FDA Briefly Appears to Announce Menthol Report Subcommittee


The Federal Register’s public inspection list of notices to be published on July 27th included a reference to a meeting of a TPSAC Menthol Report Subcommittee.  The index of the public inspection documents contained the following entry but did not include the actual announcement:


Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee

[Docket No. FDA-2010-N-0001; Filed: 07/26/10 at 8:45 am;  Publication Date: 7/27/2010

 The index entry of the meeting was removed a few hours later for unknown reasons.

 At the July 15 TPSAC meeting, an FDA slide on information requested by committee members, stated that there was a request from a TPSAC member for support for writing the menthol report and a plan for to establish a menthol report subcommittee.

 The withdrawn FDA meeting announcement appears to confirm that a menthol report subcommittee would be established.  The crucial information that was not included were the names of the subcommittee members, including non-voting consultants and other participants selected by FDA.

 The FDA needs to avoid the secrecy that characterized establishment of the Tobacco Product Constituents Subcommittee.  Instead, well in advance of the first menthol report subcommittee meeting, FDA should: 1)  announce all planned voting and non-voting members of the subcommittee; and 2) request public comment on the nominations.

 If the FDA does not announce planned membership and request comment on the nominations, TPSAC members should request that the agency do so

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