Eritrean Corporation d/b/a First Choice Pipe Tobacco Warning Letter Details

Summary

Eritrean Corporation d/b/a First Choice Pipe Tobacco, a domestic importer and manufacturer of pipe tobacco, was cited for failing to pay assessed user fees required under Section 919 of the Federal Food, Drug, and Cosmetic Act. Because the company did not remit its user fee payments by the required quarterly deadline, all regulated tobacco products manufactured and imported by the firm were determined to be adulterated under Section 902(4) of the FD&C Act. Pipe tobacco has been subject to FDA regulation as a deemed tobacco product since August 8, 2016, making user fee compliance mandatory for all domestic importers and manufacturers in this category.