TOBA-153 - Getting issue details... STATUS This section illustrates how to create CDISC-conformant datasets on
- listing of tobacco and non-tobacco ingredients,
- quantifying tobacco and non-tobacco ingredients by component and stating their function within the product, and
- testing for HPHC.
According to the PMTA rule,
"Ingredient" means tobacco, substances, compounds, or additives contained within or added to the tobacco, paper, filter, or any other component or part of a tobacco product, including substances and compounds reasonably expected to be formed through a chemical reaction during tobacco product manufacturing.
"Additive" means 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 the 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), except that such term does not include tobacco, or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.
"Constituent" means any chemical or chemical compound in a tobacco product that is or potentially is inhaled, ingested, or absorbed into the body, any chemical or chemical compound in an emission (e.g., smoke, aerosol, droplets) from a tobacco product, that either transfers from any component or part of the tobacco product to the emission or that is formed by the product, including through combustion or heating of tobacco, additives, or other components of the tobacco product.
Reference: Premarket tobacco product applications and recordkeeping requirements. Fed Regist. 2021;86 FR 55300:55300-55439. Codified at 21 CFR §1100. https://www.federalregister.gov/d/2021-21011/p-17 TOBA-238 - Getting issue details... STATUS
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