Tag: regulation

Macau Health Authorities Say Smoking Rules Apply to Vaping
Vaping devices and e-cigarettes are included and treated the same as combustible cigarettes in accordance with Macau’s local smoking control laws, according to Macau health authorities. Vaporizers or e-cigarette devices have become growingly popular in the city, and although their use outside designated areas is not forbidden, sales of vaping products are not allowed in Macau.
Credit: Timothy S. Donahue
The Health Bureau (SS) noted that some 2,368 smoking law infractions were recorded last year, with 21 cases referring to the use of electronic cigarettes in prohibited areas. The SS has called on the public to stay away from all tobacco products and all types of electronic cigarettes, to comply with and not violate the smoking law.
Some 92.5 percent of infractions were committed by men, with 40 percent of the total comprising of tourists. Most infractions were reported in parks/gardens and leisure areas, restaurants or commercial establishments.
Last year 409 inspections were also carried out in casinos, with 165 people indicted for smoking in prohibited places. Smoking is banned on the main floors of casinos, but is permitted in closed-off ventilated smoking areas, which are located on the casino floors. Macau is a Special Administrative Region of the People’s Republic of China.
Macau health officials have claimed that e-cigarettes are no safer than smoking traditional cigarettes.
January 13, 2021
Group Says Feds Making it Harder to Quit Smoking
In late December of last year, the Government of Canada announced a proposal to lower the allowable levels of nicotine in vaping products from 66 milligrams per millilitre to 20 mg/ml in an effort to curb youth vaping. The public consultation period would be in effect for 75 days, closing on Mar. 4, 2021.
Credit: Toptop54
The proposed reduction is a move vaping advocates say will minimize their value to adult smokers looking to transition away from cigarettes, according to the Morinville News.
However, the Canada-based Vaping Industry Trade Association (VITA) says smokers having access to sufficient nicotine levels in an alternate product is essential to the effectiveness of vaping as a harm reduction product. “A limit of 20mg/mL is simply too low for many smokers,” Allan Rewak executive director of VITA stated in a media release. “Adult smokers need access to higher nicotine vapor products at the beginning of their journey from smoking to vaping. Lowering this limit is just going to keep more smokers smoking.”
The Canadian government is following a move by Nova Scotia, who in April of this year, instituted a 20mg/mL nicotine cap as well as a flavor ban. VITA says that change in the rules saw a 25 percent increase in legal cigarette sales increase, an increase four times higher than surrounding provinces. The regulations also resulted in half of the province’s specialty vape shops closing their doors.
“Considering the disparity of harm between vaping and smoking, we don’t understand why the federal government would be using Health Canada resources during a global pandemic to explore making it harder for adult smokers to switch to a reduced risk product,” said VITA president Daniel David.
Enforcement the real problem
The Government of Canada has previously put some measures in place to address youth vaping. Those changes include public education campaigns and banning the advertising of vaping products in public spaces if the ads can be seen or heard by youth.
Thomas Kirsop, owner of Alternatives & Options, a vape store in Morinville and St. Albert said he believes the government is taking the wrong approach with the nicotine reduction to handle the rise in youth vaping.
“A 60 percent reduction in commercially available nicotine concentration will impede my ability to assist the heaviest smokers,” Kirsop said. “It is a federal offence to knowingly sell vapor products to minors or for members of the adult population to provide these products to underaged consumers. In practice, however, I find this law poorly enforced. I think enforcing the current law would yield more significant gains than destroying the efficacy of a less harmful solution.”
Health Canada says restricting flavors in vaping products, and requiring the vaping industry to provide information about their vaping products, including sales, ingredients, and research and development activities are under consideration.
January 7, 2021
Digital Tax Stamps for ENDS Starts Jan. 1 in UAE
Electronic cigarettes cannot be sold in the United Arab Emirates (UAE) unless they bear the digital tax stamp (DTS) beginning January 1, according to the Federal Tax Authority (FTA).
Credit: Jan Vasek
Electronic nicotine delivery systems (ENDS) products cannot be sold, transported, stored or possessed without the tax stamp. The DTS system helps the FTA “improve its ability to collect excise tax charged” on such products on being imported or manufactured locally. It also enables “stakeholders to analyse the supply chain to better control illicit tobacco products,” according to a story in the Khaleej Times.
In addition, the DTS system allows for the implementation of compliance standards. The FTA explained that the DTS system “facilitates inspection and control at customs outlets and local markets”.
The digital stamps will be placed on the packages of vapor, shisha and other tobacco products and registered in the FTA database. The DTS contains data that can be read with a special device to make sure all taxes due have been paid.
“When orders are made for these stamps, they are sent to factories to be placed individually. This will ensure each package is tracked to the port of entry of each country, with the supplier submitting the permit form and the fees for the digital stamps … This will ensure all digital stamps are registered and tracked through a central database,” the FTA said.
December 22, 2020
California Flavor Ban Postponed Beyond Jan. 1, 2021
The controversial California flavored e-cigarette ban will not take effect on Jan. 1, 2021. The Superior Court for the County of Sacramento approved an agreement between the parties in its case which will suspend the Jan. 1, 2021 date of enforcement until, at the very least, after the signatures are verified for a ballot measure proposal that seeks to repeal the law.
Credit: Viviana Rishe
The law was passed this August and was set to go into effect on Jan. 1, 2021. A campaign was started to create a ballot measure for California’s voters to repeal the law. In order to get on the ballot, those in support of the referendum needed to get 623,212 verified signatures from California voters. The group supporting the repeal said it has over 1 million signatures.
But now 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 then take effect once the Secretary of State has verified the process is complete. There are also multiple legal challenges to the law that could produce additional delays.
However, if the signatures are verified the flavor ban would be suspended until at least December 2022. California voters would have a chance to either keep the law or roll it back on Nov. 8, 2022. Those results would need to be certified, meaning even if the law was approved by voters it wouldn’t be enforceable until Dec. 8, 2022.
December 16, 2020
South Africa Vaping Ban Ruled Unconstitutional

Photo: David Carillet – Dreamstime.com
South Africa’s ban on vaping and tobacco sales during the country’s hard lockdown earlier this year was unconstitutional, the country’s High Court ruled Dec. 11.
From March to August, the government prohibited sales of tobacco products and alcohol to help stem the spread of the coronavirus. Market leader British American Tobacco South Africa (BATSA) and smaller companies united in the Fair-trade Independent Tobacco Association (FITA) challenged the ban, arguing that a short-term ban on a product whose health risks become evident only in the long run makes no sense.
They also questioned the rationale of the argument around cigarette sharing. Tobacco shortages and high prices of black-market cigarettes would only increase the likelihood of smokers sharing their “stompies,” the tobacco companies said.
The government lifted the ban before the matter had been heard in court, but BATSA decided to proceed with the court action to prevent the ban from being reintroduced at a later stage of the pandemic.
In its ruling Friday, the Western Cape High Court judges who presided over the case said Regulation 45, which Minister Nkosazana Dlamini-Zuma relied upon for the ban, “cannot and does not withstand constitutional scrutiny.”
In court, the government had argued that the ban was aimed at reducing the occupation of intensive care unit beds by smokers. If people didn’t vape or smoke, they would likely not get Covid-19 in a more severe form, it argued. But BATSA maintained the government had not justified the ban in law or science.
Tobacco companies expressed satisfaction with Friday’s ruling.
“British American Tobacco South Africa has been vindicated in its view that the disastrous ban on tobacco sales was unjustified and unconstitutional after the Western Cape High Court ruled in its favor,” the company wrote in a press release.
“The five-month ban on tobacco and vapor products sales was ill-considered, unlawful and has worsened the illicit trade in cigarettes and vapor products in the country.”
“We note and welcome the judgment of the full bench of the Western Cape High Court, wrote FITA in a statement.
“The court further found Regulation 45 to be neither necessary nor that it furthered the objectives set out in section 27(2) of the Disaster Management Act. This, of course, was one of the arguments advanced by FITA in its challenging of the ban on the sale of cigarettes and tobacco-related products, which the full bench of the North Gauteng High Court erred in finding same to be necessary.”
In the wake of the court ruling, BATSA also renewed its call for South Africa to urgently ratify the World Health Organization Illicit Trade Protocol to eradicate the illegal sale of cigarettes. The company stated that ratifying the protocol is “the only way for the country to claw back tax losses resulting from the explosion in illicit trade that occurred during the ban on tobacco and vapor products.”
In July, BATSA estimated that the ban on legal cigarette sales had cost South Africa ZAR4 billion ($241.7 million) in lost excise tax revenues and 30,000 lost industry jobs.
December 14, 2020
U.S. House to Vote on Legal Marijuana Bill Today
The U.S. House of Representatives is set to vote on marijuana legalization at the federal level today, the first time either chamber of Congress has voted on the matter.
The bill is likely to pass the chamber, but the U.S. Senate is unlikely to take up the legislation in the last two weeks Congress is in session this year, according to an article in USA Today.
Credit: Richard T. Yovh
The measure, sponsored by Rep. Jerry Nadler, D-N.Y., would remove marijuana from the federal list of controlled substances and expunge some marijuana-related criminal records. It would still be up to states to pass their own regulations on the sale of marijuana.
Nadler told USA TODAY in September the vote on the bill would be a “historic vote” as the federal government put an end to its “40-year, very misguided crusade” against marijuana.
He highlighted provisions in the MORE Act that fund community programs to benefit people previously convicted of marijuana-related offenses. He said the provisions were about “making people whole from harms suffered directly as a result of the marijuana ban,” which he said disproportionately affected racial minorities.
Advocates see the vote as a part of a move toward “justice.”
“With this vote, Congress is recognizing the disproportionate impact enforcement has had on our communities and calling for the unjust status quo to be disrupted,” said Maritza Perez, director of the office of national affairs at the Drug Policy Alliance, a group advocating for the decriminalization of drugs.
December 4, 2020
MIssoula Flavored Vapor Ban Sent Back to Committee

Credit: Vaporesso
The City of Missoula, Montana’s proposal to ban the sale of all flavored tobacco products was sent back to committee for further review. The Missoula City Council made that decision Monday night after some legal questions arose.
The proposed ordinance would ban the sale of all menthol, candy and mint flavored tobacco, smokeless tobacco and e-cigarette products. Missoula took up the proposal after the state health department earlier this year offered and then pulled back a more limited state-wide proposal on banning flavored e-cigarette products.
Proponents of Missoula’s proposal say the products are designed to attract and ultimately hook young people on nicotine. But opponents say the ordinance would devastate local retailers, who point out they already only sell to adults over the age of 21, according to Montana Public Radio (MTPR).
Mirtha Becerra, a member of the city council’s Public Safety and Health Committee, said the committee will soon take a second look at the proposal. Becerra tells MTPR the committee has no intention of watering the proposal down into a resolution with no legal weight behind it.
“The reason behind sending it back to committee is to ensure that we reinforce the ordinance, clarify some definitions, make sure that our data is the most up to date, but keeping it true to the north star, if you will, of that ordinance, which is preventing youth from getting addicted to a life of nicotine problems.”
The committee will again discuss the proposal to ban flavored tobacco product sales in Missoula, next Wednesday, November 4.
A public hearing before the full city council would follow on Monday, November 09.
October 28, 2020
Australia: Vapor by Prescription Only Starts Mid-2021

Credit: Tom Claes
Vapor products such as e-cigarettes will become available only by a doctor’s prescription, Australia’s drug regulator said on Wednesday.
The Therapeutic Goods Administration (TGA) announced its interim decision to reclassify nicotine as a prescription-only medication, meaning nicotine for use in e-cigarettes, and e-juice containing nicotine, would become prescription-only from June 2021, according to the guardian.com.
The changes would also effect heat-not-burn tobacco products, chewing tobacco, snuff and other novel nicotine products. The decision is open for consultation until Nov. 6.
Existing state and territory laws make the sale of nicotine e-cigarettes and e-juice illegal throughout Australia and its possession illegal everywhere but in South Australia.
In a statement, the TGA said the proposed changes meant that “while you would still be able to use the ‘personal importation scheme’ under the Therapeutic Goods Act 1989 to order online from your usual supplier … it would be clear that you would be required to have a prescription”.
“You would also be able to fill your prescription at your local community pharmacy, however your pharmacy may have to order it in for you,” the statement said.
September 23, 2020
China Cracks Down on Illicit Ads and E-cigarette Sales

China’s tobacco regulator has just concluded a two-month blitz on the e-cigarette market, which took aim at illicit online marketing and sales to minors.
E-cigarettes have repeatedly come into the regulatory crosshairs in China, as authorities sought to restrict how they can be sold based on concerns over their potential health impact and use by under-18s. Eye-catching designs and flavors have been blamed for a spike in young nonsmokers taking up the devices, according to a story on caixinglobal.com.
The State Tobacco Monopoly Administration (STMA) and the State Administration for Market Regulation jointly said Wednesday they had removed over 23,000 videos and links promoting the products from the internet and shuttered almost 5,000 sales platforms.
September 11, 2020
Last Call: Vapor Industry Braces for Impact of PMTAs

In just one week, the vapor industry could be drastically different. Thousands of businesses could close. Millions of products are most likely going to be removed from store shelves. Premarket tobacco product applications (PMTA) are due to the U.S. Food and Drug Administration (FDA) on Sept. 9 and the vapor industry is bracing for the impact the regulatory deadline will have on businesses and consumers alike.
To date, only a small percentage of vapor product manufacturers have publicly announced that they submitted PMTAs that had been accepted by the FDA. All the major tobacco companies have filed PMTAs for electronic nicotine delivery systems (ENDS). Avail Vapor, E-Alternative Solutions, Charlie’s Chalk Dust and Prism are just a few smaller companies that have also publicly announced PMTA filings.
The FDA has stated that there will not be a grace period for retailers to sell previously purchased product. This has confused vape shop owners who are wondering what products they will be able to sell on Sept. 10. On Aug. 25, this lack of clarity prompted a group of retailers to write a letter to the FDA urging the agency to release a list companies that filed a PMTA. The FDA then announced a week later that the agency would break from tradition and let retailers know what products can be sold, but when that list will arrive is still a question mark.
In a press note on Aug. 31, director of the FDA’s Center for Tobacco Products, Mitch Zeller, wrote that the FDA “plans to make publicly available a list of the deemed new tobacco products” that are subject to the Sept. 9 deadline and were on the market as of Aug. 8, 2016. “However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed,” Zeller wrote.
The FDA also states that it expects numerous PMTA submissions and the one-year review timeline may be exceeded. Zeller acknowledged “there are over a million deemed products” currently listed with the regulatory agency.
“Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced,” Zeller wrote. “Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.”
The Vapor Technology Association (VTA), a vapor industry advocacy group, echoed the FDA in advising retailers to ask manufacturers for specific information on whether their products are covered by a PMTA. Numerous distributors have told Vapor Voice that they intend to buy back any product that their retailers will no be able to sell.
“Each manufacturer may have a different method of providing you with evidence that it has filed PMTAs for its products, including, for example, a redacted version of its Cover Letter or proof of submission through the electronic filing portal,” said VTA Executive Director Tony Abboud. ”While FDA is not currently performing in-person inspections, they will likely resume soon after COVID-19 restrictions are lifted. So, if inspections resume before FDA publishes the list of products for which PMTAs have been filed, you can insulate yourself from potential exposure by having on hand documentation from your manufacturers regarding the product that you have on the shelves.”
Policing retailers may prove difficult for the FDA in the short term, however. In March, due to Covid-19, the FDA temporarily postponed compliance checks and vape shop inspections. This suspension of in-person retail enforcement activity is likely to continue until Covid-19 restrictions begin to lift. However, the FDA has stated it plans to continue monitoring social media, industry-related websites and publications, and issue warning letters when required.
It should also be noted that, in February of this year, the FDA outlined and reiterated its enforcement priorities. The FDA stated that it would focus enforcement efforts for flavored cartridge-based ENDS products; all other ENDS products for which the manufacturer has failed or fails to take adequate measures to prevent access or use by minors; any ENDS products that are targeted to minors or which are likely to promote use by minors; and manufacturers that have not filed PMTAs by the deadline.
The most important thing for manufacturers is to get PMTAs submitted on time, according to Zeller. The FDA announced that if a PMTA has any deficiencies, the agency will address those issues in writing. “Although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely FDA will issue a Deficiency Letter with a 90-day deadline for companies to respond,” Zeller wrote. This would give companies an opportunity to solve those issues rather than the agency outright rejecting the application.
The FDA stated that it would also devote as many resources as possible under the circumstances to help expedite the PMTA review process and the agency vows to treat all applications equally.
“As always, FDA intends to be fair in allocating FDA resources to review applications from both small and large manufacturers and importers, and from applications received through different pathways,” Zeller stated. “Additionally, we intend to maximize the resources that we have to review the most products in the shortest timeframe … To help with this, we are refining our review processes to shorten the overall review time.”
September 2, 2020