This action demonstrates that the SE premarket review pathway is viable for non-combusted cigarettes. Each of these products is eligible to serve as a predicate product for future SE reports.
FDA currently categorizes a tobacco product as a “non-combusted cigarette” if it meets the legal definition of a cigarette, but there is evidence the heat does not reach a level sufficient to cause combustion. The media and others have sometimes referred to this product category with the colloquial terms “heat-not-burn” or “heated” tobacco products. These colloquial terms do not appear to have universally agreed-upon definitions (but seem to be used interchangeably).
FDA’s scientific review of the SE reports for these two products found there were differences in characteristics between the new products and the “predicate” tobacco product, but that the differences do not cause the new tobacco products to raise different questions of public health.
Learn more on CTP’s website about the pathways to market tobacco products, along with actions FDA has taken under each.
Warning Statement Requirement: New Guidance, Webinar
FDA has issued a new guidance, "Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco,"explaining FDA's intent to comply with a recent court order by not enforcing the warning statement requirements for any cigars and pipe tobacco products until 60 days after the final decision on the plaintiffs’ appeal. The guidance also states the agency will not enforce certain labeling requirements under the Food, Drug, and Cosmetic Act for cigars and pipe tobacco while an injunction remains in effect. During this time, however, cigar and pipe tobacco firms may add the relevant warnings and make the labeling changes. FDA has also revised other guidance documents to reflect the compliance policy.
To help tobacco product retailers understand the addictiveness warning statement requirements, FDA has developed a new tobacco compliance webinar: “Retailer Requirements: New Warning Statement Requirement for Certain Tobacco Products.”
For more information, including FDA-created visual examples of the required addictiveness warning statement on different tobacco product packaging and a side-by-side product and warning statement chart, visit CTP’s "Labeling and Warning Statements for Tobacco Products" webpage.
Ingredient Listing Deadline: Extension for Small-Scale Manufacturers, Importers Impacted by Recent Natural Disasters
For small-scale tobacco product manufacturers and importers of deemed products on the market as of Aug. 8, 2016, in FEMA-declared areas impacted by recent natural disasters, FDA is extending the compliance deadline for the ingredient listing requirements to May 8, 2019. If you have questions about this new compliance deadline, please contact FDA at SmallBiz.Tobacco@fda.hhs.gov or 1.877.287.1373.
Details and a complete list of affected areas are available on CTP’s website.
For small-scale tobacco product manufacturers and importers of deemed products on the market as of Aug. 8, 2016, not affected by recent natural disasters, the compliance date did not change from Nov. 8, 2018.
For deemed tobacco products entering the market after Aug. 8, 2016, ingredient information must be submitted at least 90 days before the product is introduced into interstate commerce. FDA encourages manufacturers to start the process as early as possible.
- Using FDA Tools to Submit Ingredient Listings Electronically
- Using a Tobacco Product Master File (TPMF) for Ingredient Listing Submissions
- Examples of Ingredient Listing Spreadsheets by Product Category
Nine investigators and organizations have been named for the second round of awards for Tobacco Centers of Regulatory Science (TCORS). TCORS represents a significant investment in research designed to inform CTP’s mission to protect public health through tobacco product regulation.
Recipients of TCORS awards for fiscal years 2018–2022 are:
- Thomas E. Eissenberg. Ph.D., and Alison Breland, Ph.D., Virginia Commonwealth University, Richmond
- Stanton A. Glantz, Ph.D., University of California-San Francisco
- Stephen T. Higgins, Ph.D., University of Vermont and State Agriculture College, Burlington
- Suchitra Krishnan-Sarin, Ph.D., and Stephanie S. O’Malley, Ph.D., Yale University, New Haven
- Rafael Meza, Ph.D., and David T. Levy, Ph.D., University of Michigan, Ann Arbor
- Richard J. O’Connor, Ph.D., and Maciej Goniewicz, Ph.D., PharmD., Roswell Park Cancer Institute Corporation, Buffalo
- Mary Ann Pentz, Ph.D., and Adam M. Leventhal, Ph.D., University of Southern California, Los Angeles
- Rose M. Robertson, M.D., and Aruni Bhatnagar, Ph.D., American Heart Association, Dallas
- Andrew A. Strasser, Ph.D., and Cristine Delnevo, Ph.D., University of Pennsylvania, Philadelphia
More information, including a list of the seven scientific domains that are the focus of TCORS 2.0, is available on CTP’s website.
Upcoming Call for Applications: Jan. 3–March 1, 2019
Are you interested in helping to shape the future of tobacco regulation, or do you know someone who is? Then consider the Tobacco Regulatory Science Fellowship, a collaborative program between CTP and the National Academy of Medicine (NAM). Since 2012, this 12-month multidisciplinary program has provided opportunities for mid-career professionals from different disciplines to gain experience in developing regulatory science relating to tobacco products and FDA’s authorities under the Family Smoking Prevention and Tobacco Control Act.
The next call for applications opens on Jan. 3, 2019 and closes at 3:00 p.m. ET on March 1, 2019. Candidate webinars are scheduled for Jan. 22 and Feb. 7.
Fellows are placed in various areas within CTP, including compliance and enforcement; health communication and education; administrative management; regulations; or science. Over the course of a year, fellows help lead defined projects, actively participate in the development of science-based public health strategies, and meet with policy leaders. The fellowship culminates with a formal presentation to CTP leadership about project outcomes and lessons learned.
Each year, fellows are selected through a national competition based on professional achievements, expertise in an area of relevance to the center, and the quality of submitted essays and letters of recommendation. If selected as a finalist, each applicant must participate in an in-person interview in Washington, DC, on April 23, 2019.
On the FDA Tobacco Regulatory Science Fellowship website, you can join the mailing list, learn about important deadlines, and more. Inquiries should be directed to NAM at 202.334.1506 or email@example.com.
You’re in Good Company if You Want to Quit Smoking!
More than 22 million current adult smokers—that’s more than two-thirds of them—want to stop smoking completely. Make it your New Year’s resolution to quit smoking in 2019 and find resources to help you quit at https://smokefree.gov.