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Tobacco

Preparing for the FDA’s PMTA deadline

Photograph: Shutterstock

The vapor industry has broad changes just around the corner, which will impact retailers, brands and adult consumers all at once. Soon, premarket tobacco product applications (PMTA) are due, so it’s crucial for retailers to understand what this means for their stores and their shoppers. In these weeks leading up to the deadline, retailers need to ask themselves is if their store is ready.

What will happen on the deadline for the vapor industry?

As retailers are likely aware, the U.S. Food & Drug Administration (FDA) issued final guidance requiring the removal of flavored cartridge-based vapor products (with the exception of tobacco and menthol flavors) from the market, effective Feb. 6, 2020. Up until FDA’s PMTA deadline, the remaining vapor products (including devices and e-liquids) that were already on the market prior to Aug. 8, 2016, could continue to be sold. During this time, companies collected extensive data, reports and test results to submit to FDA via the agency’s PMTA pathway. Given that PMTAs present a significant hurdle for many brands and manufacturers, some can’t afford the cost-prohibitive process (which can extend into the tens of millions of dollars) and will ultimately be required to remove all of their SKUs from the market before the deadline.

 It’s critical to remember that all vapor products introduced to the market after August 8, 2016, are (and have been) non-compliant. The FDA has expressed its intention to prioritize enforcement, and these products will only be compliant to sell if they receive market orders from the FDA.

What does the deadline mean for retailers?

The regulatory environment where vapor now finds itself will continue to undergo changes in the near future. What’s important for retailers now is knowing if they’re working with the right brands that will be able to continue distributing vapor products to meet adult consumer demand. Shoppers will still want to purchase vapor products after the deadline, but their options may be significantly limited compared to what’s currently available. Who will retailers be turning to in order to fill the product gaps?

Choosing the right vapor partner

To help mitigate the risk of potential supply disruptions in a post-deadline vapor world, use the below checklist to assess whether vapor partners are positioned for success.

Successful, reliable vapor partners should have:

  • The compliance, regulatory and financial resources to complete and file PMTAs.
  • An extensive lineup of vapor products that were on the market prior to Aug. 8, 2016.
  • Many tobacco, menthol and flavor offerings to cater to different consumer needs.
  • A 100% Guarantee on all products given the category challenges that lie ahead.

If retailers are looking to partner with a company they can trust, they can learn more aboutat EalternativeSolutions.com.

This post is sponsored by EAS-E

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