This quarterly 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.
FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers
On April 29, FDA announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products – the leading cause of preventable death in the U.S.
FDA is working toward issuing proposed product standards within the next year: one to ban menthol as a characterizing flavor in cigarettes and another to ban all characterizing flavors (including menthol) in cigars. The authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency. The decision to advance these product standards is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009.
In This Issue:
Regulation and Guidance:
Compliance and Enforcement:
- FDA Warns Additional Firms for Making and Selling Unauthorized E-Liquids
- FDA Requires Information on Social Media Practices of E-Cigarette Brands
- Resources & Training: Retail Sales of Tobacco Products
Public Health and Education:
- How to Discuss E-cigarettes and Nicotine Addition with Youth
- New FDA & AAP Video Series: Pediatricians Discuss Youth E-Cigarette Use
- Looking for Teen Smoking Cessation Tools?
- Did You Know…?
Regulation and Guidance
On March 2, the U.S. District Court for the Eastern District of Texas granted a motion by the plaintiffs in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176, to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule by an additional 90 days.
The new effective date of the final rule is April 14, 2022. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. FDA strongly encourages entities to submit cigarette plans (as required by 21 CFR 1141.10(g)) as soon as possible, and in any event by June 14, 2021. FDA intends to revise its relevant guidance documents related to the rule with the new effective date.
Compliance and Enforcement
From Feb. 26 through the end of March, FDA issued warning letters to 49 firms respectively who manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal, and therefore they cannot be sold or distributed in the U.S. The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline.
While each warning letter issued cites specific products as examples, collectively these companies have listed a combined total of more than 400,000 products with the FDA.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for these types of products.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.
In line with the agency’s stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application. FDA has published an update on its progress on the processing and review of the applications received by Sept. 9, including a list of companies that submitted timely applications.
On March 17, FDA issued letters to four companies requesting information about their use of social media marketing and influencer marketing related to their electronic nicotine delivery system (ENDS) brands: Aspire, Joyetech, Vaporesso, and Voopoo. FDA has authority under Section 904(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to solicit this information.
Amid growing concern about the marketing of ENDS products to youth, FDA seeks to further understand the relationship between rising youth exposure to online ENDS marketing and youth ENDS use.
This request for information reflects FDA’s ongoing commitment to prevent youth use of tobacco products and is informed by research, including a CTP analysis which found that most leading ENDS brands use multiple social media platforms to market their products and do not use age restriction tools to prevent youth exposure to their marketing.
Other research has found youth engage with ENDS marketing on social media by following and sharing brand messages. Additionally, several sources report that e-cigarette companies are marketing through brand ambassadors and “influencers” – people with large social media followings who can be compensated to promote products. Influencers may be likely to engage youth while marketing tobacco products. Youth engagement with online tobacco marketing, including social media marketing, is associated with tobacco use.
Through a systematic process, FDA selected Aspire, Joyetech, Vaporesso, and Voopoo from among more than 40 leading ENDS brands, evaluating their presence, reach and activity on Facebook, Instagram, and YouTube, and whether they use age restriction tools for these platforms.
Once FDA receives the requested information, the agency will use it to assess how these companies have used social media and worked with influencers to market their products and learn who is exposed to the companies’ social media marketing.
This information will also aid FDA as it evaluates marketing plans in PMTA reviews, conducts social media surveillance and monitoring of social media and influencer marketing, and considers strategies for reducing youth exposure to digital marketing of tobacco products. The companies have 60 days to respond to the agency. Failure to provide the information is a violation of the law and subject to regulatory and enforcement action by the FDA.
Tobacco retailers play a direct role in protecting kids from nicotine addiction and the deadly effects of tobacco use. FDA offers free resources and training to help tobacco retailers comply with the rules designed to prevent our nation's youth from becoming the next generation of Americans to die prematurely from tobacco-related disease. FDA’s offerings include retail compliance webinars, “This is Our Watch” materials, age calculator app, guidance, and more.
Public Health and Education
FDA and Scholastic continue working together to develop youth e-cigarette prevention resources.
According to the 2020 National Youth Tobacco Survey, more than 3.6 million teens used e-cigarettes in the last 30 days, and nearly a quarter of high-school aged users report daily use.
In this new blog post from Kathy Crosby, Director of Communications at FDA’s Center for Tobacco Products, get tips on how to start a conversation with your child about e-cigarettes, learn to recognize the warning signs of nicotine addiction, and find resources pediatricians recommend to help youth quit vaping.
Parents and educators play an active role in fighting tobacco use among youth. National Youth Tobacco Survey data shows that youth e-cigarette use remains a public health concern and teens do not fully understand the health consequences.
FDA and the American Academy of Pediatrics (AAP) recently collaborated to develop a video series featuring pediatricians answering common questions about youth e-cigarette use.
The National Cancer Institute’s SmokeFree.gov website provides quit tools tailored to several demographics, including teens. If you need to reach teens with smoking cessation messages to help them quit, SmokeFree.gov has information on becoming smokefree, the risks of tobacco, tobacco triggers, and quitting vaping. In addition to articles, the website provides tools to put teens on the path to becoming smokefree.
…SmokefreeTXT is a text messaging program that gives 24/7 encouragement, advice, and tips for becoming smoke-free? Learn more and sign up here.