`Case 1:20-cv-00393-LO-TCB Document 957-6 Filed 02/11/22 Page 1 of 3 PagelD# 26662
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`EXHIBIT 6
`EXHIBIT 6
`(PUBLIC)
`(PUBLIC)
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`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
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, DC
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`Before the Honorable Clark S. Cheney
`Administrative Law Judge
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`In the Matter of
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`CERTAIN TOBACCO HEATING
`ARTICLES AND COMPONENTS THEREOF
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`Investigation No. 337-TA-1199
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`REBUIT AL EXPERT REPORT OF STACY EHRLICH
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`RELATING TO THF. PUBLIC INTEREST
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`51s
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`Stacy Ehrlich
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`October 23, 2020
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`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
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`entire industry how the Agency will evaluate those applications. Complainants themselves
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`recognize this.
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`121. Once concern in particular that could frustrate the authorization of certain ENDS
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`PMTAs is the “epidemic” nature of youth abuse of ENDS products, discussed supra.
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`122. Even if FDA grants PMTA authorization to some ENDS products, there are likely
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`to be many others FDA will not authorize, as the quality of both the ENDS products and their
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`PMTAs vary widely.147 Thus, it is likely that only a small percentage of those ENDS products
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`covered by timely PMTAs will ultimately be authorized by FDA.
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`123.
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`It also is unclear how long FDA will allow those products covered by pending
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`PMTAs but not authorized by September 2021 to remain on the market during the Agency’s
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`continued review of those applications. FDA has said that it “would take into account relevant
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`considerations in deciding whether to initiate enforcement action against a particular product as
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`the one-year period for review comes to an end in September 2021,” but has offered no guarantee
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`of continued marketing.148
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`124. Mr. Clissold speculates that ENDS products for which PMTAs have been submitted
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`by September 9, 2020, could remain on the market for longer than one year while FDA reviews
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`those applications.149 As one unsupported hypothetical, Mr. Clissold states that “it is entirely
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`possible that as that [September 2021] deadline approaches, FDA may approach the courts for an
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`146 Figlar Dep. at 47:5-7.
`147 See 1199_RESP00016335-46.
`148 1199_RESP50000540-0541.
`149 Clissold Rep. ¶ 30.
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`43
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