Category: News This Week

New regulations for vapor products across the UK are set to come into force on Friday. The rules will require warnings for e-cigarettes, limit their nicotine levels to 20 grams and restrict advertising and sponsorship by their makers.

The rules will be enforced under the Tobacco and Regulated Products Regulations 2016 with a one-year transitional period for the sale of old stock.

Here’s everything you need to know about the new rules:

The amount of nicotine vapers inhale in each container is set to be reduced in two ways. First, the new maximum size of each refill container will be set at 10ml. There are currently no limitations on the size of refill containers. The changes could result in a price increase for consumers as it will not allow them to buy large amounts in. Secondly, the maximum strength of e-cigarette cartridges will drop to 20mg per milliliter (2 percent) from 24mg

All vapor packaging will also now be required to carry health warnings. The front and back of e-cigarette packaging will contain health warnings much like regular cigarettes.The warnings will state: ‘This product contains nicotine which is a highly addictive substance’. All packaging must be child resistant and tamper-proof, as well.

Under the new laws, e-cigarette and vapor companies will no longer be able to make claims about vaping being beneficial to people’s health. This includes a ban on comparisons between the merits of vaping compared to smoking cigarettes. Celebrities will also not be allowed to endorse e-cigarettes and free samples cannot be given out in promotional campaigns.

Lastly, manufacturers are required to submit information to the government on exactly what their products contain in order to be allowed to sell them.

Let the litigation begin. The first of what is expected to be a plethora of companies has filed suit against the U.S. Food and Drug Administration (FDA) challenging its recently released deeming rules for the vapor industry.

Florida-based Nicopure Labs, represented by the international law firm of Covington & Burling, filed suit in the U.S. District Court for the District of Columbia in response to new FDA regulations that would subject e-cigarettes and other vaping products to more onerous restrictions than combustible cigarettes under the Tobacco Control Act.

In its court filing, Nicopure Labs argues that the FDA’s rulemaking process violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the Constitution of the United States.

“Once the Deeming Rule goes into effect on August 8, 2016, the overwhelming majority of Nicopure’s products—including hundreds of products that are neither made nor derived from tobacco nor intended for human consumption—will be subject to the premarket approval, reporting, record-keeping, inspection, labeling, manufacturing, testing, and other requirements imposed by the Act,” the suit states. “Such regulation will severely burden Nicopure and its operations— costing millions of dollars. The Deeming Rule’s premarket approval requirements will force Nicopure to discontinue existing product lines and will also prevent Nicopure from introducing new product lines after the Rule’s effective date.”

Nicopure Labs general counsel and chief compliance officer Patricia Kovacevic, said the company felt it had no other options other than to turn to the justice system to protect its rights and the rights of its customers. “The government’s role is not to regulate for the sake of regulation,” she said. “Regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”

Jeff Stamler, CEO and co-founder of Nicopure Labs, said that since 2009, Nicopure revolutionized the way e-liquid was manufactured and packaged, forever changing the vapor industry as few knew it. “Today, Nicopure Labs is again at the forefront of the industry as revolutionaries … through one voice, Nicopure Labs has taken a stand to ensure the voices of all [vapers] are heard and that [vapers] are treated fairly and not with a single stroke of a broad brush by the FDA,” he said  “We fully support reasonable regulation that protects consumers, accomplishes the public health priority to reduce the grave harm caused by conventional cigarette smoking, and allows businesses to survive and innovate for a greater [public-health] vision for our society as a whole.”

Jason del Giudice, CTO and co-founder of Nicopure Labs, said the company is committed to responsible manufacturing based on superior product standards and stringent quality requirements. “[The] FDA’s rule does not protect the consumer from low quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies,” he said.

Local vape shop operators, whether chain or mom and pop, have known for several years that federal regulators wanted their business to go up in smoke — and not in a good way.
Yet, most of the vape shops contacted by the Winston-Salem Journal were not sure how to react to the final regulatory rules disclosed May 5 by the U.S. Food and Drug Administration.

Some operators expressed surprise that their products — electronic cigarettes, water pipe/hookahs and vaporizers — were at risk for being shelved if they don’t meet new regulations that go into effect Aug. 8, according to an article in the North Carolina-based Winston-Salem Journal.

Many of the smaller vape shops make their liquid nicotine on the premises or order it from suppliers.The FDA is requiring that products from all three categories that debuted after Feb. 15, 2007, undergo a heightened regulatory review process to determine whether the product has a negative impact on public health unless there is a substantially equivalent product available before that predicate date.

The FDA allows for up to a three-year exception for products whose manufacturer enters the regulatory gauntlet by Aug. 8.

Preston Puckett, with the Avail store in Winston-Salem, said he believes the company likely has the financial resources to comply with the FDA standards. Avail, based in Richmond, has more than 70 stores in six states, including two in Greensboro and one each in Burlington and Winston-Salem.

“But I can see a lot of little shops going away because of the regulatory costs,” Puckett said. “The local market is pretty saturated as it is. We all want the products to be safe to the consumer, so we’re not opposed to additional regulations.”

Puckett said he can envision some of the smaller vape shops selling all their supplies before the Aug. 8 time frame for new regulations. “They’ll try to make as much money as they can if they determine they can’t afford the review costs,” Puckett said.

Despite a ban on selling electronic cigarettes in the United Arab Emirates (UAE), several retailers at the Chinese-themed Dragon Mart in Dubai told The National newspaper that they could get the devices.

Although they did not have the devices in their possession, the retailers said they could get them within five minutes.

Much like the EU, many parts of the world see electronic cigarettes as hugely less-risky substitutes for traditional tobacco cigarettes.

Two years ago, The National reported that retailers at the mall were flouting the ban by selling the devices in their shops, many of them unaware that a ban was even in place.

Now, it seems they are being more careful, but electronic cigarettes are still available for between Dh200 and Dh300.

One Dragon Mart retailer, who had pictures of different types of electronic cigarettes on his phone, said that he sold at least a few of the devices a week but that he kept them at another location to avoid being fined.

A spokesman for Nakheel Retail, which operates Dragon Mart, said in 2014 that it did not condone the actions of such retailers.

“Tenants are always required to be in compliance with the applicable rules and regulations,” the spokesman said.

“Any instances of non-compliance brought to the attention of the mall management is dealt with in accordance with the tenancy contract, including advising the appropriate officials of the law enforcing agencies.”

The European Union’s top court approved sweeping new rules that will require plain cigarette packs, ban menthol cigarettes and regulate the growing electronic cigarette market.

The Independent British Vape Trade Association said in a statement that it is disappointed by the ruling and argued it could push some e-cigarette smokers back to tobacco.

Tobacco companies had protested a 2014 EU directive on the new rules, calling it disproportionate. But the European Court of Justice on Wednesday upheld the directive, arguing it’s in line with efforts to fight smoking and protect public health.

The rules will require warnings for e-cigarettes, limit their nicotine levels to 20 grams and restrict advertising and sponsorship by their makers.

The court said it is OK to ban menthol and other flavorings that make tobacco more appealing. The directive also requires standardized, plain labels that cover at least 65 percent of all cigarette packs with health warnings.

A groundbreaking 200-page report that supports e-cigarettes as a tool to quit smoking and demolishes several vaping myths in the process has been released by one of the world’s most prestigious medical organizations.

The Royal College of Physicians (RCP), the most respected medical institution in the United Kingdom, concluded e-cigarettes are 95 percent safer than regular cigarettes and are likely to be hugely beneficial to public health.

Patricia Kovacevic, general counsel and chief compliance officer for U.S.-based Nicopure Labs, summarized the report’s key areas: “The Royal College of Physicians findings are clear: 1. E-cigarettes are not a gateway to smoking. 2. Their use does not result in normalization of smoking. 3. Among smokers, e-cigarette use is likely to lead to quit attempts and eventually successful smoking cessation. 4. Possibility of long term harm cannot be entirely dismissed but it is likely to be very small, and substantially smaller than that arising from smoking. These findings should weigh heavily here, in the U.S., against the (U.S. Food and Drug Administration) decision to issue a deeming rule that may decimate the vaping industry.”

Titled “Nicotine without smoke: tobacco harm reduction,” the report is one of the most comprehensive ever published examining e-cigarettes and could be a game changer for health officials and politicians all over the world, according to an article published in The Daily Caller.

The RCP’s seminal 1962 report, which demonstrated the link between smoking, lung disease and bronchitis spurred the U.S. Surgeon General to publish the historic 1964 “Smoking and Health: Report of the Advisory Committee to the Surgeon General of the United States.”

The RCP’s new report tears apart scare stories, including the ever-more popular idea that vaping is somehow a gateway to smoking. “To date, there is no evidence that any of these processes is occurring to any significant degree in the UK,” said the report’s authors.

Contrary to the claims of some public health activists in the U.S., the RCP is clear: e-cigarettes can help smokers kick their habit for good. “Among smokers, e-cigarette use is likely to lead to quit attempts that would not otherwise have happened, and in a proportion of these to successful cessation. In this way, e-cigarettes can act as a gateway from smoking.”

JTI’s New Logic PRO tank e-cigarettes have been available at Sainsbury’s stores in the UK since January, but were launched nationwide this month. The release will be boosted with a TV and outdoor media campaign beginning May 1. 

Tanks are the cartridges that hold the e-cigarette’s vaping liquid and can be replaced when empty, according to an article in City A.M.

The launch comes a year after JTI bought one of the United States’ leading independent e-cigarette makers, Logic, last April. Founded in 2010, Logic specialized in rechargeable, ready-to-use and disposable e-cigarettes, including the Logic Pro tank system.

Around 85 percent of vapers use tank e-cigarettes, equating to around two million regular users in the UK.

The U.S. House Appropriations Committee, on April 19, approved an amendment to the Agriculture Appropriations bill offered by Rep. Tom Cole (R-OK) and Rep. Sanford Bishop (D-GA), that would modify the predicate date for vapor products.  

The vapor industry has been very concerned with one proposed U.S. Food and Drug Administration (FDA) regulation in particular – a rule that would require all e-cigarette and vapor products that came on the market since February 2007 to undergo a Pre-Market Tobacco Applications (PMTA) process that  could cost each company/manufacturer millions of dollars.

“What happened today is a big boost of momentum for the industry,” said Arnaud Dumas de Rauly, treasurer of the Vapor Technology Association, which represents manufacturers and businesses. “We’re happy to have bipartisan co-sponsors because up until now we only had Republican buy-in. Now we have Democratic buy-in as well.”

The amendment to modify the “grandfather” date was approved 31-19.

The FDA is expected to issue a final rule (sometime this year, although there is no specific date) giving it authority for the first time to regulate e-cigarettes and vapor products (the White House has been reviewing the FDA deeming regulations for  exactly six months on April 19),which generated $3.3 billion in U.S. sales last year.

The committee’s decision doesn’t mean the amendment is law. It will now have the chance to go forward as part of an appropriations bill and be voted on in the House of Representatives. If passed, it would then move on to the U.S. Senate.

Vapor industry representatives say this legislation is a strong step forward. However, future innovations may not be able to meet the substantially equivalent standard, even with a 2016 date, due to the lack of a substantially equivalent product being on the market.

In the first conviction of its kind in the country, a shopkeeper in Mohali, Punjab, India has been sentenced to three years in jail for selling e-cigarettes under the Drugs and Cosmetics Act, 1940, according to a story in the Indian newspaper the Tribune Trust.

Sessions Judge Saru Mehta Kaushik also slapped a fine on 25-year-old Parvesh Kumar of Punjab Crockery. Out on bail, he’s been given a month to appeal. In 2013, the State Drugs Controller had issued a circular declaring e-cigarettes as an “unapproved drug”.

In the April 7 ruling, the judge noted, “E-cigarette contains nicotine in chemical form, which is highly addictive and potentially lethal. The youth take to such kind of addictive and potentially lethal products, and the offenders involved in promoting and selling such products should be dealt with sternly by law for the welfare of the society.”

He was sentenced to three years of rigorous imprisonment and required to pay fines.

“Having done well in the field of tobacco control in general, Punjab, with this conviction, has shown the way to the entire country to end the nicotine-delivery devices sold in the form of e-cigarettes,” Health Secretary Vini Mahajan reacted. Food and Drug Administration Commissioner Hussan Lal said, “E-cigarettes have ushered in a so-called ‘no-smoking revolution’, becoming a fad especially among the youth. They are marketed as a healthy substitute to cigarettes. There are a lot of misconceptions about their potential benefits but all this is farce. The most important ingredient of e-cigarettes is nicotine.”