Docket Number:
FDA-2014-D-1939
Issued by:
Guidance Issuing Office
Center for Tobacco Products

Section 910(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 16 387j(g)) gives FDA the authority to issue regulations to exempt tobacco products intended for investigational use from the requirements of chapter IX of the FD&C Act, including premarket submission requirements. To date, FDA has not issued such regulations; consequently, investigational tobacco products are not exempt from FD&C Act requirements, including premarket submission requirements. This draft guidance supersedes the draft guidance of the same title dated September 2015 and, when final, will describe FDA’s current thinking regarding the definition of investigational tobacco product and discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations are issued and become effective or FDA provides written notice of its intent to change its enforcement policy.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2014-D-1939.

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