09/01/2020
PMTA UPDATE FOR MANUFACTURERS & RETAILERS
August 31, 2020
As the September 9, 2020, Pre-Market To***co Application (PMTA) deadline is rapidly approaching, VTA members are working feverishly on finalizing their applications for submission to FDA. This update summarizes some important developments that will impact everyone involved. Specifically, we first address manufacturer-related updates and then retailer-related updates.
MANUFACTURER UPDATE
FDA Says It Will NOT Extend September 9 Deadline: Late on Friday afternoon, we received an e-mail from FDA, responding to our request for an extension of the PMTA deadline, saying that FDA will not extend the September 9 deadline. The FDA wrote, in part:
"Dear Mr. Abbound [sic]: Thank you for contacting the U.S. Food and Drug Administration’s (FDA’s or the Agency) Center for To***co Products (CTP) to request an additional extension of the premarket application deadline on behalf of your members with deemed new to***co products. […]
FDA has received many individual requests for a further extension of the September 9, 2020, premarket application deadline. After considering your request, FDA has determined that it will not grant a further extension of the September 9, 2020, premarket application deadline set by the Court for members’ products. Any additional delay would impede FDA’s critical public health priority to promptly require submission of premarket to***co applications.”
Important Guidance for Companies Filing Applications: In the email, FDA went on to explain that it “intends to prioritize enforcement decisions on a case-by-case basis such as prioritizing enforcement based on the likelihood of youth use or initiation. However, FDA intends to take individual circumstances into account as it considers your members’ premarket to***co product applications that are submitted by the September 9, 2020, deadline.”
Because FDA is making decisions on a case-by-case basis, it is imperative that you make your specific case if, for example, there are certain elements that may be incomplete in your application. Specifically, FDA said: “FDA encourages your members to explicitly identify any content that may be missing from an application and clearly explain how COVID-19, a recent natural disaster, or other unforeseen circumstance has affected ability to provide such information.”
Also, FDA has said that it will work with companies to get their applications through the process during the 12-month review period under certain circumstances: FDA wrote: “If an application is sufficient to be accepted, filed, and proceed to scientific review and, during such review, your member would subsequently provide the needed information and make substantial progress toward addressing deficiencies in an application, we intend to take that into account in deciding whether to initiate enforcement action against products for being on the market without premarket authorization, even where FDA is reviewing applications after September 9, 2021. The decision as to whether to enforce after the one-year review period may take into account responsiveness to our requests, the particular nature and extent of scientific evidence that is lacking, and evidence of demonstrated hardship due to the COVID-19 pandemic, recent natural disasters, or other unforeseen circumstance in obtaining such evidence.”
In addition to extending the deadline, VTA has encouraged FDA to work with companies as they navigate the process. Last Friday's email sends the message that, while they are not moving the deadline further, they are planning to take into account each companies’ special circumstances.
Today, FDA published another statement regarding upcoming PMTA submissions. The “Perspectives” piece published today by FDA today covers a number of topics. Here are the most relevant:
FDA Expects a Large Number of Applications and the One Year Review Timeline May Be Exceeded. FDA acknowledged “there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced.” […] Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all to***co product applications that we receive by Sept. 9, 2020 within the year.”
FDA Will Work With Companies By Sending Deficiency Letters: “Further, although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely FDA will issue a Deficiency Letter with a 90-day deadline for companies to respond.” Giving companies an opportunity to cure deficiencies in their applications, rather than simply rejecting the application, is something we have encouraged FDA to do.
FDA Says It Will Devote Resources to Expedite Review for both Small and Large Manufacturer Applications: Director Zeller wrote, “As always, FDA intends to be fair in allocating FDA resources to review applications from both small and large manufacturers and importers, and from applications received through different pathways. Additionally, we intend to maximize the resources that we have to review the most products in the shortest timeframe—with the above guiding principles in mind. To help with this, we are refining our review processes to shorten the overall review time."
RETAILER & DISTRIBUTOR UPDATE
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 to***co 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 v**e 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:
Flavored cartridge-based ENDS products.
All other ENDS products for which the manufacturer has failed/fails to take adequate measures to prevent access or use by minors.
Any ENDS products that are targeted to minors or which are likely to promote use by minors.
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.
