`Case 1:20-cv-00393-LO-TCB Document 918-6 Filed 01/21/22 Page 1 of 6 PagelD# 25915
`
`EXHIBIT 6
`EXHIBIT 6
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 918-6 Filed 01/21/22 Page 2 of 6 PageID# 25916
`
`UPDATES FROM FDA’S
`CENTER FOR TOBACCO PRODUCTS
`
`Mitch Zeller, J.D.
`Director, FDA Center for Tobacco Products
`
`Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy.
`
`October 27, 2021
`
`CENTER FOR TOBACCO PRODUCTS
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 918-6 Filed 01/21/22 Page 3 of 6 PageID# 25917
`
`FDA’S TOBACCO AUTHORITIES
`
`• The Tobacco Control Act—passed in 2009—gave FDA immediate authority to regulate
`cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco
`
`• When FDA’s “Deeming Rule” went into effect on Aug. 8, 2016, FDA’s authority expanded
`to cover e-cigarettes and all other electronic nicotine delivery systems (ENDS), cigars, pipe
`tobacco, nicotine gels, and hookah tobacco
`
`• As a result, deemed products are now subject to the same requirements in the Tobacco
`Control Act that apply to cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-
`own tobacco
`
`– This includes the requirement that a new tobacco product must receive premarket
`authorization from FDA to be legally marketed
`
`8
`
`October 27, 2021 | Updates From FDA’s Center for Tobacco Products
`
`CENTER FOR TOBACCO PRODUCTS
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 918-6 Filed 01/21/22 Page 4 of 6 PageID# 25918
`
`REVIEW PROGRESS
`
`• FDA has taken action on more than 98% of the over 6.5 million products in the timely
`submitted applications. As of Oct. 13, this includes:
`
`– Completing acceptance review for all applications submitted by the Sept. 9 deadline, which
`resulted in issuing refuse to accept (RTA) letters to more than 200,000 applications
`
`– Completing filing review for almost all timely submitted PMTAs, including issuing a refuse to file
`(RTF) letter to a single company for PMTAs associated with approximately 4.5 million products
`
`– Issuing Substantial Equivalence (SE) marketing orders covering more than 120 products
`
`– Issuing Exemption from SE marketing orders covering more than 230 products
`
`– Issuing marketing denial orders (MDOs) for more than 1 million non-tobacco flavored ENDS
`products
`
`– Issuing marketing granted orders for 3 new tobacco products
`
`11
`
`October 27, 2021 | Updates From FDA’s Center for Tobacco Products
`
`CENTER FOR TOBACCO PRODUCTS
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 918-6 Filed 01/21/22 Page 5 of 6 PageID# 25919
`AUTHORIZATION OF ENDS PRODUCTS THROUGH THE
`PMTA PATHWAY
`
`• On Oct. 12, FDA authorized the marketing of three new tobacco products, marking
`the first set of ENDS products ever to be authorized by FDA
`
`• R.J. Reynolds (RJR) Vapor Company submitted data that demonstrates its tobacco-
`flavored products could benefit addicted adult smokers who switch to these products—
`either completely or with a significant reduction in cigarette consumption—by reducing
`their exposure to harmful chemicals
`
`• Additionally, FDA considered the risks and benefits to the population as a whole and
`determined the potential benefits to smokers outweigh the risk to youth
`
`• FDA also issued 10 MDOs for RJR’s flavored Vuse Solo ENDS products
`
`14
`
`October 27, 2021 | Updates From FDA’s Center for Tobacco Products
`
`CENTER FOR TOBACCO PRODUCTS
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 918-6 Filed 01/21/22 Page 6 of 6 PageID# 25920
`
`REMAINING PENDING APPLICATIONS
`
`• FDA continues to work expeditiously on the remaining applications that were submitted by
`the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review
`
`– The agency has around 80,000 products pending that are the subject of timely submitted
`PMTAs
`
`• FDA continues to review PMTAs for non-tobacco flavored ENDS to determine whether
`there is sufficient product-specific scientific evidence of a benefit to adult smokers to
`overcome the risk posed to youth
`
`– The scientific review of menthol ENDS raises unique considerations, and FDA is reviewing
`every product on a case-by-case basis with the same review standards
`
`• FDA is also reviewing a smaller number of pending applications under the SE
`standard for cigars, pipes, and hookah tobacco
`
`16
`
`October 27, 2021 | Updates From FDA’s Center for Tobacco Products
`
`CENTER FOR TOBACCO PRODUCTS
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
