FDA — Menthol Cigarette Background Paper: Response to RFR

03/05/2014

March 5, 2014

Mr. Ronald S. Milstein

Senior Vice President
Legal and External Affairs
General Counsel and Secretary
Lorillard, Inc.
714 Green Valley Road
Greensboro, North Carolina 27408

Dear Mr. Milstein:

This letter responds to the Lorillard Tobacco Company Information Quality Act1 (IQA) (also known as the Data Quality Act) appeal dated January 4, 2012. This appeal is of a Food and Drug Administration (FDA) response dated December 2, 2011, to an initial request for correction dated March 16, 2011. The appeal concerns Table 1.1 and several White Papers provided as background to FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) prior to two fall meetings in 2010. We appreciate your patience with the time this response has taken to come to you.

The primary contention in the request for correction was that neither the White Papers nor Table 1.1 “meet the requirements for quality, utility, objectivity, and integrity demanded by the IQA.” FDA’s response from Dr. David Ashley, Director of the Office of Science in FDA’s Center for Tobacco Products (CTP), stated CTP’s view that the materials were not subject to the IQA, and that the agency considered external recommendations for edits and additions to the materials. FDA concluded that no further action on the materials was necessary.

Although organized slightly differently in the appeal letter, Lorillard essentially makes the following argument: the IQA applies to the White Papers and Table 1.1 because those materials were “disseminated” by FDA as the term is defined in the IQA, and the materials did not meet the requirements of the IQA. Lorillard contends FDA must take corrective and remedial actions in order to comply with the IQA.

For the reasons discussed in the previous response and below, I do not agree with Lorillard’s analysis of the materials and conclude that no corrective action is necessary, thus upholding the December 2, 2011, response to your initial request for correction.

When the IQA Applies:
As noted in the “Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies,”2 as established by the Office of Management and Budget (OMB), the IQA applies to most federal agencies, but not to all types of information. The IQA applies only to information that is “disseminated” by an agency, as that term is defined.

White Papers and Table 1.1:
The White Papers cited by Lorillard 3 consisted of compilations of peer-reviewed studies on menthol that were briefly summarized by FDA. They were presented to TPSAC as background information for the October 7, 2010, meeting. The White Papers did not endorse any of the underlying studies or purport to offer a detailed assessment of the studies. They were accompanied by a cover page stating that “[t]he findings and conclusions in these reports have not been formally disseminated by FDA and should not be construed to represent any agency determination or policy.”4 This cover page was the template for similar language on the website.

Table 1.1 was a compilation of evidence from peer-reviewed journals that was also included in the White Papers and made available for the November 18, 2010, TPSAC meeting. As indicated by the transcript of that meeting, the table was “designed to be a working document that the [TPSAC] writing groups could use…and they could fill in, edit, add, delete, change, however they wanted.”5

Relationship Between IQA and TPSAC Materials:
FDA made no judgment about any of the underlying information – a stance made clear by the disclaimers on the cover letters, as well as the direct statements at the meetings themselves. TPSAC members, industry representatives, and the public were all encouraged to comment on and criticize any information used by TPSAC, as well as to suggest additional studies and information. By inviting critique and further information, FDA made it clear that the information provided was not necessarily a complete picture, and that it did not represent a judgment on the landscape of menthol research. The agency was willing to make changes to the documents based upon additional information provided by the public. As your Request for Correction noted, Lorillard submitted comments and suggestions for revisions. Your comments, as well as other comments that were submitted, were carefully considered.

Lastly, as you know, TPSAC is an advisory committee subject to the Federal Advisory Committee Act (FACA), providing independent advice and recommendations to FDA, but not participating in agency decision-making.6

FACA requires, among other things, that certain information be made publicly available.7 Further, FDA has issued guidance which emphasizes its intent to provide such information to the public prior to advisory committee meetings.8 As such, and in the interest of transparency, FDA made the materials provided to TPSAC available to the public, while at the same time employing disclaimers on the cover pages and making public statements to emphasize their limited use.

Lorillard also notes that some of the information in the White Papers was published in Induced Disease 9 Suppl. 1 (2011), a journal issue supported by the FDA for this particular topic. Funding the journal is consistent with the FDA commitment to transparency and making information publicly available. However, supporting the publication of materials is not inconsistent with the disclaimer used, which stated: “These articles reflect the views of the authors and should not be construed to represent FDA’s views or policy.”

Application of IQA Standards to TPSAC Materials:
Lorillard next argues that the White Papers and Table 1.1 are not “objective” or “useful” under IQA standards. As discussed above, the materials do not fall under the terms of the IQA and are not subject to the standards referenced by Lorillard.

Conclusion:
The Lorillard IQA Appeal provides two appendices, which represent proposed changes to the White Papers and Table 1.1. Lorillard requests that new versions of the materials be posted online, along with public statements identifying the previous versions as inaccurate.

As discussed above, the IQA does not apply to the materials in question. Further, FDA has been thoughtful and inclusive in evaluating recommendations for edits or additions to the materials that it received from various public sources, and does not believe that any additional changes are necessary.

Going forward, if you have concerns about the quality of data being considered by TPSAC, we encourage you to use FDA’s existing procedures to raise these concerns so TPSAC will have an opportunity to consider them in a timely manner. These procedures include submitting comments to the public docket or speaking at an open public hearing portion of an advisory committee meeting.

Sincerely,

/s/ 
Mitchell Zeller

Director, Center for Tobacco Products


1 Section 515(a) of the Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub. L. No. 106-554 (Appendix C), 114 Stat. 2763A-153. Also known as the Data Quality Act.

2 67 FR 8452 (February 22, 2002) at: http://www.whitehouse.gov/system/files/omb/fedreg/reproducible2.pdf.

3 Entitled: Marketing of menthol cigarettes and consumer perceptions; Sensory properties of menthol and smoking topography; Menthol and initiation of cigarette smoking; Menthol cigarette smoking and nicotine dependence; Menthol cigarettes and smoking cessation behavior; The health effects of menthol cigarettes as compared to non-menthol cigarettes; and epidemiology of menthol cigarette use in the United States.

4 The appeal letter focuses on the word “formally” in this disclaimer, suggesting that FDA was attempting to create a distinction in the definition of “dissemination” that does not exist. No such distinction was intended.

5 TPSAC Meeting, November 18, 2010, transcript pg. 23, lines 9-20 athttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM251663.pdf.

6 21 C.F.R. 14.5(b). “The Commissioner has sole discretion concerning action to be taken and policy to be expressed on any matter considered by an advisory committee.”

7 5 U.S.C. App. § 10(b). “Subject to section 552 of title 5, United States Code, the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda or other documents which were made available to or prepared for or by each advisory committee shall be made available for public inspection and copying…”

8 “Guidance for Industry: Advisory Committee Meetings – Preparation and Public Availability of Information Given to Advisory Committee Members,” http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf.