Wednesday, October 22, 2025

How a ‘dark fleet’ of tankers helped a Mexican cartel build a fuel-smuggling empire By Stefanie Eschenbacher, Shariq Khan and Stephen Eisenhammer

 

On the afternoon of March 8, a petroleum tanker named Torm Agnes entered the Port of Ensenada on Mexico’s Pacific coast carrying almost 120,000 barrels of diesel.
Such a vessel was a rare sight in that port, which mainly hosts cruise liners, luxury yachts and container ships. Ensenada lacks the infrastructure needed to unload cargos of flammable hydrocarbons safely – making what happened later that day odder still.
Waves of fuel-hauling trucks rolled up to the dock to cart away much of the Torm Agnes’ load. Workers scurried about filling the vehicles’ cavernous tanks, up to six at a time, using hoses springing from a larger hosepipe affixed to the vessel. The operation, while risky, ran like clockwork, according to an eyewitness and a photo and video from the scene shared with Reuters.
“They had a team, they were very thorough on what to do, and they were very fast,” the person said. “They worked insane hours, like through the night.”
 The audacious maneuver was the work of cartel-linked smugglers, according to three Mexican security sources and three people familiar with the operation – part of a wave of bootleggers upending Mexico’s fuel market with a flood of cut-rate fuel procured mainly from the United States that’s disguised in customs declarations as something else.
The Mexican crooks didn’t act alone. A Houston company named Ikon Midstream played a key role in the multi-million-dollar Ensenada operation, Reuters has found. It purchased the diesel in Canada, claimed in paperwork it was lubricants, and chartered the tanker to deliver it to a customer that Mexican authorities allege is a front for one of the country’s largest and most violent cartels.
Ikon Midstream and its executive director, Rhett Kenagy, did not respond to multiple requests for comment. Attorney Joseph O. Slovacek, who represents the company and Kenagy, told Reuters in an October 18 email to stop contacting his clients. “No one will speak to your reporter!” Slovacek said.
The Port of Ensenada did not respond to a request for comment. Denmark-based Torm, which manages one of the world’s largest fleets of tankers, including Torm Agnes, said it stopped doing business with Ikon Midstream just weeks after the Ensenada incident.
 
Narcotics remain the principal money-maker for Mexico’s cartels. But illegal fuel and stolen crude oil have become the largest non-drug revenue source for these criminals, the U.S. Treasury Department says. Narcos have built this lucrative sideline by effectively embedding themselves inside North America’s vast energy sector and mastering the logistics of moving petroleum products by truck, rail and most recently tanker. Some U.S. officials have taken to calling the tankers carrying illegal fuel a new “dark fleet,” a term more often associated with illicit shipping of Russian or Iranian crude oil designed to evade sanctions.
Fuel smuggling has grown so fast that bootleg imports now account for as much as one third of Mexico’s diesel and gasoline market, swiping profits from some of the biggest names in the oil industry, five current and former Mexican government sources told Reuters. Illegal fuel entering the country is now valued at more than $20 billion a year, according to one of the people who helped Mexico’s treasury calculate the size of the illicit trade.
Law enforcement agencies on both sides of the border are alarmed. The U.S. government is offering rewards of up to $10 million for information on cartel fuel crimes. In Mexico, tanker smuggling has sparked a corruption scandal now rocking the country’s navy, which runs the ports and has long been considered one of the most trusted institutions in the country. In a September 7 press conference, the head of Mexico’s Navy, Raymundo Morales, said the institution had launched an internal investigation and “will not tolerate corruption under any circumstances." 
 
To uncover the inner workings of fuel smuggling into Mexico, Reuters spoke to more than 50 people with knowledge of the racket. They include five people who have had dealings in illicit cargos, Mexican and U.S. law enforcement officials, current and former oil industry executives in both countries, as well as energy traders and compliance specialists. Many of these people spoke on condition of anonymity out of fear for their safety.
Reuters is the first to publish a full account of Torm Agnes’ journey, from loading in Canada to discharging at Ensenada and at another Mexican port from which it beat a hasty retreat. The account is based on information from seven people, all of whom were either involved in the logistics of moving the cargo or are investigating the journey’s fallout, as well as tanker-tracking data and satellite images, internal shipping documents, customs data and port records.
Through those documents and sources, Reuters pieced together in previously unreported detail how the alleged scheme works and how it exploits loopholes in the vast and complex U.S. energy sector, touching a host of entities including oil majors, shipping companies and government agencies.
Aiding the cartels are U.S. players who help procure and transport the products, some unwittingly, others actively participating, authorities say. Texas State Senator Juan Hinojosa said his oil-producing state has become a hotbed for shady operators.
 
“The cartels have infiltrated many legitimate businesses along the border and further north,” said Hinojosa, a Democrat who sponsored legislation in March that aims to crack down on unlicensed motor fuel depots near the border, toughen regulations on fuel transporters and boost punishment for scofflaws. The bill is stalled in the Texas senate but could be revived in the future.
The fuel smuggling scheme largely boils down to a lucrative tax dodge. Mexico slaps a levy known as IEPS on a wide variety of goods, including imported diesel and gasoline. Mexico is a major crude oil producer, but it imports these fuels because its aging refineries can’t meet local demand. Crooks evade the tax, charged by the liter and often costing upwards of 50% of the cargo’s value, by declaring the foreign fuel to be some other type of petroleum product that’s exempt from the duty.

The cartels have infiltrated many legitimate businesses along the border and further north.

Texas State Senator Juan Hinojosa

U.S. and Mexican officials say smugglers typically utilize shell companies and falsified cargo documents to cover their tracks, and they pay bribes to corrupt port and customs officials to get their shipments through.
They also unload in a hurry in dicey locations, bypassing Mexico’s nearly two dozen marine terminals set up for safe discharge of fuels, authorities and industry experts say. This allows smugglers to get the illicit cargo to their customers quickly, with minimal oversight and regulations.
Bootleg diesel is then sold at a discount in the Mexican market to thousands of unlicensed diesel stations, factories and mines. The smuggled gasoline goes mainly to unbranded filling stations. Cartels also steal fuel and crude oil outright from Pemex and sell some of it in the United States, helped by crooked importers that are undercutting American producers, the U.S. Treasury Department says.
 
Pemex did not respond to a request for comment about losses linked to fuel theft and smuggling.
Other oil companies are feeling the pain, too. In May, British multinational Shell disclosed the sale of its retail fuel business in Mexico. That exit was due in part to the difficulties of competing with cheaper narco fuel, five Shell sources told Reuters. Gas stations buy smuggled fuel at a discount of 5% to 10% below the price of legitimate imports, according to two sources familiar with the trade.
Shell declined to comment on its reasons for the sale.
Torm Agnes was transporting diesel it had picked up in Canada when it started its journey to Mexico, seven sources familiar with the deal told Reuters. By the time the vessel reached Ensenada, its cargo had transformed – at least on paper – into a petrochemical used to make industrial lubricants, according to cargo documents and port records reviewed by the news agency.
If that diesel, worth some $12 million, had been declared to customs authorities it would have been subject to nearly $7 million in tax when entering Mexico, according to a Reuters calculation based on the volume of diesel and the tax rate at the time. The petrochemical, however, was exempt from the levy.
Denmark-flagged Torm Agnes was one of several tankers in recent years that carried fuel but declared its cargo as lubricants to avoid taxes and customs controls, according to an undated summary of the alleged smuggling scheme from government security forces seen by Reuters. The document's authenticity was confirmed by two security sources.
 
Mexico’s government has not said how much fuel smuggling has cost the country in lost IEPS revenue, but the source who used to help the treasury calculate the size of the illicit trade said it was nearly $4 billion in 2024. The opposition PAN party has put the number higher still – at around $10 billion – calling it “the largest corruption scheme in the history of Mexico.”
Neither Mexico’s tax authority nor its customs agency responded to requests for comment.

THE AMERICAN CONNECTION

At the center of that deal was a U.S. company: Ikon Midstream, a Houston-based fuel trader. The company bought the Canadian diesel and chartered Torm Agnes to deliver it to Mexico, according to four of the people and internal Ikon Midstream documents seen by Reuters.
In addition to the shipment to Ensenada, Ikon Midstream arranged at least four other maritime deliveries of diesel to Mexico this year, Reuters learned. Between January 8 and March 4, the company used a different tanker from the same fleet – Torm Louise – on four separate occasions to carry cargo from Texas to the Port of Tampico on Mexico’s Gulf Coast, according to tanker-tracking data and shipping company Torm, which manages both the Torm Agnes and Torm Louise vessels.
 
Torm told Reuters that both tankers were loaded with diesel. It added that Torm Louise in three of its journeys also carried naphtha. In Mexico, bootleggers frequently use that highly flammable hydrocarbon to make low-quality gasoline.
In declarations to Mexican customs, however, Ikon Midstream said all five shipments were “additives for lubricants” not subject to IEPS, according to Mexican port records obtained by Reuters through freedom of information requests.
The product that was declared on U.S. export bills of lading for two of the Torm Louise shipments was likewise lubricants, according to Kpler, a marine data provider based in Brussels. Reuters is the first to report that Ikon Midstream labeled these diesel shipments as lubricants in U.S. customs declarations.
Kpler said it was not able to share the source documents due to confidentiality agreements with its data providers.
U.S. Customs and Border Protection (CBP), which holds copies of these documents, initially declined a June freedom of information request from Reuters seeking to obtain them. In October, CBP said the information sought by Reuters was available in paper cargo manifests that would need to be requested in person at each port of export, a process the agency described as “time-consuming” and subject to further delays.
Torm in an August 5 email said it was not responsible for nor involved in completing customs paperwork for the shipments. All the documents it received from Ikon Midstream, Torm said, consistently declared the products being transported on its tankers to be “ULSD and/or naphtha.” ULSD is an industry acronym for ultra-low sulfur diesel. Torm declined to share with Reuters the documents it said it had received from Ikon Midstream, citing contractual obligations.
“Based on what has come to light, we have decided not to engage in further business with Ikon Midstream,” Torm said without elaborating in an August 27 email to Reuters. Torm broke off commercial relations with Ikon Midstream at the start of April and canceled two future contracts with the company, a Torm spokesperson said in a follow-up email to the news agency on September 5.
 
As part of Reuters’ efforts to seek comment from Ikon Midstream, a reporter stopped by the company’s Houston headquarters in August but was turned away by a person who said he worked for Ikon Midstream and gave his name only as Daniel.
Kenagy, like many executives involved in the trillion-dollar plus global oil trade, projects an image of success. Earlier this year, he bought a Houston mansion and grounds valued at more than $6 million, local property records show. His Instagram feed is peppered with images of sports cars, exotic motorcycles and private jets.
He and his wife, Janelle Alexis Flatt, appeared in a 2022 episode of the reality TV show Below Deck Sailing Yacht, which chronicles the lives of crew members aboard a luxury vessel and their experiences with guests who charter it.
 
Flatt did not respond to requests for comment.
Kenagy is also a registered agent for at least a half-dozen businesses that no longer are operational, including ventures in mining, construction and entertainment, Texas business records show.
In Mexico, a Monterrey-based company named Intanza was the recipient of the Torm Agnes’ cargo, according to Mexican port records as well as an invoice for the Torm Agnes shipment viewed by the news agency.
Mexican authorities suspect Intanza is a front company for the Jalisco New Generation Cartel, according to three Mexican security sources and a second undated document from government security forces seen by Reuters outlining cartel ties to fuel smuggling.
Intanza has no website and no social media presence that Reuters could identify. A letter sent by Reuters to the Monterrey address listed for Intanza in the invoice could not be delivered because the courier service could find no presence of the company there.
Intanza’s name surfaced again after Mexican authorities apprehended another tanker, Challenge Procyon, on March 21 at the Port of Tampico in Tamaulipas state. Intanza on March 27 filed a claim in a Tamaulipas court asking a judge to release that shipment, which it claimed was lubricants and wrongfully seized; the judge rejected Intanza’s request. Mexico’s Security Minister Omar García Harfuch in a March 31 social media post said that 10 million liters (about 63,000 barrels) of diesel had been found aboard Challenge Procyon.
Last month, García Harfuch declared that seizure to be “one of the largest in history” as he announced the arrest of 14 people, including business executives, former customs officials, and active and retired naval officials as part of investigations into Challenge Procyon and other alleged fuel smuggling. The government identified those apprehended only by their first names, as is customary in Mexico.
Mexico’s Navy and the Attorney General’s office said they could not comment on ongoing investigations and pointed Reuters to public statements on the issue. The security ministry did not respond to a request for comment.
Ramiro Rocha, listed as Intanza’s legal representative in Mexico’s official companies registry, said he has no involvement with the company and may have been a victim of identity theft.

A CARTEL SETS SAIL

Small-time thieves for decades have filched gasoline, diesel and crude oil from Pemex. Over time, as the trade grew in scale and profitability, it attracted the involvement of Mexico’s cartels. But the Jalisco New Generation Cartel has taken the scheme to a new level and is the unquestioned leader in fuel and crude oil smuggling, according to Mexican and U.S. security sources.
The cartel, whose home territory is the central-western state of Jalisco, has expanded across Mexico. Authorities say it has built a formidable smuggling operation in the northern state of Tamaulipas just across the Texas border. From there, they say, it sends stolen Mexican crude oil to the United States and brings U.S. refined products to Mexico by truck, rail and tanker. They said CJNG, as it’s known by its Spanish initials, is the only cartel currently employing tankers. 
 
Authorities first detected smuggling by tanker around 2020, according to a 2021 Mexican government document viewed by Reuters outlining initial investigations into the scheme, which at the time did not attribute this development to a specific cartel.
The jump to tankers from trucks and trains reflects a degree of business savvy and investment power that's in a different league than what has come before, said Marisol Ochoa, an expert on organized crime at Mexico’s Ibero-American University.
“You have to have a high level of sophistication and extensive networks and connections in operational logistics,” she said.
Since September 2024, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) has issued two rounds of sanctions against a dozen Mexican nationals and nearly 30 Mexican companies allegedly linked to CJNG and its fuel theft and smuggling operations.
Greg Gatjanis, a former top OFAC official, said he was “stunned at the array of companies” connected to the alleged scheme. The enterprises include gas stations, transport firms, a 3D printing company and a baguette bakery, according to OFAC.
The Trump administration in February designated several Mexican cartels, including CJNG, as foreign terrorist organizations. That mobilized more personnel and resources for the anti-cartel fight and made it easier for U.S. prosecutors to go after individuals and companies doing business with these groups.
In May, a father and son from Utah – James Lael Jensen and Maxwell Sterling Jensen – were charged with conspiracy to commit money laundering and provide material support to a designated foreign terrorist organization. Authorities allege the Jensens worked with CJNG to smuggle crude oil into the U.S.
Lawyers for James Jensen did not respond to a request for comment. Robert Guerra, a lawyer representing Maxwell Jensen, declined to comment.

You have to have a high level of sophistication and extensive networks and connections in operational logistics.

Marisol Ochoa, organized crime expert at Mexico’s Ibero-American University, on fuel smuggling by tanker

U.S. officials also met with refiners in the Houston area this year to explain the involvement of Mexican organized crime in the fuel business and to stress the importance of knowing their suppliers and customers, three industry sources and a U.S. official said. That official told Reuters that violators of U.S. sanctions up and down the supply chain could face civil and criminal penalties.
That presents “an enormous business risk” for U.S. players given the success of cartels in using front companies and intermediaries to do their dirty work, said Gatjanis, the former OFAC official.
In Mexico, the scale and increasing sophistication of fuel smuggling have spawned allegations that senior politicians are involved.
In last year’s presidential campaign, opposition candidate Xóchitl Gálvez accused the ruling Morena party of receiving funds from Sergio Carmona, a Tamaulipas businessman referred to by the Mexican press as the “The King of Illegal Fuel.” Carmona was a major trafficker linked to the Gulf Cartel and the Northeast Cartel, according to Mexican media reports. He was shot dead in a barbershop in northern Mexico by unknown assailants in 2021. No one has been arrested in his killing.
Carmona allegedly helped fund Morena election campaigns, including that of former President Andrés Manuel López Obrador who won Mexico's highest office in 2018, according to the second undated document from government security forces reviewed by Reuters.
Neither López Obrador nor Morena responded to requests for comment.
Mexican President Claudia Sheinbaum, of the Morena party, has made combating fuel smuggling and crude oil theft a security priority for her administration.
“We will not protect anyone,” Sheinbaum said in a July 8 press conference when asked about the alleged involvement of politicians in the illicit trade. Her office did not respond to a detailed list of questions for this story.
Since Sheinbaum took office in October 2024, authorities say they’ve seized around 500,000 barrels of allegedly illegal fuel and crude oil – more than the previous government nabbed over its whole six-year term. That’s barely a trickle in the torrent of bootleg fuel entering the country. Still, the fight is proving dangerous.
On August 4, Ernesto Vázquez, federal prosecutor for the state of Tamaulipas, was killed after his armored SUV was hit by an incendiary grenade on a busy street in the city of Reynosa. Footage broadcast on national television showed Vázquez escaped the burning vehicle, only to be shot from a nearby car.
In a statement the following day, the Attorney General’s office said the killing likely was the work of organized crime after the government in late July seized more than 1.8 million liters (about 11,300 barrels) of illegal fuel, trucks, pumps and other equipment in Reynosa, just across the border from McAllen, Texas.
 

A PAPER TRAIL OF TAX EVASION

Trading crude oil and fuel often entails a complex chain of custody. Transactions can involve multiple buyers, sellers and middlemen. Import-export paperwork is often incomplete or outright faked by bad actors, trade experts and law enforcement officials told Reuters.
Torm Agnes began loading from the Vancouver Wharves marine terminal in Canada on March 2, according to marine data provider Kpler. The tanker took on about 120,000 barrels of cargo, Kpler calculated, based on data transmitted by the tanker showing how low it sat in the water. Seven sources familiar with the deal confirmed it loaded diesel.
That diesel came from Imperial Oil, a Canadian oil company that’s majority-owned by ExxonMobil, according to four of the people.
Imperial Oil did not respond to a request for comment. ExxonMobil declined to comment.
Shipping documents viewed by Reuters told a different story about what was on the vessel. A February 28 invoice, bearing Ikon Midstream’s logo and Houston address, claimed the cargo was lubricants, not diesel, and that it had been sold to Intanza. The stated value was $1.3 million, or about one-tenth of the value of 120,000 barrels of diesel at the time. A cargo manifest viewed by Reuters likewise showed the cargo was lubricants loaded in Vancouver on Torm Agnes for delivery to Mexico, with Ikon Midstream as the shipper and Intanza as the recipient.
Mexico in recent years has seen erratic spikes in declared imports of lubricants, a development the government has linked to smuggling. The nation’s tax authority in a 2022 document said these products are “used as a means of tax evasion” because they’re not subject to IEPS.
Demand in Mexico for so-called base oil lubricants is a modest 1 million tons per year, according to Michael Connolly, head of refining and base oils analytics at commodities information provider ICIS. Yet official U.S. trade data shows the country exported as much as 3.5 million tons to Mexico last year, a figure Connolly says doesn’t add up.
“There’s just a significantly higher level of imports going in there than what we would expect,” he said.
 
Ikon Midstream alone declared that it shipped lubricants from the U.S. to Mexico 149 times between October 11, 2019, and May 4, 2025, with 67 of those loads coming via tanker, according to trade data compiled for Reuters by trade technology company Altana.
Intanza, the Mexican customer for Torm Agnes’ cargo, has a slew of business objectives, ranging from alcoholic beverage production to scientific research, according to Mexico’s companies registry.
Its Monterrey address, according to the shipping invoice, is a unit in a two-story residential apartment complex next to a daycare center. When a Reuters reporter visited the address, they saw no signage for Intanza.
Rocha, Intanza’s listed representative, lives in a working-class neighborhood about 40 kilometers (25 miles) outside the city, according to his address on file in the registry.
The gray-haired Rocha became a minor online celebrity in recent years by posting videos of himself falling asleep in random places. Fans nicknamed the short, stocky Rocha “Don Pug.” His popularity surged anew in February when on social media he denied press reports that he had died of a heart attack during a lap dance at a Monterrey strip club.
Rocha told Reuters he works as a security guard, has nothing to do with Intanza, and that data listed for him in the registry, including his address and three forms of identification, might have been stolen.

A SMOOTH OPERATION, THEN A SCRAMBLE

On the afternoon of March 8, Torm Agnes entered the Port of Ensenada. Within hours, the queue of fuel-hauling trucks stretched the length of the dock and well outside the terminal, said the eyewitness to the operation.
Some of these vehicles bore the logo of a trucking company named Mefra Fletes, according to the eyewitness and a photograph of the scene viewed by Reuters.
 
Ikon Midstream and Mefra Fletes have worked together on tanker-to-truck fuel transfers in at least three different Mexican ports in recent years, two sources familiar with the operations said. The employee at Ikon Midstream’s Houston headquarters in August who identified himself as Daniel told a Reuters reporter that he used to work with Mefra Fletes in Mexico.
Mefra Fletes was incorporated in 2015 in Guadalajara, the capital of Jalisco state, and is focused on transporting petroleum products, according to Mexico’s companies registry. There was no address or contact information in the registry for the company or for Roberto Blanco, who is listed as the majority owner. Reuters could find no website or social media presence for Mefra Fletes.
Reuters received no reply to a letter sent by courier with detailed questions for Blanco to a Jalisco address for Mefra Fletes printed on one of its trucks. Reporters were unable to locate the company’s legal representative, Mario Castro.
Torm Agnes unloaded much of its cargo, but not all of it, in Ensenada. From there, the tanker headed to the Port of Guaymas in the Gulf of California and again discharged straight into fuel trucks starting on March 20, according to photographs and videos of the operation viewed by Reuters. Some of those vehicles bore the Mefra Fletes insignia, the images showed.
 
But Torm Agnes managed to unload only about half of the cargo it had planned to discharge there, according to internal port emails seen by Reuters. Instead, it left Guaymas abruptly the following day, according to tanker-tracking data and three people familiar with the situation. Workers helping to offload the diesel quickly packed up their equipment, and fuel trucks sped from the port, the people said.
The exodus caused a stir locally. Photos and videos shared on social media showed a dozen fuel tanks detached from the trucks that brought them and abandoned in nearby parking lots and along the roadside.
 
Security sources told Reuters they suspect Torm Agnes took off after word spread at the Port of Guaymas that Mexican authorities were seizing another tanker, Challenge Procyon, that same day, March 21, in the Port of Tampico.
Torm did not comment on the reason for Torm Agnes’ hasty departure. The Port of Guaymas did not respond to a request for comment.
On March 28, Mexican authorities in a press release announced they had seized some 50,000 barrels of petroleum products stored haphazardly in about 100 containers in a dusty lot in the town of El Sauzal, around 10 kilometers north of the Port of Ensenada. Security forces also seized equipment and fuel trucks. Video footage from the raid broadcast by Mexican media showed Mefra Fletes trucks.
The seized petroleum products likely came from the Port of Ensenada and arrived by tanker, according to an undated summary of the case by Mexican security forces viewed by Reuters. The document did not mention Torm Agnes, but two Mexican security sources confirmed that the tanker’s activity in Ensenada is under investigation.
Anuar González, a former legal representative for Mefra Fletes, was apprehended in August. An arrest warrant has been issued for Blanco, the company’s majority owner. Both are suspected of involvement in the illegal fuel trade, according to one of the Mexican security sources and press reports.
Reuters couldn’t determine whether González has a lawyer. Blanco remains at large.
 
 

Tuesday, October 21, 2025

3 takeaways from Saturday's No Kings nationwide protests by Alana Wise , Chandelis Duster , Emma Bowman

 

One of the biggest days of protest against the Trump administration's policies happened on Saturday in cities around the U.S. The overriding theme of the marches was the accusation that President Trump is behaving more like a monarch than an elected official.

It marked the second massive wave of protests organized by No Kings — a network of progressive organizations fighting against Trump's agenda.

Organizers said about 2,600 No Kings events were planned across nearly every state, and that it projected a bigger turnout than the 5 million it said attended its previous nationwide action in June.

 Energized by a slew of actions taken by the administration since the summer protests, the group cited widespread immigration detentions carried out by often-masked Immigration and Customs Enforcement agents, the administration's aggressive slashing of federal education resources and environmental protections, gerrymandering and other concerns

 

Here's a recap of how the protests unfolded.

1. United in protests to 'protect America'

Protesters showed up to oppose a wide range of issues, including the administration's immigration tactics and its push for federal and military intervention in Democratic-led states as a way to tackle crime. The diversity of concerns was strung together by the broader messaging of democracy, constitutional rights and the freedom the U.S. was founded on.

In Washington, D.C., demonstrators filled Pennsylvania Avenue near the U.S. Capitol, many holding signs that read "No Kings, No Tyrants." Many people wore yellow, a color organizers said is to show unity.

 

Uriah Kitchen of Delaware, who attended the protest with his son Elijah, told NPR "we made a pledge of allegiance when we were in school and this is what it's all about."

"This is why we're here, we're here to protect America," Kitchen said.

Sen. Bernie Sanders of Vermont, an Independent who caucuses with Democrats, addressed D.C. protesters in remarks slamming tech billionaires who he said have become richer and more powerful since Trump became president. Sanders singled out Elon Musk, Jeff Bezos, Mark Zuckerberg "and the other multibillionaires who were sitting right behind Trump when he was inaugurated."

 On the West Coast in San Pablo, Calif., Maria Floriano attended a No Kings event with immigration on her mind. Wearing a hat and shirt decorated with butterflies, she compared immigration to butterflies and said "migration is beautiful" and "an act of courage."

 

"We want them to know that there are people fighting for them, that not everyone feels that they're not welcome here," Floriano said, noting the protest was held in a Bay Area community home to a large population of immigrants.

2. The Trump administration and Republican lawmakers weighed in

House Speaker Mike Johnson slammed Saturday's protests as a "hate America rally," and other Republicans have derided the event as anti-American.

Responding to NPR's questions about the protests, White House spokeswoman Abigail Jackson said: "Who cares?"

Trump was not at the White House during the protests but on a visit to his Mar-a-Lago resort in Florida.

Connecticut House Republican Leader Vincent Candelora told Connecticut Public that he considered the "No Kings" messaging of the protests "divisive." He also doesn't share protesters' concerns but supports their right to exercise their First Amendment rights.

"I think our democracy is still strong as ever — but, you know, they're free to express themselves," Candelora said.

3. Peaceful protesting with song and dance

Despite the many criticisms that anti-Trump protesters came to preach, there were displays of optimism, hope and whimsy in several cities.

 

Inspired by protesters in Portland, Ore., people in Los Angeles, Hartford, Conn., and elsewhere showed up to march in inflatable animal costumes. Song and dance broke out in Salt Lake City and other cities.

As with the previous mass No Kings protests, revolutionary messaging showed up in demonstrators' clothing, chants and signs as protesters sought to remind people that America was founded in opposition to monarchy.

 In Macon, Ga., protesters belted "The Story of Tonight" from the musical Hamilton — a song about the importance of sacrifice and solidarity today for the sake of freedom tomorrow.

 The protests were largely peaceful. Police in New York City and Washington, D.C., where rallies drew some of the day's biggest crowds, said no protest-related arrests were made.

 

Republican Govs. Glenn Youngkin of Virginia and Greg Abbott of Texas mobilized their states' National Guards in preparation for the protests.

"The Governor has authorized state active duty for training to help ensure the Guard will be ready to respond if needed to help keep people safe," Youngkin spokesman Peter Finocchio wrote in a statement to VPM.

The Texas Newsroom reported that Abbott said in a statement of sending the Guards to Austin: "Violence and destruction will never be tolerated in Texas." The newsroom also reported that state troopers were stationed at entrances to the Capitol grounds inspecting bags but protesters said the law enforcement presence felt smaller than the previous "No Kings" event in June.

Saturday's rally was peaceful and there were no arrests, according to the Austin Police Department.

 

Monday, October 20, 2025

When books were being pulled from Iowa classrooms, these teens started an after-school club to read them by Josie Fischels

 

Three Iowa City West high schoolers founded a book club that reads some of the country's most frequently banned books after a state law removing books with sexual content was signed in 2023. Two years later, many of the books have been reshelved and parts of the law can't be enforced.

Iowa City West High School student Alice Gooblar-Perovic credits her early love of reading with how she understands the world.

"People say [books are] like a window or like a mirror, and I see that a lot. They also help you understand yourself better," she said.

Gooblar-Perovic was a freshman when she learned that thousands of books with sexual content, like The Handmaid's Tale and Nineteen Minutes, were being pulled from Iowa classrooms to comply with the implementation of Senate File 496, which was scheduled to take effect at the start of 2024.

In response, she and her classmates, Aahana Gupta and Lydia Cruce, started a Banned Book Club. They borrowed books frequently found on "banned" book lists from the Coralville Public Library and met after classes ended for the day to discuss them.

Operating as an unofficial club, they were unable to participate in the school's activities fair or advertise their gatherings at school — posters they hung were quickly taken down. Instead, they grew a small group through word of mouth.

“Our membership was pretty low that first year," Cruce recalled.

"It was really difficult for our first year," Gooblar-Perovic added. "We couldn't be like an official club with our school, because it would be, legally, iffy."

The group persisted. After the part of the law that affects school libraries was temporarily blocked by a federal judge, the Banned Book Club gained official recognition from the school. Now, as enforcement of the book restrictions remains frozen under a second temporary injunction, the club has 15 to 25 regular members and meets weekly to discuss books like The Perks of Being a Wallflower, The Color Purple, The Handmaid’s Tale and Fahrenheit 451 — some of the same titles that had been previously removed from the Iowa City Community School District's libraries. According to Iowa City West High's library catalog, the books have since been reshelved. 

 

“Banned Book Club is really a place for discussion, no judgment, where we're just talking about what we think different themes in the book mean, and why we think it's important," Cruce said. "We're also really trying to have these important discussions about the characters in the book and the themes and why it was banned.”

While the number of book challenges in Iowa dropped significantly from the 2023-2024 to 2024-2025 school year, Iowa remains a leading state for the number of book removals.

For the founders, who are now juniors, the club is less about protesting book removals in their own district and more about sharing information and promoting access to books in general.

 

"I think a lot of times, in terms of banned books, there's a lot of confusion, especially among kids or teenagers that are often left out of these conversations," Gooblar-Perovic said. “I’ve found that a lot of people our age just don't have the information. So a lot of it is just saying, ‘OK, what exactly are banned books? What is it about these books that are so wrong or controversial?'"

Gupta said the club's meetings have become a place where students form friendships around stories that challenge them to think critically.

“Books can help bring us together. I like that our club does that for people," she said.

She described the club as student-focused and as independent from the school as possible. While school sponsorship provides them with a space to hold their meetings and the ability to promote their club, the three student founders lead all the discussions themselves. They plan the reading lists and continue to coordinate with the Coralville Public Library for copies instead of the public school library — mostly because, even if the book is available to borrow at school, there aren't enough copies available to check out for the entire club, Gooblar-Perovic explained. 

 

“Books can help bring us together. I like that our club does that for people."
Aahana Gupta, Iowa City West High School junior

If the injunction on Iowa’s book law is eventually lifted, the students said it could complicate the future of the club as an official school organization. Gooblar-Perovic said they're prepared to continue in an unofficial capacity if that happens.

“It would definitely be easier than our first year, even if we had to become unofficial again, because we’ve built this community," she said. “I feel a lot more confident that we would be able to make it work.”

For now, the club continues to meet as a school-sponsored organization, despite receiving occasional negative feedback from the public.

"The fact that it is so difficult to have a book club where we read banned books feels like exactly why we were doing it," Gooblar-Perovic said. "Because it’s so important.”

Thursday, October 16, 2025

Rethinking manufacturing quality oversight for prescription drugs by Marta E. Wosińska

 Introduction

Modern medicine depends on a guarantee we often take for granted: that the drugs we swallow, apply, or inject work as intended. By law, it is drug manufacturers who bear the primary responsibility for making sure each product meets quality standards. The role of the Food and Drug Administration (FDA) is to ensure manufacturers comply with these requirements, but as supply chains expand across the globe, this role has become harder to carry out.

 

To ensure consistent drug quality, FDA relies on a combination of prescriptive regulatory requirements, facility inspections, and various compliance tools. FDA requires manufacturers to have strong quality systems that follow Current Good Manufacturing Practices (CGMP), including oversight of every production step, checking samples during production, and keeping thorough records. FDA investigators then verify compliance with standards through both scheduled and unannounced inspections, during which they review everything from personnel training and equipment maintenance to contamination control and recordkeeping. When serious violations are uncovered, FDA can act through warning letters, drug recalls, import refusals, import alerts, and injunctions.

But the FDA oversight system is imperfect. FDA struggles with persistent staffing shortages and inspection backlogs, especially for foreign facilities in countries like India and China. Many inspections abroad are still announced in advance, which weakens detection of compliance issues. Driven by economic forces, pharmaceutical manufacturers of low-cost generics often have weak quality management systems and quality assurance units that lack the authority and resources to enforce CGMP compliance effectively. FDA’s “too important to fail problem”—where FDA will allow noncompliant facilities to continue shipping medically necessary drugs if there is shortage risk—only reinforces those weaknesses.

 

Proposals to address these shortcomings primarily focus on supporting FDA through expanding unannounced inspections, increasing inspection frequency, improving policies to ensure inspector independence, addressing inspection workforce and backlog challenges, and exploring alternative monitoring tools, such as remote access to documents, information from inspections conducted by foreign regulators not part of mutual recognition agreements, or third-party audits.

In this paper, I propose an alternative but complementary path to enhance U.S. drug quality assurance by requiring every importer to designate a qualified individual—located in the U.S.—who certifies that each batch meets Good Manufacturing Practices (GMP) standards after assessing the firm’s compliance, including through additional testing of product. This framework—already established in Europe for drugs and to some extent in the U.S. for certain food imports—raises accountability and increases oversight by adding a second, importer-level layer of verification beyond the manufacturer.

To motivate the proposal, this paper first examines how the U.S. and European systems differ in their approach to manufacturing quality compliance, including through batch release procedures, finished product testing, and facility inspections. It then reviews FDA’s Foreign Supplier Verification Program, authorized under the Food Safety Modernization Act of 2011. Next, the paper explores the benefits of adapting the “Qualified Person” and import testing systems within the U.S. drug quality oversight system—not as a replacement, but to strengthen the existing regulatory framework. Finally, the paper discusses various considerations for implementing these changes

 

Approach to accountability

International GMP standards require that drug manufacturers conduct a thorough review of all production, packaging, and testing records to confirm compliance with documented procedures and quality standards, with formal approval carried out by qualified personnel before any batch is released for distribution.

To comply with GMP standards, both FDA and EU legislation mandate that manufacturers maintain an independent department—called the ‘Quality Unit’ under FDA regulations and ‘Quality Control’ (QC) in the EU—responsible for approving or rejecting materials and products, reviewing production and quality records, investigating discrepancies, ensuring controls and procedures are followed, and maintaining the overall pharmaceutical quality system.

But the degree and nature of accountability differ substantially between the FDA and EU models.

In the EU system, the importer must designate a Qualified Person (QP)—a specific individual who holds personal responsibility to certify that each batch released for sale meets GMPs, the product’s marketing authorization (the EU equivalent of FDA drug approval), and all applicable EU laws. However, a QP is not simply appointed by the importer; the individual must have specialized academic degrees, relevant industry experience, and must be formally recognized and approved by the relevant national regulatory agency before they may take on the role. The QP’s professional qualifications, certification requirements, and responsibilities—including the non-delegable duty for batch certification—are fully detailed in EU law and accompanying guidance, particularly EudraLex Volume 4, Annex 16.

 

Because the QP operates in addition to, not instead of, the manufacturer’s QC, release of an imported batch involves two steps. First, the exporting manufacturer’s internal QC department authorizes shipping from the foreign production site to the EU importer. Second, the EU-based QP ensures that the batch is re-tested in the EU and then certifies that the batch was manufactured in accordance with EU GMP and in accordance with the EU marketing authorization. Only following the QP certification may the batch be released into distribution.

To fulfill their responsibilities, QPs review quality documentation provided by the manufacturer’s quality control or third-party laboratories. QPs have limited discretion to certify batches exhibiting minor deviations—those deviations that do not affect product quality, safety, or efficacy—but only after conducting a thorough, documented risk assessment. Batches with major deviations or out-of-specification results that could potentially impact product quality or patient safety must not be certified.

QPs can delegate to trained personnel some of the checks necessary for the review, but they cannot delegate their sign-off responsibility.

QPs may face personal liability if they negligently certify defective products that cause harm. QPs must be EU residents, putting their QP accountability within the EU importer’s jurisdiction.

QPs may join, or in some cases are required to join, national or international professional associations dedicated to supporting QPs. These organizations, such as the European Qualified Person Association (EQPA), provide platforms for ongoing education, facilitate the exchange of best practices, and promote harmonization of standards across the region. Membership can offer access to policy updates, professional discussion forums, and regular meetings or seminars to address emerging challenges in pharmaceutical quality assurance. Depending on the country, association membership may be a formal prerequisite for QP registration or may simply be encouraged as a valuable resource for professional development and networking within the highly regulated environment of drug manufacturing oversight.

 

Approach to testing

Both the U.S. and EU regulatory systems require that drug manufacturers comply with GMPs, which in turn means that manufacturers must perform in-process and final product sampling using official pharmacopeial methods—the US Pharmacopeia (USP) in the United States and the European Pharmacopoeia in the EU. In both jurisdictions, manufacturers can do their testing in-house or can contract it out to analytical labs. Contract laboratories are considered part of the manufacturing process and must be registered with regulators and subject to GMP inspections.

However, the U.S. and European regulations differ in how they approach product testing beyond the GMP-mandated analyses performed by or on behalf of manufacturers.

In the United States, FDA does not mandate testing beyond what is required for the manufacturers’ Quality Units at the site of manufacture as part of standard CGMP procedures, It may, however, require additional testing as part of enforcement actions, such as a consent decree or a warning letter. In such cases, FDA may require the manufacturer to utilize an external laboratory to perform supplemental CGMP-compliant analyses. The FDA also operates its own drug testing laboratories; however, these activities are limited in scope and volume, focusing primarily on risk-based sampling of products that are linked to safety signals or identified quality concerns.

By contrast, each batch of drugs imported into the EU must be tested again within the EU before it can be released for distribution, except when medicine is imported from countries that have a Mutual Recognition Agreement (MRA) with the EU. This exemption means that drugs manufactured in the U.S., Canada, Australia, or Switzerland are not required to undergo this additional testing, but drugs coming from India and China are. The responsibilities and requirements for batch importation testing—applicable to commercial and investigational medicinal products—are comprehensively detailed in EU law and applicable guidance, specifically EudraLex Volume 4, Annex 21 (“Importation of medicinal products”).

For imports from countries without an MRA, batch release testing must be conducted within the EU. The product batches, not just the samples, generally physically arrive in the EU before the testing is performed, as EU regulations require testing on samples representative of the actual imported batch, including shipping conditions. The importer may use an in-house EU-based laboratory for testing, or they may contract an EU-based GMP-compliant lab. Import testing in the EU is part of manufacturing, and laboratories are required to be registered and undergo GMP inspections.

The importer’s QP then uses lab reports along with other relevant information to determine whether certifying each batch for release is appropriate.

Approach to inspections

Both FDA and EU national authorities conduct inspections to ensure manufacturing facilities comply with GMPs. Common elements include a detailed review of manufacturing processes, quality systems, documentation, and personnel training, supported by risk-based site prioritization to focus resources effectively. Because the FDA and EU national authorities have similar standards and approaches, the respective regulators have signed Mutual Recognition Agreements, which allow the respective regulators to rely on the other’s GMP inspections.

The differences that do exist are perhaps more nuanced. While FDA follows a more prescriptive, audit-focused approach based on detailed CGMP regulations, with C indicating the current version of GMPs, the EU employs a principle-based GMP framework. FDA inspections typically culminate in the issuance of a Form 483 listing specific observations, which do not distinguish between their importance and, for some of them, require documented corrective actions. In contrast, EU inspections, generally conducted by national competent authorities with EMA coordination for sites located in third countries, end with a verbal or formal inspection report that classifies deficiencies by severity (critical, major, or other and requires documented corrective actions).

Food importers example

The concept of a qualified person is familiar to FDA through the Foreign Supplier Verification Program (FSVP), established under the Food Safety Modernization Act (FSMA). Under FSVP, importers must verify that foreign suppliers meet U.S. safety standards and maintain adequate records of compliance.

 

working group that included FDA responded with its draft “good importer practices” guidance, shifting part of the oversight burden from border inspection to importers themselves through systematic, risk-based verification of foreign suppliers. Multiple foodborne illness outbreaks traced to imports reinforced these concerns, and Congress codified these measures into FSMA by creating FSVP.

Just as in the EU drug QP system, FSVP requires a qualified individual—in this case, the U.S. food importer or their designated agent—to implement preventive controls ensuring the safety and integrity of imported food products. The FSVP importer is defined as the U.S. owner or consignee of the food (or, if none exists, the U.S. agent for the foreign supplier), making compliance a matter of legal responsibility for the party with actual ownership or control. Depending on the food and its hazard profile, verification may include supplier audits, record reviews, or sampling and testing.

Both the EU QP system and FDA’s FSVP use the MRA concept with countries that have comparable regulatory standards and oversight (under FSVP, the agreements are called system recognition agreements). Based on this shared trust, the EU waives batch retesting for drug imports from recognized partners. With FSVP, the requirements for food importers from recognized countries are not eliminated but reduced, meaning importers face fewer or less frequent verification steps.

FSVP also does not go as far as the EU QP system in concentrating accountability or in testing. In FSVP, responsibility for compliance rests with the importer, not a particular individual. FSVP also does not require routine batch-by-batch testing of imported food. Instead, U.S. importers must conduct risk-based supplier verification, which can include periodic testing when justified by food or supplier risk.

The QP-testing proposal

Adopting elements of the EU’s QP system along with mandatory import testing would require statutory changes to the Federal Food, Drug, and Cosmetic Act. Given how difficult it can be to pass such legislation, it is appropriate to ask whether this QP-testing proposal would provide sufficient benefits to warrant legislative action.

The effectiveness of enforcement systems like FDA’s manufacturing oversight depends on a combination of enforcement practices, incentive structures, and meaningful consequences for non-compliance. Assessing proposals by how they shift this balance helps clarify where the QP-testing approach would bring differences compared to the status quo.

The current manufacturing oversight system leaves notable gaps in incentive structure and accountability. Drug facility inspections are relatively infrequent, particularly for foreign sites, which often have advance notice of upcoming FDA visits. Violations typically result in corrective action plans rather than immediate exclusion from the market. When shortages threaten drug availability, FDA may deliberately temper enforcement by allowing non-compliant facilities to continue production and, in some cases, permitting substandard products to be distributed under additional safety measures. Executives authorizing cost-saving decisions that compromise quality rarely face personal accountability.

Layering a QP system onto FDA’s existing system would change both the probability of problems being detected and the consequences once they are uncovered. Detection probability would increase through required import testing and the additional review conducted by QPs, whether through documentation checks or site audits. Consequences would increase because—in addition to the legal responsibility of the firm—the QP would now be personally responsible for certifying each batch and, therefore, unwilling to approve products whose CGMP compliance is in doubt. Conversations with current and past QPs confirm that dynamic.

But this begs another question—why would anyone sign up to be a QP, especially in the more litigious U.S. environment?

 The answer lies in how market access and professional accountability interact, and in how regulatory design actively counters the QP’s inherent conflict of interest: QPs are paid by the importer but must maintain strict independence. In the European system, no batch can reach patients without a QP’s certification, and the QP personally carries legal liability for that decision. This dual requirement creates an equilibrium: companies must secure QPs and offer the authority and independence needed to fulfill their responsibilities. Without such assurances, a QP would simply refuse to certify batches, leaving the company unable to sell.

Over time, the scarcity and indispensability of QPs reinforce their leverage and professional stature. High turnover of QPs would severely disrupt supply and attract regulatory scrutiny, which further incentivizes companies to retain and support these professionals.

In this way, the QP role functions much like other licensed professions that carry statutory responsibilities—auditors in securities law, licensed engineers in public safety, or clinical investigators in research ethics. Each operates under personal accountability, but within an institutional framework that balances responsibility with protections against unreasonable liability.

Nonetheless, translating the European QP system into the U.S. context might require attention to liability. While a certain degree of individual responsibility is essential to make the role effective, unlimited personal exposure could discourage qualified professionals from serving as QPs. To avoid deterring qualified personnel, legislation could define the scope of liability in ways that preserve accountability but prevent excessive or disproportionate personal exposure—for example, recognizing good‑faith judgments and reasonable effort.

One other way that liability exposure can be managed is through the development of QP professional societies discussed earlier. Through their educational efforts, such societies can help QPs lower the risk of inadvertent errors. In cases where liability concerns do arise, the associations also offer access to expert legal counsel and support to help members respond appropriately to investigations or regulatory actions, ensuring their interests are represented within the bounds of professional responsibility.

Design and implementation

Effective implementation of a QP system and enhanced import batch testing hinges on addressing several design and implementation issues: designing the QP system, scoping the batch testing requirement, resolving policy obstacles related to payment, and determining appropriate phasing to safeguard drug supply. The following Q&A provides direction in these areas.

Conclusion

FDA’s traditional approach to manufacturing quality oversight faces growing challenges. As the pharmaceutical supply chain expands globally and FDA resources remain stretched, it becomes increasingly difficult for the agency to detect and address quality lapses. When inspections are infrequent and penalties are limited, manufacturers may be incentivized to cut corners, increasing risk to quality. FDA’s practice of regulatory flexibility to avoid drug shortages—allowing noncompliant facilities to continue producing medically necessary drugs—reinforces the “too important to fail” dynamic, entrenching systemic vulnerabilities.

Many recent proposals understandably focus on increasing the probability of detecting problems through expanding inspection frequency, enabling unannounced visits, and improving enforcement resources, particularly overseas. There have also been calls for increased testing. But addressing accountability has received less attention, even though it is equally critical.

Introducing a QP system, complemented by mandatory import testing of every batch, provides a stronger safeguard for drug quality. By combining mandatory product testing of imports and batch certification from a qualified U.S.-based person who bears personal sign-off responsibility, the system enhances both detection and deterrence. Above all, it underscores that accountability for safeguarding drug quality and compliance rests squarely with the industry—not with regulators.