FDA Week: Industry Warns Of Poor Data, Exclusion From New Tobacco Activities

A regulatory watchdog group and industry representatives are expressing concern with how a new FDA menthol advisory panel is proceeding, contending that agency data for a forthcoming report is flawed and could set the precedent for using inadequate information for other tobacco-related reports. The panel, whose members are mostly non-governmental experts, is charged with evaluating how the use of menthol in cigarettes affects smoking patterns. (emphasis supplied)

Meanwhile, non-voting industry members of the menthol subcommittee were also disappointed at being left out of the writing responsibilities for the menthol report required under recent legislation, disputing an FDA claim that the omission of their input reflects the agency’s desire to maintain trade secrets.

FDA Reacts to Informed Advocacy

The fact that the FDA announced that it would not prepare a draft of the report for the menthol subcommittee demonstrates that when provided with overwhelmly  convincing data and arguments , the FDA will modify its position.

 It is for this reason that stakeholders  must express their views on the five controlling issues which resulted from the first menthol subcommittee  meeting and are delineated on this post  http://www.thecre.com/tpsac/?p=561  .

It is imperative that stakeholders assist CRE in the construction of a “public docket” by providing relevant scientific and legal analysis on this forum at http://www.thecre.com/dqa/   which will  provide  the basis  for  demanding  further modifications to  TPSAC  procedures.

A Smokeless Tobacco Issue: Another TPSAC Issue? Another DQA Issue?

In an article entitiled:  “Glaxo Aims to Snub Out ‘Dissolvable’  Tobacco Items, the Wall Street Journal Reports:

  GlaxoSmithKline PLC called for the U.S. government to remove so-called   dissolvable smokeless-tobacco products from the market, a move that shows emerging battle lines between pharmaceutical and tobacco companies aiming to sell alternatives to cigarettes.

Dr. Lawrence Deyton, director of the FDA’s Center for Tobacco Products, sent letters in February to both Reynolds and Star Scientific in which he expressed concern that dissolvable tobacco lozenges, strips and sticks are candy-like in appearance and may appeal to the youth market.

FDA Makes Landmark Improvements in TPSAC Governance

Today, among other changes, FDA announced the following actions regarding the process to govern the operation of the menthol Subcommittee of TPSAC:

 1.  “FDA will not write any portion of the report.”

  2.  “The drafts-in-progress are to be kept confidential and cannot be shared with anyone other than the chair, DFO and the science writer.”

  3. “FDA will review the new information and present it, as appropriate, at a TPSAC meeting for discussion.”

 CRE applauds the FDA for the above actions.

  Several topics raised at today’s meeting are in need of additional discussion:

 l. Time Extension

Academy Awards at TPSAC?


 Less than one business day before the TPSAC meeting:

 l.   Who is on the menthol subcommittee?

 2.  Do any of the members of the subcommittee have a background independent of the public health community?

 3.   Are there any mathematical statisticians on the subcommittee?

 4.  Is FDA going to hire a consultant to review the initiation/cessation studies, give the operating instructions to the reviewer, package the analyses, reach conclusions and submit the findings to the menthol subcommittee for an up or down vote, and then claim that the process is FACA compliant because “FDA is not a member of the menthol subcommittee?  ( This was the process used for the constitutents subcommitee.)

NACS Reiterates Concerns About Eliminating Menthol Cigarettes

ALEXANDRIA, Va. – Last week, NACS sent a second letter to the U.S. Food and Drug Administration’s Tobacco Product Safety Advisory Committee (TPSAC) to emphasize concerns with discussions ongoing at the agency that would phase out or eliminate the menthol cigarette market. On September 27, TPSAC’s Menthol Subcommittee will meet to discuss regulation of the market.

The FDA has clear authority under the Tobacco Control Act to regulate the contents and safety of tobacco products. However, NACS feels that discussions leaning towards eliminating the menthol category from the marketplace will have consequences that have not been thoroughly vetted.

Center for Regulatory Effectiveness Invokes Data Quality Act Against FDA Menthol Studies


 The Center for Regulatory Effectiveness (CRE) has notified the  FDA that  the smoking initiation/cessation studies identified by the FDA and reviewed by CRE can not be used to formulate a policy on menthol cigarettes.

 The Data Quality Act  prohibits federal agencies from using studies that are non-compliant with the DQA. The  FDA has sixty days to respond to the CRE petition.

 In its petition  CRE  painstakingly reviews eight of the studies identified by  the FDA and explains  the reasons for their non-compliance with the Data Quality Act.

 In its petition CRE states:

Dr. Michael Siegel’s Comment on CRE’s Statement that FDA is Violating FACA

Center for Regulatory Effectiveness Charges that TPSAC Tobacco Product Constituents Subcommittee Violates the Federal Advisory Committee Act

In an August 29 memorandum, the Center for Regulatory Effectiveness (CRE) charges that the Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee (TPSAC) is acting in violation of the Federal Advisory Committee Act (FACA) because the Subcommittee is structured so as to be unduly influenced by the FDA.

The TPSAC is an advisory committee to the FDA set up under the Family Smoking Prevention and Tobacco Control Act. One of its initial charges is to develop a list of hazardous constituents in tobacco smoke in order to guide the development of “safety standards” to make cigarettes safer by removing or reducing the levels of various toxic components. To accomplish this task, a subcommittee was formed.

CRE Press Release: For Publication Tuesday, September 7

FDA Tobacco Advisory Committee is in Violation of  the Federal Advisory Committee Act.

The Center for Regulatory Effectiveness , a regulatory watchdog managed by former White House Office of Management and Budget regulatory officials , has issued a scathing report on FDA non-compliance with the Federal Advisory Committee Act (FACA).

 Central to CRE’s arguments is the fact that FDA is dominating the advisory committee by controlling the production of key studies. CRE has called these illegal actions to the attention of FDA a number of times but FDA continues to act outside the law because they conclude that since the product in question is tobacco that the normal rules of fair play do not apply.