Draft Guidance for Industry: Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act

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This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

Additional copies are available from the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. You may also send an e-mail request to Annette.Marthaler@fda.hhs.gov to receive an electronic copy of the guidance.

Draft Guidance for Industry and FDA Staff

Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

I. INTRODUCTION

This guidance is intended for manufacturers, retailers, importers, and FDA staff. The guidance describes FDA’s current thinking regarding the appropriate preliminary timetable for its review of applications for Modified Risk Tobacco Products (MRTP) under section 911 of the Federal Food, Drug, and Cosmetic Act (FDCA), as modified by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). For the reasons discussed below, pending further guidance or rulemaking, FDA intends to issue a decision on an MRTP application within 360 days of its receipt by FDA.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. DISCUSSION

Section 911 of the FDCA, as amended by the Tobacco Control Act, states, in pertinent part:

(a) No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.

(d) Any person may file with the Secretary an application for a modified risk tobacco product. . . .

Section 911(g) provides the criteria under which the Agency determines whether to issue an order that a MRTP may be commercially marketed. The Tobacco Control Act provides that, within two years and nine months of its enactment, the Agency shall issue regulations or guidance regarding MRTP applications, and those regulations or guidance shall “establish a reasonable timetable for the Secretary to review an application under this section.” (See section 6 of the Tobacco Control Act and section 911(l) of the FDCA as added by the Tobacco Control Act.)

FDA is issuing this guidance to describe a preliminary timetable the Agency intends to follow until such time as the Agency issues more comprehensive guidance or regulations on MRTP applications. In determining the appropriate timetable, the Agency has considered the following:

• The MRTP application procedure in section 911(d) of the FDCA provides that the application must contain: a description of the product and any proposed advertising and labeling; the conditions for using the product; the formulation of the product; sample product labels and labeling; all documents related to research findings, both favorable and non-favorable, relating to the effect of the product on tobacco-related diseases and health–related conditions; and data and information on actual consumer use. Section 911(e) of the FDCA provides that the Agency make the MRTP applications available for public comment. Section 911(f) of the FDCA requires that an MRTP application be referred to the Tobacco Products Scientific Advisory Committee for review and that the committee report its recommendations to the Agency within 60 days of the referral.
• In a related context, Congress authorized FDA to issue a decision on an application in 540 days, and that timeframe was sustained by the United States Court of Appeals for the Second Circuit in a case involving a First Amendment challenge. Nutritional Health Alliance v. Shalala, 144 F.3d 220 (2d Cir. 1998) (involving the timeframe for evaluating whether health claims for dietary supplements are truthful, non-misleading, and supported by significant scientific agreement). That timeframe took into account the time required for notice-and-comment rulemaking. Although notice-and-comment rulemaking is not required for each MRTP application, the Agency is required to make the applications available for public comment, and that process will require time. Also, the Tobacco Products Scientific Advisory Committee will have 60 days to issue a recommendation on an application, and the Agency will then review and consider the Committee’s recommendations.
• The Agency has not yet received an MRTP application. It therefore does not have experience in reviewing such applications, and has no information based on prior experience regarding the length of time required for review of such applications. Moreover, the MRTP application review process and approval criteria are new, and the Agency is likely to encounter a number of questions of first impression involving science, law, policy, and procedure. Resolving questions of first impression may mean that the initial applications will require more time than later submitted ones.
• As Congress has recognized, the Agency has historically had difficulty meeting the 180-day timeframe provided by statute for issuing decisions on new drug applications and premarket approval applications for devices, pursuant to sections 505(c) and 515(d) of the FDCA. See, e.g., H.R. Rep. No. 102-895 at 8 (1992) (“For almost two decades, there has been an intense debate in this country about whether FDA takes too long to approve new drugs. . . . The FDA has made some progress in reducing drug approval times, but today the FDA still takes an average of 20 months.”). In recognition of that difficulty, Congress enacted the Prescription Drug User Fee Act of 1992 (“PDUFA”), Pub. L. No. 102-571, Title I, 106 Stat. 4491 (1992) and the Medical Device User Fee and Modernization Act of 2002 (“MDUFMA”), Pub. L. No. 107-250, 116 Stat. 1588 (2002), which, among other things, provided additional resources for FDA review of drug and device applications, respectively. In connection with those statutes, “performance goals” have been established for the review of drug and device applications which further reflect the recognition that the 180-day time frame is not always feasible. The drug and device application processes do not involve publishing the application for public comment or a required referral to an advisory committee.

Based on all these considerations, FDA has determined that, as a reasonable preliminary timetable, the Agency intends to issue a decision on a MRTP application within 360 days of its receipt by FDA. Because section 911 is designed to protect the public health, it is important to allow the Agency sufficient time to fully evaluate all data and information submitted in an application. Nevertheless, although the Agency believes that the 180-day time periods provided for review of drug and device applications in sections 505(c) and 515(d) will not be adequate for the Agency’s review of MRTP applications, it may be able to proceed more quickly than the 540-day timeframe sustained by the court in Nutritional Health Alliance v. Shalala. Further, the statute contemplates in section 911(l) that the Agency will issue a timetable for review of MRTP applications together with more comprehensive regulations or guidance regarding MRTP applications within two years and nine months of the enactment of the Tobacco Control Act. At that time, the Agency may have more information regarding MRTP applications that will allow it to assess the time requirements with more specificity, and more experience that could help expedite the application review process.