Tag: FDA

Biden Pardons Thousands of Marijuana Convictions

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Thousands of people who were convicted of use and simple possession of marijuana on federal lands and in the District of Columbia have been pardoned, the White House said Friday.
President Joe Biden announced that the clemencies are meant to rectify racial disparities in the justice system.
The categorical pardon builds on a similar round issued just before the 2022 midterm elections that pardoned thousands convicted of simple possession on federal lands.
Friday’s action broadens the criminal offenses covered by the pardon.
Biden is also granting clemency to 11 people serving what the White House called “disproportionately long” sentences for nonviolent drug offenses, according to the AP.
Biden, in a statement, said his actions would help make the “promise of equal justice a reality.”
No one was freed from prison under last year’s action, but the pardons were meant to help thousands overcome obstacles to renting a home or finding a job. Similarly, no federal prisoners are eligible for release as a result of Friday’s pardon.
But the order expands the grounds on which pardons are issued. In the last round, people were pardoned for simple possession under only one criminal statute.
Friday’s pardons also apply to several other criminal statutes, including attempted simple possession.
December 22, 2023
Juul Labs Submits PMTA for JUUL2 Menthol Pods

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Juul Labs announced on Tuesday that it is seeking FDA approval for its new menthol-flavored pods. The JUUL2 pods require age verification and are designed to be used with Juul’s e-cigarette device, which is currently under regulatory review.
The new menthol-flavored pods have a nicotine concentration of 18 mg/mL and are Juul’s latest premarket tobacco product application (PMTA) submission to the FDA, according to media reports.
This follows a submission Juul Labs made in July for a vaporizer with a unique Pod ID chip to prevent the use of counterfeit cartridges and restrict underage access. The July application included a proposal for tobacco-flavored pods.
The vaporizer is already on sale in the UK after its launch in 2021 as the JUUL2 System.
The menthol pod contains a secure microchip that communicates a requirement for age verification to the device before use. The device can be locked by users at any time to prevent unauthorized usage.
To mitigate the risk of social sourcing, Juul said it would limit not only the number of devices that can be purchased but also the number of new devices each unique age-verified user can activate and use with menthol-flavored pods.
So far, the FDA has authorized only 23 e-cigarette products for sale in the United States, all of them tobacco-flavored. The agency has denied menthol e-cigarette applications from several high-profile manufacturers, including British American Tobacco, which is appealing those decisions.
Juul Labs said in a statement it has submitted evidence showing its new menthol pods can help more cigarette smokers transition from smoking than tobacco-flavored e-cigarettes.
December 20, 2023
FDA: New 5-Year Strategic Plan Announced for CTP

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On Dec. 18, Brian King, director of the U.S. Food and Drug Administration Center for Tobacco Products, published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next five years.
The CTP’s strategic plan defines five goals, 10 outcomes and several corresponding objectives. As outlined in the goals and outcomes in the plan, the center is collectively committed to issuing impactful regulations, using robust science to inform application reviews, pursuing timely and impactful compliance and enforcement strategies, and educating the public about the risks of tobacco products.
King said the CTP will also continue to invest in its staff by advancing operational enhancements and supporting the further development of its workforce.
In conjunction with the strategic plan, the CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. According to the agency, this policy agenda will create a more efficient approach to meeting the CTP’s strategic plan. The agenda will be updated annually.
December 18, 2023
U.S. Senators Demand FDA Reform its PMTA Process

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U.S. Senators Joe Manchin, Rand Paul and Ted Budd (R-NC) penned a letter urging the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) to reform its premarket tobacco product application (PMTA) process.
The Senators also requested information regarding CTP’s policies and actions that would ensure they are acting in an efficient way that is based on science and evidence.
“Cigarette smoking is the leading cause of preventable disease and death in the United States, where nearly 31 million Americans smoke cigarettes,” the group wrote in part. “For the FDA to meet its harm reduction goals, it must have a functioning authorization process.
“Since 2009, more than 26 million [PMTAs] have been submitted for new tobacco products in the U.S. Of those 26 million applications, the CTP has authorized fewer than 50… The availability of scientifically substantiated, authorized-PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”
For the FDA to meet its harm reduction goals, it must have a functioning authorization process, the Senators state, adding that the agency’s authorization rate is not in keeping with CTP policy acknowledging that tobacco products fall on a continuum of risk.
“The CTP has previously attributed its backlog to staffing shortages, but CTP’s staff has more than doubled over the past decade, from 426 employees in 2013 to more than 1,100 today,” the Senators state. “Since 2009, the FDA has also had the authority to assess and collect user fees from tobacco manufacturers and importers, with those fees being $712 million annually since 2019.
“Given these significant resources, there is no reason why the CTP should be so drastically out of step with the [Food, Drug and Cosmetic] Act’s requirements.”
December 15, 2023
U.S. FDA, Customs Seize $18 Million in Illegal Vapes

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The U.S. Food and Drug Administration and U.S. Customs and Border Protection (CBP) have announced that they have confiscated about 1.4 million unauthorized e-cigarette products, including controversial brands like Elf Bar.
The estimated value of these seized products is over $18 million. The impressive seizure occurred during a three-day joint operation, where 41 shipments containing banned e-cigarettes were found and taken into custody.
“The FDA is committed to continuing to stem the flow of illegal e-cigarettes into the United States,” said FDA Commissioner Robert Califf. “Unscrupulous companies try everything they can to bring unauthorized, youth-appealing tobacco products into the country. The FDA will remain vigilant, and together with our federal partners, stop these imports before they make it into the hands of our nation’s youth.”
The FDA and CBP conducted the joint operation at a cargo examination site at Los Angeles International Airport, where the team examined incoming shipments for potentially violative items.
In preparation for the three-day operation, the team worked for months to review shipping invoices, identify potentially illegal incoming shipments, and complete other investigative work that led to the operation’s success, according to an FDA release.
Once the merchandise is forfeited to the government, it will be disposed of in accordance with the law; in the case of unauthorized new tobacco products, that generally means they will be destroyed.
“This enforcement action is a prime example of CBP’s commitment to keeping our communities safe by disrupting the importation of illegal goods into our country,” said Troy A. Miller, senior official performing the duties of the commissioner for CBP. “The rise in illicit e-commerce demands that our agencies remain vigilant in intercepting shipments that could pose serious health risks to the public, including youth, while disrupting the supply chains that bring them to our borders.”
Upon examining shipments, all of which originated in China, the team found various brands of illegal flavored disposable e-cigarette products.
In addition to Elf Bar, among the seized e-cigarettes were EB Create products; earlier this year, the manufacturer of Elf Bar began marketing the product under the names “EB Design” and “EB Create.”
Other seized brands included Lost Mary, Funky Republic, RELX Pod and IPLAY Max, among others. In an attempt to evade duties and detection, many of these unauthorized e-cigarettes were intentionally mis-declared as various items such as toys or shoes and listed with incorrect values.
“Those shamelessly attempting to smuggle illegal e-cigarettes, particularly those that appeal to youth, into this country should take heed of today’s announcement,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Federal agencies are on to their antics and will not hesitate to take action. The significant value of these seized products is also a sobering reminder to these bad actors that their time and money would be better spent complying with the law.”
The FDA uses a comprehensive approach to tobacco product compliance and enforcement, taking action against those in the supply chain that violate the law, including manufacturers, importers, distributors and retailers, such as the targeted operations described in today’s announcement.
The FDA also regularly addresses the importation of illegal e-cigarettes by placing certain firms on an FDA import alert red list, which allows the FDA to detain products without conducting a full inspection at the time of entry, according to the release.
For example, in May, the FDA placed certain firms associated with unauthorized youth-appealing e-cigarettes on a red list, including firms associated with the Elf Bar brands.
December 14, 2023
More Warning Letters for Unauthorized Products

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On Dec. 13, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali and Breeze. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violations discussed in the warning letter and to prevent future violations. Failure to promptly correct the violations can result in FDA enforcement actions such as an injunction, seizure and/or civil money penalties.
“It is illegal to sell, import, distribute or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA,” said CTP Director Brian King in a statement. “The products identified in these warning letters are being marketed without the required authorization. We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product.”
As of December 2023, the FDA has issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes and filed civil money penalty complaints against more than 65 retailers and manufacturers for the manufacture or sale of unauthorized products.
To date, the FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products.
December 14, 2023
EU Parliament Endorses Vaping to Help Quit Smoking

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The European Parliament, in full assembly, adopted a report recognizing the role of vaping in aiding smoking cessation. This comprehensive adoption by the Parliament marks a pivotal moment in the fight against smoking-related illnesses, according to an emailed World Vaper’s Alliance release.
The report, a part of the Parliament’s broader initiative on non-communicable diseases, acknowledges vaping as an effective method for smoking cessation and may also set a new direction for health policies within the EU.
The move follows the EU’s Subcommittee on Public Health (SANT) endorsement on Nov. 7. However, the initial recommendation by the SANT to limit vaping in certain public areas remains a point of contention.
Michael Landl, director of the WVA, said the full adoption of the report by the Parliament is a step forward and underscores a significant shift in recognizing vaping’s positive impact on public health.
“We now call on the European Commission to align with this perspective, as it represents the collective voice and decision of the Parliament, the direct representatives of EU citizens,” he said. “Listening to this voice is not just a matter of policy but of democratic responsibility.
“While we welcome the Parliament’s endorsement, the proposed restrictions on vaping in public spaces are concerning. Such measures could inadvertently hinder smokers’ transition to a less harmful alternative.”
December 13, 2023
Imperial Calls for Better Targeted Vape Regulation

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Imperial Brands has called for a ban on vapes that are deliberately marketed to young people. In its response to the U.K. government’s consultation on “creating a smoke-free generation and tackling youth vaping,” the company argued for stronger enforcement of existing regulation.
Among other provisions, the government’s plan includes a provision that would make it illegal for anyone born on or after Jan. 1, 2009, to ever legally buy cigarettes, and a ban on disposable vapes.
“As the owner of the blu vape brand, we share the government’s concerns about the rise in youth vaping and call for a reform of vape flavor names and a ban on packaging that deliberately appeals to under-18s,” Imperial Brands wrote on its website.
However, Imperial also noted that vaping has played a key role in reducing U.K. smoking levels to the lowest on record, referring to Public Health England’s finding that e-cigarettes are around 95 percent less harmful than normal cigarettes.
“If a ban on disposable vapes is introduced—which more than half of adult vapers use—it could easily drive some nicotine users to return to cigarette smoking and reverse the positive downward trend,” Imperial wrote.
The proposed generational tobacco ban, meanwhile, would be unworkable and unenforceable, according to the company. “The prohibition of tobacco products won’t deter tobacco users from smoking; rather, it will increase the already flourishing illicit trade—as was the case in South Africa when the government outlawed the sale of tobacco products during Covid—and lead to a decline in government revenues. Last year, receipts from tobacco duty contributed £10 billion [$12.52 billion] to the public purse,” Imperial wrote.
“The government’s intention to put the U.K. on a path to a smoke-free future is one we all share; however, a generational smoking ban, coupled with a ban on disposable vapes, risks undermining the country’s progress,” said Oliver Kutz, general manager U.K. and Ireland at Imperial Brands.
“It is clear that prohibition does not reduce tobacco consumption; rather, it creates an illicit market, fuels organized crime and presents a real danger to retailers. Removing disposable vapes, the most widely used harm reduction alternative in the U.K., at the same time as prohibiting legitimate tobacco sales is illogical and counterproductive.
“If the U.K. wants to continue on its journey to reduce smoking whilst preventing the rise of youth vaping, greater enforcement of the current regulations at the point of sale is imperative. The introduction of a retailer licensing scheme, alongside Fixed Penalty Notices for breaches, would deter retailers from selling to under-18s, ensuring a crackdown on youth vaping that does not risk existing vapers reverting to smoking.”
December 13, 2023
FDA Says Next PMTA Update to Come in January

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The U.S. Food and Drug Administration stated in prior status reports for its premarket tobacco product applications (PMTAs) that the agency would complete a review of 100 percent of the applications by the end of 2023.
The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.
The regulatory agency is under court order to file regular status reports on the agency’s review of pending PMTAs for new tobacco products that were on the market as of Aug. 8, 2016.
For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.
The court order stems from litigation filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020.
The court-imposed deadline to complete the agency’s review was originally Sept. 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.
The most recent and FDA’s seventh status report was filed on Oct. 23, 2023, according to media reports. Specifically, in these reports, the FDA provides an update on the progress to finalize the agency’s review of pending PMTA “covered applications.”
A “covered application” is for new electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar, and reach 2 percent or more of the total retail sales volume in NielsenIQ’s various retail e-cigarette sales reports.
According to the FDA’s Oct. 23 status report, the agency has completed its review of 69 percent of the 186 pending covered applications.
The FDA states that it will file the next status report with the court by Jan. 22.
December 11, 2023
FDA Files Civil Money Action Against 25 Retailers

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The U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against 25 brick-and-mortar and online retailers for selling unauthorized Elf Bar, EB Design and other e-cigarette products.
In a press note, the FDA stated that it had previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products. During follow-up inspections, the agency observed the retailers had not corrected the violations, resulting in civil money penalty actions. 
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing.
Retailers that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount. 
Today’s actions bring the total number of CMPs filed against retailers for the sale of unauthorized e-cigarettes up to 67.
Previously, in September, and then again in November, FDA sought CMPs for similar amounts against 42 brick-and-mortar retailers across 18 states for the sale of unauthorized Elf Bar products. Today’s actions include retailers from 14 states and, for the first time, include cases against online retailers.
December 5, 2023