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 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 e-cigarette-forum.com
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."
BIG COMPANIES MAY BENEFIT
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.
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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 Gaļatrend 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)
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