FDA has published a draft guidance for industry on the listing of ingredients in tobacco products that manufacturers and importers are required to submit to the agency under FDCA section 904(a)(1). The FDCA does not define the term “ingredient” for purposes of section 904(a)(1), but that section calls for the submission of a listing of “all ingredients, including tobacco, substances, compounds, and additives that are. . . added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product.” In part, section 900(1) broadly defines “additive” to mean:
any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting he characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding).
Perhaps teeing off of the broad definition of “additive” and its inclusion by reference in section 904(a)(1), the draft guidance states that “FDA considers ingredients that are introduced in packaging and that are known or may be reasonably expected to become incorporated into the consumed product to be ingredients that are added by the manufacturer to the tobacco product.” The guidance further states that, under certain circumstances, reaction products are considered to be “ingredients”:
When a material is known or reasonably expected to be formed through a chemical reaction during tobacco product manufacturing, FDA considers the resultant material to be an ingredient that is added by the tobacco product manufacturer. As such these reaction products are to be listed in the ingredient listing. Reaction products may result from, among other things, reactions that occur during a mixing operation, during an in-process holding step, or during a storage period. The reaction product(s) may result from a reaction between ingredients in the same part of a product (e.g., reconstituted tobacco) or between ingredients added to different parts of the product (e.g., tobacco, paper) or added at different manufacturing steps.
For those who would like to submit comments, time is short. Comments are due by November 13.