Tag: EAS

Howard: Will Harm Reduction Prevail?

Credit: Fotolia Premium
It could be some time before the U.S. Food and Drug Administration issues marketing orders for flavored vapor products.
By Chris Howard
For the past 10 years, we have ridden a rollercoaster together. We have experienced the same highs and lows and shared the hope that harm reduction will prevail in the end. Then, over the course of the past several weeks, the journey ended abruptly with marketing denial orders (MDOs) for so many. Not surprisingly, several question whether the vapor industry can ever recover.
The FDA’s Recent Actions
For what it’s worth, the recent actions of the U.S. Food and Drug Administration should not have been a surprise to anyone in the vapor industry. We have known for several years that being part of a highly regulated segment would not be easy. In fact, the FDA made its expectations clear in its 2016 Draft Guidance entitled Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (ENDS). In sum, this document revealed that obtaining a marketing order for vapor products would require scientific expertise, extensive data development and very deep pockets.
That said, the FDA’s rationale for such broad-based denials has raised questions among many. More specifically, the FDA provided the following rationale in its Aug. 26, 2021, news release:
In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.
Chris Howard
The primary question we are left to ponder is whether this balancing of interests exceeds the FDA’s standard for assessing whether a product is appropriate for the protection of public health. Based on Section 910 of the Tobacco Control Act, which describes the appropriate standard of review, it appears that this balancing is one of many facets of an application that the FDA is required to consider.
Appropriate for the Protection of Public Health
Section 910 of the Tobacco Control Act provides the FDA’s standard of review for new tobacco products:
…whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—
(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
So clearly, the risk of initiation of flavored ENDS products by youth is relevant as is the likelihood of ceasing use by smokers generally. Without a doubt, the FDA has determined that evidence related to part (A)—cessation—must outweigh part (B), initiation. This risk balancing, in the FDA’s own words, is reflected in data from clinical studies or longitudinal studies demonstrating that adult use of flavored ENDS leads to cessation (or switching) outcomes that exceed the risk of youth initiation of tobacco product use. And yet, despite this seeming clarity, many questions surround this analysis. For example, by how much must adult cessation exceed youth initiation? What if both tobacco varieties and flavored varieties show the same or similar cessation rates? Has the FDA considered the reduction in use by youth resulting from the recent change in the age to purchase tobacco products to 21 when examining the balancing of risks versus benefits?
These questions are likely to remain unanswered for quite some time. Many committed companies are already beginning efforts to satisfy the FDA’s outstanding requests for clinical studies and/or longitudinal data, but the development of data will take several months. Obviously, this is likely to do significant damage to an already fractured market—and even more potential damage to smokers seeking an alternative to combustible cigarettes.
Flavors Are Critical for Harm Reduction
Despite these tumultuous past few weeks, the FDA is arguably the biggest advocate for harm reduction. Given the agency’s desire to provide options to adult smokers to move away from traditional combustible cigarettes, it seems clear that a pathway for flavors to return does indeed exist.
Along with the rest of the industry and many public health researchers, I believe that the removal of all flavored products would negatively impact harm reduction efforts in the United States. Some vapers will undoubtedly return to smoking combustible cigarettes. And smokers who might have transitioned to ENDS products may now elect not to do so. In the studies conducted at my company, E-Alternative Solutions, we demonstrated that adults prefer flavors and that flavors assist adults in transitioning from combustible cigarettes to potentially less harmful alternatives. Existing literature documenting the research conducted by others also supports this proposition. Moreover, anecdotal reports are easy to find on Twitter and multiple other social media forums.
While it may not be apparent from the FDA’s recent actions, I do not believe that flavored ENDS are finished in the United States. While the bar appears high, I hope and expect, for the sake of adult smokers in this country, that we will see flavored ENDS on the U.S. market again. That said, it could take time until the agency issues market orders for flavored vapor products.
What’s Next?
The FDA’s recent decisions will likely prompt many to appeal and some to resort to litigation [at least two suits are known to have been filed already]. The FDA appears prepared to address these initiatives and is prioritizing enforcement of those failing to comply with MDOs and/or who are selling vapor products that have not undergone premarket review. While these activities are ongoing, many will begin longitudinal studies and the hard work to identify alternative methods to show the FDA that flavors are determinative in adult smokers’ efforts to switch from combustible cigarettes.
Ultimately, we will have to wait while the remainder of the story unfolds. Hopefully, the FDA will be prepared to work directly with sophisticated manufacturers to ensure that flavored ENDS can continue to play a role for adult smokers seeking alternatives.
Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.

October 14, 2021
Howard: CBD Market to See Regulatory Uptick in 2021

The Covid-19 pandemic slowed the regulatory process in 2020, creating an expected uptick in 2021.
By Chris Howard, special to VV
After CBD’s explosive growth in 2019 following the passage of the 2018 Farm Bill that legalized hemp, 2020 began navigation of a regulatory environment in flux. Burgeoning federal and state regulation, as well as increased research into consumer trends and tastes, begins outlining the future of CBD.
The Covid-19 pandemic slowed progress in the U.S. Food and Drug Administration’s (FDA) decision making around CBD, setting up 2021 as a crucial year for the industry, although it is unlikely that any FDA regulations will be finalized this year. Vapor industry veterans, who witnessed the regulatory battles with the FDA, are rightfully wary of the government’s efforts to oversee CBD, but the initial steps seem promising. It is still early days for the CBD industry, and the FDA appears willing to collaborate with the industry on many issues that are important to manufacturers and retailers alike.
As we look ahead, I offer some thoughts on the current CBD market, where regulatory efforts are and finally, what to expect as the CBD space matures.
State of the market
After CBD’s rise to prominence in 2019, last year represented more incremental growth. According to the Brightfield Group, a leading cannabis and CBD market research provider, the United States CBD market grew from $627 million in 2018 to over $4 billion in 2019, an increase of over 650 percent. In 2020, market growth slowed to 14 percent as CBD could be found in more stores and additional uncertainty caused retailers to tread carefully. Despite this recent modest growth, the Brightfield Group projects the CBD market will continue to grow from $4.7 billion in 2020 to nearly $15 billion by 2024.
Driving this growth is a mixture of increased consumer awareness and interest as well as improved access. Sales continue to increase in key market areas, especially e-commerce, creating more competition for CBD specialty stores and vape shops selling these products. C-stores were previously well positioned to capitalize on the market, but research from Technomic, a management consulting company, shows that consumers are being selective where they shop to better hand-pick CBD products.
Chris Howard
Consumer form factor preference (the types of products available containing CBD) has been another important area of analysis. Tinctures remain popular, especially with new CBD users. Lotions have become a huge source of interest for consumers with many over-the-counter topical, beauty and skin care companies investing heavily in these products. Refining offerings will be a key part of crafting common sense regulation and helping CBD companies make more confident investments in their product lines.
Regulations in 2021
It is no surprise that the FDA took significant interest in CBD as it quickly grew from an industry valued in the hundreds of millions to one worth billions. Yet, the agency has been slow to definitively rule on any regulations apart from taking a firm stance against companies making therapeutic or health claims, especially during the pandemic.
Where does that leave us now? The FDA’s studies into CBD are ongoing, both analyzing the effects of the compound as well as auditing the contents of current products, although progress has slowed due to Covid-19. Meanwhile, there remains some pressure from congress to create policy around CBD to act as a stopgap while the FDA creates long-term guidance.
I remain optimistic that the FDA will introduce a framework for the specific purpose of regulating products containing CBD that permits the marketing and sale of all form factors in the U.S. This includes food and dietary supplements, a source of much back and forth between CBD advocates and regulators. That said, it is unlikely that a rule will be finalized in 2021. I expect this to be subject to a lot of discussion this year. We will find out more based on how the Biden administration addresses CBD in the year ahead.
In the meantime, CBD companies are forced to navigate a labyrinth of state-by-state regulations. CSP and Grocery Business research indicates 46 states have created CBD laws. State laws can run directly counter to existing federal guidelines, such as those concerning food and beverage products—which are prohibited federally but which are permissible for sale within some states. The patchwork created by these various regulations continues to make national distribution of CBD products a challenge and in some cases even threatens the supply chain of hemp growers and manufacturers.
Looking ahead
While we await final FDA guidance on CBD, I see companies in this industry dealing with many of the same issues we’ve seen over the years in the vapor industry.
The cost of entry for many in the space will become increasingly burdensome once the FDA begins setting regulations, forcing many smaller CBD companies to exit the market. This is similar to what we have seen with PMTAs in vapor, where the larger companies have been far more well equipped to maintain a compliant product selection.
Although it has not been a concern yet, CBD companies should remain mindful and vigilant to ensure that they are taking the necessary steps to prevent youth use of CBD products. Taking a proactive stance now and preventing youth use will help avoid many of the issues faced by the vapor category over the past two years.
Although there are many complex considerations with CBD, it is hard not to get excited about this industry’s future. With continued strong market growth and an apparent pathway to sensible regulation from the FDA for sellers and consumers alike, the future remains bright. In 2021, I hope to see more progress from regulators as we continue to create a strong framework that will work to the benefit this industry and consumers for years to come.
Chris Howard is vice president, general counsel and chief compliance officer for E-Alternative Solutions.
March 5, 2021
EAS Launches ‘The Smart Choice’ to Help Retailers

Credit: EAS
A new loyalty program aims to help retailers increase turnover of high-quality vaping products. E-Alternative Solutions (EAS), a manufacturer of consumer-centric brands, announced the launch of its “The Smart Choice” loyalty rewards campaign to support its Leap and Leap Go vapor products.
EAS submitted its premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA) for its Leap and Leap Go products in June of this year. The company received its acceptance and filing letters from the FDA in early July. Leap offers a wide variety of menthol and tobacco flavors in multiple nicotine levels, while Leap Go has three blends, including mint and mango.
The campaign improves on EAS’s Leap Smart Rewards program “to foster adult consumer loyalty and recurring revenue for retailers by providing adult consumers with points for purchases that can be redeemed for cash gift cards or gift cards to hundreds of choice retailers and restaurants,” according to a press release.
As part of this campaign, yellow promotional stickers on products provide extra points towards rewards, and Leap Device Kits can be found for $0.99 in many retail locations throughout the US, said Jacopo D’Alessandris, president and CEO of EAS.
Jacopo D’Alessandris
“We have already seen significant appreciation for and entry into the Leap Smart Rewards program, which was developed to provide adult consumers the kind of value they’re looking for in these times,” said D’Alessandris. “From the trial promotion price for the device kits, to the bonus offers encouraging the purchase of a second product, we are taking an aggressive position to reinforce to adult consumers that Leap products are the smart choice when making a vapor purchase. We plan to continue investing in this and other initiatives to grow loyalty, brand awareness and sales.”
Smart Rewards points can be earned through the purchase of products, taking a survey or referring a friend. Points are redeemable from codes in Leap and Leap Go packaging. For this campaign, Leap Smart Rewards point values have increased to 25 points for most Leap and Leap Go products during a time when value is even more important for adult tobacco consumers, the release states.
“Promotional inventory has already begun shipping out, and early indications are that both Smart Rewards and the $0.99 device kits are performing as intended,” said Jeffrey Brown, vice president of sales for EAS. “Our retail base stands to be rewarded on both the device kit and corresponding pod sales at store level, as we do not sell Leap products online.”
Additionally, as part of its ongoing commitment to its partners to drive business and increase visibility of Leap products, EAS will continue supporting retailers with a 100 percent product guarantee as well as regulatory and compliance expertise.
December 4, 2020
Purilum and EAS Enter Into Exclusive Supply Agreement
E-liquid manufacturer Purilum has entered into an exclusive, long-term supply agreement with E-Alternative Solutions (EAS), the manufacturer and supplier of Leap Vapor products.The Leap products containing e-liquids provided by Purilum have been on the market since prior to August 8, 2016, and are currently under review by the U.S. Food and Drug Administration (FDA).
“We look forward to working with EAS while leveraging our decades of experience, technical knowledge and expansive flavor library,” said Bianca Iodice, president of Purilum. “At Purilum, we set the standard for excellence in flavor formulation and e-liquid production through rigorous product testing and quality verification. This agreement is a recognition of our investment in a scientific, data-driven approach to flavor delivery, and we are excited for the opportunity to support EAS in its efforts to elevate the consumer experience.”
The contract “extends and enhances Purilum and EAS’s close and long-standing relationship, as well as offers the option for renewal of the exclusive supply agreement on a rolling basis,” according to a press release. Purilum’s e-liquids have been tested through a rigorous research and development process to meet EAS’s exact criteria for compliance adherence, product quality and consumer experience.
“At EAS, we have always held ourselves to the highest standards when supplying adult consumers with products they can trust,” said Jacopo D’Alessandris, President and Chief Executive Officer at EAS. “The quality and consistency of Purilum’s products are exemplary, and we are excited to continue working with them over the decades to come.”
November 9, 2020
Applied and Accepted

Credit: EAS
It seems the vapor industry has a future after all. Several large tobacco companies, such as Vuse, Blu, Logic and Juul, have already filed premarket tobacco product applications (PMTAs) for their vapor products with the U.S. Food and Drug Administration (FDA).
While several smaller companies have said they would file PMTAs, E-Alternative Solutions (EAS) is the only vapor manufacturer to announce that it has received both acceptance and filing letters from the FDA for its submitted vapor products.
EAS’ Leap and Leap Go brands will now move on to the substantive review stage of the PMTA process. During this phase, the FDA will decide whether the EAS products are “appropriate for the protection of public health.”
“This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS. “FDA acceptance and filing letters are a testament to the strength and thoroughness of our applications, which we believe will meet [the] FDA’s requirements.”
Leap Vapor is a closed pod system designed for adult smokers. Leap Go is a line of disposable e-cigarettes. The Leap and Leap Go products can now stay on the market past the FDA’s PMTA deadline of Sept. 9. The products will be allowed to remain on the market for one year or until the FDA decides whether the products are a benefit to public health compared to combustible cigarettes.
When asked why EAS publicly announced its accep-tance and filing letters unlike some other companies, Chris Howard, vice president, general counsel and chief compliance officer at EAS, said that many vapor wholesalers and retailers remain uninformed about the potential status for many of the vapor products they are selling. EAS wants to be “open and honest” about the process.
“We’ve taken a different approach by providing informa-tion regarding the PMTA process and what it’s like to work with [the] FDA. This gives retailers an idea of what to look for, especially after Sept. 9,” says Howard. “A lot of retailers want to do the right thing. So, after Sept. 9, they don’t want to be doing something illegal. They definitely don’t want to be confused and unsure. We’re providing retailers with a tool to be certain that they are selling legally compliant products after the deadline.”
Howard said that, unfortunately, he does not see a scenario where the FDA will allow a sell-through period for products already on store shelves. The FDA is most likely going to demand that all products that have not submitted a PMTA be removed. However, the FDA may face challenges in policing the more than 152,000 convenience stores operating in the United States, according to the 2020 NACS/Nielsen Convenience Industry Store Count.
“We know [the FDA is] not staffed adequately to do that, and that’s unreasonable. So, in large part, [the] FDA relies on the people who want to be the good actors, to adhere to the regulations,” said Howard. “I think that most will—75 percent if I had to guess. A lot of them will immediately try to be compliant.”
Many retailers wonder if they will be responsible for the products that can no longer be sold or if distributors will buy back the products. While many distributors will not buy product back, Howard says that EAS has always offered its products with a 100 percent guarantee for the retailers.
“At EAS, we make it clear that our products are 100 percent guaranteed, and we do take product back. We’ve taken back all of the flavored pods that we had on the market and provided people with full refunds or credit in the form of other product,” he explains. “I personally believe that is the right thing to do, especially in an industry where the channel was burned multiple times by various vapor companies, and retailers got stuck with inventory that they couldn’t move. I think that some companies are aligned with my view on that, and they will take it back—but I wouldn’t say it’s the majority.”
RAPID RESPONSE
The FDA does not necessarily have a reputation for moving quickly. However, EAS received its acceptance and filing let-ters just over a week after submitting the application. Howard says that there isn’t necessarily a rational reason for why it was so fast. However, the FDA is committed to its timelines and is trying to move in an expedited manner.
“When you have something that’s organized and it comes in and makes it easy for them, then yes, you’re likely going to get the benefit of a quicker review. Now, I don’t know if that translates into a quicker substance review, or scientific review,” Howard said. “I believe one of [the FDA’s] goals is to clean up this space and get their arms around the problem. One of the ways to do that is to make sure you get those acceptance and filing letters out quickly. And you reject the ones just as quickly that aren’t adequate to meet the standard.”
Howard said that the EAS PMTAs for the Leap and Leap Go products together comprised 109,000 pages. EAS essentially filed two “buckets” of PMTA data with one being the Leap Go (which contained three SKUs) and the other the Leap (which contained 26 SKUs) for a total of 29 SKUs. The data contained more than 25 individual studies. The applications also contained several digital links to data.
“The Leap application had about 45,000 links, and the Leap Go had about 46,000. We covered every discipline. We did behavioral testing. We did an assessment of popula-tion risk. We did clinical studies. You might have heard of PK [pharmacokinetic] studies to see how the body reacts to the products. We did those to show that the products have a lower abuse liability potential relative to cigarettes,” says Howard. “We did all of the required HPHC work to con-firm that our exposures are a lot lower than the combustible cigarette. We did toxicity testing. We did a comprehensive analysis of every ingredient that’s in the products. We did chemistry testing. We evaluated the products for stability and shelf life, and that’s still ongoing for the next two years. We did an environmental assessment.”
Flavors in vapor products have been a controversial subject recently. When asked if EAS had submitted any flavors other than tobacco flavors for its PMTAs, Howard said the company approached the subject carefully and with much consideration of how flavors have been shown to help smok-ers make the decision to seek an alternative to cigarettes. He also acknowledged the open question as to whether flavors may contribute to youth experimentation but noted that companies like EAS, which prioritize compliance and limit-ing access and exposure to adults, are positioned to market flavored products responsibly moving forward.
“For the Leap pods, we currently only sell tobacco and menthol, which were submitted. We also submitted all the flavors we had to remove from the market back in February. There were a handful,” said Howard. “For the Leap Go, which are disposables and flavors are permitted, we submit-ted a mango flavor as well as tobacco and mint. You have to make decisions when you’re spending millions of dollars trying to create some efficiencies, and this was one of the ways we tried to be prudent. It’s not to say that we wouldn’t file more Leap Go flavors later, but if you look at our rela-tive business model, the Leap is a more dominant product, so we had a heavy focus on its PMTA submission.”
Jacopo D’Alessandris
Howard said he could not share the total cost for the PMTA process; however, it was in the tens of millions of dollars for all 29 SKUs combined.
WAITING FOR ANSWERS
Howard says the letters are straightforward. They state that EAS’ application has been accepted and filed, respectively, and the applications are ready to move on to the next stage. This is the stage where the FDA may want a tour of the com-pany’s manufacturing facilities. “I could see this happening,” explains Howard.
The process is now completely in the hands of the FDA, according to Howard. There could also be several different types of situations that present themselves before the FDA issues either a marketing authorization or denies the applica-tion. Howard said the acceptance and filing letters do provide some clarification, but it is still a “wait and see” process.
“I think the next step should be that, if they’re going to do it, they’re going to ask for samples. I believe that is what really starts the 12-month timeline. We haven’t been asked for samples yet. We’ve immediately engaged to make sure we have the samples ready, even the flavored pods, which are not currently on the market,” said Howard. “Now, they’re going to have their hands full come Sept. 9; I’m sure they’re going to get a lot of applications, and that might slow things down.”
Chris Howard
The FDA may also need additional information, accord-ing to Howard. The agency may request additional details regarding studies EAS has already provided, for example. It’s also possible that EAS may have to complete additional stud-ies to be able to answer a specific question.
“What I like to think is going to happen in that stage is a give-and-take and sort of a collaboration about what’s reason-able because, at the end of the day, these products are clearly appropriate for the protection of public health as compared to cigarettes,” Howard said. “Then you have this engagement, and that’s consistent with what [the] FDA has said, and then you’re on your way. Additionally, if you do get a request for additional information, that technically stops the clock, so that could extend your 12-month window. After the FDA receives any additional information it may require, the next phase is receiving the marketing authorization.”
If EAS receives a PMTA, the next step for the company to consider is whether it wants to file for a modified-risk tobacco product (MRTP) application. The only products to have ever received an MRTP are snus products and Philip Morris’ IQOS heat-not-burn device. Howard says that EAS may consider going through the process, but he questions the value of an MRTP.
“We now know it isn’t just some black box that nobody gets. I mean, it’s clearly possible. But we have to wait and see how this vapor category shakes out and whether or not an MRTP claim—whether it’s reduced harm or exposure—does that really add value in the eyes of the consumer?” Howard asks. “I don’t know the answer; so it’s a wait-and-see kind of decision.”
To grant a PMTA, the FDA will have to determine a product is “appropriate for the protection of public health.” It can be interpreted that a tobacco product receiving a PMTA is less risky than a combustible cigarette. However, a company can make that claim only after receiving an MRTP. Even if granted, MRTP claims will still be limited. IQOS, for example, received an MRTP but can only make reduced expo-sure claims. The company cannot make a reduced-risk claim.
“The MRTP is also super expensive. That’s many more millions of dollars on top of what we’ve already spent for the PMTA. We’re looking into the opportunity, but we haven’t decided,” says Howard. As far as advice for companies still preparing their PMTAs, Howard says to remain diligent.
The Covid-19 pandemic has only made collecting the data more complicated. This may lead many companies to be nervous about submitting an incomplete application. Howard says he believes that companies must be open and honest with the regulatory agency.
“If you’re in a position where you can’t do it all, you focus on the statutory requirements and making sure that those are robust and complete. And then areas where you do have gaps, you very clearly explain why you have a gap and what you’re going to do to fix it and when you’re going to be done. Don’t try to do a shortcut version,” says Howard. “I think [the] FDA will be understanding and receptive and ultimately work with you to make sure that all the data is complete. I mean, they don’t want to kick you out for not having finished your human factors testing. However, if you submit without an environmental assessment, they’re going to kick it out.”
After the Sept. 9 deadline, Howard says he expects to see the industry become more streamlined. He says that there’s a strong possibility that numerous companies will go out of business. However, there will still be a sufficient amount of options at retail.
“I think that there’ll probably be multiple variations of e-liquid, so it won’t be as many selections as there are today, but there will be open system options. I think because the products contribute so much to harm reduction that it’s not in [the] FDA’s best interest, or anyone’s best interest, for the cat-egory to be gone,” he says. “So anytime I hear someone say, ‘Oh, the vapor category is going to be gone,’ I completely disagree.” V

August 17, 2020
FDA Gives EAS Acceptance and Filing Letters for PMTA

The U.S. Food and Drug Administration (FDA) has issued Acceptance and Filing letters for E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands for its Leap and Leap Go vapor products. This notification moves the EAS products to the Substantive Review phase of the Premarket Tobacco Product Application (PMTA) process.
“This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS. “FDA Acceptance and Filing Letters are a testament to the strength and thoroughness of our applications, which we believe will meet FDA’s requirements. We want to thank FDA for the prompt turnaround on these materials given the challenging circumstances, and we look forward to partnering with the Agency as we move forward in the process.”
Jacopo D’Alessandris
The Acceptance letters follow the administrative review of EAS’s filings to ensure that the submissions met the baseline criteria for review. The Filing Letters are the result of a preliminary scientific review that ensures that the applications include the necessary ingredients and health analyses. FDA will now conduct a Substantive Review to assess whether the Leap and Leap Go products are appropriate for the protection of public health. If successful, this phase will result in Marketing Orders from FDA authorizing the continued marketing and sale of these products.
“The Substantive Review is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting our proposition that the Leap and Leap Go products are appropriate for the protection of public health,” said Chris Howard, Vice President, General Counsel and Chief Compliance Officer at EAS. “We are looking forward to continued collaboration with FDA in the weeks and months to come and remain optimistic that the PMTA process will result in Marketing Orders.”
July 8, 2020
EAS Submits PMTA for Leap and Leap Go Vapor Products

Credit: Timothy S. Donahue
Finally, some positive news for the vapor industry. The much anticipated premarket tobacco product applications (PMTA) for the Leap pod system and Leap Go disposable were delivered to the U.S. Food and Drug Administration (FDA) on Tuesday. E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands, is seeking authorization for the marketing and sale of its wide-ranging portfolio of Leap and Leap Go vapor products.
“We are pleased to take this important step in demonstrating our commitment to the vapor industry, retailers and adult smokers seeking an alternative to combustible cigarette smoking with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS.
Jacopo D’Alessandris
“At EAS, we have always held ourselves to high standards, from supplying adult consumers with products they can trust to consistently following ethical marketing practices. We are confident in the strong merits of our PMTAs and want to thank our compliance and research teams for developing and delivering thorough submissions.”
The submission of PMTAs by EAS plays an integral role in supporting the proposition that Leap and Leap Go vapor products are appropriate for the protection of public health, according to a press release. The collective 75,000+ page PMTA submissions for Leap and Leap Go are the result of months of hard work and investigation that included an assessment of the stability of the products over time, toxicological formula reviews, toxicology testing, an assessment of abuse liability, label comprehension studies and behavioral studies.
In addition, EAS undertook an extensive review of available literature on vapor products related to health effects, behavioral factors and toxicological end points. Further, an exacting risk assessment was conducted across many areas of potential risk for Leap and Leap Go products, according to the release.
“Our PMTA submissions provide a robust analysis of the Leap and Leap Go products that will enable FDA to conclude these products are appropriate for the protection of public health,” said Chris Howard, vice president, general counsel and Chief Compliance Officer at EAS.
Chris Howard
“From an industry perspective, the PMTA process sets a high bar and holds companies accountable, ensuring vapor product manufacturers follow the rules and act in good faith. Looking ahead, a robust collaboration with FDA will help build a strong future for both the vapor industry and adult consumers.”
EAS continues to establish a leadership role in the creation of sensible industry standards and regulations as member of the Board of Directors of both the National Association of Tobacco Outlets (NATO) and the Vapor Technology Association (VTA), where EAS led the initiative to formulate the VTA marketing standards for membership, according to the release. The company continues to advance the interests of the industry’s consumers, manufacturers, wholesalers, small business owners, and entrepreneurs.
June 17, 2020