Category: Regulation

Attorney General of Virginia Pens Letter to U.S. FDA

Credit: RawF8
Virginia Attorney General Jason Miyares sent a letter to the U.S. Food and Drug Administration commissioner asking for increased regulation of illegal electronic nicotine delivery systems (ENDS) products.
Miyares emphasizes that despite efforts to curtail underage access to vaping and e-cigarette products, there is no centralized enforcement mechanism or license to hold shops accountable.
Additionally, many illegal knock-off ENDS products are being brought into the country from China and pose the risk of being laced with fentanyl, Miyares claims. He says the FDA must focus on bolstering enforcement and regulation to mitigate the possible risks associated with youth-targeted products.
The letter states that “the Associated Press recently advanced the opinion that the influx of illegal disposable ENDS products are due to ‘the Food and Drug Administration’s inability to control the tumultuous vaping market more than three years after declaring a crackdown on kid-friendly flavors.’”
November 12, 2023
U.S. FDA Warns Online Retailers for Illegal Vape Sales

The U.S. Food and Drug Administration issued warning letters to seven online retailers for selling unauthorized vaping and e-cigarette products.
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.
November 9, 2023
FDA Warns Nic Nac Naturals for Illegal Flavored ‘Nicotine Mints’

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.
November 7, 2023
Alabama Vape Registry Offers Louisianna Preview
Credit: Jet City Image
A Louisiana state court has put the brakes on the state’s release of its official vaping and e-cigarette registry. However, Alabama’s registry, which has been active since spring 2022, may offer some insight into what products Louisiana will allow on the market.
Passed earlier this year, Louisiana’s new law bans retailers from selling vape products not listed on a state-approved registry, known as the V.A.P.E. Directory. To receive authorization, products need a marketing order from the U.S. Food and Drug Administration or must meet one of several narrow exceptions, which favor products that have been on the market since at least 2016.
It’s still unclear which products will be listed in the directory, but Louisiana’s new law mirrors one that’s already in effect in Alabama, which has been keeping a similar list of pre-approved vaping and e-cigarette products, called the Electronic Nicotine Delivery Systems Products Directory, for over a year.
There are 1,602 vaping, e-cigarette, and alternative nicotine products listed in Alabama’s directory, meaning that many products can still be legally sold in the state, according to NOLA.com. On it are several kinds of JUUL products, various flavors of ZYN nicotine Pouches, Vuse, NJOY and BIDI Stick products.
Missing from the list are several massively popular disposable vapes, including Elf Bars, Puff Bars and EscoBars.
To check out the products on Alabama’s list for yourself, go to the Alabama Department of Revenue’s website.

Click the green box at the top right corner of the homepage that says “MyAlabamaTaxes.”
Scroll to the “Businesses” section, and click “View or upload a report.”
Under “Tobacco Reports,” click “ENDS Product Directory.”
Click the green “Search” button for every product in Alabama’s directory. Or toggle the “Manufacturer” or “Product” buttons and then search for the products you’re interested in.
If the product you search for does not appear on the list, it is not authorized for sale in Alabama and likely will not be authorized for sale in Louisiana, according to sources.
November 6, 2023
Quebec: Vaping Flavor Ban Goes Into Effect Today

Credit: CL-Medien
Vapers of scared about possibly having to return to combustible cigarettes in Quebec as the Canadian city’s flavor ban for vaping products takes effect today, Oct. 31.
Quebec’s ban includes vaping products with flavors other than tobacco and will prohibit e-liquid sold in bottles with a capacity greater than 30 mL and prefilled devices with a capacity greater than 2 mL.
The flavor ban was announced in a draft published in April. More than 30,000 citizens of Quebec commented on the proposed ban, according to the Quebec Vaping Rights Coalition, but the health ministry reportedly didn’t make any changes to the rules in response.
Quebec is the largest province in Canada to enact a flavor ban. Four other provinces and territories have flavor bans in place, and one has passed a ban but has not set an effective date yet. Three other provinces restrict flavored products to adult-only stores.
The Canadian Vaping Association (CVA) has expressed concerns to the Quebec government, arguing that this regulation will not achieve its intended goal of curbing youth experimentation.
According to the CVA, the consequences will include the closure of specialty vape shops within the province, the loss of over 1000 jobs, and a shift in consumer demand towards foreign suppliers and the illicit market.
“It’s high time for provinces like Quebec, New Brunswick, Nova Scotia, and PEI to re-evaluate their stance and stop yielding to the influence of big tobacco companies. These regions must come to the realization that they are inadvertently supporting the very issues they claim to be combating,” said Darryl Tempest, government relations counsel to the CVA.
The available data consistently finds that flavor bans fail to effectively protect youth and lead to increased tobacco sales among both young people and adults.
October 31, 2023
King: Progress Implementing Reagan-Udall Suggestions

Photo: GTNF
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has made significant progress in addressing the recommendations made by an expert panel facilitated by the Reagan-Udall Foundation, CTP Director Brian King said in a recent update.
Key areas of focus include cross-cutting initiatives, science and application review, regulations and guidance, compliance and enforcement, public education campaigns, and resource development.
According to King, the CTP is working on a new strategic plan set to be released by December 2023, which includes cross-cutting themes like science, transparency, stakeholder engagement and health equity. The center has solicited extensive feedback from both internal and external stakeholders, aiming to create a robust and inclusive plan.
Regarding science and application review, the CTP has processed more than 26 million deemed products’ applications and is committed to addressing the remaining applications efficiently while ensuring scientific accuracy and legal compliance. It has also developed resources and engaged with stakeholders to enhance the premarket application review process.
In the realm of compliance and enforcement, the CTP has taken various actions to curb the sale of illegal tobacco products, particularly those appealing to youth. They have issued warning letters and complaints for civil money penalties, demonstrating their commitment to enforcing the law.
Public education campaigns continue to play a crucial role in preventing youth tobacco product use. The CTP is actively seeking input and aims to share updated campaign information soon.
The CTP recognizes the importance of their staff and is working on enhancing their workforce development. They are also exploring options for securing user fees to support regulation efforts and requesting additional funding in the president’s fiscal year 2024 budget.
October 29, 2023
Vaping Banned in Half of Southeast Asian Countries

Photo: Aliaksandr Barouski
Of the 10 countries in the Southeast Asian region, five have banned e-cigarettes and vaping products, reports Malaya Business Insight, citing an the assessment by the Southeast Asia Tobacco Control Alliance (SEATCA).
The sale and use of vapes and e-cigarettes are already banned in Brunei, Cambodia, Laos, Singapore and Thailand, according to the SEATCA.
There are no bans in Myanmar and Vietnam while Indonesia, Malaysia and the Philippines regulate vapes and e-cigarettes. The SEATCA has urged the countries to strictly regulate the products.
October 24, 2023
Brian King Speaks About CTP Priorities and Progress
Brian King (Photo: FDA)
Throughout his first year as director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), the agency has maintained a steadfast commitment to its core principles of sound science, strategic partnerships, health equity and transparency, CTP Director Brian King said in a recent interview.
King underscored the enduring importance of these principles. He emphasized that the center’s recent decisions and enforcement efforts have been grounded in comprehensive scientific analysis. This approach, he noted, ensures that product marketing and regulatory actions are well-informed and evidence-based.
Furthermore, the director highlighted the importance of teamwork, a skill honed through his background as a scientist. Scientific thinking, rooted in objective evidence evaluation, plays a pivotal role in CTP’s work. This scientific approach is instrumental in addressing the complexities of tobacco product regulation effectively, according to King, who also emphasized the importance of effective communication in conveying scientific findings and messages.
A significant focus of CTP’s work is promoting health equity in tobacco product regulation. King discussed efforts to address disparities in tobacco use, especially among youth and young adults. Notably, the CTP is working on product standards that would prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. King views these standards as a major step toward reducing the appeal of these products, particularly among communities disproportionately affected, such as people of color, low-income populations and LGBTQ+ individuals.
To further advance health equity, the CTP has undertaken initiatives like the “Next Legends” campaign to educate American Indian and Alaska Native youth about the harms of e-cigarettes and providing Spanish-language adult cessation education resources.
During his tenure, the center welcomed Charlene Le Fauve as its first senior advisor for health equity, a crucial role in integrating health equity into the center’s programmatic plans and priorities, according to King.
Looking ahead to the next three to five years, the director stressed the importance of having a clear vision. The CTP is in the process of creating a new strategic plan with the involvement of internal staff and external stakeholders to ensure the center’s continued growth and adaptation in a dynamic regulatory landscape. The plan, to be released by December 2023, will provide a roadmap for CTP’s future, aligning its actions with changing times and the goal of reducing tobacco-related diseases and deaths in the United States.
October 24, 2023
FDA Defeats Logic in Menthol Marketing Order Suit

The U.S. Food and Drug Administration has defeated Logic Technology Development after the e-cigarette manufacturer asked the courts to block the regulatory agency’s market ban on Logic’s menthol-flavored e-cigarette products, according to media reports.
Logic filed a petition for review in the U.S. Court of Appeals for the Third Circuit, alleging the FDA violated the Administrative Procedure Act when it denied Logic’s premarket tobacco product application to market its menthol-flavored vaping products. The court denied that petition Thursday after concluding the FDA “based decisions on scientific judgments.”
Logic alleged it was arbitrary and capricious for the FDA to apply the same regulatory framework to menthol that it used to remove fruit- and dessert-flavored e-cigarettes from commerce. The Third Circuit Court entered a stay on the FDA’s marketing denial orders (MDOs) in December 2022. The MDOs were the FDA’s first-ever MDOs directed at menthol e-cigarette products.
October 20, 2023
Reynolds ITC Complaint Could Destroy Vape Industry

The implications could be far-reaching. R.J. Reynolds has filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors, and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves.
Reynolds is asking the ITC to investigate and issue an exclusion order preventing further U.S. imports of disposable vaping products. Several legal scholars have told Vapor Voice that if the ITC agrees with Reynolds, all flavored disposable vaping devices without a U.S. Food and Drug Administration marketing authorization could be stopped at the border and prevented from entering the U.S. market.
Reynolds wants the ITC to issue a permanent “cease and desist order” prohibiting any businesses from selling illegal vaping products. The move would push nearly the entire vaping industry underground, with the exception of products owned by major tobacco companies such as Reynolds that have received marketing orders from the FDA.
Several businesses were named specifically as “peddlers of illegal disposable vapes” in the Reynolds complaint, including the manufacturers, importers, distributors and retailers of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposable vapes.
Also named are several well-known U.S. wholesale and retailers of disposable vapes, including Element Vape, Flawless Vape, Magellan Technology, Mi-One Brands, Price Point Distributors, and Vape Sourcing.
The ITC complaint accuses what amounts to the manufacturers of all unauthorized vaping products of importing “illegal disposable vapes” in violation of Section 337 of the Tariff Act of 1930. Specifically, Reynolds claims the named businesses either falsely advertised that their products are authorized for sale by the U.S. government, failed to comply with federal laws imposing registration and reporting requirements and limitations on sales, or violated customs laws and regulations.
Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order (MDO), ordering Alto menthol refill pods off the market. The Alto device and tobacco-flavored pods are still under review by the agency. Two older Vuse vapes, the Solo and Vibe models (and their tobacco-flavored refills) are among the 23 products currently authorized by the FDA.
Reynolds also states it has the capacity to fill any void in the market if the illegal products were removed. “Reynolds has the capacity to replace any increase in demand if the Accused Products were excluded from importation,” the complaint states. “Reynolds is willing to meet any increased demand and can do so in a commercially reasonable time, given that it already supplies the industry with significant quantities of ENDS products, as well as oral tobacco and nicotine products.”
The ITC has not yet made a decision on the complaint that was filed on Oct. 13.
October 18, 2023