The U.S. Food and Drug Administration has issued a warning letter to Visible Vapors. The regulatory agency advised the company that marketing its electronic nicotine-delivery system (ENDS) products, which lack a premarket tobacco product authorization (PMTA), is illegal, and therefore they cannot be sold or distributed in the U.S. The FDA states that the company did not submit PMTAs by the Sept. 9, 2020 deadline.
While the warning letter issued cites specific products as examples, including Visible Vapors Irish Potato 100mL and Visible Vapors Peanut Butter Banana Bacon Maple (The King) 100mL, the company has more than 15 million products listed with FDA, and must ensure all of its products comply with federal rules and regulations, which include the premarket review requirement, according to the letter. Visible Vapors has the largest number of products registered with the FDA to have received a warning letter to date.
From January through July 2021, the FDA has issued more than 135 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline. On FDA’s Warning Letters page, you can find these warning letters by searching “Center for Tobacco Products” under “Issuing Office.”
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
The U.S. Food and Drug Administration’s process for premarket tobacco product applications (PMTAs) has not been perfect. The regulatory agency has been accused of falsely issuing warning letters, leaving companies off of its list of accepted PMTAs and of having issues with its PMTA filing software.
As of July 9, the FDA has issued 130 warning letters for the marketing of illegal vaping products. The majority of those letters centered on e-liquids produced and sold online by small-sized vape shops. As the FDA continues its blitz, however, there is some confusion as some companies who have submitted PMTAs by the Sept. 9, 2020 deadline have received warning letters.
According to Facebook posts from the American Vaping Manufacturers Association (AVM), at least two companies have received warning letters for products that submitted timely PMTAs. Posts acknowledged that the FDA corrected its mistake in a follow-up letter after receiving complaints from the companies. While the number may be small, it does show that the regulatory agency is overwhelmed by the number of submissions it is reviewing.
The FDA also had recently started listing closeout letters for companies that had responded to warning letters. Recently, however, the agency removed those letters from its website. The FDA offered no explanation for the removal of the closeout letters.
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. A court order requires the FDA to complete review of all submitted PMTAs by Sept. 9, 2021.
If a negative action is taken by the FDA on a PMTA application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
There are other issues with the FDA PMTA process, as well. The FDA released its list of products that are legal for sale in the U.S. A total of 360 companies (on the original list) filed PMTAs. However, at least five companies that filed PMTAs were erroneously left off the list, according to posts by Amanda Wheeler of the AVM.
In its own investigation, Vapor Voice found that Humble Juice Co. submitted a timely PMTA, received an acceptance letter and was subsequently misidentified on FDA’s list of approved products. The FDA has corrected the error for Humble. The AVM did not name what companies were left off the list or had falsely received warning letters.
The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on the current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed. It is possible companies were left off the list because they did not respond to the FDA before publication of the list.
Other issues with PMTAs include errors in submitting them electronically. Several companies have complained that the FDA’s software that manufacturers must download in order to submit PMTA data has randomly left out some of files that the companies are uploading. At least two companies that have helped prepare more than 500 PMTAs have acknowledged the issue and have presented the problem to the FDA.
“We did 15 PMTAs for various clients and just all of a sudden had somebody come up and they got a deficiency letter asking for information that was included in their submission. We started looking through it and it’s missing. We then spent a bunch of time going through every single one and found several others that were missing one or two files,” one of the companies that discovered errors told Vapor Voice. “We reached out the FDA, got a basic response … we’re aware of this, we’ll get back to you type of thing. We believe it’s a bug in the agency’s eSubmitter program.”
Because of these issues, some companies are offering free PMTA deficiency reviews for companies that submitted them to the FDA. Delphinus Consulting and Blackbriar Regulatory Services have said they have programs to help companies find faults in their PMTA submissions.
Warning letters are expected to continue to be issued for illegal vapor products as the deadline for FDA action moves closer. The FDA has not said if it intends to ask for an extension on the deadline, however, the U.S. Small Business Administration recently sent a letter to the FDA asking the regulatory agency to request an extension.
The FDA often only lists a few products that a company is selling as illegal in a warning letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
A more in-depth analysis of these issues will be in the next issue of Vapor Voice.
A coalition of 23 organizations have written a letter to the U.S. Food and Drug Administration (FDA) to follow the common-sense recommendations of the Small Business Administration (SBA). The SBA had recommended companies seek a court order to allow vaping manufacturers to keep products on the market while their premarket tobacco product application (PMTA) submissions are being reviewed.
Credit: Tanasin
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. All products must be removed from market on Sept. 9, 2022 without FDA approval, according to a court order.
The coalition letter, organized by the Americans for Tax Reform (ATR) acknowledged that FDA promised to exercise discretion in enforcement, stating that “this does not provide the degree of certainty necessary for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by FDA. If an extension is not granted, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality.”
The letter also argues that there “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The coalition states that the only way to avert a disastrous outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year.
“The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”
The full letter and list of signatories can be read here.
The premarket tobacco product application (PMTA) process has been a struggle for vapor industry companies that took on the time, effort and expense to keep their products on the market. During the Tobacco Plus Expo (TPE), Vapor Voice sat down with Blackbriar Regulatory Services (BRS), a firm specializing in helping small-sized to mid-sized companies navigate the regulatory landscape to bring their FDA-regulated product concepts to market, to discuss the lessons it learned while filing 365 PMTAs for its clients. BRS has helped several clients garner acceptance and filing letters from the FDA.
Credit: Coloures Pic
BRS did not exhibit at the TPE. Don Hashagen, VP of business development, and Kristina Rogers, director of marketing and brand management, attended the show to support its partners that were exhibiting. Some of these partners include the Charlie’s Chalk Dust, The Beard and Humble brands. The pair was also testing the waters for how secure other companies felt about their PMTA submissions.
“If they wait until they get a deficiency letter, that’s too late. That’s 90 days,” said Hashagen. “We want to support the industry whether they have worked with us on their PMTA or not. The more people that make it through PMTA, the better it is for everybody in the industry.”
BRS is offering any company that submitted a PMTA a free gap analysis of their submission. Hashagen said that many companies that submitted PMTAs have yet to complete clinical trials, for example, and the FDA has been clear that it’s a requirement for approval. It’s also time-consuming and expensive.
“The other one is perception and behaviors. We’ve got about 45 people that specialize in PMTAs. Now that we’ve seen enough deficiency letters coming through, we have an understanding of how to respond to those letters,” he said. “Our team can read a PMTA and very quickly say, ‘All right, here’s some major issues you’re going to need to attack. Now, you don’t want to wait too long to get started on a deficiency letter. It’s going to take you more than 90 days to remediate.”
Several manufacturers have received filing letters for their PMTA submissions. This is the stage that the FDA will ask a company to respond to questions the FDA has as well as receive deficiency letters. Because the PMTA is a “living process,” BRS can help a company potentially address a known or found deficiency often before a deficiency letter is even issued.
“Submitting your PMTA is really the first step in a very long, lengthy process. You have multiple audits afterwards with people looking into your manufacturing, into registration, into your PMTA, into post-market surveillance … even after you are authorized for marketing authorization,” explains Rogers. “It’s a long year-to-year process. This is just the beginning of something that’s going to last the length of your product lifetime.”
Having an organization like BRS managing a company’s PMTA allows the client to have access to experts that know what’s coming, says Rogers. BRS knows what’s needed to help take a brand and make it successful in the market while complying with regulatory requirements.
“You spend all this money, you get a market authorization, you’re doing well. But four months later, you trip over your own shoelaces because you did something that could hurt your brand from a marketing standpoint … how you positioned it. Maybe your brand is suddenly considered youth-friendly as FDA guidelines change,” said Rogers. “You can be taken off market almost instantly. As this evolves, you want somebody who’s talking to the [FDA] frequently. We’ve built a working relationship with the agency.” Hashagen says the main reason BRS is offering the free gap analysis is because they really want the industry to not just survive but thrive. “We really want to help people,” he said. “This industry is about helping adult smokers quit combustible tobacco for good. That’s really, really important to us.”
The U.S. Small Business Administration (SBA) has urged the Food and Drug Administration to allow nicotine products to remain on the market for another year while their premarket reviews are in progress, reports Vaping 360.
In a letter sent to the FDA on June 7, the SBA Office of Advocacy asked the agency to seek a court order extending for an additional year the current freeze on enforcement actions against small vape manufacturers who submitted Premarket Tobacco Applications (PMTAs) before last year’s Sept. 9 deadline.
In the current situation, manufacturers who submitted PMTAs on time may leave those products on the market until Sept. 9, 2021. The SBA advocacy office is asking the FDA to request that U.S. District Court Judge Paul Grimm allow the agency to extend the deadline until September 2022.
Considering the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—It is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market.
“Small ENDS manufacturers cannot afford to have their products pulled from store shelves while the FDA continues to review the timely submitted PMTAs for millions of ENDS products,” the SBA writes. “Most small ENDS manufacturers do not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. Once the FDA orders small ENDS manufacturers’ products removed from the market, those small businesses will close permanently.”
The letter also urges the FDA to end its current practice of processing PMTAs in order of manufacturer market share. By doing so, the FDA all but guarantees that small vaping companies will be unable to have their reviews completed in time to remain on the market, according to the SBA.
The SBA is a federal agency represents the views of small business to the various branches of government.
After submitting its premarket tobacco product application (PMTA) application to the U.S. Food and Drug Administration (FDA) on or before Sept. 9, 2020, Arizona-based JVapes announced that it had received a PMTA acceptance letter from the regulatory agency. The company submitted PMTAs for 992 SKUs of its JVapes e-liquids.
Credit: JVapes
The company now waits for a filing letter from the FDA. Following acceptance, applications undergo a more thorough review to determine if they include the data outlined in Section 910(b)(1) of the Tobacco Control Act (TCA). A filing status will only be received by brands that have submitted an application that contains all the necessary components with enough data included to justify a complete scientific review.
Filing is a critical milestone for a brand because once this status is reached, it is legal for products to remain on market till September 2021 while FDA completes its review.
During the substantive review phase of the PMTA process, FDA performs a detailed inspection of the documents and research that a brand has provided. This review considers whether or not an applicant product is safe for consumers and if it will be manufactured and marketed to FDA standards, with the ultimate goal of determining if a product is appropriate for the protection of public health.
Substantive review typically takes 90 days from notification of entering the review phase to receiving the first set of questions and comments from the FDA, according to the FDA. The majority of applications will receive follow-up questions and/or requests for additional data that may extend the timeline of the review phase.
The U.S. Food and Drug Administration (FDA) has issued a statement that it has updated the language used in its deficiency letters. The new language is intended to clarify the purpose of the letters that are related to its premarket tobacco product application (PMTA) process. In an email on June 3, the FDA explained that such letters are only meant to communicate information gaps identified during review. The letter offers the applicant an opportunity to provide further information.
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“The language further clarifies that the letter is not intended to convey a list of concerns about the product, and a complete response to the deficiency letter does not guarantee that the applicant will receive a positive marketing order,” the agency states. “Importantly, a final decision regarding marketing of the product(s) will be made at the end of FDA’s scientific review. FDA will base the final decision on the applicable public health standard in the Federal Food, Drug, and Cosmetic Act after reviewing the totality of all the information included in the original submission and amendments.”
Following last year’s Sept. 9 PMTA deadline for most deemed new tobacco products, including vapor and e-cigarette products, that are currently on the market, the FDA’s job is to process, review, and take action on as many applications as possible before September 9, 2021, according to the agency. The substantive review process is the longest and most thorough phase of FDA’s review. Substantive review includes the evaluation of the scientific information and data in an application and often includes identification of follow-up questions for the applicant.
Before a final decision is made based on substantive review, the FDA generally sends a deficiency letter, which allows one opportunity for applicants to provide any additional information that the FDA needs to continue its scientific review. The agency typically allows 90 days for an applicant to respond to a deficiency letter.
The U.S. Food and Drug Administration (FDA) has issued three more warning letters for illegal e-liquids. The regulatory agency issued the letters on May 28 and June 3 and posted them to its website on the same days. Companies that received the latest round of letters have a combined 750 products registered with the FDA. The agency has now issued 123 letters to vapor companies for marketing vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.
Credit: Chris Titze Imaging
North Carolina-based Asheville Vapor received letter on May 28 (50 registered products), while Kansas-based Tiger Vapes (100) and New York-based The Vapor Shop received the letters on Thursday, June 3.
In May, the FDA issued a total of 19 warning letters to firms who manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S.
While each of these 19 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively those firms have listed a combined total of more than 378,000 products with the FDA, according to an email from the agency.
Since January 2021, FDA has issued a total of 123 warning letters to firms selling or distributing more than 1,280,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline.
The FDA recently released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
Five more vapor companies have received warning letters from the U.S. Food and Drug Administration (FDA) for illegal e-liquids. The regulatory agency issued the letters on May 21 and posted them to its website on May 27. Companies that received the latest round of letters have a combined 96,960 products registered with the FDA. The agency has now issued 120 letters to vapor companies for marketing vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.
Credit: Jon
Nicfixed d/b/a Good Karma Vapor-received letter on May 27 – (1,400 registered products), Soul Vapor (2,100), Nelson Endeavors d/b/a Liberty Vape Co. (60), Premium eJuice USA d/b/a Vapor Lab (92,000) and Capitol Hill Vapor Co. (400) all received letters for illegal e-liquids.
Last week, the FDA released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
The U.S. Food and Drug Administration (FDA) continues to be adamant about removing illegal e-liquids from the market. On Tuesday, the regulatory agency issued two more warning letters for companies selling e-liquids without having filed a premarket tobacco product application (PMTA). The total now stands at 115 companies that have received notice since Jan.1 of this year.
Credit: Hurricane Hank
Adirondack Juice d/b/a Adirondack Vapor & Co. and Blue Eyed Vapor (BEV) received the letters from the FDA on May 14, however the agency didn’t post the letters to its website until May 25. Adirondack and BEV both were accused of selling or marketing multiple e-liquid flavors. The companies have 5,800 and 20 products registered with the FDA, respectively.
Last week, the FDA released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
