Japan Tobacco International U.S.A., Inc (JTI) - Comment

January 22, 2010 Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Draft Guidance for Industry on Tobacco Health Document Submission (FDA–2009–D0600) Dear Sir or Madam: In accordance with the notice published at 74 Fed. Reg. 68629 (Dec. 28, 2009), Japan Tobacco International U.S.A., Inc. (“JTI USA”), a tobacco product importer, submits the following comments to the FDA docket regarding the Draft Guidance for Industry on Tobacco Health Document Submission (Draft Guidance) pursuant to § 904(a)(4) of the Food, Drug, and Cosmetic Act (“FDCA”). Guidance from the Food and Drug Administration (the “FDA”) is very important for the implementation of FDCA § 904(a)(4) because the statutory text is vague and subject to a range of interpretation. However, the Draft Guidance adopts the most expansive possible interpretation of § 904(a)(4), and then goes much further by requesting extensive identifying information for each document that is not required by the statute. What the Draft Guidance proposes is enormously burdensome, and complying on the FDA’s proposed timeline may simply be infeasible. JTI USA respectfully requests that the FDA revisit substantial portions of the Draft Guidance and adopt an approach that is more targeted toward obtaining useful information and more faithful to the statutory text. A. Importer Identification (Section III.C.1) The Draft Guidance requests that each tobacco product manufacturer or importer provide the FEI number assigned by the FDA following establishment reporting or ingredient listing under FDCA sections 904 and 905. The FDA seems to have overlooked the fact that, for imported tobacco products, manufacturers will not be required to register under § 905 until the FDA has issued regulations pursuant to FDCA § 905(h). Because no such regulations have yet been proposed, there is no reasonable prospect they will be issued and effective before the first health information reporting deadline of April 30, 2010. Moreover, ingredients reporting under § 904(a)(1) is not due until June 22, 2010. Therefore, the FDA should clarify that the FEI number may be established at the time of making a § 904(a)(4) submission, as this will be the first submission required of tobacco product importers. B. Meaning of “Developed” (Section III.C.2) One ambiguous term that the Draft Guidance does not adequately define is the word “developed.” The Draft Guidance defines when a document is developed as being whenever it is created or modified in any way. However, the Draft Guidance does not address the relevance of who creates or modifies the document. Unless addressed, apparently every health information document in the possession or control of a tobacco product manufacturer might need to be produced, regardless of who developed the document. Thus, every news article or report on the health effects of tobacco products, of which there are legion, that is emailed to a manufacturer, printed off the Internet, or otherwise ends up in the “possession” of a manufacturer might need to be submitted. Submission of these types of documents would be burdensome to industry, and will only impede the FDA from identifying the relevant and unique information. The legislative history of this provision indicates that Congress intended § 904(a)(4) to only refer to documents developed by the manufacturer. The Congressional Budget Office analysis of § 904 states that “CBO estimates that the direct cost of complying with these requirements would be small.” Given the massive volume of research conducted regarding the health effects of tobacco products and how widely much of this research gets circulated, the reporting burden could not possibly be “small” if materials created by unrelated third parties are included. JTI USA therefore suggests that the FDA narrow submissions to documents developed only by the manufacturer and its agents. At a minimum, publicly available reports should be excluded, eliminating the submission of many duplicative documents that the FDA could easily obtain on its own. C. Interpretation of “Current” Tobacco Products (Section III.C.2) The Draft Guidance “interprets ‘current or future tobacco products’ to refer to all products commercially distributed at any time after June 22, 2009.” Unlike the Final Guidance regarding the Listing of Ingredients in Tobacco Products, the Draft Guidance does not exclude from this definition products that were discontinued prior to the date of a submission. This “interpretation” does not accord with the plain meaning of the word “current.” A product that has been discontinued is not a “current” product. JTI USA suggests that the FDA adopt the same approach to health information submissions as it did with ingredients reporting for discontinued products: namely, that § 904(a)(4) submissions are not required for products discontinued from U.S. commerce prior to the date of the first submission. D. Document Identification (Section III.C.2(a)) The Draft Guidance “interprets section 904(a)(4) to mean you are to organize or label documents to correspond to the categories of documents set out in section 904(a)(4).” In particular, each document is to be identified as relating to health, toxicological, behavioral, and/or physiological effects, and as relating to particular ingredients, products, and/or categories of ingredients or products. This “interpretation” is problematic in multiple respects. Most importantly, there is no statutory basis for the organizing or labeling “requirement.” The statute simply requires manufacturers and importers to “submit” documents. There is no language in § 904(a)(4) that suggests an obligation to do anything other than determine what documents are within the defined class and submit copies of those documents to the FDA. Second, it would be exceedingly burdensome to attempt to provide the information requested in this section of the Draft Guidance. Identifying products and ingredients to which a document relates would be particularly difficult, and would require scientists to review each document with great care. This process would take a long period of time for each document, and would make submission of documents within the timeframe proposed by the FDA impossible. Again, such requirement seems to be inconsistent with the CBO estimation that compliance costs would be small. Finally, the labeling and organizing proposed by the Draft Guidance would have little utility. The categories of “health, toxicological, behavioral, or physiological” greatly overlap, so there is no apparent purpose in applying these labels. Similarly, research into the effects of broad categories of tobacco products will “relate” to so many different products and ingredients that trying to identify those products and ingredients will only distract from the general applicability of the research. E. Document Readability and Accessibility (Section III.C.2(b)) The Draft Guidance recommends a number of additional, onerous steps to facilitate “readability and accessibility.” JTI USA is particularly concerned with the recommendation to translate all foreign language documents into English. This would be excessively burdensome and costly for products imported from foreign manufacturers that operate in non-English-speaking countries. Again, there is no statutory basis for this recommendation and it is inconsistent with the CBO estimation that compliance costs would be small. If Congress wished to impose the expense of translating health information documents on foreign manufacturers, it could have specified that the documents be submitted in English. F. Schedule for Submission (Section III.E) In light of the broad range of documents and information requested in the Draft Guidance, the schedule proposed for the ongoing submission of documents may be infeasible. Moreover, there a number of points of internal contradiction: • The health document submission is a much more complex and time-consuming endeavor than ingredient listing, yet the FDA effectively has extended the deadline for ingredients listing to June 22, 2010, while setting the effective deadline for the first health information submission earlier (April 30, 2010). • The Draft Guidance requests that documents be identified as relating to tobacco products, ingredients, additives and components using terminology as consistent as possible with the submissions under sections 904(a)(1), 904(c), and 905. However, the § 904(a)(1) and § 904(c) reports will not be due until after April 30, 2010, and § 905 reports also will not be required of imported products until some time after that date. • The Draft Guidance calls for collecting, reviewing, categorizing, and submitting a very large volume of documents, with accompanying metadata. The breadth and depth of the Draft Guidance is wholly incompatible with the mere one month between the end of a reporting period and the due date of the submission. JTI USA requests that the FDA delay the initial submission deadline to some time after June 22, 2010 in order to harmonize health information submissions with ingredient reporting requirements. We also believe that a period of at least three months is necessary between the end of a reporting period and the due date of the submission. Finally, given the heavy burden of complying with this requirement, annual reporting would be more appropriate. In many other countries, tobacco product manufacturers are required to provide toxicological information about their products on an annual basis. This frequency of reporting is sufficient for Canada, European Union members, and other nations, and the burden of these reports on industry is substantially less than under the FDA’s interpretation of § 904(a)(4). Thus, an annual § 904(a)(4) report would seem entirely reasonable and sufficient. G. Conclusion Guidance documents should be used solely to clarify ambiguous terms and provide guidance as to the logistics of submissions, so that manufacturers and importers can comply with the law; guidance should not be used to impose new burdens. Unfortunately, the Draft Guidance trespasses this principle: it purports to set out organizing and labeling requirements without any statutory basis, and it imposes a burden impossible to meet within the FDA’s narrow deadlines. JTI USA respectfully requests that the FDA make substantial changes in issuing final guidance in order to provide practical and well-founded guidance for tobacco manufacturers and importers required to make submissions under § 904(a)(4). Very truly yours, Thomas Hirshfield Director, Corporate Affairs & Communications JTI USA