E-Cigarettes Using Synthetic Nicotine Are Under FDA Watch | Economic news


WASHINGTON (AP) — U.S. regulators will soon begin cracking down on vaping companies using a now-closed loophole, including a line of fruit-flavored e-cigarettes that have become the top choice for teens.

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

The action targets Puff Bar and several other vaping companies that have recently replaced their formulas with lab-made nicotine to circumvent FDA oversight.

The change “enables the FDA to protect public health from the harms of tobacco products, regardless of nicotine source,” the agency said in a statement Wednesday. Companies must register with the FDA and submit their products for review within 30 days.

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

FDA action does not automatically ban Puff Bar and similar products. Instead, it puts them under the same regulatory regime as older e-cigarettes that got their nicotine from tobacco.

“Synthetic nicotine products don’t necessarily go away on their own,” said Robin Koval, chief executive of the Truth Initiative, an advocacy group that runs anti-smoking ads. “The FDA will have to decide how it wants to enforce the law and hopefully it will.”

The FDA has reviewed applications for a range of vaping devices, formulas and flavors — rejecting more than a million, usually because of their potential appeal to young people. Tobacco control advocates hope the agency will quickly do the same for all claims submitted by Puff Bar and other manufacturers.

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

The 2009 law that first gave the FDA oversight of cigarettes and related products only referred to tobacco-based nicotine. This left an opening for artificial nicotine, which is used in e-cigarette liquids, nicotine pouches and other products.

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

After appearing in 2019, Puff Bar has become by far the most popular e-cigarette among teens, sold in flavors like blueberry, strawberry, banana, and mango. Under pressure from the FDA, the company said it was halting sales in 2020, removing its disposable vaping devices from convenience stores, gas stations and vape shops.

Last February, the company announced a “relaunch” of its colored devices using synthetic nicotine. In marketing parlance, the company said its products “do not contain tobacco or anything derived from tobacco.” This puts Puff Bar in a legal gray area, as federal, state, and local restrictions almost always apply to tobacco products, not nicotine itself.

Last year, Stanford researchers discovered synthetic nicotine products for sale through online platforms that ban the sale of tobacco, 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.

The use of synthetic nicotine is not a new idea. Tobacco companies experimented with chemically derived nicotine as early as the 1960s, but deemed 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 overtaken more well-known brands to become the top choice among high school vapers. Juul – which is widely blamed for initially sparking the teenage vaping trend – was the fourth most popular brand.

In 2020, the FDA restricted the flavors of cartridge e-cigarettes like Juul to menthol and tobacco, which are generally preferred by adults. But the flavor ban did not apply to disposable e-cigarettes like Puff Bar and other types of vaping devices.

Anti-tobacco groups fear the FDA is always a step or two behind products that make inroads in children.

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

Follow Matthew Perrone on Twitter: @AP_FDAwriter

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

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