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FDA and Synthetic Nicotine Vape Regulation: Everything We Know

2022/07/15|Industry news

In an after-hours press release Wednesday, the FDA announced that more than 200 manufacturers of synthetic nicotine products had submitted more than 1 million premarket tobacco applications (PMTAs) ahead of the May 14 deadline, vaping360 reported.

As of July 14, the agency said it was illegal to sell any of these products.

An additional provision in the federal omnibus spending bill passed by Congress in March grants the FDA new authority over all forms of nicotine, regardless of source. The language amends the Tobacco Control Act of 2009 to include nicotine from non-tobacco.

The March 2022 law required FDA to take immediate regulatory action, setting a deadline (May 14) for PMTA submissions for synthesis-based products and granting a 60-day grace period (until July 13) during which time Products are available without authorization.

Warning messenger FDA looks tough

The FDA's press release on Wednesday linked a list of 107 retailers that have received warning letters for selling synthetic nicotine-based products (not necessarily just vaping products) to minors. All but one of the letters were sent on June 30, and most appeared to go to smoke shops, convenience stores and gas stations.

“Outside of the COVID era, the FDA and its state partners have been conducting teen access compliance checks,” Gregory Conley, president of the American Vaping Association, told Vaping360. "After a bad news month, the FDA tends to issue media releases to promote their day-to-day work."

The agency also issued warning letters to two small manufacturers for selling products without first submitting a PMTA. The companies previously registered with the FDA when they used tobacco-derived nicotine to make e-liquids.

“The easiest targets for the FDA are U.S. companies that previously registered tobacco-derived nicotine products, but have since switched to synthetic nicotine and haven’t filed PMTAs,” Conley said. "This is yet another case of the FDA placing a bet on a difficult decision, but against a small business manufacturer of open-system vaping products."

Following the September 2020 PMTA submission deadline for tobacco-derived nicotine vaping products, the FDA used its manufacturer database to find and cite small companies that did not submit PMTAs. The agency issued a scathing press release after each batch of warnings.

FDA Enforcement and Enforcement Discretion

In its press release, the FDA noted that after July 13, any new non-tobacco nicotine products that did not receive FDA premarket authorization could not be legally marketed. However, the agency did not elaborate on whether synthetic products would be the focus of enforcement.

"Over the next few weeks, we will continue to investigate companies that may be illegally marketing, selling or distributing non-tobacco nicotine products and will take action as appropriate," said Brian King, director of the FDA's Center for Tobacco Products (CTP), who Started working at the agency less than two weeks ago.

FDA does not have the resources to investigate and seize all unauthorized synthetic (or non-synthetic) nicotine products sold nationwide. It must focus on priorities set by agency leadership.

Technically, all vaping products that have not been authorized by the FDA are placed on the market illegally, and have been since the August 8, 2016, Presumptive Rule granting FDA authorization for e-cigarettes. Except for the six or so devices authorized by the agency since last fall, all vaping products exist on the U.S. market simply because of the FDA's enforcement discretion.

On September 9, 2021, at the end of the one-year full enforcement discretionary period for manufacturers of vaping products made using tobacco-derived nicotine to file timely PMTAs, the FDA issued a statement similar to the one issued late Wednesday: All New tobacco products placed on the market without a statutory premarket authorization are sold illegally and are subject to FDA discretion to take enforcement action.

In a series of tweets Wednesday night, FDA Commissioner Robert Califf repeated language from the press release before adding: "It is important to address the products with large market shares that pose the greatest risk to young people.

This seems to indicate that the FDA will focus its enforcement efforts on the myriad synthetic nicotine-based single-use e-cigarettes sold at tens of thousands of convenience stores and gas stations (as well as some vape shops). Bottled e-liquids based on synthetic nicotine are sold almost exclusively in age-restricted vaping stores and are not popular with teenage vapers.

Some e-liquid makers that sell synthetic nicotine-based e-liquids have been doing so for years. But after the FDA last August began releasing millions of boilerplate MDOs for nearly every vaping product in flavors other than tobacco or menthol, most have rolled out synthetic e-liquid lines.

A significant portion of the 200 manufacturers seeking synthetic product authorization through the PMTA pathway are members of the American Vapor Manufacturers Association (AVM), which represents mostly small companies that manufacture and sell e-liquids. In June, the AVM filed an FDA citizen petition asking the agency to expand its formal enforcement discretion to manufacturers who submit applications by the deadline and demonstrate compliance with FDA rules and local laws.

So far, nearly 4,000 people have commented on the FDA citizen petition, many through a call to action issued by CASAA. While the FDA will eventually have to formally respond to AVM Citizen's petition, its statement yesterday appeared to indicate that while it is not prepared to formally grant enforcement discretion, the agency will not focus enforcement efforts on bottled e-liquids sold by adults , in stores only.

Pressure from TFK and Congress leads to FDA misstep

The FDA is facing intense pressure from the Campaign for Tobacco Free Kids (TFK) and its allies in Congress to remove all synthetic nicotine-based products from the market. Many retrosynthetic hoops can be traced back to one product: the Puff Bar.

In July 2020, single-use e-cigarette maker Puff Bar (or the importer as it calls itself the manufacturer) announced that it would cease sales in the U.S. days before it received the FDA warning letter. Then in March 2021, a company calling itself the Puff Bar announced that the device would return to store shelves, but would now use synthetic nicotine, shielding the company from FDA rules and enforcement.

U.S. Rep. Raja Krishnamoorthi, a staunch anti-vaping lawmaker from Illinois, wrote an unhinged letter to acting FDA Commissioner Janet Woodcock, asking the FDA to use all available tools, including seizures, injunctions and criminal prosecutions, to Hold individuals responsible for these flagrant violations.

The problem is that if Puff Bar is actually using synthetic nicotine as it claims, it's not breaking the law. The Tobacco Control Act of 2009 gave the FDA authorization to “make or derived from tobacco” products that contain nicotine. The FDA cannot ban new single-use products.

Last August, when the FDA began issuing PMTA denials to many small bottled e-liquid makers, many of them reformulated their products with synthetic nicotine to legally stay on the market. Some made the mistake of announcing the move on social media, which came up in some news reports.

This makes smokeless children feel dizzy.

The group's letter to Acting FDA Commissioner Woodcock -- its third to the agency on synthetic nicotine -- actually cited a Facebook post from a small e-liquid maker that claimed switching to synthetic nicotine would make Their products exceed FDA regulations. This absolutely cannot hold.

The letter was also signed by the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Parents Against Vaping (PAVe), and the Truth Initiative. The groups are demanding that the FDA immediately declare synthetic nicotine a drug, which would hand over regulatory authority to the FDA's Center for Drug Evaluation and Research (CDER).

Other tobacco control advocates disagree with this approach. Since the FDA has unsuccessfully tried twice before to regulate nicotine as a drug, they prefer to change the law to give the CTP authority over all forms of nicotine. In December 2021, Rep. Mikie Sherrill of New Jersey introduced a House bill that could do just that. It is co-sponsored by Rep. Krishnamoorthi and Utah Republican Rep. Chris Stewart.

The bill was never brought to a committee hearing, debated or voted on, but its language became the basis for riders inserted in the spending bill that became law in March. Interestingly, the synthetic nicotine approach is backed by Juul Labs and Vuse maker RJ Reynolds, the maker of two of the most popular vaping products in the country. What are Juul's and Vuse's main competitors? Gorgeous disposables are also sold at traditional convenience stores and gas stations.

Since Krishnamoorthi and TFK's letter to the FDA last year, anti-vaping extremists in Congress have been pressuring the FDA to drop its mandatory scientific review process and ban everything -- ban all vaping flavors, ban Juul , bans synthetic nicotine products. When the FDA doesn’t do what congressional prohibitionists like TFK and Sen. Dick Durbin demand, the face turns red and the threats start flooding in.

An article in STAT News on July 8 described anti-vaping groups as a stroke because the FDA has not taken action against any companies selling synthetic products that have not filed PMTAs. Durbin said he would investigate the agency.

Anti-vaping groups expect the FDA to act quickly and withdraw all pending products from the market, according to STAT. On July 12, the day before the FDA's synthetic announcement, TFK issued a press release asking the agency to take immediate action.

“As we approach the July 13 deadline,” said TFK President Matthew Myers, “the FDA has an obligation to enforce the law and clear the market for any synthetic nicotine products, including e-cigarettes, that have not been authorized by the FDA by that date. If By allowing unauthorized products to remain on the market, the FDA would be in direct violation of laws passed by Congress and put America’s children at risk. Given the authorization and deadlines set by Congress, there is no reason for the FDA not to act.”

Senator Durbin went on. In a July 12 letter to FDA Commissioner Califf, also signed by Sen. Susan Collins, Republican of Maine, Durbin denounced the agency's previous failure to stamp out vaping and said the FDA appears once again to be at the cusp of failing to protect our country. Children are safe from the dangers of nicotine addiction.

Nothing illustrates how political pressure from Durbin, TFK and its allies has twisted the FDA into knots like the agency's actions against Juul Labs and its PMTA.

Last month, a day before the FDA issued a flimsy MDO ordering all Juul products off the market based on the FDA's dubious claims, Durbin did the same, issuing a press release slamming the FDA's response to e-cigarettes and vaping. Do nothing. Urge Galiff to do his part to protect our children or to step aside.

Both Krishnamoorthi and a Durbin staff assistant appeared at the Parents Against Vaping (PAVe) webinar to celebrate Juul MDO and tout their impact on the FDA. "So I'm very happy that after my office and I actually had a long conversation with the FDA commissioner on this matter, the FDA finally decided to block JUUL from selling the product," Krishnamoorthi told the anti-vaping panel in federal court in less than 24 hours. Before temporarily halting Juul's denial order.

Soon after, the FDA was forced to back down and reverse its decision, allowing itself to keep the MDO and promising to re-examine the vaping company's PMTA.

Comprehensive authorization process: 60-day PMTA

Despite pressure from Congress and anti-vaping groups, the FDA cannot simply issue a ban on products it doesn't like. The agency must follow its established PMTA process or be vulnerable to legal challenges from manufacturers.

The FDA is still battling dozens of lawsuits over the mishandling of the first round of PMTAs, when the agency, under pressure from Congress, eager to process millions of applications quickly, issued new PMTA requirements in 2021, then Apply it retroactively to those applications that were filed nearly a year ago. Using these after-the-fact requirements, the agency created a boilerplate rejection system for the PMTA.

A federal court panel reviewing a rejected application called the FDA's bizarre maneuver an accidental switch and issued a marketing denial order (MDO) that suspends the manufacturer.

Other manufacturers have received suspensions, and the FDA has withdrawn MDOs from some companies outright.

In its press release, CTP said it intends to issue Rejection of Acceptance (RTA) letters as soon as possible for those applications that do not meet the acceptance criteria. Acceptance is the first stage of the FDA PMTA review process and only requires that the application itself complies with legal and regulatory requirements.

After acceptance, the review phase becomes increasingly difficult: Submission follows, followed by substantive review, during which the agency is supposed to analyze the actual data provided in the application.

The biggest problem facing manufacturers of synthetic nicotine products

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