Tag: United States

FDA Almost Done Reviewing Mass Market Products: Report

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The U.S. Food and Drug Administration is almost done reviewing premarket tobacco product applications (PMTAs) for mass-market vaping products.
In a July 22 progress report the agency said it had taken action on 185 of 186 marketing applications for e-cigarette products covered by a 2022 court order, which applied to products with significant market share that filed applications by Sep. 9, 2020.
The manufacturers of those orders have received either a marketing denial order (MDO) or FDA authorization.
Observers say the one application still under review is Juul. The FDA issued an MDO to Juul in 2022, but quickly stayed its order and agreed to further review the application. In June, the FDA rescinded the denial order, returning Juul’s products to full scientific review.
In its report, the FDA says it has also issued more than 18 million refuse-to-accept decisions, over 67,000 refuse-to-file decisions, and approximately 46,000 MDOs—most of them for bottled e-liquid made by small- to medium-sized manufacturers.
The new progress report is the most recent in a series of reports mandated by the U.S. District Court for Maryland as part of its decision that forced the FDA to move the PMTA submission deadline forward.
July 26, 2024
IQOS’ U.S. Launch Postponed

Photo: A Stockphoto
Philip Morris International has postponed the test launch of its IQOS heated-tobacco device in the U.S. to the fourth quarter, reports Reuters. The company declined to say why.
The pilot was earlier scheduled to run in Austin, Texas, in the second quarter, for which the company reported results on the day.
Anti-tobacco activists have been seeking to derail the U.S. introduction of IQOS, arguing among other things that PMI exaggerates the number of people who have quit smoking regular cigarettes using IQOS.
In a joint letter to the U.S. Food and Drug Administration dated June 27, six health groups cited yet-to-be published independent studies contradicting PMI’s findings about how many IQOS users completely switch to the device from cigarettes.
Meanwhile, PMI said the impact of the EU ban on flavored heated tobacco in the European Union has had a “slightly greater” impact on IQOS sales than previously assumed.
This led the company to temper its expectations for volume growth in the heated-tobacco category to around 13 percent for the full year, down from between 14 percent and 16 percent expected earlier.
July 24, 2024
Biden Asks Judge to Drop Menthol Ban Suit

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The Biden administration asked a federal judge to dismiss a lawsuit by anti-smoking groups demanding that it end nearly a year of delay and ban menthol cigarettes, which are used disproportionately by Blacks and younger people.
In a court filing late last week, the U.S. Food and Drug Administration said the delay was not unreasonable because it had yet to determine that a ban was “appropriate for the protection of the public health.”
The FDA also said the plaintiffs had no direct stake in a ban, having alleged at most “a setback to their abstract social interests,” and therefore had no standing to sue,” according to Reuters.
It cited the U.S. Supreme Court’s June 13 rejection of a bid by anti-abortion groups and doctors to restrict access to a widely used abortion pill.
The lawsuit was filed on April 2 in the Oakland, California federal court by the American Medical Association, the African American Tobacco Control Leadership Council, Action on Smoking and Health and the National Medical Association.
Last month, the FDA authorized four menthol NJOY products through the premarket tobacco product application (PMTA) pathway.
The FDA issued marketing granted orders to NJOY, an Altria subsidiary, for two pods for its Ace closed e-cigarette device, which was authorized in April of 2022, and two disposable e-cigarettes—NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 2.4%.
July 1, 2024
Altria Submits PMTA for ‘On! Plus’ Pouches

Image: maurice norbert
Altria Group has submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration for its “On! Plus” oral nicotine pouch products. The PMTAs were submitted by Altria’s wholly owned subsidiary Helix Innovations.
On! Plus is a spit-free, oral tobacco-derived nicotine (TDN) pouch product made from a proprietary “soft-feel” material to provide a more comfortable product experience. The On! Plus pouch is designed for adults who dip and adult dual users (i.e., adults who smoke and dip).
According to Altria, On! Plus pouches are seamless and larger than the leading U.S. TDN brands. Similar to the currently marketed On! products, On! Plus packaging features a compartment to responsibly dispose of used product. Helix submitted PMTAs for three distinct On! Plus varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.
“Helix’s submission of the On! Plus applications underscores Altria’s commitment to addressing consumers’ evolving preferences through innovation in potentially reduced risk products. We firmly believe that On! Plus is a transformative product that will meaningfully contribute to Helix’s growth in the U.S. market, upon timely FDA authorization,” said Nick MacPhee, managing director and general manager of Helix in a statement.
“We’ve long believed in the value of a robust marketplace of authorized smoke-free products for adult tobacco consumers. We believe that these PMTAs demonstrate that responsibly marketed On! Plus pouches can provide a compelling alternative in the marketplace,” said Paige Magness, senior vice president of regulatory affairs, Altria Client Services.
Upon authorization, Altria expects the products to be distributed by Altria Group Distribution Co.
Helix currently sells On! nicotine pouches in the U.S. In the first quarter of 2024, On! shipment volume grew 32 percent versus the prior year and the brand achieved a 7.1 percent retail share of the total U.S. oral tobacco category.
Altria entered the U.S. oral nicotine products market in 2019 after signing a deal with Burger Söhne to acquire an 80 percent ownership stake in some companies that commercialized On! Products, according to The Wall Street Journal. In December 2020 and April 2021, Altria subsidiaries concluded transactions to buy the remaining 20 percent stake of the global on! business for about $250 million.
Altria’s PMTA announcement comes after Philip Morris International’s Swedish Match North America unit suspended nationwide sales on its U.S. website as local officials in Washington, D.C., investigate whether the company is in compliance with the district’s ban on the sale of flavored products.
June 27, 2024
PMI Suspends Zyn Sales Due to DC Probe

Photo: Swedish MAtch
Philip Morris International halted sales of Zyn nicotine pouches on its U.S. website as Washington, D.C., officials investigate the company’s compliance with the district’s ban on the sale of flavored tobacco products, reports The Wall Street Journal.
On June 17, the company’s Swedish Match North America division announced it had received a subpoena from the District of Columbia’s attorney general, requesting among other things information about the unit’s compliance with local restrictions on flavored tobacco.
A preliminary investigation by the company indicated that there had indeed been sales of flavored nicotine pouch products in the district. According to PMI, these related predominantly to certain online sales platforms and some independent retailers.
Swedish Match is currently conducting a full review of its sales and supply chain arrangement in D.C. and other U.S. localities where flavor bans apply.
Pending the investigation, PMI has suspended all online sales on Zyn.com. Sales on this platform have represented “a very small” percentage of the company’s U.S. Zyn volumes, according to PMI.
In the March quarter, Philip Morris’ shipment volumes of oral smoke-free product volumes surged by 40 percent, mainly driven by Zyn nicotine pouches in the U.S., where shipment volume reached 131.6 million cans.
Zyn has been available in the U.S. since 2014, but its sales have skyrocketed over the past year and a half, and its parent company is investing in Zyn capacity in the U.S.
Philip Morris bought Swedish Match in a $16 billion deal in 2022 as the company looked to reduce its reliance on cigarettes amid stricter regulations and a consumer shift toward alternatives to tobacco and traditional cigarettes.
June 18, 2024
U.S. Regulators Grilled Over Illegal Vapes

Photo: Katherine Welles
U.S. Senators criticized top health and law enforcement officials for their failure to tame the rapidly growing illicit e-cigarette market, reports the Associated Press.
During a hearing on June 12, lawmakers on the Senate Judiciary Committee questioned officials from the Food and Drug Administration and Department of Justice (DOJ) about attempts to manage the vaping market, which has grown to include thousands of flavored, unauthorized e-cigarettes imported from China.
“I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization or, in some cases, even filed an application,” said the committee’s chairman, Dick Durbin.
Brian King, director of the FDA’s Center for Tobacco Products, said the agency has been slowed by a backlog of applications submitted by vape companies seeking approval to sell their products in the U.S. The FDA received millions of premarket tobacco product applications, each of which must be scientifically reviewed.
An industry lobbyist told the committee that the FDA has created an untenable marketplace by rejecting more than 99 percent of applications submitted by companies.

I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application.
Dick Durbin, chairman, Senate Judiciary Committee
Ahead of the congressional hearing, several government agencies, including the FDA and the DOJ, established a task force to better coordinate the fight against illegal e-cigarettes. Republican Senator Thom Tillis called the timing of the announcement “a political stunt” and criticized the absence of other federal agencies from the initiative, including Customs and Border Protection (CBP).
“If the timing of the task force formation wasn’t evidence of how unserious the FDA is about tackling the flood of illicit e-cigarettes, FDA’s exclusion of CBP from the task force makes it crystal clear,” said Tillis, who represents North Carolina, a major tobacco-producing state. He urged officials to concentrate enforcement on Chinese brands rather than large domestic manufacturers like Reynolds American, which is based in North Carolina.
The FDA can conduct investigations and recommend cases, but only the Justice Department can bring lawsuits. The FDA has sent hundreds of warning letters to vape shops and e-cigarette manufacturers in recent years. But the letters have done little to dissuade companies from flouting FDA rules and introducing new vapes.
Disposable vapes account for an estimated 30 percent to 40 percent of the roughly $7 billion-dollar U.S. vaping market. The two bestselling disposables—Breeze and Elf Bar—generated more than $500 million in sales last year, according to Nielsen retail sales data analyzed by Goldman Sachs.
Both brands have been sanctioned by FDA regulators but remain widely available, in some cases with new names, logos and flavors.
King noted that products like Elf Bar cannot legally be sold in China because the government there has banned nontobacco-flavored e-cigarettes. Outraged that brands banned in China are sold in the U.S., Texas Senator John Cornyn vowed to introduce legislation to rectify that situation.
Jefferies analyst Owen Bennett said the congressional testimony could spur the FDA to approve more products from BAT and Juul. “This hearing is another example of increasing political pressure for the FDA to act” against unauthorized products, he said in a research note quoted by Bloomberg.
June 13, 2024
U.S. Top Court May Tame ‘Chevron Doctrine’

Photo: maurice norbert
The U.S. Supreme Court may overturn a legal doctrine that according to some vapor industry advocates has allowed the Food and Drug Administration to reach beyond its legal authority, reports Reuters, citing legal scholars.
Known as Chevron deference, the doctrine calls for judges to defer to federal agency interpretations of U.S. laws that are deemed to be ambiguous. This doctrine, among the most important principles in administrative law, arose from a 1984 Supreme Court ruling involving oil company Chevron.
It is opposed by conservatives and business interests but supported by liberals who favor robust corporate regulation. Vaping activists contend that the Chevron doctrine has, among other things, enabled the FDA to essentially ban all nontobacco-flavored e-cigarettes.
The U.S. Chamber of Commerce, which represents more than 300,000 businesses, has argued that Chevron deference has let Congress “outsource core policy decisions (particularly controversial ones) to agencies through broadly worded statutes.” That has given the agencies, it added, “free rein to enact their own new regulatory requirements through sweeping rulemakings or after-the-fact enforcement actions.”
Many legal scholars expect the Supreme Court, which has a 6-3 conservative majority, to scale back or overturn the Chevron doctrine in a case in which fishing companies are seeking to avoid bearing costs associated with a government-run program to monitor for overfishing of herring off New England’s coast. The suit is part of a broader conservative project to strip away regulatory power from federal agencies.
The justices heard arguments in the case on Jan. 17 and are expected to rule on the case by the end of June.
June 12, 2024
New U.S. Task Force to Combat Illegal Vapes

Photo: Orhan Çam
The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration have established a federal task force to combat the distribution and sale of illegal vaping products.
“Enforcement against illegal e-cigarettes is a multipronged issue that necessitates a multipronged response,” said Brian King, director of the FDA’s Center for Tobacco Products.
In addition to the FDA and the DOJ, partners in the task force will include the Bureau of Alcohol, Tobacco, Firearms and Explosives; the U.S. Marshals Service; the U.S. Postal Inspection Service; and the Federal Trade Commission (FTC).
“Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans—particularly children and adolescents—across the country,” said acting Associate Attorney General Benjamin Mizer. “This interagency task force is dedicated to protecting Americans by combatting the unlawful sale and distribution of these products. And the establishment of this task force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority.”
The federal task force will focus on several topics, including investigating and prosecuting new criminal, civil, seizure and forfeiture actions under the Prevent All Cigarette Trafficking Act; the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act; and other authorities.
“The U.S. Marshals Service asset forfeiture division stands ready to work with our task force partners in the seizure of unauthorized e-cigarettes from domestic distributors seeking to sell them unlawfully,” said Ronald Davis, director of the U.S. Marshals Service.
“The Justice Department is committed to enforcing the laws that prevent the sale and distribution of unlawful e-cigarettes,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the DOJ’s civil division. “We will work closely with our task force partners to address this crisis with all of the enforcement tools available to us.”
The FTC, which releases reports about cigarette, smokeless tobacco and e-cigarette marketing and enforces various statutory and regulatory prohibitions on false and misleading advertising, will support the task force’s activities, including by sharing its knowledge about the marketplace for vaping products.
“We look forward to sharing our experience with this rapidly changing, multibillion-dollar market through this important task force,” said Samuel A.A. Levine, director of the FTC’s Bureau of Consumer Protection.
June 10, 2024
Swedish Match MRTP Comments Due July 5

The U.S. Food and Drug Administration posted the final set of application materials related to renewing existing modified-risk tobacco product (MRTP) orders for Swedish Match U.S.A.’s General Snus products.
The agency announced a deadline for public comments. To ensure they receive consideration by FDA, the applications must be submitted to the docket by 11:59 p.m. EDT on July 5, 2024.
The application materials, redacted in accordance with applicable laws, can be found on the FDA’s website. “Before making a final determination on an MRTP application, FDA considers all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC),” a release states.
The FDA recently announced a TPSAC meeting to discuss these renewal applications, scheduled for June 26, 2024, which the public is able to attend in person at the FDA White Oak Campus or virtually. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June 20, 2024.
June 5, 2024
Biden Rolls Back Bank Restrictions for Cuba

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Accessing the global banking system just got easier for many of Cuba’s privately owned tobacco farms. The U.S. lifted some financial restrictions against the island country on Tuesday, in a move designed to boost private businesses.
The measures will allow independent entrepreneurs to open and access U.S. bank accounts online to support their businesses. They also include steps to open up more internet-based services and expand private companies’ ability to make certain financial transactions.
“These regulatory amendments update and clarify authorizations in support of internet-based services to promote internet freedom in Cuba, support independent Cuban private sector entrepreneurs, and expand access to certain financial services for the Cuban people,” the Treasury Department said in a news release.
One of the key changes will allow Cuban private business owners to open bank accounts in the United States and then access them online once back in Cuba — something they couldn’t do previously. The U.S. also is again allowing something called U-turn transactions, where money is transferred from one country to another but is routed through the United States.
“This reinstated authorization is intended to help the Cuban people, including independent private sector entrepreneurs, by facilitating remittances and payments for transactions in the Cuban private sector,” the release said, according to the Associated Press.
The Trump administration had removed permission for the U-turn transactions in 2019.
The Cuban authorities downplayed the announcement. Johana Tablada, deputy director of the U.S. department in the Cuban Foreign Ministry, said the steps were “limited” and will do little to ease the embargo or sanctions that have most hurt the Cuban people.
May 29, 2024