Category: Flavors

FDA Urged to Remove Flavors from Market

Photo: Bacho12345 | Dreamstime.com
Lawmakers in the U.S. House of Representatives have sent a letter to the head of the U.S. Food and Drug Administration (FDA) urging the agency to remove all flavored vaping products from the market. The 43 House Democrats sent the letter to acting FDA Commissioner Janet Woodcock as the agency continues to review thousands of premarket tobacco product applications (PMTAs).
“Flavored e-cigarettes are putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use,” states the letter drafted by Representatives Debbie Wasserman Schultz and Diana DeGette, according to The Hill.
The lawmakers want the FDA to ban all flavored e-cigarettes upon further review and eliminate the exemption the FDA has for menthol and disposable products.
Along with a ban on flavored e-cigarettes, lawmakers want a ban on PMTAs and the marketing of e-cigarettes that target minors. “Today, e-cigarette use by youth remains at what FDA calls ‘epidemic proportions,’ and e-cigarettes have been the most commonly used tobacco products among youth since 2014—and flavors are a key reason why,” the letter states.
The FDA has already put a ban on fruity e-cigarettes. However, brands such as Puff Bar are sidestepping the ban by selling fruit-flavored disposable vaporizers that use synthetic (tobacco-free) nicotine. “We strongly recommend that FDA’s premarket review process require manufacturers to provide convincing evidence that their products do not increase youth use of nicotine and tobacco in ways that increase the risk of abuse and addiction among youth,” the lawmakers stated.
March 25, 2021
Push for Menthol Ban Gains Momentum

Photo: Miriam Doerr | Dreamstime.com
The likelihood of a ban on menthol cigarettes in the United States is increasing as the impact of menthol cigarettes on Black Americans becomes clearer, according to an article in The New York Times.
Many public health advocates have been pushing for a crackdown on menthol cigarettes, but thus far no federal ban has been enacted.
Critics accuse the tobacco industry of marketing menthol cigarettes disproportionally to Black Americans, highlighting racial inequities. According to the Centers for Disease Control and Prevention, Black smokers smoke less but die at a higher rate from heart attacks, strokes and other tobacco-related diseases than white smokers do. The FDA reports that 85 percent of Black smokers use Newport, Kool and other menthol brands. Menthol cigarettes are easier to become addicted to and harder to quit than plain tobacco, according to health advocates.
Covid-19 exposed the discriminatory treatment that Black people have been facing for hundreds of years. It’s precisely at this time that we need strong public health measures.
Phillip Gardiner, co-chairman, African American Tobacco Control Leadership Council

“Covid-19 exposed the discriminatory treatment that Black people have been facing for hundreds of years,” said Phillip Gardiner, a co-chairman of the African American Tobacco Control Leadership Council, which has been pushing for menthol bans in communities across the country. “It’s precisely at this time that we need strong public health measures.”
Support for a menthol ban has been growing at various levels of government. Many states and municipalities have been passing laws at the state and local level to ban menthol cigarettes, and with many white parents supporting sweeping flavor bans, it has “brought new resources to the issue.”
The FDA is also under a court order to respond to a citizens’ petition for a menthol ban by April 29.

We opened the door on this in a Republican administration. You don’t think a Democratic administration will finish the business? Of course they will.
Scott Gottlieb, former FDA director
Many are hopeful that the Biden administration will move forward with a ban, looking to Biden’s past support of tobacco control measures.
“We are thinking about all of our options that could help reduce tobacco use and address persistent disparities,” said Kevin Munoz, a spokesman for the White House.
In 2018, Scott Gottlieb, FDA director under the Trump administration, announced that the FDA would enact a ban on menthol but was immediately opposed by North Carolina Senator Richard Burr, who represents a prominent tobacco-growing state. Burr later convinced the administration to kill the ban in 2019.
Gottlieb believes that the Biden administration will put a menthol ban in place. “We opened the door on this in a Republican administration,” he said. “You don’t think a Democratic administration will finish the business? Of course they will.”
March 22, 2021
Mitt Romney Calls For Nationwide Flavor Ban

Photo: Office of Mitt Romney
Utah Senator Mitt Romney has called for flavored vaping products to be pulled from shelves across the United States, reports 2KUTTV. Romney introduced legislation in September 2019 that would have banned the sale of all flavored vapor products except tobacco flavors, but it was never taken up for a vote.
“The analysis shows that nearly one-fourth of high school kids are vaping on a regular basis—tobacco products—and in many cases marijuana as well,” Romney said, adding that the government needs to do everything it can to stop the sale of flavored vaping products and implement a robust public education campaign to warn kids about the dangers of vaping.
In October 2019, the Utah Department of Health issued an emergency order banning the sale of flavored vapor products in Utah, which was met swiftly with a lawsuit from tobacco retailers. The products remain available for sale today.
In 2019, the legal age to purchase tobacco products in the U.S. was raised from 18 to 21.
March 1, 2021
Menthols Linked to Extra Smokers, Early Deaths

Photo: Photo: Miriam Doerr | Dreamstime.com
Menthol cigarettes contributed to 378,000 premature deaths in the United States between 1980 to 2018, according to a new University of Michigan study.
The research shows that about 10 million smokers were attributable to menthol cigarettes, which researchers estimate accounted for about 3 million life years lost.
“Our results indicate that mentholated tobacco products have had a significant impact on public health and could continue to pose a substantial health risk,” said David Mendez, senior author of the study and an associate professor in the department of health management and policy at the University of Michigan School of Public Health.
“We hope these data will help the Food and Drug Administration evaluate the potential regulatory actions for mentholated tobacco products.”
The study, published in Tobacco Control, indicates that the most important drivers of the relative impact of menthol cigarettes were the effects that menthol has in smoking initiation and cessation, said first author Thuy Le of the Department of Health Management and Policy at the University of Michigan’s School of Public Health.
“Previous studies have shown that menthol experimentation is positively associated with progression to established smoking,” Le said. “In addition, menthol smokers are less likely to quit smoking than nonmenthol smokers. These observations were incorporated in the model and are the key factors in determining the outcomes of our study.”
For their study, the researchers calibrated a well-established model developed by Mendez and colleague Ken Warner, dean emeritus of the University of Michigan School of Public Health. Le and Mendez used the model in conjunction with National Health Interview Survey data and other public data sources to reproduce the overall U.S. adult smoking prevalence between 1980 and 2018 and associated mortality.
They then used the model again with adjusted parameters to reflect a scenario in which menthol cigarettes were assumed not to be present in the market over the same period. Finally, they compared both scenarios to quantify the public health harm attributable to menthol over the 1980 to 2018 period.
Mendez said they hope the FDA will look at this and other data as it evaluates potential regulatory actions for mentholated tobacco products.
Menthol cigarettes were created in 1925 and became widely spread in the 1950s and 1960s. In 2009, the Family Smoking Prevention and Tobacco Control Act gave the FDA authority to regulate the manufacture, distribution and marketing of tobacco products. The FDA banned flavors such as candy, spice and fruit, but menthol was not banned.
In 2011, the Tobacco Products Scientific Advisory Committee submitted a report to the FDA concluding that the removal of menthol cigarettes from the market would benefit public health. To date, the FDA has not taken any regulatory action on mentholated cigarettes.
February 26, 2021
Court Upholds Brazil’s Power to Ban Tobacco Additives

Photo: Taco Tuinstra
Brazil’s Federal Regional Court of the First Region on Jan. 25 affirmed the Brazilian Health Regulatory Agency’s (ANVISA) power to ban the use of additives in tobacco products.
With this decision, the federal court affirms a February 2018 ruling of Brazil’s Supreme Federal Court–the country’s highest court that recognized ANVISA’s authority to regulate tobacco products and upheld a 2012 regulation prohibiting flavors and additives in tobacco products sold in the country.
Due to a quorum issue, the ruling of the Supreme Court did not have a binding effect over other lawsuits previously filed with ordinary federal courts by tobacco companies and the trade group Sinditabaco.
Based on these lawsuits, British American Tobacco subsidiary Souza Cruz and Phillip Morris International were granted injunctions and allowed to continue selling flavored products. The Federal Regional Court ruling on Monday lifted those injunctions and set a precedent for other similar cases in the country.
“This decision reaffirms Brazil’s role as a global leader in tobacco control,” said Patricia Sosa, director of Latin American and the Caribbean programs at the Campaign for Tobacco-Free Kids, in a statement. “We urge other countries in the region and around the world to follow its lead and ban all flavored tobacco products to protect youth and other vulnerable populations.”
In 2012, Brazil became the world’s first country to ban the use of flavors and additives in tobacco products, including menthol. This ban was approved following two years of public hearings and broad stakeholder participation.
January 30, 2021
Californians to Vote on Flavor Ban

A referendum to overturn California’s ban on flavored tobacco products qualified on Friday, reports AP.
Voters will nw decide in November 2022 whether to uphold the ban. The law won’t take effect until voters have decided.
The ban restricts the sale of flavored products but doesn’t criminalize possession of these products. Loose-leaf tobacco, premium cigars and shisha tobacco are exempt. Flavors including, but not limited to, “fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, menthol, mint, wintergreen, herb or spice” are included in the ban. Those caught selling banned products face a fine of $250.
Supporters of the law argue that these products are targeted at youth and Latino and Black communities while opponents of the ban argue that it goes too far and takes away products preferred by these communities while allowing continued sales of products preferred by wealthy communities.
Former state Senator Jerry Hill sponsored the legislation. He stated that his goal is to target products contributing to youth addiction, and he said tobacco companies are attempting to “delay the inevitable.”
“Voters are a lot smarter than Big Tobacco thinks they are,” Hill said.
January 25, 2021
Dutch Urged to Ditch Planned Flavor Ban
Photo: Laboko – Dreamstime.com
A recently proposed ban on vaping flavors in the Netherlands will endanger public health, according to the Independent European Vape Alliance (IEVA).
Around 65 percent of adult vapers in Europe use fruit or sweet liquids. According to the IEVA, the variety of flavors is one of the most important reasons for smokers to switch to e-cigarettes and for vapers not to go back to smoking.
Ignoring this fact, the Dutch State Secretary Paul Blokhuis announced a ban on all e-cigarette flavours except tobacco flavors in the Netherlands, to discourage youth smoking.
“This measure risks very negative consequences for public health and tobacco harm reduction,” the IEVA wrote in a statement. “With only tobacco flavors left, vapers’ threshold to relapse on tobacco smoking dangerously lowers.”
A public consultation on the plan will run until Jan.19, 2021. The vast majority of the comments so far come from vapers and scientists who reject the government’s plan.
According to the IEVA, the Dutch plan ignores important facts:
The number of young people in the Netherlands who have ever tried e-cigarettes has decreased by a quarter in the past five years.
Only 0.2 percent of 14-16 olds in the Netherlands vaped regularly in 2019.
8 percent of all Dutch users of e-cigarettes come from smoking.
“Removing flavours will not affect the rates of youth cigarette use,” said Riccardo Polosa, professor of internal medicine and specialist of respiratory diseases and clinical immunology at the University of Catania. “But, it will certainly reduce the number of options available for those adults who seek to quit smoking for good and find flavoured e-cigs effective.”
The IEVA also expressed concern about the impact of the Dutch flavor ban on the debate at the Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control, which is scheduled to take place in November in The Hague.
“Implementing the ban on flavorings could have negative effects on the conference,” cautioned IEVA Chairman Dustin Dahlmann. “Rather, COP9 should pay attention to the topic of harm reduction through e-cigarettes, so that the number of smokers worldwide could be significantly reduced”
“Flavour is not a gateway to youth uptake of smoking. No evidence substantiates the association between vaping flavours and subsequent smoking initiation. We call on the Dutch government to drop this plan. There are no winners in a flavor ban, only losers.”
January 15, 2021
Trade Body Objects to Flavor Restrictions

Photo: Tobacco Reporter archive
The Philippine E-Cigarette Industry Association (PECIA) is urging Senator Ralph G. Recto to reconsider his proposal to limit the flavors available for vapor products to just tobacco and menthol, reports Business World.
Senate Bill (SB) No. 1951, or the proposed Vaporized Nicotine Products Regulation Act, seeks to regulate the importation, manufacture, packaging, distribution, use and promotion of vapor products and heated tobacco products (HTPs).
The bill imposes an 18-year minimum age for the purchase, sale and use of these products. It also prohibits vendors from selling vapor products within 100 meters of a school, playground and other similar facilities.
“We are supportive of the proposal filed by Senator Recto. We believe that our products should not be made available to minors,” said PECIA President Joey Dulay.
“We also share his objectives of ensuring that proper product standards are put in place and that these are implemented by an able and impartial government regulator.”
But while acknowledging that some flavors target youth, Dulay noted that there are also many flavors that are not attractive to kids and have been shown to help adult smokers to switch to these products. As examples, he cited coffee, tea and plain fruit flavors.
Dulay noted that in the U.K., a wide range of flavors is offered for vapor products, which nevertheless have low youth uptake rates. He said this proves that a good law and its proper implementation are key to preventing minors from accessing such products.
December 29, 2020
California Flavor Ban Postponed

California’s controversial ban on flavored e-cigarettes will not take effect on Jan. 1, 2021. According to a report by Halfwheel, the Superior Court for the County of Sacramento has approved an agreement that postpones the enforcement date at least until the signatures are verified for a ballot measure proposal that seeks to repeal the law.
In November, the California Coalition for Fairness turned in more than 1 million signatures seeking to qualify a referendum for the November 2022 ballot aimed at overturning the legislation. Those signatures need to be verified at the county level, a process that is underway but might not be completed until Jan. 21, 2021, after the law was set to take effect. Now, the parties have agreed to delay the law until after the signature verification process is completed.
If the verified signature threshold is not met, the law would take effect once the Secretary of State has verified the process is complete. If the signatures are verified the flavor ban would be suspended until at least December 2022.
To get on the ballot, those in support of the referendum needed to get 623,212 verified signatures from California voters.
Signed by Governor Gavin Newsom on Aug. 28, the California law prohibits the sale of all flavored tobacco and vapor products, including those with menthol flavor. The legislation does not make it illegal for someone to purchase, possess or use flavored tobacco or vapor products, however.
The bill contains a provision that would impose a $250 fine for each violation.
December 16, 2020
Signatures Submitted for California Ballot

Photo: pjedrzejczyk from Pixabay
The California Coalition for Fairness has turned in more than 1 million signatures seeking to qualify a referendum for the November 2022 ballot aimed at overturning a law banning the retail sale of flavored tobacco products in California, reports The Los Angeles Times.
If the Secretary of State’s office determines there is a sufficient number of signatures to qualify the referendum, the new law, which was scheduled to take effect Jan. 1, would be suspended until the voters act on the ballot measure in November 2022.
Opponents needed to collect the signatures of 623,312 registered voters to quality the referendum.
The coalition has received more than $21 million from Philip Morris USA, U.S. Smokeless Tobacco Co., and R.J. Reynolds Tobacco Co., among others.
Health advocates criticized the initiative.
“We know Big Tobacco has hidden behind smoke and lies for years to hook generations of young people on deadly tobacco products, and this referendum is just one more tactic to continue the status quo,” said Lindsey Freitas, advocacy director for Campaign for Tobacco-Free Kids, in a statement. “If this referendum qualifies for the ballot, we’re confident that California voters will reject Big Tobacco’s desperate attempt to keep hooking our kids for a profit. But the delay will be costly and deadly.”
Governor Gavin Newsom, who signed the new law in August, denounced the referendum effort when it launched.
“This is Big Tobacco’s latest attempt to profit at the expense of our kids’ health,” Newsom said at the time. “California will continue to fight back and protect children from Big Tobacco.”
The law that Newsom signed would ban the retail sale of flavored tobacco products including menthol and fruit flavors, as well as those used in electronic cigarettes.
In addition to supporting the referendum, the tobacco industry has filed a federal lawsuit against the state, seeking an injunction to block the new law, arguing it is “an overbroad reaction to legitimate public-health concerns about youth use of tobacco products.”
A court hearing on the lawsuit is scheduled for Dec. 10.
November 25, 2020