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December 9, 2016

FDA Postpones An Important Deeming Deadline for Manufacturers

The FDA Center for Tobacco Products just announced it has postponed the deadline for U.S. manufacturers of “newly deemed tobacco products” to register and submit a listing of their products until June 30, 2017. The original deadline had been Dec. 31 of this year.

The change is probably due to the agency’s online registration system being overloaded, causing vape businesses trying to upload their product listings endless headaches. Many had complained to the FDA, and others to their congressional representatives. The system, called FURLS (FDA Unified Registration and Listing System), was not designed to have thousands of submissions uploaded simultaneously.

Today, the FDA issued the revised guidance, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” In the initial revised guidance issued in July of this year, U.S. manufacturers of newly regulated products faced a deadline of December 31, 2016 for compliance with the registration and product listing requirements of section 905 of the Tobacco Control Act. The guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8 effective date of the deeming rule must register and list immediately with the FDA.

The FDA is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date.

The registration and product listing is part of the FDA’s deeming rule, which went into effect on August 8. The rule created a two-year period during which various parts of the rule are phased in. At the end of the two-year period, all products that haven’t received “marketing orders” from the agency are banned.

One of the earliest deadlines in the two-year phase-in was the Dec. 31 requirement that all manufacturers of newly deemed “finished products” and components and parts must register their production facilities with the FDA, and submit a listing of all products manufactured, packaged, or labeled at each registered facility.

The product registration includes all bottled e-liquid, mods, and atomizers made in the U.S. It also forces vape shops that produce their own e-juice, or even wrap coils for customers, to register as manufacturers and submit product listings.

This gives small businesses a short reprieve and an opportunity to make sure their product listings are done carefully before the new June deadline. Meanwhile the fight goes on to change the deeming predicate date, or possibly to create a real long-term solution when the new president and the next Congress take office.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy


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