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.
Perspective from the CTP Director: FDA’s Preparations for the Sept. 9 Submission Deadline and Next Steps
Director Mitch Zeller published a perspective piece on CTP’s preparations ahead of the Sept. 9, 2020 premarket review submission deadline for deemed new tobacco products and the guiding principles for allocating product review resources. As the result of a court order (and a subsequent extension due to the unique circumstances of the COVID-19 pandemic), applications for deemed new tobacco products on the market as of Aug. 8, 2016 were due to FDA by Sept. 9, 2020. The court order also provided a one-year period during which products with timely-filed applications might remain on the market pending FDA review.
Director Zeller’s statement covers several important topics, such as:
- The importance of the deadline
- CTP’s expectations of applications coming in by Sept. 9
- Preparations the center made to receive and process the expected applications efficiently
- How the center plans to handle the review of this large influx of applications
Since Congress authorized FDA to regulate tobacco products in 2009, CTP’s staff has increased from just a handful to over 950 today. During that time, CTP has built product review expertise and refined its premarket review processes, enhanced technical capabilities, issued rules and guidances, met with stakeholders to get a better understanding of tobacco products and applicants’ needs for information about the process, invested in tobacco product research, and provided resources to help industry prepare and submit premarket applications. These actions have prepared the center to receive, process, and review applications in a timely manner.
FDA strives to review as many applications as possible during this one-year period and the agency has been developing a review process aimed at maximizing the number of products reviewed while ensuring the greatest public health impact. As always, FDA intends to be fair in allocating resources to reviewing different types of applications—for different types of products and companies—and as transparent as possible while meeting all necessary requirements. FDA plans to update the public and release information regularly as the agency refines plans for allocating product review resources and the process by which products would move into scientific review.
Now that the deadline has passed, and the submissions are with FDA, many may be wondering about the upcoming steps for both submitters and the Agency. FDA aims to be as transparent as possible with regards to the status of these submissions and plans to provide regular updates to the public over the course of the next year. Read more about next steps on the Sept. 9, 2020 premarket submissions.
In This Issue:
Regulation and Guidance:
- SE and EX REQ Updates: First Waterpipe Marketing Orders
- CTP Statement on Premarket Authorization Requirements for Premium Cigars
Compliance and Enforcement:
- National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
- FDA Insight Podcast: E-Cigarettes and the National Youth Tobacco Survey
Public Health and Education:
- Spanish & English Youth E-Cigarette Prevention Materials
- Tips for Safe Disposal of E-Cigarettes and E-Liquid Waste
- Did You Know…?
Regulation and Guidance
FDA issued the first marketing orders for new waterpipe (hookah) filler tobacco products. Although there are hookah products currently on the market either because they are grandfathered or are subject to current enforcement discretion, these are the first new hookah products to be reviewed and authorized by FDA under the agency’s premarket review standards. In total, 10 products manufactured by Al Fakher Distribution USA, Inc. were made eligible to enter into interstate commerce.
Four Exemption from Substantial Equivalence (EX REQ) Products
On April 3, FDA issued four orders under the exemption from substantial equivalence (EX REQ) pathway:
- Al Fakher Plum Flavour 250 grams
- Al Fakher Golden Eskandarani Apple Flavour 250 grams
- Al Fakher Cherry with Mint Flavour 250 grams
- Al Fakher Golden Strawberry Flavour 250 grams
Under the EX REQ pathway, before a tobacco product that receives an exempt order can be legally marketed, the applicant must (1) submit an Abbreviated Report; and (2) ninety days must pass since FDA’s receipt of the Abbreviated Report. Upon administrative review of Al Fakher’s Abbreviated Report, FDA notified them of the 90-day waiting period, which ended on July 8, 2020.
EX REQ is one of three FDA pathways—in addition to premarket tobacco product applications and substantial equivalence reports—for companies that seek to introduce new tobacco products to the U.S. market. Tobacco companies may submit EX REQs if the proposed new tobacco product is modified from a legally marketed tobacco product and the modifications are minor – such as adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive. In addition, companies must demonstrate that a substantial equivalence report is not necessary and that an exemption is otherwise appropriate. FDA anticipates that EX REQ may be a viable pathway to market a number of deemed tobacco products, such as waterpipes (also known also known as waterpipe tobacco, maassel, shisha, narghile, or argileh), cigars, and pipes.
Six Substantial Equivalence (SE) Products
On June 30, FDA issued six orders under the substantial equivalence (SE) pathway for additional waterpipe filler products manufacturer by the company:
- Al Fakher Melon Flavour 50 grams
- Al Fakher Pineapple Flavour 50 grams
- Al Fakher Coconut Flavour 50 grams
- Al Fakher Mango Flavour 50 grams
- Al Fakher Plum Flavour 50 grams
- Al Fakher Cocktail Flavour 50 grams
Under the SE pathway, these six products were immediately eligible to be marketed.
Companies that seek to market a new tobacco product via the SE pathway must demonstrate that the proposed new products have either the same characteristics as predicate products or have different characteristics than predicate products but do not raise different questions of public health. In this case, the corresponding predicate products are all grandfathered, meaning they were commercially marketed in the United States other than exclusively in test markets as of Feb. 15, 2007. The only change from the predicate products was reducing the quantity of each product from 250 grams to 50 grams. Based on the FDA’s experience with SE reports, FDA determined that the products met the statutory criteria to issue SE orders.
Manufacturers of hookah tobacco who wish to market a new tobacco product that may be similar to a tobacco product that is grandfathered, or to one previously found to be substantially equivalent, may want to consider the SE and EX REQ pathways. Learn more on FDA’s website.
On Aug. 19, 2020, the U.S. District Court for the District of Columbia issued a ruling, in part, to prohibit FDA enforcement of the Tobacco Control Act’s premarket authorization requirement for premium cigars until after the agency considers developing a streamlined substantial equivalence process specifically for premium cigars. Accordingly, FDA will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by the Sept. 9, 2020 deadline.
For purposes of the Court’s order, a premium cigar is defined as a cigar that meets all of the following eight criteria:
- Is wrapped in whole tobacco leaf;
- Contains a 100 percent leaf tobacco binder;
- Contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
- Is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
- Has no filter, nontobacco tip, or nontobacco mouthpiece;
- Does not have a characterizing flavor other than tobacco;
- Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and
- Weighs more than 6 pounds per 1,000 units.
In August, FDA submitted a filing with the U.S. District Court of Maryland on the topic of a potential process for case-by-case deferral of the deadline for submission of premarket applications for premium cigars, including the proposed definition of “premium cigars” being used in the U.S. District Court for the District of Columbia’s order. Following the U.S. District Court for the District of Columbia’s decision, FDA has withdrawn its letter. However, as stated in that letter, the agency intends to undertake a research effort specific to premium cigars and their health effects, patterns of use (such as frequency of use and usage patterns among underage persons), and other factors. The results of this research will inform FDA’s regulatory policy with respect to the premarket review of premium cigars.
Compliance and Enforcement
National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
FDA, in partnership with CDC, released new data from the 2020 National Youth Tobacco Survey (NYTS), which shows 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019. After two years of disturbing increases in youth e-cigarette use, the overall significant decline reported in 2020 is encouraging news; however, FDA remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes and the agency acknowledges there is work that still needs to be done to curb youth use.
The findings come as FDA marks the September 9, 2020 premarket review submission deadline, a milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by FDA. Scientific review of new products is a critical part of how FDA carries out the agency’s mission to protect the public—especially kids—from the harms associated with tobacco use. Companies must demonstrate that each product meets the applicable statutory criteria for receiving marketing authorization, such as whether marketing the product is appropriate for the protection of the public health.
In line with its enforcement priorities, FDA also issued warning letters notifying three companies who sell or distribute unauthorized ENDS products to remove those products from the market. FDA issued a warning letter to XL Vape, LLC (doing business as Stig Inc.), a popular disposable e-cigarette brand among youth, warning the company to remove their disposable e-cigarettes from the market because they do not have the required premarket authorization. Additional warning letters were issued to Flavour Warehouse LTD (doing business as Vampire Vape) and Pretty Women UK LTD (T/A Coil2oil and Mad Kingdom Liquids) for illegally marketing unauthorized menthol-flavored e-liquids. The labeling and/or advertising of these products also features cartoon images, such as vampires and kings, that are commonly marketed and/or appeal to youth.
These actions come as the 2020 NYTS data shows an alarming uptick in use of disposable e-cigarettes by youth. Specifically, in 2020, disposable e-cigarettes are being used by 26.5% of high school e-cigarette users (up from 2.4% in 2019) and 15.2% of middle school e-cigarette users (up from 3% in 2019). Furthermore, more than 8 out of 10 youth e-cigarette users report use of flavored products, with fruit, mint, candy, and menthol among the most commonly used.
Mitch Zeller joined Dr. Anand Shah, FDA Deputy Commissioner for Medical and Scientific Affairs, in a discussion on e-cigarettes and the 2020 National Youth Tobacco Survey results. Listen to the FDA Insight podcast episode or read the transcript.
Public Health and Education
FDA continues to work with Scholastic to develop youth e-cigarette prevention materials for middle and high school students. Now, these resources are also available in Spanish. All materials are accessible online for free and are adaptable for remote instruction or independent student work.
Many students are attending virtual or modified school schedules, which can be incredibly difficult for families and children. To help address these challenges, Scholastic grounded these lessons in core subjects and weaved in activities that can easily be done from home, ensuring that these digital materials are still engaging and accessible.
These educational resources are also available in English. Materials include lesson plans, activity sheets, a guide for parents to talk to kids about e-cigarettes, and infographics. Additional FDA and Scholastic resources, including videos in Spanish, are in development and are expected to be available in Winter 2020.
E-cigarettes, including rechargeable batteries and the cartridges and bottles that contain e-liquids (liquid nicotine mixtures), can pose a threat to human health and to the environment if they are not disposed of properly. E-cigarette and e-liquid waste should not be thrown in the regular trash or flushed down a sink. Instead, these items should be taken safely to a hazardous waste facility. FDA has compiled best practices and information from state departments of health and public health nonprofit organizations.
…3 out of 4 teen smokers will become adult smokers because of nicotine addiction. Help teens stay happy, brave and drug-free with free FDA prevention resources.