By Robert Margolis, J.D.
Guidance provides examples of vape shop activities that are, and are not, subject to FDC Act’s labeling, ingredient listing, HPHC reporting, and health document submission requirements.
The FDA issued a final guidance, "Interpretation of and Compliance for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops," intended to assist vape shop retailers who sell "deemed products" meet requirements of the federal Food, Drug, and Cosmetic Act (FDC Act). The guidance sets forth examples of vape shop activities related to preparation and modification of electronic nicotine delivery systems (ENDS) that will subject vape shops to the label requirement in Section 903(a)(2)(c) of the FDC Act, as well as statutory authorization, registration, and reporting requirements (Notice, 84 FR 11108, March 25, 2019).
Background. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave the FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and reduce tobacco use by minors. The Tobacco Control Act also gave the FDA regulatory authority to deem new products meeting the statutory definition of a tobacco product as being subject to the FDC Act. In 2016, the FDA issued a deeming rule that subjected ENDS to the FDC Act.
Because the deeming rule authorizes the FDA to regulate the manufacture of new tobacco products, including those manufactured at the retail level, vape shops that engage in certain activities may be subject to the FDC Act’s labeling and other requirements. The guidance addresses the vape shop activities that do and do not subject vape shops to FDC Act requirements.
Section 903(a)(2)(C) labeling requirements. The FDC Act deems a packaged tobacco product misbranded if its label inaccurately states the percentage of tobacco used in the product that is foreign-grown and domestic-grown. This requirement only applies to products made or derived from tobacco, and therefore does not apply to such products, components, and parts as cigarette filters, hookah pipes, and ENDS batteries. As a result of scientific and technical difficulties in quantifying percentages of foreign and domestic tobacco used in certain products, the FDA does not intend to enforce section 903(a)(2)(C)’s requirements in such packaged products as tobacco-derived liquid nicotine, e-liquid made or derived from tobacco, cigars, smokeless tobacco, and waterpipe tobacco.
Product modification. As a general rule, new tobacco products are subject to requirements for premarket authorization; ingredient listing, HPHC reporting, and health document submission requirements; and establishment registration and listing requirements. According to the guidance, when a vape shop modifies a product outside of the marketing authorization order it results in a new tobacco product subject to the above requirements. Similarly, for products on the market as of August 8, 2016, that as of yet do not have a marketing authorization order, a vape shop’s modification of the product would generally result in a new tobacco product for which the above-described requirements would apply. Finally, refilling an open ENDS product, if not already covered by a marketing authorization order, would generally subject a vape shop to the above-listed requirements.
While the following activities would render a vape shop within the definition of a product manufacturer, the FDA does not intend to enforce FDC Act requirements for a vape shop that: (1) maintains an ENDS product by cleaning or tightening fixtures; (2) replaces ENDS coils with identical coils from the same manufacturer; and (3) assembles a final product from components that are sold together in a prepackaged kit or sold separately if the final product consists of components also available packaged together.
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