Tag: FDA

U.S. FDA Commissioner Califf Laments Lawsuits

Image: Tobacco Reporter archive
U.S. Food and Drug Administration Commissioner Robert Califf has lamented the FDA’s ongoing tobacco industry litigation following the agency’s attempt to regulate e-cigarettes, according to Politico. The FDA is facing over 40 lawsuits from companies whose premarket tobacco product applications have been denied.
“We are in a legal battle every single day, and it’s draining on the agency,” Califf said at the annual public meeting of the Reagan-Udall Foundation. “It has a big impact and a much bigger impact than I thought.”
“None of us expected 27 million applications for vaping,” he said.
Califf also noted that enforcement is difficult when it comes to illegal product. “I find myself in the midst of really an epic struggle … when I think of how to enforce when you have an industry that is amazingly creative.”
Califf hinted that the FDA would meet with the Department of Justice soon to discuss enforcement but declined to say more: “Stay tuned on that one.”
May 31, 2023
Elf Bar Maker Wants U.S. FDA to Reverse Red List Addition

Imiracle, the manufacturer of Elf Bar, Lost Mary and EB Design vaping products, is calling on the U.S. Food and Drug Administration to reverse the agency’s recent addition of Imiracle products to its import red list and “for coherent, clear and depoliticized regulation of the U.S. vaping market.
IMiracle Shenzhen Technology Co. Ltd. issued a statement regarding the placement of its products on the FDA’s Import Alert # 98-06. The company said it is disappointed by the FDA’s decision to “abruptly and arbitrarily” add the company’s products to the FDA import red list.
The company stated that it was given no notice regarding the decision and was provided no opportunity to address any FDA concerns before action was taken.
“It is the job of the FDA to provide consistent and coherent regulatory clarity to the U.S. marketplace. This red list announcement fails to meet this responsibility and provides yet another example of FDA’s politicized decision-making,” a spokesperson for Imiracle stated. “The FDA is singling out IMiracle’s products, despite the fact that the company was working in good faith through the FDA’s PMTA process. At the same time, the FDA is failing to address the flood of products from manufacturers that have ignored and never attempted to comply with FDA regulations.
“This decision also ignores the latest science on e-cigarette use and continues to prevent U.S. adults from accessing an entire category of nicotine products that FDA knows are significantly safer than cigarettes. Further, no IMiracle brands have ever been identified in the National Youth Tobacco Survey as top brands used by youth.
“The FDA’s capricious action is not surprising given the agency’s history of regulating vaping products out of existence. It is appropriate for the industry and its more than 10 million adult consumers to demand a clear and thoughtful regulatory regime from the federal government, and they have done so. The FDA has failed to respond.
“IMiracle calls on the FDA to reverse its decision to place IMiracle products on the import red list. We welcome the engagement and the conversation needed to create a proper and fair regulatory regime around the e-cigarette marketplace that works for all stakeholders.”
The FDA last week issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.
The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as Elf Bar, EB Design, Eonsmoke, Esco Bars and Stik that are on the agency’s “Red List.”
May 25, 2023
U.S. FDA Warns Vape Makers Esco Bars, Breeze Smoke

Credit: Pastel Cartel
Two warning letters to firms that manufacture popular flavored, disposable e-cigarette products have received warning letters from the U.S. Food and Drug Administration.
Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.
Esco Bars and Breeze are presently among the most commonly sold brands of disposable products in the United States.
“Today’s actions underscore FDA’s commitment to protecting youth against illegal flavored, disposable e-cigarette products. On May 12, FDA also issued an import alert for Esco Bars products,” according to an FDA statement. “The import alert places these tobacco products on the red list, which allows FDA to refuse or detain the product at the time of entry and to prevent illegal products from being distributed in the U.S.”
Credit: Breeze
Brian King, the director of the FDA’s Center for Tobacco Products, said the science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored products. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action,” King said.
FDA generally sends warning letters the first time an investigation or inspection reveals a violation. A majority of recipients of warning letters correct the stated violation.
However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.
May 25, 2023
U.S. FDA Envisions Harm Reduction Approach to CBD

Credit: Sofia
The U.S. Food and Drug Administration envisions a harm reduction framework for CBD (cannabidiol, an active ingredient in cannabis that doesn’t make you high) through which consumers could make informed choices.
That’s the pathway described last week by Patrick Cournoyer, who heads the FDA’s Cannabis Product Committee, at the annual Food and Drug Law Institute (FDLI) conference.
In January, the FDA announced that it would not issue long-awaited guidelines for the inclusion of CBD in food and beverages, because the agency’s existing regulatory framework was not appropriate.
The FDA’s decision came nearly five years after the federal government legalized hemp-derived CBD containing less than 0.3 percent of the psychoactive compound Delta-9 THC via the 2018 Farm Act.
Concerns over the ingestion of CBD derive from the 2018 approval of the prescription drug Epidiolex, which contains CBD for the treatment of seizures associated with two forms of epilepsy.
Studies at the time showed a significant potential risk of liver disorder and other side effects from ingesting CBD.
Cournoyer shed more light on the FDA’s January decision by calling safety concerns regarding CBD in food and beverages “important toxicological red flags that are not typical for food ingredients,” as reported by Cannabis Wire.
“What’s envisioned here is really a harm reduction framework. The existing pathways that we have for foods and supplements don’t really allow for risk or harm. If it’s shown to be harmful or we can’t really show that it won’t be harmful, then it’s not allowed to be there,” Cournoyer said.
“What we’re proposing here is a more permissive category where it is acknowledged that there’s a risk here. We can’t eliminate it, but we would view that people can make an informed choice.”
He did not provide a timeline for the development of a harm reduction framework the FDA could develop in collaboration with the U.S. Congress.
Congressional lawmakers in the U.S. have refiled a pair of bills meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
Earlier versions of the bills were filed last Congress and ultimately did not advance, but advocates and industry stakeholders feel that the U.S. Food and Drug Administration’s recent announcement that it wouldn’t be taking steps to regulate CBD will put pressure on lawmakers to act this time around.
May 23, 2023
CTP Hires Its First Senior Advisor for Health Equity
Charlene Le Fauve (Credit: NIH)
The tobacco and nicotine product regulatory arm of the U.S. Food and Drug Administration has hired a senior advisor for health equity for the first time. The Center for Tobacco Products (CTP) announced Charlene Le Fauve will fill the role.
“Beginning today, she will join CTP’s Senior Leadership Team within the Office of the Center Director,” a release states. “Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research. She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”
Most recently, Le Fauve served as the senior advisor to the Chief Officer for Scientific Workforce Diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research, according to the release.
Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of Disparities Research and Global Mental Health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.
“Diversity, Equity, Inclusion, and Accessibility (DEIA) are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the release states, “She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”
May 22, 2023
U.S. FDA Issues ‘Import Alert’ to Seize Illegal Vapes

Credit: Photo Spirit
In a move that could be devastating to the vaping industry, the U.S. Food and Drug Administration has issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.
The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as ELFBAR, EB DESIGN, Eonsmoke, Esco Bar and Stik that are on the agency’s “Red List.”
The alert covers China, South Korea and the United States.
“Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP)” the alert states. “CTP concurrence is required to add a product to the Red List.”
In order to remove a firm’s product from the Red List, companies must provide information to the FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation.
“The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, ‘Detention without Physical Examination (DWPE),’” the alert states.
The FDA states that the import alert is to prevent the sale of potentially illegal goods in America; release agency resources to inspect other goods; provide uniform coverage across the country; shift the blame back to the importer to ensure that products imported into the United States comply with FDA laws and regulations, according to the agency.
In June 2009, the Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate tobacco products, recognizing that it is the primary federal regulator for the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, and smokeless tobacco.
The designation rule, published in the Federal Register on May 10, 2016, and effective August 8, 2016, extends FDA’s authority to designated tobacco products, such as e-cigarettes, cigars, hookahs, and pipe tobacco, as well as their components and parts, but not their accessories.
This story will be updated as more news and industry reaction becomes available.
May 18, 2023
Bill Threatens to Derail FDA Menthol and Nicotine Plans

Photo: Rechitan Sorin
The U.S. House Committee on Appropriations may spoil the Food and Drug Administration’s plans to ban flavored cigars, ban menthol cigarettes and limit nicotine levels in cigarettes, reports Halfwheel.
On May 17, the committee, which is responsible for allocating funds to various government entities, including the FDA and the Department of Agriculture, unveiled the draft of the Agriculture, Rural Development, Food And Drug Administration, And Related Agencies Bill.
The proposed language says that FDA cannot use any of the money Congress allocates for it to ban menthol or set nicotine levels, effectively preventing the agency from carrying out the regulations.
The relevant passages are:
SEC 768. None of the funds provided by this Act or provided from any accounts in the Treasury of the United States derived by the collection of fees available to the agencies funded by this Act, may be used by the Secretary of Health and Human Services to finalize, issue, implement, administer, or enforce any rule, regulation, or order setting a tobacco product standard that mandates a maximum nicotine level for cigarettes.
And:
SEC 769. None of the funds provided by this Act, or provided from any accounts in the Treasury of the United States derived by the collection of fees available to the agencies funded by this Act, may be used by the Secretary of Health and Human Services to finalize, issue, or implement any rule, regulation, notice of proposed rule- making, or order setting any tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes or prohibit characterizing flavors in all cigars and their components and parts.
Anti-tobacco activists were aghast. “This bill is a special interest gift to the tobacco industry that would result in more kids addicted to tobacco and more lives lost, especially Black lives,” wrote Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement. “These shameful provisions give the tobacco industry everything it wants from Congress in exchange for its campaign contributions.”
The bill is in its early stages and is likely to undergo many modifications.
May 18, 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 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
Reynolds Warns Vape Shops to Stop Selling Flavored Vapes

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A STAT news report claims R.J. Reynolds has sent letters to several small vape shops threatening to sue if the shops do not stop selling flavored vaping products.
The STAT news story claims to have obtained two letters, both of which were sent in March, giving the vape shops just a few days to confirm they will no longer sell flavored tobacco products.
Failure to comply could result in “legal action, and the costs, attorneys’ fees, and adverse publicity to which a lawsuit would subject [the vape shop],” the letters warn, according to STAT.
The letters, which were sent to stores in New Jersey and Alabama, also warn that the shops are violating local laws regulating the sale of flavored tobacco.
The New Jersey letter also copies the county prosecutor where the vape shop is located, in an apparent attempt to notify the local authorities of the violation.
he letters are the latest example — and a marked escalation — of Reynolds’ campaign to force a crackdown on illegal vaping products.
In the article, Clive Bates, a tobacco harm reduction advocate, criticized Reynolds.
“I do not think Reynolds should be hounding vape shops for selling life-saving products to their regular customers,” Bates wrote in an email to STAT. “It should not be picking on little guys, but pressing federal bureaucracies to do their job, and do it better.”
In February, RAI Services Company, a Reynolds company, submitted a citizen petition asking the U.S. Food and Drug Administration to adopt a new enforcement policy directed at flavored “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.
May 3, 2023