CTPConnect - March 2017
March 2017 Newsletter
This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our other newsletter, Spotlight on Science, and the center’s news e-blasts. Learn more.
News from CTP
Dr. Matthew Holman Is New Director of CTP's Office of Science
Please join us in welcoming Matthew Holman, Ph.D., as the new director of CTP’s Office of Science (OS). Dr. Holman has been with the FDA since 2001 and director of the OS Division of Product Science since joining CTP in 2011.
“Dr. Holman is exceptionally well qualified for this position" said Mitch Zeller, CTP director, "due to the breadth and depth of his CTP and FDA experience, his commitment to public health and the Tobacco Control Act, his scientific expertise, his demonstrated leadership within OS, and his overall contributions to the advancement of tobacco regulatory science."
FDA Takes Action on Applications Seeking to Market MRTPs
Provides recommendations for strengthening applicant’s case for modified risk order
The Federal Food, Drug, and Cosmetic Act provides a way for companies to market products for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Under this “modified risk tobacco product” (MRTP) application process, Swedish Match North America Inc. sought to remove two currently required warnings from eight of its snus smokeless tobacco products marketed under the General brand name, and to revise a third warning. Specifically, the company requested to remove a warning stating the products can cause gum disease and tooth loss, and another stating the products can cause mouth cancer. The company wanted to revise a third warning to say the products “pose substantially lower risks to health than cigarettes.”
This past December, after a thorough scientific review, CTP made a two-pronged decision on Swedish Match’s applications. The center denied the request to remove the warning about gum disease and tooth loss because available scientific evidence shows the products can cause these health outcomes. And CTP deferred final action on Swedish Match’s request to remove or revise two additional currently required warnings, issuing a response that gave the company an opportunity to amend its applications.
You can learn more about MRTPs and the Swedish Match decision on CTP’s website.
New Videos Tell Story of Toxic Chemicals in Tobacco
Cigarette smoke contains more than 7,000 chemicals. Over 70 of these chemicals are linked to cancer, but that’s just part of the story of why smoking kills. CTP recently unveiled videos and interactive tools on our website that allow site visitors to learn about the three stages at which chemicals can get into cigarettes: from plant to product to puff.
Visit CTP's new webpage for e-cigarette battery tips and resources
Electronic Nicotine Delivery System Battery Safety Concerns: Public Workshop
CTP is aware of reports of battery-related safety events, such as exploding batteries, involving electronic nicotine delivery systems (ENDS). The center is holding a two-day public workshop on April 19–20 to gather information about ENDS battery safety hazards and controls, including internal and external battery-related factors, specifications, and safety and design parameters.
In addition, CTP has announced the establishment of a docket for submission of comments in conjunction with the public workshop to gather information about batteries used in ENDS. Although registration for the workshop has closed, electronic or written comments will be accepted until May 22.
CTP also wants to know about any problems with tobacco products, including unexpected health or safety issues such as fire, burns, or other injuries. Report these types of incidents to our Safety Reporting Portal.
Upcoming Tobacco Products Scientific Advisory Committee Meeting
FDA’s Tobacco Products Scientific Advisory Committee will meet on April 6, from 8:30 a.m. to 4:30 p.m. CTP will present information to the committee on the processes used in review of tobacco product applications, including premarket tobacco, substantial equivalence, and modified risk tobacco product applications.
As seating may be limited, the public is encouraged to watch the free webcast. The link for the webcast will be available approximately 15 minutes before the meeting begins.
Just Released: CTP Ombudsman's 2016 Annual Report
This annual report summarizes the role of the CTP Ombudsman’s Office and the complaints, disputes, inquiries, and comments the office received during calendar year 2016, including the number of contacts and their source, subject matter, and status. Find the full report at the bottom on the Ombudsman’s webpage.
Did You Know...?
Giving up cigarettes can be extremely difficult. But why?
Cigarette use kills more than 1,300 people in the U.S. every day. The reason for this is not just the tobacco inside the cigarette but also how a cigarette is designed to keep people addicted. Check out our “How a Cigarette Is Engineered” infographic to learn more.
Education campaigns can cause kids to rethink their relationship with tobacco.
CTP’s “The Real Cost” tobacco education campaign has prevented hundreds of thousands of youth from smoking, according to results published in the Jan. 20 issue of CDC’s Morbidity and Mortality Weekly Report (MMWR). Regarding the powerful campaign, CTP director Mitch Zeller said, “Preventing nearly 350,000 youth from smoking will lead to lower rates of smoking-related disease and death and reduced health care costs.”
March Is Save Your Vision Month!
Smoking can seriously affect vision. Help us spread the word by sharing our tweet.