Category: News This Week

Michigan becomes the first state in the US to ban flavored e-cigarettes today, a step the governor claims is needed to protect youth from the potentially harmful effects of vaping.

Gov. Gretchen Whitmer (D), in an interview, said the state health department found youth vaping constituted a public health emergency, prompting her to take the action, according to an article in the Washington Post.

“My number one priority is keeping our kids safe and protecting the health of the people of Michigan,” Whitmer said.

She complained that e-cigarette companies are using sweet flavors, such as bubble gum and “fruit loops,” to hook young people on nicotine, with potentially long-term harmful consequences, according to the article.

The ban, which covers both retail and online sales, goes into effect immediately and will last for six months, and can be renewed for another six months, according to the article. In the meantime, state officials said, they will develop permanent regulations banning flavored e-cigarettes. The state legislature could try to block those rules, but such legislation would face a veto, they added.

Juul Labs has raised $325 million in an equity and debt offering as it looks to expand its global reach, reports Yahoo Finance.

Juul is facing intense regulatory scrutiny in its home market.

In a regulatory filing on Monday, the company did not break out the ratio of equity and debt offered but said the funds would not be used for mergers, acquisitions, exchange offers, or to pay executives, promoters or directors.

The company recently launched its popular USB flash drive-shaped products across Europe, South Korea, the Philippines and Indonesia and has plans to expand into other markets.

The offering will also give Juul Labs the capital it needs to comply with a U.S. federal order in July that stipulates that e-cigarette companies submit applications to the U.S. Food and Drug Administration to remain in the market within 10 months rather than an earlier deadline of 2022.

Competitors have rushed to fill the void after Juul, under pressure from the U.S. Food and Drug Administration, stopped selling most of its flavored nicotine pods in stores last fall, according to a report in The New York Times.

The companies are offering fruity and candy-flavored pods that are compatible with Juul devices. Sales of flavors such as “Strawberry Milk,” “Peach Madness” and “Froopy” have reportedly soared.

Juul Labs has filed numerous lawsuits and complaints with the U.S. International Trade Commission, seeking to beat back the cheaper copycat devices and pods.

“If the box isn’t around, the parent would say it’s a Juul pod, but it’s not us,” said Matthew Hult, a Juul Labs lawyer. “It injects confusion and tarnishes the Juul brand.”

The company is also targeting sellers of counterfeit vapor devices and pods sold under the Juul name and training federal customs officials to catch them at ports of entry.

“We are taking aggressive actions against counterfeit and compatible products because they are a direct threat to our plan to combat youth usage,” said Joshua Raffel, a Juul Labs spokesman.

British American Tobacco’s (BAT) proposed takeover of e-cigarette maker Twisp won approval from South Africa’s Competition Tribunal on August 13 after the company agreed to a series of conditions, reports Reuters.

BAT announced the deal in 2017 as part of its efforts to increase its offering of next-generation products or alternatives to smoking cigarettes. But the deal had faced opposition, with the Competition Commission coming out against it in July 2018.

The commission later changed its recommendation to a conditional approval.

Under conditions placed on the deal, the combined group would not be allowed to make deals with retailers to allocate their products more than 70 percent of the visible sales space given to e-cigarettes. They also can’t incentivize retailers to deny space to rival products.

The conditions will apply for five years.

The Vapor Technology Association (VTA), Vapor Stockroom (VSR) and others filed a lawsuit in federal court against the U.S. Food & Drug Administration (FDA), among others, over its unreasonable and arbitrary pre-market tobacco application (PMTA) process and the recently accelerated PMTA filing deadline.

Plaintiffs are taking action to require FDA to publish and complete the long-promised “foundational rules” describing the specific requirements for PMTAs. In addition, Plaintiffs are asking the court to enjoin FDA from enforcing the May 2020 PMTA deadline or taking enforcement action against companies that do not have a PMTA on file until a reasonable period of time after the actual foundational rules are finalized.

With over 3 million vapor products registered with FDA, the arbitrary May 2020 PMTA deadline which FDA is currently enforcing is simply impossible to meet for thousands of small and mid-sized vapor businesses, particularly in the absence of a draft or final PMTA Rule, according to a VTA press release. Any final PMTA Rule must allow sufficient time to conduct the many complex and time-consuming tests and studies currently being required by FDA, the release states.

Since 2016, FDA has provided five different PMTA submission deadlines: August 8, 2018; November 8, 2018; August 8, 2022; August 8, 2021; and now May 12, 2020. The most recent deadline was only just established on July 12, 2019 – leaving only 10 months for vapor industry manufacturers to comply, which is now 27 months earlier than previously set by FDA.

“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful. The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act. Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that ‘could adversely affect the public health,’” said Tony Abboud, executive director of the VTA.

The PMTA application is by far the most arduous of the many regulatory requirements governing ENDS products, and requires a complex, multi-year, multi-million-dollar process that FDA has still failed to fully articulate despite its repeated promises to do so, the release states.

“To be clear, no business could rationally have been expected to start conducting complex PMTA testing before FDA finally published its PMTA guidance document on June 11, 2019, the day before it asked the Court to impose a 10-month PMTA deadline,” said Abboud.

Facts set forth in the complaint are that, even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that the FDA only just laid out on June 11, 2019, by the May 2020 deadline.

Smokers should be confident that vaping with e-cigarettes is much less harmful to the lungs than smoking cigarettes, according to a new review of the relevant science. An article published in the Expert Review of Respiratory Medicine journal contends that there is growing evidence showing that electronic cigarette (EC) emission aerosols are relatively safe compared to tobacco smoke.

Led by Dr. Riccardo Polosa, director of CoEHAR, the Center of Excellence for the Acceleration of HArm Reduction at the University of Catania, The effect of e-cigarette aerosol emissions on respiratory health: a narrative review provides a critical assessment of the research published on the effects of ECs on respiratory system.

“For smokers who want to do something about their health, our review shows that switching to vaping is a very good option if they don’t want to or can’t quit completely. No-one can prove that e-cigarettes are one hundred percent safe, but all the science points to vaping being very much safer than smoking,” said Polosa. “We agree with Public Health England and the Royal College of Physicians of London that it is reasonable to proceed on the basis that vaping is at least 95% less risky than smoking, and probably even less risky than that.”

Vapor products valued at 12.25 million baht, plus various vaping paraphernalia, have been seized in Mukdahan, in far north-east Thailand. E-cigarettes and vaping products are prohibited to import into and use in Thailand.

The Mukdahan Provincial Customs Department report that they received information from related officials and planned a raid of an import shipment for a company called ‘Suvarnabhumi (Thailand)’, according to a story in The Thaiger.

Authorities learned that the e-cigarette products were going to be smuggled, mixed in with legal products that would be imported into the country on the same day, the story states.

Workpoint News reports that a total of 197 boxes were found containing electronic cigarettes and related items. There were individual e-cigarette devices, e-cigarette liquids containing nicotine and other related equipment, according to the story. In total, 21,533 prohibited items were hidden in 6 large wooden crates. The crates were mixed in with other wooden crates being imported.

The U.S. Food and Drug Administration (FDA) has told four companies to remove 44 flavored e-liquid and hookah tobacco products that were introduced to the market after Aug. 8, 2016.

In a statement, the regulatory agency said it has issued warning letters to Mighty Vapors, Liquid Labs USA, V8P Juice International and Hookah Imports.

The FDA has requested responses from each of the four companies within 15 working days on how they intend to address the agency’s concerns, including the dates on which they discontinued any violative sale and/or distribution of these tobacco products, and their plans for maintaining compliance with the federal law.

“Failure to correct violations may result in further action such as seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission,” the FDA states.

The FDA said the products had been introduced into the market after the effective date of a rule that extended FDA’s authority to all tobacco products.

Testing has begun in the UK market for an e-cigarette that can be locked to prevent anyone but its owner from puffing on it.

The Juul C1 e-cigarette pairs with an Android smartphone via Bluetooth to limit who can use it as well as to provide a way of monitoring how often the user vapes, according to an article posted on bbc.com. The product, the first in a series of bluetooth-connected e-cigarettes, was launched in the UK following a trial in Canada.

Juul said the C1 could only be used if people got through age-verification and face-recognition checks.

But anti-smoking campaigners said it was too soon to say if the tech would do much to prevent underage vaping, according to the article.

Juul has previously faced criticism that its products are being widely used by teenagers.