On March 12, the U.S. FDA issued warning letters to 13 firms who manufacture and sell unauthorized e-liquids. The regulatory agency advised the companies that selling products lacking a premarket authorization is illegal, and therefore cannot be sold or distributed in the U.S.
Credit: Isaiah Rustad
The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline, according to a press release from the FDA. The firms receiving warning letters are VapinUSA-WI, LLC d/b/a VapinUSA, Vapor Springs, LLC, Vapor Cigs, LLC, Vegas Vapor Emporium, LLC, Vape 911, The Philosopher’s Stone, LLC, The Clean Vape, Tooters Vape Shop, Cloudchasor LLC, Boardwalk Elixir, LLC, Dieselbycg-Hometown Vape Lounge, Blue Lab Vapors LLC, and Revolution Vapor LLC.
“While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 75,000 products with the FDA,” the statement reads.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for products that failed to submit a PMTA.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.
Cannabis vaping needed a full-service hardware manufacturer with products designed for CBD and THC oils.
By Timothy S. Donahue
When the cannabis industry began to take off in the U.S., vaping became a popular way to consume cannabinoids. However, many of the devices used to vape nicotine products did not work as well with the more viscous cannabinoid oils, especially THC and cannabidiol (CBD). There was a massive need for high quality vaping products that were specific to the fast-growing cannabis industry.
The Blinc Group started in 2017 to provide industry-specific vaping hardware to cannabis companies in Canada, the U.S. and Europe, according to co-founder and CEO Arnaud Dumas de Rauly. The company offers off-the-shelf products that can be fully customized and creates bespoke products. Dumas de Rauly says Blinc Group isn’t a cannabis company; it’s a technology company that serves the cannabis industry. Blinc Group provides every level of service from product design and customization to compliance testing, manufacturing, shipping and logistics.
When the legal cannabis industry began to grow and more states legalized marijuana in some form, it wanted to separate itself from the nicotine vaping industry. There was little crossover between products. To Dumas de Rauly, who honed his skills in nicotine vaping hardware, it was baffling that no one was applying the knowledge gained in nicotine vaping to cannabinoids. He says that the cannabis industry today is in the same situation the nicotine vaping industry was in two or three years ago.
Arnaud Dumas de Rauly / Credit: The Blinc Group
“It’s becoming more accepted by regulators, by the general public. However, I can see the cannabis industry making some of the same mistakes that nicotine vaping had made … such as marketing to kids. That is going to bite our industry in the ass over the next couple of years, especially when all of this becomes federally legal,” said Dumas de Rauly. “We’re going to be really frowned upon if we are using cartoons on our packaging, if we don’t use proper standards.”
In regulatory matters, the cannabis industry was trying to reinvent the wheel. Instead of using manufacturing standards and regulation that had been developed in electronic nicotine-delivery systems (ENDS), the cannabis industry wanted to create its own standards. When the industry started developing its own way of analyzing product emissions, Dumas de Rauly said he had had enough.
“We already have these standards in nicotine vaping. We can already use that basis and then just add some components we’ll be testing for that are specific to the terpenes that are specific to more viscous extracts, that are specific to cannabinoids. We already have a base,” he explains. “Radioactive components, for example. It’s something that seems logical. It’s in the nicotine vaping standards. We’ve got to make sure that there are no radioactive materials in there. That’s very easy. You just translate over to cannabis. Why the heck won’t we do it? Testing for aldehydes, heavy metals is stuff we’ve already been doing in nicotine vaping for years.”
Be on the Blinc
The same couldn’t be said for the hardware. While standards and regulation could be carried over from the nicotine vaping industry, hardware needed to be specific to cannabis. Eric Newman, director of sales for Blinc Group, says the THC industry in the beginning used hardware designed for nicotine but soon shifted to specific cannabis vaping products. Newman said to get the cannabis industry comfortable developing its own hardware was an educational experience.
Credit: The Blinc Group
“Different clouds work well with different types of products. Customer experience is something that we take seriously. For us, it was coming from a product perspective and a knowledge and educational perspective as well. We needed to teach the end user that one device or one product is better than the other and why they should use one product over another.”
Newman says that more companies are moving toward open systems and that is expected to continue moving forward. He said that Blinc Group is dedicated to passing along its knowledge across all stakeholders and getting more people talking about best practices and standard operating procedures [SOPs]. “I think it’s education first then proving that what you’re educating actually works,” says Newman. “Then you open up the network to the masses.”
A good example of a hardware change to accommodate cannabis products is the move away from poly-type or plastic cartridges, according to Newman. He says Blinc Group now uses strictly glass cartridges.
“The whole market hasn’t switched to that model, and we’re pushing the market into, from a quality and safety perspective, going to all-glass type cartridges,” he says. “The next step to that process is actually happening already. We’re making full ceramic cartridges, making full glass cartridges. Except for the inner components that still have to have some metal and ceramic cores—but it’s happening in front of us where we’re seeing those type of products. Unfortunately, Blinc Group hasn’t found any that fit our model, but there’s certainly a revolution happening already, and I think Blinc Group’s ahead of the curve on it.”
Dumas de Rauly attributes much of the Blinc Group’s success to the emphasis it placed on safety and compliance throughout the EVALI crisis of 2019 and the Covid-19 pandemic. Even outside investors are starting to notice. In early January, Blinc Group successfully raised $1.5 million in bridge funding.
“Our team navigated 2019’s vape crisis helping set standards and advise regulators on testing and compliance, and last year, the company saw our best quarter yet amid the Covid-19 pandemic as the industry learned the benefits of safety and traceability,” said Dumas de Rauly. “We have shown that we are a resilient company that puts consumers first, which has made all the difference.”
In just over a year, Dumas de Rauly and his two partners managed to turn their company into a business generating approximately $1 million in revenue, adding an additional five team members in the process. By 2019, the company was grossing over $4 million in revenue and had 15 employees. In 2020, Blinc Group more than tripled its orders with more than 330 percent year-over-year growth.
The technology company seemed to have a knack for expanding in an increasingly difficult regulatory landscape. “I don’t have the exact numbers yet, but I know in terms of sales orders, we hit $14.2 million in 2020,” said Dumas de Rauly. “We have increased our team to 21 members, and we are really excited about our future in this unique and exciting industry.”
Blinc of an eye
The Blinc Group specializes in standards and quality. The company was created to help the cannabis industry comply with Canada’s robust regulatory requirements through the highest quality testing and supply chain standards. Canada legalized recreational marijuana in 2017.
Dumas de Rauly and his two Blinc Group co-founders, Givi Topchishvili and Alexander “Sasha” Aksenov, who also serves as chief innovation officer, had the collective experience needed to change nearly every aspect of how the cannabis industry was operating, from standards and other regulatory needs to lobbying, manufacturing and even sales. Topchishvili is an entrepreneur, investor and author with 30 years of market entry experience in Europe, Asia and the U.S. Aksenov has been in the cannabis vaping industry for more than seven years. He has created several ventures ranging from branding studios, record labels and media management companies to marketing agencies.
Dumas de Rauly is the scientist. He currently chairs the ISO (International) Standards Committee TC126/SC3 on Vaping Products and the CEN (European) Standards Committee TC437 on Vapor Products. He is also a member of the informal Marijuana Science and Policy Work Group managed by the Colorado Department of Revenue’s Marijuana Enforcement Division and Colorado Department of Public Health and Environment. Dumas de Rauly is also the former president of FIVAPE, the French vaping trade federation, and now serves as the organization’s secretary-general for international relations.
“As chairman of ISO standards on vaping products, I was getting a lot of friends that were coming up to me and asking me what I thought of their vaping products. And when I looked at them, I quickly saw that the products they were using were not adapted to the format of the [cannabis] extract, which is very, very viscous, oily, in some cases, really like molasses,” explains Dumas de Rauly. “I got concerned about the safety issues, started looking into it and … my partners and I decided to create the Blinc Group to bring the wealth of experience we had in nicotine vaping over to the cannabis industry.”
What sets Blinc Group apart from other cannabis industry hardware manufacturers is its involvement in every aspect of the process, from design to sales—what Dumas de Rauly calls “enterprise solutions” or consultative sales. The company doesn’t do sales on a traditional transactional basis. Every Blinc team member gets involved. “We can move along the entire vaping value chain. We have done product formulations for clients; we go through automation with filling and capping SOPs all the way down to point of sale and training,” says Dumas de Rauly. “We train our clients’ salespeople on specific hardware. We really insert ourselves throughout the entire value chain of vaping products in cannabis.”
Eric Newman
The Blinc Group may be the only cannabis industry vaping hardware manufacturer that controls its entire supply chain. This is important because when a manufacturer orders from a factory in Shenzhen, China, where most vapor hardware is produced, that company has no clue where the raw material is sourced. The factory knows but not the client. Blinc Group sources the raw material suppliers. It then tells the subcontracted factory that those factories need to use the Blinc-sourced suppliers.
“We have an entire audit trail of every single material that comes into the device. That is one very important [differentiator] and one of our biggest differentiators. It also allows us more resiliency and redundancy within our supply chain because we’re not buying just from one factory,” Dumas de Rauly says. “We have four different manufacturers we work with—or assemblers, as we call them because they don’t really manufacture. They assemble products. And when one of them is not available, we can have the same product manufactured by another one because we own all of that supply chain.”
Blinc and you’ll miss it
There is one fundamental reason for controlling the supply chain: safety. Alongside innovation, quality and integrity, Dumas de Rauly says safety is part of Blinc Group’s foundation. It’s the company’s main focus in advocacy as well. For example, recently, the company worked with the U.S. state of Colorado to implement emissions testing in vapor products.
“[Colorado is] the first state in the U.S. that is requiring emissions testing, but that just goes to show that we’re even willing to put barriers in front of our business to make sure the consumer is safe. We have pioneered the use of medical-grade stainless steel in the products instead of using the regular H59 material to avoid any leaching of lead,” Dumas de Rauly explains. “We push our analysis and the control of the supply chain specifically for these reasons. Another example: In a typical 510-threaded cartridge, you have all of the materials that come into contact with the oil inside. Each one of those materials is sent off from each supplier—and we have four suppliers for each material—to undergo testing in an international lab. And given what we find, we adjust that material to make sure that individually, every single piece one of our cartridges will not leach, for example, heavy metals.”
Blinc Group has a large presence in Canada specifically because of the company’s compliance and regulatory stance, according to Dumas de Rauly. He expects the U.S. to adopt a similar type of regulatory framework soon. “People have already started understanding the need for regulations since the EVALI vaping crisis,” he said. “I’m very confident that this year, we’re going to be focusing a lot of our attention on the U.S. market and growing our U.S. presence.”
After Canada legalized recreational marijuana, the country passed the Cannabis Act. It includes some of the most stringent rules for cannabis on compliance and regulation in the world. Batteries, for example, need to be UL 8139 certified. In the U.S., it’s only a recommendation. The certification costs a little more, and the UL process could take anywhere from three-month to six-months, says Dumas de Rauly, but it’s necessary to protect the end user.
“We were the only ones attacking that market with UL-certified products in terms of batteries. We were the only one attacking that market with FDA, CFR21 or CPG21 certifications for our raw material. That was our edge, and that’s why we made such a big impact in Canada in 2020,” says Dumas de Rauly. “As regulation is becoming a little more stringent in the U.S. and after the EVALI scare, those consumers are starting to understand that they need to be paying attention to what’s in the vaping hardware.”
Blinc Group virtual meeting
As EVALI soared in the U.S., many believed the vaping industry was dead and the disposable option was a fad. Dumas de Rauly says that, in reality, cannabis accounts for more than 30 percent of the market in some states. Some states with legal medical marijuana allow only the sale of THC vaporizers. This is because contents and strength can be easily regulated in a vaping product. The same is not true for cannabis flower products. He sees the industry growing even more rapidly in the U.S., especially if marijuana is legalized on a federal level.
“The road is going to be bumpy. There is going to be more regulation. We are pushing for more regulation because we want to make sure that our business is sustainable over the next five to 10 years,” he says. “We don’t want to see what happened to nicotine vaping happen to cannabis vaping. We’re really pushing for good stewardship for the industry. We are thought leaders in the space, and we want to be at the forefront of education and making sure that consumers get safe products.”
As the legal cannabis market grows in the U.S., Dumas de Rauly says that the Blinc Group will be growing and continuing to grab more market share as well. He says that the Blinc process is highly developed. It runs like a well-oiled machine. “We have a very strong team,” says Dumas de Rauly. “We have a strong presence. Our processes are well refined. I believe we’re going to be doing very, very good this year.”
SnowPlus has started to re-allocate certain aspects of its production to Canada. The China-based vaping hardware manufacturer confirmed its partnership with Canadian manufacturing company, Dvine Laboratories, in a recent press release.
Credit: SnowPlus
“We are incredibly excited to partner with Dvine Laboratories to have SnowPlus products manufactured in Canada under the stringent standards of quality,” said Brad Jemmett, general manager of SnowPlus Canada “Having a trusted local manufacturing partner will not only improve our supply chain, but also allow SnowPlus to offer premium quality e-Liquids made by Canadians, for Canadian adult vapers.”
The outpost will be located in Lindsay, Ontario. The company states that localization has become an important part of its growth strategy and it no longer needs to rely on one region or producer to be responsible for all of its production needs. An estimated 90 percent of the world’s vaping and e-cigarette devices are designed and manufactured by about 1,000 factories throughout Shenzhen, China, with thousands more companies forming the supply chain throughout Guangdong province.
The move makes SnowPlus the only domestic and international source for vape products and accessories in Canada. “We’re thrilled to have a partner like SnowPlus. Not only are they as committed to quality standards as we are, they share in our values of giving back to the communities we serve,” stated Nick Paparamborda, vp of sales at Dvine Laboratories. “This partnership will create more jobs for Canadians and opportunities for small business owners.”
SnowPlus and Dvine Laboratories have stated that e-liquid for Canadian SnowPlus products will be produced in Canada, as well as filling pods, final assembly and packaging. “This ensures that product output is consistent to our government specifications and testing standards. The result is a Canadian vetted product that can be purchased locally,” the release states.
Securience, LLC, parent to the DuraSmoke, Forge, AmericaneLiquidStore, and VapeMoar brands, will be going out of business at the end of March 2021.
Credit: Durasmoke
In a letter to its partners, the company states that the recent passing of the Prevent All Cigarette Trafficking (PACT) Act, which prohibits the shipping of vapor products through the U.S. Postal Service (USPS), was the catalyst for the decision to close the company’s doors. The company cites its inability to mail product to consumers, however, the PACT Act also prevents B2B shipments by USPS, according to a representative from the Bureau of Alcohol, Tobacco and Firearms (ATF) who spoke during the recent Tobacco and Vapor Law Symposium presented by the law firm of Keller Heckman.
“Because of the complexity of these new shipping rules, FedEx, UPS, and DHL have all informed us that they will stop shipping vaping products completely — including our shipments to you, our wholesale vape shop customers, and distributors,” wrote Securience owner Don Muehlbauer. “While we have looked at some alternatives, given the geographic locations of our customers, the significant increase in compliance costs, and our capabilities as a small business, we have been unable to find a feasible alternative and have been left in a situation that makes continuing business impossible.”
Securience opened its doors in 2008 and has since been a staple in the vaping industry. Muehlbauer stated that he anticipates the PACT Act will not only impact his company, but many small e-liquid manufacturers. “Those manufacturers who are able to afford the increased compliance costs will have increased shipping costs that may impact [retail] shops,” he wrote. “The last day we will be able to accept orders for shipping is March 25 or until supplies run out.”
Vapers say taste matters. According to a survey conducted by Frost & Sullivan, among 3,000 Chinese vapor consumers, taste was a key factor in choosing an e-cigarette. The top three indexes in flavor were the overall sensation of taste (66 percent), aroma (61 percent) and the amount of vapor (50 percent).
In late-December, FEELM, a heating technology brand, introduced the industry’s first Taste Evaluation Model. The model allows FEELM researchers the ability to describe the taste of atomization scientifically. Composed of four dimensions, flavor, strength, note and vapor, and 51 specific indexes, the model establishes a system to evaluate the human senses of mouth, tongue, nose and throat.
FEELM Taste Evaluation Model
Frank Han, CEO of FEELM, said the company’s devotion to continuously improving the taste of e-cigarettes originated from a client’s concern. “How’s the taste of California strawberries at 6am? What’s the difference between it and that of refrigerated ones?” he said the client asked. “Could FEELM ceramic coils bring back the taste of California strawberry at 6am with flavored e-liquid?”
Inspired by the client, FEELM team members conducted numerous studies with the goal of developing a scientific system to properly evaluate and provide the perfect flavor. “As you can imagine, analyzing and delivering such an abstract concept as taste will [take] anyone tons of effort,” Han said.
In order to help with challenging endeavor, FEELM’s parent company, Smoore Technology, set up several research institutes both in China and other locations around the world (Smoore does not produce any e-liquid). More than 700 Smoore technical experts that have received more than 2,000 international patents began building a world-leading atomization platform, according to the release. Now, over 75 percent of those researchers are focused on understanding and improving taste through atomization. Smoore also established relationships with other research institutions such as Tongji University, Tsinghua University and Princeton University.
FEELM CEO Frank Han
“This institute will focus on the background study and harm reduction from new perspectives such as bio-medicine and artificial intelligence,” the release states. “To further study the science behind atomization, FEELM has also established a professional taste evaluation team, and built a Taste Evaluation Lab complied with the national standard and could hold seven tasters at a time.”
The process for evaluating a flavor is precise. Before picking up a vaping device, each taster washes and sanitize their hands and then chews a slice of lemon or yellow peach to clean the palate. Testers than drink boiled water to freshen up the mouth and smell coffee beans, according to a FEELM representative.
Reporter in FEELM Taste Lab
“It is not until the light and the exhaust fan in the booth are turned on that the taster begins tasting. While tasting, a recorded form with all detailed criteria is prepared for scoring and taking notes,” the representative said. “Afterwards, the same vaping device will be handed over to chromatography, electron microscope as well as reliability labs to analyze its e-liquid ingredients, coil and safety … a diagnostic report will be produced based on both human and machine criteria. FEELM is then able to figure out the deficiencies in the vaping experience and work out precise solutions.”
FEELM research lab
The FEELM Taste Scientific Institute is made up of more than 10 labs, including Cell Lab, Taste Evaluation Lab, Element Analysis Lab, Chromatography Lab, and Electron Microscope Lab. The company says its labs can produce 50 physical tests, more than 200 chemical tests, six microbiological test items, three genetic toxicology tests, three categories of clinical abuse tests, as well as three categories of human factor testing.
“Besides scientific research, great taste cannot be separated from production. Smoore has established a rigorous production safety standard, which is even stricter than the TPD in the EU and AFNOR in France,” the representative said. The production protocols are also more stringent than what is required by the premarket tobacco product application (PMTA) process for the U.S. Food and Drug Administration (FDA), covering 50 individual tests.”
FEELM also developed the first fully automated pod production line in the vapor industry. Its production capacity is 6,000 pieces per hour, boosting efficiency five times over manual production. Automated production guarantees the stability and consistency of quality.
“Taste is a meaningful word,” said Han. “Great taste relies on the scientific system of fundamental research, the persistent improvement of product development and manufacturing, strict quality control, and a devoted focus towards science and ingenuity.”
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.”
E-liquiTech, a wholly owned subsidiary of Tobacco Technology Inc. (TTI), will start distributing their patented SyNic synthetic (S)- nicotine in November.
SyNic USP/EP, SyNic nicotine bitartrate and SyNic polacrilex resin are manufactured in U.S. Food and Drug Administration-registered current good manufacturing practices facilities. These products have confirmed purity levels of more than 99.9 percent, (S)- levels of more than 99.7 percent and are free of tobacco-specific nitrosamines and carcinogens.
“Coupled with e-LiquiTech’s exclusive distribution, competitive pricing and carrying the eLiquiTech guarantee, these products will be available only to responsible partners operating within the regulatory guidelines of the global tobacco industry,” said e-LiquidTech CEO George Cassels- Smith.
KT&G’s cigarette-type e-cigarette, Lil SOLID, and its exclusive heatstick, Fiit, were launched in Ukraine on Sept. 7.
This is the second achievement of collaboration between KT&G and Philip Morris International (PMI) following the launch of the product in Russia, according to an article in Business Korea.
KT&G and PMI are stepping up their efforts to penetrate the global e-cigarette market as they expanded their presence to Ukraine in Eastern Europe about three weeks after the launch of Lil SOLID in Russia on Aug. 17. Ukraine has a population of about 42 million. Like Russia, Ukraine has many consumers who have interest in e-cigarettes.
In Ukraine, Lil SOLID comes in three colors — dark navy, white and blue. Its exclusive stick also comes in three types — Fiit REGULAR, Fiit VIOLA, and Fiit CRISP. They are the same products as those launched in Russia.
Under the deal with KT&G, PMI will fully manage product sales by utilizing its resources, knowledge and infrastructure in the Ukrainian market.
Philip Morris Fortune Tobacco Co. (PMFTC) is opening its first four IQOS stores in Manila, reports The Manilla Standard.
While the heat-not-burn product has been available in the Philippines through several retail outlets since April, the opening of the stores marks a significant step towards achieving the company’s vision of a smoke-free future, according to PMFTC President Denis Gorkun.
“PMFTC’s vision is to help adult smokers who would otherwise continue to smoke to move away from cigarettes as quickly as possible and switch to a better alternative,” Gorkun said.
PMFTC parent company Philip Morris International has invested more than $7 billion in research, development and production capabilities to create smoke-free products such as IQOS, which are now available in several countries.
In July, the U.S. Food and Drugs Administration (FDA) authorized the marketing of IQOS and heat sticks in the U.S. with a reduced exposure claim adding that such issuance is appropriate for the promotion of public health.
Gorkun said the FDA decision shows that IQOS is a fundamentally different tobacco product compared to cigarettes and a better choice for adults who would otherwise continue smoking.
About 60 percent of Filipino adult smokers are willing to try smoke-free alternatives provided they are made commercially available and meet quality production standards, according to a study commissioned by PMFTC.
PMFTC said IQOS is aimed at adult smokers. The company is implementing age verification and access restriction to ensure that only legal age consumers 21 years old and above will have access to the stores, the e-commerce website and the IQOS products.
Blackbriar Regulatory Services (BRS), a firm specializing in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market, is expanding.
The company announced today that it is growing its facility and services to meet increasing client demand. Immediate expansion efforts include adding cleanroom manufacturing space, increasing its analytical capabilities and expanding regulatory service offerings.
“With the [U.S. Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) deadline approaching within weeks for existing nicotine-based vaping products currently on the market, we are now seeing an increase in PMTA demand for new, innovative nicotine-based vaping products,” said Russ Rogers, CEO at BRS. “The FDA rightly worked with the industry to pause and take a look at the appropriateness of the products on the market, and those companies who understand how to make the highest-quality products are in a position to start working on applications for next generation technologies that should create dramatically improved user experiences and step-wise safety improvements.”
BRS was established to address challenges such as those that the PMTA process creates for manufacturers and brand holders. Its unique business model and capabilities provide numerous cost and speed advantages to clients who are looking for solutions to keep their products on the market in the United States, according to Rogers.
BRS is under contract to file more applications before the Sept. 9, 2020, deadline for several U.S. and international customers, and is now starting to prepare PMTA submissions for next generation nicotine-based vaping products for companies that are seeking to revitalize their product portfolio after the recent industry-wide focus on obtaining approval for legacy products.
Post Market Surveillance is an integral and mandatory commitment manufacturers must make to the FDA as part of their PMTA submission. BRS has also expanded its capabilities in this area to service clients both domestic and international to help them remain compliant in this regard, according to Rogers.
