CTP Connect—October 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.

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

Regulation and Guidance

SE and EX REQ Updates: First Waterpipe Marketing Orders

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.

CTP Statement on Premarket Authorization Requirements for Premium Cigars

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.

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.

FDA Insight Podcast: E-Cigarettes and the National Youth Tobacco Survey

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.

Public Health and Education

Spanish & English Youth E-Cigarette Prevention Materials

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.

Tips for Safe Disposal of E-Cigarettes and E-Liquid Waste

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.

Did You Know…

…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 .