Tag: AVM

Longtime Vaping Advocate Greg Conley to join AVM

Greg Conley
Gregory Conley, a longtime advocate for the vaping industry and founder of the American Vaping Association (AVA), is joining the American Vapor Manufacturers Association (AVM) as its director of Legislative and External Affairs.
“Over the last decade-plus, myself and millions of American adults have given up cigarettes because of vaping,” said Conley. “During that time, I have been proud to advocate for vaping from the perspective of a consumer and harm reductionist. In this new role at AVM, I will continue to push for appropriate regulations to ensure that American businesses are not replaced with a multibillion-dollar illicit market. I look forward to helping grow AVM alongside Amanda and her board.”
His role with the AVM will be to advance public policy supporting the American vaping product industry in its fight for survival, according to press release. Conley, who has led the AVA as its president since 2014, will focus his efforts on government and media relations under the direction of AVM President Amanda Wheeler.
“Gregory is a critical voice for vaping and understands adult smokers and ex-smokers face dire circumstances because of the FDA,” said Wheeler. “One billionaire is pumping hundreds of millions of dollars into campaigns designed to end the vaping industry. The stakes have never been greater and I am thrilled to have him aboard to work towards a unified industry.”
Conley has a long history of advocacy for vaping products and tobacco harm reduction, dating back to 2010. While receiving a la and business degree from Rutgers University, Conley served as the pro bono legislative director for the Consumer Advocates for Smoke-Free Alternatives Association.
Conley then founded the AVA, and during his time there he testified before dozens of state legislative bodies, appeared on numerous news networks, and participated in a White House listening session with then-President Donald Trump. Conley plans to continue working with AVA as it charts a new path forward focusing on voter education and outreach.
July 28, 2022
Vaping Industry Advocates ‘Not Surprised’ by Logic Approval

When U.S Food and Drug Administration authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S. the vapor industry wasn’t surprised. Vaping advocacy groups have long expected the FDA to approve many of the brands that had premarket tobacco product applications (PMTAs) submitted and are owned by major tobacco companies.
“Although we are not surprised to learn that Japan Tobacco Inc., brand owner of Logic, is now among the Big Tobacco companies with FDA market authorization, we certainly aren’t pleased with FDA’s consistent rejection of flavored products and will continue to apply pressure in that regard, as well as in the enforcement discretion arena – particularly for the manufacturers with products still in review that participate in our Responsible Industry Network program,” said April Meyers, CEO of the Smoke-Free Alternatives Trade Association (SFATA). “As the nation’s leading regulatory body, the agency appears to be cherry-picking what science it utilizes for decision making. That FDA cited the recent NYTS data but failed to acknowledge the steep decline in youth use while coining the low rates an “epidemic”, makes its rejection of flavored products today seem more an act of fear over what might happen than a decision based on scientific evidence. This is disappointing, at best, but again, not surprising.”
Logic, based in Teaneck, New Jersey, is a part of the JT Group of companies. JTI is a international tobacco and vaping company headquartered in Geneva, Switzerland, with operations in more than 130 countries. JTI employs over 50,000 people. In a release, Logic stated that it submitted PMTAs for its Logic Pro, Logic Power, and Vapeleaf products on August 19, 2019, well before the Sept. 9, 2020, PMTA deadline.
“We take the quality of our products extremely seriously, along with the way they are marketed and sold, and we are proud that we have received marketing orders from FDA for our Logic products to remain on retailers’ shelves,” said Corrado Mautone, president of Logic. “By receiving FDA marketing orders now, Logic can remain a reliable partner for retailers going forward.”
Amanda Wheeler, owner of Jvapes and the president of American Vapor Manufacturers, said that it is good to see that the FDA is acknowledging that vaping is safer than combustible cigarettes, but the fight for small business owners continues.
“People forget that in the story, Dr. Jekyll was a benevolent physician in a lab coat who only wanted to help people. But tomorrow morning, (FDA Commissioner) Robert Califf and (director of the FDA’s Center of Tobacco Products) Mitch Zeller will transform back into their Mr. Hyde alter-egos and resume their hellbent mission to sabotage the single-most effective smoking cessation device ever devised,” said Wheeler. “Well, the American people are watching and I for one am not going to stand by and let them get away with it. So, here’s my own announcement for today: FDA and CDC have my approval to stop deceiving the American public about the safety and efficacy of nicotine vaping.”
The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products, mostly non-tobacco flavors.
“While Logic received marketing orders for its tobacco-flavored products, it is still awaiting a determination from the FDA on its menthol products. At the FDAs discretion, products like Logic’s menthol capsules can continue to be marketed while under review,” Logic stated in the release. “Additionally, Logic received marketing denial orders (MDOs) for flavored products that are not currently on retailers’ shelves. Logic is reviewing the FDAs determination and rationale before taking further action.”
The FDA also indicated that it was moving closer to issuing decisions on other applications that account for “a large part” of the marketplace, which based on Nielsen ratings, are mostly owned by large tobacco companies.
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
March 25, 2022
House to Vote on Budget Bill, Synthetic Nicotine Today
Update: At 2:56 pm the House went into recess, to presumably make amendments to the bill. Media outlets have reported it is to remove some Covid-19 related measures (30 states at risk of losing Covid relief funding previously promised). Currently, the vote on the omnibus appropriations bill is expected to occur this evening or late tonight.
It is possible that the omnibus appropriations bill vote is delayed. In case Congress does not complete work on the omnibus by the end of the week, the House is also expected to vote on a CR through March 15 today to allow time for Senate passage and signing by the President.
If the synthetic nicotine language remains in the bill, the rule will become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
The U.S. House of Representatives is expected today to vote on an omnibus appropriations bill (page 1,870) that includes language that would give the U.S. Food and Drug Administration the power to regulate synthetic nicotine . Lawmakers have said some add-ons have already been agreed to, such as a package of health care provisions including Medicare program extensions and eliminating the synthetic nicotine loophole.
The House is planning to vote sometime today before going to Philadelphia for its annual issues conference. The bill must clear the Senate before stopgap funding expires at midnight Friday. GOP objections to a unanimous consent agreement to speed consideration in the Senate could delay final passage into the weekend, lawmakers warned, but both sides expect the process to be complete in time to avoid a partial government shutdown when federal agencies open Monday.
House Appropriations Chair Rosa DeLauro was adamant after a private House Democratic Caucus meeting Tuesday morning the omnibus would be ready for the House to pass on Wednesday, according to RollCall.
“It’s not going to get delayed. We’re going to vote tomorrow,” she said.
If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”
Amanda Wheeler, president of American Vapor Manufacturers association, said the of banning synthetic products is going to drive millions back to combustible cigarettes.
“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said. “It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever. This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”
Amanda Wheeler
Yaël Ossowski, deputy director of the Consumer Choice Center, said the legislation will actively harm adults who want to quit smoking. He says that the method of “fattening up continuing resolution bills with laws that benefit special interests, without broader democratic debate or analysis of the costs and benefits,” is shameful in a modern American Republic.
“The byzantine process of asking permission to sell harm reducing vaping products in the 21st century is asinine in itself. But using sleight of hand during an emergency government funding bill to castigate millions of vapers and the entrepreneurs who make and sell the products they rely on is the definition of active harm,” said Ossowski. “Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options. Many will be forced back to cigarettes.
“Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A back door bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”
Yaël Ossowski
Ossowski said he hopes elected representatives reject the synthetic nicotine inclusion and “go back to the drawing board” to offer a more permanent policy.
Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.
Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”
March 9, 2022
Many Firms Received FDA Marketing Denial Overnight
According to sources, numerous companies received marketing denial orders (MDO) from the U.S. Food and Drug Administration overnight. A major white label manufacture confirmed that several of their clients received MDOs. The FDA is expected today to announce the fate of the vaping industry when it makes final decisions on premarket tobacco product applications submitted by Sept. 9. 2020.
Credit: Zoran Milic
The manufacturer can not be named because he had yet to speak with his clients about the denial order. The exact number of products that have received MDOs could not be confirmed, but some are suggesting its “hundreds of thousands” of products.
Several companies have announced on Twitter having received them on Sept. 8, many late in the evening. Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM) tweeted “Today was a tough day. Lots of very good people who I respect deeply and who helped thousands of smokers quit, got told by our government that their products were illegal. To all of you, I am so very sorry. To your customers, I am even more sorry. Our government is wrong on this.”
The FDA has yet to update its list of companies that received MDOs. Recently, the agency announced it had sent in total 34 MDOs from Aug. 27 to Sept. 1, covering more than 300,000 products. At least one company has already filed a lawsuit against the FDA, according to Vape Radio.
Many manufacturers have also said they would turn to synthetic nicotine because the FDA lacks the authority to regulate it. Vapor Salon will be switching to synthetic nicotine, the company wrote in a public Facebook post dated Aug. 26.
The post was published on the same day that the U.S. Food and Drug Administration denied some 55,000 marketing applications by Vapor Salon and two other companies on the ground that they “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by well-documented, alarming levels of youth use of such products,” according to an FDA press release.
“VaporSalon is switching to TOBACCO FREE NICOTINE on Friday, 8/27/2021,” the Facebook post reads. “The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement which takes full effect on Sept 9th 2021 with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to-date.”
September 9, 2021
FDA Falsely Issued Warning Letters, Other PMTA Problems
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.
July 9, 2021