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Wednesday, December 6, 2023

China e-cigarette titan behind 'Elf Bar' floods the U.S. with illegal vapes

 A new breed of e-cigarette has addicted teenagers and confounded regulators worldwide by offering flavors like Blue Cotton Candy and Pink Lemonade in a cheap, disposable package.

The tycoon dominating this latest wave is Zhang Shengwei, 50, a veteran of China’s vape industry in the southern manufacturing hub of Shenzhen.

Most people have never heard of him. Zhang quietly rose over 15 years from a boutique exporter to become one of the world’s largest vape manufacturers. His main company, Heaven Gifts, now competes with industry giants Juul Labs Inc and British American Tobacco Plc in the United States, the United Kingdom and across Europe.

Zhang has navigated shifting regulations in countries cracking down on candy-flavored vapes, which many health advocates say are designed to hook teenagers. In the United States, the firm simply ignored regulations on new products and capitalized on poor enforcement. It has flooded the U.S. market with flavored vapes that have been among the best-selling U.S. brands, including Elf Bar, EBDesign and Lost Mary. In the United Kingdom, by contrast, Zhang has complied with regulations requiring lower nicotine levels and government registration while building an unmatched distribution network — and driving a surge in youth vaping.

In China — where more than 90% of the world’s vaping devices are manufactured — Zhang steered clear of domestic sales, resisting the temptation of a gargantuan market with 300 million smokers who might be converted to vaping. His focus on exports looked prescient when Beijing last year banned all domestic sales of flavored vapes, crushing some of Zhang’s competitors that had bet heavily on the China market.

Zhang, who also does business under the corporate name Shenzhen IMiracle Technology, declined requests for an interview. A Heaven Gifts spokesperson, Jacques Li, said the company does not market to children and takes youth-vaping concerns seriously. He acknowledged the company’s flavors could attract teens but said the company is modifying its packaging to be less appealing to youth and discontinuing some flavors, such as “rainbow candy.”

Flavored vapes are more effective in helping smokers quit than those that mimic cigarettes, he said.

“Adults like flavors, too,” Li said. “Flavored e-cigarettes shouldn’t be demonized. They’re not evil.”

Zhang’s deft maneuvering illustrates the difficulty of curtailing youth vaping despite a global effort to halt a new wave of teenage nicotine addiction. It also highlights how China’s domestic candy-vape crackdown is proving to be a rare success — even as its homegrown e-cigarette industry continues to dominate manufacturing and exports.

China’s enforcement wins owe to its communist government’s greater power over companies and willingness to levy stiff penalties. Chinese state media has trumpeted crackdowns including a March raid on a nationwide distribution network, in which authorities seized e-cigarette inventory valued at 150 million yuan ($21 million USD) and arrested 10 people. Sales of vapes, now permitted only in unpopular tobacco flavors, plummeted from $2.9 billion in 2021 to $1.7 billion in China last year, according to market research firm Euromonitor International. Sales are predicted to fall much further this year.

In banning flavors, China cites the same health concerns with youth vaping as other governments. But Beijing has a unique conflict of interest in the crackdown: It also runs a state cigarette monopoly, which accounts for 8.7% of China’s tax revenue and directly benefits from strict e-cigarette regulation. China National Tobacco Corp, according to Euromonitor, last year sold more than 2.4 trillion cigarettes, nearly four times as many as U.S.-based tobacco giant Philip Morris International reported selling last year.

“Everything about the regulations is about protecting cigarettes,” said Geoff Fong, founder of the International Tobacco Control Policy Evaluation Project at Canada’s University of Waterloo, which evaluates the impact of tobacco regulation across 31 countries.

China National Tobacco and the State Tobacco Monopoly Administration, which regulates cigarettes and e-cigarettes, did not comment.

As China cracks down on e-cigarettes at home, it continues to help vape manufacturers including Heaven Gifts export millions of candy-flavored vapes. With the domestic flavor ban, China also levied new taxes on e-cigarette manufacturers, importers and domestic distributors. But those taxes don’t apply to e-cigarette manufacturers targeting overseas markets. Authorities also smoothed the way last year for overseas shipping by “white-listing” Heaven Gifts and many other Chinese vaping companies at Shenzhen’s airport, requiring fewer export inspections, according to Heaven Gifts and a post last year from China’s e-cigarette association.

In the wake of China’s domestic flavored-vape ban, the value of the nation’s exports of e-cigarettes and related products jumped 29.9% to $5.48 billion in the first half of 2023 from the same period a year earlier, according to data from China’s General Administration of Customs.

The U.S. Food and Drug Administration (FDA), by contrast, has had little success curtailing flavored e-cigarettes under restrictions implemented since 2020 amid public outrage over youth vaping. Heaven Gifts and many other China-based manufacturers are selling millions of vapes in the United States without getting FDA authorization for their products, which is required of any foreign or domestic e-cigarette purveyor.

By moving forward with illegal sales, the Chinese firms are grabbing market share from companies trying to comply with the FDA’s lengthy and expensive approval requirements. The FDA requires extensive studies to prove any vaping product is a net benefit to public health by helping adults quit smoking without addicting new users to nicotine.

Brian King, who heads FDA’s Center for Tobacco Products, which regulates e-cigarettes, said in an interview the agency can’t levy penalties or file lawsuits against foreign companies. The FDA, he said, also lacks enough enforcement resources to stem the tide of cheap Chinese vapes once they reach U.S. shores. Asked what he knows about Zhang, King declined to comment on any individual or company but said the agency is “obviously aware of the Elf Bar product.”

In a statement, British American Tobacco called on the FDA and law enforcement to crack down on illegal products from Heaven Gifts and others that have “overrun” the U.S. market. These manufacturers, it said, are “flagrantly violating virtually every rule and guidance FDA has issued. These products continue to pour across our borders and target youth.”

Juul said in a statement that “inadequate enforcement” against illicit disposable products “undermines FDA’s ability to oversee a properly regulated marketplace.”

Company spokesman Li said Heaven Gifts is “trying our best to stay compliant in the U.S.” but did not answer questions about whether the company had filed required FDA applications. He called the FDA rules incoherent and unclear as to “what standards you have to meet,” without citing specifics.

The FDA had no comment on Li’s critique.

U.S. youth vaping rates have dropped significantly since the coronavirus pandemic. But Elf Bar has quickly grown into the most popular product among teens. A June study released by the U.S. Centers for Disease Control and Prevention (CDC) found that Elf Bar was the number one U.S. disposable e-cigarette brand in December 2022, about a year after it went on sale. A separate national survey of youth tobacco use released last month by the CDC and FDA found Elf Bar was the brand of choice for 56.7% of middle- and high-school vapers.

Matthew Myers, who recently retired as president of advocacy group Campaign for Tobacco-Free Kids, said the government’s failure to enforce the law is allowing companies like Heaven Gifts to make "massive profits," while putting "anybody who tries to do the right thing” at a disadvantage.

The open sale of products without FDA authorization “is about the most blatant thing that I’ve seen,” said Myers, who worked for four decades as a tobacco regulator and anti-smoking advocate. “What you’ve got is a guy who’s thumbing his nose at the United States government.”

Li said in a statement Tuesday that the company was “working with regulators in the U.S. to solve the issue,” without elaborating on those communications. The FDA did not immediately comment on whether it has interacted with the company.

WINNERS AND LOSERS

Zhang’s meteoric rise has left a trail of damaged competitors who responded differently to the global regulation wave.

Beijing-based RLX Technology, founded in 2018, made the opposite moves: Betting big on the Chinese market and complying with new U.S. regulations.

The company was valued at nearly $35 billion in a January 2021 initial public offering on the New York Stock Exchange. Now, after the Beijing ban, it’s worth $3.3 billion.

In the United States, RLX has been mired in regulatory approval processes. It has spent millions on extensive FDA-required studies since 2020 but still awaits an agency decision. RLX declined to comment for this report.

Heaven Gifts and others have thrived by disregarding U.S. regulations. Zhang’s fruity vapes racked up more than $650 million in U.S. sales over the year ending in mid-October 2023, according to private retail data from Circana, a Chicago market research firm formerly known as IRI. The data, which measures purchases from January 2018 through mid-October of this year, was shared with Reuters by a person outside Circana who asked not to be identified.

Heaven Gifts sales for the year ending September 2023 represent more than 9% of the U.S. e-cigarette market, according to the data. That put Zhang’s disposable brands behind only the Vuse Alto, made by British American Tobacco, and Juul, in market share.

In May, more than a year after Heaven Gifts started flooding U.S. stores, the FDA took aim at Elf Bar by sending alerts to customs officials instructing them to stop shipments of the company’s products. Li said that none of the company’s shipments have been “seized or sent back.”

A Reuters review of a FDA database listing shipments blocked at the ports showed that FDA and customs officials, on November 6, stopped an unspecified amount of products from a Zhang company from entering the United States. FDA and customs officials did not comment about the detained products.

Li said the firm has stopped shipping e-cigarettes under the Elf Bar and EBDesign brands, which were named in the May import alert. Li did not address whether the company has halted shipments under other product names, such as Lost Mary. He said “we don’t think we are still a leading brand” in the United States, and the company believes counterfeit versions of its products are “rampant.”

The FDA said it is still assessing information on detained imports but that such data can’t capture the “true impact” of its alerts. The agency said it believes the alerts likely cause “countless firms” to voluntarily stop importing illegal e-cigarettes.

Five current and former executives in the Chinese vaping industry told Reuters that Heaven Gifts’ flouting of FDA rules follows a common playbook across China’s e-cigarette industry. Following the rules, they said, costs companies millions of dollars in compliance expenses and lost profits while competitors enter the U.S. market illegally with little or no consequences.

Elf Bar and other Heaven Gifts brands remained the market leader in disposable e-cigarettes in the quarter ending in September, according to the Circana data.

The FDA’s King said the agency acted on Elf Bar once it had data showing that the product was a top seller and popular among youth. He said it takes time to build enforcement cases against U.S. based suppliers or retailers selling illegal vapes.

“We can't be everywhere at every time,” King said. “So I've got to prioritize the resources we do have.”

The agency has relatively little money to pursue e-cigarette companies, King said, because it does not assess fees on the industry for that purpose. It’s now seeking the authority from Congress to do so. Enforcement is also slowed by the need to consult with the U.S. Justice Department before suing violators, King said, and an agency practice of sending distributors and retailers warnings before taking action.

After sending warning letters beginning in June to more than 300 retailers selling Elf Bar, the agency has since fined more than 60 businesses, many of them gas stations and convenience stores.

MEET ‘WAYNE’

Disposable vapes such as the Elf Bar typically contain much higher volumes of nicotine liquid than earlier versions of e-cigarettes, including those from Juul. And they’re easier to use: Just open the box and start puffing.

Before the 2020 U.S. rules, Juul dominated the U.S. vaping market with a device using “pods” of nicotine liquid in an array of flavors that were a hit with teenagers, making the company the prime target of public outrage.

A Juul pod has about 200 puffs; some Heaven Gifts vapes offer up to 5,000 drags. A Juul starter kit costs at least $40 for a charger, device and pack of four pods. Zhang’s devices commonly sell for about $20.

Juul pulled popular flavors such as Mango ahead of the 2020 FDA restrictions, which prohibited flavors in pod-based devices. Heaven Gifts has offered Lemon Drop, Strawberry PiƱa Colada and Tropical Rainbow Blast, among many others.

Sales of disposable vapes including the Elf Bar have exploded because users consider them a good value, said Becky Freeman, an associate public-health professor at the University of Sydney in Australia, which has also seen a sharp rise in unauthorized e-cigarettes, many from China, and youth use.

“If you’re a group of kids, you pitch in some money, and you share it,” Freeman said. “It’s the right product, the right price, and you can get it in all these flavors.”

Five years ago, Heaven Gifts made no products of its own, operating as an exporter and distributor of other Chinese-made vaping products, such as the Suorin and Smok brands. Zhang originally exported vaping products made by the Chinese company Ruyan, which is credited with inventing the modern e-cigarette.

In the industry’s early days, in the late 2000s, Zhang was widely known as “Wayne” on online vaping forums. He started the company in a Shanghai apartment with five other staffers, said company spokesperson Li. Zhang used the bathroom as his office, he said. Heaven Gifts was founded in 2007, Li said. The name evoked the notion that vaping offers a miracle cure for the afflictions of tobacco cigarettes.

Trading companies like Zhang’s targeted mom-and-pop vape stores and regional distributors who couldn’t afford to buy the large minimum orders demanded by manufacturers in Shenzhen’s “Vape Valley.”

Heaven Gifts moved from Shanghai to Shenzhen in 2014 in a bid to make its own product. Early efforts failed, said Oliver Kershaw, founder of e-cigarette-forum.com, a popular hub for industry players and vaping enthusiasts. But Heaven Gifts excelled in cultivating ties with distributors, particularly in the UK.

In 2019, still determined to manufacture his own e-cigarettes, Zhang started investing heavily across the production chain. Heaven Gifts took a 14.6% stake in manufacturer Shenzhen Youme Technology, the maker of Suorin vaping products, according to Chinese corporate data website Tianyancha. Shenzhen Youme did not comment.

Zhang also invested in makers of batteries, heating chips, nicotine liquid, and a highly automated vape factory in the nearby city of Zhuhai. Li said such investments were “very important” strategic moves for Heaven Gifts.

Li said the company launched the Elf Bar first in the UK, in 2021, and later that year in the United States. Heaven Gifts has grown from 200 staff around a year ago to more than 700 today, Li said. At a time when many Chinese graduates struggle to find jobs, the company presents itself as friendly and international, with promotional videos showing 20-something staffers fistbumping and clinking bubbleteas in a bright modern space.

Two people who work with Zhang describe him as low key. He dresses simply, despite his newfound riches, in jeans and collared shirts. He’s a hands-on manager with sales, research and strategy teams but keeps relatively quiet in meetings.

He still goes by Wayne, Li said.

SPARKING A UK YOUTH-VAPING BOOM

Before launching the Elf Bar, Heaven Gifts established a distribution beachhead in the UK. While operating as a middleman, moving products from China’s Vape Valley through local distributors, Zhang also set up his own branded website called Deepvaping to sell directly to consumers and retailers.

The UK offered a more permissive regulatory environment. As the United States debated banning flavors, the UK allowed them, while setting limits on nicotine levels and requiring vape companies to register with regulators. Heaven Gifts says it abided by the UK rules.

U.S. youth vaping surged with the rise of Juul in 2018 and 2019, but it was more controlled in the UK until the introduction of the Elf Bar and similar flavored disposables. Then it jumped: A survey released in June by Action on Smoking and Health (ASH), a British public-health organization, found that more than 20% of children aged 11 to 17 had tried vaping by 2023, up from about 14% in 2020. The increase, the survey found, was driven overwhelmingly by disposables, the Elf Bar being the most popular.

Hazel Cheeseman, deputy chief executive of ASH, said disposable-vape manufacturers such as Heaven Gifts “have not been taking remotely seriously that their products are so appealing and so widely used by under-18s.”

The UK and the European Union both have regulations restricting nicotine levels, which means the amount of nicotine in a European Elf Bar isn’t enough to satisfy most cigarette smokers trying to quit, said Kershaw, the e-cigarette-forum.com founder. But it’s enough to lure nonsmokers and potentially addict them.

In July, consumer-products and vaping wholesaler Supreme Plc announced a deal to supply Elf Bar and Lost Mary to several major British supermarket and convenience store chains. Supreme says on its Elf Bar product webpage that about 2.5 million of them are sold weekly in the UK. Supreme did not answer questions about public-health advocates’ concerns with the products, but said the company expects to generate 40 million pounds ($50.4 million USD) in revenue from the products for the year ending in March 2024.

Elf Bar and other flavored e-cigarettes are illegal in some parts of Europe, including Hungary, where local laws are more restrictive than EU tobacco regulations.

Hungary has battled a surge of illegal disposable vapes for more than a year, according to Tibor Demjen, who leads Hungary’s anti-tobacco efforts. The government has slowed sales but not stopped them, he said. He accused the disposable purveyors of trying to “infiltrate the young population with nicotine.”

“It’s their job,” Demjen said, “and they do it well.”

Heaven Gifts spokesperson Li said the company is “paying great attention” to the issue and blamed illegal smuggling of products meant for other markets into Hungary.

BOTCHED CRACKDOWN

When the U.S. FDA tightened e-cigarette rules in 2020, it made what public health groups would call a monumental blunder that supercharged production of disposables in flavors appealing to teenagers.

In the year before the implementation of those rules, Juul dominated the market with its flavored pods, the favorite among teens. The FDA outlawed sweet flavors in pod-based devices — but exempted other device types, including disposables. The agency said it didn’t want to restrict options for adults who might use other kinds of e-cigarettes to quit smoking. All companies would still need FDA authorization to sell specific products.

The result: The industry shifted en masse toward producing candy-flavored disposables for the U.S. market.

Juul pulled all flavors except tobacco and menthol by late 2019, ahead of the FDA’s 2020 flavor restrictions. The firm’s market share, according to the Circana retail data, fell from a peak of 71% in the fourth quarter of 2018 to 21% in the third quarter of 2023. Flavored disposable brands like those made by Heaven Gifts climbed from 4% of the market to 43% over the same period, the data show.

Mitch Zeller, who retired as the head of FDA’s tobacco division last year, told Reuters that he was informed in December 2019 by FDA’s chief of staff, Keagan Lenihan, that the White House wanted flavor restrictions only on pod-style e-cigarettes. In September of that year, then-President Donald Trump had announced plans to ban all e-cigarette flavors except tobacco because of their popularity among teenagers, a move that sparked blowback from the industry and adult vapers.

Zeller said he told Lenihan teenagers would just switch to flavored disposables, and that the FDA needed to push back on the White House. “I was hugely concerned that this policy was drawing a line in the wrong place,” said Zeller, who now advises a pharmaceutical company developing smoking-cessation drugs.

Lenihan said the White House’s decision was final, according to Zeller. Lenihan, who now works as an external-affairs executive for Philip Morris International, did not comment. A Trump spokesperson also had no comment.

In a statement to Reuters, the FDA said data in 2020 showed teens “overwhelmingly preferred” cartridge e-cigarettes like Juul, and that the agency “has the ability to shift enforcement priorities based on new data and information.”

The bigger problem for the FDA: Its approval process is considered so onerous that many e-cigarette manufacturers just skip it, even though sweet flavors remain potentially legal in disposable vapes.

On paper, U.S. e-cigarette regulations are far stricter than those in Europe and the UK, requiring companies to prove a net benefit to public health. To date, the agency has only granted authorizations to 23 vaping products, all of them tobacco-flavored.

Yet those 23 products combined represented less than 3% of e-cigarette sales in the United States from July through September, according to the Circana data. In all, the data show more than 3,000 new vaping products have been introduced to the United States market over the past year.

Heaven Gifts launched the Elf Bar in the United States in late 2021 without getting FDA authorization to sell. Sales skyrocketed. Zhang saw weekly sales of Elf Bar and his other U.S. brands grow from less than $100,000 a week in early February 2022 to more than $9 million a week in early October 2023, according to data produced by Circana. Heaven Gifts products rang up about triple the sales of all the FDA-authorized products combined from July through September, the data show.

After launching U.S. sales, Zhang quickly built out his distribution network and then introduced new brands alongside the Elf Bar. When the agency issued import alerts in May, seeking to block Heaven Gifts shipments, it included some brands but omitted others, including Lost Mary and Funky Republic.

Lost Mary sales jumped from less than $100,000 a week in September 2022 to more than $3 million for the first week of October, putting it among the top 10 U.S. disposable vapes, the data show.

Li said Heaven Gifts regularly adds new brands to diversify its product portfolio.

“Staying ahead of regulators, honestly, is not on our agenda,” he said in a statement. “We must work with regulators instead of tiptoeing around them.”

The FDA faces a complex challenge in stopping the illegal vape import surge but has been “unacceptably slow” in responding, said Kurt Ribisl, a public-health professor at the University of North Carolina at Chapel Hill.

“It’s kind of a cat-and-mouse game,” he said, “but the FDA is a slow-motion cat.”

https://news.yahoo.com/special-report-china-e-cigarette-110602773.html

FBI says interviews of priest, choir director were part of investigation of ‘an individual,’ not Catholics

 The FBI said its interviews of a Catholic priest and choir director were conducted during an investigation of "an individual threatening violence who has since been arrested," and not a broader probe into Catholics.

The FBI’s comment comes after the House Judiciary Committee and the Select Subcommittee on the Weaponization of the Federal Government released a report suggesting the bureau has been investigating Catholic Americans as potential domestic terrorists after an FBI Richmond internal memo, titled "Interest of Racially or Ethnically Motivated Violent Extremists in Radical-Traditionalist Catholic Ideology Almost Certainly Presents New Mitigation Opportunities." 

The committee stated that the FBI "relied on at least one undercover agent to develop its assessment and the FBI even proposed developing sources among the Catholic clergy and church leadership." It also said the FBI "interviewed a priest and choir director affiliated with a Catholic church in Richmond, Virginia for the memorandum."

FBI Director Wray Appears In Senate Judiciary Hearing

FBI Director Christopher Wray testifies before the Senate Judiciary Committee on Capitol Hill on Dec. 5, 2023. (Kevin Dietsch/Getty Images)

The committee said whistleblower disclosures reveal that the FBI interview of a priest and choir director affiliated with a Catholic church in Richmond, Virginia, was used to "inform on the parishioner under investigation." 

But the FBI told Fox News Digital that "any characterization that the FBI is targeting Catholics is false."

The FBI explained that "the interviews of the priest and choir director highlighted by the committee’s report were conducted by FBI Richmond during an investigation of an individual threatening violence who has since been arrested." 

"The interviews were not conducted for the domain perspective as characterized by the report," the FBI said. 

The FBI has maintained that "the intelligence product prepared by one FBI field office did not meet the exacting standards of the FBI and was quickly removed from FBI systems." 

"An internal review conducted by the FBI found no malicious intent to target Catholics or members of any other religious faith, and did not identify any investigative steps taken as a result of the product," the FBI said. "The FBI is committed to upholding the constitutional rights of all Americans and we do not conduct investigations based solely on First Amendment protected activity, including religious practices." 

The FBI said it "investigates violence, threats of violence, and violations of federal law." 

"We have provided hundreds of pages of documents and briefings to the Committee to address our findings and the numerous actions we are taking to address identified shortcomings," the FBI said. 

But House Judiciary Committee spokesman Russell Dye pushed back at the FBI's denial, maintaining the committee's findings.

"The facts speak for themselves," Dye told Fox News Digital. "Contrary to the FBI’s assertions, the Committee has presented evidence that the FBI’s infamous Catholic memo relied on information from multiple field offices, not just the Richmond Field Office." 

Rep. Jim Jordan addressing the media.

Rep. Jim Jordan speaking to the press. (Anna Moneymaker/Getty Images)

"The evidence shows that the Richmond Field Office conducted the interviews of a priest and choir director as part of an investigation that served as a basis for the creation of the Catholic memo," Dye continued. "Whistleblowers have told us that the memo was distributed around the country." 

Dye also said the evidence shows that "FBI employees at all levels in the Richmond Field Office, including the office’s top lawyer, saw no concerns with the contents of the memo or its portrayal of faithful Americans." 

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"Worse, the evidence shows that the FBI considered formalizing the memo into an external product," Dye said. "The FBI’s actions here are inexcusable, period."

The committee report also states that the basis of the original Richmond memo "relied on a single investigation in the Richmond Field Office’s area of responsibility in which the subject ‘self-described’ as a ‘radical-traditionalist Catholic.'" But the committee found that FBI employees "could not define the meaning of an RTC when preparing, editing, or reviewing the memorandum." 

"Even so, this single investigation became the basis for an FBI-wide memorandum warning about the dangers of ‘radical’ Catholics," the report states.

"While the FBI claims it ‘does not categorize investigations as domestic terrorism based on the religious beliefs – to include Catholicism – of the subject involved,’ an FBI-wide memorandum originating from the FBI’s Richmond Field Office did just that," the report states. "Under the guise of tackling the threat of domestic terrorism, the memorandum painted certain ‘radical-traditionalist Catholics’ (RTCs) as violent extremists and proposed opportunities for the FBI to infiltrate Catholic churches as a form of ‘threat mitigation.’"

During a hearing in the Senate Tuesday, FBI Director Wray was pressed on the matter by Sen. Josh Hawley, R-Mo. 

Wray maintained that the interview of the priest and choir director was part of "an investigation of a specific individual who was amassing Molotov cocktails and posting about killing people. And it does not surprise me that there were people who knew that subject in that investigation."

Josh Hawley and Christopher Wray

Sen. Josh Hawley got into a tense exchange with FBI DIrector Christopher Wray over the FBI's infamous anti-Catholic memo during a Senate Judiciary Committee hearing. (Kevin Dietsch/Getty Images)

Meanwhile, the committee's report states that the FBI produced a version of the Richmond memo with fewer redactions than the two previous versions it provided. That version revealed that investigations into Catholic organizations in Los Angeles and Portland fed into the Richmond office memo. The report states that FBI Milwaukee was also involved. 

But Wray, during the Senate hearing, said the "notion that other field offices were involved is a garble." 

"And let me explain why," Wray said. "I mean, why I say that the only involvement of the two other field offices was the Richmond authors of the product, which included two sentences or something or thereabouts, referencing each of these other offices' cases. And they sent those sentences about the other office cases to them, not the whole product, and asked them, ‘Hey, did we describe your case right?’" 

Wray added: "That's all the other offices had. So it was a single field office product, and I stand by that."

Meanwhile, the report said the documents obtained by the committee's subpoena show that "the FBI singled out Americans who are pro-life, pro-family, and support the biological basis for sex and gender distinction as potential domestic terrorists."

https://www.foxnews.com/politics/fbi-interviews-priest-choir-director-investigation-individual-not-catholics

US announces visa bans after warning Israel over West Bank violence

 The U.S. on Tuesday began imposing visa bans on people involved in violence in the Israeli-occupied West Bank, Washington officials said, after several appeals for Israel to do more prevent violence by Jewish settlers.

A new State Department visa restriction policy targets "individuals believed to have been involved in undermining peace, security, or stability in the West Bank, including through committing acts of violence or taking other actions that unduly restrict civilians’ access to essential services and basic necessities," Secretary of State Antony Blinken said in a statement.

President Joe Biden and other senior U.S. officials have warned repeatedly that Israel must act to stop violence by Israeli settlers against Palestinians in the West Bank. Attacks there have surged in recent months as Jewish settlements have expanded, and then spiked again since the Oct. 7 Hamas attacks on Israel.

Blinken made clear to Israeli officials during a visit last week that "they need to do more to stop extremist violence against Palestinians, and hold those responsible for it accountable," State Department spokesperson Matthew Miller told reporters in a press briefing after the announcement.

Palestinian leaders must also do more to curb Palestinian attacks against Israelis in the West Bank, he added.

The first bans under the new policy would be imposed on Tuesday and more designations will be made in the coming days, Miller said.

"We expect ultimately for this action to impact dozens of individuals and potentially their family members," Miller said, adding that any Israeli with an existing U.S. visa who was targeted would be notified that their visa was revoked.

Since a 1967 Middle East war, Israel has occupied the West Bank, which Palestinians want as the core of an independent state. It has built Jewish settlements there that most countries deem illegal. Israel disputes this and cites historical and biblical ties to the land.

Asked about settler violence in a news conference on Tuesday, Israel's Defense Minister Yoav Gallant said no one besides Israeli authorities had the right to use violence.

"Israel is a state of law. The right to use violence belongs only to those who are certified to do so by the government," he said.

Miller said Israel had taken some steps to hold people responsible for the West Bank violence, like putting them in administrative detention, but U.S. officials believe they should be prosecuted.

Washington's move on Tuesday "does not obviate the need for the government of Israel to take its own actions and we will continue to be clear with them about it," he said.

https://news.yahoo.com/us-impose-visa-bans-those-175103573.html

Novartis OKd for paroxysmal nocturnal hemoglobinuria treatment

 

  • Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement inhibitor-naĆÆve patients1-5
     
  • In APPLY-PNH, patients who switched to Fabhalta experienced superior increases of hemoglobin levels ≥ 2 g/dL (82.3% vs. 0%) and hemoglobin level ≥ 12 g/dL (67.7% vs. 0%), both in the absence of red blood cell transfusions, vs. patients who continued on anti-C5 treatment1,2  
     
  • Fabhalta, now available for both previously treated and treatment-naĆÆve patients, is the only FDA-approved Factor B inhibitor of the immune system’s complement pathway, which drives complement-mediated hemolysis in PNH1,6
     
  • Significant unmet need remains in PNH, a chronic and rare blood disorder; despite anti-C5 therapy, a large proportion of patients can remain anemic and dependent on blood transfusions7,8
     
  • Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions

Merck KGaA’s BTK Inhibitor Fails Phase 3 MS Studies

 Germany’s Merck KGaA on Tuesday announced that its investigational BTK inhibitor evobrutinib did not meet its primary efficacy endpoint in the Phase III evolutionRMS 1 and evolutionRMS 2 trials in relapsing multiple sclerosis.

In evolutionRMS 1, patients treated with evobrutinib saw an annualized relapse rate (ARR) of 0.11, similar to those patients treated with Sanofi’s Aubagio (teriflunomide) tablets. In evolutionRMS 2, ARR following evobrutinib treatment was 0.15 versus 0.14 in counterparts on Aubagio. Both treatment effects fell short of statistical significance, according to Merck KGaA’s announcement.

EvolutionRMS 1 and evolutionRMS 2 are randomized, parallel-group, double-blinded and active-controlled studies, and both fall under Merck KGaA’s Phase III EVOLUTION clinical development program for evobrutinib in relapsing multiple sclerosis (RMS), including relapsing-remitting disease or secondary progressive MS with relapses.

Patients in the program were given 45 mg of evobrutinib two times a day, while Aubagio was administered at a 14-mg once-daily dose. Treatment lasted for at least 24 weeks and could run up to 156 weeks.

Merck KGaA said the ARR rates for Aubagio in EVOLUTION were “lower than reported in other recent Phase III studies.” The company will “complete a full evaluation of the data from the EVOLUTION clinical trials,” working toward a future presentation or publication.

In terms of safety, evobrutinib’s overall profile was consistent with what had been established in its Phase II development program.

Evobrutinib is an orally available and highly selective inhibitor of the BTK enzyme, which plays a key role in the development and activation of B cells. This mechanism of action allows evobrutinib to modulate B cell responses, including their release of antibodies and cytokines, as well as their proliferation. Evobrutinib is also designed to be able to penetrate the central nervous system.

In April 2023, the FDA placed EVOLUTION under partial clinical hold after two patients treated with BTK blocker showed signs of liver injury. The regulatory pause formally froze new enrollment into the program. However, at the time, the company noted that EVOLUTION was fully enrolled and participants had already been treated with evobrutinib for more than 70 days, adding that the clinical hold was unlikely to derail EVOLUTION’s timeline.

Evobrutinib’s Phase III failure on Tuesday demonstrates the difficulties of developing BTK inhibitors. Last week, the FDA placed Roche’s candidate fenebrutinib on partial clinical hold after the pharma detected potential cases of liver injury.

In December 2022, Biogen and InnoCare’s orelabrutinib was put on regulatory pause, also for liver injury. Biogen abandoned the candidate in February 2023.

https://www.biospace.com/article/merck-kgaa-s-btk-inhibitor-fails-phase-iii-multiple-sclerosis-studies/