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.
A Perspective on the FDA’s COVID-19 Response
By Mitch Zeller, Director of FDA’s Center for Tobacco Products
I have the honor to run the FDA’s Center for Tobacco Products (CTP). While CTP’s work to protect the public health is essential and continues during the pandemic, we are the least involved of the FDA centers when it comes to working directly on the coronavirus (COVID-19) response. That said, I’ve been proud to join my FDA colleagues in our “all-hands-on-deck” approach to tackling this pandemic, lending as much support as possible as my FDA colleagues across the entire organization work tirelessly for the American people.
The COVID-19 pandemic represents a new and significant challenge for all of us – both personally and professionally. Despite these challenges and the impact on all of us, I am hopeful and inspired by what I see happening behind the scenes at the agency.
I’d like to offer my own perspective, from where I sit, on how the FDA is battling this pandemic.
In This Issue:
Regulation and Guidance:
- Deadline Extended to Sept. 9 for Submission of Certain Premarket Tobacco Applications
- Final Rule: Required Warnings for Cigarette Packages & Advertisements
- FDA Extends Comment Period for RFI on Vaping Products Associated with Lung Injuries
Compliance and Enforcement:
- FDA Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette Products, Including Products Targeted to Youth, from the Market
- FDA Releases New Webinar on Tobacco 21, ENDS Enforcement Priorities
- FDA Warns Maker of Nicotine-Containing Toothpicks of Several Violations, Including Illegal Sales
Public Health and Education:
- Virtual Learning: Youth E-Cig Prevention Materials for Middle and High School Students
- Did You Know…?
Regulation and Guidance
On April 22, the United States District Court for the District of Maryland granted FDA’s request for a 120-day extension of the May 12, 2020 premarket review deadline for manufacturers of many e-cigarettes, cigars and other deemed new tobacco products that were on the market as of August 8, 2016. The court order means applications are now required to be filed by Sept. 9, 2020.
Consistent with the original court order, for companies that submit timely applications, FDA may continue to exercise enforcement discretion – meaning their products would generally continue to be marketed without being subject to FDA enforcement actions – for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by FDA on an application during that time.
Solely as a result of the coronavirus pandemic and exceptional and unforeseen circumstances, FDA requested this extension from the court on March 30. FDA remains acutely aware of the recent surge in youth use of e-cigarettes and the public health imperative that these and other deemed new tobacco products undergo premarket review.
The ENDS enforcement priorities guidance, which independently prioritizes earlier enforcement against certain e-cigarette products that are widely used by youth, remains in effect regardless of whether an application is submitted. FDA recently revised this guidance to update the May 12 date to Sept. 9, 2020 as appropriate.
In accordance with this new date for submission of premarket applications to the agency and the new statutory minimum age of sale for tobacco products, FDA also issued changes to two other guidance documents:
- Revised the guidance for small businesses, “FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements”
- Withdrew the guidance for industry, “Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule”
FDA has also released two webinars to provide updates for both importers and manufacturers on the Sept. 9, 2020 application deadline for deemed new tobacco products and enforcement priorities for ENDS and other deemed tobacco products. The webinar for importers explains a new subclass created for use in building product codes, the impact of the compliance policy on imported tobacco products, and two new import alerts. The webinar for manufacturers describes tobacco product manufacturer responsibilities related to the recent enforcement priorities final guidance and premarket review submission deadline. Additionally, FDA has compiled a webpage with information and resources to assist with submission of premarket review applications.
FDA strongly encourages applicants who are able to submit premarket applications to do so as soon as possible. Those that plan on submitting applications for a large number of products are encouraged to contact the Agency as soon as possible to discuss their plans and method of submission. Sharing information about the number and nature of applications being developed will help FDA to prepare more efficiently for the influx of applications, enabling review of quality applications. Manufacturers can find additional information and resources for submitting an application on FDA’s website.
On March 17, FDA announced the issuance of a final rule to require new health warnings on cigarette packages and in cigarette advertisements to promote greater public understanding of the negative health consequences of cigarette smoking. The eleven warnings feature text statements accompanied by photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, and diabetes.
Beginning in 2021, these new cigarette health warnings will be required to appear prominently on cigarette packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. Once implemented, the warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.
In addition, FDA has issued the guidance “Required Warnings for Cigarette Packages and Advertisements Small Entity Compliance Guide,” which assists small businesses in understanding and complying with the final rule.
On March 19, the agency also issued the final guidance “Submission of Plans for Cigarette Packages and Cigarette Advertisements” to assist those submitting a cigarette plan detailing the random and equal display and distribution of the required warnings on cigarette packages and the quarterly rotation of the required warnings in cigarette advertisements. The guidance provides recommendations related to preparing and submitting cigarette plans, including information on who should submit, when to submit, and what information should be in a cigarette plan.
In response to requests from the public, FDA extended the comment period for a request for information (RFI) seeking data and information related to the use of vaping products that are associated with lung injuries. Responses to this RFI may be submitted to docket FDA-2020-N-0597 on regulations.gov through June 19, 2020.
The RFI, initially published in the Federal Register on Feb. 18, responds to direction from Congress to gather additional information that could help identify and evaluate additional steps that could be taken by the agency to “address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.”
Compliance and Enforcement
FDA Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette Products, Including Products Targeted to Youth, from Market
On March 10, FDA issued 22 warning letters to online and brick-and-mortar e-cigarette product retailers and manufacturers across the country who sell flavored, cartridge-based electronic nicotine delivery system (ENDS) products advising them that selling products, which lack marketing authorization, is illegal. The warning letters were sent to some establishments with well-known names, such as 7-Eleven and Shell, and were the first in a series of ongoing actions consistent with FDA’s recently issued enforcement priorities for e-cigarettes and other deemed products on the market.
On April 27, FDA issued ten warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. The warning letters were sent to establishments marketing unauthorized products, such as 1) a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette and 2) ENDS products that resemble smartwatches or devices appearing as children’s toys (such as a portable video game system or fidget spinner). Warning letters were also issued to companies marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.
As announced earlier this year, FDA is prioritizing enforcement against the following unauthorized ENDS products: 1) flavored, cartridge-based ENDS products (other than tobacco or menthol flavored); 2) all other ENDS products for which the manufacturer has failed to take adequate measures to prevent underage access; and 3) any ENDS product that is targeted to youth or likely to promote use by youth. Under this policy, companies that do not cease manufacture, distribution and sale of these unauthorized tobacco products risk FDA regulatory actions ranging from warning letters to injunction, seizure and/or civil money penalty actions. Through the end of April, FDA has issued warning letters to an additional 150 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products.
These warning letters notify the retailers and manufacturers that new ENDS products without a marketing authorization order are adulterated and misbranded, and selling or distributing these products to customers in the U.S. is prohibited under the FD&C Act. Retailers and distributors are encouraged to communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.
FDA invites you to watch the new webinar, “Recent Changes that Impact the Sale of Tobacco Products in Retail Establishments.” This webinar provides an overview of two recent changes that impact tobacco product retailers, specifically:
- The Tobacco 21 Legislation, which increased the federal minimum age of sale of tobacco products to 21 years
- FDA’s recently published final guidance, which outlines the enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization
This webinar offers particularly relevant information for retailers on what retailers should know about the Tobacco 21 legislation and the enforcement priorities guidance, including helpful tips on manually checking IDs to verify the age of the customer, as well as FDA’s premarket enforcement priorities for flavored cartridge-based ENDS and the impact on retailers.
FDA issued a warning letter on Jan. 31 to Smart Toothpicks LLC, of Tempe, Ariz., for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells dissolvable tobacco products, including Peppermint Ice Nicotine Toothpicks.
FDA sent a warning letter to the manufacturer for three specific violations
- Selling a tobacco product to a minor through the company’s website
- Selling unauthorized modified risk tobacco products
- Failing to include required nicotine warning statements on both packaging and advertising
FDA requested that Smart Toothpicks provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the FD&C Act, including its plan to prevent the same or similar violations. Failure to ensure compliance with the FD&C Act may result in FDA initiating further action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Public Health and Education
With many schools across the country currently closed, FDA and Scholastic continue to develop youth e-cigarette prevention educational materials for middle and high school students. All materials are available online for free on “The Real Cost of Vaping” website and are adaptable for virtual learning.
Missing school is not easy for families, but Scholastic grounded these lessons in core subjects and weaved in activities that involve statistics, reading comprehension, writing, presenting, and media literacy so during this unexpected time at home, these digital materials are still accessible for learning.
New resources are available, including two new lessons and worksheets and five short videos focused on content areas that align with e-cigarette prevention lesson plans. These new materials join the previously developed content including lesson plans, a guide for parents to talk to kids about e-cigarettes, infographics, and youth cessation resources.
… smoking cigarettes can leave you more vulnerable to respiratory illnesses such as COVID-19?
Smoking cigarettes is known to cause heart and lung disease and people with underlying heart and lung problems may have increased risk for serious complications from COVID-19. Smoking can also cause inflammation and cell damage throughout the body, and can weaken your immune system, making it less able to fight off disease. COVID-19 primarily attacks the lungs and those with underlying lung disease are at increased risk of serious complications.
There’s never been a better time to quit smoking. If you need resources to help you quit smoking, FDA’s #EveryTryCounts campaign has supportive tips and tools to help you get closer to quitting for good.