On February 16, 2021, the Food and Drug Administration (FDA) published the long-awaited “public list” of “deemed” tobacco products that: (1) were on the US market on August 8, 2016, (2) are currently on the US market, and (3) were the subject of a request for marketing authorization submitted to FDA by September 9, 2020.
The stated intent of the “public list” is to advise stakeholders of “deemed” tobacco products that can be legally sold in the United States. However, FDA’s approach to the list leaves critical gaps that, in many cases, fails to apprise stakeholders of unlawfully marketed products and, in other cases, fails to identify products that are lawfully marketed.
The initial version of the list includes cigar, pipe tobacco and waterpipe tobacco products that were the subject of substantial equivalence (SE) or exemption from substantial equivalence (EXSE) applications filed by September 9, 2020. However, the list expressly does not include any submissions for electronic nicotine delivery systems (ENDS), apparently because FDA has not yet completed its intake review of the thousands of Premarket Tobacco Applications (PMTAs) submitted for ENDS products.
This omission is striking, given what appears to be the plethora of ENDS products that are currently on the market and for which no PMTA was submitted by the manufacturer or importer. Although FDA has issued a few warning letters to sellers of these unauthorized products, it appears that these warning letters have only scratched the surface of unauthorized products.
The “public list” is also underinclusive in that it does not contain “deemed” products that are grandfathered from the premarket review process. Under the Family Smoking Prevention and Tobacco Control Act, products sold in the US as of February 15, 2007 (and unchanged since then) are not subject to premarket review. There are thousands of grandfathered deemed products that are not subject to premarket review.
Although FDA has published a separate database of products that have received standalone grandfather determinations, industry stakeholders are rightly concerned that distributors and retailers may conclude a product is not legally marketed if it does not appear on the “public list.” Distributors and retailers would need to separately consult the grandfather database, which is itself underinclusive because there are many grandfathered products that have not received formal FDA determinations.
The “public list” is also underinclusive in that it does not contain “deemed” products that have actually received FDA marketing authorization. For that, stakeholders would need to consult separate databases of products that have received either SE, EXSE or PMTA marketing orders. However, those databases are not current. Indeed, to our knowledge, there are scores of deemed products that obtained FDA marketing authorization months ago, and those products have not been identified in any of FDA’s databases.
The “public list” was ostensibly designed to be a tool for stakeholders to understand products that can, and cannot, be legally marketed in the United States. In order to better advise the public as to which products can legally be sold, FDA will need to expedite the inclusion of ENDS products on the list, as well as consider better ways to advise the public of products that are exempt from premarket review or that have obtained marketing authorization.
The above opinion may not be the same as Vapor Voice or it’s staff. Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
Mitch Zeller speaking at a TMA annual meeting. Photo: Taco Tuinstra
FDA Center for Tobacco Products (CTP) director Mitch Zeller stated as of mid-January 2021, the agency has completed the Processing step of applications for more than 4.8 million products from over 230 companies. “We have accepted applications for about 84,000 products and refused to accept applications for about 3,100 products submitted through the PMTA pathway,” wrote Zeller. “As of mid-January 2021, of the applications submitted by Sept. 9, we have filed applications for about 29,000 products and refused to file applications for about 1,650 products submitted through the PMTA pathway.”
He also stated that several factors have slowed the agency’s progress in getting application’s into the system. Companies submitted PMTAs differently, for example some applicants provided information on one product per submission while other applicants provided information for all of the company’s products within one submission.
“One firm submitted information on more than 4 million tobacco products within a single submission,” Zeller wrote. “The amount of content in each submission also greatly varied, with some applications including up to 2,000,000 files where each file contains multiple pages of content for FDA to review.” The letter is part of a pledge Zeller made that the agency would keep interested stakeholders updated on the agency’s progress.
FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency did not receive a product application. To date, the FDA has sent warning letters to 30 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, which lack premarket authorization, according to the letter.
The agency also stated that the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low. Because of the sheer number of applications, the agency has set aside the products with the greatest market share and will push those products through the process more quickly. “[We will] focus resources on products where scientific review will have the greatest public health impact, based on their market share, while also committing to providing an opportunity for review to all companies,” Zeller wrote. This could prove positive or negative as a quick denial would force the product off the market.
The agency can still not confirm when it would release a list of products that are approved to be on the market. Zeller wrote that the agency continues to work on processing submissions and verifying the dates of initial marketing and current marketing status of products that submitted a timely PMTA.
“We have already verified this information for around 86,000 products received through the PMTA pathway,” he wrote. “Due to the size and volume of the PMTA submissions and the variable quality, format and presentation of these submissions, processing these submissions and verifying this information will take more time.”
Update: The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, according to a press release.
More than 15,000 premarket tobacco product applications (PMTA) were submitted to the U.S. Food and Drug Administration (FDA) during fiscal year 2020, according to data provided on the regulatory agency’s website.
In August 2020, the FDA received 10,184 applications and in September 2020 it received 4,567. Prior to August, the FDA had only received 686 applications. The FDA does not distinguish how many of those products are electronic nicotine-delivery system (ENDS) devices.
Of the 15,437 applications turned in during fiscal year 2020 (October 2019 to September 2020), 767 PMTAs were closed, according to FDA data. An application is considered closed after the FDA issues an order letter, a refuse-to-accept letter or the PMTA is withdrawn by the applicant.
Companies that submitted a PMTA by the Sept. 9, 2020 deadline and were previously on the market before Aug. 8, 2016, can remain on the market for up to one year while the FDA reviews the PMTA. The FDA said it will release a list of the deemed new tobacco products that were subject to the Sept. 9 PMTA deadline, however, no date has set for the list’s release.
The U.S. FDA issued warning letters today to 11 firms who manufacture and sell unauthorized e-liquids for premarket tobacco product application (PMTA) violations. The regulatory agency advised the manufacturers that selling products which lack PMTA authorization is illegal, and therefore cannot be sold or distributed in the U.S. The firms did not submit PMTA by the Sept. 9, 2020 deadline.
The firms receiving warning letters are Jojo’s Smokeless World Inc. d/b/a Mod Shield; Sugar Vapor Company; DC Vapor, Inc.; Take Off Corp; The Vapor Spot, LLC; Premium Vapor Technologies LLC; Vaping Xtreme, LLC; Vapes Gone Wild Juice, LLC; Vapeoholic LLC; Vaporescence LLC d/b/a Vape King USA; and Elemental Vapor Bar, LLC.
Credit: Premium Vapor Technologies
While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 150,000 products with the FDA, according to a to the FDA’s website.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for these types of products. The FDA sent 10 warning letters in mid-January.
“Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application,” the agency wrote. “In line with the agency’s stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application.”
After submitting its PMTA application to the U.S. FDA on Sept. 8, 2020, Bidi Vapor, the producer of the Bidi Stick closed system, announced yesterday that it had received a PMTA acceptance letter from the regulatory agency.
“It has always been our goal to provide a premium vape experience as an option to traditional, combustible tobacco that meets the needs of every adult smoker, age 21 and older,” said Niraj Patel, the president and CEO of Bidi Vapor and Kaival Brands Innovations Group, global distributor of all Bidi brand products “We couldn’t be more pleased that we are one step further in achieving this goal.”
The company now waits for a filing letter from the FDA. The Bidi Stick PMTAs would then move on to the Substantive Review phase where the scientific data is analyzed. The Bidi Stick, is the fastest-growing closed system vaping product in the U.S., based on Goldman Sachs’ equity research report on the Nielsen data for total nicotine volumes in 2020. Nielsen data showed the Bidi Stick as the second-largest disposable electronic nicotine-delivery system (ENDS) offering based on retail sales for previous 52-week period.
The acceptance letter covers all 11 flavors in the Bidi Stick lineup. “Moving to the filing and, we anticipate, to the substantive review phase of the PMTA process is where our months of extensive data collection, investment and hard work assembling 285,000 pages of science-based evidence will pay off,” Patel said. “Receipt of the acceptance letter is a major step, as we await the FDA’s filing letter and then substantive review of our products.”
The press release also states that the Bidi Stick is also the only adult-focused vape product on the market with an ecologically friendly, mass-recycling program. Kaival Brands also recently launched Bidi Vapor ‘s Bidi Pouch, a tobacco-free nicotine pouch.
The Biden administration has announced a regulatory freeze on all new and pending rules introduced in the last part of the Trump administration. Included in the freeze are the new finalized rules for premarket tobacco product applications (PMTA) and substantial equivalence (SE) that were announced on Jan. 19, the last full day of the Trump administration.
The FDA’s CBD enforcement policy draft guidance, which had been under review at the White House Office of Management and Budget (OMB) since July, was also withdrawn.
Stakeholders and lawmakers have been anticipating the guidance for two years, since the 2018 Farm Bill gave FDA authority over hemp-derived CBD. Representatives from the U.S. Hemp Roundtable and the National Industrial Hemp Council, both of which met with OMB to discuss the draft guide in late July, say the lack of regulatory clarity from the FDA has led to uncertainty in the hemp and CBD industry.
The memo, issued by White House Chief of Staff Ronald Klain, calls on the heads of executive departments and agencies to “propose or issue no rule in any manner – including by sending a rule to the Office of the Federal Register [OFR] – until a department or agency head appointed or designated by the president after noon on January 20, 2021, reviews and approves the rule.” Previous administrations, including those of Trump and Barack Obama, issued similar memos to stop last-minute actions by the outgoing administration.
What this means for the vapor industry is unclear. It does not change the rules concerning the Sept. 9 deadline to submit a PMTA to be eligible to stay on the market for year. Because the rule was not formally published in the Federal Register by the U.S. FDA before the end of Trump’s presidency, the Biden administration could move forward with the rule as is, make changes to the rule or scrap the rules entirely.
An editor’s note on the Federal Register website reads, ” The Food and Drug Administration withdrew this document while it was on public inspection. It will remain on public inspection until the close of business on January 27, 2021. A copy of the withdrawal request is available at the Office of the Federal Register.”
The White House memo also explains that it does not strictly apply to “rules” but also to “any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and any agency statement of general applicability and future effect that sets for a policy on a statutory, regulatory, or technical issue or an interpretation of a statutory or regulatory issue.”
Vapor Voice has reached out to the FDA for a response concerning the status of PMTAs for electronic nicotine delivery system (ENDS) products.
The U.S. Food and Drug Administration on Jan. 20 finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
Stephen Hahn
“The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn.
Mitch Zeller
“These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”
Both of these final rules are effective 30 days after publication in the Federal Register.
More information about the two foundational rules is available on the FDA website.
The Jones Labs announced it has received filing letters from the U.S. Food and Drug Administration (FDA) for both its premarket tobacco product application (PMTA) and its modified-risk tobacco product application (MRTP).
Credit: The Jones Labs
“The Jones product family is being evaluated for safety and efficacy as alternatives to combustible cigarettes and their comparable safety to smoking the Harmful or Potential Harmful Constituents (HPHCs) of combustible cigarettes,” a press release states. “As a leader of pre-August 8 [the FDA’s deadline for a product to be on the market to be eligible to remain on the market while going through the PMTA process] compliance, The Jones Labs registered with the FDA in July 2016 in preparation for Electronic Nicotine Delivery System regulations.”
The Jones Labs states that the potential of electronic drug-delivery systems remains at the core of its technology. “Due to our record of compliance with the Center for Tobacco Products (CTP), our products are eligible for enforcement discretion until our application process has been completed,” the release states.
The core technology of The Jones Labs submissions are based in “Buffered Aerosol Drug Delivery,” a review article published in the inaugural edition of the United Journal of Drug Development and Industrial Pharmacy. “The technology submitted for review is being further developed in parallel to address other cessation and medicine-assisted therapeutic needs in the market,” the review states. “With this unique drug-delivery platform technology they stand to disrupt the established order of all smoking and smokeless products, cannabis or tobacco.”
The Jones Labs offers universally compatible tobacco vapables as an alternative to smoking combustible cigarettes, the release states. “With multiple present and future product offerings similar to The Jones Pods (www.thejonespod.com), we are developing Rise, by The Jones (www.risebythejones.com), a state-of-the-art smoking cessation platform that utilizes the core technology for replacement and cessation therapies across the board.”
VDX Distro announced today the launch of its e-liquid brand, Four Seasons Fine Tobacco. The brand was founded to give smokers a more authentic and pleasing replacement for traditional cigarettes, according to a press release.
Credit: Four Seasons
“Four Seasons’ e-liquids are designed to withstand flavor bans by being what they are and no more – pure, authentic tobacco flavors. Its flavors are all made from naturally extracted tobacco, with no artificial flavors, colors, additives, or sweeteners, giving consumers that pure tobacco taste,” the release states. “Each flavor is carefully crafted to emulate those of the most widely appreciated cigarette brands, resulting in a vaping experience that most closely resembles the mouth feel, throat hit, and taste.”
Four Seasons’ products have received an acceptance letter from the U.S. Food and Drug Administartion (FDA) for its premarket tobacco product application (PMTA) accepted, according to the release.
“At Four Seasons we seek to bring you a satisfying vaping experience that will give you the tools you need to make the switch away from combustible tobacco for good,” said Four Seasons CEO and Founder Ryan Chalmé. “Our mission from day one remains the same as it does today, helping adults discover an alternative to traditional tobacco.”
The FDA requires a product to have been on the market prior to Aug. 8, 2016 and have filed a PMTA in order to remain on the market after Sept. 9, 2020. There was no mention if Four Seasons was on the market prior to Aug. 8, 2016.
Photo Credit: Peggy und Marco Lachman / Photo Illustration by Mike McDonald
By Maria Verven
Char Owen and Amanda Wheeler knew the enormous uphill battle other vape business owners would face when pulling together their premarket tobacco product applications (PMTA) for the U.S. Food and Drug Administration (FDA). After all, the PMTA process—which the FDA has foisted on thousands of small business owners—had been built for billion-dollar tobacco manufacturers. Every flavor in every nicotine level—even the smallest differences—needed its own PMTA, and each PMTA cost hundreds of thousands of dollars.
Add it all up, and some manufacturers had to submit PMTAs for more than 2,000 products. The costs will be astronomical—estimated in the hundreds of millions. Aside from the costs, there’s another huge hurdle: Very few vape business owners have information technology experts or paid scientists on staff—the kind of expertise necessary to submit the extensive paperwork required by a PMTA.
And what about the help for small businesses that the FDA promised? It never arrived. So Owen and Wheeler stepped up to help their colleagues. After downloading the complete list of manufacturers from the FDA site, they called each and every one to announce their new group, simply called PMTA Sharing.
Ultimately, the group grew to 1,700 members, including vape businesses all across the country as well as several suppliers that offered to pitch in to help business owners through the PMTA process. The group’s services are completely free; the only fee members pay is for environmental assessments or cover letters and forms created by industry attorneys. Thus far, the PMTA Sharing group has helped more than 200 businesses submit PMTAs for 1.7 million products. But Owen and Wheeler didn’t stop there.
They’re now starting a new nonprofit trade association called American Vapor Manufacturers (AVM) to help small businesses meet the FDA’s onerous scientific testing requirements (see sidebar).
Here’s their story.
Vapor Voice: Tell me more about your vapor businesses. How have your businesses fared over the years?
Owen: I own two brick-and-mortar vapor shops as well as a very small wholesale line. We started in 2013 as a labor of love dedicated to my father whom I lost from lung cancer in 2001. I’ve since gained more friends in my little town of Seguin, Texas, than I can count. We all have one common goal—keep people away from combustible tobacco.
We lost some sales due to the EVALI (e-cigarette or vaping product use-associated lung injury) scare, but thankfully most did not return to smoking, and those who did are slowly returning to vaping. Our retail lobby had to close during the shutdowns in Texas, but I fought extremely hard and was able to at least keep curbside service available. So while we lost a bit of sales, we didn’t have to close. We are grateful, as many others were not so lucky.
Wheeler: I own Jvapes E-liquid, founded in 2011, headquartered in Prescott, Arizona, with stores in Arizona, Colorado and Oklahoma. We also sell online at www.jvapes.com and wholesale at www.wholesalejvapes.com.
Both my husband and I are former smokers who quit with vaping. At the time, vapor products were not widely available in our local community. We started out with a tiny 400-square-foot store, but the response to vapor products was so positive, our business quickly grew into what it is today.
With the exception of late 2019 and misinformation surrounding EVALI, our business has fared very well over the years as people have seen for themselves the effectiveness and positive change from vaping. Our target audience are cigarette smokers, age 49 on average, who have not been able to quit by other means. We learned during our PMTA data collection that 83 percent of our customers have quit smoking entirely.
Have you been involved in vape advocacy?
Owen: I have been involved with advocacy in Texas for the last three years through SFATA [the Smoke Free Alternatives Trade Association] and have also been involved with federal advocacy. I am a member of SFATA, USVA [U.S. Vaping Association], a monthly supporter of CASAA [Consumer Advocates for Smoke-Free Alternatives Association] and am now the vice president of our new company, AVM.
Wheeler: I am the president of Rocky Mountain Smoke Free Alliance, our Colorado trade association. I’m also executive director of the Arizona Smoke Free Business Alliance where I’ve worked on everything from vapor taxes to flavor and public vaping bans to licensing. Prior to starting AVM, I was involved in federal advocacy for PMTA reform where we spent over a year lobbying Health and Human Services [HHS] to have small business PMTA applications accepted.
When and why did you start the PMTA Sharing group?
Owen: I was in the process of doing my own PMTAs. As a 20-year computer engineer, I had an extensive history in document replication and information technology, so I knew I could create the documents I needed. But I also knew that most small businesses did not have the same ability. Most could not even use Microsoft Excel.
I started the PMTA Sharing group on Feb. 17, 2020—a significant date for me because it was my son’s birthday. I lost my son in 2013 just a few weeks before we opened our first brick-and-mortar store. I tried many times to help him quit cigarettes but was never successful.
So after filing our own PMTAs, we created applications for other businesses to create and file their documents and then held Excel training classes. We even did computer support when their machines were unable run the applications, implemented a Microsoft OneDrive for data collaboration, and created training videos and step-by-step instructions.
Amanda Wheeler
Wheeler: I began advocating for a streamlined PMTA process for small businesses. I knew that my business as well as my state’s group members and most independent vapor manufacturers would not have the financial resources to complete the full PMTA process. Without significant changes to the process, only large corporations would survive PMTA regulations.
Does the work keep you up at night?
Owen: Helping the group submit PMTAs was a monumental undertaking, requiring 14[-hour] to 16-hour workdays most of the time. It has taken a toll on both my physical and mental health.
We put as much effort as was needed to make sure no one would be left behind. We’ve received tons of feedback [see testimonials] and gratefulness for our group. They now have hope that their small businesses can continue to help people who have quit and those who want to quit smoking.
It’s an amazing feeling when you’re walking in your town and someone who has smoked for 30-plus years recognizes you and gives you a hug because they can finally live a life away from combustibles. We all feel that same joy with each and every person who puts down cigarettes.
I remember one lady who called me to thank me, explaining that if it wasn’t for our group, she would have no means to support herself and her two-year-old daughter. Of course that makes me happy, but also very angry that the FDA put her in that situation and treated her as if she was a big tobacco business with all the resources necessary to meet their requirements.
Char Owen
The FDA has publicly acknowledged that the costs associated with the PMTA process may be challenging to small businesses and that many would go out of business. That is not how our government is supposed to operate.
What else do people in the vapor industry need to know that would help and motivate them?
Owen: We are optimistic that we will complete this process through sheer determination. While we don’t expect help from the FDA, the HHS has been willing and open to listen to our challenges.
We hope to move the group through to the testing phase and move the membership to the AVM. We have accomplished the monumental task of completing the first part of the process. It will be difficult, but we will move as many small businesses through the entire process as soon as we possibly can.
Our colleagues in the vapor industry need to know that we will not stop fighting for them. We understand what they are facing better than anyone. We are them. There is no one better to fight for small manufacturing than small manufacturers. Our hearts are fully invested in this industry.
Wheeler: I am optimistic. We have a very solid plan and approach, and we have the right scientific, legal and lobbying expertise to get the job done. Many passionate and dedicated individuals are on the AVM board, guiding our organization in the best interests of small businesses.
We are unified and moving together toward the same goal, and I believe we have a recipe for success.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
