FDA Compliance Deadline Looming: Tobacco Product Listing and Registration Deadline

FDA Tobacco Product Listing and Registration Compliance Deadline

The end of 2018 may be weeks away but there are still important compliance deadlines ahead for manufacturers of tobacco products. The U.S. Food and Drug Administration (FDA) recently reminded tobacco manufacturers and those of other deemed tobacco products about the annual tobacco registration and product listing (TRLM) deadline of Dec. 31, 2018.

This is an important deadline for any manufacturer of a deemed and covered tobacco product. Even if your company has introduced a minor change to your product, it must be re-registered and re-listed. As part of the Registration and Listing for Deemed Tobacco Products process, deemed products had to be registered and listed by Oct. 12, 2017, and those listings had to be updated on June 30, 2018. Dec. 31, 2018is the annual registration deadline. Any product that has not yet been introduced or changed since 2017’s deadline should not be resubmitted. The FDA recommends companies submit their establishment registration and product listings online using the tobacco registration and listing module in FDA Unified Registration and Listing System (FURLS). More information about this process can be found by clicking here.

In other compliance news, attorneys representing the cigar industry lawsuit against the FDA have asked for a delay in the submission of data reporting the harmful and potentially harmful constituents found in cigars and pipe tobacco. Known as HPHC, this has been named by cigar advocates and manufacturers as a costly compliance requirement and one that won’t be easy to complete. The FDA is expecting each cigar manufacturer to identify potential harmful constituents found in every cigar it produces and sells. They expect this report to be submitted by Nov. 8, 2019.

Despite the deadline being next year, the HPHC report will be a costly one for manufacturers to complete. Another issue is that there’s no clear way for manufacturers to go about testing their products to complete this report. The FDA itself has not yet supplied guidance or instructions for how to complete the HPHC report. Traditional combustible cigarettes already undergo this testing and type of reporting to the FDA but cigar manufacturers have long argued that a premium cigar is vastly different from a combustible cigarette, thus the same testing method can’t be applied to both products.

To learn more about compliance deadlines impacting tobacco manufacturers, click here.