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GUIDANCE DOCUMENT

“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry and FDA Staff August 2016

Final

“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act

Issued by:
Guidance Issuing Office
Center for Tobacco Products

August 2016

For the purpose of establishing “a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand,” as required under section 904(e) of the FD&C Act, FDA believes that the phrase “harmful and potentially harmful constituent” includes any chemical or chemical compound in a tobacco product or in tobacco smoke that:

a) is, or potentially is, inhaled, ingested, or absorbed into the body, including as an aerosol (vapor) or any other emission; and

b) causes or has the potential to cause direct or indirect harm to users or non-users of tobacco products. Examples of constituents that have the “potential to cause direct harm” to users or non-users of tobacco products include constituents that are toxicants, carcinogens, and addictive chemicals and chemical compounds. Examples of constituents that have the “potential to cause indirect harm” to users or non-users of tobacco products include constituents that may increase the exposure to the harmful effects of a tobacco product constituent by:

  1. potentially facilitating initiation of the use of tobacco products;
  2. potentially impeding cessation of the use of tobacco products; or
  3. potentially increasing the intensity of tobacco product use (e.g., frequency of use, amount consumed, depth of inhalation). Another example of a constituent that has the “potential to cause indirect harm” is a constituent that may enhance the harmful effects of a tobacco product constituent.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)