The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.
Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.
A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.
The Philippine House of Representatives and Senate have ratified a vaping bill that critics describe as too industry-friendly. The legislation will now be forwarded to President Rodrigo Duterte for his signature.
Among other provisions, the bill transfers regulatory powers from the Food and Drug Administration to the Department of Trade and Industry (DTI) and lowers the legal purchase and consumption age for vapor products from 21 to 18. The DTI is also in charge of setting technical standards for the safety, consistency and quality of these smoking alternatives.
Philippine College of Physicians (COP) President Maricar Blanco-Limpin said he was particularly concerned about the lower vaping age. “We have been telling all the legislators that making these more available at a younger age is making these e-cigarettes and heated-tobacco products more available to all, including the nonsmokers,” she told CNN Philippines.
Blanco-Limpin said vape products could lead to health concerns and the “mandate to protect the health of the country falls under the FDA, not the DTI.”
If the president signs the measure, Blanco-Limpin said the COP would consider all actions, including bringing the issue to the Supreme Court.
Nine out of 10 smokers in the Philippines support the country’s proposed vaping bill, according to a study, reports the Manila Times. A majority of respondents said the government should enact policies to encourage adult smokers to switch to less harmful alternatives while also ensuring these products are not used by minors.
In 2021, the Senate and House of Representatives approved their respective versions of the measure. The bills must be reconciled by a bicameral conference committee and ratified by the two chambers. If President Rodrigo Duterte then signs the bill into law, the Vaporized Nicotine Products Bill will regulate e-cigarettes, heated-tobacco products and other vaporized nicotine products while ensuring that they contribute to government revenues.
The study was conducted by Acorn Marketing and Research Consultants and commissioned by consumer advocacy group Vapers PH in August 2021. The survey sampled 2,000 legal-age smokers.
The State Duma MPs in Russia have adopted a bill restricting the use of electronic cigarettes and hookahs.
According to a statement from the lawmaking authority, the measure sets restrictions on the use of electronic nicotine delivery systems (ENDS) and hookahs inside certain territories, premises and objects; issues requirements for demonstration of electronic smoking articles in audiovisual works for minors and adults.
Moreover, the document restricts the sale of vapor products and bans their sale to minors and involvement of children in the use of them, according to a Russian state information agency.
There is also a proposal to introduce administrative fines for violations of the imposed restrictions.
The German government plans to limit the outdoor advertising of tobacco products, reports DW. Germany is the only EU state that still allows tobacco companies to broadly advertise their products.
Under the new rules, advertising of tobacco products will be authorized only in tobacco shops. In cinemas, commercials for tobacco products may be shown only in films aimed at adult (18+) audiences. Distribution of free tobacco samples will also be prohibited outside of specialist stores.
The restrictions on outdoor advertising will be implemented in stages. They will apply from Jan. 1, 2022, for tobacco products, from Jan. 1, 2023, for tobacco-heating devices and from Jan. 1, 2024, for e-cigarettes. The new rules for tobacco advertising in movie theaters are expected to come into force at the turn of the year.
Anti-smoking activists have long pushed for tighter restrictions on advertising but met with fierce opposition. An attempt to pass similar legislation in 2016 failed to garner the required support. After resisting tighter laws for many years, Chancellor Angela Merkel’s CDU/CSU coalition changed its position at the end of 2019.
Tobacco companies expressed concern about the new legislation. Philip Morris International Managing Director Claudia Oeking suggested that, without advertising, it would be difficult to inform smokers about less-harmful products.
The tobacco industry spent an estimated €100 million ($112 million) a year on cinema and outdoor advertising in Germany.
Health officials in the Netherlands are considering a stricter approach to electronic nicotine delivery systems (ENDS). Junior health minister Paul Blokhuis has told MPs he is considering extra legislation to limit the use of e-cigarettes following research which shows they are widely used by teenagers.
Electronic cigarettes are more dangerous to health than first thought and are seen by teenagers as a first step to smoking real cigarettes, according to a new fact sheet produced by the Trimbos addiction clinic on behalf of the health ministry, according to a story on dutchnews.nl.
Fifteen years after they first came on the market, some 3.1 percent of Dutch adults now use an e-cigarette on occasion, Trimbos said. Their use is largely seen as a way to stop smoking cigarettes, although almost three quarters of users still smoke in the traditional way, according to the story.
However, the organisation also stated that the health of the Dutch would be best served if the use of e-cigarettes is restricted to hardened smokers who cannot stop using other tried methods. “The new Trimbos insights raise questions about introducing additional legislation,” Blokhuis said in his briefing to MPs. The minister will now study the research in more detail and, according to the Telegraaf, a ban on flavourings is one of the options being considered.
Today, the U.S. Food and Drug Administration (FDA) issued 10 warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner.
Warning letters were also issued to companies marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.
“The FDA is focused on manufacturers and retailers that make and sell ENDS products that are targeted to youth and increase their appeal. The public should really be outraged by these products. The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Even in the midst of the COVID-19 pandemic, we have not lost our focus on protecting youth against the dangers of e-cigarettes and will do everything we can to take action. These warning letters should send a clear message to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace. If you’re marketing or selling these products to youth, the FDA will not tolerate it.”
The following retailers and/or manufacturers or importers received a warning letter:
Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (importer, retailer)
The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products. This follows 22 warning letters that FDA issued last month for similar violations to online and brick-and-mortar retailers and manufacturers across the country. These warning letters are part of a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.
The U.K.’s new anti-tobacco measures may not achieve their stated objectives.
By Giles Roca
Giles Roca is the director general of the U.K. Tobacco Manufacturers’ Association.
May 20 saw a series of major changes to the U.K. tobacco market, the most noticeable being the full introduction of standardized or plain packaging. This was accompanied by a suite of other measures, including a ban on all small packs (which previously made up around 75 percent of the U.K. market); a ban on flavored tobacco; new pictorial health warnings; and various restrictions on e-cigarette size, tank size, nicotine liquid strength, etc. On the same day, the government introduced a minimum excise tax.
All of these measures were introduced directly or, in the case of plain packaging, indirectly under the revised EU Tobacco Products Directive (TPD2) that was transposed into U.K. law by David Cameron’s government in May 2016. While TPD2 does not mandate plain packaging, it allows member states to adopt it as a tobacco control measure.
To understand the impact of these measures, the Tobacco Manufacturers’ Association (TMA) undertook three waves of consumer polling of 1,000 smokers. The results should worry all of those involved in law enforcement, those in the U.K. treasury who depend on the annual £12.5 billion ($16.22 billion) in tobacco taxation and of course those legitimate independent retailers for whom tobacco often makes up 30 percent of sales.
Deprived of the ability to purchase smaller and therefore more affordable packs of tobacco, smokers are not, as those in the health lobby claim, simply quitting, but they are moving into buying from the black market or from abroad, thereby avoiding U.K. duty and benefitting the criminal gangs involved in tobacco smuggling. Over the past six months there was a 15 percent increase in smokers buying packs of 20 cigarettes from illicit sources and abroad. Smokers buying larger packs of hand-rolling tobacco from such sources and abroad almost doubled with a 91.7 percent increase. There was a 32 percent increase in smokers buying online from social media and websites advertising cheap illegal tobacco, and there was a 22 percent increase in smokers buying any tobacco product from abroad, thereby avoiding U.K. duty.
Despite how some like to portray it, the tobacco industry does not believe its products should go unregulated. It is clear about the risks involved, and that is why the industry is at the forefront of developing reduced-risk alternatives. However, it is opposed to measures that are proved to not work, where there is no evidence of their effectiveness or where they are more about totem interventions championed by largely taxpayer-funded health lobbyists.
Indeed, on some of these recently introduced measures, the health lobby itself cannot agree on their merits. “People buy smaller pack sizes, such as 10s, when they are attempting to reduce their tobacco consumption and quit,” said Martin Dockrell, then head of policy at the U.K. anti-tobacco lobby group Action on Smoking and Health, in 2008. “If you wanted people to lose weight, you wouldn’t take away fun-sized chocolate bars and only sell jumbos. I’m with the retailers on this one.” Dockrell is now head of tobacco control at Public Health England, the lead agency tasked with promoting good health.
Plain packaging will simply make it easier to produce counterfeit packaging, while there is no evidence that it has been effective in reducing youth access to cigarettes either in Australia, where it was introduced in 2012, or in France, which introduced it at the start of this year and has seen overall sales actually increase.
Meanwhile, the restrictions on e-cigarettes will have the perverse effect of deterring those who wish to move off combustible tobacco by reducing the experience available in electronic form. It is notable that the recent U.K. smoking prevalence figures, published in June, show a steeper decline since 2013 thanks to emergence of harm reduction technology such as e-cigarettes. This stands in direct contrast to the tranche of tobacco control measures implemented in the U.K. by successive governments over the past decade, which have had minimal effect on smoking rates and negative consequences such as making the problem of black market tobacco even worse.
The TMA will continue to closely monitor the impact of these measures and is currently conducting a survey of 12,000 smokers across the U.K. that will give unprecedented insight into the impact that they are having. It will make its data fully available for all interested parties to see.
So what lessons can we draw from this? Clearly, don’t believe the hype that some of those in the health lobby both generate and want you to believe. Measures are advocated with scant evidence while their adoption into law has more to do with keeping such groups quiet—a damaging way to make public policy.
We also know that what happens in tobacco will happen sooner or later in other sectors, regardless of any evidence on the effectiveness of the measures—just look at the growing calls for plain packaged food and alcohol both in the U.K. and around the world. We also know what happens in the U.K. will happen sooner or later in other places, particularly following the decision of the U.K. government to provide £15 million to the World Health Organization’s Framework Convention on Tobacco Control to push forward with implementing a U.K. model of tobacco control in other countries.
Given that many of these measures originated in Europe, we will be calling on the government to look again at them as the U.K. leaves the European Union so that we have an approach based not on legislative totems but on hard facts, evidence and education.
Giles Roca is the director general of the U.K. Tobacco Manufacturers’ Association.
The Canadian House of Commons’ Standing Committee on Health has released a report asking the federal government to establish new legislative framework for the regulation of vapor products.
The report, titled “Vaping: Towards A regulatory framework for e-cigarettes,” includes provisions to regulate e-liquid content; prohibit e-liquid flavorings that are “specifically designed to appeal to youth”; require child-resistant packaging for e-cigarettes and refill containers; ban the use of vapor products in public places where use of traditional cigarettes is already banned; restrict advertising and promotion of vapor products; and prohibit the sale of vapor products to anyone under the age of 18.
Health Canada indicated that it would respond to the proposed regulation in “due course,” but no specific timeframe regarding its implementation was given.
