In light of the FDA’s plan to finalize its tobacco product deeming authority and its user fee calculation rules for cigar and pipe tobacco, and the likely influx of applications for new electronic nicotine delivery systems (ENDS), the agency is announcing the availability of four guidance documents designed to assist manufacturers in understanding and complying with these requirements.
The first document is a draft guidance designed to assist sponsors with submission of their premarket tobacco product applications (PMTAs) for ENDS. The second is a guidance providing recommendations on the use of tobacco product master files (TPMFs) to make submissions easier. The last two documents are small entity compliance guides (SECGs) designed to assist small businesses with understanding and complying with the new tobacco product deeming authority and cigar and pipe tobacco user fee regulations.
Background. On June 22, 2009, the enactment of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (P.L. 111-31) granted the FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. As such, the FDA’s tobacco product authority now applies to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other products that HHS deems to be a tobacco product. This FDA tobacco product deeming authority will be formally published in the Federal Register on May 10, 2016 (see FDA extends age restrictions to e-cigarettes, hookah tobacco, cigars, May 5, 2016) concurrently with these four guidance documents.
Under the FDC Act, persons seeking to market a new tobacco product must first submit a PMTA to the FDA and obtain a marketing authorization order, unless the FDA has issued an order that the new tobacco product is substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, or the new tobacco product is exempt from demonstrating substantial equivalence.
ENDS applications (draft guidance). Given the relatively new presence of ENDS on the U.S. market and FDA’s Final rule deeming these products to be subject to the tobacco product authorities in the FDC Act, the FDA expects to receive many PMTA submissions from manufacturers of ENDS. The draft guidance titled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems" will assist persons with their PMTA submissions for ENDS products.
Specifically, the draft guidance explains products to which the guidance applies, when a PMTA is required, general procedures for review of an ENDS PMTA, what information the applicants must submit in a PMTA, and what information the FDA recommends applicants submit in an ENDS PMTA to show whether permitting the new tobacco product to be marketed is appropriate for the protection of the public health.
TPMF (guidance). The guidance titled “Tobacco Product Master Files” provides recommendations on establishment and use of TPMFs. TPMFs are voluntary submissions used to permit the person that owns the TPMF to authorize other parties to rely on information in the TPMF to support a submission to the FDA without the TPMF owner having to disclose that information to the authorized parties. Parties that obtain a right of reference from a TPMF owner may reference information in a TPMF that the TPMF owner does not want to make public, but that the other party would otherwise need to develop on its own to make a complete submission to FDA.
Deeming rule (SECG). The SECG titled “FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements,” sets forth in plain language the requirements of the FDA’s tobacco deeming rule to help small businesses understand and comply.
Cigar and pipe tobacco user fee rule (revised SECG). Also publishing on May 10, 2016 in the Federal Register is an FDA Final rule requiring domestic manufacturers and importers of cigars and pipe tobacco to submit to the FDA information needed to calculate the amount of user fees that should be assessed to them under the FDC Act. The FDA will formally publish this user fee Final rule together with its deeming Final rule, which among other things, subjects domestic manufacturers and importers of cigars and pipe tobacco to the FDC Act’s user fee requirements.
The revised SECG titled “Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products,” will help small businesses comply with the final user fees rule published July 10, 2014 (79 FR 39302), and new user fee regulations (see Tobacco manufacturers to send fees to FDA beginning October 2014, July 10, 2014). The revised SECG replaces the SECG of the same name published on July 16, 2014 (see Small tobacco businesses user fee data submission clarified, July 16, 2014).
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