The Canadian Vaping Association (CVA) says it is astounded by “the hypocrisy and inequity” in the regulation of adult products.
Alcohol, a substance known to cause significant harm to health, faces no restrictions on the use of flavorings or warning label requirements in Canada, according to the association. On the other hand, nicotine vape products, a harm reduction product used primarily by smokers seeking to quit, have undergone rigorous regulation culminating in a proposal to restrict all pleasant “sensory attributes.”
Darryl Tempest
“Flavors are a common denominator across adult products,” the CVA wrote in a statement. “As the cannabis and vaping industries battle to keep flavors for adults, the alcohol sector operates freely and advertises broadly. The staggering double standard that exists for alcoholic beverages is absurd when compared side by side. “
“Vaping, unlike recreational cannabis or alcohol, provides a public health benefit,” said Darryl Tempest, executive director of the CVA. “The goal of health policy should be to capitalize on public health gains. Canada has now seen through Nova Scotia’s flavor ban, that reducing the appeal of vaping products to smokers results in increased smoking and the destruction of small businesses. The proposed regulations are not fit for purpose. Canadians don’t want regulation that causes increased smoking rates and fewer jobs.”
When the U.S. Food and Drug Administration announced it was delaying premarket tobacco product application (PMTA) decisions, Iowa Attorney General Tom Miller says he become concerned about the impact the regulatory agency’s actions. What worried him was the unintended consequences of pulling from the market less harmful alternatives to combustible cigarettes.
Iowa AG Tom Miller
“We believe the best information available indicates that most youths are not getting e-cigarettes from vape shops and that a significant number of adults are using products from vape shops to move away from combustible cigarettes. Let’s not forget the overwhelming risk to public health: The CDC estimates the burden of tobacco use in the United States is 480,000 lives a year, all of which is due to the use of cigarettes,” Miller wrote in a statement. “We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policy makers must strike the right balance between making accessible potentially lifesaving lower-risk nicotine products while discouraging use by those who wouldn’t smoke, especially youth.”
On Sept. 9, the FDA finally made its announcement on the fate of millions of PMTAs. However, only small businesses that submitted PMTAs for flavored products got any answers. The FDA issued marketing denial orders (MDOs) to more than 130 companies requiring them to pull an estimated 946,000 products from the market. There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
The following day, the agency increased that number to 168 companies that were issued MDOs for an estimated 992,000 products. According to a press release, the regulatory agency released a revised listing of MDOs that includes 125 company names but not any specific products that were denied.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
Ireland has made progress toward its goal of being smoke-free by 2025, according to the republic’s department of health, reports Joe.
The announcement follows the publication of the Tobacco Free Ireland 2020 Annual Report, which outlines “several key achievements” in 2020, despite Covid-19 disruptions. These achievements consist of the inclusion of information on the dangers of tobacco use in Healthy Choices 1, the first substance misuse module of Junior Cycle Social, Personal and Health Education; the launch of a new quit marketing campaign called The Last Stop; the completion of three comprehensive evidence reviews on electronic cigarettes and heated-tobacco products by the Health Research Board; and an increase of $0.50 per pack of cigarettes with pro-rata increases on other tobacco products included in Budget 2021.
“By working to remove smoking from daily life in Ireland and educating young people on the dangers of tobacco while making cessation assistance as widely available as possible, we can continue to build on the promising results we have seen in recent years,” said Health Minister Stephen Donnelly. “I urge anyone that is thinking of quitting to act now. Stopping smoking remains one of the best decisions a person can make for their health. The last 18 months has further highlighted the importance of being proactive about our own health and the health of those around us. The HSE quit service remains available to anyone that needs it.”
The U.S. Food and Drug Administration has now issued 168 companies marketing denial orders (MDOs) for an estimated 992,000 products. According to a press release, today the regulatory agency released a revised listing of MDOs that includes 125 company names but not any specific products that were denied.
Credit: FDA
The remaining 43 are expected to be for companies that did not currently have any electronic nicotine-delivery products on the market. “Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. To protect confidential commercial information (CCI), we cannot release additional information about those actions,” the agency stated.
Yesterday, the FDA announced it had issued MDOs to more than 130 companies requiring them to pull an estimated 946,000 products from the market. There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
The Campaign for Tobacco-Free Kids (CTFK) is urging U.S. states and cities to step up their efforts to eliminate all flavored nicotine products, including e-cigarettes, in the wake of the Food and Drug Administration’s failure to rule on the premarket tobacco product applications (PMTAs) of market leaders Juul, Vuse, NJOY, Blu, and Logic by yesterday’s deadline.
On Sept. 9, the FDA announced it had denied market access to nearly 1 million electronic nicotine delivery devices owned primarily by smaller vapor companies. At the same time, the agency indicated it would require more time to process the remaining PMTAs, including those submitted by Juul Labs, BAT, NJOY, Imperial Brands and Japan Tobacco International, which account for the lion’s share of U.S. e-cigarette sales. Juul alone has a U.S. market share of more than 40 percent.
“The FDA will leave our kids at risk unless it acts quickly on the remaining applications, including for products like Juul that have driven the youth e-cigarette epidemic, and eliminates all flavored e-cigarettes, including menthol-flavored products that are widely used by kids,” wrote CTFK President Matthew L. Myers in a statement. “Every day these products remain on the market, our kids remain in jeopardy.”
The FDA’s failure to act on the market leaders is remarkable given that the agency had previously indicated it would prioritize those brands while processing marketing applications. Decisions on the bestselling brands would likely have the greatest impact on public health, the agency explained in earlier communications. The failure also raises legal questions, considering that the Sept. 9 deadline was ordered by a court following litigation from public health groups, including the CTFK.
The CTFK indicated if the FDA does not decide on major application soon it would return to court to have the court enforce its order requiring the FDA to begin removing unauthorized products.
The U.K. Vaping Industry Association (UKVIA) has issued compliance guidance for U.K. retailers who sell disposable vape products. Earlier, the association had called on regulators to crack down on resellers and retailers who were found to be flouting U.K. regulations for such products.
An investigation by the UKVIA has revealed mounting evidence of illicit and inappropriately branded disposable vape products hitting the U.K. market and noncompliant sales of such products, particularly in convenience shops and on major online marketplaces. U.K. regulations mean they should contain no more than 20mg/ml of nicotine, yet evidence collected by the UKVIA reveals that some listed as this amount contain higher concentrations of nicotine and some products are being openly sold with 50mg/ml strength. Furthermore, product packaging is not including warnings about the nicotine content, which is a legal requirement.
The association has been in discussions with the Medicines & Healthcare Products Regulatory Agency and Trading Standards to address the problem.
“We are doing all we can as a trade association to ensure the industry’s reputation is not tarnished by a minority of resellers and retailers intent on making a quick buck out of a trending product,” said John Dunne, director general of the UKVIA, in a statement. “Whilst disposables have a major role to play in the vape market, like all products they need to adhere to the legislation.
“Our guidance is designed to ensure retailers keep on the right side of the law. We’re also working closely and are in discussions with leading disposable vape product manufacturers and the major online marketplaces to ensure they play a key role in taking a hard line against those behind the sale of non-compliant products in the country.”
The free guide, available for download here, which has been produced in conjunction with leading vaping compliance specialists, Arcus Compliance, provides information on current UK regulations in relation to tank/reservoir capacity of devices, nicotine levels and the elements that must be contained on packaging. It also provides details in respect to registrations with and notifications from the MHRA.
The U.S. Food and Drug Administration had the vapor industry on its heels today as the businesses that filed premarket tobacco product applications (PMTAS) awaited the fate of their products. However, when the FDA finally made its announcement, it seems only small business that submitted PMTAs for flavored products got any answers. The FDA issued marketing denial orders (MDOs) to more than 130 companies requiring them to pull an estimated 946,000 products from the market.
There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
Interestingly, the agency saw fit to issue marketing orders for more than 350 combustible tobacco products under the standard equivalency pathway, many of which, hookah tobacco for example, are flavored tobacco products. All of the issued MDOs were for flavored electronic nicotine-delivery systems (ENDS) products.
Harm reduction advocates were aghast by the FDA’s announcement. “So far, this looks like being a public health own-goal of historic proportions,” Jonathan Foulds, professor of public health sciences and psychiatry at Penn State University, College of Medicine, wrote on Twitter. “Will be interesting to see whether the stock value of cigarette manufacturers goes up.”
Many experts are concerned that banning e-cigarettes from the market could harm public health. In a commentary published on the Reason Foundation’s website, Guy Bentley, the organization’s director of consumer freedom research, warned that the result of shutting down a vast portion of the vape industry would be more smoking.
The majority of products denied market access by the FDA, he noted, were likely rejected not because they are inherently riskier than any approved products but because the applicants were unable to navigate the FDA’s complex regulatory system.
What’s more, several studies suggested that if vape products were restricted to tobacco flavors, many vapers would switch to smoking. One study, published in Nicotine & Tobacco Research, analyzed data from February to May 2020 and looked at 2,159 young adults in Atlanta, Boston, Minneapolis, Oklahoma City, San Diego and Seattle, examining support for e-cigarette sales restrictions and the perceived impact of flavor and vaping bans.
“While lower-risk users may be more positively impacted by such policies, other young adult user subgroups may not experience benefit,” the authors concluded. “Moreover, if vape product sales were restricted to tobacco flavors, 39.1 percent of users reported being likely to continue using e-cigarettes, but 33.2 percent were likely to switch to cigarettes.”
Two other recent studies showed similar results. A study in JAMA Pediatrics showed that following San Francisco’s flavor ban, teens were more likely to smoke than those in other school districts. A different study in Nicotine & Tobacco Research shows that teens who vape would be smoking cigarettes if vapes hadn’t become available.
The FDA’s failure to decide on the marketing applications for leading brands such as Vuse and Juul—the latter of which accounts for more than 40 percent of U.S. e-cigarettes sales—left many furious.
“I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized,” tweeted Greg Conley, president of the American Vaping Association. “But to see them likely get more time from @FDATobacco after good small businesses spent the last month getting wrecked … Just wrong.”
“While FDA has said it has ruled on 93 percent of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic,” said Matthew Myers, president of the Campaign for Tobacco Free Kids, which sued the FDA to create the Sept. 9 deadline. “Every day those products remain on the market, our kids remain in jeopardy,” he told Stat.
Myers added that if the FDA does not decide on the major applications soon, his group will “have no choice but to go back to the court to have the court enforce its order requiring FDA to begin to remove any product not authorized.”
The U.S. Food and Drug Administration is expected to ask for more time before deciding whether some “e-cigarettes from market leader Juul Labs Inc” and others can be sold in the United States, the Wall Street Journal reported today, citing people familiar with the matter. The FDA is expected today to announce the fate of more than 2 million vaping products that had submitted a premarket tobacco product application (PMTA).
Many businesses have already received marketing denial orders (MDO) from the FDA. Many companies have gone out of business, filed a lawsuit, or switched to synthetic nicotine after receiving MDOs.
Concerning the FDA asking more time for a Juul Labs PMTA review, Greg Conley, president of the American Vaping Association, tweeted, “I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized. But to see them likely get more time from FDATobacco after good small businesses spent the last month getting wrecked … Just wrong. Good job, FDA.”
He also tweeted: “If I had the choice between 50,000 flavored vaping products being available or Juul surviving, I’d walk Juul over the plank myself. But that’s not the choice we have.”
After news of the FDA request was reported, Guy Bentley, director of consumer freedom research at the Reason Foundation, tweeted, “The FDA couldn’t get it together to make a decision on one of the biggest companies in this space. Complete shambles.”
No further information was provided. The FDA did not immediately respond to Reuters’ requests for comment.
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.”
Banning many e-cigarettes from the market could harm public health, warns Guy Bentley, director of consumer freedom research at the Reason Foundation, ahead of the deadline for the U.S. and Drug Administration to decide the fate of millions of premarket tobacco product applications (PMTAs).
In a commentary published on the Reason Foundation’s website, Bentley says that the sooner that U.S. public health officials embrace vaping’s potential to improve public health by reducing smoking and smoking-related deaths, the better off we’ll all be.
Today, the FDA is expected to announce which electronic nicotine delivery devices (ENDS) will be allowed to remain on the U.S. market. The sheer volume of PMTAs—the agency has received more than 6.5 million applications—means that there may not be decision on every product, but the FDA’s announcement will likely cover the majority of the vape market.
To remain on the market, every vapor products must prove to the FDA that it is “appropriate for the protection of public health. Because the process is expensive and complex, larger companies enjoy a big advantage over their smaller competitors. Experts expect considerable consolidation in the vapor market after today’s announcement.
Most of the vapor products that are likely to be banned are the non-tobacco flavors that have proved popular among America’s 15 million vapers. Bentley pointed to a recent study on the effects of San Francisco’s ban on flavored tobacco products, which showed an increase in high school smoking following prohibition. He also cited research by the Centers for Disease Control and Prevention revealing that sweet or fruity flavors are not the primary reason why youth vape.
On the positive side, argues Bentley, if the FDA approves some e-cigarettes today, it will help put to rest the arguments about whether these products are beneficial to public health. Many studies suggest that vaping is considerably less harmful than smoking. It has also proven effective in helping people quit smoking traditional cigarettes. Public Health England has famously found e-cigarettes to be 95 percent safer than smoking, for example.
An FDA seal of approval for some cigarettes would force policymakers and antismoking advocates to justify their crusades against products that the agency deems to play a role in improving public health.
The majority of vapor products are likely to be banned today, however. In most cases, it won’t be because they are inherently riskier than approved products but because the applicants were unable to navigate the FDA’s complex regulatory system, according to Bentley.
The result of shutting down a vast portion of the vape industry, he warns, will be more smoking.
The U.S. Food and Drug Administration had the vapor industry on its heels today as the businesses that filed premarket tobacco product applications (PMTAS) awaited the fate of their products. However, when the FDA finally made its 
