New draft guidance

New draft guidance

February 27, 2019

The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance titled Use of Investigational Tobacco Products. This draft guidance supersedes the draft guidance of the same title published in September 2015

Based on review of comments received on the original draft guidance, FDA determined that the guidance contained information that could be potentially confusing or misinterpreted. Therefore, this revised draft guidance aims to clarify FDA’s thinking on investigational tobacco products and replaces the previously published draft guidance.

When final, the guidance will describe the current thinking of FDA 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.

Stakeholders can comment on any guidance at any time. However, to consider input before finalizing the current guidance, the FDA needs to receive comments by April 22.

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