Vaping

Thousands of illicit vapes are entering the US despite FDA enforcement of its ban on fruity flavours.

Washington, D.C. According to closely restricted sales statistics obtained by The Associated Press, the variety of electronic cigarette devices marketed in the U.S. has nearly tripled to over 9,000 since 2020, driven almost entirely by a wave of illegal throwaway vapes from China.

The increase is in stark contrast to authorities’ own statistics, which claim that only a small number of new e-cigarettes intended for adult smokers were approved while 99% of corporate petitions to sell them were denied.

The statistics show that more than three years after announcing a crackdown on kid-friendly flavours, the Food and Drug Administration is still unable to manage the volatile vaping business. Teenagers‘ preferred tobacco product is the disposable electronic cigarette, which is thrown away after use and typically comes in flavours like pink lemonade, gummy bear, and watermelon.
Although theoretically all of them are unlawful, their flood has altered the FDA’s regulatory structure. Regulators now have to find a way to recover thousands of unlawful products that were sold by unscrupulous importers and distributors, rather than carefully examining specific products that might assist adult smokers.

Although many disposables are copies of a few well-known brands, like Elf Bar or Puff Bar, hundreds of new variants are introduced each month. Companies steal one another’s designs, making it difficult to distinguish between genuine and fake products. Entrepreneurs can easily launch a new product by asking Chinese manufacturers to produce tens of thousands of units in just a few short weeks in exchange for their logo and preferred flavour.

According to statistics from analytics company IRI that the AP received, cheaper disposables, once a niche industry, made nearly 40% of the almost $7 billion retail market for e-cigarettes last year. Sales of barcode scanners from convenience stores, gas stations and other retailers are collected and stored in the company’s confidential data.

According to the data, there are currently more than 5,800 distinctive disposable goods being marketed in a variety of flavours and compositions, an increase of 1,500% from 365 in early 2020. At that time, the FDA effectively prohibited all flavours from cartridge-based e-cigarettes like Juul, the rechargeable device blamed for igniting a statewide upsurge in teenage smoking, with the exception of menthol and tobacco.

But because disposables were not included in the FDA’s policy, developed under President Donald Trump, many teenagers chose to move from Juul to the more recent flavoured products.
According to Dr. Robert Jackler of Stanford University, who has researched the emergence of disposables, “the FDA moves at a ponderous pace, and the industry knows that and exploits it.” The vaping industry has continuously developed to evade efforts to ban its goods that appeal to young people from the market.

The fact that foreign producers of the prefilled devices are not required to register with the FDA makes the situation even more difficult for authorities, who have minimal access to information about the vast sector centred in China’s Shenzhen manufacturing hub.

The FDA recently delivered warning letters to more than 200 businesses selling well-known disposables, like Elf Bar, Esco Bar, and Breeze, in response to pressure from legislators, parents, and big vaping firms. Additionally, the agency issued orders prohibiting the import of those three brands. However, according to IRI data, these businesses only represented 14% of disposable sales in 2017. Numerous other brands, such as Air Bar, Mr. Fog, Fume, and Kangvape, remain unaffected.

Brian King, the FDA’s director for tobacco, declared that the organisation is “unwavering” in its commitment to combating illegal e-cigarettes.

King remarked, “I don’t think there’s a magic bullet here.” We use a complete approach, which involves dealing with all parties involved in the supply chain, including producers, importers, distributors, and retailers.

In addition to statistics revealed last week by government researchers, which projected that the number of vaping brands in the U.S. will increase by nearly 50% to 269 by late 2022, the IRI data obtained by the AP offers important additional insights.
IRI limits who has access to the data it sells to businesses, financial firms, and academics. Access was provided to the AP under the condition of anonymity by a party not authorised to share it. IRI doesn’t provide such information to news organisations, according to the corporation, thus it declined to comment or corroborate the statistics.

It is true that the FDA has made headway in completing the approximately 26 million product applications that firms submitted in an effort to enter or continue on the market. King added that once the agency has processed all of the applications, it intends to return to “true premarket review.”

But in the interim, manufacturers of disposable vapes have taken advantage of two oversight gaps at the FDA, only one of which has been closed.

Initially, the FDA’s power only applied to goods that contained nicotine derived from tobacco plants. Puff Bar and other disposable businesses started employing nicotine produced in a lab in 2021.

Last year, Congress addressed that gap, but the move resulted in an additional backlog of FDA applications for synthetic nicotine products. The FDA was required by law to immediately decide on the petitions. While many others debut illegally, the FDA has allowed the majority to remain on the market.

According to the previous director of the FDA’s tobacco programme, an earlier loophole resulted from a decision made by Trump’s White House without consulting the FDA.
According to Mitch Zeller, who left the FDA last year, “it was preventable.” Yet, I was informed that there was no appeal.

At a press conference in September 2019, Trump declared his intention to outlaw non-tobacco flavours from all e-cigarettes, including reloadable and throwaway models. However, the president’s political advisors were concerned that may turn off voters.

In December 2019, Zeller claimed he received a phone call informing him that the flavour limits wouldn’t apply to disposables.

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