Category: U.S. FDA

FDA Increases Civil Monetary Penalties for Retailers
The U.S. Food & Drug Administration (FDA) announced that it has increased the penalties that nicotine companies and retailers pay if found in violation of the various federal laws regarding nicotine products.
The changes are part of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which requires the penalties to adjust with inflation.
The updated penalties are:

First Violation — $0 (Warning Letter)
2 within a 12-month period — $345 (Previously $320)
3 within a 24-month period — $687 (Previously $638)
4 within a 24-month period — $2,757 (Previously $2,559)
5 within a 36-month period — $6,892 (Previously $6,397)
6 within a 48-month period — $13,785 (Previously $12,794)
The civil monetary penalties are handed out to vaping and other tobacco companies or retailers that are found to violate FDA’s rules regarding vaping and other tobacco products.
Examples could range from an e-cigarette company failing to use a proper warning label to a retailer caught selling any nicotine product without checking the I.D. of an undercover buyer.
November 15, 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
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
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
FDA Denies Marketing Order for Flavored Vuse Alto Pods

Image: Rangizz
The U.S. Food and Drug Administration on Oct. 12 issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Co. for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths.
After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth, according to the agency.
“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Product’s Office of Science. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”
Vuse is the most commonly sold e-cigarette brand in the U.S., with Vuse Alto being its most popular sub-brand. Further, findings from the National Youth Tobacco Survey (NYTS) show that Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly reported e-cigarette brand used by youth in the U.S. since 2021.
These actions are among many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. The FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. These authorizations include other products under the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and accompanying cartridges. Applications for six tobacco-flavored Vuse Alto products remain under FDA review.
October 12, 2023
U.S. Supreme Court Declines to Hear Avail Vapor Case

Credit: Avail Vapor
The U.S. Supreme Court declined Tuesday to hear arguments against the Food and Drug Administration’s regulatory authorization process.
The denial order comes in one of several cases questioning the FDA’s oversight of the vaping industry.
The US Court of Appeals for the Fourth Circuit sided with the FDA, finding that Avail hadn’t shown that its products had benefits for adults that offset the risk to youth.
The case is connected to the FDA’s 2021 determination to deny all of Avail Vapor’s requests to approve fruit and dessert-flavored e-cigarettes. The company claimed that the agency made the application process intentionally difficult, which led to mass denials of new product submissions.
In a Supreme Court brief filed Aug. 3, the company claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco flavored ones as an aid in adult smoking cessation.
Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.
In its petition, known as a Writ of Certiorari, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues in its petition that the FDA’s decision making was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.
October 10, 2023
FDA Issues Civil Money Penalties to 22 Retailers

Credit: VetKit
The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.
The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the civil money penalty actions.
“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.
The retailers can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint or file an answer and request a hearing. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
Courtesy: US FDA
In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.
Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure or civil money penalties.
“We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement in the CTP. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.”
September 28, 2023
U.S. FDA Seeks New Industry TPSAC Nominations

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) is requesting nominations by Oct. 11, 2023, for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization.
In addition, the CTP is seeking any industry organizations interested in participating in the selection of this TPSAC nonvoting representative.
Nomination materials for prospective TPSAC candidates and letters from industry organizations interested in participating in the selection process should be sent to the CTP by Oct. 11, 2023. Please see the Federal Register notice for further details on the nomination and selection procedures.
TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.
September 18, 2023
CTP Launches Latest PMTA Resource Website

Credit: Suphakant
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has launched new resources to help applicants navigate the agency’s premarket tobacco product application (PMTA) process.
Specifically, CTP is offering a new webpage with more in-depth information on how to complete the three required PMTA forms to submit and amend pending applications.
Over the last few years, CTP has received more than 26 million PMTAs and made determinations on 99% of those applications.
Based on this experience and communications with applicants, CTP has developed the new online resources, which includes easy-to-access tips to help applicants submit in the future.
“These new online resources are part of CTP’s ongoing efforts to enhance the center’s efficiency, effectiveness, and transparency in response to recommendations from an independent external evaluation led by the Reagan-Udall Foundation,” a release states.
These latest resources build on tips CTP provided earlier this year for applicants preparing amendments to pending PMTAs.
September 7, 2023