Category: Regulation

Massachusetts officials ended their emergency ban on the sale of vapor products on Dec. 11. The ban had been set to expire Dec. 24, but Governor Charlie Baker had said his administration would end the ban early in light of new legislation restricting the sale and use of flavored tobacco and vapor products.

Retailers will now be allowed to sell unflavored vapor products, which account for a small share of pre-ban sales.

A handful of states have imposed temporary bans on vapor products, but Massachusetts is the first with permanent restrictions.

The new law restricts the sale and consumption of flavored tobacco and vapor products to licensed smoking bars. The restriction extends to popular menthol cigarettes and flavored e-cigarettes, cigars, pipe tobacco and chewing tobacco.

Retailers will have to place vapor products behind the store’s counter, just like tobacco products.

The new law also places a 75 percent excise tax on nicotine vapor products and restricts nicotine concentrations to less than 35 milligrams per milliliter of vaping solution.

Avail Vapor has signed nine major brand U.S. Food and Drug Administration (FDA) regulatory contracts. As a result, Avail will take the lead in submitting an array of products for the FDA’s premarket tobacco product application (PMTA) process, with the first of those applications being submitted in early in 2020, and completing the portfolio before the May 2020 deadline.

“We are thrilled these major brands are placing their trust in us as we move forward together to provide leadership in raising the standards of our industry to help build trust in our products,” said Russ Rogers, COO of Avail.

“We have spent significant time, focus and energy in building our regulatory, ISO 17205 analytical lab, and manufacturing teams to position our company for success with regard to the FDA’s public health expectations. Collaborating with great U.S. e-liquid companies and international device manufacturers on such a critical initiative as PMTAs will validate the value Avail can add in ensuring the appropriateness of these products on the market. Ensuring the highest-quality standards in the ENDS and CBD industries is at the forefront of our mission.”

All e-liquid and device manufacturers have until May 2020 to submit PMTAs for electronic nicotine delivery systems (ENDS) under section 910 of the Federal Food, Drug, and Cosmetic Act. This includes liquids, devices and any affiliated products related to electronic nicotine delivery systems. From there, the FDA has six months to review applications.

If the product application provides scientific data “to demonstrate that marketing the new tobacco product is appropriate for the protection of public health,” the FDA will issue a marketing order, which means the product can continue to be sold to consumers. Avail plans to submit its first batch of PMTAs to the FDA for its own e-liquid brand of products very early in 2020.

“When an e-liquid company signs on with us for contract manufacturing, we are able to assure them that roughly 40 percent of the PMTA process is already complete based on the work we have done to develop our manufacturing and quality systems,” said Vince Angelico, director of regulatory affairs at Avail.

“We can provide a turnkey solution to meet their needs with a science-driven approach to testing for harmful and potentially harmful constituents—demonstrating good manufacturing practices—as well as additional analytical lab testing critical to the PMTA process. This provides a cost-effective path for e-liquid brand holders who are committed to remaining on the market and may otherwise have to exit in 2020.”

To further service the regulatory contracts, Avail has plans to open a facility in southern California.

Germany’s Christian Democrats (CDU) and their Bavarian sister party, the CSU, have backed a plan to phase out tobacco advertising in outdoor areas from 2022, reports DW.

The move marks a break with the group’s longstanding opposition to restrictions on tobacco advertising.

A policy paper endorsed by the bloc’s parliamentary group on Tuesday said the move was necessary to confront “the biggest avoidable health risk of our time.”

Germany is the only EU country that still allows tobacco advertising in public spaces. The paper proposes that tobacco ads on outdoor posters and billboards be curbed from Jan. 1, 2022. It also calls for a ban on cigarette advertising in cinemas from 2021, on tobacco heating product ads from 2023, and on e-cigarette advertising from 2024.

Tobacco advertising is already banned in magazines, newspapers and on TV and radio in Germany. With the proposed bans in place in the future, advertising will still be allowed in other areas, such as inside tobacco shops, or at national sporting events.

Around 120,000 people die annually from smoking-related causes in Germany, according to medical authorities.

Nova Scotia will ban the sale of flavored vapor products on April 1, making it the first Canadian province to take such action, reports CBC.

According to Smoke Free Nova Scotia, 95 percent of youth who vape in Nova Scotia prefer flavored juices, and more than 48 percent said they would quit if flavors were banned.

“This is a good first step and I think we can anticipate a reduction in the number of youth vaping,” said Health Minister Randy Delorey.

Other provinces have moved to regulate vaping, including restrictions on advertising and promotion. Last month, Prince Edward Island passed legislation that will allow it to ban certain flavors.

In May 2018, the federal government passed legislation to legalize and heavily regulate vaping in Canada. The legislation included regulations banning flavors designed to mimic “confectionery,” cannabis, soft drinks or energy drinks.

India’s upper house of Parliament, the Rajya Sabha, on Dec. 2 approved a bill to prohibit the production, trade, transport, storage and advertisement of electronic cigarettes in the country, reports India Today.

The new law, which passed Parliament’s lower house earlier this month, replaces an ordinance issued by the government in September.

First-time violators face fines of up to INR100,000 ($1,393) and imprisonment of up to one year. Subsequent offenses are punishable with fines up to INR500,000 and imprisonment of up to three years.

During the debate on the bill, some lawmakers expressed concern that the government had brought the legislation under pressure from the tobacco industry and demanded the ban be extended to raw tobacco and conventional cigarettes.

“We have done it with very pious intention. There is no vested interest,” Health Minister Harsh Vardhan told the Rajya Sabha.

Hungary’s Parliament on Dec. 3 approved legislation limiting the sale of vapor products to the state-run network of tobacco shops.

The legislation also reduces the excise tax on e-cigarette liquid from HUF55 ($0.18) to HUF20 per mL, closer to levels in neighboring countries to reduce illegal imports.

In addition, it introduces an excise tax of HUF19,160 per kg on smokeless tobacco products and “smoking substitutes containing nicotine” next year.

The law will reduce the number of tobacco shops in the country by raising the population threshold per shop from 3,000 to 4,000.

Bangladesh plans to prohibit the sale and use of vapor products in response to a global health scare, reports Reuters.

“We are actively working to impose a ban on the production, import and sale of e-cigarettes and all vaping tobaccos to prevent health risks,” said Shaikh Yusuf Harun, secretary at the health education and family welfare division of the Ministry of Health and Family Welfare.

The health ministry had taken into consideration the recent spate of deaths and illnesses linked to e-cigarette use in the United States, he said.

As of Nov. 20, the U.S. Centers for Disease Control and Prevention had registered 2,290 cases of lung injuries and 49 deaths related to vaping. Public health officials have fingered black market THC products as the most likely culprit.

India, the world’s second-largest tobacco market, banned the sale of e-cigarettes in October as it warned of a vaping “epidemic” among young people.

The global market for e-cigarettes was worth $15.7 billion in 2018, according to Euromonitor International, and is projected to more than double to $40 billion in 2023.