FDA rules TODAY that ingredient in Benadryl Tylenol and Sudafed from pharmacy shelves doesn't work

 A medicine used by millions of Americans for a stuffy nose does not work, a Food and Drug Administration panel ruled today.

Phenylephrine is the most common active compound in over-the-counter drugs like Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night.

But an FDA panel said after a two-day review that the oral decongestant ‘is not effective’ at standard or even high doses compared to a placebo.

Their ruling is not binding but strongly suggests the agency could soon heed their advice and pull its approval, forcing companies to pull or reformulate their products. 

The ingredient is protected under the FDA’s Generally Recognized as Safe and Effective (GRASE) designation, but a reversal of its approval could mean manufacturers including Bayer and Johnson and Johnson might need to reformulate.

Phenylephrine is everywhere, so much so that nearly every nasal decongestant on pharmacy shelves contains it.

Drugs that contain it generated almost $1.8 billion in sales last year, according to data presented Monday by FDA officials. 

A unanimous vote by the 16-member Nonprescription Drug Advisory panel could issue a major blow to the industry.

Today's ruling only applies to oral formulations of phenylephrine.

If the agency decides to pull oral phenylephrine's GRASE designation, major manufacturers of drugs like Sudafed PE and Benadryl may be forced to reformulate them.

Yes! That's what we need..... More Guns!

 

What this world needs is more good guys with guns. Share this video far and wide.pic.twitter.com/JSzBjqvOh5

— End Wokeness (@EndWokeness) September 12, 2023

Martin Indyk the Leftist Stooge is Disappointed by "his personal friend "Abbas

 

I have been despairing about how to respond to Abu Mazen’s profoundly anti-Semitic diatribe. How could someone who has treated me as a personal friend for three decades at the same time harbor such hateful views of my people? https://t.co/ExG0mvlzJZ

— Martin Indyk (@Martin_Indyk) September 11, 2023

Shtisel Writer Becomes Chareidie

Yehonatan Indursky

Yehonatan Indursky co-wrote the international hit show “Shtisel,” one of TV’s most sensitive portrayals of haredi Orthodox life, as a secular Jew. After growing up the youngest of five in Jerusalem’s Givat Shaul neighborhood, in a haredi family, and studying in a yeshiva in Bnei Brak, he left the haredi world at age 19.

Last week, he said that he identifies as haredi once again.

“For many years, I fought the fact that I was haredi. I worked hard at being secular,” he told the Israeli publication Ynet in an interview about his life and his work. “Until suddenly I stopped.”

That kind of identity switch, from haredi to secular and then back to haredi, is very rare. Yet some would argue that through his work, Indursky never strayed too far from the haredi world of his youth.

In “Shtisel,” along with his show “Autonomies” and his debut play “Babchik” — which tells the story of a haredi restaurant owner trying to combat a deadly family curse — he has found ways to continue “live” in the haredi Jewish world.

US releases $6 billion to Iran BEFORE prisoner swap ..Iran Says "we will use it as we see fit"

 

The US cleared the way for $6 billion in oil proceeds to be returned to Iran and agreed to release five Iranians as part of a secretly negotiated deal that will clear the way for five American citizens detained in Iran to return home.

Secretary of State Antony Blinken notified Congress on Monday of a waiver that will let German, Irish, Qatari, South Korean and Swiss banks transfer the $6 billion from South Korea without fear of running afoul of US sanctions. He said the $6 billion would be held in restricted accounts in Qatar, where it will be “available only for humanitarian trade,” according to a copy of the notification. Iran stated unequivocally that it will use the funds as it sees fit.

Beloved singer "Dedi" Graucher passes away at 62

 The Hasidic singer and businessman David 'Dedi' Graucher passed away this evening (Monday) following a lengthy battle with cancer. He was 62-years-oldGraucher's songs, such as 'Chevron' and 'Lecho Etain,' are very popular in Israel.

Over the years, Graucher collaborated with other prominent Hasidic singers, including Mordechai Ben David and Abraham Fried, with whom he held a concert in 1996 in Yarkon Park considered to be the largest outdoor concert in Israel's history.

His son Natan wrote: "Blessed is the True Judge, Oded David ben Tzipora. Father, I will miss you."

Haredi radio broadcaster Menachem Toker eulogized the legendary singer: "Dedi, my friend, a singer of rare talent, an amazing person, who was always helping everyone, who, even in the most difficult moments had a joke and a smile, the biggest heart I've ever seen in my life, I just can't believe it. Go make the angels happy up there, sing to them from your sacred songs."

Graucher was diagnosed with cancer about five years ago and has been hospitalized several times since then. He stopped performing following the diagnosis.

Haaretz Lets Lying Tom Friedman Publish Garbage That Even the NY Times Won’t print

 

Thomas L. Friedman on Sunday published an op-ed he titled, “The Thread Connecting Trump, Putin and Netanyahu,” which was so outlandish and chock full of unabashed antisemitism, he couldn’t run it in his own paper, The NY Times, but ran it instead in Israel’s Pravda wannabe, Haaretz.

Arguing that “The Israel We Knew Is Gone,” Friedman recalls telling his fellow Upper-West Siders following the November 1, 2022 victory of Israel’s right over a bizarre coalition of anti-Arab, anti-Haredi, leftist, and Muslim Brotherhood parties: “You did not go to Camp Ramah with these people. Your family did not vacation in the Catskills with these people. Your parents did not meet these people on their last UJA tour to Israel. They are to the right of the far right. But now they have positions of real and central power.”

Turns out, Friedman’s livid hatred for us, the folks on the right, is identical to the hate we receive from the violent crypto-fascists and anarchists on Israel’s highways, in its airport terminals, trains, public institutions, and in front of coalition members’ homes at five in the morning: We are not like them.

Netanyahu to Meet with Elon Musk – No Biden Meeting Planned

 

Prime Minister Benjamin Netanyahu is set to travel to the United States next Sunday (Sept. 17) for the first time since his reelection last November.

He has a busy schedule but so far, there is no meeting has been planned with President Joe Biden.

The Biden Administration appears to be continuing its boycott of Israel’s longest-serving prime minister, who is now in his sixth term.

Netanyahu is scheduled to arrive in San Francisco on Monday, where he is expected to meet with high-tech billionaire Elon Musk, who owns X (formerly called Twitter), as well as SpaceX, Tesla, Neuralink, and other companies.

Musk, who recently “liked” posts with the hashtag #BanTheADL, was accused of allowing antisemitic tweets to run rampant on his social media platform. He threatened to sue the Anti-Defamation League, accusing the organization of falsely accusing him and X of being antisemitic.

The prime minister is scheduled to travel Monday evening to New York, where he will address the United Nations General Assembly that Thursday (Sept. 21), according to Israel’s Ambassador to the UN, Gilad Erdan.

Thus far, there are no published plans to meet with America’s president.

More than 3,500 Israeli cultural and academic “elite” signed a letter urging Biden not to meet with Netanyahu.

Netanyahu is expected to return to the Jewish State the following Sunday.

NJ court rules in favor of woman who used social media to lobby for Jewish divorce

 

Advocates for Jewish women who say their estranged husbands are abusing them by refusing to assent to a religious divorce are cheering after a New Jersey appellate court overturned a ruling against a woman in that state who used social media to advocate for her divorce.

A lower court ruled in 2021 that the woman’s social media posts constituted harassment and incitement. The American Civil Liberties Union of New Jersey got involved in the case then, joining several Orthodox women’s rights groups who had already been working on her behalf.

The woman, who was identified only by her initials, LBB, in Wednesday’s 39-page court ruling, has been separated from her husband since 2019. She says that he has refused to give her a get, or ritual divorce document.

In 2021, the man received a temporary, and later a final, restraining order that barred his estranged wife from contacting him and ordered her to remove social media posts calling for the get. The court that issued the restraining order ruled that the social media posts constituted harassment, an invasion of privacy and incitement, and were thus not protected under the First Amendment’s free speech provisions.

The appellate court’s three-judge panel rejected that reasoning, saying that her social media activism did count as protected speech.

“In sum, the judge’s finding that the Jewish community was prone to violence against get refusers — and the implicit holding that defendant was aware of and intentionally availed herself of such violent tendencies — is not supported by the record,” the decision says. “The video was intended to get a get. The video did not threaten or menace plaintiff, and nothing in the record suggests that plaintiff’s safety or security was put at risk by the video.”

Netanyahu’s Remark That ‘G-d Didn’t Always Protect Us’ Incenses Charedi Coalition Partners

 

DIN: I don't understand what the big deal is. Didn't the late Satmar Rebbi z'l say something similar during the 6 day war? 

In his "al hagilah" the rebbe wrote that Hashem had nothing to do with the victory of the 6 day war, he attributed the success of the war to the great IDF and of course the "samach mem." the "devil." 

Interesting that when the IDF then took credit for the victory, the rebbe yelled "oy vey, they are saying "koichi ve'etzem yadi" but he himself agreed that they victory was because of the strength of the IDF which is basically saying the same thing, he never saw the irony in his own reasoning!

During a cabinet meeting on Sunday regarding the pilgrimage to the Uman for Rosh Hashana, Israeli Prime Minister Benjamin Netanyahu emphasized the danger of traveling to the wartorn country and called on the pilgrims to be responsible.

“Israeli citizens who are traveling to Ukraine need to bear personal responsibility at this time,” Netanyahu stated and then added the following: “G-d did not always protect us, not on European land and not on Ukrainian land.” Netanyahu’s controversial statement apparently referred to the question that has been asked over the last 80 years: “Where was G-d during the Holocaust.”

Netanyahu’s remark however was seen as blasphemy by charedi leaders. The editor-in-chief of the haredi news site B’Chadrei Charedim, Moshe Weisberg, wondered if the charedi MKs would respond to the remark in silence. “Will the charedi MKs swallow Netanyahu’s contemptuous remarks as well?” he wondered.

Haredi journalist Michael Shemesh also responded: “It’s hard to believe that the charedi ministers will let this statement pass silently.”