The U.S. Food and Drug Administration’s implementation of the 2009 Tobacco Control Act, which gave the agency authority to regulate tobacco products, has been fundamentally flawed from the beginning, according to Azim Chowdhury, a partner in the Keller and Heckman law firm.
Writing inFilter, Chowdhury explains that the premarket authorization requirements for “new” products subjects potentially reduced-harm products to nearly insurmountable hurdles while allowing preexisting products, including combustible cigarettes, to mostly escape FDA scrutiny.
In his article, Chowdhury suggests several ways in which the FDA can more effectively implement the Tobacco Control Act.
For example, rather than conducting reviews in a silo, the FDA should consider the totality of evidence in a premarket tobacco product application, according to Chowdhury.
“It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement,” he writes.
“Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.”
All nontobacco nicotine is now subject to the same regulations as tobacco-sourced nicotine in the U.S.
By Timothy S. Donahue
It was both expected and unexpected. Everyone in the vaping industry knew that at some point the U.S. Congress and the Food and Drug Administration were going to decide on how to handle synthetic and nontobacco nicotine. It was generally believed that regulation would appear in an appropriations bill in September, meaning vaping advocates thought they had time to fundraise and prepare for a battle.
They did not. Instead, the language for changing the definition of the Tobacco Control Act (TCA) to include all nicotine products was buried on page 1,861 of the 2,741-page omnibus spending bill that was signed by President Joe Biden in March. How the rider found its way into the omnibus has caught the ire of many in the industry who say major tobacco companies are seizing the vaping industry away from the small business owners who got it started.
Senator Richard Burr was allegedly approached by R.J. Reynolds and Juul Labs representatives about getting the synthetic nicotine rider in the omnibus that at the time was winding its way through Congress. Burr joined forces with fellow senators Dick Durbin and Patty Murray and Representative Frank Pallone to get the nontobacco nicotine language into the omnibus, according to two Senate sources familiar with the discussions, as reported by Bloomberg Law.
Azim Chowdhury
Azim Chowdhury, a partner with the law firm Keller and Heckman, said he interprets the rule to mean 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 law became effective on April 14, and manufacturers will have until May 14, 2022, to either submit a premarket tobacco product application (PMTA) to the FDA for each vaping product that contains synthetic nicotine or pull their products from the market.
Manufacturers that submit PMTAs to the agency by the May 14 deadline can continue marketing their products until July 13, 2022. Beyond that date, all products must be removed from retail stores unless the FDA has issued a marketing authorization, 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 (the term Fatal Flaw was used by the FDA for PMTA submissions that didn’t have specific studies and were subsequently denied) 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, refuse-to-file, 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.”
MIchelle Minton / Credit: Competitive Enterprise Institute
Michelle Minton, writing for the Competitive Enterprise Institute, states that given the FDA’s sluggish track record, many of the applications may not even be reviewed, let alone approved, in that time, which would make the bill a de facto prohibition on those products. “FDA has made it painfully clear that there is no way for those companies to earn its approval,” Minton said. “All it will do is guarantee that companies and consumers are pushed in ever-greater numbers toward a growing illicit market where there are no consumer protections and no age restrictions—or back to smoking.”
Stately response
Beyond the PMTA conditions, if a marketing order is granted, manufacturers of synthetic nicotine products are also subject to all the regulations for tobacco products. Keller and Heckman interpret this to include all additional TCA 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 others.
Many states had already started to ban synthetic nicotine unless a product gets marketing approval from the FDA. Legislation has been introduced in four state capitals and enacted in one state, Alabama, that effectively bans all products containing synthetic nicotine. Patrick Gleason, vice president of state affairs at Americans for Tax Reform, said Alabama, then Mississippi, Maryland and Georgia, were the first states to introduce legislation effectively banning synthetic nicotine products. However, he says there will be no need for more state legislation to ban synthetic nicotine now that the federal government has added it to the TCA.
Yaël Ossowski
Yael Ossowski, deputy director of the Consumer Choice Center, said that making companies ask permission to sell harm reduction products in the 21st century is “asinine.” 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,” he noted, is the definition of active harm.
“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 hardworking 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,” said Ossowski. “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 backdoor 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.”
There is no sell-through period for retailers of synthetic nicotine products if the manufacturer does not file a PMTA with the FDA by May 14. While some manufacturers plan to end sales of their synthetic products by the deadline, as Ossowski suggests, others plan on submitting robust and timely applications. Patrick Mulcahy, CEO and co-founder of Streamline Group, parent to the Streamline Vape Co., wrote in an email that his company has been working toward a solution to navigate the regulatory landscape for newly deemed synthetic nicotine products.
“We have recently contracted with Accorto Regulatory Solutions to manage, submit and deliver a complete set of premarket tobacco [product] applications. To date, their track record of applications submitted have received zero MDOs. Their commitment to submitting a complete and robust PMTA is the level of service Streamline aims to provide the market with our current and future line of products,” he said.
“Streamline’s goal during this process is a commitment to provide full transparency, informational updates and other news related to these regulatory requirements as we progress through the various phases of the PMTA,” Mulcahy stated, adding that market confidence is a top priority for Streamline Group, which was submitting PMTAs for its Juice Head brand e-liquids, disposables and nicotine pouches along with its NIIN brand e-liquid and pouches.
Organized approach
April Meyers, SFATA
April Meyers, owner of Connecticut-based Northeast Vapor Supplies and CEO of the Smoke-Free Alternatives Trade Association (SFATA), told Vapor Voice that her organization believed the industry would have more time to hold discussions with legislators on the Clarifying Authority Over Nicotine Act of 2021 (HR 6286) introduced by Representative Mikie Sherrill in December of last year. SFATA members were aware of the mounting pressure on the subject of synthetic nicotine and had been developing strategies to counter the pressure.
Given the inclusion of vapor in the Prevent All Cigarette Trafficking (PACT) Act in the 2021 omnibus, the nonprofit vapor industry advocacy group was not completely surprised to learn that HR 6286’s language had been included in the 2022 omnibus bill, according to Meyers.
“We went immediately to work educating our members on the issue, executing a call to action and making a volley of calls to sources at the Capitol, including our contacts at the freedom caucus,” said Meyers. “Those sources confirmed that a handful of large vapor companies and several Big Tobacco companies were in support of the measure. We were also informed that the House and Senate votes would move quickly and that there was little opportunity to get the provision removed. This was discouraging, to say the least, but did not dissuade us from acting. This industry has learned to mobilize quickly and has achieved several victories under similar circumstances.”
Meyers said that while the sponsors of the synthetic nicotine rider claimed the intent was to close a loophole on synthetic nicotine-derived products from large companies now popular among youth, the rule, and others like it, are very unlikely to have that intended effect. Instead, she said, consumers using these products as a harm reduction option will suffer alongside all the small businesses that have always operated 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, gray and black markets emerge where there are no regulations requiring safe products or ID checks. The vapor industry is incredibly resourceful,” Meyers said. “SFATA believes our government should have learned its lesson from the 1920s that prohibitionist policies never work. In this country, and particularly, this industry, where there is a will, there is a way. Despite the attempt to bring the vapor industry to heel, adults have been vaping flavored products in the U.S. for [nearly 15 years]. It is delusional to think that will be snuffed out with the signing of a law. Our fear is that this will pave the way to a growing illicit trade market while simultaneously increasing smoking rates across the country as studies have already demonstrated in localities with flavor bans.”
Tony Abboud, VTA
Tony Abboud, president of the Vapor Technology Association (VTA), said that everyone who understands anything about PMTAs knows that an application cannot be filed within the 90-day time frame, particularly because the FDA requires at least six months of scientific data for such an application. He said the new rule could become a de facto ban on synthetic nicotine that would have some unintended consequences.
The VTA hired economic research firm John Dunham & Associates to evaluate the negative economic impacts that a synthetic nicotine ban would have in the U.S., according to Abboud. The results included 16,100 lost jobs, over $800 million in lost wages and $2.5 billion in lost economic output. It would also cost the U.S. more than $500 million in yearly taxes.
Amanda Wheeler
Amanda Wheeler, owner of Jvapes and president of American Vapor Manufacturers, said during the 103rd annual meeting of Vapor Voice’s parent company, TMA, that she hopes the FDA offers “some kind of enforcement discretion” to small businesses, especially those manufacturers that are trying to follow the rules.
“I can only plead with the FDA at this point not to repeat the mistakes of 2020 and 2021, finding an arbitrary reason to toss all of those applications out on their ear. The consequences this time are even more dire,” said Wheeler. “We have this serious handicap on our hands as far as the time frame … I think we need to treat businesses equitably and recognize that there is only so much that people can do in 60 days. And enforcement discretion would be the thing that’s most helpful to prevent companies from having to look for an alternative solution.”
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.”
On January 1, 2022, two new state laws will become effective in Illinois and Oregon and could cause significant disruption to the vapor industry. According to Azim Chowdhury and Taylor D. Johnson, with the Keller and Heckman law firm, The Preventing Youth Vaping Act, will take effect in Illinois and HB 2261, will take effect in Oregon.
Photo: Skypixel | Dreamstime.com
Under the Illinois law, an electronic cigarette is broadly defined as
any device that employs a battery or other mechanism to heat a solution or substance to produce a vapor or aerosol intended for inhalation;
any cartridge or container of a solution or substance intended to be used with or in the device or to refill the device; or
any solution or substance, whether or not it contains nicotine, intended for use in the device
“Critically, SB 0512 considers an electronic cigarette to be adulterated (and prohibited for sale) if, “it is required by 21 U.S.C. 387j(a) to have premarket review and does not have an order in effect under 21 U.S.C. 387j(c)(1)(A)(i) or is in violation of an order under 21 U.S.C. 387j(c)(1)(A).” In other words, if an e-cigarette is required by the federal Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387j(a)) to have premarket authorization from the U.S. Food and Drug Administration and does not have a Premarket Tobacco Product Application (PMTA) order in effect (or is in violation of such an order), it would be considered adulterated under the Illinois law,” the post states. “Although the law exempts e-cigarettes “first sold prior to August 8, 2016 and for which a premarket tobacco product application was submitted to the U.S. Food and Drug Administration by September 9, 2020” from the adulteration definition, products that are subject to timely submitted PMTAs that FDA has either refused-to-accept, refused-to-file, or have received marketing denial orders from FDA would likely still be considered adulterated by the state (as well as FDA).”
The rules do not apply to synthetic nicotine or CBD products.
In Oregon, the legislation prohibits the shipment of “inhalant delivery systems” to any person in Oregon other than a distributor or a retailer. The legislation effectively prohibits direct-to-consumer (DTC) sales (including online sales) of the vast majority of vapor products in Oregon, according to the blog post.
“Inhalant delivery systems” are defined in the legislation as “a device that can be used to deliver nicotine in the form of a vapor or aerosol to a person inhaling from the device; or a component of a device described in this paragraph or a substance in any form sold for the purpose of being vaporized or aerosolized by a device described in this paragraph, whether the component or substance is sold separately or is not sold separately.”
As such, the legislation would appear to prohibit the DTC sale of most types of vapor products, but likely would not cover non-nicotine closed-system products:
Type of Vapor Product
Subject to Oregon HB 2261 shipment ban?
Bottled e-liquid (with or without nicotine)
Yes – language covers “a substance in any form sold for the purpose of being vaporized or aerosolized by a [inhalant delivery system] device”
Open-system/Open-tank ENDS Device
Yes – language covers “a device that can be used to deliver nicotine in the form of a vapor or aerosol to a person inhaling from the device”
Yes – language cover “or a component of a [inhalant delivery system] device”
Closed-system ENDS (e.g.., pod/cartridge or disposables) pre-filled with nicotine-containing e-liquid
Yes – language covers “a substance in any form sold for the purpose of being vaporized or aerosolized by a [inhalant delivery system] device”
Closed-system ENDS (e.g.., pod/cartridge or disposables) pre-filled with non-nicotine containing e-liquid
No – this type of product (i.e., a pre-filled CBD or THC vapor device) would not fall within meaning of a inhalant delivery system
An e-cigarette is also considered adulterated if (A) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or deleterious substance that may render the product injurious to health; or (B) it is held or packaged in containers composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.
China’s recently announced intention to regulate e-cigarettes as tobacco products will reverberate around the world, according to an analyses published on Keller And Heckman’s The Continuum of Risk blog.
On Nov. 26, 2021, China’s State Council announced it would amend the country’s tobacco monopoly law to subject e-cigarettes to the same requirements as traditional cigarettes. On Dec. 2, the State Tobacco Monopoly Administration (STMA) published on its website the draft management rules for e-cigarettes for public comment.
The draft rules define “e-cigarette” as an electronic delivery product that produces nicotine-containing aerosol for human inhalation. The definition does not include heat-not-burn tobacco products, which are already regulated as combustible cigarettes in China, according to Keller and Heckman. The draft rules make clear that e-cigarettes should be regulated like tobacco products by STMA and its local agencies and provide that e-cigarettes must comply with the e-cigarette national standard.
Among other things, e-cigarettes will be subject to premarket registration upon a safety review by the STMA under the draft rules. Producers and sellers of e-cigarettes in China must obtain the same tobacco monopoly licenses as traditional cigarette manufacturers. In addition, all vapor product companies will be required to trade on a national e-cigarette platform to be set up by the SMTA. The draft rules also contain requirements to protect minors such as age-restrictions and warning labels.
Because the draft rules’ registration and production licensing requirements apply to all e-cigarette manufacturers operating in China, they will also impact products sold abroad. China manufactures more than 95 percent of the world’s e-cigarette hardware.
In 2019, China notified the World Trade Organization about its first national standard on e-cigarettes, which covers raw materials, technical requirements, testing methods and labeling, among other topics. On Nov .30, 3021, China published updated draft of the standard for comment.
According to Keller and Heckman, the STMA plans to implement the standard “three to five months after its publication.”
During the transition period, existing enterprises can continue manufacturing and operational activities. However, investors are banned from investing in new e-cigarette enterprises; existing e-cigarette production and operation entities must refrain from constructing or expanding production capacity, and they may not establish new e-cigarette retail outlets and market new products. “New import of e-cigarettes” will also be suspended during this period.
The public comment period for the draft management rules closes on Dec. 17, 2021, 15 days after its publication, and the public comment period for the draft standard closes on Jan. 29, 2022.
