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What Has FDA Proposed as its New Compliance Policy on Vape Products?
The US Food and Drug Administration (FDA) announced in March that in light of the increase in youth vaping, it intends to change its 2017 compliance policy and its enforcement priorities against electronic nicotine delivery systems, aka “ENDS.” On top of this, FDA is considering to move the date up to August 8, 2021 as the new deadline for the submission of a Pre Market Tobacco Application (PMTA), effectively cutting off one year for manufacturers of ENDS to file it.
FDA intends to focus on those products considered “new tobacco products,” which are those which had not been in the marketplace as of February 15, 2007, which would include e-liquids, e-cigarettes, cartridges, tanks, mods, etc. Having concluded that flavored e-liquids are attracting youth to vaping, FDA intends to focus it enforcement priorities on such products that are any flavor other than tobacco, mint, and menthol.
What Changes Does FDA Plan to Make?
Under current FDA laws, in order to lawfully sell an ENDS product, an approval known as a “marketing order” must first be received from the FDA for that specific product. As no e-liquid or other ENDS has been approved yet by the FDA, technically none of the ENDS products currently in the marketplace may be lawfully sold. The only reason they have been able to be sold without consequence is because FDA has put its enforcement of this law on “hold” for those products which had been in the U.S. market as of August 8, 2016. FDA now plans to change this policy and has prioritized the way in which it will begin systematically pulling products off of the market. More specifically, it is planning to take the following approach:
1. Targeting flavored ENDS products that are a flavor other than tobacco, mint and menthol, which are offered for sale in ways that pose a greater risk for minors to access such products
2. Targeting flavored ENDS products that are a flavor other than tobacco, mint and menthol, for which no PMTA has been submitted by a manufacturer before August 8, 2021
3. Targeting all ENDS products that are likely to promote the use of ENDS by minors or are actually targeted to minors
4. Targeting products sold in locations where minors can enter at any time of day, e.g., convenience stores
5. Targeting products sold in retail establishments or online locations where minors have been known to have successfully purchased from
6. Targeting products sold where there is no cap on the quantity which may be purchased within a given period of time, and
7. Targeting products sold in locations where there is no independent age-verification service which could compare customer information against third party data sources
In addition to these, it is important to remember that FDA has been and continues to target products which have NOT been listed with the agency. Therefore, if you are a retailer shopping for new products at your store, be sure to ask the distributor/manufacturer for documentation of their FDA registrations and the date it was done so that you don’t find yourself with a violative product on your shelf which you cannot lawfully sell.
What Should I DO With My Business to Ensure FDA Compliance?
If you are a Retailer:
1. Ensure your Tobacco Product Retailer (TPR) Training Program is up to date
2. Ensure you train your staff in the next 30 days on age verification procedures and document that the training occurred
3. Ensure your website’s age verification protocols are solid and in working order
4. Place a limit on your website of the maximum number of purchases that can be made in a given period of time
5. Register for my firm’s webinar on the Tobacco Product Retailer Training Program entitled, “D-I-Y Tobacco/Vape Retailer Training Program” at www.Eventbrite.com – take $20 off with code “CELF”
If you are a Manufacturer or Importer:
1. Eliminate any marketing (including product labels, names, etc.) that resemble kid-friendly food or drink or resembles other non-ENDS products that are often consumed by youth
2. Ensure you know which FDA filings you needed to have made and that you actually did make all of them
3. Ensure your written FDA Compliance Manual is (a) in existence and, (b) up-to-date
4. Ensure you have a written plan (with a timetable) in place for the timely submission of the PMTA
5. Ensure the website parameters set forth in the Retailer section above are in effect for your website
6. If an importer, ensure your foreign factory has its products listed with FDA
What Can I Do if I Disagree with FDA’s Proposed Changes?
Submit YOUR comments (instructions below) to FDA about their proposed changes. FDA is requesting comments related to:
· The requirement for PMTA submission by Aug. 8, 2021 (instead of 2022) for vape industry products, which gives you an opportunity to explain how the 1 year reduction in time hinders the successful completion of a PMTA application
· Measures, including technologies, that are tailored to address youth access to ENDS
· Examples of products targeted or likely to promote use of ENDS by minors
How Can I Submit My Comments to FDA?
Head over to the www.regulations.gov website and search for FDA-2019-D-0661 which is entitled, “Modifications to Compliance Policy for Certain Deemed Tobacco Products.” The page looks like the image below and you can follow the instructions to submit your comments here. If it’s unclear what to do, just send us a message through the Contact form on the Home page and we'll walk you through it.
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