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. Learn more.
CTP Marks 8 Years of Tobacco Oversight
It has been 8 years since the landmark Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was signed into law in June 2009. The Tobacco Control Act authorized the
FDA to regulate the manufacture, marketing, distribution, and sale of tobacco products, and the agency has taken important science-based measures under this authority to protect Americans—and youth, in particular—from tobacco-related disease and death.
CTP is proud of our public health improvement efforts over the 8 years since the FDA gained tobacco regulatory authority, including achievements featured in this newsletter. In one sign of important headway, recent CDC and FDA findings from the 2016 National Youth Tobacco Survey show downward trends in several areas of tobacco use by middle and high school students. (These findings will be discussed in the next issue of CTPConnect.) Despite these and other encouraging indications of progress, a great deal of work remains to be done in further reducing the death and disease toll of tobacco.
CTP Takes Steps to Help People Avoid, Report E-Cigarette Battery Explosions
Following reports of fires and explosions related to electronic nicotine delivery systems (ENDS) such as e-cigarettes, or “vapes”—some of which have been associated with serious injury—CTP is reviewing these types of incidents for their potential to inform regulatory action and education. And the Center already has taken important steps for public health protection. For example, to help e-cigarette users avoid explosions, which evidence suggests may be battery-related, CTP has developed a new Tips to Help Avoid “Vape” Battery Explosions webpage with an infographic and other public health resources. Additionally, the FDA has a Safety Reporting Portal that allows people to notify the agency about e-cigarette battery failures and other unexpected problems related to tobacco products.
“The injuries from fires and explosions associated with e-cigarettes differ from the harms typically associated with tobacco use,” said Matthew Holman, Ph.D., director of CTP’s Office of Science. “Although the risks are different, CTP is committed to reducing harms for all regulated tobacco products, and the Center is studying these incidents and taking steps to protect the public from these dangers.”
Toward Reducing Risk: Infographic and More Materials
Currently, e-cigarette users’ best protection against a battery-related event may be knowing as much as possible about their device and how to handle and charge its batteries. CTP’s new infographic, 5 Tips to Help Avoid “Vape” Battery Explosions, contains information for reducing the risk—for example, never charging an e-cigarette with a phone or tablet charger and keeping loose batteries in a case to prevent contact with metal objects. The infographic, along with additional tips and shareable content to help spread the word about preventing e-cigarette battery explosions, is available on a new CTP webpage.
Reporting Tool to Help Reduce Hazards
To reduce the risk of e-cigarette overheating, fires, and explosions, and to support our regulatory decision-making, the FDA is working to determine the reasons for these types of device issues. An important tool in this ongoing examination is the Safety Reporting Portal, which allows consumers, health professionals, manufacturers, and clinical investigators to report unexpected health or quality issues with a tobacco product. The FDA hopes those with an unexpected issue they believe to have been caused by a tobacco product (whether by using it or being exposed to it) will use this reporting tool to provide information to the agency.
On our batteries-related webpage, CTP offers a video about how to report a vape battery explosion to the FDA using the Safety Reporting Portal.
When completing a report about an unexpected problem such as an e-cigarette explosion, the FDA asks for information including:
- E-cigarette manufacturer name
- E-cigarette brand name, model, and serial number
- Battery brand name and model
- Where the e-cigarette was purchased
- Whether the e-cigarette product was modified in any way, or used differently than intended by the manufacturer.
The FDA’s Safety Reporting Portal for Tobacco Products webpage provides additional information about using the portal. Beyond overheating, fires, and explosions, CTP also is interested in reports about a wider range of unexpected problems with tobacco products. These could include product quality issues such as a product that is damaged, defective, or contaminated, or that smells or tastes wrong, or health issues including burns or other injuries, allergic reactions, or poisoning, including a child’s accidental poisoning.
Ongoing Efforts to Avert Dangerous Incidents
Additional CTP efforts focus on determining what manufacturers, government agencies, and consumers can do to limit the risk of overheating and exploding e-cigarettes and other ENDS. The FDA plans to consider battery-related hazards as part of our review of these devices. As another example of the agency’s efforts to build on the current understanding of safety concerns associated with e-cigarette batteries, the FDA held a public workshop in April to obtain input from experts in a variety of related fields and from the general public. “The meeting represents the types of efforts CTP is undertaking to continually build on our current knowledge base and steer further steps to protect public health,” Holman said.
Did you know...? E-Cigs should be protected from extreme temperatures
Summer's here! Don't leave your vape in direct sunlight or in your car in extremely hot temperatures. (Same goes for extreme cold.)
Visit CTP's new webpage for e-cigarette battery tips and resources
Certain Deeming Rule Compliance Dates Extended by 3 Months
The FDA has extended the compliance dates for certain provisions under the deeming rule finalized in May 2016, and has issued a guidance, Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, discussing the extension.
The extension applies to compliance deadlines set for May 10, 2017, or later. All provisions with compliance dates that have occurred—such as mandatory age and photo ID checks to prevent illegal sales to minors—will remain in effect. The FDA will continue to enforce such requirements.
These are among the provisions to which the 3-month extension applies:
- Submission of rotational warning plans for cigars
- Registration and listing
- Ingredient listing
- Health documents
- Substantial Equivalence (SE) exemption requests
- Substantial Equivalence applications
- Premarket tobacco product applications (PMTAs)
- Harmful and potentially harmful constituent (HPHC) reports
For more information, including a chart with affected provisions and corresponding new compliance dates, please read the guidance [PDF–140KB]. You can find information about more deeming provisions and important associated dates in this chart: Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products [PDF–267KB].
Connecting at the National Conference on Tobacco or Health
CTP representatives were among more than 1,850 tobacco control professionals at the 2017 National Conference on Tobacco or Health, held March 22 to 24 in Austin, Texas. The purpose of the annual conference, as summed up by organizers, is “to help improve and sustain the effectiveness and reach of tobacco control programs and activities in the United States.”
“The expertise, passion, and dedication of everyone at the conference was powerful,” said Eshael Johnson, CTP’s director of stakeholder relations. “Each session was filled with interesting information.”
CTP Director Mitch Zeller participated in a panel, “Everything You Need to Know and Want to Ask About the Center for Tobacco Products at FDA.” Center staff also participated as panel moderators and experts during other sessions, including “Using Data to Understand Quit Methods Used by Smokers,” “Premarket Tobacco Product Review by the FDA,” and “The Impact of Three National Anti-Tobacco Mass Media Campaigns.”
CTP presented 12 posters—among them, “Honoring Our Relationships: Engaging with Tribal Stakeholders,” “How FDA Assists Small Tobacco Product Businesses With Compliance With FDA’s Tobacco Laws and Regulations,” “Nicotine Content and Physical Properties of Large Cigars and Cigarillos in the United States,” and “Behind the Scenes: Announcing FDA’s Deeming Regulation” (see photo below). The Center also offered exhibits and hosted an informal meet-and-greet where attendees could speak with CTP’s director and other Center representatives. “Even though our meet-and-greet was scheduled during dinner hours, so many people showed up to meet CTP leadership and ask questions,” Johnson said.
“A lot of people who attend this national conference know about agencies like the CDC, but not too much about us,” Johnson added. “This was a great opportunity for the public health and tobacco control communities to really understand CTP’s relatively new public health protection role.”
The Office of Health Communication and Education’s Andrea Takash and Kanika Watson present their poster on deeming rule communications.
After the deeming regulation announcement last year, CTP’s social media channels saw a spike in daily traffic of nearly 900 percent. The Center was equipped to respond to the surging attention, relying on our new communication tools tailored for educating businesses, consumers, and other specific audiences about the rule.