FDA Sept 9th Deadline!

Many of our retailers are asking about what they can expect and what they should do regarding the upcoming PMTA deadline. Here’s a quick update on FDA planned actions that affect retailers.

Will There Be a Sell-Through Period After September 9, 2020?  No. Unlike with prior regulations for which FDA has permitted a “sell-through” period allowing the continued sale of non-compliant products (i.e., non-compliant labels), there will be no sell-through period allowed for non-compliant products after September 9, 2020.  In other words, if a product SKU is not covered by a PMTA that has been accepted for review by the FDA, or if a manufacturer has simply failed to file any PMTA, those products cannot continue to be legally sold after September 9, 2020.

So What Happens on September 10, 2020? In the past, FDA has focused its initial enforcement activity around manufacturers and importers rather than at the distributor and retail levels of the supply chain as this is the most efficient use of its limited enforcement resources. Importantly, it will take FDA some time to compile a list of those products for which it has received PMTAs in order to begin its enforcement activity. 

FDA to Publish PMTA List: Last month, VTA made a specific request to the FDA that it change its prior practice and publish a list of the products covered by PMTAs so that retailers and distributors have a clear understanding of the specific products (not just brands or manufacturers) for which FDA has received an application. Today, FDA announced, “In addition, we plan to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline, were on the market as of Aug. 8, 2016, and for which a premarket application is submitted by Sept. 9, 2020.”  FDA will do this while also respecting the confidentiality requirements under the Federal Food, Drug and Cosmetic Act.  FDA also noted that while the deadline is on September 9, 2020, it will take FDA some time for them to compile and confirm that their list is accurate before publication. The fact that FDA will be publishing such a list is dramatic change from their prior practice. In the meantime, we will do our best to inform you of VTA members which are participating in the process.

FDA Has Suspended In-Person Inspections:  In March, due to COVID-19, FDA issued a partial stop-work order instructing all of the agencies with which it contracts at the state level to stop doing compliance checks and vape shop inspections.  This suspension of in-person retail enforcement activity is likely to continue until COVID-19 restrictions begin to lift, but FDA has stated it plans to continue its monitoring of social media, websites and publications and will issue warning letters when needed.

FDA Will Continue Its Enforcement Priorities: In February 2020, and more recently the FDA outlined and reiterated its enforcement priorities.  FDA will continue to focus its enforcement efforts on:

1. Flavored cartridge-based ENDS products.
2. All other ENDS products for which the manufacturer has failed/fails to take adequate measures to prevent access or use by minors.
3. Any ENDS products that are targeted to minors or which are likely to promote use by minors.
4. Manufacturers which have not filed PMTAs on or by September 9, 2020.

What Can Retailers Do Now?  Beginning on September 9, 2020, retailers can ask manufacturers for specific information on whether their products are covered by a PMTA.   Each manufacturer may have a different method of providing you with evidence that it has filed PMTAs for its products, including, for example, a redacted version of its Cover Letter or proof of submission through the electronic filing portal.  While FDA is not currently performing in-person inspections, they will likely resume soon after COVID-19 restrictions are lifted. So, if inspections resume before FDA publishes the list of products for which PMTAs have been filed, you can insulate yourself from potential exposure by having on hand documentation from your manufacturers regarding the product that you have on the shelves.