How can the deadline be postponed?
The FDA has published the citizen petition submitted two days ago by a group of vaping manufacturers and trade associations to a public docket. The agency is now asking for public comment on the request for a 180-day postponement of the PMTA deadline.
The deadline is just two weeks away. Without massive engagement from businesses and vapers, the FDA is unlikely to ask the federal court for permission to postpone it, especially since any attempt will almost certainly be opposed by the anti-vaping groups that sued last year to move up the deadline. There are sympathetic elected officials working behind the scenes to support a delay, but they will be unsuccessful if the vaping community doesn’t turn out to ask for the postponement.
The FDA must request permission for any postponement from Judge Paul Grimm of the Maryland U.S. District Court. Judge Grimm granted the agency permission in April 2020 to postpone the deadline from May 12 to Sept. 9, based on the “extraordinary circumstances” caused by the coronavirus crisis.
Since then, circumstances have barely changed. Because laboratories and suppliers have often been closed, or have operated with reduced hours and staff, the testing and studies that must be done to create a complete Premarket Tobacco Application (PMTA) have been unavoidably delayed. Although some large manufacturers with their own labs and compliance staff have been able to submit PMTAs, small manufacturers who depend on outside facilities and experts have been hamstrung by the pandemic.
Those small businesses need our help. There will be no additional opportunities to ask for a delay, or to stop the PMTA process once Sept. 9 arrives. This is it.
Consumers and business owners need to approach the comment process differently, so we have provided separate sections below—one for each group of stakeholders.
For vapers, CASAA has made the process quite simple. The consumer group’s call to action allows you to post comments directly to the FDA docket, without signing in to the government website. Additionally, it includes a pre-written message that addresses the key consumer talking point: vapers depend on the small businesses that are affected by the PMTA deadline.
You’re are free to add any other comments you wish to make. Once the “send” button is pressed, the comment will be entered in the official FDA docket.
If you are commenting as a business owner, you must access the docket directly to comment (see link below). Do not use the CASAA engagement form, which is intended for vaping consumers only.
If you own a vape shop, but are not a manufacturer, you can pick and choose what you wish to discuss—but it’s crucial that you make clear that the Sept. 9 deadline poses an existential threat to your small business. Explain that the challenges posed by the coronavirus epidemic have prevented the manufacturers that supply your store from completing the PMTAs that will allow them to remain in business. Therefore, the Sept. 9 deadline is a death sentence for your business too.
The Regulations.gov docket is relatively simple. Click the “comment” button and either upload your comments as a document file, or type them directly into the form. (Warning: the page may time out before your post is complete if you try to write it as you go. Please write it somewhere else and copy/paste it into the site!)
If you are commenting as a manufacturer, you must access the docket directly to comment (see link below). Do not use the CASAA engagement form, which is intended for vaping consumers only.
Industry advocate Amanda Wheeler of Arizona-based retailer and e-liquid manufacturer Jvapes has provided a list of topics businesses should address in comments to the FDA. These are the same points addressed by the vendors who provided the affidavits included with the petition, and were designed by experienced advocates and lawyers:
1. Describe your position (e.g. CEO) and basic facts regarding your company (e.g. location, date started, number of employees, confirm limited to open systems products, etc.)
2. Summarize your responsibilities (e.g oversee product development, etc.)
3. Summarize efforts to prevent access by and sales to underage consumers (e.g. online age-verification system, ID check and brick and mortar stores, etc)
4. Summarize efforts to limit advertising and marketing to adults only and to avoid attracting underage consumers (e.g. no Instagram account, no kid-friendly branding, etc.)
5. Summarize efforts taken to complete PMTA by the FDA deadline (e.g. literature review, product testing, etc.)
6. Describe the impact of COVID-19 on company personnel availability, company shutdowns or slowdowns, etc.
7. Describe impact of COVID-19 on ability to conduct product testing (e.g. labs closing, lab backlogs, etc.)
8. Describe impact of COVID-19 on consultant services (e.g. inability to travel, consultant shutdowns, etc.)
9. Describe any additional delays or problems due to COVID-19 (e.g. inability to get ingredient information from suppliers)
10. Describe impact of COVID-19 on company revenues and budgets.
11. Affirmatively state that delays may impact company’s ability to file a PMTA by the September 9, 2020 deadline and request additional time (e.g. 180 days or until March 2021)
Although the petition asks for a postponement only for certain manufacturers, all manufacturers should comment on the petition, because if the FDA requests an extension of the deadline from the court, the agency may simply ask that the date be changed for everyone. Further, the extra time may make it possible for you to submit PMTAs for additional products.
The Regulations.gov docket is relatively simple. Click the “comment” button and either upload your comments as a document file, or type them directly into the form. (Warning: the page may time out before your post is complete if you try to write it as you go. Please write it somewhere else and copy/paste it into the site!)
