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FDA Delays September 30th Deadline

FDA Delays September 30th Deadline

 

On the evening of September 26th, Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration announced that a looming September 30th deadline for new "tobacco product" manufacturers to register their facilities and provide product listings to the FDA would be receiving a "short term extension." The news acknowledged a flaw in the FDA's online registry that has been hampering many vapor product suppliers who've been attempting to comply with new regulations.

 

This followed more than a week of problems for companies working to register with the FDA - the system was simply swamped when confronted with millions of data entries, and wasn't able to handle a surge of last-minute uploads. While the website hadn't developed much of a user-friendly reputation to begin with, it didn't help that hundreds of brick-and-mortar shops that mix liquids on-site were left scrambling to register.

 

Confusion on the deadline grew surrounding an extension of the PMTA deadline, which gives manufacturers of products introduced before August 8, 2016 until 2022 to file pre-market applications to keep their products legal to sell.

 

Those who manufacture e-liquid or devices are still required to meet the now delayed September 30th deadline to register their businesses. Those who manufacture vapes and e-liquids that do not meet the registration deadline will be considered in noncompliance and may face FDA enforcement actions, including orders to cease marketing products or even product seizure by the Administration.

 

Registration hasn't been an easy process for companies who didn't wait to comply - each product has to be registered individually, even if the flavor of e-liquid comes in different sizes. For each bottle size, nicotine strength, PG/VG ratio, and flavor, an individual entry must be made. In addition, companies must provide their labels and packing artwork for the products as well.

 

While the extension of the September 30th deadline may bring a sigh of relief from some, it's not worth getting too excited over just yet. The deadline extension won't be extended to any length resembling the PMTA change, and no one's entirely sure at the moment what will become either of those who manage to register or those who don't. We'll be watching this one in the weeks to come.

acuity