U.S. Food and Drug Administration - Tobacco Reporter

FDA Rejects 6,500 Flavored Vape Products

On May 12, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to 10 companies, which collectively manufacture and market approximately 6,500 flavored e-liquid and e-cigarette products. The companies may not market or distribute these products in the U.S., and retailers who sell these illegal products risk FDA enforcement action.

According to the FDA, the premarket tobacco product applications (PMTAs) provided insufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health. The flavor names of some of the products denied include Citrus, Strawberry Cheesecake, Cool Mint, and Menthol.

Since the spring of 2020, the FDA has received applications for over 26 million new tobacco products, the majority of which were for e-cigarette products. To date, FDA has completed review and taken action on over 99 percent of these applications, according to the agency.

“Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products in a statement. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”

The companies that received MDOs include Imperial Vapors, Savage Enterprises, Big Time Vapes, SWT Global Supply, Great Lakes Vapor, DNA Enterprise (“Mech Sauce”), Absolute Vapor and ECBlend.

FDA is withholding the names of the other two companies that received MDOs to protect potential confidential commercial information.

May 12, 2023

Modified-Risk Orders for Copenhagen Snuff

The U.S. Food and Drug Administration has authorized U.S. Smokeless Tobacco Co.’s (UST) Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified-risk tobacco product (MRTP). Copenhagen’s moist snuff smokeless tobacco product has been marketed in the U.S. for years without modified-risk information.

The FDA’s action now allows UST to market the product as a modified-risk product with the claim: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”

After a rigorous review of the available evidence, including recommendations from the Tobacco Products Scientific Advisory Committee, public comments and other available scientific information, the FDA says it concluded that the specific claim related to lung cancer risk is scientifically accurate with respect to Copenhagen Classic Snuff. The review also found the public health gains are unlikely to be offset by nonusers starting to use the product.

UST will be required to conduct post-market surveillance and studies that include an assessment of product users’ behavior, understanding and any previous use of cigarettes as well as a scientific model to assess continued impact on population health.

This modified-risk granted order will expire in five years.

March 16, 2023

Hearing on FDA Manufacturing Rules

Registration is open for U.S. Food and Drug Administration’s upcoming public oral hearing on April 12, 2023, from 9:30 a.m. to 5 p.m.

The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule Requirements for Tobacco Product Manufacturing Practice. The FDA is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.

Speaking spots are limited, and the FDA says it cannot guarantee that it will be able to accommodate all requests. Groups and organizations should select a single spokesperson to help the agency hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Registration to provide oral comments will close on March 31, 2023.

The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.

March 14, 2023

Webinar on FDA Warning Letters

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 6, 2023

Industry Unimpressed by CTP ‘Reset’

Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.

“While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.

The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.

To address such criticisms, FDA Commissioner Robert Califf in July 2022 ordered an independent investigation into the CTP’s operations.

On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.

In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.

Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.

Tony Abboud, executive director, Vapor Technology Association

Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.

“After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.

“But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”

Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.

While welcoming the CTP’s new commitment to transparency, the Premium Cigar Association (PCA) expressed concern that the CTP continues to view industry engagement as an afterthought rather than a means to better understand how its approach can be better designed in the developmental phase of regulations, guidance or strategic planning.

The PCA also questioned the CTP’s desire to increase its workforce and raise more funds through user fees. “Until the systemic failures are addressed, growing an agency that already spans over 1100 employees will only complicate and compound its problems,” the PCA wrote in a statement. “Rather, CTP should embrace Congressional oversight, as does every other Federal Agency, to ensure that its ongoing efforts remain in-line with its statutory mission and public demands.

February 27, 2023

FDA Appeals Rejection of Graphic Warnings

The U.S. Food and Drug Administration has appealed a court ruling that found the agency’s graphic health warning rule unconstitutional, reports CSP.

On Dec. 7, a federal judge in Texas blocked the FDA from enforcing a rule requiring tobacco companies to print graphic health warnings on their products, saying they violated free speech protections under the First Amendment.

The graphic cigarette health warning rule required manufacturers and retailers who sell cigarettes to rotate 11 health warnings on cigarette packs, which consisted of textual statements and color graphics depicting the negative health consequences of cigarette smoking.

The Texas court said the graphic cigarette health warnings would have compelled manufacturers and retailers to speak by displaying cigarette packages on store shelves and advertising cigarettes when, if given the choice, manufacturers and retailers would choose not to do so. The court also said the warnings were not purely factual and were open to interpretation by consumers and more extensive than necessary.

The FDA appealed that decision on Feb. 1 in the U.S. Court of Appeals for the Fifth Circuit, according to court documents.

The Family Smoking Prevention and Tobacco Control Act of 2009 instructs the FDA to create visual health warnings, but the D.C. Circuit in 2012 blocked the agency’s first attempt, saying that regulators had not convincingly demonstrated that the warnings would actually reduce smoking.

In March 2020, the FDA released the final rule requiring new graphic warnings for cigarettes that feature some of the lesser known but still serious health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.

Several tobacco companies, including R.J. Reynolds Tobacco Co., filed a First Amendment challenge in April 2020. The rule was set to take effect in November 2023 after the deadline was repeatedly pushed back by court.

According to health groups, the U.S. has fallen behind other countries with its tobacco control policies. Prior to 2009, when Congress passed the Tobacco Control Act, only 18 countries required graphic warnings for tobacco products, they pointed out. Today, more than 120 countries require them.

February 24, 2023

CTP Outlines Responses to Reagan-Udall Report

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Feb. 24 outlined the steps it plans to take in response to an external evaluation of its operations conducted by evaluators working through the Reagan-Udall Foundation.

The expert panel issued its final report on Dec. 19, 2022, and included 15 recommendations across a number of areas.

To address concerns raised in the report about transparency, the CTP said it would appoint internal transparency liaisons within each CTP Office, who will be responsible for objectively identifying areas for transparency enhancement. The center will also create a new webpage to feature its responses to citizen petitions and will resume posting scientific policy memos and reviewer guides “when appropriate.”

To enhance efficiency of its premarket tobacco product application review process, the CTP said it has started developing a more efficient framework for high-quality reviews. The center said it aims to better communicate on scientific issues and practices; hire additional staff and increase internal communication to improve scientific engagement and deliberation. Among other activities, the CTP said it will resume posting of scientific policy memos and reviewer guides, along with communication through public events, such as workshops and listening sessions.

The CTP also expressed its intention to hold more frequent meeting of the Tobacco Products Scientific Advisory Committee to obtain input on scientific issues.

To improve its operations in the areas of regulations and guidance, the CTP said it will create a new policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination across the CTP.

The FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products.

Robert Califf, Commissioner, FDA

Recognizing opportunities to enhance its compliance and enforcement work, the CTP said it will convene a summit related to enforcement with senior officials from the Department of Health and Human Services, the FDA, and the Department of Justice (DOJ). The CTP will consider whether statutory changes are needed to assist the center in enforcing the law. It will also explore approaches to achieve compliance outside of judicial enforcement actions through DOJ.

The CTP said it plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization; routinely reach out to industry stakeholders to keep them apprised of new enforcement priorities and updates; and enhance the FDA’s tobacco product marketing order webpage. Planning has already begun for development of a searchable public database of all tobacco products that have an FDA marketing order, according to the center.

To improve engagement on its public education campaigns, the CTP said it will develop, publish and promote resources that describe the mechanisms it currently uses to solicit and consider public input on its campaigns. It will also explore new ways for soliciting and considering public input on its campaign program.

Consistent with the Reagan-Udall report recommendation, the CTP is also engaging with relevant entities within FDA, the Department of Health and Human Services, and the Office of Personnel Management to identify solutions to facilitate more timely and efficient hiring of professionals that match CTP’s needs.

To achieve its goals, the CPT stressed the importance of having appropriate resources, which it suggested could be raised through additional user fees for regulated products, including e-cigarettes. “Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products,” said FDA Commissioner Robert Califf in a statement.

A detailed description of the CTP’s plan for addressing the Reagan-Udall recommendations is available at the center’s new website.

February 24, 2023

Civil Money Penalty Complaints Against Vape Companies

The U.S. Food and Drug Administration has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization. The targeted companies are VapEscape, Great American Vapes, Vapor Corner and 13 Vapor.

This is the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.

It is illegal to manufacture, sell, or distribute e-liquids in the U.S. that the FDA has not authorized. 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 premarket requirements for tobacco products and that failure to correct these violations could lead to an enforcement action, such as a CMP. Despite the agency’s warning, these 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, director of the FDA’s Center for Tobacco Products, in a statement. “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.”

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.”

Between January 2021 through Feb. 17, 2023, the FDA has issued more than 550 warning letters to firms for manufacturing, selling, and/or distributing new tobacco products without marketing authorization from the FDA. After receiving warning letters, a majority of these companies have complied and removed their products from the market.

February 22, 2023

PMTA Review Target Date Pushed Back

The U.S. Food and Drug Administration has submitted a new timeline for its review of premarket tobacco product applications (PMTAs).

In prior status reports, the FDA indicated that it expected to have taken action 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 acted 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

In response to litigation by public health groups, a Maryland Federal District Court in April 2022 ordered the FDA to file regular status reports on its progress in reviewing PMTAs for the most popular vapor products on the U.S. market, including Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar.

The original target completion date for the review process 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 due in part to ongoing litigation and to the agency’s acceptance of amendments to some already filed PMTAs, according to the report.

The FDA is expected to give its next status update to the court on April 24.

February 9, 2023

CTP to Detail its Reagan-Udall Response

The U.S. Food and Drug Administration Center for Tobacco Products (CTP) will provide an update in February on its planned actions in response to the Reagan-Udall Foundation’s evaluation of its program, CTP Director Brian King wrote in a letter published on the FDA website today.

In July 2022, FDA Head Robert Califf instructed the Reagan-Udall Foundation to review the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews.

The report, published in December, highlighted several problems at the agency and offered suggestions for improvements in regulations and guidance, application review, compliance and enforcement.

“We are in the process of closely reviewing this feedback and in February will provide an update on our planned actions in response to the evaluation,” wrote CTP Director Brian King.

In his letter, King also noted the CTPs priorities for 2023, which include finalizing the product standards relating to menthol cigarettes and flavored cigars, along with developing a proposed product standard that establish a maximum nicotine level to reduce the addictiveness of cigarettes and other combusted tobacco products.

January 31, 2023

Tag: U.S. Food and Drug Administration