Category: U.S. FDA

Esco Bars Manufacturer Files Suit to Challenge FDA
Credit: Pastel Cartel
Pastel Cartel, the manufacturer of Esco Bars vaping devices, has submitted a legal complaint to the U.S. Federal District Court in the Western District of Texas.
The dispute is in regards to a U.S. Food and Drug Administration decision to reject over one hundred documents that Pastel Cartel had included in their premarket tobacco product applications (PMTAs), according to court records.
In the lawsuit, Pastel Cartel accuses the FDA of acting negligently and carelessly by issuing refusing to accept (RTA) letters for the company’s PMTAs on technical grounds.
The company is seeking:

A preliminary injunction staying the RTA orders until the case is decided;
A judgment finding the RTAs violate the Administrative Procedure Act (APA) and the U.S. Constitution (the Due Process Clause of the Fifth Amendment);
A final judgment setting aside the RTA orders and remanding the company’s PMTAs back to the FDA for further review.
Earlier this year, Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products also received warning letters for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.
September 7, 2023
FDA Posts New Warning Letter Webinar for Retailers
The U.S. Food and Drug Administration has posted a new webinar to help online retailers respond to warning letters from regulatory agency’s Center for Tobacco Products (CTP).
The webinar provides an overview of warning letters and outlines the process for responding to a warning letter, such as corrective action taken by the firm to address any violations and its plan for maintaining compliance, according to an FDA release.
In the webinar, you will learn about:

FDA’s internet and publication surveillance of tobacco products
Examples of violations cited in warning letters sent to online tobacco product retailers
Actions to take after receiving a warning letter
Regulators in the United States began cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration last week issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon characters, school supplies, toys, and drinks.
August 30, 2023
Another Appeals Court Accuses FDA of ‘Switcheroo’

The U.S. Court of Appeals for the D.C. Circuit yesterday found that the Food & Drug Administration failed to conduct the proper analyses before rejecting some vaping product applications.
The court’s unanimous decision in Fontem US v. FDA upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products, in line with prior D.C. Circuit precedent, but rejected the FDA’s denial of Fontem’s applications for unflavored products.
This is the second circuit court of appeals to accuse the FDA of a “surprise switcheroo” when reviewing vaping product applications.
Fontem, the company behind the Blu and myBlu vaping brands, argued that the FDA had not conducted the proper analysis prior to rejecting their applications. The D.C. Circuit Court agreed with Fontem in regards to their unflavored products, ruling that the FDA had “neglected to conduct the overall public health review specified by law.”
Judge Rao’s opinion for the court (joined by Judge Walker and Senior Judge Ginsburg), stated that with respect to Fontem’s unflavored products, the FDA also denied Fontem’s applications on the public health ground.
“While the FDA identified multiple ‘deficiencies,’ it failed to analyze the tradeoffs necessary to make a public health finding. Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health,” the opinion states. “The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”
In denying Fontem’s unflavored products, the FDA relies solely on the public health ground. The FDA could have promulgated regulations imposing consistent requirements on the composition and manufacturing of tobacco products, according to the order.
“Had the agency done so, Fontem’s failure to meet those standards would be an independent and sufficient ground for denying the applications, regardless of the overall public health consequences of Fontem’s products,” the order states. “But the agency has not exercised its regulatory authority. Because the FDA has chosen to proceed application by application under the public health ground, it must undertake the holistic inquiry required by the statute.”
Instead of making an overall assessment that Fontem had not shown its products were beneficial to the public, the agency identified five highly technical deficiencies, according to the order. But nothing in the denial order explains how the deficiencies relate to the overall public health consequences of Fontem’s unflavored products.
The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the order. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.
“Cf. 21 U.S.C. § 387j(c)(3) (providing an application denial “be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form”),” the order states. “But in several instances, the FDA changed its tune in the denial order, reproaching Fontem for failing to provide information the agency had never explicitly sought.
“Shifting the regulatory goalposts without explanation is arbitrary and capricious. By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”
August 30, 2023
FDA Extends Manufacturing Rules Comment Period

Credit: Yury Zap
On March 10, the U.S. Food and Drug Administration published a proposed rule titled, Requirements for Tobacco Product Manufacturing Practice (TPMP).
FDA is extending the proposed rule’s comment period by an additional 30 days to allow people additional time to submit comments. Comments on the proposed rule will now be accepted through Oct. 6, 2023.
The proposed TPMP rule would place new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.
These proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.
August 28, 2023
U.S. FDA Cracking Down on Kid Friendly Products
Credit: FDA
Regulators in the United States are cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration today issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon 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 (CTP). “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, including “SpongeBob,” “Lots-o’-Huggin’ Bear,” and “Mario.” The also imitate drinks from companies such as Starbucks and Dunkin coffee cups, soda and water bottles, according to press release.
“The retailers receiving these warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a requirement under the Federal Food, Drug, and Cosmetic (FD&C) Act to legally market a new tobacco product,” the FDA states. “In addition to the specified products mentioned in the warning letters, the retailers were warned to address any violations that are the same as or similar to those stated in the warning letter, and promptly take any necessary actions to bring the tobacco products that they offer for sale in the United States into compliance with the FD&C Act.”
The retailers were 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.
“CTP will continue to closely monitor all those in the supply chain, including retailers, for compliance with federal law,” said attorney Ann Simoneau, director of the Office of Compliance and Enforcement within the CTP. “As always, we will hold anyone accountable that sells unauthorized tobacco products labeled, advertised, and/or designed to encourage use by our nation’s youth.”
The companies receiving warning letters include:

VR Products I LLC d/b/a eJuiceDB
Titan Star Resources d/b/a Vape Vandal Ltd
Vapesstores.com
Disposable Vapes Wholesale
Vapestore.to
Venture Concept Groups d/b/a High Light Vape Co.
Best Vapes Store
Apex Vape
The Juice Machine
StrikesUSA
Finest Ounce Vape Stor d/b/a Finest Ounce Vape Malaysia
Spongbob Vape
Mini Cup Vape
Vape123
Viper Vapor d/b/a Viper Vapor Kelso
Mochivap
These new warning letters mark another step in the FDA’s continued efforts to remove illegal e-cigarettes from the market, particularly those that appeal to youth, the agency states. As of August 2023, the FDA has issued approximately 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, filed civil money penalty complaints against 26 e-cigarette manufacturers, and worked with the Department of Justice to seek injunctions against 6 e-cigarette manufacturers.
August 23, 2023
U.S. FDA to Hold Public Meeting on PMTA Process

The U.S. Food and Drug Administration will hold a two-day public meeting on the agency’s premarket tobacco product application (PMTA) process on Oct. 23–24, 2023.
The meeting will be held on the FDA’s White Oak Campus in Silver Spring, Maryland, and will be in a hybrid format with the option to attend virtually.
Staff from the Center for Tobacco Products’ Office of Science will present on topics related to the PMTA process and be available to respond to questions received from stakeholders on the topic, according to a press note.
Additional information, including registration and question submission processes, will be available soon.
August 17, 2023
FDA Makes Next TPSAC Meeting Materials Available

The U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) met on May 18 to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. All the meeting materials, including the recording, transcript and summary minutes, are now available online.
The proposed rule, if finalized, lays out the FDA’s requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of tobacco products.
Comments on the proposed rule must be submitted by 11:59 p.m. Eastern Time on Sept. 6, 2023.
July 25, 2023
FDA Grants $3.9 Million to Study Effects of Flavors

Image: Tobacco Reporter archive
The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.
The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.
Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”
“The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”
The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.
“If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.
July 13, 2023
U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for myblu Menthol 2.4%. Fontem US, a subsidiary of Imperial Brands, is banned from marketing or distributing the product in the United States, or they risk enforcement action by FDA.
The company may resubmit a new application to address the deficiencies of the product subject to this MDO, according to an FDA press release.
“Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweigh the known risks.”
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth).
“After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act,” the release states. “For example, among other deficiencies, the application did not present sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”
The FDA has not authorized for sale of any flavored vaping product other than tobacco. Fontem is expected to challenge the denial order in court.
In April of last year, The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu.
July 10, 2023
Ninth Circuit Denies Lotus Vaping MDO Review

Entrance to United States Court of Appeals for the Ninth Circuit . Headquartered in San Francisco, California, the Ninth Circuit is by far the largest of the 13 courts of appeals. (Credit: Eric BVD)
A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit on Friday ruled 3-0 to deny Lotus Vaping Technologies’ petition for review of a marketing denial order (MDO) for its flavored e-liquid products. The company could now ask for an en banc rehearing with all Ninth Circuit judges
The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.
The panel held that the text of the Family Smoking Prevention and Tobacco Control Act (TCA) authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids, the judges wrote in the denial that is not considered an opinion.
The panel also held that the FDA did not arbitrarily or capriciously deny Lotuss’ applications and that “any error the agency committed by failing to comparisons of flavored e-liquids to tobacco-flavored e-liquids.” The panel also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless
July 8, 2023