Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry
Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act
- This document, when finalized, will provide guidance on how companies can comply with the requirement to report on the quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products.
- FDA recognizes that industry may be unable to meet the deadline due to current testing limitations. In recognition of this, the draft guidance identifies 20 HPHCs from the full list of 93 HPHCs, for which testing methods are well established and widely available. FDA intends to exercise enforcement discretion to require reporting about only these 20 constituents this year.
- The abbreviated list of 20 HPHCs is included in the draft guidance and listed below.
Table 1. Abbreviated List of Harmful and Potentially Harmful Constituents
HPHCs in Cigarette Smoke
HPHCs in Smokeless Tobacco
Nicotine (total and free)
1 - Roll-your-own tobacco is defined in section 900(15) of the FD&C Act to mean “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.” The term cigarette filler is not defined in the FD&C Act. For purposes of this draft guidance, we intend cigarette filler to mean the cut, ground, powdered, or leaf tobacco that is a component of a cigarette.