substance

FDA to weigh looser rules on unproven peptides touted by RFK Jr., MAHA

The Food and Drug Administration will hold a meeting in the summer to consider easing restrictions on more than a half-dozen peptide injections, a group of unapproved therapies that have become popular among wellness influencers, fitness gurus and celebrities.

The meeting announcement Wednesday follows repeated pledges by Health Secretary Robert F. Kennedy Jr. to loosen regulations on peptides, which are often pitched as a quick way to build muscle, heal injuries or appear younger. There’s little research behind those claims and most peptides have not been reviewed for safety by the FDA.

Kennedy has discussed using peptides for his own injuries. And some major supporters of his Make America Healthy Again movement are big proponents of them, including Gary Brecka, a self-described “longevity expert” who sells various peptide formulas through his website.

The FDA said in a federal notice Wednesday that it will ask a panel of outside advisors to review seven peptides at a meeting in July, specifically whether they should be added to a list of substances that can be safely produced by pharmacies. In the meantime, the agency said it would soon remove the chemicals from a restrictive list reserved for unapproved, high-risk drugs. The peptides under discussion include some of the most popular among influencers, such as BPC-157, which is marketed to heal injuries and reduce inflammation.

“The Wild West is about to become wilder,” said Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest. In an interview, Lurie said allowing peptides on the market without clinical testing poses a “profound threat” to FDA’s decades-old system for vetting drugs.

“I don’t see why one would take the path of a proper drug approval if there is now this less rigorous, alternative path to market,” he said.

Under President Biden, the FDA added nearly 20 peptides to the federal list of substances that should not be produced by compounding pharmacies — businesses that mix medications that aren’t available from drugmakers.

At the time, the FDA’s panel of pharmacy advisors voted overwhelmingly that the peptides did not meet the criteria for substances that can be safely compounded. And FDA regulators agreed, saying later that the substances “present significant safety risks,” because most have not been extensively tested in humans.

Many of the FDA advisors and internal staff who oversaw those decisions no longer work for the agency. The FDA’s pharmacy panel currently has a number of vacancies, which Kennedy could fill before the July meeting.

Kennedy previewed Wednesday’s move in an interview with podcast host Joe Rogan. Both men have repeatedly spoken about peptides and claimed to have benefited from their use.

RFK Jr. claims personal benefit from peptides

“I’m a big fan of peptides,” Kennedy told Rogan. “I’ve used them myself and with really good effect on a couple of injuries.”

Given Kennedy’s statements, Lurie said it was doubtful the drugs would receive real scrutiny from FDA.

“Everybody knows the outcome that the secretary wants,” Lurie said. “I don’t believe for one moment that what’s going on here is an honest investigation of whether these products should be compounded.”

Scott Brunner of the Alliance for Pharmacy Compounding said the coming meeting will be the start of a “protracted process.” Even if the panel votes to make the peptides available, and the FDA agrees, the agency will still have to draft and publish rules on the change, he noted.

Peptides are essentially the building blocks of more complex proteins. Inside the human body, peptides trigger hormones needed for growth, metabolism and healing.

In recent years peptides have become widely known through the blockbuster success of GLP-1 medications, which the FDA has approved for treating obesity and diabetes. Other FDA-approved peptides include insulin for diabetics and hormone-based drugs for several medical conditions.

But many of the peptides promoted online have never been approved, making them technically illegal to market as drugs. Several peptides, such as BPC-157 and TB-500, are banned by international sports authorities as doping substances.

But that has not stopped them from gaining a foothold in the burgeoning marketplace for wellness hacks and alternative remedies.

“I think this is a disaster in the works,” said Dr. Eric Topol of Scripps Research Translational Institute, who has studied the issue. “These peptides have no data to support their safety and efficacy.”

Meanwhile, some dietary supplement makers have begun mixing peptides into capsules, protein powders and gummies. At a recent FDA meeting, the industry argued for expanding the federal definition of supplements to permit the use of newer ingredients such as peptides in their products.

Safety risks were cited previously

When the FDA added a number of injectable peptides to its list of restricted substances in 2023, it cited safety risks including cancer and liver, kidney and heart problems.

That triggered pushback from wellness entrepreneurs, compounding pharmacies and their allies in Washington.

Last year several members of Congress, including Republican Sen. Tommy Tuberville of Alabama, sent letters to Kennedy asking him to lift limits on peptide production.

Some in the compounding industry argue that FDA restrictions have given rise to an illicit market of imported chemicals from China and other countries, which are not subject to U.S. drug standards.

Kennedy has echoed those concerns.

“With the gray market you have no idea if you’re getting a good product,” Kennedy told Rogan. “And a lot of this stuff that we’ve looked at is just very, very substandard.”

Perrone writes for the Associated Press.

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Why Miguel Rojas was bothered by erroneous suspension report

Dodgers infielder Miguel Rojas addressed an erroneous report from earlier in the week with understanding while also making his feelings clear.

On Monday, a senior baseball writer at the Athletic misidentified Rojas as the recipient of an 80-game suspension for the use of a banned substance on X, the social media platform formerly known as Twitter. It was in fact Phillies outfielder Johan Rojas who had tested positive for Boldenone. The writer, Evan Drellich, quickly deleted the post and corrected it.

“I’m not frustrated because of the report, because we are all humans and we make mistakes,” Rojas said Wednesday morning in front of his locker at Camelback Ranch. “I was expecting a little bit more of an apology, not just to me, but the organization. Because it wasn’t just my name, it was pretty clear that it says, ‘Miguel Rojas from the Los Angeles Dodgers.’ And I don’t think anybody in this organization should be kind of freaking out and jumping out of their seats for the six or seven minutes that it happened.”

Rojas saw the correction post as an opportunity to issue that apology.

“It wasn’t just my name, it was the organization that I represent too, and that’s really important to me,” he said. “So that’s the only thing that I’m kind of bothered [by].”

Later on Wednesday, Drellich followed up with another post: “To Miguel Rojas and the Dodgers, I sincerely and publicly apologize. I’ve reached out to Miguel, the Dodgers and Miguel’s agent to say the same. Once again, I’m sorry.”

In the midst of the fallout from the report, Rojas watched Team Venezuela, who he would have represented in the World Baseball Classic if it weren’t for insurance issues, win the tournament with a victory against the United States in Tuesday’s final.

“It was really special to see my kids kind finding joy in that moment that the third strike was called,” he said, noting that his children were born in the United States. “And they felt Venezuelan the same as I did, and every other family in Venezuela.”

Rojas said he’d moved on after the insurance snag.

“When I made my last post, when I came to spring training, I made a decision of being another fan and supporting from any anywhere that I was going to be,” he said. “Because I knew I wasn’t going to be there anymore. So I had to kind of remove myself from the possibility of playing, and now I’m just becoming another Venezuelan pulling for a team that are getting ready and preparing for something like that.”

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Where was A Woman of Substance filmed as Vera star’s Channel 4 drama debuts

A Woman of Substance is premiering tonight on Channel 4 starring Vera legend Brenda Blethyn and Outlander star Jessica Reynolds.

A Woman of Substance draws from author Barbara Taylor Bradford’s novel, widely regarded as amongst the best-selling books ever published.

Channel 4 unveils its fresh adaptation of A Woman of Substance tonight, Wednesday, March 11, featuring actress Brenda Blethyn in her debut role following the conclusion of ITV drama Vera.

Adapted from the identically titled novel, A Woman of Substance follows housemaid Emma Harte as she challenges societal conventions to establish a worldwide business empire.

Spanning dual timelines, the eight-episode series chronicles Emma’s (portrayed by Jessica Reynolds) ascent from her formative hardships through to the present day, where she (Brenda Blethyn) confronts fresh, unforeseen challenges.

Where was A Woman of Substance filmed?

Captured during spring 2025, sequences depicting young Emma in the early 1900s were shot throughout Yorkshire, with the Grade I-listed Georgian residence Broughton Hall serving as Fairley Hall.

Broughton Hall previously featured as a filming venue in Channel 4’s original 1984 adaptation of A Woman of Substance.

Broughton Hall is the 16th Century manor house situated at the centre of the 3,000 acre Broughton Sanctuary estate.

Whilst the property remains unchanged, it’s now encompassed by the sanctuary, housing the Avalon Wellbeing Centre and offering holiday accommodation available for guest bookings.

Production teams were additionally observed at Ilkley Moor, Barnsley Town Hall and at Brodsworth Hall and Gardens in Doncaster.

Speaking about the use of Brodsworth Hall in the series, a representative from English Heritage said: “Last year we were pleased to welcome a production company, filming scenes for an adaption of Barbara Taylor Bradford’s A Woman of Substance.

“Filming took place within our Servants’ Wing, Laburnam Arch and Target House/Range and we are extremely excited and proud to see Brodsworth on the small screen!”.

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Reynolds, who portrays the younger version of Emma Harte, shared her experiences of filming in Yorkshire with Country and Town House.

She said: ‘I know the crew worry about wind and rain, but I just love being able to have nature around me and working off the elements.

“I feel much less self-conscious, and freer.

“Some of the locations were just breathtaking and those are the images that stick in my mind today when I think back to filming; Yorkshire is just stunning.

“Those are some of Emma’s happiest moments too, when she’s so connected to the land – it’s a beautiful thing.”

Meanwhile, the contemporary scenes featuring Vera legend Blethyn, which are supposed to be set in New York, were actually filmed in Liverpool.

This isn’t the first time Liverpool has served as a stand-in for New York in film production, with major films including Fantastic Beasts and Where to Find Them and 2022’s The Batman also shot in the UK city.

A Woman of Substance premieres on Wednesday, March 11, at 9pm on Channel 4.

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