Does the FDA's delay of a key certification deadline for manufacturers benefit small businesses?
The FDA's CTP has announced that it will extend the deadline for U.S. manufacturers to submit paperwork for approval under the new tobacco control law to June 30, 2017. The deadline was originally extended to December 31 of this year.
The change may be because the agency’s online registration system has become overloaded, causing headaches for vape companies as they try to file their product listings. Many have complained to the FDA and congressional representatives. The system, called FURLS (Uniform Registration and Listing System), isn’t designed to handle thousands of applications at once.
The registration and listing of products is part of a regulatory law that went into effect on August 8 by the FDA. The law was prepared two years in advance to add some provisions before it was implemented. After the two-year period, all unapproved products will be banned.
One of the earliest deadlines in the two-year period is December 31, requiring all manufacturers of finished and related products to be registered with the FDA, and they must submit a list of all products manufactured, packaged, and labeled at each registered facility.
The products that must be registered include all e-liquids , devices, and atomizers made in the United States. It also requires vape shops that make their own e-liquids and coils for customers to register as a manufacturer and submit a product listing.
That gives small businesses a short break and an extra chance to make sure their product listings are in order before the June deadline next year. Meanwhile, the fight to change the law’s implementation date or even create a permanent solution when a new president and Congress take office continues.
This article was published on Vaping360 by Jim McDonald and translated by The Vape Club.
