FDA Releases Draft Guidance Regarding the Use of Investigational Tobacco Products

Currently, there are no regulations specifically regarding investigational tobacco products. As such, at this time they are not exempt from requirements stated in the FD&C Act. Last week, FDA released a draft guidance that “discusses the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until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.” While this is not the first draft guidance discussing investigational tobacco products (two others have been published, including Applications for Premarket Review of New Tobacco Products (September 2011); and Modified Risk Tobacco Product Applications (March 30 2012)), when finalized, the recently released document will provide the most in-depth and detailed recommendations from the Agency regarding these products.

According to Section 910(g) of the Food, Drug, & Cosmetic Act, “The Secretary may exempt tobacco products intended for investigational use from the provisions of this chapter under such conditions as the Secretary may by regulation prescribe.” Additionally, this section requires that any “new tobacco product” undergo premarket review. FDA intends to exempt certain investigational tobacco products from these requirements under certain [ pre-determined ] conditions.

According to the draft guidance, FDA intends to consider the following information in making enforcement decisions regarding the use of investigational tobacco products in nonclinical laboratory studies:

1. “Whether there are controls on how and to whom the tobacco products for use in a nonclinical laboratory study are distributed. For example, whether investigational tobacco products are distributed only to qualified investigators with labeling indicating that they are limited to investigational use in research animals or for tests in vitro.
2. Whether there are adequate procedures in place to ensure that investigational tobacco products are not commercialized.
3. Whether the study is designed to ensure the quality and integrity of the study 185 data and permit other investigators to replicate the findings.”

The document also provides information and recommendations regarding studies conducted outside the US, preparation and maintenance of study records, submitting information for the proposed use of an investigational tobacco product, and requesting meetings with FDA. In summation, the overall purpose of the guidance is discusses the type of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products in the US.

The Agency released the guidance for comment purposes only, and is asking people within the industry to submit their comments on the draft within 60 days of being published (by November 23, 2015). For more information and details, view the full guidance here.

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