Category: U.S. FDA

U.S. FDA Warns Retailers for Elf Bar, Esco Bar Sales

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The U.S. Food and Drug Administration is continuing its crackdown on illegal disposable vape devices. The regulatory agency has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands.
“The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” said FDA Commissioner Robert M. Califf. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.”
The warning letters are the result of a nationwide retailer inspection blitz over the past several weeks cracking down on the sale of these unauthorized e-cigarettes.
The FDA continuously monitors the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people, according to an FDA release. More specifically, the agency’s ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the United States and having high youth appeal.
“All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”
Last month, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands. An import alert places these tobacco products on the red list, which makes them subject to Detention Without Physical Examination and allows the FDA to detain a product without physically examining it at the time of entry.
Elf Bar and Esco Bars products do not have the required marketing authorization from the FDA.
June 23, 2023
Second Circuit Appeals Court Rules in Favor of FDA

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A federal appeals court has ruled that the U.S. Food and Drug Administration didn’t change its position on admissible evidence and the agency’s failure to consider a marketing plan didn’t impact the outcome.
The FDA acted reasonably in denying vapor maker Magellan Technology Inc.’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the Second Circuit ruled Friday.
The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.
The agency found Magellan’s evidence—four non-clinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine delivery systems (ENDS) in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberglaw.
The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.
New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process which cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.
“Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.
Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.
“FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”
The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full Second Circuit) or could appeal to the Supreme Court of the United States.
June 19, 2023
Lawmakers Continue to Urge FDA to Finish PMTA Reviews

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U.S. lawmakers are urging the Food and Drug Administration to wrap up its review of pending e-cigarette premarket tobacco product applications, reports Law360.
In a letter to FDA Commissioner Robert Califf, 50 members of Congress requested the agency finalize its review of pending applications for e-cigarette products; deny applications for all nontobacco-flavored e-cigarette products, including menthol; and utilize the enforcement tools that have been given to the agency to remove all synthetic nicotine products from the market, including those with pending applications.
The lawmakers’ call comes after the FDA failed to meet a court-ordered deadline of Sept. 9, 2021, to complete its review of all pending e-cigarette applications submitted to the agency. In its most recent filings with the court, the FDA has indicated that it will not be able to finalize its review of products with the largest market share until December 2023.
“FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” said Colorado Representative Diana DeGette in a statement. “FDA needs to step up its enforcement of these harmful products and get them off our store shelves now. Every day that these products remain on the market, the more harm they cause to young people’s health.”
While the FDA has completed its review of many e-cigarette products, it has not yet completed its review of thousands of pending applications—including those for popular products manufactured by Juul Labs, Reynolds Vapor Co. and Smok.
The lawmakers urged the agency to complete its review of all its pending applications no later than Dec. 31, 2023.
June 16, 2023
Group: Debt Ceiling Could Limit U.S. FDA’s Budget

Image: Tobacco Reporter archive
The proposed debt ceiling budget could stress the U.S. Food and Drug Administration’s budget, according to Inside Health Policy.
The legislation’s nondefense federal funding cap makes it harder for programs like the FDA’s budget to get funding increases, and it could threaten some agencies’ existing funds, according to Steven Grossman, director of the Alliance for a Stronger FDA. “This is never a good situation for agencies whose mission and responsibilities keep expanding each year, as is the case with FDA,” he wrote.
The Fiscal Responsibility Act of 2023 caps nondefense federal spending at $704 billion for the next two years. According to Grossman, after taking out funding for Veterans Affairs medical care and appropriations adjustments, the remaining nondefense funds are about $637 billion, which is roughly unchanged from fiscal 2023.
There is still room to determine how much funding can be specifically allocated to the FDA, though, according to Grossman, despite the FDA’s funding being limited by the macro-budgetary levels determined by the debt ceiling.
“FDA’s mission and responsibilities are incredibly consequential and visible,” he wrote. “It needs resources to protect public health and safety and to set standards for products that encompass 20 percent of all consumer spending (about $2.7 trillion).”
The House GOP’s FDA funding bill cleared the Appropriations FDA-agriculture subcommittee last month; it would provide $6.6 billion in total funding with $3.5 billion in flat discretionary funding.
June 9, 2023
Mother’s Milk Denied Marketing for More Than 250 E-Liquids

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The U.S. Food and Drug Administration on May 18 issued marketing denial orders to Mother’s Milk WTA for more than 250 flavored and tobacco-flavored e-liquids.
After completing an initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence to show the products are appropriate for the protection of public health.
For example, the applications did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the U.S. market, information assessing the abuse liability of the new products, or that the new products could be manufactured consistently.
“One of our most important responsibilities is to ensure new tobacco products undergo scientifically rigorous premarket review,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products, in a statement. “We remain committed to evaluating these applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
The agency has received premarket tobacco applications for more than 26 million deemed products, most of which are e-cigarettes. The agency says it has made determinations on 99 percent of these applications. This includes more than 1 million applications for non-tobacco nicotine products, including those containing synthetic nicotine, after Congress clarified FDA’s authority to regulate these products in April 2022.
Further, 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. FDA has also denied marketing applications for millions of products that did not meet the requirements in the law.
May 19, 2023
TPSAC to Discuss Proposed TPMP Rule Tomorrow

Image: Tobacco Reporter archive
The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice (TPMPs) proposed rule Tomorrow, May 18, 2023, from 9 a.m. to 2 p.m.
The proposed rule is open for public comment until Sept. 6, 2023.
The TPSAC meeting will be available via a free webcast. Electronic or written comments on the meeting needed to be submitted by May 11 for consideration by the committee.
May 17, 2023
U.S. FDA Issues 6,500 MDOs to Small Businesses
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On Friday, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to 10 companies that collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products.
The health regulator said these companies cannot market or distribute the products in the U.S. and retailers who sell them risk FDA enforcement action.
“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. “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 LLC
Savage Enterprises
Big Time Vapes
SWT Global Supply Inc.
Great Lakes Vapor
DNA Enterprise LLC dba Mech Sauce
Absolute Vapor Inc.
ECBlend LLC
FDA is not disclosing the names of the other two companies that received MDOs to protect potential confidential commercial information (CCI).
The FDA added the premarket tobacco product applications (PMTAs) submitted for a variety of flavored e-cigarette products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for public health.
The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol.
“It doesn’t really matter to the FDA what your scientific evidence is or anything else, they’re pretty much handing anyone out there an MDO,” said Char Owen, president of the American Vapor Manufacturers Association.
She said some of the companies targeted Friday had just one or two storefronts and were genuinely trying to help adults stop smoking through the use of flavored products, according to the Washington Post.
“It’s tough out here because you’re dealing with lives and businesses,” Owen said.
Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.
The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.
May 14, 2023
U.S. Supreme Court Asked to Review Avail Case

Avail Vapor has asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the Food and Drug Administration to Avail products.
In its petition, known as a Writ of Certiorari, Avail asks 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 decisionmaking 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.
The Supreme Court has not yet decided whether it will hear Avail’s case.
May 12, 2023
U.S. FDA on Track to Complete PMTAs by End of Year

The U.S. Food and Drug Administration says it is on track to finish reviewing premarket tobacco product applications (PMTAs) for the most prevalent e-cigarettes by the end of the year, reports CSP.
The FDA has reviewed 52 percent of covered applications as of March 31. Covered applications are for new tobacco products on the market as of Aug. 8, 2016, with a PMTA filed by Sept. 9, 2020, and sold under the brands Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar and reach 2 percent or more of total retail sales volume per NielsenIQ reports, according to CSP.
Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.
The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.
May 4, 2023
Watchdog Group Says FDA Ignoring Science on Vapor

The government watchdog group Protect the Public’s Trust filed a complaint with the Department of Health and Human Services over what it says are scientific integrity violations involving the impact of vaping.
The complaint states the U.S. Food and Drug Administration is promoting public health messages on vaping that appear to be unsupported by its own research and scientific findings, according to Center Square.
Protect the Public’s Trust stated the FDA was making “scientifically unfounded statements about the vaping industry” contrary to its own research, adding the agency’s own data appeared to contradict the FDA’s public stance on vaping products.
Protect the Public’s Trust said an FDA report found that “only a subset” of the many harmful compounds found in cigarettes are found in vapes and “at much lower levels” than those in cigarette smoke. That FDA report found that menthol-vapes were helping adult smokers quit cigarettes better than fruit, candy or traditional tobacco flavors.
In the complaint, Protect the Public’s Trust stated that FDA Commissioner Scott Gottlieb presented vaping as comparable to smoking traditional cigarettes because “several of the dangerous chemicals in tobacco smoke are also present in the aerosol of some [vaping] products.”
The FDA didn’t respond to an email seeking comment.
But the FDA declared that “Vaping is not harmless. It carries real health and safety risks, including addiction and other negative health effects.”
“Many studies suggest e-cigarettes and noncombustible tobacco products may be less harmful than combustible cigarettes. However, there is not yet enough evidence to support claims that e-cigarettes and other ENDS [Electronic Nicotine Delivery System] are effective tools for quitting smoking,” the FDA stated on its website.
Protect the Public’s Trust stated there has been a pattern of the government not following “the science.” Protect the Public’s Trust also claimed in December 2022 that the Centers for Disease Control and Prevention failed to track side effects of taking the COVID-19 vaccine.
“Once again, it appears that federal public health leadership has chosen to sacrifice scientific integrity and the public’s rapidly disappearing trust on the altar of political and special interest agendas,” said Michael Chamberlain, director of Protect the Public’s Trust, in an email to The Center Square. “While we were promised that health officials would follow the science, what we have observed instead is a disturbing trend of ignoring or disregarding scientific research and data that don’t fit their particular biases.”
April 27, 2023