Washington County voters Tuesday overwhelmingly upheld a ban on sales of flavored vaping and other tobacco products.
According to election returns released by the Secretary of State’s Office, 76 percent of ballots were against a repeal of a county policy banning sales of flavored products.
The ban is the first of its kind among Oregon counties.
County commissioners originally passed the policy banning flavored tobacco in November before a vaping industry advocate Jonathan Polonsky successfully gathered enough signatures to put the issue up to voters, according to Pamplin Media Group (PMG).
On the ballot, the measure read “Should ordinance 878, prohibiting flavored tobacco products, machine sales, coupons, discounts, and moveable sales of tobacco products, be repealed?”
Polonsky tried to challenge the wording of the measure, which required voters to vote “yes” against the ban or “no” in favor of the ban, in Washington County Circuit Court, but a judge upheld the measure.
Polonsky told the PMG earlier this month if a majority of voters choose “no,” he intends to appeal the results to an appellate court to determine whether the results of the election are valid based on the ballot language.
According to Tuesday’s results, 66,192 ballots were in favor of the ban, while 20,089 were against it.
The U.S. Food and Drug Administration has submitted a status report for products that currently have a premarket tobacco product application (PMTA) under review. The regulatory agency states that it expects to have resolved 63 percent of the applications set out in its original priority by June 30, 2022, and 72 percent of the applications in its original priority set by the end of this year. However, the agency does not expect to complete its review of timely submitted applications until June, 2023.
“The FDA’s progress largely reflects the review priorities that the agency established in 2020, when review began. Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the report states. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95 percent of the e-cigarette market at that time: Fontem (blu), JUUL, Logic, NJOY, and R.J. Reynolds (Vuse).”
During a House subcommittee meeting after the release of the report, the head of the FDA said the agency needs more resources to speed up its review of e-cigarettes and is avoiding making hasty decisions that could incite lawsuits from the industry.
“This is an industry that has amazing capabilities on the legal front,” FDA Commissioner Robert Califf said. “If we make one single error in the process, we can be set back for years in these applications.”
In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.
To determine which applications are for products sold under the listed brand names, the FDA used its internal PMTA database, which organizes applications by manufacturer, according to the agency. The FDA searched its database for the brand names to identify the manufacturers related to each relevant brand name and then searched its database to identify applications submitted by the manufacturers.
The FDA stated that it had conferred with the plaintiffs in the case who agreed that only one brand beyond those listed meets the 2 percent threshold. That brand was not identified. Of those applications the FDA deems requiring status reports, the agency stated that it had identified 240 covered applications. The agency estimates that its best forecast, based on current information, the FDA will take action on:
51% of covered applications by June 30, 2022;
52% of covered applications by September 30, 2022;
56% of covered applications by December 31, 2022;
56% of covered applications by March 31, 2023; and
100% of covered applications by June 30, 2023.
The agency also states that not every covered application has an equal potential impact on the public health. For example, more than 25 percent of the covered applications are for products not currently on the market.
The FDA identified two applications for products sold under the relevant brand names where the applicant stated that the products were not on the market as of August 8, 2016. The FDA also identified three other applications for products sold under the relevant brand names where the applicant did not state whether the products were on the market as of August 8, 2016. The FDA has not included information about these five applications in the current status report.
“Also, some e-cigarette devices consist of a small number of components, resulting in a small number of individual product applications for the entire system. A disposable prefilled device, for example, could constitute a single product, with one application. Other e- cigarette devices, by contrast, consist of many components, with separate tanks, coils, tubes, and pods, resulting in dozens of separate product applications for a single system,” the status report states. “Of the covered applications that the FDA anticipates will remain to be resolved beyond the end of 2022, more than half are for components of a limited number of e-cigarette device systems representing under 2.5 percent of the e-cigarette market. The FDA has made and will continue to make significant progress in reviewing and resolving applications for e-cigarette products to achieve the greatest impact on public health.”
The agency stated that it will file another status report by July 29, 2022, that will include any revisions to the estimates disclosed in the first report.
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.”
A bill banning flavored e-cigarettes and other tobacco products failed to make it past key Democratic state senators Tuesday.
Members of the Senate appropriations committee voted down the bipartisan proposal, HB22-1064, on a 5-2 vote, according to Colorado Public Radio. Three Republicans were joined by Democratic state Sens. Robert Rodriguez and Rachel Zenzinger in voting no.
The bill had been heavily lobbied and one of the session’s most high-profile and closely watched bills. But Gov. Jared Polis said he opposed it and said the issue should be handled at the local level.
Rep. Kyle Mullica, a Democrat from Northglenn, said he hoped the measure would help prevent young people from getting hooked on flavored vaping products.
“We’ve already seen a whole generation become addicted and (the bill) was going to do something about that and was going to make sure that we took a stand here in Colorado and that we put the health of our kids first,” said Mullica, one of four sponsors. “It’s a little disappointing not seeing it get passed.”
Senate President Steve Fenberg signaled the demise of the bill with reporters earlier in the day. The Senate’s top Democrat said he didn’t think there was time left in the calendar given everything else lawmakers had to finish.
On Monday, the bill was still alive and moving through the Senate. The finance committee advanced it on a 4-1 vote.
Innovations in technology and regulation could help ease the concerns surrounding youth access to vaping products.
By Timothy S. Donahue
Most tobacco control experts agree that vaping is safer than smoking combustible cigarettes. The primary concern for anti-vaping groups, legislators and regulatory officials isn’t where e-cigarettes fall on the continuum of risk, it’s about preventing youth access to nicotine products. The best way to prevent youth access is through innovation, according to vapor industry experts. Technology and regulatory policies will both be required for the vaping industry to satisfy its skeptics.
Technological innovations have been the vaping industry’s primary contribution to battling youth access. Several companies have developed devices that use biometrics, such as fingerprint and facial recognition. The OBS Cube FP Kit, for example, uses fingerprint recognition to prevent unauthorized use. However, a 2020 review by ecigclick.com found the fingerprinting function complicated to configure. “The instruction manual is total pants … it really is,” the reviewer wrote. “So far I haven’t worked out how to use the fingerprint stuff, there are diagrams in the book which relate to bugger all on the actual device.”
Juul Labs launched its C1 in Canada in 2019. The device paired with an Android smartphone to limit who could use it and to provide monitoring of what and how often the user vaped. Juul says the C1 could only be used if people got through age-verification and facial-recognition checks. The C1 also had a system that could be set to automatically lock when it was not being used or away from the phone to which it was linked.
Credit: Juul Labs
Juul Labs then launched the JUUL2, which had many of the same child safety features as the now discontinued C1. The JUUL2 also can recognize and authenticate proprietary JUUL2 pods when they’re attached, limiting the ability to use counterfeit pods or refill pods with other substances, such as THC.
Steven Yang, senior director of FEELM R&D, says that FEELM has incorporated designs into its products that prevent misuse by children, for example, by requiring the user to follow a specific sequence of procedures to activate the device.
“With a number of industry’s leading patents, FEELM is exploring ways to integrate Bluetooth, fingerprint, airflow switch, sensor and other electronic technologies to create a child lock on products,” he says, adding that many Chinese vaping industry leaders have already adopted ID verification and facial recognition technologies.
“FEELM’s strategic partner and China’s leading vape brand, RELX, has initiated Sunflower Systemin 2019. Based on AI and big data, the Sunflower System is integrated into different scenarios, such as RELX chain stores and the RELX app to prevent minors from purchasing vaping products,” explains Yang. “The Sunflower System has been extended to all RELX chain stores in China, to ensure each purchase order is traceable. Moreover, through big data and GPS, the Sunflower Systemcan automatically filter the addresses that do not meet the legal requirements of opening a vape store—for example, near schools.”
Project Sunflower consists of adopting ID and facial recognition technologies to ensure that only adults can purchase products in its China stores, according to RELX. Minors are not allowed to enter RELX stores, and in-store face-scanning cameras send alerts to RELX store staff if a suspected minor enters the store. Any suspected minor that is not able to present legal, valid ID proving his or her age is asked to leave the RELX store.
Upon purchasing a product, RELX customers also need to verify their age through a facial recognition process that matches the customer’s face with the photo on the customer’s Resident Identity Card,” says a RELX representative. “This process is to ensure that the person in the store is using their own valid identification and not attempting to impersonate an adult.”
While facial-recognition measures are widely used and accepted in China, they may encounter resistance elsewhere. Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, a U.S. based e-cigarette manufacturer, says that consumers have generally accepted biometric controls in phones, tablets and other devices that use fingerprints or faces to unlock the screens.
Those who are tech savvy would likely welcome such an alternative in their vaping products, he says. However, traditional cigarettes don’t have any electronic controls to prevent unlawful use, so if vaping regulations follow tobacco rules that would limit these types of innovations.
“The idea that such a requirement would be necessary for vapor products to receive marketing orders seems unlikely. It is important to remember that adult smokers may be unwilling to deal with an electronically locked tobacco product,” says Howard. “While some may enjoy the novelty, many may just use a tobacco product—likely higher risk—that is easier to use. Many questions surround the use of biometrics in products. There are legal privacy issues which would increase the cost of such devices.”
Manufacturers must also remain aware of regulatory restrictions in the markets they operate, according to Yang. FEELM has developed protocols to help retailers and distributors keep in compliance with local guidelines. Yang says the company attaches clear warning labels on its closed-system vaping devices and includes language in user manuals stating that the products are intended for use only by adults.
“We also focus to ensure that the retail stores in which our products are sold have mechanisms in place to verify the age of the consumers purchasing products manufactured by us so as to comply with local laws and regulations in relation to age restriction,” Yang says. “Moreover, our website and our major customers’ web stores require visitors to enter their age before entering the websites.”
Regulatory response
Taxation has long been the preferred deterrent to youth access by regulators. Studies suggest, however, that increasing taxes don’t always have the desired impact. Instead, these measures discourage combustible smokers from switching to a safer alternative, according to a study by Steve Pociask and Liam Sigaud for the American Consumer Institute, Center for Citizen Research. The researchers state, “overzealous or poorly designed restrictions [like tax increases] on vaping, combined with misleading information about e-cigarettes’ actual health risks, are deterring smokers from pursuing a potentially life-saving alternative.”
Tim Andrews, director of Consumer Issues for Americans for Tax Reform, says the evidence is clear that increasing taxes on reduced risk tobacco alternatives will do nothing to reduce youth access, but will punish adult vaping consumers, leading many back to deadly combustible cigarettes. He says one example is when the state of Minnesota imposed a tax on vaping products. It was determined that it prevented 32,400 additional adult smokers from quitting smoking, according to Andrews.
“Paradoxically, by creating a booming black market, which, by definition, possesses none of the rigorous age verification processes required by legal retailers, vapor taxes may increase not decrease youth access. This is similar to how evidence shows in states where cannabis is illegal, it is easier for high school students to purchase cannabis than beer. Increasing taxes on vaping will create a boon for smugglers—and will hurt everyone else,” he says. “Youth vaping has plummeted in recent years due to increased enforcement of existing law (according to the U.S. Centers for Disease Control and Prevention, only 3.1 percent of high school students vape daily). Adequate and appropriate enforcement of existing law—not increasing taxes—is what will continue to drive this number down.”
The recent Population Assessment of Tobacco and Health (PATH) study suggest Tobacco 21 laws are having the intended effect. Howard suggests that while limiting the minimum age of sale is seemingly effective, “it remains an open question as to whether any additional innovation is required, as additional time may show that youth access has been sufficiently curbed.”
Other innovative regulatory responses to youth vaping have had mixed results. Outside taxation and Tobacco 21 laws, any effectiveness seems hard to prove. Research suggests that there are few studies available that show what impact differing regulatory actions have on youth vaping. A study published in BMC Public Health, Policies that limit youth access and exposure to tobacco: a scientific neglect of the first stages of the policy process, examined 200 international peer-reviewed articles. The researchers found that scientific evidence on the policy process for youth-prevention initiatives were scarce.
“The processes influencing the adoption of youth access and exposure policies have been grossly understudied. A better understanding of the policy process is essential to understand country variations in tobacco control policy,” the researchers wrote. They then went on to suggest that “policymakers can adopt and implement various supply-side policies to limit youth access and exposure to tobacco, such as increasing the minimum age of sale, limiting the number or type of tobacco outlets, or banning the display of tobacco products.”
Credit: Balakley PB
Howard questions whether regulations limiting the number of tobacco outlets/vape shops or display bans would materially impact youth access. “Which companies should lose their business licenses? Should only major chains, with arguably more control over storefronts, be permitted to sell tobacco products?” Howard asks. “How will removal of businesses prevent youth from obtaining tobacco products? Yes, there will be less stores to find products, but that doesn’t mean youth vaping will decline. During the ‘youth vaping epidemic,’ Walmart, arguably the largest retail footprint in the U.S., removed vapor products from its stores—is there evidence of reduced youth vaping as a result? Finally, banning tobacco product displays may impact youth exposure to products, but would also reduce adult smokers’ exposure to different, potentially less harmful, products.”
Incentivizing success
There may be more innovative options to consider in controlling youth access. Another potential avenue to curb youth access may be to require manufacturers to offer incentives to retailers to maintain good practices. B2B sales discounts or incentives for meeting certain standards is likely to go a long way toward limiting youth access, according to Howard.
“Manufacturers can incentivize limiting the number of products in a transaction to prevent straw sales, passing compliance checks, tobacco sales training and participating in the We Card program to encourage retailers to ‘up their game’ in preventing youth access,” he says.
States are slowly becoming more innovative in their regulatory approach to youth vaping. Hawaii, for example, is considering the passage of a law that would require its Department of Health (DOH) to coordinate with its Department of Education (DOE) to establish a “take back” program for students to “voluntarily dispose of electronic smoking devices, flavored tobacco or synthetic nicotine products, and tobacco products in their possession.” If passed, the rules would also require DOH and DOE to coordinate quarterly meetings with students on addressing the youth vaping epidemic.
Many industry experts agree that the vaping industry, tobacco control community and regulators should be working together to solve the problem of youth uptake. However, that seems unlikely. It could be argued that the world’s most prominent regulator, the FDA’s Center for Tobacco Products (CTP), should be bringing stakeholders together to seek out common solutions to these problems. That hasn’t happened, according to Howard.
“It appears CTP felt compelled to use a club, as opposed to a scalpel, to excise youth vapor use. Banning flavored pods and blanket denials of millions of [premarket tobacco product applications] PMTAs for flavored products through sweeping [market denial orders] MDOs removed most industry stakeholders in just about a month,” says Howard. “While much of this was thrust upon CTP by outside forces, it is hard to imagine, when they can completely control the issue, why would CTP now resort to compromise solutions?
“CTP and the tobacco control lobby both detest those bad actors that market their products without regard to this important issue. Companies that actively follow the rules detest these bad actors, too. CTP, tobacco control and the ethical side of the industry should join forces to root these bad actors out.”
Another California city is considering a flavor ban for vaping products. The Orinda City Council introduced and unanimously passed the first reading of an ordinance during its meeting last week, that would ban the sale of all flavored vaping and other tobacco products within the city beginning in just a few weeks.
The ban would prohibit the sale or any other former of distribution of flavored tobacco products, which would include products with menthol, to Patrick Lagreid of Halfwheel. There are no exemptions for premium cigars or other products.
The ordinance will return for a second vote on May 17; if approved it will go into effect 30 days later, though there will be a 120 day grace period before enforcement begins.
The U.S. Food and Drug Administration today issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (THC). The regulatory agency claims that the companies violated the Federal Food, Drug, and Cosmetic (FD&C) Act. It’s the first time the FDA has issued warning letters for products containing delta-8 THC.
“Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products,” the agency stated in a release. “There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug.”
The states that it has not evaluated whether “these unapproved drug products” are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns, according to the statement.
“Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects,” the release states. “Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.”
The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum and peanut brittle.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”
The FDA recently published a consumer update expressing concerns about the potential health effects of delta-8 THC products. The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment, according to the agency.
The FDA states that it is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.
In addition to the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.
“CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements,” the release states. “One of the letters expresses concerns regarding CBD products marketed for food-producing animals, and the potential safety concerns related to human food products (e.g., meat, milk, eggs) from animals that consume CBD, as there is a lack of data on safe CBD residue levels.”
The FDA issued warning letters to:
ATLRx Inc.
BioMD Plus LLC
Delta 8 Hemp
Kingdom Harvest LLC
M Six Labs Inc.
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food products. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy, according to the agency.
The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
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.”
A demonstrative policy debate event on whether e-cigarettes should be regulated was held on March 8, 2022, in Taipei, showing how different public policy viewpoints can be rationally discussed, according to The Taipei Times. The debate was held by the Chinese Debate Promotion Association (CDPA) at the Taipei NGO House.
CDPA Chairman and Founder Chia Pei-te said that the Executive Yuan in January approved a draft amendment to the Tobacco Hazards Prevention Act proposed by the Ministry of Health and Welfare for legislative review. The proposed regulations on emerging tobacco products have sparked discussions, he said.
The amendment would classify emerging tobacco products as “tobacco-like products” and “designated tobacco products.” E-cigarettes would be classified as “tobacco-like products” and be fully banned while heated-tobacco products would be classified as “designated tobacco products” and be subject to regulation.
The reasoning behind banning e-cigarettes includes keeping curious teenagers away from the products, preventing consumers from adding nicotine to e-cigarette e-liquids and lowering the risk of teenage users turning to smoking.
The debate participants went back and forth discussing the pros and cons of regulating e-cigarettes versus banning them, bringing up subjects such as public health, tax revenue options and teenage use.
National Yang Ming Chiao Tung University (NYCU) College of Pharmaceutical Sciences Dean Kang Jaw-jou said that he was moved by opinions for and against e-cigarettes. He said the affirmative side proposed to directly manage e-cigarette use through regulations and an approval system while the opposing side stressed their attitude to life—banning a substance if the public consensus deems it harmful to society.
Many aspects of the topic can be argued, but e-cigarettes can cause negative health effects, and supporters and opponents must clearly present this fact to the public in further discussions, stated Wang Hsiang-tsui, NYCU Faculty of Pharmacy associate professor.
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.”
