FDA Vaping

FDA Vaping

The FDA vaping regulation (a/k/a Deeming Regulation) currently requires companies to register and list their products. Previous posts discussed the FDA vaping regulation and provided updates on the registration process. After two weeks interacting with the FDA’s Center for Tobacco Products registration system it appears there is a design flaw. The system is formally known as the Tobacco Registration and Listing Module (TRLM). It is part of the FDA’s borader registration system known as FDA’s Unified  Registration and Listing System (FURLS). FURLS is the account created to use the TRLM system to register and listing products under the FDA vaping regulation. It is the same for device listing and food and supplement registration. What is different is the scale of registration under the Deeming Regulation. Small scale registrations include several hundred product listings and the largest registrations in excess of 10,000 individual listings. There is nothing like this on the device listing or food and supplement registration side. Traditional tobacco products, that previously used the TRL also did not have the magnitude of flavors, nicotine levels and of course hardware variations. Simply put the system was not designed and is not functioning under the crushing demand. Below is a letter I sent on behalf of clients to the CTP Ombudsman and Director.

For companies waiting to register the best advice is to start now. The system makes an already long process subject to more delays.

 

Contact our Washington DC or Charlotte NC office with any FDA Deeming Regulation questions.

 

I wanted to write to express concerns about the FURLS registration process. I’ve previously registered for other centers – CDRH, CFSAN – and even the cumbersome system used by CDER (both the ESG Gateway and the new CDER Direct).
In that time I have never experienced the issues I’ve had with FURLS CTP interface since August 8th. I’ve e-mailed FURLS support with over 30-emails since last Friday.
The issues include:
  • In ability to access accounts due to technical issues for several days at a time;
  • Product listings uploaded duplicated;
  • Product listings altered (e.g. flavor mismatch from uploaded template); and
  • Slow system processing times (6-10 minutes to confirm/finalize product listings).
I understand slow processing times and occasional crashes are to be expected given the situation. Still the burden imposed by the system is untenable.
I don’t believe CTP anticipated the scale of product listings. On average clients are listing 3-5,000 products. In some cases where liquids and hardware are listed over 10,000.
The system does not allow en-masse deletion of duplicates, en-masse confirmation of labeling, or the easy correction of system errors like mismatched flavors.
FURLS support seem flummoxed. At times an issue is corrected only to create a new issue. For example, one account was generating a “quota exceed error” – a pop up message that interfered with account access. When that was corrected, product listings were duplicated and flavors previously correct in the system mismatched. Other times the issue is not corrected for several days – I’m still waiting on an issue with account access since Friday. Apparently the system was not designed or intended to handle the amount of listings – FURLS support continues to ask which accounts will have listings over 800.
I am certain you are receiving similar complaints. It is still early and there is time to register, but if the system continues on as it has, then CTP will need to consider an extension of the registration deadline for new deemed tobacco products. CTP also needs to consider the burden placed on firms from the errors in the system.
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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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