Tag: Agrafiotis

FDA Sends PMTA Denial Orders to 3 More Companies
All of the premarket tobacco product applications (PMTAs) that have received marketing denial orders (MDOs) from the U.S. Food and Drug Administration have been for flavored products other than tobacco. On Aug. 31, the agency issued MDOs to three companies for only their other-than-tobacco flavored e-liquids, bringing the total number of companies known to have received MDOs to six. According to Filter, approximately 800 PMTAs were denied in the recent round of denials.
Credit: Veeranggull
“Dimitris Agrafiotis, the self-described ‘Vapin’ Greek’ who runs International Vapor Solutions, a consultancy firm, told Filter that three e-liquid companies companies he represents—two of them large and one medium-sized—were sent marketing denial orders (MDOs) by the agency,” Alex Norcia writes. “None of the PMTAs Agrafiotis helped file were totally finished, and the companies’ intention was to send more data piecemeal to the agency as substantial product stability testing wrapped up. Agrafiotis said he could not reveal the names of the companies because of nondisclosure agreements.”
Norcia was able to confirm that the FDA had issued additional MDOs, after it issued its first-ever MDOs for products from JD Nova Group, Great American Vapes and Vapor Salon for an estimated 55,000 products on Aug. 26. In its first MDO release, the agency stated that more marketing decisions would be forthcoming. The agency stated it would continue to review other premarket tobacco applications for non-tobacco flavored electronic nicotine-delivery systems (ENDS) to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth.
“If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization,” the FDA spokesperson explained to Norcia. “But in the absence of this evidence, the agency intends to issue an MDO. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”
Many in the vaping industry believe that the FDA will not approve a PMTA for a non-tobacco flavored product. A major e-liquid manufacturer recently told Vapor Voice that the agency may not immediately enforce the marketing of some flavored e-liquids for open systems that have submitted a PMTA, but the agency “will never give marketing approval for a flavor other than tobacco and menthol.”
The FDA’s review of new tobacco products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health, according to the agency. The agency noted that “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.” The FDA stated that there is the possibility that other types of evidence may exists that could be adequate if sufficiently robust and reliable. However, because the evidence was absent in these applications, the FDA issued MDOs.
The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group. According to the FDA release, the products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.
In June, the Agrafiotis’s three clients got a letter from the FDA that their PMTAs had been received and would be moving onto the review stage, according to the Filter story. Last week, his clients drafted letters to the FDA, stating that they would be sending further information. “They have done substantial scientific work and testing,” Agrafiotis said. “They invested some real money in this.” One company, which filed 45 product applications, spent close to $1 million. “Some of the PMTAs were not complete, and some of them were more complete than others.” Of all his clients’ applications, only those for tobacco or menthol flavors now remain pending.
“It’s not clarified exactly why they were denied,” Agrafiotis said. “The FDA mentioned youth. The usual spiel. And I was honest with my clients that some of the product names might be considered appealing to youth by the FDA. I’m very honest with the industry.”
Agrafiotis added that now each company he represents is moving into the synthetic nicotine space. One of the large companies is totally transitioning to synthetic nicotine, a legal gray area, because it does not want to spend any more money on the PMTA process. The other was beginning to explore synthetic nicotine as a stopgap solution while pursuing legal action against the FDA. Numerous companies that have received either a warning letter or MDA from the FDA have chosen to start using synthetic nicotine in order to attempt to avoid FDA regulation.
The FDA has not stated whether or not it believes it has the authority to regulate synthetic nicotine.
September 1, 2021
TSFA Leader Says PACT Act Impacts Older Vapers More
When former President Donald Trump signed the amended Prevent All Cigarette Trafficking Act, or PACT Act, into law late last year, the goal was to stop teenagers from buying nicotine vape products online.
However, the Tennessee Smoke Free Association’s (TSFA) executive director Dimitris Agrafiotis cited the “Youth source of acquisition for E-Cigarettes” survey from 2019 that shows most teenagers don’t get their e-cigarette products online. Instead, the survey, published in Science Direct, found that most kids get them from friends.
Dimitris Agrafiotis Credit: TSFA
A quarter of youth surveyed reported living with someone who uses e-cigarettes (26.1 percent). The most common location or source for getting e-cigarettes was a friend (51.5 percent), followed by a family member (16.4 percent), a vape shop (16.2 percent), and a retail location (12.3 percent).
Few of the survey participants reported getting e-cigarettes from another person that was not a family member or a friend (6.1 percent), the Internet (3.8 percent), or another place not listed (3.5 percent). The majority of adolescents reported getting e-cigarettes from one place (92 percent, data not shown), according to the survey data.
Agrafiotis says this law will do more harm to the older generation who rely on vape products to quit smoking cigarettes.
“The main point that I wanted to get across in this story is that in every corner of America you can buy cigarettes and a much less harmful product … [than] smoking is being squashed and eliminated,” Agrafiotis said.
If anyone wants to try to make a change, there are two things you can do, says Agrafiotis. First, call your representatives in Congress. Second, submit a comment to the U.S. Postal Service. Interested parties have until March 22nd to comment.
The PACT Act requires the Postal Service to begin enforcement starting on April 26, 2021.
March 7, 2021
Agrafiotis: Vape Shops Suffer From Misinformation, Covid-19
By Dimitris Agrafiotis
The COVID-19 pandemic has changed the conventional wisdom about many things, and upended the world and our economy in ways we could not have imagined in January. The proliferation of misleading, conflicting and sometimes outright false information, coupled with the constantly changing norms brought on by the pandemic, have hit business owners particularly hard.
Dimitris Agrafiotis Credit: TSFA
The Tennessee Smoke Free Association is an advocacy group and trade organization with a focus on tobacco harm reduction through the use of personal vaporizers (electronic cigarettes) and other smokeless tobacco products shown to reduce the morbidity and mortality associated with smoking. While our primary focus is the prevention of tobacco harm, we are also a group of small business owners trying to stay afloat in these uncertain times.
In the summer and fall of 2019, mysterious lung injuries were making headlines in the United States. By October, the Centers for Disease Control and Prevention had taken notice and given it a name: EVALI, which stands for e-cigarette, or vaping, product use-associated lung injury. They began issuing warnings about vaping devices, and guidelines were issued on treating it. And then, in early November 2019, the CDC reversed course and issued a report naming the actual culprit as tainted vitamin E acetate cartridges in illicit marijuana vaporizers — not the vaporizers themselves.
However, the damage to our industry was already done, and stigma of the original incorrect conclusions persists. Standard vaporizers contain varying levels of nicotine (which can be controlled by the user) but don’t have many of the harmful carcinogens found in cigarettes. We are still fighting the battle of misinformation and working to get our message out that e-cigarettes and vape devices can be used by adults addicted to cigarettes in a responsible way that improves their health.
And then, in the wake of the confusion and misinformation surrounding EVALI, the pandemic hit. Cities and counties began shutting the economy down, separating businesses into categories of “essential” and “non-essential.” In many places, vape shops were designated non-essential and forced to close, while gas stations, grocery stores and convenience stores — all of which sell cigarettes — were permitted to stay open.
We were able to advocate for ourselves, and many cities and counties reversed course and allowed us to reopen with curbside services, which almost all of our members did, following strict safety protocols. We continue to be grateful to the elected officials who responded to our hardship and worked with us so we could operate in a responsible manner.
Prior to discovering vaping, I was a longtime heavy smoker with a family history of poor health and even death because of smoking cigarettes. I feel that e-cigarettes saved my life, and many members of the TSFA have had similar experiences. We are knowledgeable and honest about our products and are small-businesses owners who contribute to our communities.
However, as small-business owners, though, we are still struggling with the aftereffects of the EVALI fallout, which were compounded by the pandemic. At the Tennessee Smoke Free Association, we will continue our work to put out critical scientific information and bust myths surrounding the use of e-cigarettes.
Dimitris Agrafiotis is the executive director of the Tennessee Smoke Free Association. This article first appeared on Knoxnews.com.
January 5, 2021
TSFA Applauds Drop in Vapor Use by Teens
The Tennessee Smoke Free Association (TSFA), a trade organization with a focus on tobacco harm reduction (THR) through the use of personal vaporizers, today applauded the news of dropping e-cigarette use among teens in the U.S.
“There has been a significant effort on the part of the Tennessee Smoke Free Association, and other organizations like ours around the world, to discourage those under 21 years of age from using e-cigarette and vapor products,” said Dimitris Agrafiotis, executive director of the TSFA. “As with the previous studies, we have also been very encouraged by the confirmation that using vapor products does not typically lead to smoking traditional tobacco products. Many of our association members–myself included–are former cigarette smokers who have kicked the habit completely by responsibly using vapor products.”
Credit: TSFA
The U.S. Centers for Disease Control and Prevention (CDC) recently released National Youth Tobacco Survey (NYTS) that showed a decline of almost 2 million in teens who reported vaping in 2020. The report comes on the heels of other studies that confirmed teen smoking overall has shown a dramatic decline in recent years.
The CDC’s study comes as health organizations have raised the alarm about teen vaping, leading to regulations in some states that have nearly put those who sell vapor products out of business. Many of the retailers in Tennessee that sell the products are small business owners, who have been struggling during the pandemic and have had to deal with different lockdown orders across the state by adapting quickly–for example, offering curbside services, according to Agrafiotis .
“The Tennessee Smoke Free Association continues to support regulations that prohibit teens from smoking or vaping. We do not market to teens or initiate vape use to non-smokers. We fully support strong regulations like limiting tobacco sales to those 21 and up, and harsher punishments for anyone caught selling nicotine-containing or illegal vape products to minors,” said Agrafiotis. “But we will continue to fight for responsible adults who use vaping as a way to kick the harmful and deadly habit of smoking.”
October 8, 2020
‘We Vape, We Vote’ Movement Descends on D.C. for Rally

Credit: UVA
This weekend’s “We Vape, We Vote” movement descended on D.C. to advocate for continued access to vapor products as an alternative to deadly combustible cigarettes.
Organized by United Vapers Alliance (UVA), advocates protested to show the world that “We Vape, We Vote” is a movement that has the influence to disrupt the upcoming election with millions of potential votes up for grabs. The organizers and attendees vowed to continue to push elected officials to “reject prohibitionist policies that threaten access to life-saving vapor products,” according to a UVA press release.
“If President Trump does not deliver on real reform at FDA, he is not only risking the destruction of an American industry, but he will be also be creating a situation where millions of adult ex-smokers could return to deadly combustible cigarettes,” said Dimitris Agrafiotis, who serves as executive director of the Tennessee Smoke-Free Association. “HHS Secretary Alex Azar has pledged PMTA reform, but he failed to deliver. Now, it is up to President Trump to stop the FDA from destroying 99 percent of the industry and leaving 160,000 Americans unemployed in the middle of the Covid-19 pandemic.”
Over 20 vaping consumer advocates shared life-changing stories during the rally on their journey to vaping and how it has positively impacted their friends and family since switching to a tobacco-free lifestyle. They were also joined by featured speakers and leaders in the industry Dimitris Agrafiotis, executive director of the Tennessee Smoke-Free Association; Amanda Wheeler, president of Rocky Mountain Smoke-Free Alliance; and Gregory Conley, president of American Vaping Association.
Wheeler says the FDA’s PMTA rules are too burdensome for small business owners (Wheeler owns five vape shops across three states. “The costs associated with PMTA will force Jvapes’ five locations in Arizona, Colorado, and Oklahoma to close doors,” she said.
September 6, 2020
A Love Story
Everyone can find something to love about Innokin’s new Ares 2 RTA rebuildable tank from Phil Busardo and Dimitris Agrafiotis.
By Mike Huml
The Ares 2 RTA is the latest rebuildable tank from Innokin. With input from avid mouth-to-lung (MTL) vapers Phil Busardo and Dimitris Agrafiotis, the Ares 2 provides one of the best MTL vape experiences possible. With the popularity of rebuildables, and subsequently sub-ohm tanks followed by pod systems, many more advanced vapers who preferred MTL vaping were left with very few options. Today, the Ares 2 stands out as the pinnacle of MTL vaping for intermediate to advanced vapers.
Historically, rebuildable atomizers have generally been considered a cloud-chaser’s game. While it is true that most rebuildables are intended for lung hits, huge airflow and massive vapor production, there are many who prefer MTL vaping but still want to gain the advantages of rebuilding. These include cheaper upkeep, a more customizable vape experience and generally improved flavor. Additionally, many prefer the ability to pair a 510 atomizer with a multitude of mods rather than be limited to the proprietary ecosystems provided by pod systems. The Ares 2 was created to fill the needs of these vapers and is largely successful in doing so.
The Ares 2 features a 2 mL reservoir and a wide range of airflow options. Many atomizers that claim to allow MTL vaping end up falling short due to compromises in airflow. MTL atomizers work best when the entire airflow chain is consistent rather than utilizing the adjustable airflow alone to restrict the airflow. The latter causes vapor production and flavor to be poor and the throat hit to be too harsh. The Ares 2 allows for adjustments to be made to the internal airflow underneath the coil as well as to the external airflow.
As a result, the Ares 2 could allow for restricted lung hits as well as MTL vaping without compromising vapor, flavor or throat hit. The internal adjustment is made by using the included screwdriver to rotate the ring that sits underneath the coil. While this may seem slightly obtuse, it effectively prevents accidental adjustments. The internal airflow is meant to be a “set-and-forget” adjustment, and while it might be odd, it’s also an ingenious solution to an underrated problem for many MTL vapers.
The Ares 2 is filled from the top by simply sliding the entire top cap in the direction indicated next to the mouthpiece. This reveals the fill port, which is sealed with silicone flaps. These flaps maintain pressure within the tank to ensure that open pressure does not cause liquid to flood the coil chamber. The tip of the e-liquid bottle splits the flaps and allows air to escape while filling, which prevents the e-liquid from backing up and overflowing. It’s a simple but elegant filling system that works perfectly.
While the Ares 2 comes with several premade coils, many will choose this tank to build their own coils. With the tools provided in the box, wrapping a coil is extremely easy, and installation is specifically designed to be as painless as possible. The coil is to be wrapped with a lead facing in either direction. The post screws on the deck are then loosened, the coil laid in and the screws tightened. The wicking material, preferably cotton, is then threaded and the ends trimmed to a length where they just barely contact the base. These are then inserted into the juice-flow holes. All that remains is to saturate and prime the wick, reassemble the tank and fill it up. While nothing fancy, the deck is one of the most forgiving on which to build a coil. This makes it the ideal tank for those new to rebuilding. While brand-new vapers will want to start with something nonrebuildable, the Ares 2 can make for an excellent second step into the vaping world.
The package comes with one of the most comprehensive tool kits to ever be included with a tank. Replacement tinted glass and replacement O-rings, gaskets and screws are all included. The replacement O-rings are multicolored, so they can be changed out due to the original O-rings getting lost or worn out or simply for a change in color. For rebuilding, the Ares 2 comes with two premade coils. These are 1-ohm, 26-gauge Kanthal coils. Additionally, one meter of 26-gauge Kanthal wire is included as well as a sheet of organic Japanese cotton.
Lastly, two building tools and a double-ended screwdriver are also included. The screwdriver has a flat head on one side and a Phillips head on the other, but it’s the building tools that are unique. One, marked as “Phil’s Build Tool,” has a smooth 3 mm diameter rod on one side and a 2.5 mm rod on the other. This is perfect for building contact coils but can also be used to build spaced coils. However, the other tool, labeled “Dimi’s Build Tool,” is better for this application. Dimi’s tool has threading to ensure perfect spacing, and each side facilitates wrapping in opposite directions. For the Ares 2, using the side marked “R” is preferred as this will ensure that the leads are in the proper position in relation to the post terminals.
No matter what type of coil is used in the Ares 2, it’s important to push the coil down with a tool as much as possible. A steel bridge ensures that the coil cannot be pressed so far down as to make contact with any of the metal on the deck. However, if the coil is not pressed down and aligned properly, it runs the risk of contacting the top of the bell and shorting out. Getting the coil as close to the airflow as possible is generally considered best practice when it comes to installing coils anyway, but the Ares 2 makes it foolproof.
Two mouthpieces are also included. One is black plastic and must be removed to slide open the top cap when refilling. The other is stainless steel and can remain attached when refilling. These can be changed purely based on personal preference. Both are extremely comfortable without being too long, and neither are too narrow that it causes accumulation and spitback, which generally isn’t as much of a problem with MTL vaping as it is with direct-lung vaping.
The result of the build is a smooth, quiet draw with airflow that can be adjusted to each vaper’s liking. With all the airflow closed, the draw is almost nonexistent. While vaping in this way is not recommended, it does demonstrate the quality and precision of the Ares 2. With the smallest airflow hole open, the draw is tight, which is great for vapers seeking the most analog-accurate vaping experience. At its most open, the Ares 2 is capable of restricted lung hits comparable to a Kayfun V5 or many pod systems.
Due to the nature of the wicking system and airflow, any e-liquid can be used. On one end of the spectrum, the Ares 2 can be built using looser wicking and maximum airflow in order to use e-liquid with a higher VG component to get flavorful restricted lung hits. On the other hand, airflow can be minimized and more wicking can be used to facilitate the use of thinner liquid or even high-nicotine liquids and nicotine salts to get a true smoking experience. Either route can be taken with no compromises.
In addition to the inherent versatility of being rebuildable, the Ares 2 has a standard 510 connection, so it can be paired with any mod or device that is compatible with atomizers that have a diameter of 24 millimeters or more. Most modern 510 mod or battery will fit this description, which leaves a near-limitless number of options open to pair with the Ares 2.
Mouth-to-lung vaping is not as much of a niche as it was several years ago. Pod systems have introduced many people to vaping, and a good number continue to upgrade as new products are made available or their old setups wear out. With the Ares 2, vapers such as these now have a rebuildable option without having to switch over to direct-lung vaping.
Not everyone has the desire to turn vaping into a full-blown hobby, but many still want a better vaping experience, and the Ares 2 is the best option. Not only does it provide arguably the best MTL experience possible, but it’s easy to use, customizable and versatile. Not to mention it comes with everything needed to build and install coils save for scissors.
Adding the Innokin Ares 2 to any product offering is undoubtedly a wise move. It’s a fantastic product on its own, but there are very few atomizers that are similar, let alone in the $30 to $40 price range. Anyone coming from pod systems can find something to love about the Ares 2, but advanced vapers looking to get a quality MTL vape can’t go wrong either. Innokin has never been a cloud-chaser’s brand, but it is renowned for its quality and reliability—two attributes exemplified by the Ares 2 RTA.
August 18, 2020