FDA Delays Deadline for New E-Cigarette Regulations

The U.S. Food and Drug Administration's Center for Tobacco Products has just announced that it has postponed the deadline for U.S. manufacturers to submit their "latest tobacco product designation" to June 30, 2017. The original deadline was set for December 31 of this year.

This change may be due to the agency's online registration system being overloaded, causing vape companies to encounter endless troubles when uploading their product registrations, with many complaining to the FDA and their congressional representatives. The system, known as FURLS (FDA Unified Registration and Listing System), does not support the simultaneous upload of thousands of documents.

Today, the FDA released revised guidance on "Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments." The preliminary revised guidance was published in July of this year, and the final deadline for U.S. manufacturers facing the latest product regulations is December 31, 2016, in compliance with the registration and product listing requirements of Section 905 of the Tobacco Control Act. This guidance has been revised again to clarify that for U.S. manufacturers facing the latest tobacco product regulations, the FDA does not intend to enforce the registration and product listing deadline for those products first produced before August 8, 2016, as long as the FDA receives the submitted materials by June 30, 2017. However, companies that begin producing the latest regulated tobacco products domestically after August 8 must immediately register with the FDA and list their products.

The FDA is currently accepting submissions and encourages companies to register and list their products before the new enforcement date.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 nbsp; —— FDA Center for Tobacco Products

Registration and product listing are part of the FDA's proposed rule, which took effect on August 8. This rule created a two-year period during which different parts of the rule will be gradually implemented. At the end of the two-year period, all products that have not received a "sales order" from the agency will be banned.

The earliest deadline during the two-year phased implementation period is December 31, requiring all newly designated "finished products" and components manufacturers to register their production facilities with the FDA and submit a list of all products produced, packaged, or labeled at each registered facility.

Product registration includes all bottled e-liquids, MODS, and atomizers produced in the U.S. It also forces vape shops that produce their own e-liquids or coil wraps for customers to register as manufacturers and submit product materials.

This gives small businesses a short reprieve and an opportunity to ensure that their product listings are carefully prepared before the new June deadline. Meanwhile, the struggle continues to change the date announced for this proposed rule or to create a real long-term solution when the new president and the next Congress take office. #p#分页标题#e#