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August 8th, 2016:

E-cigarette makers rush new products to market ahead of U.S. rules

NEW YORK, Aug 8 (Reuters) – The e-cigarette market is suddenly getting more crowded.

Makers of the “vaping” devices launched a flood of new products in the United States ahead of new federal regulations, taking effect on Monday, that require companies to submit e-cigarettes for government approval before marketing them, according to company officials and industry experts.

The U.S. Food and Drug Administration, which announced the regulations in May, will allow e-cigarette devices introduced before the regulations came into force to be sold for up to three years while companies apply and await regulatory review.

The regulations also ban the sale of e-cigarettes to anyone under age 18.

The multibillion-dollar industry had sought to delay the new rules through lawsuits and proposed legislation in the U.S. Congress. At the same time, many of the smaller players hedged their bets by releasing new products during the three-month period between the announcement of the regulations and their effective date.

“I would be surprised if there was any other period when so many products were introduced,” said Bryan Haynes, an attorney with the firm Troutman Sanders who represents several e-cigarette companies.

Not of all the new products may be available immediately to consumers. Many companies beat the regulatory deadline with only limited shipments and product prototypes.

“There are scores of new products getting out ahead” of the deadline, said Oliver Kershaw, founder of the website that tracks the industry.

“They’ve been put quietly into the market. Some of them are just brand refreshers. Some are quite interesting products,” Kershaw said, referring to such innovations as “pods” – capsules that can be inserted into the devices – that are prefilled with flavored nicotine.

The FDA regulations for the first time bring regulation of e-cigarettes, cigars, pipe tobacco and hookah tobacco in line with existing rules for cigarettes, smokeless tobacco and roll-your-own tobacco.

The rules require companies to submit these products for government approval, list their ingredients and place health warnings on packages and in advertisements.

Cigar makers also rushed new products to the market to beat the regulations.

“We have attempted to do in 90 days what we usually do in three years,” said Eric Newman, president of J.C. Newman Cigar Co, in business since 1895. “If it wasn’t so serious, it would be comical to see the hoops we’re going through.”


E-cigarettes are handheld electronic devices: metal tubes that heat liquids typically laced with nicotine and deliver vapor when inhaled. The liquids come in thousands of flavors, from cotton candy to pizza. Using them is called “vaping.”

Reynolds American Inc, Altria Group Inc and Fontem Ventures, a subsidiary of Imperial Brands Plc, are among the leading manufacturers of the devices.
Their use has grown quickly in the past decade, with U.S. sales expected to reach $4.1 billion in 2016, according to Wells Fargo Securities.

The healthcare community remains divided over the devices. Some experts are concerned about how little is known about their potential health risks and about growing use by teenagers, fearing that a new generation will become hooked on nicotine.

Others support them as a safer alternative to tobacco for smokers unable to quit.

The FDA regulations are expected to shutter many “vape shops” that make their own products and cannot afford undergoing the approval process. The rules may benefit the big manufacturers, especially tobacco companies like Reynolds and Altria, which have the checkbooks and experience to navigate regulatory agencies.

Despite the new rules, France’s leading manufacturer of “e-liquids” used in the devices started doing business in the United States last month. The company said it hoped the new market could help double its current sales of about $55 million.

“The vaping consumer is going to be drowned in a lot of new products,” said Arnaud Dumas de Rauly, president of Gaïatrend USA, referring both to new devices and to types of liquids.

Reynolds, which makes the top-selling VUSE, did not introduce any new products this summer. Altria launched new flavor varieties including Menthol Ice and Smooth Cream.

Altria’s Nu Mark e-cigarette company “has a robust pipeline of products and takes a disciplined approach to introducing those products to understand adult smoker and vaper acceptance,” Altria spokesman Steve Callahan said.

Callahan said the company was also mindful of the requirements of the new regulations and complying with the timelines the FDA established.

Mistic E-Cigs had planned to introduce sometime this year a new product called the Mistic 2.0 POD-MOD personal vaporizer, which has pods prefilled with liquids, but said its staff worked 14-hour days to ensure it was ready before the regulations took effect.

“We got a little lucky but we had to work a little extra hard,” said Justin Wiesehan, Mistic’s vice president of regulatory affairs. (Reporting by Jilian Mincer; Editing by Michele Gershberg and Will Dunham)

Protecting the Public and Especially Kids from the Dangers of Tobacco Products, Including E-Cigarettes, Cigars and Hookah Tobacco

This month, for the first time, FDA will be able to help protect the public, and especially kids, from the dangers of all tobacco products.

For years, it has been illegal under federal law to sell cigarettes and smokeless tobacco to minors. Under a rule finalized in May, federal law now prohibits retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18.

Beginning today:

 It will become illegal nationwide to sell cigars, hookah tobacco, and e-cigarettes to anyone under age 18 and retailers will need to check photo ID of anyone under age 27.
 Retailers will not be allowed to give away free samples of newly deemed tobacco products.
 Retailers will not be allowed to sell cigars, hookah tobacco, and e-cigarettes in a vending machine where anyone under age 18 has access at any time.

In 2009, the President signed the Family Smoking Prevention and Tobacco Control Act into law, giving FDA the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. But cigar, hookah tobacco and e-cigarette markets remained unregulated, creating a market environment I have equated in the past to the Wild, Wild West.

While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb – putting a new generation of kids at risk of addiction. E-cigarette use, for example, skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) among high school students; and hookah use also increased significantly. And every day, more teenage boys try a cigar than try a cigarette.

That’s why this historic rule is so important. It enables FDA to regulate all tobacco products except accessories – improving public health and protecting future generations from the dangers of tobacco.

In addition to restricting youth access to tobacco products, FDA will now be able to review new tobacco products not yet on the market, prevent misleading claims and help better provide consumers with information to make informed decisions about their tobacco use. This means tobacco product manufacturers will be required to register and list their products with FDA. And all newly regulated products will need to get a marketing order from FDA, unless they are grandfathered (were sold in the U.S. as of February 15, 2007.) Manufacturers will also be required to report ingredients and harmful and potentially harmful constituents in their products.

Under these public-health based regulations, tobacco product manufacturers seeking a marketing order from FDA must now demonstrate what is actually in these products, and how these products impact the health of those who use them – important rules to be expected for products that expose consumers to known or potential health risks.

To assist companies in making the transition to an FDA-regulated marketplace, we have published several guidance documents to help businesses, big and small, meet these new requirements. We also continue to offer webinars for retailers and manufacturers and support from our Office of Small Business Assistance.

This historic final deeming rule is a major public health step forward. We believe by restricting youth access to additional tobacco products such as cigars, hookah, and e-cigarettes and by scientifically reviewing these products, we will reduce the public health toll of tobacco use, which remains the leading cause of preventable disease and death in the country and the world – and keep our kids tobacco-free.

Mitch Zeller, J.D., is the Director of FDA’s Center for Tobacco Products

Macau legislators resume tobacco bill scrutiny in Oct

Scrutiny of Macau’s revised tobacco control bill will only start again after October 15 at the earliest. The territory’s Legislative Assembly working committee tasked with the job is still awaiting the government’s feedback regarding some comments the committee has made on the content of the bill.

So said legislator and businessman Chan Chak Mo – the head of the relevant working committee – in comments to GGRAsia.

“The government is yet to give us a feedback regarding the content of the bill – namely whether it accepts our opinions on the bill,” Mr Chan told us. “It is only when we have the government’s response, that we’ll be able to resume discussion.”

Mr Chan added that his committee is currently occupied with other bills and will be up to August 15; at which time the assembly starts a two-month summer recess.

A majority on the relevant working committee supported the retention of smoking lounges on casino main floors, Mr Chan had said in comments to the media following a closed-door committee discussion on May 26. The working committee’s tentative support for smoking lounges is on condition that second-hand smoke can be kept away from casino staff and from guests that don’t smoke, Mr Chan said at the time.

“Regarding tobacco control in casinos, that is what our committee has suggested to the government,” Mr Chan told GGRAsia in his latest comments. He added: “But we don’t oppose the [government] suggestion of banning tobacco sales inside casinos.”

“After the government tells us what their opinions are on the bill, I don’t think it will take long for the assembly to process the bill,” the legislator added. “In terms of technicality, the bill is not hard to handle – it’s more the political will from the government that weighs on the progress of the legal revisions,” explained Mr Chan.

The government has proposed a total ban on smoking in the city’s casinos. A number of investment analysts have said that could depress revenue for the already beleaguered industry, which in July had recorded its 26th consecutive month of year-on-year decline in casino gross gaming revenue.

Macau’s Secretary for Social Affairs and Culture, Alexis Tam Chon Weng, told media on June 26 that the government was still open to suggestions from legislators regarding the revisions to the tobacco control bill.

“The [smoking control] bill would definitely not be dropped. Because the bill has already been approved through first reading by the Legislative Assembly,” said Mr Tam at the time.

“It’s only that now the [working] committee has raised some suggestions regarding the bill, which we’re open to discuss them. And we’ll have to see if their suggestions are appropriate,” the secretary said.