Category: U.S. FDA

U.S. FDA Issues Denial Orders for 2 Vuse Menthol Products
The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.
Reynolds is expected to challenge the order.
The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, according to a statement. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.
“After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products 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.
Specifically, the evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.
In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stayed the order.
The case continues.
March 17, 2023
U.S. FDA has Made Decisions on Over 99 Percent of PMTAs

The U.S. Food and Drug Administration today stated it has made determinations on more than 99 percent of the nearly 26 million deemed tobacco products for which premarket tobacco products applications (PMTAs) were submitted. The agency has said previously that reviews for some of the most popular vaping products may take until the end of the year.
The FDA also announced it issued a refuse-to-accept (RTA) letter on Feb. 21, to one applicant notifying a company that their PMTAs, which are associated with approximately 17 million individual tobacco products, do not meet the acceptance requirements outlined in FDA’s regulations.
“The applications were for a grouped submission of e-liquids in varying size, nicotine strength, and flavor combinations, each of which was treated as an individual product application according to existing premarket review processes,” the FDA wrote in a statement.
The agency’s overall determinations include authorizing 23 new e-cigarette products and devices, and issuing refuse to accept (RTA) letters, refuse to file letters, or marketing denial orders for millions of products.
The data includes determinations on applications for nearly 6.7 million products received by the Sept. 9, 2020, deadline, more than 18 million products received after the Sept. 9 deadline, and applications for nearly 1 million non-tobacco nicotine products submitted by May 14, 2022, in accordance with the new federal law passed in April 2022.
Under a federal court order, manufacturers of deemed new tobacco products that were on the market as of the deeming rule’s effective date (Aug. 8, 2016) were required to submit premarket review applications by Sept. 9, 2020.
March 15, 2023
U.S. FDA Webinar Outlines Warning Letter Response
Credit: Marcus Krauss
The U.S. Food and Drug Administration has posted a new webinar to help manufacturers and vape shop owners respond to warning letters from the agency’s Center for Tobacco Products (CTP).
The webinar outlines the appropriate items for a response to a warning letter, which should be received by FDA within 15 business days. The webinar also includes an explanation of proper documentation concerning corrective actions that entities have taken.
In the webinar, participants will learn about:

Preparation for a response to CTP

Important items to include in a response

Additional compliance resources
March 7, 2023
U.S. FDA Files First Civil Money Penalties for Illicit Sales
Credit: VetKit
Some manufacturers of e-liquids could soon be paying nearly $20,000 per violation for selling vaping products without approval. Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.
This marks the first time the regulatory agency has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket tobacco product application (PMTA) process.
The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s PMTA requirements and that failure to correct these violations could lead to enforcement action, such as a CMP, according to a press release.
Despite the agency’s warning, the companies continue to make and sell their unauthorized e-liquids to consumers.
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.”
As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:

BAM Group LLC doing business as VapEscape

Great American Vapes LLC doing business as Great American Vapes

The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner

13 Vapor Co. LLC doing business as 13 Vapor
Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases.
The companies the FDA has filed CMP complaints against 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. Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
“These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” said King. “These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law.”
Manufacturers that continue to violate the law risk subsequent enforcement, according to the FDA. In addition to CMPs, the agency also has the authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.
February 22, 2023
RJ Reynolds Wants Enforcement of Disposables
Credit: Casimiro
RAI Services Company submitted a citizen petition asking the U.S. Food and Drug Administration to adopt a new enforcement policy directed at “illegally marketed disposable electronic nicotine delivery system” (ENDS) products.
The petition was filed on Feb. 6 and posted by the FDA to Regulations.gov for public comment on Feb. 8.
RAI Services and R.J. Reynolds Vapor Company, the maker of Vuse e-cigarettes, are owned by BAT. Vuse is the most popular brand in the c-store segment, according to Neilsen data.
“As the Agency well knows, use of ENDS products in the United States has shifted to disposable products. And a new enforcement policy, one that is specifically directed at these disposables that are on the market illegally, is needed to better protect public health,” the petition states.
Reynolds requested that the FDA prioritize enforcement for:

Any flavored disposable ENDS (except for tobacco- or menthol-flavored products);

Any disposable ENDS containing nicotine derived from any source other than tobacco that lacks premarket authorization;

Any disposable ENDS containing nicotine derived from tobacco that was not on the market as of August 8, 2016, or for which the manufacturer either failed to submit an application by September 9, 2020, or submitted a PMTA to FDA by that deadline, but received a negative action that is not being challenged in court;

Any disposable ENDS for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and

Any disposable ENDS targeted to, or whose marketing is likely to promote use by, minors.
Reynolds does not sell disposable vapes or vaping products in flavors other than tobacco or menthol. The U.S. Court of Appeals for the Fifth Circuit granted an administrative stay of an FDA marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.
“Such a policy,” writes Reynolds regarding its desired enforcement priorities, “will close an existing loophole in FDA’s current tobacco enforcement efforts, especially when it comes to youth.”
February 13, 2023
Status Report Confirms FDA Time Changes to PMTAs
Credit: Fizkes
The U.S. Food and Drug Administration has submitted a new timeline for its expected finish to the review of premarket tobacco product applications (PMTAs) in a court-mandated status report. As previously reported by Vapor Voice, the agency doesn’t expect to complete PMTAs for the most popular vaping products until the end of the year.
In prior status reports, the FDA indicated that it expected to finalize actions on all covered applications by June 30, 2023. Filed with the Maryland Federal District Court on Jan. 24, 2023, the agency’s fourth report states that it now expects to have taken action on PMTAs as follows:
52 percent of Covered Applications by March 31, 2023
53 percent of Covered Applications by June 30, 2023
55 percent of Covered Applications by Sept. 30, 2023
100 percent of Covered Applications by Dec. 31, 2023
The FDA is expected to give its next status update to the court on April 24.
The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of PMTAs. The court case that ended in a court-imposed deadline for the FDA was filed by health groups seeking a timeline for the review of the PMTAs that were filed with the agency by Sept. 9, 2020.
In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.
The original completion date was Sept. 9, 2021, however, the FDA was unable to meet it due to the extremely large number of PMTAs filed by manufacturers.
The most recent delay is partially being caused by ongoing litigation and by the agency accepting some amendments to already filed PMTAs that the agency now needs to review, according to the report.

Credit: JHVEPhoto
February 9, 2023
CTP to Release Reagan-Udall Response in February

The Head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) said in a perspective released today that the Center recently received the findings from the Reagan-Udall Foundation’s independent evaluation of its program and is in the process of closely reviewing the feedback. In February, the Center will provide an update on its planned actions in response to the evaluation.
When the Reagan-Udall Foundation submitted its recommendations to Robert Califf, commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process.
CTP Director Brian King also announced the Center has accepted for review more than 8,600 marketing applications for synthetic products. In a recently released perspective, King said the center received more than 1 million premarket tobacco product applications (PMTAs) from 200 companies by May 14, 2022.
“FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance,” King wrote. “The RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.”
Brian King / Credit: FDA
He also stated that in 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since King became director. King also stated that starting when the FDA was given the authority by Congress to regulate non-tobacco nicotine products in April 2022, the CTP has issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar.
“We have also issued over 585 warning letters to retailers for the sale of non-tobacco nicotine products to underage purchasers as of December 2022. In October 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA,” filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers that failed to submit PMTAs and continued to sell products,” wrote King.
In a court filing last week, the FDA stated it will take until possibly December 31, 2023, before it completes the PMTA review process for some of the most popular vapes on the market.
Much like an earlier op-ed this year, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
King also failed to address the conclusion of a recent investigation conducted by the U.S. Office of Special Counsel that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.
January 31, 2023
FDA Says PMTA Reviews to Take Until End of Year

Credit: F Armstrong Photo
In a court filing this week, the U.S. Food and Drug Administration stated it will take until possibly December 31, 2023, before it completes a premarket tobacco product application (PMTA) review process for some of the most popular vapes on the market.
Upon being informed of the delay, Senator Dick Durbin of Illinois began demanding the FDA act immediately in removing e-cigarettes and vaping products from store shelves saying the agency has ignored a court order requiring them to take action by September 2021.
“On Tuesday, in a stunning filing to the federal judge, the Food and Drug Administration disclosed that it will take another six-month delay in fulfilling the public health duty announced by the court years ago. That the Food and Drug Administration will not finish reviewing applications for the most popular e-cigarettes until the end of 2023, is another outrageous delay,” said Durbin. “How can this federal agency knowingly, willingly ignore this court order to protect America’s children?”
Durbin, who has repeatedly urged FDA to complete the premarket review of e-cigarettes, called on FDA to use its authority to swiftly remove any and all unreviewed vaping products from store shelves for the safety of American consumers.
“While the FDA has dithered, dallied and delayed, more than one million of America’s kids have started vaping,” Durbin stated this week calling on the agency to obey the court order. “Not next year. Not next month. Immediately. Today,” Durbin stated in a release.
January 28, 2023
FDA Authorizes Three New Heated Tobacco Products

The U.S. Food and Drug Administration today authorized the marketing of three new tobacco-flavored heated tobacco products included in Philip Morris Products S.A.’s supplemental premarket tobacco product applications (PMTAs).
The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks.
The three HeatSticks products are “heated tobacco products” (HTPs) used with the IQOS device.
Based on FDA’s review of the supplemental PMTAs, the agency determined that the marketing of these products should be authorized because, among other things, the net population-level benefits to adult smokers outweigh the risks to youth.
In 2019, FDA authorized the marketing of IQOS and several other Marlboro HeatSticks products through the PMTA pathway. Philip Morris pursued marketing authorization for these new Marlboro HeatSticks by submitting supplemental PMTAs for modified versions and line extensions of the tobacco-flavored product for which the company had previously received a marketing granted order.
A supplemental PMTA can be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which they have already received a marketing granted order.
“Following FDA’s rigorous scientific evaluation of the applications, the agency determined that Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks are comparable to the previously authorized tobacco-flavored product,” according to FDA. “Like the previously authorized products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.”
January 26, 2023
U.S. FDA to Seek Congress’ Help in CBD Regulations
“FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward”
The U.S. Food and Drug Administration has concluded that a new regulatory pathway for cannabidiol (CBD) is needed. The regulatory agency states it will seek guidance from the U.S. Congress. The new rules would need to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks, according to a press release.
The FDA is also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” the release states. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
FDA Principal Deputy Commissioner Janet Woodcock stated that a working group she chaired on the subject of CBD regulations closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” she stated. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.
“CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”
Woodcock said the FDA will continue to take action against CBD and other cannabis-derived products to “protect the public, in coordination with state regulatory partners,” when appropriate.
The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.
The FDA has said it is planning to release CBD guidance this year.
January 26, 2023