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Case 1:20-cv-00393-LO-TCB Document 957-6 Filed 02/11/22 Page 1 of 3 PageID# 26662
`Case 1:20-cv-00393-LO-TCB Document 957-6 Filed 02/11/22 Page 1 of 3 PagelD# 26662
`
`EXHIBIT 6
`EXHIBIT 6
`(PUBLIC)
`(PUBLIC)
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 957-6 Filed 02/11/22 Page 2 of 3 PageID# 26663
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, DC
`
`Before the Honorable Clark S. Cheney
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN TOBACCO HEATING
`ARTICLES AND COMPONENTS THEREOF
`
`Investigation No. 337-TA-1199
`
`REBUIT AL EXPERT REPORT OF STACY EHRLICH
`
`RELATING TO THF. PUBLIC INTEREST
`
`51s
`
`Stacy Ehrlich
`
`October 23, 2020
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 957-6 Filed 02/11/22 Page 3 of 3 PageID# 26664
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`entire industry how the Agency will evaluate those applications. Complainants themselves
`
`recognize this.
`
`
`
`
`
`121. Once concern in particular that could frustrate the authorization of certain ENDS
`
`PMTAs is the “epidemic” nature of youth abuse of ENDS products, discussed supra.
`
`122. Even if FDA grants PMTA authorization to some ENDS products, there are likely
`
`to be many others FDA will not authorize, as the quality of both the ENDS products and their
`
`PMTAs vary widely.147 Thus, it is likely that only a small percentage of those ENDS products
`
`covered by timely PMTAs will ultimately be authorized by FDA.
`
`123.
`
`It also is unclear how long FDA will allow those products covered by pending
`
`PMTAs but not authorized by September 2021 to remain on the market during the Agency’s
`
`continued review of those applications. FDA has said that it “would take into account relevant
`
`considerations in deciding whether to initiate enforcement action against a particular product as
`
`the one-year period for review comes to an end in September 2021,” but has offered no guarantee
`
`of continued marketing.148
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`124. Mr. Clissold speculates that ENDS products for which PMTAs have been submitted
`
`by September 9, 2020, could remain on the market for longer than one year while FDA reviews
`
`those applications.149 As one unsupported hypothetical, Mr. Clissold states that “it is entirely
`
`possible that as that [September 2021] deadline approaches, FDA may approach the courts for an
`
`
`146 Figlar Dep. at 47:5-7.
`147 See 1199_RESP00016335-46.
`148 1199_RESP50000540-0541.
`149 Clissold Rep. ¶ 30.
`
`
`
`43
`
`

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