By:  Cindy Miner, Ph.D.

Providing stakeholders with easy to find information that they need to know on FDA’s web site is paramount.

Today, I am pleased to announce a new tobacco product section on FDA’s website that organizes important information on tobacco product regulation. This new section brings together information on the three pathways available to legally market new tobacco products under the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA).

We created this section, called Tobacco Product Review and Evaluation, to centralize information on the pathways for review and evaluation of new tobacco products, before they are marketed. This information does not replace the TCA or any other legal document – it simply guides the user through the key elements of each of the three pathways to market.

Using a creative new interactive tool, users can determine which of the three pathways is most appropriate when seeking to market a new tobacco product. To legally market a new tobacco product in the United States, manufacturers must seek and receive permission from FDA by either:

• Submitting a Substantial Equivalence Report;
• Requesting an Exemption from Substantial Equivalence; or
• Submitting a Premarket Tobacco Product Application.

Although FDA may issue a marketing order for a tobacco product to be marketed, that order does not indicate the tobacco product is either safe or “approved.” The marketing order means the manufacturer has complied with the requirements under the law to bring its product to market. With the passage of the TCA, manufacturers of tobacco products are now required to submit scientific information and seek permission from FDA prior to marketing a new tobacco product, including when making changes to existing products. Learn more about how FDA is protecting public health through tobacco regulation.

This section will also serve as a building block for more information as we develop it. We have already added additional content on modified risk tobacco products and guidance on how to request a meeting with FDA’s Center for Tobacco Products Office Science.

Three years after the Tobacco Control Act was signed into law, we have taken great strides in implementing its provisions. Making sure stakeholders can get the information they need quickly and in a user-friendly manner is a critical aspect of our overall mission.

Cindy Miner is the Associate Director for Scientific Communication, Office of Science, at FDA’s Center for Tobacco Products