The Vapor Technology Association (VTA) has again met with the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) to help clarify any questions the regulatory agency may have surrounding synthetic nicotine.
VTA representatives met with dozens of CTP regulators from seven different offices inside CTP to confront any concerns about premarket tobacco product applications (PMTAs) for synthetic products that are due on May 14, according to a VTA email.
Credit: Opolja
During the meeting, several speakers joined the VTA in shedding light on how synthetic nicotine is manufactured, its purity, and its similarities and differences compared to tobacco-derived nicotine. Dr. Bill Jackson, PhD (Organic Chemistry), Dr. David Johnson, PhD (Physical Analytical Chemistry), Dr. Ray McCague, PhD (Organic Chemistry), and Dr. Willie McKinney, PhD (Inhalation Toxicology), all have experience in synthetic products and shared that expertise with the regulatory agency.
Johnson and McKinney also have extensive experience with the FDA having previously served on FDA’s Tobacco Products Scientific Advisory Council, according to the VTA.
“As with our first meeting, we are encouraged by the level of engagement by the CTP’s Office of Science on this issue,” the VTA stated in a release. “And, we greatly appreciate the participation of numerous FDA scientists from the various responsible divisions within the office with whom we were able to share our scientific knowledge and advanced thinking on the key issues.”
The VTA is hoping to continue to engage the FDA to help the agency better understand the nature of synthetic nicotine, according to Tony Abboud, executive director of the VTA.
“Our work is not done. These meetings, and the additional meetings that we are working on, are just part of VTA’s multi-pronged strategy to ensure the proper and full assessment of synthetic nicotine PMTAs,” said Abboud. “If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, you should strongly consider being engaged in our strategic efforts.”
E-LiquiTech says it has large quantities of Zanoprima’s SyNic in stock to help companies introduce new products to the U.S. market ahead of the mid-April deadline imposed by a new law.
On March 15, 2022, President Joe Biden signed into law a spending bill that includes a provision to regulate products containing synthetic nicotine the same as products containing tobacco-derived nicotine. This means that companies selling products containing synthetic nicotine will be required to file a premarket tobacco product application in order to keep their product(s) on the market. The deadline for filing such applications is less than 60 days away.
According to E-LiquiTech, SyNic is the same chemical composition of (S)-nicotine as natural tobacco-derived nicotine but without any of the impurities. Specifically, SyNic achieves a purity profile of 99.9 percent and is devoid of tobacco-specific nitrosamines, heavy metals and other impurities that are present in tobacco-derived nicotine.
SyNic is manufactured through a patented process in a cGMP facility approved by the U.S. Food and Drug Administration and meets or exceeds the U.S. Pharmacopeia monograph, making SyNic a 1-to-1 replacement for tobacco-derived nicotine and enabling manufacturers to use it as a CAS number substitute, according to E-LiquiTech.
The company says all of the scientific data that is applicable to tobacco-derived nicotine is equally applicable to SyNic. The manufacturing process is replicable from batch to batch, and every batch of SyNic is fully trackable and traceable.
Earlier this month, Zanoprima filed a patent lawsuit against Hangsen International in the U.S. District Court for the Western District of Texas to enforce Zanoprima’s patented process for manufacturing (S)-nicotine, demonstrating its long-term commitment to the U.S. market.
President Joe Biden on Tuesday signed a bill that gives the U.S. Food and Drug Administration powers over over any nicotine, not just tobacco-derived nicotine. Part of a $1.5 trillion government spending measure, the rider was slipped into the bill with no debate or notification to the vaping industry.
The language of the Tobacco Control Act will now change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”
“You know, in a moment, I’m going to sign this bipartisan government funding bill,” Biden said. “But with this bill, we’re going to send a message to the American people – a strong message – that Democrats and Republicans can actually come together and get something done.”
Bryan Haynes, a partner with Troutman Pepper, said that the amendment has an effective date 30 days after the bill is enacted (April 14) and gives a manufacturer of a tobacco product with synthetic nicotine (or nicotine derived from a source other than tobacco) 30 days after the effective date to file a premarket tobacco product application (PMTA) with FDA.
“If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market. This is likely to amount to an effective ban on synthetic nicotine products,” he wrote in the firm’s Tobacco Law Blog. “FDA is highly unlikely to authorize a PMTA in 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years.”
April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA), told Vapor Voice that the bill will have little effect on youth vaping, which is already down significantly since highs in 2015. “Although the sponsors of the bill claim the intent was to close the loophole on synthetic nicotine-derived products from large companies now popular among youth, the reality is that this bill – and others like it – aren’t likely to have the intended effect,” she said. “Instead, consumers using these products as a harm reduction option will suffer, as will licensed small businesses in full compliance with federal, state, and local laws.
“The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, grey and black markets emerge where there are no regulations requiring safe products or ID checks.”
President Biden on Tuesday is expected to sign a $1.5 trillion spending bill that funds the government through September and includes a rider that places synthetic nicotine products under the authority of the U.S. Food and Drug Administration. The Senate passed it late Thursday night by a 68-31 margin. Biden signed a stopgap measure Friday that averts a partial government shutdown that would otherwise have occurred midnight Friday.
The rule will become law 30 days after the bill’s signing date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
Azim Chowdhury, a partner with the law firm Keller and Heckman said that the way he interprets the rule is that all synthetic products already on the market or newly marketed within 30 days after the enactment date can continue to be marketed during the 60-day period following the enactment date.
The language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption,” when Biden signs the bill into law.
Products subject to timely submitted PMTAs can remain on the market for 90 days after the effective date, which is 120 days after enactment. Any product not authorized by FDA within 120 days of enactment must come off the market, according to Chowdhury.
“We do not anticipate FDA authorizing any synthetic nicotine products by the end of the 90-day period, though they may take another fatal flaw approach to quickly deny applications,” said Chowdhury. “Significantly, the rider in its current form indicates that a synthetic nicotine version of a product that already went through the PMTA process and is subject to a Refuse-to-Accept (RTA), Refuse-to-File (RTF), Marketing Denial Order (MDO), or withdrawal of a marketing order would have to come off the market as of the effective date – i.e., after 30 days of the law’s enactment.
“In simpler terms, for products that were previously formulated with tobacco-derived nicotine (and the only change was a switch to synthetic nicotine) and whose PMTAs have already been refused or denied, those products will effectively be banned on the effective date (30 days after enactment) with no opportunity to submit a new PMTA. (This is Congress’ way of punishing companies whose PMTAs were denied and then, in their view, sought to circumvent the law by switching to synthetic nicotine).”
Beyond the PMTA conditions, manufacturers of synthetic nicotine products would be subject to ‘all requirements of the regulations for tobacco products. Chowdhury said he and his team interpret this to include all additional Tobacco Control Act requirements, including tobacco product establishment registration and product listing, ingredient listing, ensuring that labeling is compliant including required warning statements, and health document submissions, among other.
April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA), wrote in a release that her organization is disappointed by the Biden administration’s use of earmarks in a omnibus appropriations bill without giving an adequate amount of time for interested parties to review and discuss the rule.
She stated that the vaping industry has helped millions of American adult consumers that have relied on flavored vapor products for over a decade to successfully remain combustible tobacco-free.
“Sadly, it is those consumers who will pay the ultimate price of this legislation,” she said. “Over the last decade of SFATA’s existence, we have fought diligently to keep flavored products accessible to smokers. Any battle lost means consumers are potentially driven back to deadly combustible cigarettes, and therein lies the real tragedy.
“It is shameful that public health officials prefer to carve legislation with a butcher’s knife, rather than with the skill and precision of a scalpel better served to ensure the nation’s public health.”
Synthetic nicotine will now require U.S. Food and Drug Administration marketing approval. The U.S. Senate approved a $1.5 trillion legislation by a 68-31 bipartisan margin that includes language that changes the definition of a tobacco product to include synthetic nicotine. The Senate sent Biden the omnibus appropriations bill, and a separate bill financing agencies through Tuesday in case it takes time to complete the required reprinting and proofreading of the lengthy omnibus measure. Biden has said he will sign the bill into law.
Credit: f11photo
“We thank leaders in the House and Senate for their partnership in getting this bill done, and the President looks forward to signing it into law,” wrote White House spokesperson Jen Psaki in an email. “The bipartisan funding bill proves once more that members of both parties can come together to deliver results for the American people.”
The rule will become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
The language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption,” when Biden signs the bill into law.
Synthetic nicotine—nicotine that is made in a lab rather than derived from tobacco—has long existed in a legal grey area, and many companies started using it after their natural nicotine products were denied market access by the FDA. Public health groups have been warning that synthetic nicotine e-cigarettes, such as Puff Bar, have grown in popularity among teens while skirting FDA oversight.
The House passed the bill late last night. Leaders in both parties have declared the legislation a win. Democrats boast of the almost 7 percent increase they secured for non-defense agencies, increasing that funding to $730 billion. Top Republicans tout the $782 billion they locked in for national defense, a 6 percent hike from current spending, according to Politico.
Proponents of the policy change refer to it as closing a loophole. Meanwhile critics of the rider contend that, given the well documented flaws and deficiencies in the FDA approval process, the budget rider will likely result in the prohibition of products that former smokers have used to quit smoking and stay off cigarettes. Vaping advocates have been working on overdrive the last three days trying to get the nicotine rule removed form the bill.
Amanda Wheeler, president of American Vapor Manufacturers association, said the of banning synthetic products is going to drive millions back to combustible cigarettes.
“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said. “It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever.
“This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”
The House passed a $1.5 trillion federal spending bill that includes language that gives the U.S. Food and Drug Administration power over synthetic nicotine. The bill now moves to the Senate and, if passed, will require a presidential signature to become law.
Not long after the 2,700-page spending bill was released early Wednesday and just hours before a scheduled vote, a number of Democrats privately registered their dismay with party leaders, raising the prospect that the entire package could collapse for lack of support. The dispute froze activity on the floor for hours as top Democrats rushed to salvage the spending measure, according to the New York Times.
By midafternoon, Speaker Nancy Pelosi of California notified Democrats in a brief letter that the coronavirus money would be dropped.
If the synthetic nicotine language remains in the bill and clears the Senate, Biden is expected to sign the measure. The rule will then become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotinefrom any source, that is intended for human consumption.”
Update: At 2:56 pm the House went into recess, to presumably make amendments to the bill. Media outlets have reported it is to remove some Covid-19 related measures (30 states at risk of losing Covid relief funding previously promised). Currently, the vote on the omnibus appropriations bill is expected to occur this evening or late tonight.
It is possible that the omnibus appropriations bill vote is delayed. In case Congress does not complete work on the omnibus by the end of the week, the House is also expected to vote on a CR through March 15 today to allow time for Senate passage and signing by the President.
If the synthetic nicotine language remains in the bill, the rule will become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
The U.S. House of Representatives is expected today to vote on an omnibus appropriations bill (page 1,870) that includes language that would give the U.S. Food and Drug Administration the power to regulate synthetic nicotine . Lawmakers have said some add-ons have already been agreed to, such as a package of health care provisions including Medicare program extensions and eliminating the synthetic nicotine loophole.
The House is planning to vote sometime today before going to Philadelphia for its annual issues conference. The bill must clear the Senate before stopgap funding expires at midnight Friday. GOP objections to a unanimous consent agreement to speed consideration in the Senate could delay final passage into the weekend, lawmakers warned, but both sides expect the process to be complete in time to avoid a partial government shutdown when federal agencies open Monday.
House Appropriations Chair Rosa DeLauro was adamant after a private House Democratic Caucus meeting Tuesday morning the omnibus would be ready for the House to pass on Wednesday, according to RollCall.
“It’s not going to get delayed. We’re going to vote tomorrow,” she said.
If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotinefrom any source, that is intended for human consumption.”
Amanda Wheeler, president of American Vapor Manufacturers association, said the of banning synthetic products is going to drive millions back to combustible cigarettes.
“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said. “It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever. This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”
Amanda Wheeler
Yaël Ossowski, deputy director of the Consumer Choice Center, said the legislation will actively harm adults who want to quit smoking. He says that the method of “fattening up continuing resolution bills with laws that benefit special interests, without broader democratic debate or analysis of the costs and benefits,” is shameful in a modern American Republic.
“The byzantine process of asking permission to sell harm reducing vaping products in the 21st century is asinine in itself. But using sleight of hand during an emergency government funding bill to castigate millions of vapers and the entrepreneurs who make and sell the products they rely on is the definition of active harm,” said Ossowski. “Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options. Many will be forced back to cigarettes.
“Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A back door bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”
Yaël Ossowski
Ossowski said he hopes elected representatives reject the synthetic nicotine inclusion and “go back to the drawing board” to offer a more permanent policy.
Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.
Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”
The regulation of synthetic nicotine has been a recent focus for many U.S. states. If a yet-to-be unveiled budget bill is passed, it is expected to include giving the U.S. Food and Drug Administration new powers to regulate synthetic nicotine, a lawmaker confirmed on Tuesday. The omnibus appropriation bill is slated to be passed in the next few days.
Language included in the omnibus spending package bill to fund the government through September would give the FDA the authority to regulate products that contain nicotine but aren’t derived from tobacco, such as synthetic nicotine, according to a document obtained by Bloomberg.
Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.
Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”
The change will stop “bad actors attempting to evade FDA regulation and hook a new generation of young people into a lifetime of nicotine addiction,” Pallone said.
Public health groups have been warning that synthetic nicotine e-cigarettes such as Puff Bar have grown in popularity among teens while skirting FDA oversight. The FDA has authority to regulate natural tobacco products, but it’s unclear if that extends to lab-made nicotine.
More than a quarter of middle and high school e-cigarette users reported using Puff Bar as their usual brand, according to a survey from the Centers for Disease Control and Prevention. Puff Bar didn’t immediately respond to a request for comment.
The same survey found brands that use traditionally derived nicotine, such as those sold by Vuse, SMOK, and JUUL Labs Inc., are also popular among teens, even though people under age 21 can’t purchase them legally.
Georgia, Maryland and Mississippi legislators recently introduced bills in their respective states that would only allow the sale of vapor products that are authorized by or pending authorization from the U.S. Food and Drug Administration, according to a Filter article.
Credit: Billion Photos
The pieces of legislation would also establish directories to inventory authorized vapor products, which would eventually be made public. On the surface, these bills look like they are reiterating what the FDA is already doing through its premarket tobacco product application (PMTA) process, through which the FDA has denied millions of products. However, many have noted that the bills serve as a roundabout way to ban synthetic nicotine.
Many manufacturers have turned to synthetic nicotine as a way to continue selling their products since synthetic nicotine is not currently regulated.
“The elected officials sponsoring these bills may be under the mistaken impression that their proposals are only targeted at illicit and counterfeit dealers,” Greg Conley, president of the American Vaping Association, told Filter. “The reality is that these bills would shut down licensed small businesses that are operating in full compliance with federal, state and local laws.”
The Republican lawmakers who introduced the bills—Maryland State Senator JB Jennings, Georgia State Senator Jeff Mullis and Mississippi Representative Nick Bain—have all received campaign funds ranging from $500 to $4,800 from Juul Labs, according to Filter. Some feel that Juul and other large companies want to see synthetic nicotine (and competition) diminished.
“To preserve the harm reduction opportunity for adult smokers, Juul Labs supports a fully regulated, science-based marketplace,” a Juul spokesperson said. “Illegally marketed and illicit products and products designed to evade federal and state oversight undermine harm reduction and a responsible e-vapor category.”
A bill in Hawaii’s House of Representatives (HB 1570) proposes to prohibit the sale of flavored tobacco and synthetic nicotine products. HB 1570 would also prohibit companies from mislabeling e-liquid products as nicotine-free and marketing electronic smoking devices to appeal to anyone under the age of 21.
Retailers who violate the proposed rule would face a $500 fine for a first offense and between $500 and $2,000 for a second violation, according to KITV.
Anyone under the age of 21 in possession of a synthetic nicotine product or electronic smoking device would be fined $10 for a first offense. Any repeats would cost $50 or between 48 and 72 hours of community service.
After Thursday’s hearing, lawmakers advanced and amended the bill to include quarterly meetings between the Department of Health and students across all schools on the matter. Establishing a vape and e-cigarette take-back program at high school and intermediate campuses statewide was also added to the measure.
HB 1570 faces several other hearings and readings in the house.
