In less than a month, the US FDA has halted the sale of almost all non-tobacco and non-menthol flavored e-liquids. Meanwhile, the big tobacco companies are allowed to continue selling their e-cigarettes.
"It is clear that the FDA intends to wipe out the small-scale vejp industry. We're talking about thousands of businesses that will now have to dump their inventory, lay off employees and close their stores." says shop owner and vejp activist Amanda Wheeler.
The independent US vejp industry is stunned. This is after the FDA (US Food and Drug Administration) banned over 90% of all flavored e-liquids in the country within a month.
Only menthol and tobacco left
The sweeping decision went out to hundreds of smaller manufacturers of e-juice and other vejp products in mid-September. According to the FDA, not a single one of the flavored products met the requirements. And according to the agency, e-liquid that tastes anything other than tobacco or menthol will likely not making it through the process
"The FDA has ultimately placed unreasonable demands on manufacturers. They are now basically demanding randomized control trials for every single e-liquid. They want studies where the manufacturer not only shows that the flavored e-juice in question helps smokers quit smoking tobacco better than a so-called tobacco flavor. They also need to prove that the flavoring does not entice minors to use it. That would be absurd." says Amanda Wheeler, CEO of American Vapor Manufacturers (AVM).
Permits for e-cigarettes cost millions
Over the past year, AVM has helped hundreds of small businesses apply for permits to sell their products. Each process has cost several million kronor. The FDA's more or less sweeping rejection therefore comes as a blow to the stomach, she says.
"It is clear that our authorities intend to completely wipe out the industry I represent. We are talking about thousands of companies that will now have to dispose of their stocks, lay off workers and close their shops." says Amanda Wheeler.
Counting on a few - getting several million
Since 2016, the FDA has regulated e-cigarettes and similar products under the same regulatory framework as tobacco products. Each individual product must be approved separately by the FDA. And to be allowed to sell a so-called harm reduction product, companies must demonstrate through peer-reviewed research that the product provides a public health benefit. After a lengthy process, the agency set a deadline for companies to submit applications by September 2020. Despite the high cost - an application including research on health risks and a scientifically reviewed summary costs up to one million US dollars - applications poured in. The Agency expected to receive only a few. In the end, there were 9 million applications, from 500 companies.
"The FDA had completely misjudged how the open systems industry works, with different nicotine strengths for the same e-liquid and thousands of flavors. They couldn't possibly have gone through all the applications. Instead, they decided to move the goalposts and chose an enormously high bar for approving individual products. Our members and their customers are paying the price. 92% of our sales are e-liquid with flavors other than tobacco and menthol" says Amanda Wheeler who also runs the family business JVapes.
Tobacco leaf was the target
Today, nearly 10 million Americans use a vejp product to deliver nicotine. 3-4 million of these are former smokers. At the same time, the climate of debate around e-cigarettes is infected. Young people who test e-cigarettes are in the spotlight and in recent years the FDA has been courted by several lobby organizations that want to ban tempting flavors in the e-liquid. The focus is on large companies, most of which are wholly or partly owned by tobacco companies, such as JUUL (partly owned by Altria), Vype (British American Tobacco) and Vuse (tobacco giant Reynolds). Their products, simple closed systems with high nicotine content, became popular among young people a few years ago, providing a new target for anti-tobacco groups and moneyed activists.
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Small businesses in the firing line
Also in the firing line were small independent companies that mainly produce products for more advanced e-cigarettes, open systems and, in particular, e-liquid with lower nicotine levels.
"The average age of our customers is 42. We know this because we check the age of every customer who enters our stores. According to the statistics, it is not our products that attract young people to try e-cigarettes. What the FDA is doing now will only create an industry dominated by big tobacco." says Amanda Wheeler.
JUUL, Vype and Vuse still there
At present, only products from smaller manufacturers have been denied marketing authorization. The aforementioned JUUL, Vype and Vuse are still under review and according to several analysts, at least one of these will be authorized to continue selling flavored e-cigarettes.
Activist and reviewer Phil Busardo does not mince words when commenting on the FDA's decision.
"They give the finger to small shops and manufacturers that help people quit smoking. This is something they do on purpose. They drop the big bombs on companies that can only defend themselves with wooden stakes. JUUL is another matter. They have the money, the lobby and the ability to hit hard." says Phil Busardo to the Regwatch channel. "I worry most about today's smokers, who will die prematurely in the future, when a tasty e-cigarette could have saved their lives."
"We will not give up"
Two weeks after the FDA began systematically rejecting applications for flavored e-juices, the company chose Turning Point Brands to sue the FDA for what they claim are "decisions made on unsound and improper grounds". The case is now pending in a federal court. Amanda Wheeler is not ready to give up either.
"We will not give up. We are going to do everything we can to stay open and not let down the customers who rely on these products to not fall back into smoking. That's why we started our business and that's who we're fighting for" says Amanda Wheeler.
