Dear Editors,

The FDA has regulated the manufacturing, distribution and marketing of all cigarette, roll-your-own, and smokeless tobacco products since 2009; in 2016 it expanded that regulation to all tobacco products1. The Tobacco Products Scientific Advisory Committee (TPSAC) is an advisory panel that makes recommendations for approval regarding various tobacco products. The meetings of this panel include presentations from representatives of the tobacco industry and an Open Public Hearing section. The Open Public hearing section of this meeting allows for advocacy groups and the general public to make statements regarding the topic or product being discussed by the committee. These speakers include physicians, cancer survivors and their families, and representatives from patient advocacy groups and other organizations. Also included are speakers from various backgrounds whose presence at the meeting is funded by the tobacco companies or other outside groups. At the start of each Open Public Hearing section, participants are encouraged to disclose any financial conflicts of interest (FCOI) at the beginning of their testimony. However, they are also told that not disclosing any FCOI will not preclude them from speaking. Here we describe the association between Open Public Hearing speakers and financial conflicts of interest with the tobacco industry.

The methods have been previously described in relation to oncology and analgesic drugs2,3. We obtained transcripts of TPSAC meetings between March 2010 and April 2015 (n=26). We excluded any meetings that did not have speakers during the Open Public Hearing section (n=8). We used a pilot tested Google Form to extract the following information: 1) speakers’ names, 2) the organization they represented, if any, 3) the product being discussed, 4) does speaker currently use the product, and 5) whether the speakers reported any FCOI and, if so, the company names providing the payments. We then classified the person’s statement as either positive, negative or neutral. SJ and CC performed all data extraction independently and resolved any discrepancies by mutual agreement. A third author (MV) was available to adjudicate any discrepancies, but was not ultimately needed.

Our study included 108 speakers over 20 meetings of the TPSAC (Table 1). Of the included speakers, 48 (44%, 48/108) reported a conflict of interest. Out of those 48, 33 (68%, 33/48) received funding directly from tobacco companies. Positive statements or statements against the ban of a tobacco product were made by 58 (53%, 58/108) of the speakers, 22 (20%, 22/108) made neutral comments, and 28 (26%, 28/108) made negative statements or spoke in favor of banning a tobacco product.

Table 1

Characteristics of included TPSAC meetings

DateTopicNumber of speakersNumber disclosing FCOI
30 August 2010Tobacco products65
16 July 2010Menthol83
15 July 2010Excluded0-
30 March 2010Excluded0-
31 March 2010Menthol116
7 October 2010Menthol22
18 November 2010Menthol72
10 February 2011Menthol76
10 January 2011Menthol106
11 January 2011Excluded0-
21 July 2011Excluded0-
22 July 2011Dissolvable tobacco products52
17 March 2011Menthol42
18 March 2011Excluded0-
2 March 2011Menthol43
18 January 2012Dissolvable tobacco products0-
19 January 2012Dissolvable tobacco products143
20 January 2012Dissolvable tobacco products0-
1 March 2012Dissolvable tobacco products42
30 April 2013Modified risk tobacco product applications71
16 April 2013Modified risk tobacco product applications53
16 April 2014Dependence and addiction20
17 April 2014Tobacco products21
18 April 2014Modified risk tobacco product applications51
9 April 2015Modified risk tobacco product applications50
10 April 2015Excluded0-

Of the included speakers that disclosed any FCOI, the majority had received funding from a tobacco company. The level of industry involvement described by this study is consistent with the findings of previous studies2,3. The Open Public Hearing sections are designed to allow for the unique perspectives of the general public on these drugs and devices, and the manufacturers of these products are given time elsewhere in the meeting agenda to give their input. In order to preserve the integrity of the Open Public Hearing forum within the TPSAC meetings, we advocate for the least amount of industry involvement possible. We also urge the TPSAC to require the actual disclosure of any FCOI, instead of merely encouraging it.