E-cigs that use synthetic nicotine are subject to FDA supervision

WASHINGTON (AP) – U.S. regulators will soon begin cracking down on vaping companies using a now-closed loophole, including a series of fruit-flavored e-cigarettes that have become teens’ best choice.

Under a law coming into force Thursday, the Food and Drug Administration can regulate e-cigarettes and similar products that use synthetic nicotine.

The action is aimed at Puff Bar and several other vaping companies that recently switched their formulas to lab-produced nicotine to avoid FDA oversight.

The change will allow the FDA to “keep e-cigarette companies using synthetic nicotine to the same public health standards we have implemented for other tobacco products,” said FDA Commissioner Robert Califf in a tweet Wednesday. Companies must now register with the FDA and submit their products for review within 30 days.

Puff Bar did not immediately respond to a request for comment.

The FDA’s action does not automatically prohibit Puff Bar and similar products. Instead, it brings them under the same regulatory regime as older e-cigarettes that get their nicotine from tobacco.

“The synthetic nicotine products do not necessarily just disappear by themselves,” said Robin Koval, CEO of Truth Initiative, an advocacy group that runs anti-tobacco advertising. “The FDA will have to decide how they want to enforce the law, and hopefully they will.”

The FDA has reviewed applications for a wide range of vaping devices, formulas and flavors – and rejected more than $ 1 million., usually because of their potential appeal to young people. Anti-tobacco advocates hope the agency will quickly do the same for all applications submitted by Puff Bar and other manufacturers.

Nicotine, the chemical that makes smoking and vaping addictive, occurs naturally in tobacco plants.

The 2009 law, which first approved the FDA for cigarettes and related products, referred only to tobacco-based nicotine. It left an opening for artificial nicotine, which is used in e-cigarette liquids, nicotine bags and other products.

Last month, Congress passed language that clarified that the FDA can regulate any form of nicotine, regardless of the source.

After performance in 2019, Puff Bar has grown to become the most popular e-cigarette among teens, by far, sold in varieties like blueberry, strawberry banana and mango. Under pressure from the FDAthe company said it stopped sales in 2020, pulling its disposable vaping devices out of grocery stores, gas stations and vape stores.

Last February, the company announced a “fresh launch” of its colorful devices that use synthetic nicotine. In marketing parlance, the company said their products “do not contain tobacco or anything derived from tobacco.” That put Puff Bar in a legal gray area because federal, state, and local restrictions almost always apply to tobacco-based products, not the nicotine itself.

Stanford researchers last year found synthetic nicotine products for sale through online platforms that ban tobacco sales, such as Amazon, eBay and Target. Under the new law, synthetic nicotine will be subject to the same federal age limit and sales restrictions as other tobacco products.

Using synthetic nicotine is not a new idea. Tobacco companies experimented with chemically extracted nicotine as early as the 1960s, but considered it too expensive for mass production. Advances in manufacturing in recent years have finally made it a viable alternative to tobacco-derived nicotine.

A major government survey last year showed that Puff Bar had skipped better-known brands to become the best choice among high school students who vape. Juul – who is widely accused of initially triggering the teen-vaping trend – was the fourth most popular brand.

By 2020, the FDA limited flavors in cartridge-based e-cigarettes like Juul to only menthol and tobacco, which are generally preferred by adults. But the taste ban did not apply to disposable e-cigarettes like Puff Bar and other types of vaping devices.

Anti-tobacco groups are concerned that the FDA consistently appears to be one or two steps behind, no matter what products are making inroads among children.

“The lesson we can all learn from this is that when the FDA’s actions are incomplete and happen after the fact – as has often been the case with e-cigarettes – you will always play a mole and catch up,” Koval said.


Follow Matthew Perrone on Twitter: @AP_FDAwriter


The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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