Category: News This Week

The Philippine Food and Drug Administration (FDA) has urged doctors to refrain from dealing with vapor companies following reports of attempts by the industry to recruit medical professionals to its cause.

“E-cigarette companies are currently engaging physicians in an attempt to recruit them in disinformation campaigns that promote electronic cigarette use as viable harm reduction options,” said Health Undersecretary and acting FDA chief Eric Domingo.

Domingo said it would look bad for doctors to support vapor products because e-cigarettes have been “proven to introduce new risks above and over those already present in traditional combustible cigarettes.”

Last month, President Rodrigo Duterte ordered a ban on the use and importation of e-cigarettes.

Before that, the Department of Health recorded the first case of vaping-related lung injury in a 16-year-old girl from Central Visayas.

Health authorities in the United States have attributed the outbreak of vaping-related injuries in that country to THC products obtained on the black market.

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.

Broughton Nicotine Services has launched an in-house service focused on enabling companies in the Electronic Nicotine Delivery Systems (ENDS) sector to fully understand the chemistry and safety of their products.

The new extractables and leachables team will adopt scientific techniques to investigate any compounds present in an e-liquid or delivery device that could present a health risk to the end user.

“Our extractables and leachables service will enable ENDS companies to work with one key partner throughout the regulatory process and demonstrate the potential impact of their products on public health,” said Leon Birch, head of scientific development at Broughton Nicotine Services.

“It’s great to be part of a team dedicated to supporting companies in the ENDS sector, helping them to advance a smoke-free future.”

The U.S. Court of Appeals for the District of Columbia in Washington has upheld the Food and Drug Administration’s (FDA) regulatory power over vapor products, report Bloomberg and Reuters.

The agency’s authority had been challenged by e-cigarette maker Nicopure Labs and the Right to be Smoke Free Coalition, who argued that the FDA violated the federal Tobacco Control Act by failing to provide an easier path to market for their products and their First Amendment rights by banning the distribution of free samples.

A three-judge panel unanimously said on Tuesday that the FDA’s application to e-cigarettes of rules governing tobacco marketing makes sense because the new products “are indisputably highly addictive and pose health risks, especially to youth, that are not well understood.”

“The First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers have shown that they actually are safer as claimed,” U.S. Circuit Judge Cornelia Pillard wrote for the court.

While the FDA prevailed in the case, the agency still faces stiff resistance from trade groups and conservative activists in anticipation of its e-cigarette flavor restrictions.

Opponents say flavor restrictions will stifle a budding e-cigarette industry while killing thousands of jobs and small businesses.

Tuesday’s appellate ruling affirmed a 2017 decision by U.S. District Judge Amy Berman Jackson in Washington.

Figr Brands, a subsidiary of Pyxus International, has entered legal cannabis market of Ontario, Canada. Figr’s cannabis products are now available for sale online through the province’s Ontario Cannabis Store, as well as at various retail locations.

“The entrance into Ontario marks yet another significant milestone for Figr as it continues to expand its footprint across Canada,” said Pieter Sikkel, president, CEO and chairman of Pyxus. “Ontario is the most populated province in Canada with more than 14 million residents, all of whom now have the opportunity to purchase Figr’s high-quality, fully traceable cannabis products.”

Figr’s entrance into Ontario follows the November approval by Health Canada of the company’s license amendment for its Charlottetown, Prince Edward Island, facility.

The amendment permitted the facility to operate in an additional 210,000 square feet, resulting in an expected run rate of up to approximately 28,000 kilograms of product per year. Upon completion and licensing of the full Prince Edward Island expansion project, Figr expects the facility’s production capacity to be up to approximately 43,000 kilograms annually.

With the addition of Ontario, Figr’s products are now available in four Canadian provinces: Nova Scotia, Prince Edward Island, New Brunswick and Ontario.

Nearly 70 percent of Malaysian smokers want the government to permit the distribution and sale of nicotine e-cigarettes to give them a viable alternative to smoking tobacco, reports The Straits Times, citing a recent poll conducted by Green Zebras.

The poll also found that 58 percent of Malaysians surveyed believe that nicotine e-cigarettes should be taxed but at a level lower than regular cigarettes.

More than half of parents (55 percent), teachers (51 percent) and healthcare professionals (52 percent) polled agreed that the government should emulate health ministries of countries like the United Kingdom and New Zealand that regulate the sale of nicotine e-cigarettes as a means to help smokers quit.

Nicotine-containing vape products are currently illegal for sale in Malaysia. The government is in the process of drafting a new Tobacco Control and Smoking Act.

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.

Brazilian pharmaceutical regulator Anvisa on Dec. 3 approved regulations for medicinal cannabis-based products but blocked a proposal to allow domestic medical marijuana growing, reports Reuters.

An Anvisa spokesman said that Brazilian firms interested in manufacturing cannabis-based products would need to import inputs from abroad.

Anvisa also set out specific rules for the manufacture, import, sale, packaging, marketing and regulation of cannabis-based products.

The new rules will be published in the country’s official gazette in the next few days and come into law 90 days after that.

Brazil’s decision to allow cannabis-based products is part of a slowly changing worldwide view toward illegal drugs.

Uruguay legalized the growing, sale and smoking of marijuana in December 2013.

Colombia has also legalized medical marijuana while in Mexico, the supreme court ordered the country’s health ministry to speed up its issuance of medical marijuana regulations with recreational cannabis also being discussed by lawmakers.

The U.S. Senate Health, Education, Labor and Pensions Committee on Tuesday approved the nomination of Stephen Hahn to be head of the Food and Drug Administration (FDA), reports The Washington Post.

During his confirmation hearing, senators grilled Hahn about his position on e-cigarettes and the Trump administration’s apparent backtracking on earlier announced measures to ban flavored products.

Hahn said he was alarmed by 2019 data showing that almost 28 percent of high schoolers have vaped in the past 30 days but said he didn’t want to prejudge the administration’s e-cigarette policy because he hasn’t been involved in developing it. He vowed to use “science and data” to address that issue and others.

In September, the Trump administration announced it would clear the market of flavored e-cigarettes, but the president has yet to act, citing concern about black market sales.

Vapor advocates have protested that a flavor ban would cause job losses and drive vapers to cigarettes while conservative pressure groups warned that the measure would erode support for Trump’s reelection.

Vapor activists have also argued that a flavor ban would hurt adults using e-cigarettes to quit smoking and that youth use should be reduced in other ways, such as by restricting where the products are sold.

If approved by the Senate, Hahn, a top official at MD Anderson Cancer Center in Houston, will be the fourth head of the FDA in less than a year.

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.