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$HIMS 🚨 NEEDHAM'S RYAN MACDONALD SAYS HIS "BASE CASE" IS THAT PEPTIDES WILL BE APPROVED Jonathan Stern: "I have seen a ton of alarmist tweets saying, 'RIP to the peptide bros', essentially. And what you're saying, Ryan, is that it's really not that simple." "We have a process here....

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Hims House

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20,423 просмотров • 1 месяц назад •via X (Twitter)

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The FDA’s recent recommendations on peptides are a *significant* setback for new and existing companies being built around the expectation that they will be able to sell compounded peptides. That’s because the 503A Bulks List is basically a pathway that lets compounding pharmacies use certain bulk drug substances to compound drugs for patient-specific prescriptions. The FDA is recommending against adding seven popular peptides to the list. Unless RFK goes against the FDA staff recommendation, these companies’ path to legally compounding and selling peptides becomes very difficult.
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The FDA’s recent recommendations on peptides are a *significant* setback for new and existing companies being built around the expectation that they will be able to sell compounded peptides. That’s because the 503A Bulks List is basically a pathway that lets compounding pharmacies use certain bulk drug substances to compound drugs for patient-specific prescriptions. The FDA is recommending against adding seven popular peptides to the list. Unless RFK goes against the FDA staff recommendation, these companies’ path to legally compounding and selling peptides becomes very difficult.

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One of the largest raw dairy farms in America was told to lie on their raw cheese label by the FDA They were told to pasteurize the cheese then put “raw” on the label The FDA has been telling other brands to do this, and it’s true. He shows proof with examples He’s brought to tears saying he works for his customers not the FDA “We refuse to lie to our consumers — Clearly, the FDA is not connected to consumers, and I don't serve the FDA. I serve people. Excuse me for being emotional, but it's that deep” Why is this happening People for “Raw” dairy products argue it offers superior nutrition, enzymes, and gut health benefits when properly produced and testing The FDA and state health departments) warn that unpasteurized products carry significantly higher risks of foodborne illness from bacteria like E. coli, Salmonella, Listeria, and Campylobacter He says they test their products, its negative The bigger issue here is the FDA is telling companies to lie and then letting them package the product with the lie. This is so corrupt

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🚨Where is the $200M allocated for illegal vape enforcement going? RFK Jr. told Congress: “We confiscated a million vapes that were Chinese” BUT “a regulatory complication with FDA, because we were not able to get enough American vapes approved for this country.” RFK and MAHA want the FDA and Dr. Marty Makary to step up and keep the crackdown going.

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Bob Malone/RFK Jr. think you're stupid. Malone says the latest Moderna jab was FDA authorized while RFK Jr. & he were on a "boat" (yacht) in Italy & the decision wasn't "communicated up the chain of command." Oh, and RFK Jr's right-hand was taking vacay at the exact same time. This clip of Malone is taken from an interview with Tommy Carrigan posted to the Tommy's Podcast Rumble channel on July 27, 2025. ---------------Partial transcription of clip--------------- "The decision to authorize the Moderna product was not communicated up the. Up the chain of command. Now, it turned out that Bobby was on the boat at that particular time and his right-hand person, Stefanie Spear, had just gone on vacation. Also. Neither one of them were notified. "And, the people don't realize that the secretary does not have a magic wand that he can wave, and he or she can wave, and past FDA decisions go away. There are firewalls between the secretary and the political apparatus and the decision-making at FDA, so all of this. Well, can't. How come Bobby didn't stop that? And this kind of jibber jabber, it. That's not the way the system works. And good thing too, because administrators, administrations change and we would have absolute chaos if. If it was anything otherwise. "So, but. But absolutely there was a failure to communicate. And, that's a reference to Cool Hand Luke, in case you didn't get it. And, and whether this was cause and effect or not, as soon as Bobby got back, there was a major restructuring of, leadership underneath him, chief of staff and deputy chief of staff. And that. That restructuring is ongoing right now. So after, whatever it's been six months or whatever, I think it's less than that. They've kind of done the trial run, the shakedown crews. They've determined that, they got to move around some of the positions. Some people have to find nice lobbyist jobs and no longer work for the administration. And, I hear that that reorg has gone fairly well, but it's still a fair amount of chaos, as you'd expect."

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$HIMS THE CAT IS OUT OF THE BAG WITH PEPTIDES Jonathan: "There is no going back to 2010. These have taken over the cultural consciousness and are here to stay... What happens, though, if the 7 peptides are not approved?" Jesse Morse, M.D.: "So here's the problem. The demand is there. Right now, the supply is the problem, and part of that supply is purity and safety." "Millions of people are taking peptides every day in the United States." "Less than 5% of them, if I were to guess, are being compounded by American pharmacies." "That means 95% of the peptides that are not GLPs are being ordered from some random website or picked up at a bodega in New York." "The FDA has to see this, and they have to say, 'Hey, I understand this is not ideal, and we don't have 10 years of beautiful data. But unfortunately, this is the situation we're in.' "
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$HIMS THE CAT IS OUT OF THE BAG WITH PEPTIDES Jonathan: "There is no going back to 2010. These have taken over the cultural consciousness and are here to stay... What happens, though, if the 7 peptides are not approved?" Jesse Morse, M.D.: "So here's the problem. The demand is there. Right now, the supply is the problem, and part of that supply is purity and safety." "Millions of people are taking peptides every day in the United States." "Less than 5% of them, if I were to guess, are being compounded by American pharmacies." "That means 95% of the peptides that are not GLPs are being ordered from some random website or picked up at a bodega in New York." "The FDA has to see this, and they have to say, 'Hey, I understand this is not ideal, and we don't have 10 years of beautiful data. But unfortunately, this is the situation we're in.' "

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