Tag: U.S. Food and Drug Administration

FDA Asked to Clarify PMTA Process

Photo: Me studio
U.S. senators Ted Budd, Rand Paul and Joe Manchin, sent a letter to Food and Drug Administration Commissioner Robert Califf requesting he explain and clarify the FDA’s approach to nicotine product regulation and urging him to reform the tobacco product application process, according to Vaping360.
“Since 2009, more than 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S.,” the senators wrote.
“Of those 26 million applications, the CTP [Center for Tobacco Products] has authorized fewer than 50. Remarkably, it has also authorized a total of only 16 modified-risk tobacco products (MRTPs) for only four unique products and their accessories.
“This miniscule authorization rate is not in keeping with the CTP policy acknowledging that tobacco products fall on a continuum of risk. The availability of scientifically substantiated, authorized PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”
The Tobacco Control Act requires that the CTP review and decide on PMTAs and MRTPs within 180 days, however, the FDA has not delivered on this timeline.
The senators cited the Reagan-Udall Foundation’s report on the CTP and posed a series of questions to Califf.
The senators are asking Califf to respond to their questions within 30 days.
December 15, 2023
Warning Letters for Unauthorized Products

Photo: Ljupco Smokovski
On Dec. 13, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali and Breeze. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violations discussed in the warning letter and to prevent future violations. Failure to promptly correct the violations can result in FDA enforcement actions such as an injunction, seizure and/or civil money penalties.
“It is illegal to sell, import, distribute or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA,” said CTP Director Brian King in a statement. “The products identified in these warning letters are being marketed without the required authorization. We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product.”
As of December 2023, the FDA has issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes and filed civil money penalty complaints against more than 65 retailers and manufacturers for the manufacture or sale of unauthorized products.
To date, the FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products.
December 14, 2023
MRTP Renewal Filed for General Snus
On Nov. 30, 2023, the U.S. Food and Drug Administration filed for scientific review modified-risk tobacco product (MRTP) renewal applications submitted by Swedish Match USA for General Snus smokeless tobacco products, including:
General Loose;
General Dry Mint Portion Original Mini;
General Portion Original Large;
General Classic Blend Portion White Large, 12 count;
General Mint Portion White Large;
General Nordic Mint Portion White Large, 12 count;
General Portion White Large; and
General Wintergreen Portion White Large.
In 2019, the FDA issued modified-risk granted orders for eight smokeless tobacco products made by Swedish Match USA. These orders expire in 2024. To continue marketing the MRTPs after the authorized five-year term, the company submitted an MRTP renewal application to the FDA.
Starting Dec. 1, the public may submit comments on these applications on regulations.gov.
November 30, 2023
Stronger Enforcement Urged of Violations

Photo: momius
The U.S. Food and Drug Administration could take stronger enforcement action against tobacco retailers with histories of sales to youth and other violations, according to a report published by the Office of Inspector General (OIG) of the Department of Health and Human Services.
The authors analyzed the extent and nature of the FDA’s inspections of, and enforcement actions against, vendors occurring over nearly a decade through the agency’s tobacco retailer compliance check inspection program.
The OIG found the FDA conducted more than 1 million inspections from 2010 through 2019, by inspecting, at least once, 74 percent of tobacco retailers that were in business nationwide as of 2020. The FDA almost always returned to inspect retailers where it found violations within 12 months. In some States, inspection activities were correlated with neighborhoods’ socioeconomic conditions, raising questions about how FDA and its contractors select retailers to inspect.
Overall, FDA’s actions against retailers that violated tobacco laws and regulations were in accord with its policies.
However, retailers with histories of violations were often not subject to the strongest enforcement actions. FDA collected the full amount for only 9 percent of the civil money penalties (CMPs) it issued to retailers with histories of violations compared to 60 percent of CMPs it issued to retailers with fewer violations. Also, retailers in our sample that could have been subject to a no-tobacco-sale order usually did not receive one.
However, the OIG did not determine the extent to which FDA’s consideration of mitigating factors or actions by Administrative Law Judges played a role in these outcomes.
In its report, the OIG recommends that FDA give greater weight to retailers’ past noncompliance when taking enforcement actions against retailers with histories of violations, and determine whether variation in inspection activity on the basis of neighborhoods’ socioeconomic status is appropriate and the extent to which it is meeting FDA’s objective for protecting vulnerable populations.
November 8, 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
King Reflects on 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
Menthol Rule Advances to U.S. Budget Office

Photo: Alicia
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) sent its rules to prohibit the sale of menthol cigarettes and flavored cigars to the White House Office of Management and Budget (OMB) for final review, reports CNN.
The final rules will be issued following this last regulatory step.
The American Lung Association (ALA) said this regulation may be the most significant action the FDA has taken in the 14 years since it was given the authority to regulate tobacco.
“It’s a big, vital and critical step on the way to banning these products,” said ALA Assistant Vice President of National Advocacy Erika Sward. “ Truly, it’s momentous.”
According to a 2022 study published in Tobacco Control, prohibiting menthol cigarettes would save up to 654,000 lives in the U.S. within 40 years, including the lives of 255,000 members of the Black community.
The Campaign for Tobacco-Free Kids called for the White House and the OMB to expedite their review and issue the final rule by the end of 2023.
October 17, 2023
Marketing Denials for Flavored Vuse Alto

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 percent 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
Retailers Chided for Youth-Appealing Products

Photo: Nadia L/peopleimages.com
On August 23, 2023, the U.S. Food and Drug Administration issued warning letters to 15 online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like youth-appealing characters, school supplies, toys and drinks.
“The design of these products is a shamelessly egregious attempt to target kids,” said Brian King, director of FDA’s Center for Tobacco Products, in a statement. “It’s a tough sell that adults using e-cigarettes to transition away from cigarettes need them to look like SpongeBob in order to do so successfully.”
The unauthorized products described in the warning letters include e-cigarettes that feature youth-appealing characters from TV shows, movies and video games; products that are designed to look like school supplies and toys; and vapes that imitate youth-appealing drinks such as Starbucks and Dunkin Donuts coffee cups.
The recipients of the letters have 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations.
leo.
August 23, 2023
Distributors Warned Over Unauthorized Products

Photo: Ljupco Smokovski
The U.S. Food and Drug Administration has put ABS Distribution, EC Supply and Easy Wholesale on notice for selling and/or distributing multiple unauthorized e-cigarette products. The illegal products listed in the warning letters include the popular and youth-appealing e-cigarette products Elf Bar/EB Design, Esco Bars and Puff Max.
“FDA is committed to keeping a finger on the pulse of the rapidly evolving e-cigarette landscape, including through a variety of scientific assets equipped to quickly identify products with high youth appeal,” said FDA Center for Tobacco Products Director (CTP) Brian King in a statement. “We will continue to use this data-driven approach to inform actions across the entire supply chain, including against those who distribute illegal products between manufacturers and the point of sale.”
Warning letters are generally the first step once an inspection reveals a violation of the law. “We will monitor to ensure these violations are corrected, and if they are not, the recipient is at risk of further actions such as civil money penalties, seizures, and injunctions,” said Ann Simoneau, director of the CTP Office of Compliance and Enforcement.
July 28, 2023