Category: News This Week

The Tobacco Products Scientific Advisory Committee (TPSAC), which advises the U.S. Food and Drug Administration (FDA), has denied the first efforts by Philip Morris International (PMI) to label its iQOS device as a modified-risk tobacco product (MRTP). TPSAC’s denial of the request creates speculation as to how PMI will move forward with introducing the device into the U.S. market.

The FDA must not follow TPSAC recommendations, though historically the regulatory agency has followed the committee’s advice.

According to Bonnie Herzog, senior analyst for Wells Fargo Securities, TPSAC votes have been broadly opposed to PMI’s MRTP application (the majority of the panel has voted “No” in 3 out of 4 questions posed to it so far on health risk/exposure labeling/advertising for iQOS), she does not don’t view today’s events as a total disaster. In a recent email, Herzog writes that “given: (1) much of the panel’s concerns were around how [PMI] worded it’s proposed reduced risk claims and how [PMI] “messages” those claims to the consumer (we’re hopeful there is room for [PMI] & the FDA to work on this); (2) the TPSAC’s recommendation to the FDA is non-binding; and (3) the FDA, we think, seems more supportive of ultimately approving [PMI’s] MRTP application as it is in line with agency’s plan for a comprehensive nicotine strategy. We note, however, the Panel’s seeming dissatisfaction with [PMI’s] data on topics such as youth initiation, impact on vulnerable populations, and in support of some of the claims as currently worded. Therefore, we wouldn’t be surprised if more data/research is requested to more effectively demonstrate the science to support the claim that switching to iQOS from combustible cigs definitively reduces risk of disease & exposure to harmful toxins, i.e., it’s a process! Ultimately we think the chances for the FDA to approve [PMI’s] MRTP are still good but timing is tough to predict.”

These MRTP decisions are not related to PMI’s premarket tobacco product application (PMTA) currently being reviewed by the FDA. An PMTA approval would allow the company to market and sell iQOS in the United States. That decision is expected in February.

Scott D. Ballin, a health policy consultant, told the committee that tobacco and nicotine policies have been at a ‘crossroads’ for a number of years now and given the rapidly changing technological, innovative and competitive environment, has allowed for some serious discussions about what a more modernized regulatory framework can and should look like.

“This is not something unique to tobacco but modernization is routinely carried out by FDA (and Congress) in such areas as drugs, devices, foods, dietary supplements and even cosmetics,” Ballin told the TPSAC. “Consideration of a product like IQOS is just a piece of this new visionary puzzle and which calls for a reassessment of how best to regulate the growing spectrum of products in this rapidly changing environment.”

Bantam Vape has announced the launch of its first five premium e-liquids, all in the strawberry family. The company boasts the only Strawberry Shortcake on the market completely free of diacetyl, according to a press release. The other four flavors being introduced in the initial line include Strawberry Chew, Strawberry Limeade, Strawberry Banana Milkshake and a Strawberry Ice menthol.

All Bantam flavors are available in 60 ml bottles with nicotine levels of 0mg, 3mg and 6mg. Additional flavor families are planned to be launched strategically through 2019 to keep consumer interest high, according to the release.

All Bantam e-liquids are made in America, using raw materials and ingredients exclusively sourced from the U.S. Bantam vape juice is crafted in an ISO-certified cleanroom environment. A fully-automated production process ensures a consistent customer experience and enables the company to respond swiftly to growing customer demand, and a 10,000 square foot shipping facility allows for plenty of product to be staged for expedited delivery, according to the release.

Bantam e-liquids are ahead of the market in preparation for deeming FDA regulations. All raw materials are USDA food-grade quality and are completely traceable throughout the production process, and all bottles are labeled with a batch number and date. Additionally, the brand has a full catalog of flavors that are registered with the FDA, according to the release. The brand is making its formal introduction to consumers at the upcoming Tobacco Plus Expo in Las Vegas on January 31st.

Forty-three percent of adults in Great Britain believe that vaping is less harmful than smoking, according to the results of a survey carried out by YouGov on behalf of the British online vaping retailer Electric Tobacconist.

The survey was carried out amongst 2,134 adults who were asked for their perceptions about e-cigarettes. Respondents were advised that ‘smoking’ included all products that used burning tobacco, such as cigarettes, pipes and cigars, while vaping meant inhaling vapor from electronic cigarettes and other devices, including vaporizers.

Asked if they thought vaping was generally better for people’s health than smoking was, 43 percent of respondents said yes, while five percent held the view that vaping was worse for people’s health than smoking was.

Thirty-one percent said they believed that vaping and smoking had the same impact on people’s health, while 21 percent of respondents said they did not know whether vaping was better or worse than smoking.

More men (46 percent) than women (41 percent) agreed that using e-cigarettes was less harmful than was smoking.

Roughly half of those who had been active on various social media channels in the past month said vaping was less harmful than was smoking (46 percent Facebook, 49 percent Twitter and 52 percent LinkedIn), while under 30 percent of those who believed vaping had the same health impact as smoking had used social media in the past month (29 percent Facebook, 25 percent Twitter and 26 percent LinkedIn).

Fieldwork for the survey, which was carried out online, was undertaken on January 18 and 19.

The figures have been weighted and are representative of all British adults aged 18+.

A Chinese news outlet is reporting that “millions of dollars” worth of heat-not-products have been seized in China and 13 suspects are under arrest. According to Modern Gold News the Ningbo Municipal Public Security Bureau and Ningbo Municipal Tobacco Monopoly Bureau led a joint operation to confiscate more than $15 million in hardware and tobacco sticks.

In August 2017, Yinzhou District Tobacco Monopoly Bureau Inspection Brigade received a report from the several individuals that (commercial outlets) were wantonly selling a “cigarette branch” that does not burn and ancillary smoking sets. These products were reportedly discovered to be iQOS heat-not-burn products and Marlboro Heatsticks along with various other heat-not-burn products, according to the news report.

Vapor products were not involved in the incident.

At present, nine of the suspects have been arrested according to law and the other four are released on bail pending further investigation.

The story can be found here (it must be translated in your browser): http://bit.ly/2n98VAC

Avail Vapor has joined forces with The Drip Club, a Los Angeles-based e-liquid company. The partnership comes through Avail’s e-liquid contract manufacturing services division. According to a press release, some of The Drip Club’s e-liquids are now available to Avail customers nationwide. Consumers can now experience flavors such as The Milkman, a confection of strawberry toaster pastry and cream, and Churrios (Churros & Milk).

Avail will also offer the newest product release of Milkman Delights, which is Drip Club’s latest extension of the line’s dessert-based recipes. The latest line delivers timeless flavorful treats, but also adds staples unique to Los Angeles such as Boba Milk Tea and Melon Bar Ice Cream. The current Milkman Delights campaign “Treat Yourself!” will be brought to life at all of Avail’s 102 retail stores.

“We are thrilled to be offering these high-quality products from a company whose mission mirrors our own,” said James Xu, CEO of Avail Vapor. “Our customers can look forward to ‘treating themselves’ to these flavorful e-liquids with the peace of mind in knowing that they have been through rigorous testing during our manufacturing process.”

Avail’s full-service manufacturing capabilities include an in-house, state-of-the-art ISO Certified class 6 cleanroom in addition to an in-house, state-of-the-art analytical testing lab located in Richmond, VA.

“Quality standards are of upmost importance to us,” said Mike Zhang, CEO of The Drip Club. “That is why we trust Avail for our manufacturing services and look forward to this partnership with them. In return, we know that Avail customers will love the fresh perspective we are providing with our west coast influenced products.”

The EU Commission believes that excise tax should not be applied to electronic cigarettes or heat-not-burn (HNB) products, according to a story by Sarantis Michalopoulos for euractiv.com.

Given the tobacco market’s shift away from traditional tobacco and toward new generation products such as e-cigarettes and HNB devices, and in the light of new developments in the illegal tobacco trade, the EU Council asked the Commission in March 2016 to come up with a proposal on the revision of the Tobacco Excise Directive.

This legislation sets out harmonised rules on the rates of excise duty applied to manufactured tobacco across the EU.

E-cigarettes and other novel products are not covered by the directive and the member states asked the Commission to conduct a study to explore the possibility of imposing excise taxes on them.

But, due to the availability of only limited data on these products, the Commission decided not to propose a harmonised approach until further information was available.

The Commission said that it would re-examine the situation in the next regular report on tobacco taxation, which is due in 2019.

The findings of a report into the public health effects of electronic-cigarette use in the US are due to be discussed during a public webinar next week.

According to a National Academies News press note, millions of US citizens use electronic nicotine delivery systems, which were described as a diverse group of devices such as ‘cig-a-likes’ and vape tank systems that produce an aerosol that users inhale via a mouthpiece.

‘A new congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine evaluates the available evidence of the short- and long-term health effects related to the use of e-cigarettes in users; vulnerable populations of users such as youth, pregnant women, and individuals with underlying medical conditions; and non-users exposed to second- and third-hand aerosol generated by use of these devices,’ the note said.

The report is said to contain dozens of conclusions in areas such as smoking initiation and cessation; the health effects of using e-cigarettes compared to those of smoking combustible tobacco cigarettes; and the health effects related to cancer, cardiovascular disease, and respiratory and oral diseases.

The note said that members of the committee that conducted the study and wrote the report will present their findings and recommendations, and answer questions during a public webinar beginning at 11.00 Eastern Standard Time on January 23.