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Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry

Marzo de 2012

Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug,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.

 

• La FDA reconoce que es posible que la industria no pueda cumplir con el plazo debido a las limitaciones actuales de las pruebas. En base a esto, la guía preliminar identifica 20 HPHC de la lista completa de 93 HPHC, para la cual hay métodos de prueba bien establecidos y ampliamente disponibles.  La FDA tiene el propósito de ejercer su potestad para requerir informar estos 20 constituyentes este año. 

 

• La lista abreviada de los 20 HPHC está incluida en la guía preliminar y se enumera a continuación.
  

 

Tabla 1. Lista abreviada de componentes nocivos y potencialmente nocivos

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 For purposes of this draft guidance, we intend cigarette filler to mean the cut, ground, powdered, or leaf tobacco that is a component of a cigarette.

*4-(metilnitrosamino)-1-(3-piridil)-1-butanona

** N-nitrosonornicotina