Category: News This Week

Retail Groups Urge FDA to Release List of PMTA Filers

Retailers are struggling to know what vapor products will be able to remain on the market after Sept. 9. That’s the deadline for manufacturers to file premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA).
In a letter to the FDA, several retail associations are asking the regulatory agency to release a list of manufacturers that have PMTAs on file so retailers can know what electronic nicotine delivery system (ENDS) brands can remain on store shelves.
“As the September deadline approaches, the PMTA List will be critical to support compliance across the tobacco trade channel, helping inform distributors, wholesalers, and retailers which ENDS products are being marketed legally in accordance with FDA’s compliance policy,” the group wrote. “Relatedly, such a list also would facilitate enforcement against those manufacturers that continue to introduce illegally marketed products without premarket authorization or, in the case of deemed, currently marketed products, without a PMTA submitted by the deadline.”
FMI (the Food Industry Association), the National Association of Convenience Stores, the National Association of Truckstop Operators, the Petroleum Marketers Association of America, and the Society of Independent Gasoline Marketers of America state that “unlike the confidentiality provisions that are afforded to applicants” of PMTAs, such restrictions are not applicable when the PMTA filing applies to a currently marketed product.
“While FDA typically does not disclose the existence of a premarket product application (unless the applicant has publicly disclosed or acknowledged the existence of the application), the underlying rationale for non-disclosure does not apply in this situation,” the letter states. “Unlike PMTAs for products that have not yet been marketed, disclosing the existence of PMTAs submitted for ENDS products that have been on the market since at least August 8, 2016, through publication of the PMTA List, would not reveal any trade secret or (confidential commercial information).”
In the 6-page letter to Matthew Holman, director, Office of Science for the FDA’s Center for Tobacco Products, the retail group also stated that if the FDA would require consent from the manufacturer before disclosure, the retail group could provide “recommendations on a streamlined process for obtaining such consent” quickly.
“For example, FDA could ask for an applicant’s consent at the time of submission. To do so, [the] FDA could add a field in its submission portal notifying the applicant of the option to permit the agency to disclose the existence of its PMTA in a public list,” the group suggests. “Alternatively, in its initial acknowledgement letter, which provides the submission tracking number (STN) to applicants, FDA could ask for such consent. In both cases, the applicant would have the opportunity to provide affirmative consent.”
August 31, 2020
Australia’s Cigarette Sales Plummet While Vapor Rises

Credit: Srikant Sahoo
Cigarette sales in Australia are plunging faster than any time in history as smokers turn to less-risky alternatives like vaping. There were 410 million fewer smokes sold in the country than two years ago.
Dr Murray Laugesen, a trustee of the End Smoking NZ charity, analysed tobacco company returns that are published by the Ministry of Health and found a remarkable drop in sales, according to an article on NZherald.com. About 2132 million cigarettes were sold last year – 193 million fewer than 2018, and following a 217 million drop the previous year.
The trend is driven by factors including cost and alternative products like vaping e-cigarettes – but needs to be accelerated if the December 2025 goal of less than 5 percent smoked tobacco prevalence is to be met. A 25-pack of cigarettes was Aus16.39 in 2011 and is now about Aus41.89 ($32).
“Continuation of a 9.5 percent annual per-capita decline in tobacco use, suggests the goal will still not be met until at least 2029, four years overdue,” said Dr George Laking, an oncologist and chair of End Smoking NZ. “Success in the goal would imply a further reduction of tobacco imports by 5 per cent per year from 2021 onwards.”
Laking said increasing the cost was one of the best ways to drop smoking rates, but prices had reached a point where doing so might create more harm than good. “Hardship experienced by disadvantaged people is so severe … if everyone in New Zealand enjoyed a middle class standard of living then we would not be in a grey area – we would say, ‘this is the most effective tool that we have,” he said.
Setting aside cost, Laking added that other effective measures would be to reduce to availability of tobacco, and offer hardcore smokers an acceptable alternative. The latter had advanced from nicotine patches and gums to e-cigarettes and “heat not burn” devices, which heat tobacco to lower temperatures than cigarettes.
“Although electronic cigarettes and heat not burn products are not perfect – the best thing is to not use any of these products at all – actually, if we were to convert our smoking epidemic into a situation of people using reduced-harm products, that would actually be a much better situation.”
This month, legislation banning advertising and restricting e-cigarette flavors was passed, 620 days after Associate Health Minister Jenny Salesa promised to regulate the industry in November 2018. The bill will come into effect in November, and will also allow the Ministry of Health to recall products, suspend them and issue warnings.
Laking noted the new legislation sought to strike a balance between helping people quit smoking, and avoiding uptake of vaping and new products by non-smokers including young people.
“You have to strike a balance between those two things, and the question is, where do you strike it and how do you strike it?,” he asks. “Those of us who support vaping-to-quit do often feel somewhat overwhelmed by the barrage of claims asserting the risks of vaping, that are, scientifically, very poorly constructed.”
August 30, 2020
California Becomes Second State to Ban Flavored Vapor

Finding a flavored vapor product in California is now an illegal act. The Golden State’s governor, Gavin Newsom, signed SB793 into law on Friday. His signed the bill after California’s Senate unanimously approved (34-0) an amended version of the bill returned by the Assembly. The law does not apply to online sales.
The bill prohibits a Vape shop owner or tobacco retailer, or any of those entities retailer’s agents or employees, from selling, offering for sale, or possessing with the intent to sell or offer for sale, a flavored tobacco product or a tobacco product flavor enhancer, subjecting them to a fine of $250 for each violation. It also allows local governments to impose greater restrictions on the access to tobacco products than the bill imposes.
California joins Massachusetts as the two states having flavored vaping bans, though each have unique exemptions to the laws. In Massachusetts, businesses defined as “smoking bars” are still able to sell flavored vaping and tobacco products.
In California, premium cigars and shisha/hookah products are exempt. The law also does not include the possession or use of flavored tobacco products.
The ban goes into effect on Jan. 1, 2021.
August 30, 2020
Britton: Better Vapor Access Will Aid Cigarette Decline
Easier access to better smoking alternatives will usher the decline of smoking prevalence, according to a British physician and tobacco control expert.
“Governments should make e-cigarettes easily available, introduce modest regulations to reduce the risk of irresponsible marketing and product safety approaches, and give a medical endorsement,” said Dr. John Britton, the director of the UK Centre for Tobacco and Alcohol Studies, adding that these are considered the key approaches for countries to adopt if they want to see smoking rates decline, according to an ar
Dr. John Britton / Courtesy UK Centre for Tobacco and Alcohol Studies
ticle in the Manilla Standard.
A member of the Royal College of Physicians Tobacco Advisory Group and of the board of trustees of Action on Smoking and Health, Britton said, “clinical trials have demonstrated that vaping is probably the most effective way to quit smoking. The long-term harms of e-cigarette use are not known, but they will be substantially less than those of continued smoking or of attempting to quit unaided and then, as is usually the case, failing.
“Electronic cigarettes are a game changer―there is no going back from that. The whole market in nicotine delivery has been revolutionized by these products and I just hope that there are even more exciting products on the way,” he said. “Smoking prevalence in the UK is falling fast, and faster than in the US and Australia where vaping is not endorsed by national authorities. Smoking decline in the UK will have generated savings to the National Health Service,.”
August 30, 2020
Kiwi Group Argues Against Curtailing Flavors

Photo: Duh84bk – Dreamstime.com
End Smoking NZ group has urged the government of New Zealand to curtail legislation set to impede vapor product sales.
The government aims to restrict vapor product flavors to three varieties—mint, menthol and tobacco. End Smoking NZ fears the rule will drive people who have used vapor products to quit smoking back to cigarettes.
“This rapid decline in cigarette sales shows vaping products are clearly working,” said Ends Smoking NZ in statement. “However, the government’s over-regulation of flavors will mean cigarette sales are set to get a boost. No wonder tobacco companies are welcoming the flavor restrictions as they will simply help preserve traditional tobacco’s longevity.”
In 2019, cigarette sales totaled 2.13 billion pieces in New Zealand.
“The success of vaping, and the huge dent it has made on cigarette sales, is due to the accessibility and appeal of vaping to adult smokers,” said Ben Pryor, co-owner of Alt New Zealand and VAPO. “Adults love flavors, and those successfully transitioning from cigarettes to vaping need comparable nicotine. If you tighten the screws on both, you are simply making it harder for Kiwis to quit smoking and that’s a very poor public health outcome.”
August 28, 2020
Yale Study: Flavor Bans Can Make Vaping More Dangerous

Credit: Yale University
Increased rates of vaping nicotine and marijuana products in the U.S. did not result in more e-cigarette or vaping-related lung injuries (EVALI) cases, according to a new study from the Yale School of Public Health (YSPH).
“If e-cigarette or marijuana use per se drove this outbreak, areas with more engagement in those behaviors should show a higher EVALI prevalence,” said assistant professor Abigail Friedman, the study’s author. “This study finds the opposite result. Alongside geographic clusters of high EVALI prevalence states, these findings are more consistent with locally available e-liquids or additives driving the EVALI outbreak than a widely used, nationally-available product.”
Published in the Journal Addiction, the research estimates the relationship between a state’s total number of reported cases of EVALI per capita as of January 2020, and pre-outbreak rates of adult vaping and marijuana use, according to a release from the YSPH. Results show that higher rates of vaping and marijuana use are associated with fewer EVALI cases per capita.
The U.S. Centers for Disease Control and Prevention (CDC) announced in February that it had officially classified vitamin E acetate, an additive long linked to EVALI and most common in THC e-liquids that are informally-sourced—i.e., purchased off the street or home-mixed—as “a primary cause of EVALI.”
The EVALI outbreak has motivated a variety of state and federal legislation to restrict sales of nicotine e-cigarettes, including a temporary ban on all e-cigarette sales in Massachusetts in late-2019 and bans on flavored e-cigarette sales in several states and localities. However, if the goal was to reduce EVALI risks, the study suggests that those policies may have targeted the wrong behavior.
The study found that the five earliest states to legalize recreational marijuana—Alaska, California, Colorado, Oregon and Washington—all had less than one EVALI case per 100,000 residents aged 12 to 64, according to the release. None of the highest EVALI-prevalence states—Utah, North Dakota, Minnesota, Delaware and Indiana—allowed recreational marijuana use.
August 27, 2020
Smoore Posts 40 Percent Jump in Profits Over 2019

Smoore’s Chairman and CEO Chen Zhiping
Smoore International is defying numerous challenges. The world’s most-valuable vapor company has overcome a pandemic, a trade war and tightening regulations to report a huge increase in profit.
Smoore International Holdings, based in Shenzhen, China, posted a 40 percent year-on-year jump in underlying net profit on Monday for the first half of 2020, to 1.3 billion yuan, according to the South China Morning Post. Revenue rose 18.5 percent to 3.88 billion yuan. Last year Smoore posted a 16.5 percent share of the $763 billion global vaping devices market, up from 10 percent in 2018, according to Smoore’s chief financial officer Wang Guisheng
“In the year’s first quarter, our sales dropped 8.8 per cent year-on-year, as the pandemic curtailed our production capacity for a month,” said Wang Guisheng on Tuesday. “We quickly resumed normal operation, with second-quarter revenue doubling from the first-quarter, and rising 38.9 per cent year-on-year.”
While only half its production capacity was used in the first six months, the company is undergoing phase one expansion that it says will double it next year. Phase two expansion will boost production by a further two thirds by 2023. Smoore just recently joined the Stock Exchange of Hong Kong.
“The expansion will further drive down our unit production cost through automation,” said chairman Chen Zhiping, according to the release.
Smoore recently had a premarket tobacco product application (PMTA) accepted by the U.S. Food and Drug Administration (FDA) for its flagship brand, Vaporesso. The regulatory agency requires all manufacturers and distributors to submit PMTA data by September 9.
The US made up around half of Smoore’s sales, while 18.6 percent came from mainland China and 12.5 percent came from each of Japan and Europe. Chen said the company had made a filing to the FDA for one of its self-branded products, and has been assisting with its US customers’ filings.
Since 2018, its US customers have had to pay a 25 percent additional import tariff as part of the fallout from the trade spat between Washington and Beijing. The firm said the tariff has not stopped US demand from growing since its products are “technologically superior”.
August 26, 2020
California Ban on Flavored Vapor Products Expected
Credit: Katherine Chase
California is on track to ban the sale of most flavored tobacco products, joining states like New York and Massachusetts. The state Assembly passed the ban on Monday, two months after the state Senate passed a similar proposal.
The move sets up negotiations between the Assembly and Senate to resolve differences in the bill before it heads to the desk of Gov. Gavin Newsom, who has indicated his support for the ban.
The bill does not make it a crime for people to possess flavored tobacco products, but it bans retailers from selling them. Violators would face a $250 fine.
There is also a sizable exemption for flavored shisha tobacco that is sold by a hookah tobacco retailer, though the law requires several conditions to be met:
The hookah tobacco retailer has a valid license to sell tobacco products;
The hookah tobacco retailer does not permit any person under 21 years of age to be present or enter the premises at any time;
The hookah tobacco retailer shall operate in accordance with all relevant state and local laws relating to the sale of tobacco products; and
If consumption of tobacco products is allowed on the premises of the hookah tobacco retailer, the hookah tobacco retailer shall operate in accordance with all state and local laws relating to the consumption of tobacco products on the premises of a tobacco retailer.
The two chambers must now resolve the differences in their versions of the bill; the Senate bill did not include the exemptions that were passed in the Assembly.
August 26, 2020
MIchigan City Restricts Outdoor THC and Vapor Use

The Saginaw City Council adopted two ordinance changes on Monday, Aug. 24, as the city moves towards legalizing recreational marijuana within city limits. The move comes after the council previously approved other ordinance changes relating to issues such as recreational marijuana facility licensing and zoning issues on Aug. 11.
The first ordinance prohibits the consuming of marijuana products in any manner or form in public places within city limits or smoking marijuana in a private place where prohibited by the property owner, according to an article on Mlive.com.
“Violations of this chapter shall be deemed a public nuisance in accordance with chapter 94 of this code of ordinances, and any person who violates this chapter is responsible for a class C municipal civil infraction,” reads the newly approved ordinance.
Meanwhile, the second ordinance focuses on the consumption of tobacco products as well as marijuana products and sets the groundwork for regulations in city parks, according to the article.
The ordinance reads, “For purposes of this section, smoke or smoking means possessing a cigarette, e-cigarette, cigar, hookah, or pipe that contains tobacco, marijuana, or any other product that is lit or burning; lighting a cigarette, e-cigarette, cigar, hookah, or pipe that contains tobacco or any other product; or exhaling smoke from burning tobacco or any other burning product that is contained in a hookah, pipe, cigar, cigarette and/or e-cigarette.”
According to the ordinance, no individual is allowed to engage in any of the aforementioned activities and smoking in any city park, including, any playground, tennis court, community center or outdoor athletic complex owned by Saginaw, according to the article.
Violating the ordinance could result in a fine of $50, according to the ordinance, and community service may be ordered in lieu of a fine.
Both ordinances will become effective as of Sept. 3, and changes were unanimously approved by the City Council, with no discussion or objections.
August 26, 2020
Canete: Flavored Vapor Ban Hurts Small Businesses

Credit: Tim Mossholder
After enjoying economic growth for 10 years and record low unemployment, small businesses are feeling a disproportionate brunt of the COVID-19 pandemic. After California’s initial stay-in-place order and closure of non-essential businesses, the economic consequences have severely impacted nearly 4 million small businesses in the state.
Even efforts by state legislators to address the state’s pandemic-caused budget deficit, too many of the policies aimed to close the gap will severely burden small businesses. That list includes Senate Bill 793, introduced by state Sen. Jerry Hill, a Democrat from San Mateo, a ban on the sale of all flavored tobacco products, which will profoundly impact California’s 12,000 convenience stores.
Even during years of economic growth, many small businesses operated on relatively tight margins, leaving them poorly positioned for a financial setback from COVID-19. Yet, the state budget attempts to squeeze even more out of battered businesses, including $4.4 billion in tax increases.
Julian Canete /Credit: CalMatters
They will also feel the downward pressure of a gas tax increase that will increase distribution and production costs, and for those selling gas, they will likely see a decrease of customers at the pump. To top it all off, these businesses are also feeling the impact of new minimum wage, family leave and other mandates and environmental regulations.
For convenience stores, SB 793 presents an even greater risk. The threat of a sales ban on flavored tobacco products, which includes menthol, coupled with Gov. Gavin Newsom’s decision to enact a second wave of shutdowns could spell disaster. With individuals encouraged to again stay home and businesses unable to open, this potential ban on a high revenue generator – flavored tobacco products – could spell the end for many of small businesses and the thousands of jobs they provide.
What’s worse is this ban penalizes otherwise law-abiding, compliant business owners. According to FDA data, California’s statewide compliance rate of selling tobacco to legal age adults was 95%, 97% in Sacramento. Yet, lawmakers seem to trust the internet over hard-working men and women who would do anything to keep their business open and profiting.
The most recent analysis by the Mackinac Center found almost 50% of the cigarettes consumed were smuggled in, or acquired through tax avoidance or evasion. Furthermore, the Centers for Disease Control and Prevention found the strange string of vaping deaths in 2019 was caused by products illegally obtained on the black market, not from regulated products sold in stores.
If lawmakers want to curb youth vaping – their stated goal of this legislation – putting more faith in illegal, predatory online vendors over vigilant store owners and their trained employees does the exact opposite: it puts children at risk.
The National Federation of Independent Business July jobs report shows the small business labor market has continued to weaken. Firms reduced employment by 0.28 workers per firm in June, weaker than the decrease of 0.17 workers per firm in May. These figures are not likely to improve as data was collected well before the recent renewal of state-imposed business shutdowns. And with the money provided by the federal government’s Paycheck Protection Program loans essentially used up, coupled with the unknown length of shutdowns, who knows how long convenient stores can weather the storm.
There’s no doubt we need to address the rise in youth vaping. But to water down the problem and propose a unilateral flavored tobacco ban as the solution is at best a half-hearted approach. Convenience store owners have proven to be responsible sellers – they are not the problem. It’s not too late for legislators to go back to the drawing board and, with input from the small business community, find a comprehensive solution to tackle a community problem without putting key members of the community out of business.
Julian Canete is the president and CEO of the California Hispanic Chamber of Commerce, canetej@cahcc.com. This commentary was originally written for CalMatters.org.
August 26, 2020