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FDA E-Cig Regulation

FDA E-Cig Regulation: First Steps for Manufacturers Explained

Although there’s still hope for changing the situation for vaping, the FDA e-cig regulations will start to impact the industry very soon. Vaping product manufacturers have until June 30th to register with the FDA, and you’ll also have to submit a list of products, including their labeling and a sampling of marketing materials. It may be nothing compared to submitting the premarket application (estimated to cost between $300,000 and $2 million per product), but it still means a lot of work.

So what do you have to do?

There are some differences depending on what your company does, but every manufacturer will have to use the FDA Unified Registration and Listing System (FURLS) and the Tobacco Registration and Product Listing Module (TRLM), as well as a Data Universal Numbering System (D-U-N-S) number.

You can read the full requirements in the guidance document, but we’ll go through the basics of what the systems are and what you have to do here.

FDA Vape Regulation: What Happens on June 30th

The timeline for the FDA vaping regulations means that while full applications won’t need to be submitted until August 8th, 2018, companies will have to register their establishment and give the FDA Tobacco Products office a list of products by the 30th of June this year.

This all takes place through the Tobacco Products Registration and Product Listing Module (TRLM), which is part of the FDA Unified Registration and Listing System (FURLS). Understanding how to operate these systems is the main thing you have to do for FDA compliance in the coming month.

Getting a D-U-N-S Number

The FDA tobacco office uses the Universal Numbering System (D-U-N-S), and so you’ll need a D-U-N-S Number for your business before you proceed. This is a 9-character code provided by Dun & Bradstreet, which you can get for free from this page.

To get one, you’ll need:

  • The legal name of your company
  • The name and address of your headquarters.
  • The year the business was established.
  • It’s legal structure and main area of business.
  • The name of the CEO or owner and his/her telephone number.
  • The number of employees working at your physical location.
  • Your SIC code (which you can find here).

With this information, you can request your D-U-N-S number for FDA compliance, and you should receive it within a day.

What is FURLS?

FURLS is the FDA’s main system for registering your manufacturing facility and your products. You’ll need to create a FURLS account at FDA to comply with the FDA vaping rules, and this should be done as soon as you can. You can either register as an owner/operator or as an “official correspondent,” which basically just means somebody appointed by the owner/operator to handle regulatory tasks. If you already have a FURLS account at FDA, then you should use your existing account rather than create a new one.

You need to make a payment to register your establishment, which you can do using this website. When you’ve made your payment, you will receive both a Payment Identification Number (PIN) and a Payment Confirmation Number (PCN). You’ll need both of these later on in the process.

Using the TRLM: Registering Your Products

The most important and demanding part of the initial stages of FDA compliance is fully registering your products with the FDA. When you’ve set up your FURLS account at FDA, you can click on the DRLM button to register your facility. Choose the “Register a Medical Device Facility” option from the menu, and then confirm that you don’t have any existing registrations and that your establishment isn’t already registered. If everything is fine, you can select “Register a New Facility” and proceed to the next stage.

As long as the information displayed is correct, you can choose “Continue Registration” and enter the required details about your facility. When you’re done with this, you press to continue again and then you’ll be taken to the next section: listing information about your products.

Although it leads you through the specifics, for each product you’ll need to identify the product’s category, its unique name and identification number (e.g. SKU or UPC). You also need to submit all of the labeling for the product in question, and provide a representative sampling of marketing materials. This isn’t 100% unambiguous, but broadly, if two ads are basically the same with only minor differences, you don’t need to submit both of them. If you give any information direct to consumers (that isn’t part of an ad), you’ll also have to include this as part of the submission.

For now, this is the most demanding part of compliance for the FDA vaping rules, and will require quite a lot of work if you have numerous products on sale.

If you need more information and a more detailed guide as to how you use the TRLM, this manual is thorough and easy-to-follow.

What Comes Next for FDA Vape Regulation?

This post has covered everything you need to have done by June 30th, but there are more requirements just around the corner. If you’re a small-scale manufacturer (defined as having 150 or fewer employees and annual revenues of under $5 million), the deadline to submit your “tobacco health documents” is August 8th. The requirements for this are described in this document

If you’re a large manufacturer, you also have to submit an ingredient listing to the FDA tobacco office by August 8th this year. However, most vaping companies will undoubtedly class as “small scale” manufacturers, and if your business does, then you have until February 8th next year to complete this step.

The FDA E-Cig Regulations Are Starting to Hit the Industry

The initial requirements might not be too severe, but the regulations are becoming increasingly real now, with vaping companies across the US having to take their first steps towards submitting a burdensome pre-market application for a new product. The first experience with FDA compliance isn’t going to hit many companies that hard, but it’s really just the start for the FDA vaping regs.   

https://www.nrcs.usda.gov/wps/portal/nrcs/detailfull/wa/programs/?cid=nrcs144p2_036140

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm#9

https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm189539.htm

https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm386651.htm

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM208916.pdf

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM456130.pdf

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