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25/09/2015

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24/09/2015

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21/09/2015

15/09/2015

E-cigs are positive for public health, says UK government body

The British government’s main public-health body has put its weight firmly behind e-ci******es as a solution to the problems caused by smoking, calling for them to be available to consumers through the National Health Service, for smoking cessation services to support va**ng, and for light-touch regulation.
A scientific report commissioned by Public Health England (PHE) also suggests that the process for medical licensing of e-cigs might need to be overhauled, and that the government should beware of inadvertently stifling the market through its implementation of the European Union’s To***co Products Directive (TPD).
PHE says in a policy paper issued this week, accompanying the scientific report, that “the potential of e-ci******es to help improve public health depends on the extent to which they can act as a route out of smoking for the country’s eight million to***co users, without providing a route into smoking for children and non-smokers. Appropriate and proportionate regulation is essential if this goal is to be achieved.”
In particular, it says, “local stop smoking services provide smokers with the best chance of quitting successfully and we want to see them engaging actively with smokers who want to quit with the help of e-ci******es”.
The organisation, part of the government’s Department of Health, also wants “to see all health and social care professionals providing accurate advice on the relative risks of smoking and e-cigarette use”, and “looks forward to the arrival on the market of a choice of medicinally regulated products that can be made available to smokers by the NHS [National Health Service] on prescription”.
The NHS offers largely free healthcare throughout British society, although some patients pay a small fee for prescriptions, unrelated to the actual cost of the products they receive. The advisory remit of Public Health England does not cover Wales, Scotland or Northern Ireland, the other regions of the UK with varying levels of autonomy. However, its points will undoubtedly be taken note of by authorities in these areas.

Academic agreement

Backing up PHE’s policy paper, a separate scientific report by academics from the UK Centre for To***co & Alcohol Studies – commissioned by PHE and issued at the same time – contains barely-veiled criticism of the process for pharmaceutical licensing of e-ci******es operated by Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA).
As yet no medically-licensed products have appeared and few applications have been made, yet such approval will presumably be necessary if PHE’s goal of making e-cigs available on the NHS is to be achieved.
“Much of England’s strategy of to***co harm reduction is predicated on the availability of medicinally licensed products that smokers want to use. Licensed [e-ci******es] are yet to appear. A review of the…licensing process therefore seems appropriate, including manufacturers’ costs, and potential impact,” says the scientists’ report for PHE. “This could include a requirement for MHRA to adapt the processes and their costs to enable smaller manufacturers to apply, and to speed up the licensing process. The review could also assess potential demand for the [e-cigarette] prescription market and what types of products would be most appropriate to meet that demand.”
It adds: “The fact that no licensed [e-ci******es] are yet on the market suggests that the licensing route to market is not commercially attractive. The absence of non-to***co industry products going through the MHRA licensing process suggests that the process is inadvertently favouring larger manufacturers including the to***co industry, which is likely to inhibit innovation in the prescription market.”

It’s not smoking

Also questioned is the approach of some public bodies in the UK in prohibiting va**ng on their premises. There is no national va**ng ban across the UK as there is on smoking, although Wales is introducing one.
E-ci******es “should not routinely be treated in the same way as smoking. It is not appropriate to prohibit [their] use in health trusts and prisons as part of smokefree policies unless there is a strong rationale to do so,” the scientists say.
Indeed, they seem to imply, regulation of e-cigs can become too risk-averse.
Acknowledging the need for child-proofing, they nevertheless add that “whilst protecting non-smoking children and ensuring the products on the market are as safe and effective as possible are clearly important goals, new regulations currently planned should also maximise the public health opportunities of [e-ci******es]”.

Don’t over-regulate

A similar attitude could be taken toward labelling, they suggest. “The accuracy of ni****ne content labelling currently raises no major concerns,” they observe, adding that “general labelling of the strength of e-liquids, along the lines used for example indicating coffee strength, provides sufficient guidance to consumers”.
Overall, they propose, “regulatory interventions should ensure optimal product safety but make sure [e-ci******es] are not regulated more strictly than ci******es and can continue to evolve and improve their competitiveness against ci******es”.
To this end, they urge the government to take care in its transposition of the TPD into British law: “An assessment of the impact of the TPD regulations on the UK [e-cigarette] market will be integral to its implementation. This should include the degree to which the availability of safe and effective products might be restricted.”
The report team was led by professors Ann McNeill of King’s College London and Peter Hajek of Queen Mary University of London, two of the best-known British e-cig researchers.
What This Means: As ringing endorsements go, PHE’s is deafening, portraying e-ci******es as an almost unmitigated public-health boon
It will not bring the debate over e-cigs to a close, but coming just days after similar pronouncements from the Royal Society for Public Health it should leave the government in little doubt of the arguments in favour of e-ci******es.
The heavy media coverage already being given to it may even help to win over some of the 45% of Britons who, as PHE’s scientists report, do not realise that e-ci******es are much less harmful than smoking.
And in the slightly longer term, it could well lead to an important change of attitude within the NHS’s smoking cessation services. Yet, as the PHE papers imply, making the most of this will also necessitate care with the TPD implementation and possibly some changes at the MHRA. We can expect more debate to come as a result of these papers, but in time we can also expect action.
– Barnaby Page ECigIntelligence staff

15/09/2015

“Most online e-cig vendors make false claims,” says watchdog

The majority of U.S. e-cig vendors make unsupported claims on their Websites, a watchdog group has charged after surveying the online presence of 159 companies.
Truth in Advertising (TINA), a nonprofit based in Connecticut, examined the firms’ online content including “social media, testimonials, [and] links to studies or media reports” – not just advertising in the conventional sense – to enumerate claims of four kinds that it contends are misleading:
That e-ci******es have health benefits.
That they can help with smoking cessation.
That they can be legally used nearly everywhere.
That they are cheaper than to***co smoking.
Two thirds of the suppliers made at least one of these assertions, it found.
Most frequently seen were health-benefit claims, made by around half the companies. More than 40% suggested that e-cigs are cheaper than to***co ci******es; nearly a third referred to e-cigs’ usefulness in giving up smoking, while a similar number said their products could be used virtually anywhere.
TINA also noted examples of companies selling e-liquid in what it calls “kid friendly flavors”, and found that around 40% offered such products.
“Online e-cigarette companies are taking advantage of the regulatory gap to market their wares with a variety of suspect claims. Some are blatant while others are subtle, craftily-drafted veiled claims,” TINA said.
Only three companies of the 159 fell foul of TINA’s criteria in all four categories and also sold flavoured e-liquid with supposedly child-friendly flavours: they were LeCig, Mt. Baker V***r, and Va**ngZone.
Last year a notification from TINA was among the prompts that led Utah’s division of consumer protection to crack down on e-cig companies that had “advertised false health claims, posted false customer testimonials, marketed ‘free’ trial offers that were not in fact free of charge, and…charged customer accounts without consent”.
What This Means: It is a little unfortunate that TINA – a respectable, generally non-hysterical organisation – saw fit to jump on the “kiddie flavours” bandwagon, since selling these products has nothing to do with the issue of truth in advertising, regardless of whom they may or may not appeal to.
However, we shouldn’t write off the research because of that. It’s undoubtedly the case that, while the industry as a whole is responsible, there are a lot of dubious claims being made for e-cigs online.
This likely out of ignorance or enthusiasm in most cases, rather than with any intention to deceive; but that won’t be a much of an excuse in the eyes of regulators. Bringing this issue to the forefront with some startling numbers is therefore welcome.
– Barnaby Page ECigIntelligence staff

06/09/2015

Based on the evidence, it is time for public health groups to recommend that smokers should switch to electronic ci******es.

19/08/2015

Family, friends influence teens’ adoption of e-ci******es

19/08/2015

British health charity calls for promotion of e-ci******es

01/07/2015

TV, point of sale dominate European e-cigarette advertising

Written by Freddie Dawson || 30 June, 2015

Days since publishing: 0

European consumers see TV ads for e-ci******es nearly as often as point-of-sale promotions, but there is a significant divide between east and west in terms of frequency and impact, according to a new report.

The European Commission – the executive arm of the European Union – dedicated part of its recent Eurobarometer report on European attitudes towards to***co and e-ci******es to examining consumer reactions to advertising.

It found that nearly 39% of Europeans had seen some form of advertising for e-ci******es, with 8% saying they had seen e-cigs ads frequently.

The most commonly seen advertising was that at points of sale, encountered by 36% of respondents. But television was a close second at 35%, perhaps a surprising result for a much more expensive and heavily regulated form.

The Netherlands (66%), Estonia (61%) and the UK were the countries with the highest proportions of people exposed to TV ads. Ireland, Luxembourg and Spain had the highest percentage of people noticing point-of-sale advertising, with 50% in each country reporting having seen displays.

In contrast, mobile and online advertising – as well as celebrity use, sponsored events and free samples –had very little impact, with only 2% of respondents saying they had encountered them.



On target?



Despite the apparently poor performance of some media, demographics may result in them gaining a share of e-cigarette advertising budgets.

Online advertising tended to be seen more by younger, more educated consumers, while the audience for point of sale and TV was more likely to include older consumers who had spent less time in education.

“The longer a respondent remained in education, the less likely they are to mention television, and the more frequently they mention [online],” the report said. “For instance, 43% of those with the lowest education levels mention television, compared with 30% of those with the highest levels.”

There also appears to be a substantial advertising gap between western and eastern Europe. Western Europeans are three or four times more likely to encounter e-cigarette advertising than their eastern counterparts – perhaps not surprising given the further development of Western e-cig markets.

However, even eastern European countries considered to be important e-cigarette markets, such as Poland (where 31% of respondents had seen an e-cig ad), lagged behind most Western markets.

“The map [below] clearly illustrates an East/West divide, with the Western Member States having the highest proportions who have seen ads or promotions for e-ci******es or similar devices,” the report said. “At least half of all respondents in the Netherlands (69%), the UK (62%), France (59%), Estonia (54%) and Denmark and Ireland (both 50%) have seen such ads or promotions, compared with 15% in Hungary and Slovenia and 16% in Malta.”

What This Means: The wide-ranging impact of television is in many legislators’ minds as countries debate restrictions on e-cigarette advertising ahead of the May 2016 deadline for implementation of the EU To***co Products Directive (TPD).

But the lack of impact that online advertising, celebrity use and sponsored events have had is somewhat surprising.

It’s also remarkable how little e-cig companies appear to have been advertising in eastern European markets thus far. With growing va**ng populations in many of these nations, now could be a good time to spread the word.

– Freddie Dawson ECigIntelligence staff

01/07/2015

New York fines e-cig suppliers over child-proofing failures
New York state’s attorney general has cracked down on e-cigarette firms that violate state laws against selling e-liquids without child-proof packaging.

Four companies will have to pay a combined $95,000 as part of settlement deals. They will also have to ensure that ni****ne products are not sold in New York again without the proper child-resistant packaging.

“New York law is clear: liquid ni****ne is highly toxic and must be sold in child-resistant packaging. Today, we are taking action against four companies, and putting others on notice: stop selling liquid ni****ne in anything but child-resistant containers, or we will come after you,” said New York attorney general Eric Schneiderman in a statement.

Two of the companies – Henley V***rium and Beyond V**e – have a physical retail presence in New York and will also be required to ensure the removal of all stock without child-proofing, train staff in compliance measures, and accept stiffer penalties if found to be noncompliant again in the future.

The other two companies involved in the action are online retailers selling their products to New York customers. They are Rocket Sheep, an e-liquid manufacturer; and ECig Distribution, a corporation that also does business as ECigDistributors.com, Ejuices.com, and Eliquid.com, according to the New York attorney general’s office.

Individual fines were not disclosed.



Proof of innocence



All four firms will have to provide regulators with proof of testing for containers that demonstrates they meet poison prevention standards. They must also allow consumers to exchange any bottle that was sold without appropriate protection.

“The reason I introduced and passed the bill into law barring sales of e-liquid to minors and mandating child-resistant packaging was to protect children from gaining access to the toxic liquid and being poisoned by it,” said New York assembly member Linda Rosenthal.

“Tragically, some retailers and manufacturers flouted the law and continued selling the product without the required precautions. I am gratified that the attorney general, recognising the dangers of liquid ni****ne, pursued those who violated the law, and will see that the offending parties comply with it in the future. Liquid ni****ne should never be in the hands of children, and following the law to prevent that from occurring must be a top priority for all retailers and manufacturers.”

The law follows the death of an 18-month-old child in New York last year caused by ni****ne poisoning from e-liquid. The death, which was ruled accidental, took place after the parents and guardians of the child left him unattended with an open bottle of e-liquid in reach on a low table.

Despite the accidental death verdict, the parents of the child said they plan on filing a lawsuit against Heartland V***r, the company from which the bottle was purchased. However, a spokesperson for Heartland V***r told ECigIntelligence that no legal action had been taken yet.

What This Means: The prosecution is the first known case of firms being fined for not following child-proof packaging laws in the U.S., but it is certainly not going to be the last. Expect to see plenty more retailers, distributors and manufacturers run afoul of the law as they try to keep up with a rapidly evolving regulatory environment.

It is also a stark reminder that while leaders in the sector talk about industry best practice, there are still many companies out there falling short – whether that be due to ignorance of the law, lack of resources or indifference.

– Freddie Dawson ECigIntelligence staff

01/07/2015

Congress opens new attack on FDA grandfathering date

Written by Jim Myers || 30 June, 2015 || Regulatory News

A crucial appropriations bill in the U.S. Congress is being used to launch a pre-emptive strike against the grandfather date for e-cigarette products that has been proposed by the Food and Drug Administration (FDA).

The move comes after leaders in the House of Representatives warned of the grandfather date’s negative impact on e-ci******es and other products. One had already introduced separate legislation with similar provisions to the new appropriations bill.

The grandfather date proposed by the FDA would exempt only e-ci******es that were on the market before a particular day in 2007 – effectively meaning none of those available commercially now – from the FDA’s forthcoming deeming regulations, which are expected to impose a range of requirements on e-cig products.

Action on the spending bill was expected last Thursday from the House Appropriations Committee, but that session was postponed.

A new date has not been announced, and members of Congress have left Washington for a week-long break to celebrate Independence Day. They are scheduled to return the week of 6th July.

Earlier in June, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee approved the appropriations bill – which would change the grandfather date to the same as the date on which the deeming regulations come into effect, allowing all current e-cigarette products to escape much of the FDA’s proposed regulation.

The vote on the appropriations bill follows the introduction of another bill in April by Oklahoma Republican representative Tom Cole, a close ally of the House Republican leadership.

Cole also targeted the grandfather date of 15th February 2007, warning that under it e-ci******es and other to***co products coming under FDA regulation for the first time would face harsh restrictions and could even be forced off the market.

However, a press aide said that Cole had not advocated for the new language to be inserted in the appropriations bill, even though it would have the same impact as his standalone bill.

Cole serves on the House Appropriations Committee, but not the subcommittee that oversees FDA funding.



Dating game



Late last year, three top Republican leaders – house speaker John Boehner of Ohio, majority leader Kevin McCarthy of California, and Fred Upton of Michigan, chairman of the Energy and Commerce Committee – wrote to U.S. health and human services secretary Sylvia Burwell to raise concerns over the impact of leaving the FDA’s proposed grandfather date in place.

Critics and backers wasted no time in turning the matter into a contentious issue.

“Without action by Congress, the FDA’s proposed regulations threaten to ban 99%-plus of vapour products currently available on the market. This would be a disaster not only for thousands of small businesses, but also public health,” said Gregory Conley, president of the American Va**ng Association.

“This proposal does not remove the FDA’s ability to regulate vapour products. The FDA will retain the authority to immediately move forward with science-based product standards, disclosure requirements, and many other measures,” Conley argued.

But in a co-ordinated response, the Campaign for To***co-Free Kids, American Cancer Society Cancer Action Network, American Heart Association and American Lung Association urged law-makers to reject the language inserted into the appropriations bill.

They warned that the bill, as written, would limit significantly the FDA’s ability to protect children from flavoured ci**rs and e-ci******es with flavours such as gummy bear and cotton candy.

“The appropriations language would undermine a key provision of the landmark 2009 law giving the FDA authority over to***co products and weaken the FDA’s proposed regulation of e-ci******es, ci**rs and other to***co products,” the organisations stated.

“Rarely has Congress so blatantly put the special interests of the to***co industry above the health of America’s kids.”

The proposed change to the grandfathering date is not the only challenge that the FDA faces in D.C. For example, another bill currently wending its way through Congress – the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2015 – would exempt certain types of cigar from the agency’s regulation.

What This Means: Using the appropriations process to over-rule the FDA’s original proposals in this way was bound to provoke Congressional response.

House Republicans clearly have the votes to keep the language in the bill as its proceeds along the appropriations process, but that pathway can be uncertain.

Republicans and Democrats remain at odds over budget caps, and the appropriations bills further along in the process this year have prompted veto threats from the White House. That could lead to some kind of showdown in September.

– Jim Myers ECigIntelligence Washington correspondent

01/07/2015

FDA bows to pressure on child-proofing and warning labels
The U.S. Food and Drug Administration (FDA) is considering new rules that could require manufacturers of e-liquids and other products to child-proof their packaging and affix warnings about ni****ne poisoning.

The federal agency is likely responding to Congressional and public criticism over the lack of child-proofing and other safety requirements in its deeming regulations, which it announced in April 2014 and which have been expected to form the basis of its new regulatory regime for e-ci******es.

The deeming regulations require only a general warning that e-cigarette products contain ni****ne, and do not specify any child safety measures. The final version of the rules had originally been expected this month, but appears to have met with delays in an FDA currently without a permanent leader and struggling to deal with the volume of information and public submissions it must digest in order to come up with a science-based policy for e-cigarette regulation.

In the meantime, it has faced criticism over the absence of child-protection provisions, from influential public bodies such as the American Medical Association (AMA) as well as from members of Congress such as senator Bill Nelson, who has introduced legislation in an attempt to force through child-proofing measures himself.

Now, however, the agency says it is “considering whether, based on the acute toxicity of ni****ne (up to and including ni****ne poisoning), it would be appropriate for the protection of the public health to warn the public about the dangers of ni****ne exposure, especially due to inadvertent ni****ne exposure in infants and children, and/or require that some to***co products be sold in child-resistant packaging”.

It has issued an advance notice of proposed rulemaking (ANPRM) in which it seeks comments on “ni****ne exposure warnings and child-resistant packaging for liquid ni****ne and ni****ne-containing e-liquid(s) that are made or derived from to***co and intended for human consumption, and potentially for other to***co products including, but not limited to, novel to***co products such as dissolvables, lotions, gels, and drinks”.

It says it is launching this consultation following an evaluation of the relevant science, including some of the submissions made when it asked for comments on the proposed deeming regulations, but also acknowledges that it is responding to “recent increases in calls and visits to both poison control centers…and emergency rooms in the United States involving liquid ni****ne poisonings and exposures”.

Statistics on those incidents have fuelled much of the criticism of the agency.

The FDA sets out no policy positions or recommendations in the ANPRM, but its numerous questions do provide an indication of the possibilities it has been considering so far.



Child-proofing



The FDA asks:
•Is child-resistant packaging required at all?
•If so, should it be required “if the liquid ni****ne product is not intended to be opened by the consumer (e.g., liquid ni****ne in permanently sealed, prefilled, and/or disposable cartridges)”?
•“What type of exposure risks (e.g., oral, ocular, dermal) should [the] FDA seek to mitigate with the requirement?”
•Should child-resistance be defined by the presence physical features, for example “a squeeze-to-turn lid [or] flow restrictor”, or should it be defined by performance characteristics, such as “unable to be opened by 80 percent or more of 5-year-olds who try to open the package, and more than 90 percent of adults on average between the ages of 50-70 can successfully open the package”?
•Should the FDA go beyond physical child-proofing and consider regulating “other factors…to further prevent or discourage people (especially infants and children) from inadvertently consuming or being exposed to liquid ni****ne”? Examples the agency gives include “attractiveness of the product or packaging (e.g., appealing images, fragrance, flavors), resemblance of packaging to food and drink items (e.g., candy, fruit), color of the product (e.g., resemblance to beverages such as juice), resemblance of packaging to that of medications (e.g., eye drops)”.



Warning labels



The FDA asks:
•Is there a necessity for warning texts on e-liquids and other products?
•If so, what factors should determine whether a given product ought to carry such warnings? The FDA cites “physical characteristics or appearance of the product or packaging, product risks, form of marketing, route of exposure, type of packaging” as possible examples.
•What should the warnings say? For example, should they be broad, or “specifically address oral, ocular, and dermal exposure dangers”? Should they “focus exclusively on the risks to children and youth, or include the risks to vulnerable populations, such as pregnant women, adults with medical conditions, and pets”?



The FDA additionally poses many more detailed questions about the possible implementation of policies in both areas, and asks for data to support commenters’ recommendations.

It also asks for examples of “ni****ne exposure warnings (textual and/or graphic) for liquid ni****ne required by authorities at the local, State, or Federal (i.e., other agencies) level, or by foreign governments”.

Responses can be made until 1st September via the Federal eRulemaking Portal.

What This Means: Nobody should be surprised that the agency is considering these kinds of measures, given the public and political noise around the issue of ni****ne poisoning. But many important questions are, necessarily, unanswered by the ANPRM.

Is the agency already convinced by the need for such rules, and merely seeking justification, or is it genuinely unsure? Is it likely to turn now to other issues not encompassed by the deeming proposals? And what could that mean for the schedule of U.S. federal e-cigarette regulation?

– Barnaby Page ECigIntelligence staff