Today, FDA issued the “Use of Investigational Tobacco Products Draft Guidance.” When finalized, this guidance will reflect FDA’s detailed recommendations on the use of investigational tobacco products.

For the purpose of the draft guidance, an “investigational tobacco product” is a tobacco product that is:

(1)  a new or modified risk tobacco product that is not legally marketed, or

(2) a tobacco product that is required to comply with a tobacco product standard that does not conform in all respects to the standard, and is intended for investigational use.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) 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.  FDA intends to propose regulations establishing conditions for exempting investigational tobacco products from certain FD&C Act requirements.  Until then, investigational tobacco products are not exempt from applicable FD&C Act requirements, including premarket submission requirements and tobacco product standards.  This draft guidance describes FDA’s current thinking regarding the definition of an investigational tobacco product and discusses the kind of information FDA intends to consider when 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.

For sponsors who would like FDA’s feedback on a particular proposed use of an investigational tobacco product, there are three ways to submit information regarding proposed use of an investigational tobacco product:

• Electronic format submitted via the FDA Electronic Submission Gateway;
• Electronic format submitted on physical media (e.g., CD or DVD); or
• Paper format.

FDA has created a form to assist sponsors who choose to submit information regarding a proposed use of an investigational tobacco product. That form can be found in Appendix A of the guidance.

Comments on the draft guidance will be accepted until Nov. 23, 2015.