158 context in which it is sold (see, e.g., 21 CFR 201.128 (drugs), 21 CFR 801.4 (devices); see also U.S. v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)) and sales data. Some examples of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product are:
Atomizers and cartomizers used with ENDS;
water filtration base additives (including those which are flavored) used with waterpipe tobacco; and
pouches or flavorings used with any of the newly deemed products (whether or not the pouch or flavoring contains nicotine or tobacco).
Some examples of materials intended or reasonably expected to alter or affect the tobacco product's performance, composition, constituents, or characteristics are:
The cellophane wrapping or plastic tube for a single cigar;
a plastic bag or tin holding loose pipe tobacco; and
a glass or plastic vial container of e-liquid.
Although these examples are materials that are generally intended to prevent unintended changes to the characteristics of the tobacco product, they are also intended or reasonably expected to alter or affect the performance, composition, constituents, or characteristics of a tobacco product. For example, these materials often leach ingredients into the consumed product. As some comments noted, with ENDS, there is the potential for substances to leach from the containing vial into the e-liquid and these leachates may be inhaled when the e-liquids are used as intended, posing additional health risks for consumers.
