Tag: news

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
Juul Labs Pays to Publish 11 Studies in Medical Journal
Juul Labs paid $51,000 to buy out an entire issue of the American Journal of Health Behavior (AJHB) and make it publicly available, the New York Times reported.
The AJHB’s May/June issue published 11 company-funded studies that promote the health benefits of Juul devices in helping smokers quit traditional tobacco products.
“Electronic nicotine delivery systems (ENDS) represent a significant opportunity to realize tobacco harm reduction at the population level around the world,” the authors write in an introduction to the journal.
Juul Lab’s five-figure buyout of the journal issue is part of a public influence campaign that the Center for Responsive Politics tallied at more than $3.9 million in 2020 alone.
Juul Labs recently reached a legal settlement with the state of North Carolina in which it will pay $40 million to avoid a jury trial over the question of whether it illegally marketed nicotine products to teens.
July 8, 2021
Stroud: Hypocrisy of the American Healthcare System
You don’t have to be a doctor, or even play one on TV, to see the conflict: American healthcare policy that promotes taxpayer-funded needle exchanges for drug addicts, but opposes vaping as an alternative for smokers.
The Biden administration recently announced a robust plan to address the nation’s crippling opioid epidemic, which was responsible for 500,000 American deaths between 1999 and 2019. That harm reduction includes needle exchanges, long a controversial policy. In 1988, Congress barred the use of federal funding for needle exchange programs. In 2015, amid the growing opioid crisis, then-President Barack Obama signed the Consolidated Appropriations Act, “which modified the restriction on use of federal funds for distributing sterile needles or syringes,” and allowed for funding to be used for other services, but not syringes.
The Biden administration plan mentions “harm reduction” a total of 12 times and hopes to “enhance” and “support” emerging harm reduction efforts. Although attempting to tackle the opioid epidemic is an admirable goal, the administration is doing an about-face in terms of adult access to all harm reduction products, and they’re not the only ones.
Rhode Island lawmakers recently held hearings on a series of bills that would ban flavored tobacco substitutes like vaping products. But those same Ocean State legislators held a floor session for the final vote on a bill that would establish “harm reduction centers.” A spirited debate took place for nearly an hour. Ultimately the measure passed by a vote of 62-9.
Harm reduction centers for opioid users are a worthwhile goal, but it is overwhelmingly hypocritical for lawmakers to support government funding those, while simultaneously blocking adult access to tobacco harm reduction products including e-cigarettes, heat-not-burn, and smokeless tobacco.
It is the smoke in combustible cigarettes that is responsible for the damage wrought by tobacco. Tobacco harm reduction products eliminate that smoke while allowing adult users to access nicotine, which in itself is not the harmful component of cigarettes. The U.S. Food and Drug Administration (FDA) has noted that it is the “mix of chemicals – not nicotine – that causes serious disease and death in tobacco users.”
The FDA currently regulates vapor products. But the agency, which fought so hard to regulate these products, has yet to approve a single premarket tobacco product application for any e-cigarette product. During a U.S. House oversight subcommittee meeting last month, lawmakers urged the agency to not approve any flavored e-cigarette product to “protect youth.”
In the Rhode Island House hearing, a spokesman for Campaign for Tobacco-Free Kids (CTFK) urged lawmakers to ban flavored tobacco and vapor products while supporting lawmakers’ efforts in increasing access to clean syringes and opioid antagonist medications, including methadone.
This makes no sense.
Is anyone arguing that more Americans should smoke? Or that health policy should promote smoking? Of course not, just as needle exchange advocates aren’t hoping more people will get hooked on heroin. It’s simply an acknowledgment of human nature, and an effort to reduce harm.
The infamous anti-tobacco and vaping crusader Michael Bloomberg similarly supports opioid harm reduction, but not tobacco harm reduction. A recent New York Times article interviewed the director of drug use initiatives at Vital Strategies, a Bloomberg-backed “philanthropic group.” The director noted that harm reduction programs help persons “stay safe and healthy and alive first and foremost.” Since 2016, Vital Strategies has worked in tandem with the World Health Organization to ban adult access to tobacco harm reduction products. In 2019, the organization highlighted India’s ban on e-cigarettes as a victory. Bloomberg himself has donated $160 million over a three-year period to “fight flavored e-cigarettes.”
In Rhode Island, the CTFK spokesperson noted that opioid harm reduction programs don’t create new users. That may be true, but e-cigarettes create former smokers by helping adults quit smoking. Moreover, they don’t cost taxpayers a dime, and as a harm reduction product, they help to reduce health care and other smoking-related costs.
The FDA has the ability to save millions of lives by approving tobacco harm reduction products. They shouldn’t let misinformed entities and people like CTFK and Michael Bloomberg stand in the way of science and common sense.
This opinion originally appeared at Inside Sources.
July 8, 2021
Taiwan Study: E-cigarette Use has Tripled Since 2018

Photo: Richie Chan
E-cigarette use in Taiwan has tripled since 2018, reports The Taipei Times, citing a study by the Ministry of Health and Welfare’s Health Promotion Administration (HPA).
In 2018, e-cigarette use was at 0.6 percent; in 2020, that rate grew to 1.7 percent, according to the study, which looked at responses from 25,000 people 18 years and older.
The highest e-cigarette use rates were found in men ages 26 to 30, at 6.3 percent, and women ages 21 to 25, at 4.6 percent.
“To put this growth into perspective, use of traditional cigarettes grew only marginally over this period, from 13 percent in 2018 to 13.1 percent in 2020,” said Lu Meng-ying, HPA Tobacco Control Division official. “The situation needs urgent attention, especially as new e-cigarette users are almost all young people.”
Most respondents said they use e-cigarettes out of curiosity while 17.3 percent use them to quit smoking combustible cigarettes and 9.7 percent use them because friends use them.
Use of flavored tobacco products is increasing as well, from 8.2 percent in 2018 to 15.6 percent in 2020. Majority of the increase was seen in women.
“There are more than 1,200 additives used in flavored tobacco products, and the vast majority of them are chemically derived,” Lu said. “The goal of manufacturers is to prevent new smokers, especially young women, from being turned off by foul smells.” He added that the effects of long-term use of flavored products are not well understood.
July 8, 2021
VPZ Opens First Vape Clinic to Help Smokers Quit
U.K.-based vaping retailer VPZ launched its pilot Vape Clinic on July 5 at its flagship Newbridge store. The company now plans to roll out the service across all its locations in the coming months. According to a press release, the vape clinic was begun to meet the growing demand for smoking cessation services.
Credit: VPZ
The moves comes as access to local stop smoking services and vaping retailers massively reduced during Covid-19 lockdowns, according to the release, adding that thousands of smokers were left without any services to help them quit smoking combustible cigarettes. Vape Clinic quit coaches will be specialists in helping smokers quit and advising the alternatives available. VPZ recently announced it had opened five stores since the end of lockdowns.
“With around 78,000 people in the U.K. dying from smoking year on year, and with many more living with debilitating smoking-related illnesses, the vape clinic has been designed to support the nation’s smokers quit for good,” the release states. “VPZ’s confidence in the success of the new Vape Clinic service is backed by its customer promise to provide a money back guarantee for hardware purchased and any unopened boxes of e-liquids and coils if customers are unable to make the switch to vaping entirely.”
Doug Mutter, director of VPZ, said the company is spearheading the fight against the nation’s No. 1 killer: smoking. He says that the “coaches” are trained and have expert knowledge and work to the individual needs of the customer. Many of the specialists are former smokers who have quit through vaping, so they understand the ups and downs of the journey.
“Smoking statistics are continuing to rise as the pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for National Health Service (NHS) stop smoking services and local support groups,” Mutter stated in the release. “Our new Vape Clinic concept is an investment to fill the void left by the loss of local NHS stop smoking services. We are so confident in the success of our new service that we are offering our customers a money back guarantee if they are unable to make the switch entirely.”
VPZ Vape Clinic is open 7 days a week, 10am to 5pm to all customers who book a free, 30-minute appointment here.
July 7, 2021
North Carolina Marijuana Bill Survives Committee
Medical marijuana won near-unanimous approval in a committee hearing in the Republican-controlled North Carolina General Assembly last week, the first of potentially many votes standing in the way of the plan becoming law. It’s a sign the bill could have broad support, according to the News & Observer. While the votes were not officially recorded, it appeared that all but two or three lawmakers voted for the bill.
Credit: Pro Mesa Art Studio
The bill’s sponsor is Sen. Bill Rabon, an influential committee chairman. And one of the votes in favor of it came from Senate Majority Leader Kathy Harrington. She said her husband was recently diagnosed with multiple myeloma, a type of blood cancer, and she has since come to realize that medical marijuana could help other patients in similar, painful situations.
“If you had asked me six months ago if I would support this bill, I would have said no,” Harrington said. “But life comes at you fast.”
If the bill is passed into law, North Carolina doctors would be able to prescribe marijuana for PTSD, cancer, sickle cell anemia, ALS and several other specific health problems. Lawmakers had initially included glaucoma on the list too, but deleted it during committee.
July 7, 2021
Former Juul Executive Joins Poda Lifestyle and Wellness

Photo: Poda Lifestyle and Wellness
Former head of corporate affairs for Juul Labs Nicholas Kadysh has joined Poda Lifestyle and Wellness as a member of the global advisory board.
With over a decade of experience as a public affairs and regulatory expert, Kadysh has led government relations and regulatory departments for a number of large corporations, including acting as head of corporate affairs for Juul Labs, as government affairs and public policy leader for General Electric Canada and as director of public affairs for Red Bull Canada. Kadysh is currently the founder and CEO of PharmAla Biotech.
Prior to his work in the corporate sector, Kadysh gained a deep understanding of government as a campaign and legislative staff member in multiple levels of government, most recently directing the outreach department of the Office of the Leader of the Opposition at Queen’s Park in Toronto. He has also worked at the Canadian Parliament as a policy advisor.
Kadysh is trilingual (English, French and Russian) and is a graduate of Queen’s University. He is active in nonprofit and community initiatives in Toronto, including fundraising for Toronto East General Hospital and as a member of the board for Yonge-Dundas Square.
“I believe that Poda is well poised to gain significant market share in the rapidly growing heat-not-burn market,” said Kadysh in a statement. “With my vast experience in public affairs and as a regulatory expert, I look forward to helping guide Poda as they continue their global expansion. Entering highly regulated markets requires careful planning and skillful execution, and there are many potential pitfalls to be avoided.”
“Having worked closely with Nick at Juul Labs Canada, I can personally attest to the skill and expertise that Nick brings to the table,” said Michael Nederhoff, previous president of Juul Labs Canada, who joined Poda’s global advisory board in early July. “Nick has a wealth of regulatory experience across various categories and in multiple countries, which will be invaluable as we scale the business.”
July 7, 2021
Jamaican Tobacco Company Warns Against Vape Rules
Jamaica’s largest tobacco distribution company Carreras Limited has cautioned the Government against an excessive regulatory regime for vaping and other tobacco products. Managing director of Carreras, Raoul Glynn, says the regulations will be tough to implement and enforce, and will impose provisions that will put the industry at a disadvantage.
Credit: Miro Novak
He stressed that the company took no issue with lawful, evidence-based regulation. However, excessive regulation will cause more revenue losses, pointing out that government revenue lost to the tobacco black market in 2020 was $2.1 billion.
“Jamaica is one of those markets that have a significant illicit component, not just on tobacco but other products [too],” Glynn told a joint select committee that is reviewing the country’s proposed Tobacco Control Act, according to the Jamaica Observer. “What we saw happening in 2017 when there was a significant increase in the excise, you had an almost immediate jump in the illicit volume, so consumption remains the same because of a proliferation of very cheap products that doesn’t pay the taxes.”
The company’s view is that new category products, such as e-cigarettes, and combustibles should be regulated separately. Lumping them with the same regulations for tobacco products would send an “incorrect and unhelpful message that both product categories have the same risk profile and perpetuate the misconception that tobacco and nicotine carry same risks,” according to Glynn.
The proposed legislation goes beyond traditional tobacco products to include prohibiting the use of electronic nicotine delivery systems (ENDS) in public spaces. This and other changes to the legislation is supposed to make Jamaica fully compliant with the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC).
Glynn pointed to evidence that new category products have contributed to reduced smoking prevalence in countries with a more flexible regulatory landscape. It referenced the United Kingdom’s House of Commons Science and Technology Committee, which found that e-cigarettes could significantly accelerate already declining smoking rate and are about 95 percent less harmful than conventional cigarettes due to the absence of tar and carbon monoxide.
He noted that the Canadian Government says switching from tobacco cigarettes to vaping products will reduce exposure to many toxic and cancer-causing chemicals. The tobacco company’s view is that e-cigarettes should be regulated proportionately on an evidence-based approach, taking into consideration freedom to innovate, dialogue and responsible marketing freedoms, according to Glynn, who said also that the legislation, technically, places a ban on the sale of cigarettes in all public spaces, despite arguments that it does not.
Glynn also cautioned that the law puts small businesses at a severe disadvantage by prohibiting retailer incentives and promoting discounted products.
July 6, 2021
Malaysia’s Customs Seizes 1,276 Liters of Illegal E-Liquid
The Royal Malaysian Customs Department has seized RM2.7 million worth of e-liquid, which also carried RM273,480 in unpaid taxes. The KLIA Central Zone Enforcement Unit III personnel conducted an inspection on two containers from the United States in Northport, Port Klang, at 6pm on June 24.
Central Zone Customs principal assistant director Datuk Zazuli Johan said the team found 1,276.24 liters of e-liquid suspected to contain nicotine that had been declared as “atomizer devices” (hardware) in the containers. The e-liquid was also found to have exceeded their expiration date, according to the Philippine Star.
“We believe that the product would be repackaged before being distributed in the local market. The consignment was brought in without a valid import license and tax on it had not been paid,” he is quoted as saying in a statement on July 2, adding that e-liquid is classified as prohibited merchandise in Malaysia under the Customs (Prohibition on Imports) Order 2017.
July 6, 2021
RELX International Steps Up Efforts to Curb Youth Use
RELX International recently launched its initiative to boost efforts to prevent youth use of vaping products. The initiative, RELX Pledge, is guided by three key pillars: Guardian program, Golden Shield and Green Shoots, according to a release.
The Guardian program is an initiative that stretches from product development to sales, preventing and discouraging the use of vape products by minors through joint efforts with retailers to step up on-site identification, according to RELX’s head of marketing, Leina Chedid.
“Since our inception, youth prevention has been an integral part of RELX International’s core company values. Our Guardian program applies across all our sales and marketing and supports effective legislation and regulation to prevent the purchase and use of our products by minors,” she said.
The Golden Shield program aims to end the sale of counterfeit products by working closely with investigation firms, e-commerce platforms and local authorities to weed out such products from the market, according to RELX’s global head of external affairs Jonathan Ng. He said that through Golden Shield RELX has assisted in 28 successful cases, removing over 550,000 fake products from the market and over 77,000 websites since 2019.
Green Shoots program is an initiative created to give back to the community, using the brand’s experience to help aspiring entrepreneurs and small business owners get their businesses on the track to growth and success, according to NG
“Startups and small businesses are the economic backbone of societies around the world. As a company that grew from a startup ourselves, we understand the numerous challenges that small businesses encounter daily. Through the Green Shoots program, we hope to share our experience and knowledge to help them get on the right track towards growth and success,” he said. “Protecting minors is an issue we take very seriously, as our pledge commitment shows. We sincerely hope that others in the industry take this lead and also commit to this new era of responsibility.”
Components of the RELX Pledge will be rolled-out globally (excluding Mainland China and the United States) throughout 2021, and will be further enhanced in 2022, according to the release. The RELX Pledge will be localized in countries in which RELX International holds a market presence to account for applicable local customs, cultures and traditions.
July 6, 2021