According to a press release, the warning letters cite the sale of “popular and youth-appealing” disposable products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars, and Lava.
The warning letters were aided by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, the agency states.
Findings released last week from the 2023 National Youth Tobacco Survey found that more than half of current youth e-cigarette users reported using the disposable e-cigarette brand Elf Bar; earlier this year, the manufacturer of Elf Bar began marketing the product under the name “EB Design.”
In addition, the brands Bang, Cali Bars, and Lava were identified as popular or youth appealing by the agency following a review of retail sales data and emerging internal data from a survey among youth, according to the agency.
“FDA’s robust surveillance of the e-cigarette landscape helps us to identify youth-appealing products and to act quickly to protect public health,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “The goal is to identify, prevent, and reduce these risks to our nation’s youth before they escalate further.”
The retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act, according to the agency.
Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
In the past year, the FDA has issued more than 400 warning letters to retailers for the sale of illegal e-cigarettes, including through a series of nationwide inspection efforts of brick-and-mortar retailers that resulted in civil money penalties issued to more than 40 retailers nationwide for the highest amount levied to date.
“CTP will continue to closely monitor all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement within CTP. “As always, we will hold anyone accountable who sells unauthorized e-cigarettes labeled, advertised, and/or designed to encourage youth use.”
The FDA has authorized 23 tobacco-flavored e-cigarette products and devices.
The Tholos Foundation, in partnership with Japan-based Pacific Alliance Institute and Sweden-based consulting firm Scantech Strategy Advisors, has released a policy paper, Safer Nicotine Works, on how Sweden and Japan have successfully reduced smoking rates by introducing safer alternative nicotine products.
Safer Nicotine Works investigates oral nicotine and heated tobacco’s effects on smoking rates in Sweden and Japan. It follows Vaping Works, which studied four countries’ vaping experiences. The latter found that nations adopting vaping, like the United Kingdom, France, Canada, and New Zealand, experienced smoking rate reductions at double the global average.
In Japan, the introduction of heated tobacco products has remarkably reduced male smoking rates below 30 percent for the first time, reversing previous stagnation.
Sweden, with a smoking rate of 5.6 percent 1 is poised to be “smoke-free” within the year. The recent decline in smoking is attributed to the rise of nicotine pouches introduced in 2019.
Tholos Foundation’s research indicates consumers in both countries led the shift to safer alternatives. Policymakers’ key role was to ensure these alternatives were accessible and viable. Data confirms that safer nicotine significantly aids smoking cessation. With safer nicotine products like vaping, heated tobacco, nicotine pouches, and snus, smoking rates are dropping rapidly.
“Safer nicotine is, quite literally, saving lives around the world,” said Tholos Foundation Vice President Lorenzo Montanari in a statement. “The experience of Sweden and Japan, just as in the U.K., Canada, New Zealand and France, proves that when people have access to safer products, they choose them in huge numbers. We now have the tools we need to fight harmful high smoking rates: governments around the world must now support their citizens to make a better choice.”
According to the Tholos Foundation Sweden and Japan’s success in lowering smoking rates highlights the efficacy of comprehensive tobacco control strategies. “They have regulated alternative nicotine products, prioritizing public health,” the organization wrote in a press note. “Sweden and Japan’s experiences provide key lessons for nations aiming to decrease smoking and encourage smoke-free alternatives. By enabling access to safer alternative nicotine products and implementing appropriate regulations, countries significantly improve public health outcomes and address smoking.”
Supporters of a nicotine product flavor ban gathering signatures as voters hit the polls Tuesday in Maine.
The Flavors Hook Kids Maine Coalition has been at several polling places around the state claiming they want to continue putting names behind the statewide flavor ban effort as the House of Representatives considers the bill in the next legislative session.
They say the most recent polling shows 63 percent of Mainers strongly support a ban on flavored tobacco and vaping products.
One of their biggest goals is to reduce teen vaping and tobacco use.
”To a young person whose brain is not yet fully formed at the age of 15, 16 years old, nicotine is even more addictive because of that,” said Dan Cashman, Flavors Hook Kids Maine spokesperson. “So, the reason for getting them hooked on nicotine is to get them hooked on tobacco. It’s a pretty easy line to draw from one to the next and none of it is okay.”
It’s been a hot topic in Maine with some health advocacy groups claiming flavored vaping and other tobacco products are marketed toward children while many shop owners owners say banning it would be a big blow to business.
The Supreme Court of Panama has decided to hear a lawsuit challenging the constitutionality of the country’s ban on e-cigarettes and heated tobacco products.
In early August, the Panamanian Tobacco Harm Reduction Association (ARDTP) filed a lawsuit with the Supreme Court, arguing that Law No. 315, which prohibits the use, sale, and import of e-cigarettes and heated tobacco in the country, is unconstitutional and should be repealed.
The Panama Association for Tobacco Damage Reduction (ARDTP) had its appeal case advanced by the Supreme Court on Sept. 21 following a lawsuit, according to media reports.
If the Supreme Court deems the unconstitutional statement valid, the 315 bill will return to the legislative body for modifications.
Once the bill is amended, it will be resubmitted to the Supreme Court to confirm its constitutionality. A proposed new law is being drafted to replace the current 315 bill, thereby supporting provisions based on “risk.”
Panama is one of several Latin American countries, including Mexico, Argentina, and Venezuela, that have implemented strict legislation since 2022 to restrict the use, sale, and import/export of vaping products.
Many harm reduction advocates argue that the enactment of such legislation has resulted in the creation of a black market for safer nicotine products within their respective countries.
The World Vapers Alliance (WVA) states that Panama’s Supreme Court’s decision to hear this lawsuit is a positive first step.
Ohio is the 24th U.S. state to allow adult marijuana use for non-medical purposes. Voters in the state approved a measure legalizing recreational marijuana on Tuesday, defying Republican legislative leaders who had failed to pass the proposed law.
“Marijuana is no longer a controversial issue,” said Tom Haren, spokesman for the Coalition to Regulate Marijuana Like Alcohol. “Ohioans demonstrated this by passing State Issue 2 in a landslide. Ohioans are being extremely clear on the future they want for our state: adult-use marijuana legal and regulated.”
The new law will allow adults 21 and over to buy and possess up to 2.5 ounces of cannabis and to grow plants at home. A 10 percent tax will be imposed on purchases, to be spent on administrative costs, addiction treatment, municipalities with dispensaries and social equity and jobs programs supporting the industry itself.
The election’s outcome represents a blow to GOP lawmakers, Republican Gov. Mike DeWine and business and manufacturing organizations concerned about its impact on workplace and traffic safety, according to the AP.
But as a citizen-initiated statute, the law is subject to change. Republicans who remain opposed to it in the Legislature are free to make tweaks to the law — or even repeal it, though the political stakes are higher now that the voters have approved it.
LeafLink, a large wholesale cannabis marketplace, commended Ohio residents on approving Issue 2 and urged lawmakers to promptly enact the law as passed.
“This vote presents a tremendous opportunity for the state where legal adult-use sales are projected to exceed $1 billion annually,” Policy Director Rodney Holcombe said in a statement. “This move puts Ohio in league with 23 other states that have taken this significant stride forward. We have witnessed firsthand the positive impact of legalized cannabis, including job creation, tax revenue for vital government services and unique business opportunities for entrepreneurs.”
The U.S. Food and Drug Administration issued a warning letter to Nic Nac Naturals for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and which resemble a pack of mints. These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children, according to the FDA.
“FDA remains steadfast in our commitment to actively monitor the marketplace and to crack down on companies selling unlawful products, particularly those that can appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our goal is to identify and prevent these emerging threats to our nation’s youth before they become mainstream.”
The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 mg or 6 mg). The packaging states the products contain nontobacco nicotine. The FDA regulates tobacco products containing nicotine from any source, including nontobacco nicotine. Nic Nac Naturals does not have a marketing authorization order from the agency to sell or distribute these products in the U.S.
One container of 15 of these mints can have as much as 90 mg of nicotine total. According to research, the FDA stated, ingesting 1 mg to 4 mg of nicotine could be toxic or severely toxic to a child under 6 years old, depending on body weight. This means ingesting one mint could be severely toxic to a child under 6 years old. Nicotine toxicity among youth of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. The FDA also stated that nicotine is highly addictive and exposure during adolescence can harm the developing brain.
“Today’s action is another example of our ongoing efforts against illegal nontobacco nicotine products,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “We remain unwavering in our use of compliance and enforcement resources to curb unlawful marketing of tobacco products, particularly those that youth could easily confuse with something that they consume regularly—like candy.”
The company has 15 working days to respond to the FDA with steps they will take to correct and prevent future violations. Failure to respond and correct violations may result in addition FDA action, such as an injunction, seizure and/or civil money penalties.
The European Union’s Subcommittee on Public Health (SANT) has endorsed the potential role of vaping in supporting smoking cessation.
Parliament’s report on non-communicable diseases acknowledges that vaping is a way for smokers to quit smoking combustible cigarettes gradually. However, the SANT’s recommendation to ban vaping in some public areas has sparked debate and concern.
Michael Landl, director of the World Vapers’ Alliance, said Parliament’s recognition that vaping can help smokers quit is a step in the right direction.
“With the well-documented success of vaping as a smoking cessation aid, it’s crucial for the EU to fully embrace this tool within its strategy to reduce smoking-related illnesses,” he said. “Vaping not only offers a way out for smokers but is instrumental in achieving public health goals.”
Despite this recognition, the report’s proposal to extend smoking bans to vaping is seen as problematic, according to Landl.
“Treating vaping the same as smoking in public spaces sends the wrong message to smokers who want to quit. There is no evidence of harm from secondhand vaping,” Landl said. “The Subcommittee must reconsider the broader impact, including the risk of former smokers relapsing. A more thoughtful regulatory approach based on common sense is imperative to ensure that vaping remains a viable option for those committed to quitting cigarettes.”
Ontario, in partnership with Canada’s national government, will double the tax on all vaping products sold in the province.
The federal/provincial tax partnership scheme that was announced in 2022 allows provinces to double the current federal vape tax and keep half the proceeds, according to Vaping360.
The Canadian Vaping Association (CVA) urged the federal government to reconsider its proposal to impose an additional provincial levy, as this would effectively double the already substantial tax burden. “The CVA suggests a more equitable approach where the federal government shares the revenue generated by the current levy with the provinces,” the industry group wrote in a statement.
“With the introduction of the excise tax, depending on product type, vape products are now almost as expensive as cigarettes despite the significant reduction in risk,” the statement says.
The CVA cautioned that the increased tax may lead to more illicit trade. “Legal businesses will find it nearly impossible to compete with the unregulated market that remains largely unchecked. The consequence of such punitive taxation will be widespread business closures, significant job losses and an increase in criminal activity.”
“The CVA encourages the province to leverage its negotiating influence with the federal government to establish a fair revenue-sharing framework for the existing tax revenue. Preserving the regulated market, rather than destroying it, will lead to higher tax revenues. The additional revenue generated can be used by the province to increase enforcement resources and support educational programs for youth,” said Darryl Tempest, government relations counsel to the CVA.
KT&G has expanded its Sin Tanjin next-generation product (NGP) factory to establish an innovation hub for electronic cigarette production.
During a ceremony celebrating growth the attended by CEO Baek Bok-in and over 40 employees, the company pledged to nurture its NGP segment into a leading business.
The South Korean tobacco company has installed three additional electronic cigarette stick production lines this year, bringing the total number to eight. It also established an automated warehouse capable of storing up to 360,000 boxes.
KT&G plans to further expand its production innovation hubs, focusing on domestic manufacturing facilities such as Sin Tanjin and Gwangju, to ensure a smooth response to the rapidly growing demand for its NGP products.
The expansion of the Sin Tanjin NGP factory is part of KT&G’s investment plan that was announced during the “Future Vision Proclamation” in January.
During that event, KT&G announced its strategy would focus on e-cigarettes, heated tobacco and the international expansion of its combustible cigarette business. The company intends to increase the revenue share of its noncombustible products to more than 60 percent by 2027 through investments and innovation.
The Sin Tanjin NGP factory will play a role as a growth engine that enhances the essential competitiveness of the NGP business, which is strengthening its market leadership.
In September, KT&G announced the construction of a new factory in Indonesia, which will be manufacturing for exports. In October, it broke ground for a new factory in Kazakhstan, establishing a foothold in Eurasia.
“The Sin Tanjin NGP factory will play a role as a growth engine that enhances the essential competitiveness of the NGP business, which is strengthening its market leadership,” said KT&G Baek in a statement.
“In the future, we will lead the growth of the NGP business based on innovative technology and advanced global partnerships and will leap to the ‘global top-tier’ through domestic innovative growth investments, including expanding production infrastructure.”
Hemp is cannabis, and it should be subject to reasonable regulations of quality, safety and youth access.
By Rod Kight
The hemp industry is subject to numerous regulations. Aside from hemp production, which is regulated by the U.S. Department of Agriculture (USDA) either directly or via USDA-required approval of state hemp plans, every state in the country has laws regarding hemp. Most states also regulate hemp products. Some states, such as California, Colorado and Oregon (to name a few), have very detailed hemp regulations that are much more stringent than federal regulations for their similar noncannabis product categories (i.e., foods, dietary supplements, etc.).
Other states, including but not limited to Florida, Tennessee and Texas, have detailed but less stringent regulations. Several states regulate hemp more generally, including Alabama, Indiana, Louisiana and Washington. To be clear, I am not making value judgments about any of these states’ regulatory schemes nor am I being comprehensive. The point I am making is that hemp and hemp products are subject to regulations of some sort, often stringent regulations, on a state-by-state level.
A hemp company that distributes products nationally, or even regionally, must deal with many compliance hurdles, including state laws that directly contradict other state’s laws, labeling requirements that are well beyond any labeling requirements under federal law, analytical testing, permitting, advertising, and age restrictions. Additionally, more and more states are imposing hemp-specific taxes. On top of this web of sometimes conflicting regulations, law enforcement is often behind the curve, and lawful hemp operators constantly live in fear of an unfounded, but stressful and expensive, raid of their businesses.
Additionally, the claim that hemp is “merely” regulated at the state level undercuts all the arguments regarding regulation promulgated by the marijuana industry since marijuana is federally illegal and is thus solely regulated by the states. This is particularly true since at the federal level, the U.S. Food and Drug Administration, the USDA and the Federal Trade Commission (not to mention the Drug Enforcement Administration) have all flexed their regulatory muscles at the hemp industry during its decade-long evolution. In short, the claim that the hemp industry is “unregulated” is simply false. Most of my time is spent advising clients on how to stay compliant with the patchwork of state and federal regulations governing the hemp industry.
Rod Kight
The hemp industry desires reasonable federal regulations
The hemp industry is often portrayed as populated by greedy “cowboys” who despise regulation and will do anything they can to sell contaminated bathtub gin products to unassuming consumers and to minors. In the popular trope, the hemp industry abhors and shuns regulations. This view is entirely unfounded. In nearly a decade of representing hemp companies, I have been fortunate to represent many of the largest and most well-known ones in the world. I have also enjoyed representing hundreds of small, mostly unknown hemp companies founded and operated by regular people who are following their dream of owning a business and expanding cannabis access to their fellow Americans.
Additionally, I have been privileged to represent and interact with many hemp associations and attorneys who represent hemp companies throughout the U.S. The common denominator of all of these people and companies is a desire to be subject to a single set of reasonable regulations. I am not aware of a single client of mine, or any other hemp executive, who does not agree with the statement, “The hemp industry should be subject to reasonable regulations regarding safety and access by minors.” Sure, cowboys exist in every industry, including the marijuana industry, but in the legitimate hemp industry, everyone is like-minded on this point.
What are “reasonable regulations”? First, and just like any other consumer packaged goods (CPG) industry, the hemp CPG sector should be subject to regulations regarding the quality and purity of its products. Moreover, marketing and labeling of hemp products should be uniform and provide the consumer with sufficient information about a product to make an informed decision about whether to purchase it and how to consume it. These types of regulations already exist for foods, dietary supplements and “vice” products, such as alcohol and tobacco. The hemp industry wants to be treated the same way with respect to quality control and marketing—no more, no less.
Second, access to hemp products by minors should be restricted. There is a lot of focus on “intoxicating” versus “nonintoxicating” products, however, classifying hemp products based on the potential for intoxication is a fool’s errand. Rather, all hemp products, with perhaps the exception of CBD isolate topicals, should be subject to age-gating, with the proviso that a minor’s parent or guardian can purchase a hemp product for the minor’s use and also provide authorization to third parties regarding its use by the minor.
I recognize that this proposal will annoy many people, but it is simple and avoids messy distinctions that are difficult to articulate and mostly unfounded in science, tricky regulations and an overall regulatory structure that will be resource intensive and, frankly, unnecessary. Distributors should be required to age-gate, but minors who need hemp cannabinoids should be able to access them with parental/guardian consent. I will also say that there are other ways to restrict access by minors and that my proposal is up for negotiation. Remember, however, that the point of this article is not to propose a detailed regulatory regime. Rather, it is to make it clear that the hemp industry agrees with age-gating and regulations regarding safety and quality.
A short note about convenience stores
Finally, I’d like to make a side comment about the sale of hemp products in convenience stores. I frequently hear the claim that “hemp products are sold in convenience stores” used as an argument about how bad and unregulated the hemp industry is. This is a red herring. Of all the possible distribution outlets for hemp products, convenience stores are among the best. Convenience stores have for decades been selling highly regulated products, such as alcohol and tobacco, that are subject to strict age-gating.
To be clear, I am in favor of all sorts of properly regulated distribution outlets for hemp products, from e-commerce sites to boutique hemp wellness centers. However, to claim that the hemp industry is somehow bad and unregulated because its products are sold at convenience stores, which are highly regulated and frequently subject to agency audits, licenses, high fines and even criminal action if certain products are sold to minors, is ridiculous. The “convenience store” argument against hemp should die because it is totally unfounded.
Conclusion
The hemp industry has been the subject of a smear campaign based on unfounded allegations that it is unregulated and that it opposes regulations. Both claims are untrue. The hemp industry is highly regulated by both federal and state laws. Additionally, the hemp industry favors reasonable regulations regarding product safety, consumer safety and access by minors. Reasonable people can differ on how these types of regulations should be written, but they are necessary and welcomed by the hemp industry.
Finally, the particular distribution outlet for hemp products is immaterial provided that hemp products are properly and uniformly regulated for quality and safety and that access by minors is restricted. To claim that an industry is unregulated and illegitimate because its products are sold at convenience stores, which happen to be some of the most regulated distribution outlets in the U.S., is a ridiculous argument that needs to be put to rest.
Hemp is cannabis, and cannabis should be subject to reasonable regulations regarding quality, safety and access by minors so that all consenting adults can have the access they need and that all Americans who desire to operate a legally compliant hemp business can take part in the burgeoning cannabis industry.
Rod Kightis an international cannabis lawyer. He represents businesses throughout the cannabis industry.
The Tholos Foundation, in partnership with Japan-based Pacific Alliance Institute and Sweden-based consulting firm Scantech Strategy Advisors, has released a policy paper, 
