Category: News This Week

US Health and Human Services (HHS) Secretary Alex Azar and departing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, penned an op-ed in The Washington Post last week warning of a regulatory crackdown on the electronic cigarette industry if teen use didn’t decline, according to a story by Tal Axelrod published at thehill.com.

Gottlieb, who announced his resignation earlier this month, has repeatedly raised concerns about teenage use of e-cigarettes. And the FDA threatened earlier this year to take these products off the market if vaping rates didn’t drop in the coming months.

‘The e-cigarette craze among teenagers has become an epidemic,’ the two wrote in the joint op-ed.

‘We agree with those who believe that e-cigarettes may offer a lower-risk alternative for adult smokers who still want access to nicotine. But the continued availability of this opportunity to adults is being endangered by the e-cigarette industry’s slowness to address the dangers its products pose to teens.

‘While we pursue changes to regulatory policy, we call on the industry – manufacturers and retailers – to step up with meaningful measures to reduce the access and appeal of e-cigarettes to young people.’

Imperial Brands said today that its Myblu vaping device was performing well, with increased investment driving brand awareness among smokers and vapers and significant year on year revenue growth.

Under a Next Generation Products heading within a trading update posted on its website, Imperial said it had built strong retail share positions in Europe and in Japan. ‘In the USA, we have achieved good year-on-year revenue growth, despite some constraints due to market uncertainty following statements by the US Food & Drug Administration.’

In its update issued ahead of its close period on April 1, Imperial confirmed it was on track to meet constant currency net revenue and earnings expectations for the full year, with group net revenue growth at, or above, the upper end of its 1-4 percent revenue growth range and EPS growth within its 4-8 percent guidance range.

Imperial said it was on track to deliver modest revenue growth in tobacco, with growth weighted to the second half more than offsetting a slight decline in the first half. Price/mix continued to be strong, while volume trends were slightly behind those of the second half of last year, impacted by the phasing of trade inventories, including in the US following a recent Imperial price increase.

‘Operating profit in the first half reflects continued underlying growth in tobacco profits albeit more than offset by increased investment in blu of £100 million, as highlighted in November,’ Imperial said.

‘First half earnings per share will also be impacted by the reduction of our Logista stake and last year’s divestment of our Other Tobacco Products business.

‘We continue to expect to realise £50-100 million of other gains this year which will benefit the second half.

‘Translation FX at current rate of exchange is expected to benefit first half earnings by c. 2 percent and be flat for the full year.’

KT&G sold more than 200,000 of its lil Hybrid devices within 80 days of their launch in South Korea, according to a story by Baek Byung-yeul for The Korea Times.

The new device is a hybrid in that it uses both electronic-cigarette and heat-not-burn (HNB) technologies, which means that the consumer uses both e-liquid cartridges and tobacco sticks at the same time.

The company’s lil Hybrid device, its MIIX tobacco sticks and e-liquid cartridges were launched in December.

KT&G said yesterday that sales of the hybrid device were growing faster than those of the original lil HNB device, which took about 100 days to pass the 200,000 mark.

Sales of its lil HNB device hit one million in October 2018 and 1.5 million this month.

South Korea’s e-cigarette market has seen growing competition in recent years and industry insiders believe the race to take the lead will peak this year because JUUL Labs is expected to roll out its e-cigarette.

Lim Wang-seop, the chief of KT&G’s innovative product department, was quoted as saying that his company had been developing new products that could compete with Juul.

The e-cigarette market accounted for only 3.13 percent of the entire tobacco market in South Korea, he said, but KT&G expected this share to grow to about 14 percent to 15 percent after the introduction of Juul.

Nevertheless, Cho Sang-hoon, an analyst at Samsung Securities, was quoted as saying that KT&G wouldn’t be negatively affected by the market changes.

KT&G’s share in the regular cigarette market would grow by about one percent to 62.9 percent this year, while its share in the e-cigarette market would increase to about 30 percent this year, from about 17 percent in 2018.

Today, the US Food and Drug Administration (FDA) has posted a notice in the Federal Register announcing the publication of the final guidance, “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.” This guidance finalizes the draft guidance of the same title, which was available for public comment on January 17, 2017.

For example, under the Food, Drug, and Cosmetic Act, a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of tobacco used in the product that is foreign-grown and domestic-grown, according to the FDA. The FDA does not intend to enforce this for tobacco-derived liquid nicotine, e-liquid made or derived from tobacco, cigars, smokeless tobacco, and waterpipe tobacco, according to the FDA.

 
Additionally, For products that do not yet have marketing authorization orders, a vape shop’s modifying a product would generally result in a new tobacco product for which the vape shop is required to seek premarket authorization (PMTA).

The FDA does not intend to enforce these requirements if the vape shop modifies a tobacco product consistent with the specifications provided by the original manufacturer. FDA is providing this compliance policy because FDA does not expect these modifications to alter the performance of the tobacco product as described or intended by original manufacturers.

Refilling open systems is allowed if the vape shop does not make any further modifications to the product or any modifications to the e-liquid (e.g., mixing) before, during, or after the refill, that are either outside the marketing authorization order or, if there is no marketing authorization order, inconsistent with the original manufacturer specifications, then FDA does not intend to enforce these requirements.

For the below actions a PMTA would be required, including HPHC reports, and health documents pursuant to section 904 of the FD&C Act); and engaged in the manufacture, preparation, compounding, or processing of tobacco products (and thus required to register and list pursuant to section 905 of the FD&C Act):

• A vape shop that modifies a closed ENDS14 to refill it for a customer. • A vape shop that repairs and modifies an atomizer head, and the modification is outside the marketing authorization order.

• A vape shop that replaces the coils in an ENDS product that was on the market as of August 8, 2016 but that does not yet have a marketing authorization order with coils that have a different ohm15 and/or wattage rating. 16 If there are no specifications from the original manufacturer, then the vape shop would not be subject to the compliance policy described above (in section IV.B.1.b).

• A vape shop that assembles a custom final product17 from components or parts sold individually or from multiple pre-built kits, that were on the market as of August 8, 2016 but that do not yet have marketing authorization orders.18

If a vape shop performs the following activities in the examples below, the vape shop would not be required to seek premarket authorization; submit ingredient lists, HPHC reports, and health documents in accordance with section 904 of the FD&C Act; or register and list in accordance with section 905 of the FD&C Act:

• A vape shop that demonstrates the use of an ENDS product without assembling the product, including by providing instruction designed to assist users on the correct use of the product.19

• A vape shop that explains how to charge the battery or fill the ENDS tank, or how to turn on the ENDS device If a vape shop performs the activities in the examples below, the vape shop would not be required to seek premarket authorization.

To the extent that the vape shop would be a tobacco product manufacturer (and thus required to submit ingredient lists, HPHC reports, and health documents pursuant to section 904 of the FD&C Act) and engaged in the manufacture, preparation, compounding, or processing of tobacco products (and thus required to register and list pursuant to section 905 of the FD&C Act), FDA does not intend to enforce those requirements:

• A vape shop that maintains an ENDS product by cleaning or tightening fixtures (e.g., screws)

• A vape shop that replaces the coils in an ENDS product with identical coils from the same manufacturer (e.g., same ohm and wattage rating)

• A vape shop that assembles a final product from the components or parts packaged together in a pre-built ENDS kit or from components and parts sold individually or from multiple kits if the final assembled product consists of components and parts that are also available packaged together in a single pre-built ENDS kit.

The Broughton Group said yesterday it had launched Broughton Nicotine Services, a spin-off from Broughton Laboratories that will specialize in ‘accelerating safer nicotine-delivery products to market; advancing a smoke-free future’.

‘The launch coincides with the development of a 15,000 ft² CRO [contract research organization] facility (pictured – Karen Ross Photography Studio) in Lancashire [UK] designed specifically to address the needs of the Electronic Nicotine Delivery Systems (ENDS) market,’ Broughton said in a press note.

‘Having operated in this rapidly expanding and changing market for almost 10 years, the company is now perfectly placed to guide ENDS companies through a period of growth and regulatory change.

‘Broughton Nicotine Services raised over £5 million in 2018 to invest in the new facility which includes several specialist laboratories equipped with the latest aerosol collection instruments, high-spec analytical equipment and fully validated software data management systems.

‘An impressive stand-alone stability facility covering all ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] storage requirements has been included in this initial phase of developments.

‘Led by a growing team of experienced scientists and analytical chemists, the operation is aligned with capacity for further expansion during 2019 to meet the expectations of its global client base.’

Chief executive Dr. Paul Moran was quoted as saying that there had been a rapid change during recent years within the reduced-risk nicotine products market. “At Broughton Nicotine Services, we are committed to supporting this evolving industry towards creating a smoke-free future through innovations, scientific advancement and regulatory compliance,” he said. “Operating as an independent company within the Broughton Group, specialising in next generation nicotine delivery, will enable us to continue to accelerate the transformation of this exciting industry for our clients.”

Two San Francisco officials on Tuesday introduced bills that would ban the sale of electronic cigarettes in the city until the US Food and Drug Administration had evaluated their effect on public health, according to a story at cbsnews.com.

Supporters say that if the ban is approved, it will be the first in the country.

City Attorney Dennis Herrera and Supervisor Shamann Walton also proposed a bill at a Board of Supervisors meeting that would prohibit companies that make, sell and distribute tobacco products, including e-cigarettes, from occupying city-owned property.

The San Francisco Chronicle was quoted as saying that tobacco companies were already barred from doing business on city property, but that the proposed legislation would embrace e-cigarettes.

It wouldn’t apply retroactively, so Juul Labs would be allowed to stay in space it rents for its headquarters at Port of San Francisco property on Pier 70. But, says the Chronicle, e-cigarette companies wouldn’t be able to lease city property in the future.

Juul said in a statement to CBS News that the proposed legislation would limit adult smokers’ access to e-cigarettes that could help them kick regular smoking habits.

‘We encourage the City of San Francisco to severely restrict youth access but do so in a way that preserves the opportunity to eliminate combustible cigarettes,’ Juul said.

“This proposed legislation begs the question – why would the City be comfortable with combustible cigarettes being on shelves when we know they kill more than 480,000 Americans per year?”

Herrera said San Francisco, Chicago and New York had sent a joint letter demanding that the FDA begin its review. He said the review should have been done before e-cigarettes ever hit the market.

The US Food and Drug Administration Commissioner Scott Gottlieb, MD, has said that his agency might need to pull pod-based nicotine products off the market to fight teen vaping, according to a story by Anna Edney published by the LA Times.

Speaking at the Brookings Institution on Tuesday, Gottlieb said he had had a contentious meeting last week with executives of Altria and Juul Labs.

“The e-cigarette industry has been overly dismissive” of the risk that young people could become addicted to nicotine through e-cigarette use, Gottlieb said. “We’re capturing an exploding epidemic right now.”

Gottlieb said the FDA was working on defining what constituted a pod-based product in case it needed to ban them temporarily.

Sales of vaping pods could resume if manufacturers showed that their devices were geared toward adult cigarette smokers trying to quit, and not toward young people.

“It was a difficult meeting,” the commissioner said, noting that there was a “disconnect” between the companies’ priorities and those of health officials.

He added that it appeared Altria’s decision to purchase a stake in Juul was purely a business decision and not driven by public health concerns.

Edney said that Altria and Juul hadn’t responded to Gottlieb’s characterization of the meeting.

But she added that both companies said they remained committed to combating underage use of e-cigarettes.

A public health expert in the US has set out to answer a question that has probably popped into many heads in recent times: why does vaping seem so threatening to the tobacco control movement?

Writing on his blog, The Rest of the Story, Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, starts off by saying that he and his colleagues in the tobacco control movement had based their entire careers on the principle that it was wrong to lie to the public.

On the other hand, much of their campaign against Big Tobacco had been based on the contention that cigarette companies lied to the public about the health risks of smoking.

However, Siegel said he believed that during the past few years the tobacco control movement had largely abandoned truth as a central value in so far as its campaigns against vaping were concerned.

Why is vaping so threatening to the tobacco control movement? he asks. Is it threatening because it is extremely dangerous – basically as harmful as smoking – and is therefore harming the health of the nation’s 11 million adult vapers?

No, he replies to his own question; it’s precisely the opposite…

‘The problem with vaping is that it is not killing anyone, so there is no punishment for the vice of being addicted to nicotine,’ he said. ‘And that’s something that the tobacco control movement can simply not tolerate.’

The High Court of Delhi, India, has stayed the Central Government’s attempt to ban electronic cigarettes in the country under the Drugs and Cosmetics Act, saying that these products do not fall within the Act’s definition of a drug, according to a story in the Bar & Bench, relayed by the TMA.

Two e-cigarette companies, Litejoy International Pvt Ltd and M/S Focus Brands Trading were said to have petitioned the court in response to a February 22 Communication from the Directorate General of Health Services asking state licensing authorities to prohibit the sale, manufacture, distribution, importation and advertisement of e-cigarettes and ENDS [electronic nicotine delivery systems] in their jurisdictions.

The petitioners argued that ENDS were less risky substitutes for combustible cigarettes and that the Government’s decision affected the right of consumers to choose e-cigarettes in place of cigarettes.

Additional Solicitor General, Maninder Acharya, submitted that since ENDS assisted smokers to give up their tobacco addiction, ENDS and all other devices fell within the definition of ‘drugs’ as defined under Section 3(b) of the Act.

The court observed that the devices were not sold as therapeutic devices so the Central Government did not have the jurisdiction to issue the circular.

The government has two weeks to issue its response and the case will be heard on May 17.

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Ned Sharpless, the director of the US’ National Cancer Institute, is expected to be named as the temporary chief of the Food and Drug Administration, according to a storyby Anna Edney for Bloomberg News.

Sharpless is due to serve as acting head of the agency when commissioner Scott Gottlieb leaves later this year, the Health and Human Services Secretary Alex Azar was quoted as saying at an appearance on Capitol Hill on Tuesday.

Edney said that the appointment of Sharpless could allay the concerns of health advocates that Gottlieb’s departure would signal a let-up in the FDA’s crackdown on flavored electronic cigarettes and teen smoking. Sharpless has apparently supported Gottlieb’s efforts to stem what the commissioner has called an “epidemic” of smoking among young people.

In addition, Edney said, the National Cancer Institute had worked closely with the FDA to fund research related to e-cigarette use, including the device’s impact on smoking cessation.