CTPConnect — August 2020
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.
CTP Director Mitch Zeller Speaks with the Oncology Nurses Society
In a podcast interview with the Oncology Nursing Society, CTP Director Mitch Zeller discusses tobacco’s effect on American health, communication strategies for patients with cancer who want to quit, and what FDA is doing to mitigate its harm.
For a round-up of recent perspectives, commentary, testimonies, and podcast appearances by Mitch Zeller, visit the new CTP Director’s page.
In This Issue:
Regulation and Guidance:
- FDA Completes Scientific Review, Authorizes Reduced Exposure Marketing for IQOS Heated Tobacco System
- FDA Issues Orders to Stop the Sale of 13 Tobacco Products
- CTP Expands Hiring to Meet Regulatory Goals
Compliance and Enforcement:
- FDA Shares Resources for Tobacco Product Applications Due Sept. 9, 202
- FDA Releases New Webinar on Cigarette Warnings and Plan Requirements
- FDA Issues Warnings for Unauthorized and Youth-Appealing ENDS
Public Health and Education:
- Q&A with CTP’s Director of Communications
- CTP’s Exchange Lab Offers Free Tobacco Education Materials
- Did You Know…?
Regulation and Guidance
FDA Completes Scientific Review, Authorizes Reduced Exposure Marketing for IQOS Heated Tobacco System
On July 7, FDA authorized the marketing of “IQOS Tobacco Heating System,” which includes the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks as modified risk tobacco products (MRTPs).
With this action, FDA issued exposure modification orders authorizing Philip Morris Products S.A. to use the following information in their advertising and marketing of the products:
“AVAILABLE EVIDENCE TO DATE:
- The IQOS system heats tobacco but does not burn it.
- This significantly reduces the production of harmful and potentially harmful chemicals.
- Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
Even with this action, these products are not safe nor "FDA approved"—there are no safe tobacco products. The exposure modification orders do not permit the company to make express or implied statements that convey or could mislead consumers into believing that the product is endorsed or approved by FDA, or that FDA deems the product to be safe for use by consumers.
The company must request and receive authorization from FDA to continue marketing the products with the same modified exposure information after the initial order expires in 4 years. FDA also may withdraw the initial and any potential subsequent exposure modification orders if the agency determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole, for example as a result of an uptake in use of the products by youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.
FDA previously authorized the marketing of these products in April 2019 via the premarket tobacco application (PMTA) pathway. To limit youth access to the products and to limit youth exposure to IQOS advertising and promotion, the PMTA authorization placed stringent restrictions on how the products are marketed – particularly via websites and through social media platforms – by including requirements that advertising be targeted to adults of legal age to purchase tobacco products.
See the FDA’s MRTP webpage for more information, including the application process and a summary of past MRTP application actions.
FDA Issues Orders to Stop the Sale of 13 Tobacco Products
In May 2020, FDA issued Not Substantially Equivalent (NSE) orders for 13 tobacco products that had been provisionally permitted to be sold on the market since 2011. These tobacco products are now misbranded and adulterated and can no longer be distributed, imported, sold, marketed or promoted in the United States.
R.J. Reynolds Tobacco Company
- Camel Sticks Mint [PDF – 354KB]
- Viceroy Flex [PDF – 566KB]
- Camel Strips Mint [PDF – 491KB]
- Camel Orbs Mint [PDF – 422KB]
U.S. Smokeless Tobacco Company [PDF – 583KB]
- Skoal Smooth Mint Tobacco Stick
- Skoal Rich Tobacco Stick
- Skoal Mint Tobacco Stick
- Skoal Original Tobacco Stick
Heritage Tobacco LLC [PDF – 613KB]
- Union Full Flavor 100’s Box
- Union Gold 100’s Box
- Union Platinum 100’s Box
- Union Menthol 100’s Box
- Union Menthol Gold 100’s Box
Retailers with remaining inventory of the combustible cigarette and smokeless tobacco products listed above should work with the product manufacturer or supplier to discuss options for disposing of these products. Failure to comply with the Federal Food, Drug and Cosmetic (FD&C) Act may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalties, seizure, and/or injunction.
Upon scientific review of the Substantial Equivalence (SE) Reports submitted by R.J. Reynolds Tobacco Company and U.S. Smokeless Tobacco Company for their smokeless tobacco products, FDA determined that the new tobacco products were not substantially equivalent to the predicate tobacco products. In both sets of applications, the FDA found that there were differences in characteristics between the new and corresponding predicate tobacco products and some of these differences raised different questions of public health.
Regarding the Heritage Tobacco LLC cigarette products, FDA determined the information submitted failed to sufficiently demonstrate that the predicate tobacco products listed in the SE Reports were commercially marketed in the United States as of Feb. 15, 2007; therefore, they were not eligible predicate tobacco products. An eligible predicate tobacco product is either a tobacco product commercially marketed (other than exclusively in test markets) in the United States as of Feb. 15, 2007 or a tobacco product that FDA has previously determined to be substantially equivalent and in compliance with the requirements of the FD&C Act.
Before the issuance of the NSE orders, these provisional SE tobacco products were allowed to be marketed because new tobacco products first commercially marketed after Feb. 15, 2007 but before March 22, 2011 – with an SE Report submitted to FDA by March 22, 2011 – could remain on the market unless FDA issued an order that the new product is not substantially equivalent.
CTP Expands Hiring to Meet Regulatory Goals
FDA’s Center for Tobacco Products (CTP) is currently expanding hiring to support our mission of protecting Americans from tobacco-related disease and death. Learn about the many types of career opportunities available, our work culture, and the innovative ways we build talent pipelines to recruit a diverse and qualified workforce.
Compliance and Enforcement
FDA Shares Resources for Tobacco Product Applications Due Sept. 9, 2020
FDA launched a new webpage to provide a single location for information and resources that may be helpful to all interested parties, including manufacturers and importers, preparing and submitting tobacco product applications for deemed new tobacco products by Sept. 9, 2020.
This webpage provides a compilation of information on a variety of topics related to product applications, including the following:
- How to Determine if an Application is Needed: Information about which tobacco products are required to obtain premarket authorization.
- How to Determine the Appropriate Pathway to Legally Market a New Tobacco Product: Information on each of the three pathways—Premarket Tobacco Product Application (PMTA), Substantial Equivalence (SE) and Exemption from SE—to legally market a new tobacco product in order to help applicants pick the most appropriate application type for their tobacco products.
- Tips and Resources to Efficiently Prepare an Application: Tips include information on approaches such as considering grouped submissions—the submission of a single premarket submission for multiple products from the same manufacturer or domestic importer, in the same product category and subcategory. Key resources, such as slides and other material from the FDA’s public meeting on deemed tobacco product applications, relevant rules and guidances, and FDA reviewer guides/scientific policy memos are also linked from the webpage.
- How to Submit an Application: Information on using FDA’s e-Submitter tool to package application files and information on using the CTP Portal to submit the application online. FDA recommends electronic submissions to efficiently transmit and receive applications. Information on electronic submissions and file types and specifications is also linked from the webpage.
The premarket review submission deadline for deemed new tobacco products—which was extended due to the impact of the coronavirus pandemic—applies to products that were on the market as of Aug. 8, 2016. Manufacturers and importers that wish to market these tobacco products must submit an application to FDA by Sept. 9, 2020.
FDA strongly encourages applicants who are able to submit applications in advance of the Sept. 9, 2020 deadline to do so as soon as possible. Those that plan on submitting applications for a large number of products are also encouraged to contact the agency as soon as possible to discuss their plans and method of submission.
FDA has also created a limited email and social media series of “FDA Tobacco Application Tips.” This series highlights application tips that will be helpful to companies preparing to submit their premarket review applications to FDA by Sept. 9, 2020 and will conclude at that time. To subscribe to the email, visit Sign Up for Email Updates from CTP and select CTP News. All tweets related to the series are available at @FDATobacco and all previous emails are available on FDA’s website.
FDA Releases New Webinar on Cigarette Warnings and Plan Requirements
FDA’s Center for Tobacco Products invites you to watch the new Tobacco Compliance webinar, “Cigarette Warnings and Cigarette Plan Requirements.” This webinar discusses the 11 new cigarette health warnings and the requirements for both cigarette packages and advertisements, and provides an overview of cigarette plans for cigarette packages and cigarette advertisements. As a reminder, the new effective date of the final rule is Oct. 16, 2021. FDA strongly encourages entities to submit cigarette plans as soon as possible and in any event by Dec. 16, 2020.
To watch additional compliance webinars, visit the FDA Tobacco Compliance Webinars webinar page.
FDA Issues Warnings for Unauthorized and Youth-Appealing ENDS
FDA issued warning letters notifying 10 companies, including Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization. These new actions are part of FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America.
Puff Bar, HQD Tech USA LLC and Myle Vape Inc. received warning letters for illegally marketing disposable e-cigarettes. Puff Bar and HQD Tech USA LLC were also cited for an additional violation for marketing their products as modified risk tobacco products without an FDA order in effect that permits such marketing.
Additionally, FDA issued seven other warning letters to the following firms: Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises (doing business as Just Eliquids Distro Inc.), who sell or distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. These firms were cited for marketing unauthorized e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as Cinnamon Toast Crunch cereal, Twinkies, Cherry Coke and popcorn, or feature cartoon characters.
FDA requested responses from each firm within 15 working days detailing how each company intends to address the agency’s concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance. Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission.
Public Health and Education
Q&A with CTP’s Director of Communications
Kathy Crosby is the Director of the Center for Tobacco Products (CTP) Office of Health Communication and Education. This multidisciplinary office contains several specialized divisions and teams, including regulatory communications, public education, research and evaluation, and Freedom of Information Act. Learn how these diverse teams of experts work together to support CTP’s public health mission.
CTP’s Exchange Lab Offers Free Tobacco Education Materials
The Exchange Lab provides free print materials, web content, and social media posts to help keep communities informed about tobacco-related issues. The site includes a wide variety of science-based content focused on public health education, tobacco research, retailer information, and tobacco regulations and compliance.
Did You Know…
…about 1 out of 4 nonsmokers in the U.S. are exposed to secondhand smoke?
With more of us spending time together at home, help protect your loved ones from secondhand smoke by keeping your home safe and smoke-free.