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FDA Issues Draft Guidance on Investigational Tobacco Products

WASHINGTON — The U.S. Food & Drug Administration (FDA) has issued the Use of Investigational Tobacco Products Draft Guidance.

When finalized, this guidance will reflect the 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For the purpose of the draft guidance, an “investigational tobacco product” is a tobacco product that is a new or modified-risk tobacco product that is not legally marketed, or a tobacco product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 & Cosmetic Act (FD&C Act) gives the FDA the authority to issue regulations to exempt tobacco products intended for investigational use from the requirements the FD&C Act.

The FDA said it 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This draft guidance describes the FDA’s current thinking regarding the definition of an investigational tobacco product and discusses the kind of information the FDA intends to consider when making enforcement decisions regarding the use of investigational tobacco products until regulations are issued and become effective or the FDA provides written notice of its intent to change its enforcement policy, it said.

The agency will accept public comments on the draft guidance until Nov. 23, 2015.

Also, the FDA has announced a final rule, National Environmental Policy Act: Environmental Assessments for Tobacco Products; Categorical Exclusions, in the Federal Register.

Based on the FDA’s experience preparing and reviewing environmental assessments (EA), including those for tobacco products, it said it has determined that certain types of actions regarding tobacco products normally do not cause significant environmental effects. These actions should be added to the list of actions that are categorically excluded from the requirement to prepare an EA or an Environmental Impact Statement (EIS).

The rule reasons that it would be in the best interest of the FDA, regulated industry and the public as a whole if the FDA and industry were able to categorically exclude these actions, and instead, focus their efforts on issues that may significantly impact the environment. For those actions that would require an EA or an EIS, such as applications for a regular Substantial Equivalence (SE) report, Premarket Tobacco Application (PMTA) or Modified Risk Tobacco Product (MRTP), the FDA has recently posted examples of EAs and Findings of No Significant Impact (FONSI) documents on its 2014 SE marketing orders page.

And the FDA has announced in the Federal Register a proposed rule entitled Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products; Amendments to Regulations Regarding Intended Uses.

This proposed rule describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device or a combination product under the FD&C Act.

This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

The proposed rule was developed in accordance with regulatory guidance and will be available for comment until Nov. 24, 2015.


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