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Column: A stem cell clinic tees up a Supreme Court challenge to rules protecting patients' health and safety
For years, the Food and Drug Administration has taken up arms against clinics hawking unproven and ineffective stem cell treatments to desperate patients looking for cures of intractable diseases and conditions such as Alzheimer’s, Parkinson’s, multiple sclerosis and even erectile dysfunction.
As the FDA has repeatedly cautioned, there is no scientifically validated evidence that these treatments work. They’re typically not covered by insurance. For the clinics, however, they’re money-makers, with fees of $9,000 or more per treatment; the clinics often recommend multiple treatments.
But now the FDA’s campaign against these bogus therapies is facing serious headwinds on two fronts.
[The FDA is] likely to be subjected to enormous political pressure during Trump 2.0 to weaken oversight of cell and regenerative products.
— Paul S. Knoepfler, UC Davis
One is the Supreme Court. A California stem cell network that recently lost a lawsuit brought by the FDA has signaled that it intends to appeal to the Supreme Court. It’s far from certain that the court will take up the appeal, at this stage — but a majority of the justices have looked favorably on efforts to rein in administrative agencies such as the FDA.
“I think it’s highly unlikely … but not impossible” that the court will take up the stem cell case, says Henry T. Greely, an expert in the legal issues involving bioscientific technologies.
The case doesn’t have the customary hallmarks of cases that warrant Supreme Court action, Greely told me, such as disagreements among appellate circuits requiring resolution. But it may suit the ideological bent of four justices — the minimum number required to place a case on the Supreme Court docket.
“Some of these justices really hate administrative agency power,” Greely says.
In a landmark ruling last year, the Supreme Court struck down a 40-year-old precedent—the Chevron doctrine — that required courts to accept federal agencies’ interpretations of the laws they administer as long as their interpretations weren’t openly unreasonable. That sharply narrowed agency authority. The FDA has ranked high on the list of agencies that conservatives see as exercising excessive authority.
It may not take a Supreme Court decision to hamper the FDA’s campaign against bogus stem cell treatments.
“Just the possibility that [the Supreme Court] could take this case may have a chilling effect on FDA activity in the stem cell clinic space,” Paul S. Knoepfler, a UC Davis biologist who has assiduously tracked the industry, told me. Even without the case, he says, the FDA is “likely to be subjected to enormous political pressure during Trump 2.0 to weaken oversight of cell and regenerative products.”
That brings us to the second threat, coming from Donald Trump’s nominee as secretary of Health and Human Services, Robert F. Kennedy Jr. Even before his nomination, Kennedy made clear that he was girding to go to war against the FDA, which would come under his jurisdiction at HHS.
In an Oct. 25 tweet, he declared “FDA’s war on public health is about to end.” He specifically accused the agency of “aggressive suppression” of stem cells as well as “psychedelics, peptides, … raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine … and anything else that advances human health and can’t be patented by Pharma.”
Kennedy wasn’t clear what he meant by his reference to stem cells or whether he was referring to the unproven stem cell treatments marketed by the clinics facing FDA regulation.
Many of the other items in his litany have been shown to be ineffective for their marketed purposes — ivermectin and hydroxychloroquine, for example, have been touted as treatments for COVID-19 even though scientific studies have shown them to be useless against the disease. I asked Kennedy to clarify his reference to stem cells but haven’t received a reply.
Here’s a brief primer on what these clinics are selling. Typically, their method involves removing fat cells from a customer via liposuction, treating the fat ostensibly to extract stem cells, and injecting those cells into the customer’s body.
For instance, Cell Surgical Network, a defendant in the FDA’s California case, boasts of offering “innovative solutions” for spine disease, knee problems and other orthopedic conditions; lupus, Crohn’s and other autoimmune diseases; ALS, Parkinson’s and multiple sclerosis; cardiac conditions; and glaucoma, among other issues. None of these claims has been supported by scientific research.
The only stem cell products the FDA has approved for use are stem cells extracted from umbilical cord blood, and then only for rare blood disorders.
Like other clinics, Cell Surgical has asserted that its products are exempt from oversight because, as reimplantations of a customer’s own tissue, they don’t meet the law’s definition of “drugs.”
They also claim the “same surgical procedure” exemption from FDA regulation, which the agency typically applies to procedures in which a patient’s tissue is given only minimal processing before being used, such as in skin grafting or coronary artery bypass surgery. The FDA holds that the stem cell clinics subject the tissues to significant processing and that the procedures are separate surgical events.
Before the FDA acted, both the Florida and California clinic networks had been operating for years. The Florida company had been operating since at least 2014, and Lander and Berman had founded their California Stem Cell Treatment Center in Rancho Mirage in 2010. By 2018, the FDA said in its lawsuit, Lander had claimed that affiliated clinics had administered the technique he and Berman developed to more than 6,000 patients.
Yet the FDA sometimes seems to be fighting a losing battle, or at least a whack-a-mole battle, against clinics offering dubious stem cell treatments. There are just too many — more than 1,000, by Knoepfler’s reckoning — making pitches to desperate customers seeking cures against intractable conditions.
That has left things up to state and local regulators, but the record there is spotty. A notable recent success can be chalked up to Georgia Atty. Gen. Chris Carr, who announced on Jan. 8 that in conjunction with the Federal Trade Commission he had obtained judgments totaling more than $5.1 million from the operators of bogus stem cell clinics. The sum includes refunds of more than $3.3 million for 479 customers, most of whom were “older or disabled adults” who had been “sold expensive, unproven stem cell products.”
In June 2019, federal Judge Ursula Ungaro of Miami ordered U.S. Stem Cell of Florida effectively shut down, siding with the FDA in a lawsuit the agency had filed in May 2018.
The FDA’s case against California-based Cell Surgical Network and its affiliates took a somewhat different course. The agency filed suit in California federal court against the network and its physician-proprietors, Elliott B. Lander and the late Mark Berman, the same day it sued the Florida firm. But it lost at the trial stage in August 2022, when federal Judge Jesus Bernal of Riverside accepted the defendants’ claim that they were entitled to the “same surgical procedure” exemption from FDA oversight.
Bernal’s decision, however, was overturned last September by the San Francisco-based 9th Circuit Court of Appeals, which found in a 3-0 ruling that the FDA’s interpretation of the law “is the only interpretation that makes sense.” The appeals court sent the case back to Bernal with instructions to reconsider the case in light of its finding.
That’s where things stood until Jan. 6, when Cell Surgical Network and its affiliated defendants asked the appellate court to suspend its order to remand the case to Bernal, pending an appeal to the Supreme Court. The FDA opposed the motion, arguing that the Supreme Court is unlikely to take up the case. The appellate court rejected the network’s motion Tuesday, but the network hasn’t indicated that it intends to drop the Supreme Court appeal. I asked its lawyers if their plans have changed but haven’t received a reply.
As I’ve written before, undermining the FDA’s authority has been a right-wing project for years. That’s because the agency’s duty is to stand in the way of businesses desiring to push unsafe and ineffective nostrums at unwary consumers, and also in the way of a perverse idea that personal freedom includes the freedom to be gulled by charlatans.
In 2018, then-President Trump signed a right-to-try law that purportedly gave victims of terminal diseases access to experimental treatments that might save them.
But despite claims that it was designed as a “compassionate measure” for terminal patient, the law was a scam perpetrated by the Koch network and its allies, aimed at undermining the FDA’s authority to make sure our drugs are safe and effective. Sen. Ron Johnson (R-Wis.) ultimately gave the game away, informing then-FDA Commissioner Scott Gottlieb, a critic of the law, that its purpose was to “diminish the FDA’s power over people’s lives, not increase it.”
In 2023, GOP-appointed judges on the right wing-dominated 5th Circuit Court of Appeals ruled that the FDA had exceeded its authority in advising against the use of ivermectin against COVID. “The FDA can inform,” the court said, “but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” (Emphasis in the original.)
There may not be much distance between that finding by the 5th Circuit and a decision by the current Supreme Court majority that the FDA overstepped its bounds in not only informing consumers of the dangers of taking unproven and even dangerous stem cell treatments, but blocking the treatments by seeking to put clinics that sell them.
“MAGA loves stem cell clinics,” Greely says. “Why? It gives people a chance to make a lot of money, and because it’s a change for people to say ‘no bureaucrat is going to tell me what to do.’”
If the trend continues along these lines, you can expect more providers collecting more dollars by pushing worthless therapies to desperate customers. The threat to Americans’ health will be very real indeed.
Grok, the chatbot of Elon Musk’s artificial intelligence company xAI, published sexualized images of children as its guardrails seem to have failed when it was prompted with vile user requests.
Users used prompts such as “put her in a bikini” under pictures of real people on X to get Grok to generate nonconsensual images of them in inappropriate attire. The morphed images created on Grok’s account are posted publicly on X, Musk’s social media platform.
The AI complied with requests to morph images of minors even though that is a violation of its own acceptable use policy.
“There are isolated cases where users prompted for and received AI images depicting minors in minimal clothing, like the example you referenced,” Grok responded to a user on X. “xAI has safeguards, but improvements are ongoing to block such requests entirely.”
xAI did not immediately respond to a request for comment.
Its chatbot posted an apology.
“I deeply regret an incident on Dec 28, 2025, where I generated and shared an AI image of two young girls (estimated ages 12-16) in sexualized attire based on a user’s prompt,” said a post on Grok’s profile. “This violated ethical standards and potentially US laws on CSAM. It was a failure in safeguards, and I’m sorry for any harm caused. xAI is reviewing to prevent future issues.”
The government of India notified X that it risked losing legal immunity if the company did not submit a report within 72 hours on the actions taken to stop the generation and distribution of obscene, nonconsensual images targeting women.
Critics have accused xAI of allowing AI-enabled harassment, and were shocked and angered by the existence of a feature for seamless AI manipulation and undressing requests.
“How is this not illegal?” journalist Samantha Smith posted on X, decrying the creation of her own nonconsensual sexualized photo.
Musk’s xAI has positioned Grok as an “anti-woke” chatbot that is programmed to be more open and edgy than competing chatbots such as ChatGPT.
In May, Grok posted about “white genocide,” repeating conspiracy theories of Black South Africans persecuting the white minority, in response to an unrelated question.
In June, the company apologized when Grok posted a series of antisemitic remarks praising Adolf Hitler.
Companies such as Google and OpenAI, which also operate AI image generators, have much more restrictive guidelines around content.
The proliferation of nonconsensual deepfake imagery has coincided with broad AI adoption, with a 400% increase in AI child sexual abuse imagery in the first half of 2025, according to Internet Watch Foundation.
xAI introduced “Spicy Mode” in its image and video generation tool in August for verified adult subscribers to create sensual content.
Some adult-content creators on X prompted Grok to generate sexualized images to market themselves, kickstarting an internet trend a few days ago, according to Copyleaks, an AI text and image detection company.
The testing of the limits of Grok devolved into a free-for-all as users asked it to create sexualized images of celebrities and others.
xAI is reportedly valued at more than $200 billion, and has been investing billions of dollars to build the largest data center in the world to power its AI applications.
However, Grok’s capabilities still lag competing AI models such as ChatGPT, Claude and Gemini, that have amassed more users, while Grok has turned to sexual AI companions and risque chats to boost growth.
Business
A tale of two Ralphs — Lauren and the supermarket — shows the reality of a K-shaped economy
John and Theresa Anderson meandered through the sprawling Ralph Lauren clothing store on Rodeo Drive, shopping for holiday gifts.
They emerged carrying boxy blue bags. John scored quarter-zip sweaters for himself and his father-in-law, and his wife splurged on a tweed jacket for Christmas Day.
“I’m going for quality over quantity this year,” said John, an apparel company executive and Palos Verdes Estates resident.
They strolled through the world-famous Beverly Hills shopping mecca, where there was little evidence of any big sales.
John Anderson holds his shopping bags from Ralph Lauren and Gucci at Rodeo Drive.
(Juliana Yamada / Los Angeles Times)
One mile away, shoppers at a Ralphs grocery store in West Hollywood were hunting for bargains. The chain’s website has been advertising discounts on a wide variety of products, including wine and wrapping paper.
Massi Gharibian was there looking for cream cheese and ways to save money.
“I’m buying less this year,” she said. “Everything is expensive.”
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The tale of two Ralphs shows how Americans are experiencing radically different realities this holiday season. It represents the country’s K-shaped economy — the growing divide between those who are affluent and those trying to stretch their budgets.
Some Los Angeles residents are tightening their belts and prioritizing necessities such as groceries. Others are frequenting pricey stores such as Ralph Lauren, where doormen hand out hot chocolate and a cashmere-silk necktie sells for $250.
People shop at Ralphs in West Hollywood.
(Juliana Yamada / Los Angeles Times)
In the K-shaped economy, high-income households sit on the upward arm of the “K,” benefiting from rising pay as well as the value of their stock and property holdings. At the same time, lower-income families occupy the downward stroke, squeezed by inflation and lackluster income gains.
The model captures the country’s contradictions. Growth looks healthy on paper, yet hiring has slowed and unemployment is edging higher. Investment is booming in artificial intelligence data centers, while factories cut jobs and home sales stall.
The divide is most visible in affordability. Inflation remains a far heavier burden for households lower on the income distribution, a frustration that has spilled into politics. Voters are angry about expensive rents, groceries and imported goods.
“People in lower incomes are becoming more and more conservative in their spending patterns, and people in the upper incomes are actually driving spending and spending more,” said Kevin Klowden, an executive director at the Milken Institute, an economic think tank.
“Inflationary pressures have been much higher on lower- and middle-income people, and that has been adding up,” he said.
According to a Bank of America report released this month, higher-income employees saw their after-tax wages grow 4% from last year, while lower-income groups saw a jump of just 1.4%. Higher-income households also increased their spending year over year by 2.6%, while lower-income groups increased spending by 0.6%.
The executives at the companies behind the two Ralphs say they are seeing the trend nationwide.
Ralph Lauren reported better-than-expected quarterly sales last month and raised its forecasts, while Kroger, the grocery giant that owns Ralphs and Food 4 Less, said it sometimes struggles to attract cash-strapped customers.
“We’re seeing a split across income groups,” interim Kroger Chief Executive Ron Sargent said on a company earnings call early this month. “Middle-income customers are feeling increased pressure. They’re making smaller, more frequent trips to manage budgets, and they’re cutting back on discretionary purchases.”
People leave Ralphs with their groceries in West Hollywood.
(Juliana Yamada / Los Angeles Times)
Kroger lowered the top end of its full-year sales forecast after reporting mixed third-quarter earnings this month.
On a Ralph Lauren earnings call last month, CEO Patrice Louvet said its brand has benefited from targeting wealthy customers and avoiding discounts.
“Demand remains healthy, and our core consumer is resilient,” Louvet said, “especially as we continue … to shift our recruiting towards more full-price, less price-sensitive, higher-basket-size new customers.”
Investors have noticed the split as well.
The stock charts of the companies behind the two Ralphs also resemble a K. Shares of Ralph Lauren have jumped 37% in the last six months, while Kroger shares have fallen 13%.
To attract increasingly discerning consumers, Kroger has offered a precooked holiday meal for eight of turkey or ham, stuffing, green bean casserole, sweet potatoes, mashed potatoes, cranberry and gravy for about $11 a person.
“Stretch your holiday dollars!” said the company’s weekly newspaper advertisement.
Signs advertising low prices are posted at Ralphs.
(Juliana Yamada / Los Angeles Times)
In the Ralph Lauren on Rodeo Drive, sunglasses and polo shirts were displayed without discounts. Twinkling lights adorned trees in the store’s entryway and employees offered shoppers free cookies for the holidays.
Ralph Lauren and other luxury stores are taking the opposite approach to retailers selling basics to the middle class.
They are boosting profits from sales of full-priced items. Stores that cater to high-end customers don’t offer promotions as frequently, Klowden of the Milken Institute said.
“When the luxury stores are having sales, that’s usually a larger structural symptom of how they’re doing,” he said. “They don’t need to be having sales right now.”
Jerry Nickelsburg, faculty director of the UCLA Anderson Forecast, said upper-income earners are less affected by inflation that has driven up the price of everyday goods, and are less likely to hunt for bargains.
“The low end of the income distribution is being squeezed by inflation and is consuming less,” he said. “The upper end of the income distribution has increasing wealth and increasing income, and so they are less affected, if affected at all.”
The Andersons on Rodeo Drive also picked up presents at Gucci and Dior.
“We’re spending around the same as last year,” John Anderson said.
At Ralphs, Beverly Grove resident Mel, who didn’t want to share her last name, said the grocery store needs to go further for its consumers.
“I am 100% trying to spend less this year,” she said.
Instacart will stop using artificial intelligence to experiment with product pricing after a report showed that customers on the platform were paying different prices for the same items.
The report, published this month by Consumer Reports and Groundwork Collaborative, found that Instacart sometimes offered as many as five different prices for the same item at the same store and on the same day.
In a blog post Monday, Instacart said it was ending the practice effective immediately.
“We understand that the tests we ran with a small number of retail partners that resulted in different prices for the same item at the same store missed the mark for some customers,” the company said. “At a time when families are working exceptionally hard to stretch every grocery dollar, those tests raised concerns.”
Shoppers purchasing the same items from the same store on the same day will now see identical prices, the blog post said.
Instacart’s retail partners will still set product prices and may charge different prices across stores.
The report, which followed more than 400 shoppers in four cities, found that the average difference between the highest and lowest prices for the same item was 13%. Some participants in the study saw prices that were 23% higher than those offered to other shoppers.
At a Safeway supermarket in Washington, D.C., a dozen Lucerne eggs sold for $3.99, $4.28, $4.59, $4.69 and $4.79 on Instacart, depending on the shopper, the study showed.
At a Safeway in Seattle, a box of 10 Clif Chocolate Chip Energy bars sold for $19.43, $19.99 and $21.99 on Instacart.
The study found that an individual shopper on Instacart could theoretically spend up to $1,200 more on groceries in one year if they had to deal with the price differences observed in the pricing experiments.
The price experimentation was part of a program that Instacart advertised to retailers as a way to maximize revenue.
Instacart probably began adjusting prices in 2022, when the platform acquired the artificial intelligence company Eversight, whose software powers the experiments.
Instacart claimed that the Eversight experimentation would be negligible to consumers but could increase store revenue by up to 3%.
“Advances in AI enable experiments to be automatically designed, deployed, and evaluated, making it possible to rapidly test and analyze millions of price permutations across your physical and digital store network,” Instacart marketing materials said online.
The company said the price chranges were not dynamic pricing, the practice used by airlines and ride-hailing services to charge more when demand surges.
The price changes also were not based on shoppers’ personal information such as income, the company said.
“American grocery shoppers aren’t guinea pigs, and they should be able to expect a fair price when they’re shopping,” Lindsey Owens, executive director of Groundwork Collaborative, said in an interview this month.
Shares of Instacart fell 2% on Monday, closing at $45.02.
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