Once of the concerns that I had about the FDA getting into the tobacco business was that it would divert limited resources available to the public health community into useless bureaucratic processes.

This concern was realized in spades as people worked to get public comments into the FDA in response to its request for public comments on its Advanced Notice of Proposed Rule Making (ANPRM) on menthol.

The FDA is required to consider information submitted by the public (including the tobacco companies as well as public health and other interested parties) to its "docket," which is the office record of submitted materials. Only comments submitted to the docket can be considered.

The way that the FDA has chosen to interpret this requirement, however, has generated a lot of extra work that adds nothing of substance to the discussion, as the following tale from the Tobacco Control Legal Consortium illustrates:

When the FDA announced the Menthol ANPRM and request for public comments, the agency explained that the docket created would remain the same if they propose a rule on menthol. This means that this docket is the official record on menthol for agency action and all evidence must be in this docket for the agency to rely on it. Information can get into the official record either by public submission to the docket or if the agency takes notice of the information.

The Tobacco Control Legal Consortium wanted to make sure that all of the public health research and submissions on menthol over the last four years made it into the record, especially the full body of evidence compiled by TPSAC on menthol and the comments submitted on the Menthol Citizen Petition docket.

Accordingly, Consortium attorneys asked the FDA to take the necessary action to fold the Menthol Citizen Petition, supporting documents, and public comments into the ANPRM docket. The FDA declined, stating that if the Consortium wanted to ensure the FDA would consider that evidence, the Consortium would have to resubmit it even though this material had already been submitted to the FDA through the docket and the FDA could have either "taken notice" of this material or simply loaded it into the ANPRM docket itself..

Because the FDA does not make most of the public comments on the Menthol Citizen's Petition (and most other dockets) public, the FDA forced the Consortium staff to submit a Freedom of Information Act (FOIA) request to the FDA for all of the petition comments.

After the FDA produced this material to the Consortium, the Consortium loaded them on a disc along with the Citizen Petition and all of the supporting research, then re-submitted those to the FDA on the ANPRM docket.



The Consortium staff also learned that the FDA is not required to consider the full record submitted to the FDA's own Tobacco Products Scientific Advisory Committee (TPSAC) on menthol as part of its promulgation of a rule on menthol. The Tobacco Control Act provides that if the FDA proposes a tobacco product standard that restricts/prohibits menthol cigarettes, it must consider the TPSAC Menthol Report, but it is not required to consider the full record of evidence submitted to TPSAC. This does not mean that the FDA is prevented from relying on the evidence presented to TPSAC, but it is not required to consider it.

When the Consortium asked whether the FDA could assure the public health community that it would consider TPSAC’s full evidence base on menthol and it would not commit to doing so. Put another way, Congress formed TPSAC to advise the FDA and directed TPSAC to study menthol first and advise the FDA on this subject, yet the FDA would not commit to reviewing the enormous evidence accumulated by TPSAC when determining what action to take.

This refusal to take steps to incorporate all available evidence into the record is the FDA’s own decision, it is not required by law. In response, Consortium staff assembled the full TPSAC record (except for industry submissions) for submission on the ANPRM docket, to ensure that the FDA considers all of that evidence. This included the transcripts of each TPSAC hearing through July 2011, all public presentations and submissions at those meetings, and the all of the studies referenced in the TPSAC Report that they were able to access.

To highlight the absurdity of the FDA’s refusal to act, the Consortium staff downloaded most of the TPSAC materials from the FDA’s own website and then sent those documents back to the FDA.



In the end, to ensure the official menthol docket includes the menthol citizen petition documents and the TPSAC documents, it took the Consortium two days of staff time to compile and submit information that the FDA already had in its possession.

I had a similar experience: When I asked the FDA if it would consider the information in research papers that are freely available to everyone in the open scientific literature that I (and others) cited in our comments that were submitted to the docket, I was told that they could not assure that the FDA would. To be safe, I was instructed to load copies of all the published papers into the docket.

The FDA would not consider previous submissions to other menthol dockets as part of the record; I was told to resubmit those, too, even though the FDA already had them, too.

And, of course, the same burden was imposed on the other public health commentors who thought to ask the FDA about this issue. Since many of us are citing the same scientific papers, this means that multiple people have to waste their time submitting duplicate copies of the same research. (This also makes more work for the FDA to wade through a lot of duplicate material.)

This problem will continue to get worse and worse as time passes because the volume of evidence will only grow and have to be submitted over and over and over again.

This kind of behavior from the FDA creates a barrier to access for the public health community, which has vastly fewer resources than the industry.

The FDA.needs to adjust its procedures to stop this wasteful process. Some options: