News on September 14, according to foreign reports, on September 6, Brian King, the new director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), was unwilling to say in an interview with Politico whether the agency was willing to use unauthorized of e-cigarette products withdrawn from the market.

This is Kim's first interview with the media since he started in the role in early July. While everyone was eager to hear what he revealed, they were likely all disappointed in the end.

He said he is committed to exploring all possible avenues that are legally and scientifically defendable, adding that nothing is impossible.

He has not admitted anything about commissioning an outside expert to investigate the CTP process. He didn't provide any details on the upcoming FDA enforcement, much to the chagrin of public health groups like the Michael Bloomberg-funded Campaign for Tobacco-Free Kids (CTFK) and lawmakers like Senator Dick Durbin .

But it turns out that the agency has already begun to take action.

The FBI is seeking a court order threatening a lawsuit and requiring the destruction of unauthorized products.

Filter has confirmed that the FDA notified the Department of Justice (DOJ) by September 1 that at least two open-system e-cigarette companies violated the Federal Food, Drug, and Cosmetic Act (FDCA) because manufacturers did not submit premarket tobacco products Apply (PMTA) and continue to sell their products.

According to a letter to one of the vaping companies seen by Filter, the federal government is seeking court orders, threatening lawsuits and requiring the destruction of unauthorized products.

All vapor manufacturers are required to submit a PMTA by September 2020. These have to be proven through extensive and expensive research, and many companies say they only learned after the deadline that their products are more likely to convert adult smokers to safer nicotine substitutes than to introduce nicotine to a new generation.

To date, the CTP has rejected about 99 percent of such applications, and dozens of companies have sued over their rejections, which they largely view as arbitrary and capricious.

"We plan to seek a court order permanently prohibiting you from... inter alia, directly or indirectly manufacturing, distributing, selling and/or offering any new tobacco products at or from any of your facilities unless and until, except Among other things, this product has been granted marketing authorization by the FDA." The letter, signed by Justice Department senior litigator Christina Parascandola, is dated Sept. 1. The terms of the government's willingness to settle the lawsuit we plan to bring.

Because of the potential lawsuit, Filter agreed not to name the individuals and companies that received the letters (one of which has now ceased business operations). The FDA did not respond to Filter's request for comment by press time.

"Defendants should bear the cost of destruction and the cost of FDA supervision."

An industry insider who requested anonymity so as not to affect his company's PMTA process said the letter was a clear escalation -- the first time, to his knowledge, that the FDA went beyond the warning and explicitly threatened to sue for the sale of unauthorized nicotine electronics. cigarette. (Both companies have received warning letters in the past.) Some manufacturers don't even bother to submit PMTAs because of the labor and costs involved—and know that the FDA will likely reject them anyway.

"The extent to which they have exercised their enforcement discretion has been almost legendary so far, so that would be at least a little bit off that." Cliff Douglas, director of the University of Michigan Tobacco Research Network and former vice president of tobacco at the American Cancer Society. Cliff Douglas) said. "My sense is that there's a lot of this happening across the country, Mitch Zeller and others mentioned asking the FDA to whack the gophers, so the big question seems to be whether this marks a new direction or a random chance of enforcement action. example."

At least two companies known to have received letters have been ordered to physically destroy their products under FDA supervision.

“Within thirty (30) days after the effective date of this decree, the Defendant shall, under FDA supervision and in accordance with a written destruction plan approved in writing by FDA prior to implementation, destroy all Defendant’s ENDS products in its custody, control, or possession. From the date of signature by all parties," the letter said. "Defendants shall bear the costs of destruction and FDA oversight incurred under this subsection."

The financial penalties for ignoring the ban will naturally be severe.

"If any Defendant fails to comply with any provision of this Act, the Act or its implementing regulations, including any time frame set forth in this Act, the Defendant shall pay liquidated damages to the United States of America of five thousand dollars ($5,000) for such violation. For each consecutive day; for each violation of this Act, the Act, or its implementing regulations, an additional four thousand dollars ($4,000) per day for each violation; and for any product that violates this Act, the Act, or its implementing regulations Additional liquidated damages of twice the retail value," the letter reads.

"The FDA is now enlisting the Department of Justice in its wrongful war on vaping, which is outrageous."

If the FDA takes all this further, it could target many manufacturers who have already received PMTA rejections and continue to sell their products, especially if the agency continues to bow to political pressure that many observers have pointed out wrong.

Critics and the independent vaping industry have also repeatedly pointed out that small and medium-sized manufacturers, especially those of open-system products, have not contributed to the past rise in youth vaping consumption (and the general panic)—and that the FDA has not yet Authorized single-use e-cigarettes are equally concerned, with many Chinese-made e-cigarettes flooding the market and becoming the most popular e-cigarettes among teens.

Arizona vape shop owner and president of American Vapor Manufacturers (AVM) Amanda Wheeler told Filter: "It's outrageous that the FDA is now enlisting the Department of Justice in its wrong war on vaping. We're talking about the hard-working small businesses that help ordinary Americans quit smoking, and they're now facing a jaw-dropping threat from federal law enforcement.