By Rebecca Mayo, J.D.
A new guidance clarifies when premarket approval is required for a new electronic nicotine delivery system and what specific considerations applicants should take in to account in preparing their applications.
The FDA has provided recommendations on the appropriate means of addressing the premarket authorization requirements for deemed electronic nicotine delivery systems (ENDS) products. The FDA aims to improve the efficiency of the premarket tobacco product application (PMTA) submission and review process for ENDS through this new guidance. The guidance explains which products the guidance applies to, when a PMTA is required, general procedures for review of an ENDS PMTA, what information is required and what information the FDA recommends that an ENDS PMTA contain (Notice, 84 FR 27200, June 12, 2019).
Tobacco Control Act. In 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) (P.L. 111-31) gave the FDA authority to regulate tobacco products. In 2016, the FDA issued a final rule which extended the agency’s tobacco product authorities to all products, other than accessories of deemed tobacco products, that meet the statutory definition of tobacco product. This also applied to all ENDS, which included e-cigarettes, e-pens, e-cigars, e-hookah, vape pens, personal vaporizers, and electronic pipes. This classification subjected these products to most of the same provisions to which cigarettes, cigarette tobacco, roll-you-own tobacco, and smokeless tobacco were subject, including premarket review requirements and the adulteration and misbranding provisions.
When a PMTA is required. PMTAs are required for new finished tobacco products, including components and parts of ENDS products sold or distributed separately for consumer use. They are not required for components or parts that are sold or distributed solely for further manufacturing into finished tobacco products and not sold separately to the consumer. However, it does apply to retail establishments that mix or prepare combinations of liquid nicotine, flavors or other e-liquids for direct sale to consumers for use in ENDS.
Content of the PMTA. The FDA recommends including a cover letter that contains basic information identifying the applicant and the specific product that needs the marketing order. The PMTA should describe the major aspects of the new tobacco product, including a unique identification, a complete description of the product, an overview of the formulation and designs, the name of any characterizing flavor, the nicotine strength, the conditions or instructions for use, and any restrictions on sales and distribution, if any. The PMTA should contain samples of the new product and its components as FDA my reasonably require. Specimens of proposed labeling should also be included. Additionally, full reports of all research information and investigations into health risks should be included.
Considerations for e-liquid products. In addition to a test analysis, adequate information should be provided to characterize the ingredients in the e-liquid and identify characteristics of the e-liquid that may impact the constituents in the aerosol. Scientific reviews of flavors and their potential impacts and health risks should be included in the PMTA. The FDA recommends describing research on flavor development, including market segmentation analysis or sensory testing.
Considerations for e-cigarette products. A full statement of the components, ingredients, additives, and properties, and the principles of operation should be included in the PMTA. Information about the properties and principles of operation of an ENDS product will help FDA in determining the impact of the aerosol on health. The PMTA should also include a detailed e-cigarette schematic with dimensions, pictures, and labeling, accompanied by engineering design parameters. Electrical safety should also be discussed and applicable standards to which conformance have been demonstrated should be identified.
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