Hometown Hero PMTA Update

Dear customers,

The Tobacco Control Act amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to give FDA authority to regulate tobacco products:

• Section 901 authority – FDA has immediate authority over certain tobacco products; allows FDA to deem others subject to its tobacco product authorities that meet the statutory definition of tobacco product under its authority
• Section 906(d) authority – Provides FDA the authority to issue regulations restricting the sale and distribution of tobacco products, including the advertising and promotion of tobacco products

All new (i.e. non-grandfathered) tobacco products (including vapor products) are required to obtain premarket authorization (PMTA). Products that have been deemed “tobacco” products are those that were on the market as of August 8, 2016, which means that manufacturers like us must submit a marketing application by September 9, 2020. You can read a simple version of the requirements dictated by the FDA’s deeming regulations here.

The FDA distinguishes among an application that has been “accepted,” an application that has been “filed,” and an application that is “complete.”

• Accepted: An application has been “accepted” after the Agency completes a preliminary review and determines that the application appears on its face to contain information required by the statutory provisions and any applicable regulations.
• Filed: After FDA accepts a PMTA, an application has been “filed” after FDA completes a filing review and determines that the application is sufficiently complete to permit a substantive review. This filing review occurs only for a premarket tobacco application or a modified risk application and results in either a filing letter or a refusal to file letter.

Hometown Hero will make timely PMTA submissions and fully plan to move from “Accepted” to “Filed” and ultimately, receive our PMTA. As always, our customers are our top priority; please feel free to contact us.

Sincerely,

Lukas Gilkey