Tag: regulation

U.S. FDA Issues Denial Orders for 2 Vuse Menthol Products
The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.
Reynolds is expected to challenge the order.
The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, according to a statement. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.
“After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, the evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.
In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stayed the order.
The case continues.
March 17, 2023
Elfbar Avoids Mandatory Recall Notice for E-Liquid Fiasco

Authorities are satisfied with Elfbar’s response to the controversy over the company’s products that did not meet legal requirements, reports ECigIntelligence, and there was no need for a mandatory recall.
Elfbar worked quickly to recall the product with retailers, and the company has confirmed that it was not subject to any formal recall or withdrawal notice issued by regulators.
The products in question cannot be legally sold, however.
The company was found to be selling e-liquid with volumes more than 50 percent over the UK’s legal limit after an investigation by The Daily Mail.
The Chinese vaping giant admitted “inadvertently” breaking the law and ‘wholeheartedly apologized’ following lab tests of its 600 brand of disposable vape pens.
Recently, another Elfbar brand is being pulled from U.K. store shelves after finding the products surpass the legal limit for e-liquid volumes.
March 17, 2023
Hawaii Lawmakers Propose Tobacco ‘Endgame’ Bill

Credit: Oleksandra Voinova
Generational bans on vaping and other tobacco products are becoming more popular with lawmakers.
A new bill introduced in the Hawaii Senate would make it illegal for anyone born after 2002 to possess, purchase or use tobacco or vaping products.
S.B. 148 would change the state’s tobacco rules to deny anyone born after to Jan. 1, 2003, from purchasing and consuming these products.
The rules would only apply while in Hawaii, meaning out-of-state visitors would need to comply with Hawaii’s laws, though Hawaii residents would not be subject to the laws while visiting other states, reports Halfwheel.
Those caught selling or providing tobacco or vaping products would be subject to the existing fine structure for selling to those under 21: $500 for a first offense, and $500-$2,000 for any offense after that.
In addition, anyone born after 2002 caught violating the law as a consumer would be subject to a $10 fine for the first offense, a $50 fine for a subsequent offense, or the option to do between 48-72 hours of community service.
If passed, the change would take effect on Jan. 1, 2024. S.B. 148 currently has six sponsors.
The concept was introduced in New Zealand in 2021 and was approved by that country’s government late last year. It has also been proposed in Malaysia.
Since then similar proposals have been introduced in California, Hawaii and Nevada, though none have been passed.
In 2015, Hawaii became the first to increase the minimum age to purchase tobacco products to 21 years old, which has since become the federal standard.
In 2019, Hawaiian lawmakers proposed a bill that would slowly increase the age to purchase tobacco products starting with raising the minimum age for buying cigarettes from 21 to 30 in 2020.
By 2022, no one under 50 would have been able to buy cigarettes.
March 16, 2023
Court Rejects Challenge to California’s Flavor Ban

Photo: mehaniq41
A U.S. federal judge has thrown out a tobacco industry lawsuit against California’s statewide ban on the sale of flavored vaping and other tobacco products, reports Law360.
On March 15, Judge Cathy Ann Bencivengo rejected the plaintiffs’ claim that the measure would unfairly discriminate against out-of-state businesses. Bencivengo argued that the contested law applies to sales only; manufacturers are still permitted to manufacture flavored tobacco products in California. Most manufacturers of flavored tobacco products are located outside California.
R.J. Reynolds and other tobacco companies sued California after voters approved the ban in a November referendum, claiming the law violates the federal Tobacco Control Act (TCA), as well as the U.S. Constitution’s commerce clause.
The law was originally passed by the state legislature but didn’t take effect after industry opponents gathered enough signatures to put the issue on the November ballot.
In rejecting the TCA claim, Bencivengo cited a Ninth Circuit ruling in March 2022 that upheld a Los Angeles County ban on flavored tobacco products. The tobacco industry lawsuit also doesn’t meet the standards for arguing a state law discriminates against or unduly burdens interstate commerce, she argued.
The court also rejected the tobacco companies’ claim that out-of-state manufacturers of flavored tobacco products would be forced to change their operations to the tune of “tens of billions of dollars” to comply with the law’s new standards for tobacco products, an undue burden on interstate commerce.
California’s flavor ban doesn’t set new standards for the manufacture or marketing of tobacco products that depart from federal regulations, Bencivengo said. And financial losses for the tobacco industry alone are “not excessive enough for the Court to find that the ban substantially burdens interstate commerce,” she added, citing the law’s aims to protect public health.
The TCA also gives states the authority to “opt out of the market for flavored tobacco products,” Bencivengo said in the ruling, which does not allow the tobacco companies to file an amended complaint.
March 16, 2023
U.S. FDA has Made Decisions on Over 99 Percent of PMTAs

The U.S. Food and Drug Administration today stated it has made determinations on more than 99 percent of the nearly 26 million deemed tobacco products for which premarket tobacco products applications (PMTAs) were submitted. The agency has said previously that reviews for some of the most popular vaping products may take until the end of the year.
The FDA also announced it issued a refuse-to-accept (RTA) letter on Feb. 21, to one applicant notifying a company that their PMTAs, which are associated with approximately 17 million individual tobacco products, do not meet the acceptance requirements outlined in FDA’s regulations.
“The applications were for a grouped submission of e-liquids in varying size, nicotine strength, and flavor combinations, each of which was treated as an individual product application according to existing premarket review processes,” the FDA wrote in a statement.
The agency’s overall determinations include authorizing 23 new e-cigarette products and devices, and issuing refuse to accept (RTA) letters, refuse to file letters, or marketing denial orders for millions of products.
The data includes determinations on applications for nearly 6.7 million products received by the Sept. 9, 2020, deadline, more than 18 million products received after the Sept. 9 deadline, and applications for nearly 1 million non-tobacco nicotine products submitted by May 14, 2022, in accordance with the new federal law passed in April 2022.
Under a federal court order, manufacturers of deemed new tobacco products that were on the market as of the deeming rule’s effective date (Aug. 8, 2016) were required to submit premarket review applications by Sept. 9, 2020.
March 15, 2023
Congress Seeks to Close E-Cigarette Ad Loophole

For more than five decades, tobacco ads have been prohibited on radio, but advertising for e-cigarettes and other vaping related products have made their way onto the airwaves in recent years.
In an effort to make such marketing less attractive, the U.S. Congress wants to close a tax loophole that allows manufacturers to claim federal tax deductions for the cost of advertising for e-cigarettes and tobacco products. That includes the ads they buy on the radio.
Senators Jeanne Shaheen and Richard Blumenthal have reintroduced the No Tax Subsidies for E-Cigarette and Tobacco Ads Act (S. 464), which if passed would not make the direct-to-consumer ads illegal, but would end the ability for companies to take tax deductions for advertising expenses related to vaping and other tobacco products, according to Insider Radio.
“Tax breaks for tobacco and e-cigarette giants allow the industry to profit from its manipulative marketing,” Blumenthal said. “Our legislation ends these write-offs to protect kids and other consumers from being lured into lifetimes of addiction.”
Radio and television advertising for traditional tobacco products has been banned under federal law since January 1971, and certain other forms of tobacco advertising are restricted under the 1998 Tobacco Master Settlement Agreement. However, none of these restrictions apply to e-cigarettes.
March 15, 2023
New Bill Proposes Combustible ‘Endgame’ in Nevada

Credit: Peter Zayda
A new bill in the U.S. state of Nevada seeks to end all combustible cigarette sales in the state by 2030 and would also include flavored e-cigarettes.
The bill would ban all e-cigarettes that are flavored to taste like something other than tobacco, but spares most other non-combustible tobacco products.
Assemblyman David Orentlicher has introduced A.B. 294, which would make several changes to how combustible tobacco products other than premium cigars are sold in the state, essentially outlawing their sale by 2030, reports Charlie Minato of Halfwheel.
Among other things, the bill would bar the Nevada Department of Taxation from issuing any license to any vending machine operator, manufacturer or wholesale dealer of combustible cigarette products on or after Jan. 1, 2029.
The licenses are only valid in the calendar year they are issued, meaning there would be no licensed wholesale dealers beginning on Jan. 1, 2030.
It would also make it illegal to sell combustible tobacco products to anyone born on or after Dec. 31, 2002.
March 15, 2023
Hearing Set for FDA Manufacturing Requirements

Photo: Jon
Registration is open for U.S. Food and Drug Administration’s upcoming public oral hearing on April 12, 2023, from 9:30 am to 5 pm.
The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.” The FDA is proposing new requirements for vaping and other tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.
Speaking spots are limited, and the FDA says it cannot guarantee that it will be able to accommodate all requests. Groups and organizations should select a single spokesperson to help the agency hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Registration to provide oral comments will close on March 31, 2023.
The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.
March 14, 2023
Court: Prohibition of Vapes in County Jail ‘Went too Far’

Credit: Methaphum
An attempt by county commissioners in the U.S. state of Indiana to regulate e-cigarette and nicotine use in the local jail went too far, the state’s Court of Appeals has affirmed.
In 2012, the Indiana Legislature prohibited smoking in places of employment, state government vehicles, public places, and within eight feet of an entrance to a public place or place or employment.
After passage of that legislation, the commissioners of Clinton County enacted an order prohibiting smoking in all county offices and places of employment, including the county jail, according to The Indiana Lawyer.
Then in 2019, the Clinton County Sheriff’s Office received a certificate from the Indiana Alcohol and Tobacco Commission authorizing it to sell e-cigarettes and nicotine pouches to inmates. The inmates began purchasing the products and using them while housed in the jail.
According to the sheriff’s office, “disciplinary incidents and property damages … significantly decreased” after it received the certification, and the sales were generating enough income to be used for educational programs, religious literature and extra training opportunities for the inmates.
However, in 2021, the county commissioners passed an order that prohibited e-cigarettes and any smokeless tobacco in all county offices and buildings. The sheriff’s office immediately stopped selling e-cigarettes and nicotine pouches at the jail.
But the sheriff’s office also filed a complaint for declaratory judgment in Montgomery Superior Court, arguing the commissioners were attempting to regulate the conduct of inmates, which exceeded their authority.
For their part, the commissioners claimed they had authority to enact the order based on Indiana’s Home Rule Law.
Both parties moved for summary judgment, and the trial court ruled in favor of the sheriff’s office. It also denied the commissioners’ subsequent motions to correct error and for relief from judgment based on newly discovered material evidence.
The commissioners appealed and the Court of Appeals affirmed.
“In circumstances like those before us, where the Sheriff’s Office is required to take reasonable precautions to protect the life, safety, and health of an inmate in the county jail, ‘county commissioners do not have control over the acts of a sheriff,’” Judge Melissa May wrote, citing Robins v. Harris, 740 N.E.2d 914, 919 (Ind. Ct. App. 2000). “While the Commissioners have the power to enact a general ordinance governing the use of e-cigarettes in county buildings under the Home Rule Act, the Commissioners do not have the authority to regulate the use of e-cigarettes in the county jail because that power is entrusted in the Sheriff’s Office pursuant to the Take Care Provision (Indiana Code § 36-2-13-5(a)(7)).”
March 14, 2023
Call for Action Against Noncompliant U.K. Vapes

Photo: zef art
The Chartered Trading Standards Institute (CTSI) has called for stronger actions against noncompliant vape products in the U.K., reports Convenience Store.
Stating that the rise in noncompliant products is “getting out of hand,” the CTSI has asked for “clearer direction from government” and greater resources to fight the noncompliant trade.
The CTSI has also suggested that manufacturers publish batch numbers of noncompliant products and introduce restrictions to stop youth vaping, including prohibiting cartoon characters or light-up vapes, restrictions on packaging colors and the promotion of vapes on social media platforms such as TikTok. The group also suggested looking at where the products are positioned in stores and increasing the sanctions available for those producers, suppliers retailers who don’t comply with the law.
Vaping industry representatives applauded the CTSI’s position. “We share the CTSI’s concern over the growth in illicit and underage vape product sales and fully support their call for more resources,” the U.K. Vaping Industry Association said in a statement.
“We also agree wholeheartedly that restrictions need to be explored to address youth vaping without impacting on adult smokers who wish to switch to vaping in order to quit their habits.
“That’s why we are leading the way in forming a Youth Access Prevention Taskforce to develop detailed proposals to deal with the situation, and these include on-the-spot fines of up to £10,000 ($12,176.32) per instance for retailers who are found to be selling to minors and for selling illicit products; a national registration scheme for all retailers, meaning only those outlets that meet qualifying criteria can legally sell vapes; and a national test purchasing scheme that will ensure constant monitoring of retailers’ selling vapes to ensure that they are not turning a blind eye to purchases involving minors.
“Critical to the success of our proposals will be a ramping up of enforcement, and this requires major funding in resources on the ground.
“By Trading Standards’ own admission, resources are sadly lacking, and the government needs to step in and look at this situation as a matter of urgency. Our proposals are designed to support this funding need as monies will be raised from the fines and registration scheme.
“We will be presenting our proposals to government and parliamentarians at the end of March.”
March 13, 2023