Tag: FDA

Change of the Guard

What might the new U.S. President’s administration have in store for the vapor industry?
By Patricia Kovacevic
At the time of writing, the results of the U.S. elections are still contested by the presidential incumbent, a Republican, via various vote recount requests and litigation; however, it is a virtual certainty that the U.S. will have a new president, representing the Democratic Party, as of Jan. 20, 2021.
The heads of departments, including the head of the Department of Health and Human Services (HHS), are appointed by the president, subject to confirmation by the Senate, and typically change with the administration. In turn, the Food and Drug Administration (FDA), which is the agency within the HHS with primary jurisdiction over tobacco products (including electronic nicotine-delivery systems, or ENDS) as well as drugs, foods and other products, will be led in the new administration by a new commissioner.
Given the Covid-19 crisis, the new president will be under immense pressure to appoint a new FDA commissioner immediately. Interestingly and somewhat surprisingly, a former FDA commissioner, David Kessler, was recently named co-chair of the new administration’s Covid-19 task force, although Kessler resigned his commissioner role in November 1996 amid controversy for overbilling his travel expenses during his tenure.
Also during Kessler’s tenure, the FDA attempted to regulate tobacco products as “delivery devices for the drug nicotine” to bring tobacco products under FDA jurisdiction. Tobacco companies challenged the rules all the way to the Supreme Court and won (FDA v. Brown and Williamson Tobacco Corp.). The Supreme Court ruled that “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA’s [Food, Drug and Cosmetic Act] overall regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA’s assertion of jurisdiction is impermissible.”
Kessler’s wish to see tobacco regulated by the FDA was eventually granted by Congress in June 2009 through the bipartisan passage of the Family Smoking Prevention and Tobacco Control Act. While some speculate that Kessler may be on the short list for HHS commissioner, it is likely that the administration will bring forward new faces. Still, Kessler’s life-long anti-tobacco stance and past working relationship with the current head of the Center for Tobacco Products might give an indication of the increased scrutiny of the tobacco sector in the years to come.
Patricia Kovacevic
The ENDS industry status quo, from a legislation point of view, while far from ideal, is by now familiar to the ENDS industry. The recent premarket tobacco product application (PMTA) filing deadline has come and gone, and, as expected, we have not seen a flurry of warning letters post-September 2020 ordering certain vapor manufacturers to stop selling their products because they did not submit a PMTA.
The FDA is, however, expected to start enforcing this legislation sooner or later. For any dramatic change to occur, the governing legislation, the Food, Drug and Cosmetic Act, would have to be amended, which is not likely to be top of the list for the upcoming Congress given the priorities the new administration announced during the election campaign. Still, the House of Representatives, one of the chambers of the U.S. legislature, remains dominated by the Democrats, the same party whose representatives initiated several tobacco-related bills and called for confrontational hearings on vapor products. The most recent one, in February 2020, was relatively tame compared with the tone of the July 2019 Juul hearing and even with the June 2014 Senate hearing.
Senate races in Georgia will require runoff elections on Jan. 5, 2021. If Democrats gain both Senate seats in Georgia in January, there would be a 50-50 tie in the Senate, and the vice president would have the tie-breaking vote in case the Senate is deadlocked on a piece of legislation. When the House, Senate and White House are controlled by the same party, the chances of the current administration to pass laws in support of its agenda are greatly increased, though divisions exist within each party, and surprises always happen. Furthermore, 34 out of the 100 Senate seats are up for regular election in two years as well as all 435 House seats; these will be a trying two years for Americans in an economic crisis, and the public sentiment can swing in the other direction. Thus, the new president may have only two years, if even that long, to pass a flurry of laws, and there may be more urgent matters than revisiting the Tobacco Control Act, which, for better or for worse, has worked so far.
The FDA already has broad powers to expand requirements and restrictions involving ENDS products, including the authority to impose product standards through notice-and-comment rulemaking. Ingredient caps and bans are among the standards the FDA has the authority to promulgate via regulation.
The latest unified agenda of regulatory and deregulatory actions
As of spring 2020, active regulatory actions include four potential future regulatory actions by the FDA, rolled over from previous agendas, with no clear deadline for publication of a proposed rule:
Requirements for Tobacco Product Manufacturing Practice (colloquially referred to as “Good Manufacturing Practices”)
Tobacco Product Standard for Characterizing Flavors in Cigars (follow-up to the 2018 Advance Notice of Proposed Rulemaking); this is unlikely to move into the final rule stage on account of recent courtroom successes by the cigar industry.
Modified-risk tobacco product applications; this future proposed rule would establish content and format requirements to ensure that modified-risk tobacco product applications contain sufficient information for the FDA to determine whether it should permit the marketing of a modified-risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified-risk tobacco product application review and require applicants receiving authorization to market a modified-risk tobacco product to establish and maintain records, conduct post-market surveillance and studies, and submit annual reports to the FDA.
Premarket tobacco product applications and recordkeeping requirements, a 2019 proposed rule, which would have as a next step at some point in the future, likely in 2020, a final rule.
Notably, ingredient bans and nicotine caps are not on the regulatory agenda. A first step toward an ingredient ban would likely be an Advance Notice of Proposed Rulemaking (ANPRM), although the FDA can in theory skip this step and move directly to a proposed rule, open a docket for comment, collect comments and consider whether it has sufficient information to finalize the rule. Given the complexity of the issue and the current research focusing on flavor ingredients in ENDS, if the FDA determines that an exploration of a flavor ban is desirable, the FDA will probably go through the ANPRM step.
One would have to wonder, though, why engage in rulemaking when the FDA already reviews all relevant information about every ENDS product on the U.S. market, present and future, through the PMTA process—thus allowing the agency to make a case-by-case determination—and the FDA will no doubt pay considerable attention to certain flavored products. In the author’s personal opinion, the PMTA process is the FDA’s preferred avenue to make decisions on individual products rather than issuing rules on product categories, which can also be challenged—and the current Supreme Court might entertain challenges to the FDA’s behavior if it came to it down the road.
Meanwhile, the majority of states by number still lean conservative, which likely means fewer developments in taxation, some scrutiny of ENDS but not necessary priority placed on shrinking the lawful ENDS market as there is no immediately quantifiable health benefit from doing so, and many potential harms. Of note are the California litigation and the potential referendum in California to overturn SB 793 (the flavor ban legislation). By the time this you read this article, we should know whether the bill opponents succeeded at collecting the necessary signatures to place the referendum on the November 2022 California elections ballot and suspend the application of the California flavor ban until then and pending the referendum’s outcome.
The question we must also ask, given the political, public health and economic crisis context is whether ENDS are a threat to anyone and why any administration would, at this juncture, prioritize overregulating a harm reduction asset over the important, systemic changes Americans expect from the administration and drastically mitigating the Covid impact. The industry is likely to consolidate and survive.
A global legal and compliance nicotine industry expert, Patricia I. Kovacevic has experience that includes general counsel and chief compliance officer roles at Nicopure Labs as well as leading senior legal and regulatory positions at Philip Morris International and Lorillard. Kovacevic served on the board of directors of the Vapor Technology Association and on the advisory board of the Global Tobacco & Nicotine Forum. She is the founder of RegulationStrategy, a global legal and compliance FDA-regulated industry consultancy.
December 23, 2020
Riot Squad Receives PMTA Acceptance Letter from FDA
Credit: Riot Squad
The U.S. Food and Drug Administration (FDA) has given an acceptance letter to the UK-based e-liquid manufacturer Riot Squad for its premarket tobacco product application (PMTA), the company confirmed today.
“We continue to move through the PMTA process and are very happy to get to this stage”, said Ben Johnson Riot Labs CEO. “We remain committed to working with the FDA throughout the process. With our award-winning products and flavors we continue to provide better alternatives to combustible tobacco products and look forward to working in this industry for many more years to come.”
The company confirmed that it had submitted PMTAs for seven flavors in three freebase nicotine strengths (0mg, 3mg and 6mg) and 2 nicotine salt strengths (20mg Hybrid and 48mg). The flavors submitted include:
Pink Grenade
Sub Lime
Tropical Fury
Blue Burst
Cherry Fizzle
Rich Black Grape
Ultra peach Tea
“Receipt of this acceptance letter is a significant milestone, which confirms that Riot Labs products have now met the statutory and regulatory requirements for a PMTA submission, based on Section 910 of the FD&C Act,” a press release states. “The application is now under preliminary scientific review, before going forward to substantive review by the FDA.”
The FDA requires applicants to show their products are appropriate for the protection of public health. Riot Labs began building its PMTA data in 2018. The process has taken over 2 years, with 7 applications and over 1.8 million pages of scientific data submitted, according to Johnson.
Riot Labs was established in 2016 by Johnson who has an extensive background in pharmaceuticals. He set out to build ‘Riot Squad’ into an innovative brand, with the aim of encouraging consumers to find the confidence to give up smoking and engage in a healthier alternative. Riot Squad products are now available in over 86 countries.
December 11, 2020
FDA Approves PMTA for IQOS 3 Sales in U.S. Market

Credit: Altria Group
The U.S. Food and Drug Administration (FDA) has authorized the commercialization of the IQOS 3 heated tobacco product. Today, the Altria Group said the authorization follows review of the IQOS 3 premarket tobacco product application (PMTA) submitted by Philip Morris International Inc. (PMI).
Philip Morris USA (PM USA), under an exclusive agreement with PMI, commercializes the IQOS system in the U.S. with three HeatStick variants. Unlike cigarettes, the IQOS system heats but does not burn tobacco. IQOS 3 offers several enhancements to the IQOS 2.4 currently being sold in select U.S. markets, including a longer battery life, faster re-charging time, a side opening mechanism, and magnetic closure, according to a press release.
“Altria’s 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future and we’re excited to build on our first-mover advantage with the enhanced IQOS 3 device which has performed successfully in international markets,” said Jon Moore, president and CEO of PM USA.
IQOS is currently available in the Atlanta, Georgia, Richmond, Virginia and Charlotte, North Carolina markets. With PMTA authorization of IQOS 3, PM USA expects to begin quickly marketing the IQOS 3 device to U.S. adult smokers once the regulatory and U.S. importation logistics have been satisfied.
To secure market authorization under a PMTA, U.S. federal law obligates an applicant to demonstrate that marketing of a new tobacco product is appropriate for the protection of public health and requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.
On March 30, 2020, PMI submitted a supplemental PMTA to the FDA for the IQOS 3 tobacco heating system device. The original IQOS 2.4 device was authorized by the FDA for commercialization in the U.S. on April 30, 2019.
December 7, 2020
Court Upholds FDA Right to Regulate Vapor as Tobacco
The U.S. Food and Drug Administration’s (FDA) decision to regulate e-cigarettes as tobacco products has been upheld in a federal court. The ruling rejects challenges from the e-cigarette industry claiming the agency had violated the U.S. Constitution’s Appointments Clause.
Photo: Skypixel | Dreamstime.com
A unanimous panel of the D.C. Circuit U.S. Court of Appeals ruled Thursday that the regulation did not run afoul of the Appointments Clause because the FDA official who promulgated it was not appointed by the president and confirmed by the Senate, according to Westlaw Today.
Jonathan Wood of the Pacific Legal Foundation, a lawyer for the plaintiffs, said he and his clients were “disappointed” and considering next steps. “The Appointments Clause is an essential constitutional protection for democratic oversight and accountability,” he said. “Yet the court’s decision all but assures that agencies will suffer no consequences when they violate this clause.”A spokeswoman for the FDA did not immediately respond to a request for comment.
The appeal came from a group of vape shops including Michigan-based Moose Jooce and manufacturers of the liquid used in e-cigarettes, all represented by the Pacific Legal Foundation, a conservative legal group.
They argued that the FDA’s then-associate commissioner for policy Leslie Kux, who issued the 2016 rule deeming e-cigarettes to be tobacco products, lacked the authority to do so because she was a career employee, not a principal officer appointed by the president.
The FDA countered that the authority had been delegated to Kux by the agency’s commissioner. Furthermore, it said, her authority did not matter because the rule was ultimately ratified by two different FDA commissioners, most recently FDA Commissioner Scott Gottlieb in April 2019.
U.S. District Judge Christopher Cooper in Washington, D.C. agreed that the ratification overcame any Appointments Clause issues, and the plaintiffs appealed. Circuit Judge Judith Rogers, writing for a unanimous panel Tuesday, agreed, rejecting the plaintiffs’ arguments that Gottlieb was required to conduct a new review before ratifying the rule, and noting there was no evidence in the record that he had not.
“Commissioner Gottlieb’s ratification, for the reasons discussed, cured any potential Appointments Clause defect arising from Associate Commissioner for Policy Kux’s issuance of the Deeming Rule,” she wrote.
Circuit Judge Cornelia Pillard and Senior Circuit Judge David Sentelle joined in the opinion.
E-cigarettes are handheld electronic devices that vaporize a fluid that often contains the addictive substance nicotine. The devices have been grabbing market share from traditional tobacco companies.
December 2, 2020
Looking Back: 2020 NYTS Showed Decline in Youth Use
AS recently reported, data from the 2020 National Youth Tobacco Survey (NYTS) found that 1.8 million fewer U.S. youth are currently using e-cigarettes compared to last year. The NYTS, conducted by the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), data shows an alarming increase in the number of youth who use disposable e-cigarettes.
Compared to 2019, the number of youth using e-cigarettes is down 1.8 million. However, the number of youth using disposable e-cigarettes has risen: 26.5 percent of high school users are using disposables, up from 2.4 percent in 2019, and 15.2 percent of middle school users are using disposables, up from 3 percent last year.
The FDA did not include disposable products when it announced its flavor ban for closed-pod systems in February of this year. The 2020 NYTS showed that more than 8 out of 10 youth e-cigarette users report use of flavored products and the majority of those used a disposbale product.
The study states that almost 40 percent of high school users are using an e-cigarette on 20 or more days out of the month and almost a quarter of them use e-cigarettes every day.
Last week, the FDA issued warning letters notifying three companies who sell or distribute unauthorized ENDS products to remove those products from the market. The regulatory agency issued a warning letter to XL Vape LLC (doing business as Stig Inc.), warning the company to remove their disposable e-cigarettes from the market because they do not have the required premarket authorization.
The additional warning letters were issued to Flavour Warehouse LTD (doing business as Vampire Vape) and Pretty Women UK LTD (T/A Coil2oil and Mad Kingdom Liquids) for illegally marketing unauthorized menthol-flavored e-liquids. “The labeling and/or advertising of these products also features cartoon images, such as vampires and kings, that are commonly marketed and/or appeal to youth,” according to the FDA.
November 20, 2020
Bantam Vape Moves to FDA’s Substantive Review Phase

Bantam is seeking marketing orders from FDA for its suite of e-liquid products. Credit: Bantam Vape
Bantam Vape has received a filing letter for its premarket tobacco product application (PMTA). The filing letter signifies completion of FDA’s preliminary review of Bantam’s PMTA and the progression of its application into the formal substantive review phase. Bantam is seeking marketing orders from FDA for its suite of e-liquid products.
During this phase, the U.S. Food and Drug Administration (FDA) will conduct an in-depth evaluation of the scientific studies and other materials submitted in conjunction with Bantam’s application. Bantam, a provider of high-quality, science-based e-liquid products submitted its PMTA to FDA on Sept. 2 and received its initial acceptance notification from the agency the following month.
“Bantam is pleased its PMTA has been formally filed and will be entering the scientific review phase of this process. Bantam looks forward to engaging with FDA as it reviews the submission and scientific research provided in support of the filing,” said Bantam spokesperson Anthony Dillon. “Bantam’s goal has always been to provide consumers with high-quality, science-based e-liquid products that can be enjoyed for years to come. News of the filing brings Bantam one step closer to reaching that goal.”
Bantam has invested significant resources into the PMTA process and remains confident that the content and quality of materials in its submission will result in the receipt of the necessary marketing orders from FDA, according to a press release.
November 18, 2020
New U.S. FDA Draft Guidance for Perception Studies
The U.S. Food and Drug Administration (FDA) has released a draft guidance for tobacco product perception and intention (TPPI) studies. The studies must be submitted as part of a modified risk tobacco product application (MRTP), a premarket tobacco product application (PMTA) or a substantial equivalence report (SE Report).
The guidance is aimed at helping applicants design and conduct the studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products.
It is possible for a TPPI study to also include an actual use component (e.g., an actual product utilized in a simulated use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this draft guidance, according to the FDA.
This draft guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications:
Developing TPPI study aims and hypotheses
Designing quantitative and qualitative TPPI studies
Selecting and adapting measures of TPPI study constructs
Determining TPPI study outcomes
Selecting and justifying TPPI study samples
Analyzing TPPI study results
The administration is accepting public comments related to the draft guidance through Dec. 28. The application deadline was Sept. 9 for deemed new tobacco products that were on the market as of Aug. 8, 2016, and the FDA said it intends to make a public list of what products were submitted on time.
October 29, 2020
USA Vape Lab Gets Filing Letter From FDA for PMTA

Credit: Naked 100
USA Vape Lab, one of the largest e-liquid manufacturers in the world, announced that it received its filing letter from the U.S. Food and Drug Administration (FDA). The filing letter acknowledges that the company’s premarket tobacco product applications (PMTAs) for their Naked 100 products are sufficiently complete, advancing the brand’s application forward to the substantive review phase.
During the substantive review phase, the FDA evaluates the scientific studies and data presented in the applications submitted to ensure that the products are appropriate for the protection of the public health (APPH).
“We are excited to be advancing further through the PMTA process. Our team has dedicated time and resources to ensure we have the data, research, and necessary components needed for our applications,” said Huy Nguyen, CEO of USA Vape Lab. “We are optimistic that our applications will continue to advance and result in the FDA granting USA Vape Lab with marketing orders.”
The company says it continues to maintain the highest standards of regulatory compliance and is committed to working with the FDA as its applications undergo review.
October 20, 2020
An Avalanche of Paper

Gerri and James Jarvis
The ‘Davids’ of the vapor industry prepare for war.
By Maria Verven
In many ways, Gerri and James Jarvis are the epitome of the Davids who are up against the Goliaths of the vapor industry.
Now that the U.S. Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) deadline of Sept. 9 has come and gone, the wait is on to see which products—and which Davids—will survive.
The PMTA battle plan
Gerri and James own Jarvis Vaping Supply, a wholesale vaping supply store, as well as four retail stores called Vapor Station in and around Columbus, Ohio. James is also president of the Ohio Vapor Trade Association, and both Gerri and James are avid advocates of the vapor industry.
The Jarvis’ first got into the industry after watching the growth of Westside Vapor, which was started by their friend, Jason Gang.
“My passion for the industry came from the loss of my grandmother when I was 16 due to smoking-related issues,” James said. “I saw how successful vapor was for Jason in his goal of quitting smoking. It really made me want to help others do the same thing.”
The Jarvis’ business was going gangbusters until media reports of e-cigarette or vaping product use-associated lung injury (EVALI). Now known to have been caused by the addition of vitamin E acetate, a product that isn’t used in any store-bought e-liquids, EVALI scared many customers away from vaping.
Vapor Station experienced a devastating 50 percent loss in sales from EVALI reports, and then Covid-19 hit, causing another major loss as stores had to close during the early months of the pandemic. “Unfortunately, during the pandemic, several people went back to smoking since cigarettes were so easy to get,” James said.
While James continued to run the business, Gerri worked day and night over six months to fill out PMTAs for 998 products (SKUs). In the end, she dumped roughly 3 million pages off at the FDA.
With just the help of a Facebook group called PMTA Sharing, Gerri was able to climb the PMTA mountain without any help from firms experienced in submitting PMTAs. The Jarvis’ were among 1,600 vapor company representatives who joined this and other private groups to help them navigate the PMTA process.
“With Covid-19 hitting right in the thick of the PMTA process, money was so tight that we needed to be careful with spending. Thanks to the help of the Facebook group, we were confident that we could turn something in to the FDA,” Gerri said.
But that wasn’t enough. She then went on to help her friend Jason Gang of Westside Vapor as well as several other small companies negotiate the PMTA process, including Dripology, Vapor Generation, KL Labs and E Cig Cafe. Gerri said Westside Vapor’s PMTAs for its 1,800 products totaled over 6 million pages.
The waiting game begins
Now the wait begins. Encouraged by the successful FDA acceptance achieved by business colleagues at ECIG Charleston and Bad Drip, the Jarvis’ have high hopes for their PMTAs. All had used processes shared in the PMTA Sharing Facebook group.
They are also realistic, knowing that the FDA has received a flood of applications. The Jarvis’ are one of many e-liquid manufacturers and small vape shops that make their own e-liquids in dozens, if not hundreds, of flavors and in a variety of nicotine strengths and volumes. And each of these distinct products in every flavor and nicotine strength requires a separate PMTA.
The FDA publicly acknowledged that the market for vapor products is extremely large—“several orders of magnitude greater than anything the agency has experienced … The likelihood of [the] FDA reviewing all of these applications during the one-year review period is low.”
We asked Gerri to give us a glimpse inside the process of pulling together PMTAs for nearly 1,000 products. Here’s what she shared with Vapor Voice:
When did you start pulling together all the information you needed to complete the PMTAs?
As an industry, we’ve been working on this since August 2016, but we started really getting the paperwork together in March of 2020. I guess it took deadlines from the FDA to really hit us to get to the point of pulling together the PMTAs.
We currently offer 998 SKUs, or products. We provided information on and requested PMTA approval on every one of our products.
Please tell me all about the PMTA process: How long did it take? What sort of information did you provide?
I started working in March 2020 and worked pretty close to nonstop from July to September. The Facebook PMTA Sharing group helped me run the studies and programs to gather the needed data, such as underage studies, customer surveys and PMTA review literature.
In our customer survey of around 5,000 customers, we learned that 90 percent used flavors—and most preferred the fruit flavors. If those flavors go away, the majority—76 percent—said they would go to the black market or back to smoking. We have the weirdest industry in the world: Our business model is to get people to switch to vaping from smoking and then reduce their level of nicotine and eventually [get] off of vaping all together.
Why did you decide to do it on your own? How confident did you feel about the process?
With Covid-19 hitting right in the thick of the PMTA process, money was so tight that we needed to be careful with spending. Thanks to the help of the Facebook group, we were confident that we could do the initial submissions ourselves.
Please share what you can about the expense of pulling together the PMTAs.
For the preliminary review, we had to pay for programs such as the Environmental Assessment Generator and Cover Letter Generator and other environmental assessments. If the FDA accepts our initial applications, we will then move into the substantial review phase for the product testing analysis and safety information. The FDA has only accredited six labs, and the expenses are exorbitant: Each SKU could cost us anywhere from $84,000 to $480,000, depending on which lab we use.
That’s why we’re working to try to get some kind of reform through Congress by reaching out to our senators and congressional leaders and explaining that these costs will kill small businesses—all but about 5 percent of the industry. The costs are blowing their minds. If we can pass some type of reform, there are labs right here in Ohio that can do the testing for a whole lot less.
Please share your emotions during this process: Were you ever frustrated? Were you worried about what should or should not be included? Were you worried it might not pass or pay off in the long run?
During all the hours we were putting together the PMTA, there was always that thought in the back of our minds that all this work could be for naught. We had no clue if what we were putting together was going to be enough to get us to the next level of the process or not.
We were very stressed with all the work on the PMTAs while also running the day-to-day operation of our shops. We had very late nights when our systems stopped working and the generators were running slow. And to top it off, the FDA brought out a new system just nine days before the submission deadline.
What’s the status of your PMTA?
We are still waiting on the news. We know people who used the same process who were accepted, which gives us hope for our PMTAs. We were told we might have to wait up to 180 days to hear back from the FDA. There is no real timeframe established. We just have to sit and wait for the FDA to contact us. But we are encouraged by the fact that three or four companies in the PMTA sharing group have received acceptance letters.
I understand you’ve helped other companies navigate the PMTA process.
I helped our friend Jason Gang pull together the files to run the programs for the cover letters, description sheets and environmental assessments. I would stay up for hours making sure the files were correct.
And I completely fixed one company’s FURLS (files with product information that must be submitted to the FDA) so they could complete the filing. We spent hours on the phone and Facebook Live, helping walk them through the process.
What are your takeaways? What would you do the same? What would you do differently?
I learned that a lot of the process is repetitive. I would spend the same time helping others get to the finish goal. I would have started earlier and kept better records, such as more proof of the dates [that] our products went on the market.
How is business going now? Do you have any predictions for the future of your business?
Business online and at our vape shops has been terribly slow with Covid-19. We are hopeful that with all of our teamwork, this community of small independent businesses will grow stronger.
We need everyone to see the unrealistic, onerous and prohibitively expensive process we were thrust into and how hard we are working to save our technology for consumers, our employees and our businesses.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
October 12, 2020
Humble Juice Co. Receives Filing Letter for PMTA

The Humble Juice Co. is moving on to the scientific review stage of its premarket tobacco product application (PMTA). The leading e-liquid company with a humble beginning, announced that it had received a filing letter from the U.S. Food and Drug Administration (FDA). The letter indicates the FDA has completed its preliminary review of Humble’s PMTA, advancing the brand’s application forward in the review process.
Humble submitted its PMTA to the FDA on Sept. 3.
“We were excited to receive a filing letter from the FDA just days after being notified of our PMTA’s acceptance,” said Humble CEO Daniel Clark. “To my knowledge, there are a limited number of e-liquid companies that have moved forward to this phase of the PMTA process thus far. We hope our application continues to advance in a timely manner and we remain committed to working with the FDA in order to achieve this.”
A filing letter from the FDA is a result of a preliminary scientific review of a PMTA. This review ensures an application includes the necessary components and scientific analyses. FDA will now conduct a Substantive Review of Humble’s application to evaluate the scientific information and data submitted within its PMTA. If successful, this phase will result in the FDA granting marketing orders, authorizing the continued marketing and sale of Humble’s products.”
October 9, 2020