Category: Flavors

Kaival Expects Boost From Court Ruling

Photo: Kaival Brands Innovations Group
Kaival Brands, the U.S. distributor of products manufactured by Bidi Vapor, expects sales of its Bidi Stick vapor product to benefit from a recent court decision instructing the U.S. Food and Drug Administration to take another look at the company’s premarket tobacco product applications (PMTAs).
On Aug. 23, the U.S. Court of Appeals for the 11th Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications. According to Chief Judge William Pryor, the agency didn’t properly assess the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access.
This ruling effectively reverses the marketing denial orders and allows Bidi Vapor to continue to market all flavor varieties of the Bidi Stick in the United States. The company submitted PMTAs for all 11 flavor of its Bidi Stick prior to the Sept. 9, 2020, PMTA deadline.
“As the exclusive U.S. distributor of Bidi Vapor’s products, this [ruling] is a significant event for us and our downstream partners, as many awaited the decision before expanding distribution, and paves the way for potential revenue growth for our company,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement.
“But more than that, we are glad the appellate court recognized the potential importance and direct effects that an adult-focused marketing plan and strict sales and access restrictions may have on addressing the youth access problem.”
At press time, the FDA had not announced how it would respond to the court ruling. The agency could appeal the ruling or put Bidi Vapor’s PMTAs for its nontobacco-flavored devices into scientific review.
August 29, 2022
‘Flavor Bans Failed to Reduce Youth Vaping’

Photo: Pixel-Shot
Restrictions on the sale of flavored tobacco products were not associated with a decrease in current or ever e-cigarette use among high school students in the California Bay Area one-year after their implementation, according to a new study.
Researchers analyzed data from the California Healthy Kids Survey to look at e-cigarette use among high-school students in the California Bay Area. They compared changes in e-cigarette use between 2018 and 2019 among students attending school in a city with a flavored e-cigarette ban and students attending school in a city without a flavor ban.
The researchers concluded that flavored vape bans “did not significantly change” the odds of current and ever e-cigarette use among students.
Vapor industry advocates contend that flavor bans have negative consequences for public health because flavors are essential for adults trying to quit smoking. State finances are impacted by flavor bans as well. For example, Massachusetts’ ban on flavored vaping and tobacco products is costing the state an estimated $10 million in revenues each month, according to Americans for Tax Reform.
August 29, 2022
FDA Starts Reviewing Menthol and Flavored Cigar Feedback

Photo: Bits and Splits
The U.S. Food and Drug Administration has received nearly 175,000 comments on its proposed Tobacco Product Standard for Menthol in Cigarettes and approximately 71,000 comments on its proposed Tobacco Product Standard for Characterizing Flavors in Cigars.
On May 4, 2022, the FDA published the proposed tobacco product standards in the Federal Register. Initially, the FDA provided a 60-day comment period for the rules, but the FDA later extended the comment period to a total of 90 days. On Aug. 2, the comment period closed.
In addition to accepting written public comments, the agency convened public listening sessions on June 13 and June 15.
The agency stressed that it would take a while to review the submitted comments, scientific data, expert opinions and facts. “FDA is committed to completing the rulemaking process as quickly as possible; however, the agency will need ample time to comprehensively review and analyze all of the comments,” wrote FDA Public Health Analyst Beaza Yeheyes in an email.
August 11, 2022
Industry Group Opposes Flavored Cigar Ban

Photo: Andrii
The Cigar Association of America (CAA) has filed comments opposing the Food and Drug Administration’s (FDA) proposed flavored cigar ban, saying FDA’s own data show that underage usage of flavored cigars—the main rationale for the proposal—is at historic lows, after years of continued decline.
“This clearly shows that FDA is proposing a solution in search of a problem. The underage usage of flavored cigars is minuscule,” said CAA President David M. Ozgo in a statement. “It is a blatant example of targeting an industry that is clearly marketing its products to legal age adults.”
The comments note that one of the key purposes of the Tobacco Control Act—the law giving FDA authority to regulate tobacco—is to continue to permit the sale of tobacco products to adults, in conjunction with measures to ensure tobacco products are not sold or accessible to underage purchasers. The current historically low youth usage rates show the success of existing measures.
According to the CAA, government evidence shows that youth usage of cigars is so low as to be almost immeasurable. When the FDA first sought to exercise regulatory authority over certain tobacco products in 1996, the only survey that tracked youth usage of cigars in 1997, the National Survey on Drug Use and Health (NSDUH), showed last 30-day youth usage at 5 percent in 1997. In 2020 NSDUH tracked last 30-day youth usage of cigars at 0.8 percent.
The CAA comments highlight the most recent data from the government’s Population Assessment of Tobacco and Health Survey (PATH) showing that youth last 30-day usage of cigars overall was down to 0.75 percent and that youth usage of flavored cigars is around just 0.29 percent.
“In short, youth usage of flavored cigars continues to decline to almost unmeasurable levels,” Ozgo stated in the filed comment. “FDA asserts that flavored cigars attract youth. If that were true, we would expect flavored cigars to account for a majority of youth cigar use,” the comment added.
“But the government data clearly show that youth usage of flavored cigars is tiny and declining further,” Ozgo noted.
The comments also state there is no scientific basis for the proposed ban, but there would be devastating economic consequences. Many small businesses, often minority owned, would be negatively impacted as well as an assortment of cigar manufacturers, suppliers and producing countries such as the Dominican Republic and Honduras.
Additionally, the CAA comments go on to demonstrate how the FDA does not show any differentiated health effects posed by flavored cigars and that banning flavored cigars would only lead to the development of an unregulated illegal market for flavored cigars. Illegally produced and sold product can often have dangerous additives.
August 7, 2022
VTA: Give Menthol Smokers Alternatives

Photo: Andrey Popov
The U.S. Food and Drug Administration’s proposal to a menthol flavored cigarettes will improve public health only if there are viable menthol and flavored vapor products on the market, according to the Vapor Technology Association (VTA).
In April, the FDA announced a plan to ban the sale mentholated cigarettes, which account for about one-third of the U.S. market. The public was invited to share its thoughts on the measures and the official comment period ended Aug. 2.
In its official comment submission to the agency’s proposed product standards, the VTA urges the FDA to continue to build an “offramp” to menthol and flavored vaping products for smokers to access effective smoking alternatives.
“The menthol cigarette rule “has the potential to dramatically reducing cigarette smoking—the leading cause of death and disease of Americans—but only if the agency heeds the warning of scientists that menthol smokers must have access to less harmful vaping and other alternative nicotine products,” the VTA wrote in a statement.
“These limitations threaten to take what should be a public health victory and turn it into a half measure that, in the absence of other decisive action from the FDA, will fall far short of the benefits the agency claims.”
“FDA’s own proffered scientific experts acknowledge that at least 50 percent, and in some cases a larger percentage, of smokers will continue to smoke cigarettes or other combustible products after the menthol cigarette rule is put into effect unless provided access to effective alternatives.
“To fulfill its own harm reduction mission, the agency must use its PMTA process to ensure a rational, regulated legal marketplace with suitable less harmful non-combustible alternatives,” the VTA wrote.
August 6, 2022
Strong Opposition to FDA Flavor Bans

Image: nosyrevy
The U.S. Food and Drug Administration has received more than 110,000 comments on the proposed rule that would end the sale of menthol cigarettes and nearly 60,000 comments on the proposed rule that would prohibit characterizing flavors in cigars.
Many wrote to oppose the ban, including business owners who said it would force them to cut jobs.
“If implemented, this proposal could hurt retailers and wholesalers in the U.S. and directly impact my bottom line,” wrote a tobacco retailer in Florida. “This ban targets a significant portion of my revenue; menthol cigarettes alone make up 36 percent of all cigarette sales in the United States. Additionally, adult customers who purchase menthol cigarettes also purchase gas, food and other items that my store depends on.”
Thousands of letters submitted online came from menthol cigarette smokers who perceived the proposed restrictions as an unfair attack on personal liberty.
“This regulation far beyond overreaches the authority that the government should have over the American people,” wrote one respondent. “We have age restrictions for a reason, and once you reach that age you should be able to make the choice to use any legal product that you wish.”
Others supported the proposal, saying removing menthol and other flavors would improve health and help rectify racial injustices.
“The ban on menthol in cigarettes is a necessary step toward health equity and health promotion,” wrote Kaelor Gordon. “This substance unjustly and unfortunately places the burden of tobacco use and death on Black individuals and communities of color at higher and disproportionate rates, so to ban menthol would be in tune with the anti-racist and health equitable culture we are strongly cultivating today.”
The FDA recently extended the comment period from July 5 to Aug. 2, 2022.
July 8, 2022
EPA Ruling Threatens FDA’s Tobacco Plans

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The U.S. Supreme Court’s recent decision to block the Environmental Protection Agency from curbing power-plant emissions also threatens the Food and Drug Administration’s attempts to limit nicotine and ban menthol in cigarettes, according to an article published by Bloomberg Law.
In their ruling, the Supreme Court judges endorsed a legal approach that requires agencies to obtain Congressional approval to address issues of major financial or political importance in novel ways. The court’s conservative members have lamented the power agencies have to create and enforce their own rules.
According to Lindsay Wiley, a professor at UCLA School of Law, the decision will be considered in any situation where an administrative agency is trying to solve a problem using authority given to it by Congress in more general terms.
In the case of tobacco, the FDA will face greater pressure to prove it is authorized by Congress to propose its draft ban on menthol in cigarettes and cigars and other major rule changes, according to Marc Scheineson, a former FDA commissioner.
While the Tobacco Control Act gives the FDA the authority to adopt product standards—including on the content of cigarettes—through notice and comment rulemaking, legal experts believe the June 30 court ruling will embolden tobacco manufacturers to challenge the menthol ban and other policies once they are finalized.
“It definitely provides a roadmap that the industry will follow trying to attack the menthol regulation with everything they can come up with,” said Joelle Lester, director of commercial tobacco control programs at the Mitchell Hamline School of Law’s Public Health Law Center.
July 2, 2022
Commission Wants Ban on Flavored THPs

Photo: Kuznietsov Dmitriy
The European Commission on June 29 proposed a ban on the sale of flavored heated tobacco products.
The move is part of Europe’s “beating cancer plan,” which envisions less than 5 percent of the EU population using tobacco by 2040.
“With nine out of 10 lung cancers caused by tobacco, we want to make smoking as unattractive as possible to protect the health of our citizens and save lives,” said EU health commissioner Stella Kyriakides.
According to EU figures, cancer is the second-leading cause of death in the bloc of 450 million residents. There are about 1.3 million cancer deaths and 3.5 million new cases per year in the EU.
Kyriakides said that regulators need to “keep pace” with new developments to “address the endless flow of new products entering the market.”
A recent report showed a 10 percent increase in sales volumes of flavored heated tobacco products in more than five EU countries between 2018 and 2020. Overall in the EU, these products exceeded 2.5 percent of total tobacco product sales in 2020.
The Council and the Parliament will debate the Commission’s proposal before it enters into force 20 days after the publication in the Official Journal. EU countries will have eight months to transpose the directive into national law, and a further three months before the provisions will apply.
June 29, 2022
Police: Menthol Ban Will ‘Create Crime’

Photo: Nomad Soul
The U.S. Food and Drug Administration’s proposed ban on menthol cigarettes could have unintended consequences, according to leading law enforcement officers.
Among other problems, it could boost the illicit cigarette market. In 2020, of the $203 billion cigarettes sold in the United States, 37 percent were menthol. “Transitioning from a regulated market to an illicit one will lead to about $30 billion of an illicit market,” said Major Neill Franklin, former executive director of the Law Enforcement Action Partnership, in a statement published by Menthol is Not a Crime.
If the FDA bans menthol cigarettes, this will “create crime,” and you will get “homemade menthol cigarettes,” said retired Bureau of Alcohol, Tobacco, Firearms and Explosives agent John Rotunno.
Charles Giblin from the Center for the Advancement of Public Safety and Security stated, “Despite the good intentions … the ban will have unintended consequences. Cross-border smuggling will fill the gap of the prohibition.”
Others highlighted the racist implications of the ban since more than 80 percent of African Americans who smoke prefer menthol cigarettes.
“Bans do not work. During the war on drugs, more Black and Brown people went to jail than in all of slavery. About 90 percent of people targeted by stop-and-frisk were Black and Brown people,” according to John Dixon III, former police chief of Petersburg, Virginia, and former president of the National Organization of Black Law Enforcement Executives.
“We are not promoting people to smoke,” but “we don’t want another situation like that of Eric Garner [Garner was killed by New York Police Department officers after they approached him on suspicion of selling single cigarettes],” said Charles Billups, founding member of the NCJP, retired law enforcement officer and chairperson of the New York State Grand Council of Guardians.
Franklin expanded, “An illicit market is even more problematic for the Black community. Law enforcement will have no option other than to aggressively enforce smuggling and smoking bans … In an effort to identify smugglers, police will ‘creatively interact’ with citizens for minor crimes, like jaywalking, loitering, trespassing, traffic violations—using those crimes for leverage for information on their tobacco sources. This is the same tactic we use for locating guns and drugs.”
The public has until Aug. 2 to submit a written comment via the FDA website.
June 27, 2022
Sweden: Lawmakers Reject Vape Flavor Ban

Photo: WDnet Studio
Sweden’s Parliament, the Riksdag, rejected a ban on sales of flavored vaping products, with 177 lawmakers voting against the proposal and 126 lawmakers voting in favor, reports Vaping360.
Introduced by the government’s Ministry of Social Affairs in late February, the new rules would have taken effect next January, and would have prohibited flavors other than tobacco in all e-liquid, including zero-nicotine vape juice.
In rejecting the proposal, lawmakers heeded the advice of the Riksdag’s social affairs committee, which had recommended adopting proposed regulations for nicotine pouches and synthetic nicotine but eliminating the flavor ban.
Seven other European countries have banned non-tobacco vape flavors. In Denmark, Estonia, Finland, Hungary and Ukraine, flavored vape restrictions are currently in place. Lithuania’s flavor ban will take effect July 1. In the Netherlands, the flavor prohibition scheduled to begin in July has been postponed until January 2023.
No European country has banned vaping products outright.
June 22, 2022