In less than a month, the US FDA has stopped the sale of almost all e-liquids with flavours other than tobacco and menthol. 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 are talking about thousands of businesses that will now have to scrap their inventory, lay off employees and close their stores." says shop owner and vejp activist Amanda Wheeler.
The independent US vejp industry is paralysed. Within a month, the FDA (the US equivalent of the Food and Drug Administration) has banned over 90% of all flavoured e-liquids in the country.
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 one of the flavoured products met the requirements. And according to the agency, e-liquid that tastes like anything other than tobacco or menthol is likely to not making it through the process
"The FDA has ultimately placed unreasonable demands on manufacturers. They are now basically demanding randomised control trials for every single e-liquid. They want studies where the manufacturer not only shows that the flavoured e-juice in question helps smokers quit smoking tobacco better than a so-called tobacco flavour. They should also prove that the flavouring does not attract minors to use it. This is absurd." says Amanda Wheeler, Managing Director of American Vapor Manufacturers (AVM).
Authorisation of e-cigarettes costs millions
Over the past year, AVM has helped hundreds of small businesses apply for licences to sell their products. Each process has cost several million kronor. The FDA's more or less sweeping rejections therefore come as a blow to the stomach, she says.
"It is clear that our authorities intend to completely wipe out the industry that I represent. We are talking about thousands of companies that now have to scrap their stocks, lay off employees and close their shops." says Amanda Wheeler.
Counted on a few - got several millions
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 able to sell a so-called harm reduction product, companies must demonstrate, through peer-reviewed research, that the product provides a benefit to public health. After a lengthy process, the agency set a deadline for companies to submit applications by September 2020. Despite the high costs; an application including research on health risks and a peer-reviewed summary costs up to one million US dollars, the applications poured in. The Agency expected to receive only a few. There were eventually 9 million applications, from 500 companies.
"The FDA had completely misjudged how the open system industry works, with different nicotine strengths for the same e-liquid and thousands of flavours. They couldn't possibly have reviewed all the applications. Instead, they decided to move the goalposts and chose a hugely high bar to approve individual products. Our members and their customers are paying the price. 92% of our sales consist of e-liquids with flavours other than tobacco and menthol," said Mr. Perez. Amanda Wheeler who also runs the family business JVapes.
Tobacco gangs were targeted
Today, nearly 10 million Americans use a vejp product to consume nicotine. 3-4 million of these are ex-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 lobbying organisations that want to ban tempting flavours in the e-liquid. The focus is on large companies, in most cases wholly or partly owned by tobacco companies, such as JUUL (partly owned by Altria), Vype (Brittish American Tobacco) and Vuse (tobacco giant Reynolds). Their products, simple closed systems with high nicotine content, became popular with young people a few years ago, giving anti-tobacco groups and moneyed activists a new target.
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Small businesses in the firing line
Small independent companies that mainly produce products for more advanced e-cigarettes, open systems and especially e-liquid with lower nicotine levels were also targeted.
"The average age of our customers is 42 years. 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 companies." said Amanda Wheeler.
JUUL, Vype and Vuse still there
At present, only products from smaller manufacturers have been denied marketing authorisation. The aforementioned JUUL, Vype and Vuse are still under review and, according to several analysts, at least one of them will be authorised to continue selling flavoured e-cigarettes.
The activist and the reviewer Phil Busardo does not mince words when commenting on the FDA's decision.
"They give the finger to small shops and manufacturers who help people quit smoking. This is something they do on purpose. They are dropping the big bombs on companies that can only defend themselves with wooden sticks. JUUL is a different story. They have the money, the lobby, and the ability to play hardball." says Phil Busardo to the Regwatch channel. "I worry most about today's smokers, who in the future will die prematurely, 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 flavoured e-juices, the company chose to Turning Point Brands to sue the FDA for what they say are "decisions made on unsound and erroneous grounds". The case is now in a federal court awaiting trial. Amanda Wheeler is not ready to give up either.
"We will not give up. We're going to do everything we can to stay open and not let down the customers who rely on these products to keep them from relapsing into smoking. That's why we started our company and that's who we're fighting for," says Mr Perez. Amanda Wheeler.
