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.
Ten years ago this month, the landmark Family Smoking Prevention and Tobacco Control Act granted FDA oversight of tobacco products. For the past decade, FDA has used the regulatory tools under this legislation—often referred to as the “Tobacco Control Act” (TCA)—to regulate the manufacture, distribution, and marketing of tobacco products to protect the public and create a healthier future for all Americans. The agency’s Center for Tobacco Products, created just two months after the legislation was passed, handles these responsibilities.
For 10 years, CTP has used its public health protection tools toward tackling U.S. tobacco use, the leading cause of preventable disease and death in this country. Relying on the full strength of its authorities, we are committed to stopping a new generation of kids from getting hooked on tobacco products, while also helping adults who want to quit.
As FDA commemorates a decade of tobacco regulation for public health protection, we hope you’ve been keeping an eye out for information from the agency about important public health headway we’ve made—and the challenges that remain. In a new blog titled “Achievements in Tobacco Regulation Over the Past Decade and Beyond,” CTP leadership reflects on a decade of tobacco regulation.
The CTP Connect newsletter helps keep you up-to-date on CTP’s efforts to protect the public, and especially youth, from tobacco-related health harms.
On this page:
- Tobacco Product Application and Review
- Compliance Updates
- More From CTP
- Some E-Cigarette Users Are Having Seizures
- Feature Stories: CTP Perspectives on Tobacco Products and Public Health
- Did You Know…?
Tobacco Product Application and Review
FDA Finalizes Guidance on Premarket Tobacco Product Applications for E-Cigarettes and Other ENDS
For companies seeking to market e-cigarettes or other electronic nicotine delivery systems (ENDS), the premarket tobacco product application (PMTA) pathway is the most likely option for pursuing FDA authorization. On June 11, FDA finalized its “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)” guidance, which presents FDA’s current thinking on what information it recommends be included in a PMTA for ENDS products.
Under the PMTA pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of the product would be “appropriate for the protection of the public health.” This standard requires the agency to consider the risks and benefits to the U.S. population as a whole—including users and non-users of tobacco products. Considerations include the likelihood that existing users will stop using tobacco products and that others who do not use tobacco products will start using them. This is especially important for youth.
“FDA’s ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission, and especially to protecting kids from the dangers of nicotine and tobacco-related disease and death,” said Acting FDA Commissioner Ned Sharpless, M.D., in a news release about this important step in FDA’s ongoing commitment to tobacco product oversight. “The final guidance provides companies seeking to market ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help FDA evaluate the public health benefits and harms of a product.”
FDA’s news release contains additional details about the newly finalized guidance, including recommendations for applicants on addressing public health issues such as accidental nicotine exposure and battery safety in the design and manufacturing of products.
FDA Authorizes New Non-Combusted Cigarettes, With Marketing Restrictions
FDA authorized the marketing of new tobacco products manufactured by Philip Morris Products S.A. The IQOS “Tobacco Heating System” is an electronic device that heats tobacco-filled sticks wrapped in paper to generate an aerosol containing nicotine. The new tobacco products include the IQOS system holder and charger, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks.
Through its rigorous science-based review of the company’s premarket tobacco product applications, FDA determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combusted cigarettes.
The action permits marketing of the tobacco products but does not mean that these products are safe or “FDA approved.” All tobacco products are potentially harmful and addictive and those who do not use tobacco products should not start using such products.
“Ensuring new tobacco products undergo a robust premarket evaluation by FDA is a critical part of our mission to protect the public, particularly youth, and to reduce tobacco-related disease and death,” said CTP director Mitch Zeller. To prevent youth access and exposure to the products, the agency has placed stringent marketing restrictions on the products.
The action is not a decision on the separate “modified risk tobacco product” (MRTP) applications the company also submitted to market these non-combusted cigarettes with proposed claims of reduced exposure or reduced risk of tobacco-related disease. FDA is continuing its scientific review of these applications. The company would need an MRTP order from FDA before marketing a tobacco product with any claims that, among other things, a product reduces exposure to certain chemicals or that use of the product is less harmful than another tobacco product or would reduce the risk of disease.
FDA Takes New Steps to Improve Tobacco Product Application Review Process
FDA has announced new actions to help ensure sound regulatory oversight of tobacco products and an effective application review process that considers the impact on public health. These steps involve:
- Issuing a proposed rule, “Content and Format of Substantial Equivalence Reports: Food and Drug Administration Actions on Substantial Equivalence Reports.” The proposed rule would establish requirements for the content and format of reports manufacturers must send to the agency to demonstrate the substantial equivalence (SE) of a new tobacco product. After a recent extension of the comment period, the proposed rule is available for public comment through July 17.
- Providing additional information on FDA’s website about several improvements to the tobacco product application process. The agency recently posted six SE Report Appendices that identify common SE report issues for specific product categories and subcategories.
- Implementing additional improvements to the SE application process, based on input FDA has received from stakeholders. FDA provides applicants with 180 days to amend applications before scientific review begins and 180 days to respond to a deficiency letter.
- Releasing the latest results of internal performance measures the agency has used for several years to help improve timeliness and predictability of the review of certain applications. FDA surpassed most of the performance goals in fiscal year 2018.
“We are working to establish foundational rules that make the science-based regulatory review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission,” said CTP director Zeller. “In particular, it’s critical we have a strong, science-based application review process that ensures new products meet public health standards.”
An FDA statement provides additional detail about the types of steps being taken by the agency to help clarify the information needed to support its science-based consideration of whether to authorize new tobacco products to come to market.
Companies Warned for Violations in Social Media Influencers’ Posts on the Companies’ Behalf
FDA and the Federal Trade Commission (FTC) issued joint warning letters to four firms that manufacture, advertise, and offer for sale or distribution several flavored e-liquid products for violations related to online posts by social media influencers on each company’s behalf. FDA has determined that the e-liquid products labeled and/or advertised on behalf of the companies in these social media posts, or in two cases, on the companies’ own social media accounts, were misbranded under the Federal Food, Drug, and Cosmetic Act because they failed to include the required statement, “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” The FTC joined FDA on the warning letters under Section 5 of the Federal Trade Commission Act, which prohibits unfair or deceptive advertising.
Through social media sites such as Facebook, Instagram, and Twitter, influencers posted content on behalf of Solace Technologies LLC (doing business as Solace Vapor), Humble Juice Co. LLC, Artist Liquids Laboratories LLC (doing business as Artist Liquid Labs), and Hype City Vapors LLC, touting the flavored e-liquid products or recommending their social media followers try the products without including the required nicotine warning statement.
FDA and the FTC requested responses from each company within 15 working days. The companies were directed to inform each agency of the specific actions taken to address concerns. Failure to correct violations may result in further action such as seizure or injunction. In addition, misbranded or adulterated products offered for import into the United States are subject to detention and refusal of admission.
An FDA news release contains additional details about this effort, under the Youth Tobacco Prevention Plan, to tackle the epidemic of youth e-cigarettes use.
FDA to Companies: Stop Making, Marketing E-Liquids Resembling Prescription Cough Syrups
FDA issued warning letters to companies for manufacturing, selling, and/or distributing nicotine-containing e-liquids with labeling and/or advertising that cause the products to appear to be ingestible by imitating prescription cough syrups. The products identified in the warning letters include “Double Cup Liquids Spritech Lemon Lime E-Juice Syrup” and “Double Cup Liquids Pineapple Phantom E-Juice Syrup.”
For both adults and children, exposure to the nicotine in an e-liquid product—even in relatively small amounts—could result in acute toxicity. In small children who ingest liquid nicotine, even more severe harm can occur, such as death from cardiac arrest and seizure, coma, or respiratory arrest.
The action is part of the agency’s ongoing efforts to protect kids from tobacco products, including the risk of poisoning from e-liquids that misleadingly appear to be ingestible. It follows actions taken by the agency in 2018 against makers and sellers of other e-liquids that misleadingly looked like food products such as juice boxes, candy, and cookies. “FDA will continue to crack down on misleading labeling and advertising and e-liquids that may put consumers, including youth, at risk,” said CTP director Zeller.
New Webinar Explains Tobacco Product Recalls
A new CTP webinar, “Introduction to Tobacco Product Recalls,” explains tobacco product recalls and provides an overview of recall classification, determination, and process. The webinar also provides information about public warnings, the monitoring and auditing of recalled tobacco products, and circumstances related to recall termination. This is the newest in a series of FDA tobacco compliance webinars.
The recently finalized guidance titled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C” provides more information about recalls.
More from CTP
Some E-Cigarette Users Are Having Seizures
Most reports involve youth, young adults
FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users. Seizures or convulsions are known potential side effects of nicotine toxicity and have been reported in the scientific literature in relation to intentional or accidental swallowing of e-liquid. A recent uptick in voluntary reports of adverse experiences that mentioned seizures occurring with e-cigarette use signals a potential emerging safety issue.
FDA continues to monitor all adverse experiences reported to the agency about the use of e-cigarettes and all other tobacco products and encourages the public to report about individuals who use e-cigarettes and have had a seizure via the online Safety Reporting Portal.
Feature Stories: CTP Perspectives on Tobacco Products and Public Health
How are Non-Combusted Cigarettes, Sometimes Called Heat-Not-Burn Products, Different from E-Cigarettes and Cigarettes?
You may have heard about non-combusted cigarettes, heated tobacco products, or heat-not-burn products. These products generally heat tobacco filler to create an aerosol that the user inhales.
Read about the difference between cigarettes, non-combusted cigarettes, and e-cigarettes.
Questions and Answers on the National Youth Tobacco Survey: How We Collect and Analyze Data to Understand Youth Tobacco Use
Find out how FDA and the Centers for Disease Control and Prevention (CDC) collect and analyze National Youth Tobacco Survey (NYTS) data to understand youth tobacco use.
Check out this conversation with CTP Scientist and National Youth Tobacco Survey Researcher Karen Cullen, Ph.D.
Chemicals in Tobacco Products and Your Health
You probably know that cigarette smoking kills you. You probably know that cigarettes contain chemicals—a mix of over 7,000 chemicals, in fact—that can cause diseases including cancer, cardiovascular disease, and COPD. You may not know that other tobacco products, like e-cigarettes, hookah, and smokeless tobacco, contain some of the same chemicals as cigarettes.
Read about these chemicals, and how they might affect your health.
Did You Know…?
June is Men’s Health Month!
Men who smoke are at risk for heart disease, cancer, lower respiratory diseases, stroke, and diabetes—the first, second, fourth, fifth and sixth leading causes of death among men. Learn about “Men’s Health and Smoking” on CTP’s website.
July is Cleft Awareness and Prevention Month!
Cigarette smoking during pregnancy can lead to babies born with cleft palates, which can only be corrected with surgery. Find tools online for women who want to quit and stay quit—before, during, or after baby.