Big Tobacco Is About to Dominate the E-Cig Industry
The
electronic cigarette industry is poised to irreversibly change next
week. Manufacturers face a Sept. 9 deadline to submit premarket tobacco
product applications (PMTA) to the Food & Drug Administration or
face having their e-cigs and e-liquids pulled from store shelves.To get
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Because
the cost of complying with the regulations is staggeringly high, many
manufacturers will not be able to make it over the hurdle, and the e-cig
market will be left largely to the tobacco giants.Some 650 PMTAs have
been submitted to the FDA as of June, the most recent data available,
but each application covers a separate product. Philip Morris
International (NYSE:PM), the first company to file an application, had
four separate PMTAs approved: one for its IQOS heated tobacco device and
three for flavors of its disposable Heatsticks.
Although the FDA
estimates a single PMTA costs anywhere from $117,000 to $466,000, those
figures are considered low by the industry. The Rocky Mountain
Smoke-Free Association estimates a single PMTA costs between $8.6
million and $11.1 million per stock keeping unit (SKU). It forecasts
14,000 small vape businesses employing 166,000 workers will be
destroyed, representing $24 billion in economic activity.
The
problem is it's not just e-cig manufacturers that need to comply with
the regulations, but also manufacturers of the e-liquids the devices
use, as well as the vape shops that sell them.Amanda Wheeler, the owner
of five Jvapes vape shops in Arizona, Colorado, and Oklahoma, explained
the situation this way: "Let's say I have 100 products and each of the
flavors has five nicotine levels, which means five SKUs per flavor,
legal and other fees will cost my stores in excess of $5.5 billion.
There's not a small business owner in the United States who can afford
$5.5 billion for SKU applications."
She likens the situation to
what would occur to a liquor store if it had to pay and apply for every
SKU in its store. "We wouldn't have liquor today," Wheeler said.
Where
British American Tobacco (NYSE:BTI) and Juul Labs (which is backed by
Altria (NYSE:MO)) can afford to pay such rates, the vast majority of
businesses serving the industry are small ones and will find the
technical hurdles difficult to surmount.The FDA doesn't identify
companies that have submitted applications until it takes action on
them. However, several other companies have applied, including Imperial
Brands, which says it has submitted PMTAs for a "wide range of its myblu
electronic vaping products," as well as Japan Tobacco, which submitted
one for its Logic brand of e-cigs.
At least one independent vape
manufacturer was also able to see it through to the end. E-Alternative
Solutions, the maker of the Leap brand of devices and pods, submitted
over two dozen applications for flavors and nicotine strength, as well
as for its devices. Avail Vapor, one of the biggest vape shop chains (in
which Altria once had a minority interest), says it also has submitted
PMTAs for its products.
It's possible then this small coterie of
companies account for the vast majority of PMTAs submitted. With
applications running several hundred thousand pages long and containing
scientific studies and data to support the application, only the most
well-financed company can afford to submit an application.