From the FDA's Website

---

E. Request for Comments Regarding Components, Parts, and Accessories

FDA asks for comments, including supporting facts, research, and other evidence, as to whether FDA should define components and parts of tobaccoproducts and how those items might be distinguished from accessories of tobacco products. As stated throughout this document, the FD&C; Act defines “tobacco product” to include the components, parts, and accessories of such tobacco products (section 201(rr) of the FD&C; Act). At this time, FDA is proposing to deem those products meeting the definition of tobacco product, except the accessories of proposed deemed products, to be subject to its tobacco control authorities. Therefore, components and parts of the proposed deemed tobacco products would fall under the scope of this rule, but accessories would not. We are proposing to include components and parts within the scope of this proposed rule, because they are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. However, because accessories are not expected to be used in the consumption of a tobacco product, we expect that accessories will have little impact on the public health. FDA is seeking comment on its proposal to exclude accessories from the scope of the deeming rule.Show citation box

FDA believes that components and parts of tobacco products are those items that are included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes. In addition, FDA considers accessories to be those items that are not included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product, but may be used, for example, in the storage or personal possession of a proposed deemed product. Therefore, items such as hookah tongs, hookah bags and cases, hookah charcoal burners and holders, cigar foil cutters, humidors, or cigar carriers would be considered accessories and would not fall within the scope of this proposed rule.

At this time, FDA is not proposing definitions for components, parts, or accessories. If FDA were to develop definitions of these categories of products, the definitions likely would include factors such as whether these items are directly involved in the consumption, storage, or personal possession of tobacco products. These definitions also likely would take into account the foreseeable effect on public health of these items and whether a tobacco product can effectively be consumed without such items. If you believe FDA should define these terms, we seek comment on how to define the categories of "components," "parts," and "accessories." We also ask for comments on whether and how the use of certain components, parts, or accessories might be used to alter the effects of the tobacco product on public health, the constituents delivered by the product, or the potential initiation of new tobacco users.