FDA slaps damning warnings on COVID-19 vaccines; highlights Biden administration's safety-risk gloss



Federal health authorities rebuked Florida Surgeon General Dr. Joseph Ladapo for suggesting in 2022 that the benefit of COVID-19 vaccination among healthy young men was outweighed by the risk of heart conditions, myocarditis in particular.

Ladapo issued guidance that stated, "Based on currently available data, patients should be informed of the possible cardiac complications that can arise after receiving a mRNA COVID-19 vaccine."

“Our goal is not to get into like a fight or a tiff, because public health isn’t served well by this,” said Dr. Peter Marks, then-director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research. "Our goal is to help get to … an acceptance that there are overall benefits of these vaccines, despite the fact that yes, it is true that there could be some side effects."

'Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis.'

Marks' former agency has since acknowledged that there is a greater risk of post-vaccination myocarditis than the so-called experts were first willing to publicly admit.

Months after telling both vaccine manufacturers to include new safety information regarding their respective drugs in the stated interest of "radical transparency," the FDA indicated on June 25 that it required Pfizer and Moderna to note the estimated unadjusted incidence of heart conditions following administration of the 2023-2024 formula of the Comirnaty and Spikevax vaccines, as well as the longitudinal results of a 2024 study concerning cardiac manifestations and outcomes of vaccine-associated myocarditis in American youths.

The FDA also required Pfizer and Moderna to describe the new safety information in the adverse reactions section of their vaccine information inserts.

RELATED: How Big Pharma left its mark on woke CDC vax advisory panel — and what RFK Jr. did about it

 Photo illustration by Joe Raedle/Getty Images

For years, the fact sheets for the mRNA COVID-19 vaccines noted that reports of adverse events demonstrated increased risks of myocarditis and pericarditis, particularly following the second dose, and that the "observed risk is highest in males 12 through 17 years of age."

Now, the package inserts state that "the observed risk has been highest in males 12 years through 24 years of age" and:

Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.

The package inserts for both drugs also now state:

Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known. Information is not yet available about potential long-term sequelae of myocarditis or pericarditis following administration of mRNA COVID-19 vaccines.

When discussing the updates, Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, provided a refresher about the effort by the previous administration to downplay the risk of myocarditis.

Prasad, referring to congressional testimony given by Sen. Ron Johnson (R-Wis.) in May, noted that Centers for Disease Control and Prevention and the FDA officials were aware in early 2021 of a safety signal for the heart condition on the basis of Pentagon and Israeli data.

'The FDA's new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.'

A day after health officials at the agencies acknowledged a safety signal, and after the CDC discussed whether to issue a Health Alert Network message on myocarditis, the Biden White House distributed talking points to top U.S. health officials de-emphasizing the risk.

On May 26, 2021, then-acting FDA Commissioner Janet Woodcock told then-CDC Director Rochelle Walensky that the "FDA does not concur with the issuance of the myocarditis HAN as written."

That day, both agencies reportedly decided to "nix the HAN" alert.

"The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered," Woodcock stated the following month. "The benefits of COVID-19 vaccination continue to outweigh the risks, given the risk of COVID-19 diseases and related, potentially severe, complications."

The nixed alert could have made a difference.

After all, Prasad noted that "in August of 2021, in an FDA regulatory action, we document that based on the health insurance claims Optum dataset, the rate of post-vaccination myocarditis from the Pfizer-BioNTech vaccine was approaching 200 cases per million or approximately 1 in 5,000" among 16- and 17-year-old males.

RELATED: Democrats who locked down America during COVID now cry dictator over Trump's deportations

— (@)  
 

FDA Commissioner Martin Makary and Prasad noted in a May article in the New England Journal of Medicine that "the FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk."

Blaze News reached out to the FDA but did not immediately receive a response.

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General Mills to remove artificial colors from cereals. Is chemical linked to infertility next on chopping block?



Health and Human Services Secretary Robert F. Kennedy Jr. keeps racking up the wins in his campaign to help President Donald Trump make America a healthier nation, particularly on the dietary front.

His latest victory — and American consumers' by extension — was secured at General Mills, the American ultra-processed food giant with cereal brands that include Cheerios, Chex, Cocoa Puffs, Lucky Charms, and Wheaties.

General Mills announced plans on Tuesday to remove artificial colors from all of its U.S. cereals and all K-12 school foods by next summer. The company indicated that it also intends to remove all fake coloring from its full lineup of American-facing products by the end of 2027.

How it started

In April, the U.S. Department of Health and Human Services and the Food and Drug Administration outlined a plan to phase out all petroleum-based synthetic dyes from America's food supply.

The FDA initiated the process to revoke authorization for Citrus Red No. 2 and Orange B in the short term and to eliminate another six synthetic dyes — FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2 — by the end of next year.

'That era is coming to an end.'

The agency also requested that companies move up their timelines for the removal of FD&C Red No. 3.

RELATED: Kennedy has Big Pharma ads in his sights — and he's not the only one mulling a crackdown

 Photo by Andrew Harnik/Getty Images

Vani Hari, a critic of the food industry who founded Food Babe, told Blaze News in November that the brighter artificial colors, which are helpful with sales and attractive to children, are harmful to their health.

"The science shows that these dyes cause hyperactivity in children, can disrupt the immune system, and are contaminated with carcinogens," said Hari. "There are safer colors available made from fruits and vegetables, such as beets and carrots. Food companies already don't use artificial dyes en masse in Europe because they don't want to slap warning labels on their products that say they 'may cause adverse effects on attention in children.'"

Extra to seeking the removal of the harmful chemicals, the FDA indicated in April that it would partner with the National Institutes of Health to conduct research on how food additives impact kids' health and development.

"For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent," said Kennedy. "These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We're restoring gold-standard science, applying common sense, and beginning to earn back the public's trust."

FDA Commissioner Marty Makary noted that "given the growing concerns of doctors and parents about the potential role of petroleum-based food dyes, we should not be taking risks and do everything possible to safeguard the health of our children."

How it's going

A number of companies have proven amenable to the changes advocated by the Trump administration.

RELATED: How Big Pharma left its mark on woke CDC vax advisory panel — and what RFK Jr. did about it

 Michael M. Santiago/Getty Images

Thirteen days after HHS' announcement, Tyson Foods indicated it was on track to remove all petroleum-based dyes from its production process by the end of May. Top executives from PepsiCo, Danone North America, and TreeHouse Foods similarly signaled commitments to scrap artificial colors.

'When the government sets clear, science-based standards, the food industry listens and acts.'

The American fast-food chain In-N-Out Burger revealed last month that it was removing artificial coloring from two of its drinks and swapping out its high-fructose corn syrup-based ketchup for an alternative that uses real sugar.

A spokesman for the company told CNN that the changes were part of the chain's "ongoing commitment to providing our customers with the highest-quality ingredients."

Kennedy encouraged more companies to similarly volunteer "to prioritize Americans' health and join the effort to Make America Healthy Again."

Blaze News previously reported that Kraft Heinz got on board this week, stating that it will remove artificial food, drug, and cosmetic colors from products in the United States before the end of 2027.

"This voluntary step — phasing out harmful dyes in brands like Kool-Aid, Jell‑O, and Crystal Light — proves that when the government sets clear, science-based standards, the food industry listens and acts," tweeted Kennedy.

While stressing that 85% of its full U.S. retail portfolio is "currently made without certified colors," General Mills said Tuesday it would eliminate the remainder of artificial coloring in short order.

"Across the long arc of our history, General Mills has moved quickly to meet evolving consumer needs, and reformulating our product portfolio to remove certified colors is yet another example," said General Mills CEO Jeff Harmening.

RELATED: Meat the enemy: How protein became the left's newest microaggression

 Daniel Acker/Bloomberg via Getty Images

"Knowing the trust families place in us, we are leading the way on removing certified colors in cereals and K-12 foods by next summer. We're committed to continuing to make food that tastes great and is accessible to all," added the executive.

The removal of synthetic dyes from the food supply is a giant step, though there remains at least one chemical in cereals with effects that may warrant further action.

No artificial colors — but infertility?

A peer-reviewed study published last year in the Journal of Exposure Science and Environmental Epidemiology suggested that current concentrations of chlormequat chloride in oat-based foods "warrant more expansive toxicity resting, food monitoring, and epidemiological studies."

Researchers on the study from the Environmental Working Group, a chemical watchdog accused in recent years of exaggeration, indicated that food samples purchased in 2022 and 2023 "show detectable levels of chlormequat in all but two of 25 conventional oat-based products."

Quaker Oats and Cheerios were allegedly among the affected cereals.

'Do we really need more chemicals in our food?'

Chlormequat, first registered in the U.S. in 1962 as a plant growth regulator and recognized decades later by the U.S. Environmental Protection Agency as "toxic to wildlife," has been linked in animal studies to disrupted fetal growth, damage to the reproductive system, delayed puberty, and reduced fertility.

While the EPA suggested in 2023 that there were no dietary or residential risks of concern associated with human exposure to chlormequat, the 2024 study suggested that "more recent reproductive toxicity studies on chlormequat show delayed onset of puberty, reduced sperm motility, decreased weights of male reproductive organs, and decreased testosterone levels in rats exposed during sensitive windows of development, including during pregnancy and early life."

RELATED: HHS scraps COVID vaccine schedule for children and pregnant women: 'It's common sense, and it's good science'

 

  Rebecca Noble/Getty Images

Secretary Kennedy has criticized the use of chlormequat chloride, which he deemed "one of those 'forever chemicals,'" on grains.

He noted in July 2023, "This chemical was prohibited by the very same EPA in 1962 for use on anything but ornamental plants in greenhouses. That was before the agency was captured by industry."

Kennedy added, "Chlormaquat is linked to disruption of fetal growth, metabolic alterations, lower sperm motility, deceased testosterone, delayed development in puberty, and other effects. At a time when chronic disease is at an all-time high, do we really need more chemicals in our food?"

Blaze News reached out to HHS about the removal of artificial dyes as well as about chlormequat in the food supply but did not immediately receive a response.

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FDA Vaccine Advisor Calls For COVID Victims To Sue Trump Admin

'What you would like to see is ... the inevitable happening'

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[rebelmouse-proxy-image https://thefederalist.com/wp-content/uploads/2025/06/Screenshot-2025-06-12-at-7.46.47 AM-e1749732490458-1200x675.png crop_info="%7B%22image%22%3A%20%22https%3A//thefederalist.com/wp-content/uploads/2025/06/Screenshot-2025-06-12-at-7.46.47%5Cu202fAM-e1749732490458-1200x675.png%22%7D" expand=1]The resolution acknowledges the abortion pill causes unborn babies deaths and ‘physical, emotional, and spiritual harm to the mother.’

HHS scraps COVID vaccine schedule for children and pregnant women: 'It's common sense, and it's good science'



The Health and Human Services Department announced Tuesday that the COVID vaccine will be dropped from the Centers for Disease Control and Prevention's recommended vaccine schedule for healthy pregnant women and children.

By amending the vaccine schedule, HHS Secretary Robert F. Kennedy Jr. is combatting the residual COVID hysteria from former President Joe Biden's administration. Kennedy made the highly anticipated announcement alongside Dr. Jay Bhattacharya, director of the National Institutes of Health, and Dr. Martin Makary, who serves as commissioner of the Food and Drug Administration.

"I couldn't be more pleased to announce that as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Kennedy said.

'We're now one step closer to realizing President Trump's promise to make America healthy again.'

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RFK JR: “As of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule. We’re now one step closer to realizing President Trump’s promise to Make America Healthy Again.”

HUGE! pic.twitter.com/Zq5eRhdQkf
— TheBlaze (@theblaze) May 27, 2025
 

"Last year, the Biden administration urged healthy children to get yet another COVID shot, despite the lack of any clinical data, to support the repeat booster strategy in children," Kennedy said.

"That ends today," Bhattacharya added. "It's common sense, and it's good science."

Prior to the announcement, the CDC recommended the COVID vaccine to any person over 6 months old, particularly people over the age of 65, pregnant women, breastfeeding mothers, and women planning to conceive.

Despite the CDC's previous recommendations, several studies and medical professionals have indicated that the COVID vaccines are not as effective or as necessary as they were originally made out to be. Some even noted a range of adverse effects on children and pregnant women.

"There's no evidence healthy kids need it today, and most countries have stopped recommending it for children," Makary said.

RELATED: HHS scrapping COVID jab recommendations for pregnant moms and kids: Report

  Photo by Andrew Harnik/Getty Images

This is just the latest effort from President Donald Trump's administration to restore faith in American institutions, especially when it comes to health. Just last week, Kennedy released his highly anticipated MAHA report, which shed light on potential root causes for chronic health issues like chemical exposure, ultra-processed foods, and over-medicalization of children.

"We're now one step closer to realizing President Trump's promise to make America healthy again," Kennedy said.

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HHS scrapping COVID jab recommendations for pregnant moms and kids: Report



The Department of Health and Human Services is reportedly preparing to scrap its recommendation that pregnant women and kids get the COVID-19 vaccines. Individuals said to be familiar with the matter told the Wall Street Journal that the announcement is imminent and will coincide with the Centers for Disease Control and Prevention kicking off a new vaccine approval framework.

While the relevant agencies apparently did not respond to the Journal's requests for comment, U.S. Food and Drug Commissioner Dr. Marty Makary provided a fairly strong indication this week that the change was coming.

Makary told Turning Point USA CEO Charlie Kirk that he would "love to see the evidence to show that giving young, healthy children another COVID-19 shot — you know, a sixth COVID booster — would help them, but that evidence does not exist, and so we're not going to rubber-stamp things at the FDA."

"I don't think you're going to see a push at the CDC to be pushing COVID shots in young, healthy children," continued Makary, adding that he expected an announcement on that front in the coming weeks.

Sources told the Journal that it would only be a matter of days.

At the time of publication, the CDC was still recommending that everyone ages 6 months and older get a COVID-19 vaccine.

'Connected to serious adverse events, including myocarditis and pericarditis, failed pregnancies, and deaths.'

The agency states on its website that getting the shot is especially important for individuals who have survived this long without one, geriatrics, pregnant women, those planning to conceive, and breastfeeding mothers. The agency urges parents to get their children 6 months to 4 years of age loaded up with two doses of the Moderna vaccine or three doses of the Pfizer vaccine if they were starting fresh.

As of April 26, 14.4% of pregnant women had received a 2024-25 COVID-19 vaccine and 13% of children 6 months to 17 years of age were up to date, CDC data shows.

RELATED: Jab first, ask questions never: Vaccine truths your doctor won't tell you

 EKIN KIZILKAYA/iStock/Getty Images Plus

The CDC stuck with its recommendations until now despite credible warnings from Florida Surgeon General Dr. Joseph Ladapo and other experts; troubling scientific studies demonstrating the vaccines were not as safe and effective as advertised; glaring evidence that kids and teens were at low risk for COVID and could go without; and damning state-leveled allegations that one of the primary vaccine manufacturers sat on evidence that its COVID-19 vaccine "was connected to serious adverse events, including myocarditis and pericarditis, failed pregnancies, and deaths."

Just last month, a preprint study backed by the Florida Department of Health suggested that adults in the Sunshine State who received the Pfizer vaccine had "significantly higher risk of 12-month all-cause, cardiovascular, COVID-19, and non-COVID-19 mortality" than those who received the Moderna shot.

A study conducted by the Global COVID Vaccine Safety Project — a Global Vaccine Data Network initiative supported by both the CDC and the HHS — and published last year in the journal Vaccine detailed troubling links between the AstraZeneca, Moderna, and Pfizer vaccines and medical conditions such as Guillain-Barré syndrome, brain and spinal cord inflammation, Bell's palsy, and convulsions.

Another peer-reviewed study published last year in the pharmacotherapy journal Therapeutic Advances in Drug Safety indicated that "COVID-19 vaccination is strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death."

"COVID-19 vaccines induce an uncontrolled expression of potentially lethal SARS-CoV-2 spike protein within human cells, have a close temporal relationship of events, and are internally and externally consistent with emerging sources of clinical and peer-reviewed data supporting the conclusion that COVID-19 vaccines are deterministic for myocarditis, including fatal cases," said the study.

'The current risks of serious adverse events or deaths outweigh the benefits.'

Texas cardiologist Peter McCullough, a leading critic of the vaccines, said in a statement Thursday, "Two presidents, three HHS Secretaries, three FDA Commissioners, and nearly five years into the disastrous COVID-19 vaccine debacle, women and children receive long overdue yet welcome news. After record vaccine injuries, disabilities, and death, America is wondering will any of these leaders be held accountable?"

Dropping the recommendations appears to be a half measure, given that HHS Secretary Robert F. Kennedy Jr. previously fought to revoke authorization of COVID-19 vaccines altogether.

RELATED: Mandates, masks, and mayhem: Never again!

 Photographer: Al Drago/Bloomberg via Getty Images

In a petition he filed with the FDA on May 16, 2021, Kennedy said the agency should revoke all emergency use authorizations and refrain from approving future EUAs for any COVID vaccine for all demographic groups "because the current risks of serious adverse events or deaths outweigh the benefits, and because existing, approved drugs provide highly effective prophylaxis and treatment against COVID, mooting the EUAs."

Kennedy noted further that the agency should specifically spare children and pregnant women from the novel vaccines.

Kennedy's warnings and requests evidently fell on deaf ears.

In its final weeks, the Biden HHS extended liability protection to COVID-19 vaccine manufacturers and administrators through Dec. 31, 2029, precluding vaccine recipients who reportedly end up injured or their surviving family members from holding those responsible to account. This was the latest of several such extensions.

The reports of the HHS dropping the vaccine recommendations and other moves made in recent months by the Trump administration have elements of the medical establishment clutching pearls.

Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, told the New York Times, "I think that we are in the midst of watching the vaccine infrastructure being torn down bit by bit."

"I think everything is a target," said Tara Smith, an epidemiologist at Kent State University College of Public Health.

"Overturning the recommendation means that insurance companies will no longer have to cover these vaccines," Dorit Reiss, a law professor at UC Law San Francisco, complained to the health publication Stat.

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More Than 100 Organizations Plead With FDA To Protect Women From Dangerous Abortion Drug

'The evidence strongly suggests that mifepristone is unacceptably dangerous, and those who removed such protections put American women directly in harm’s way.'

Will the Supreme Court rein in rogue judges — or rubber-stamp them?



Nationwide injunctions — once unknown in American legal tradition — have exploded in popularity, driven by single federal district court judges eager to block policies enacted by the political branches. Supreme Court justices appointed by presidents of both parties have raised alarms about the trend.

Justices Clarence Thomas, Samuel Alito, Neil Gorsuch, Brett Kavanaugh, and Amy Coney Barrett have criticized these injunctions in written opinions. Chief Justice John Roberts and Justice Elena Kagan have raised similar concerns in public comments. In the 2018 Trump v. Hawaii decision, Thomas called them “legally and historically dubious.” Speaking at a Ninth Circuit judicial conference, Kagan reportedly remarked, “It just can’t be right that one district judge can stop a nationwide policy in its tracks and leave it stopped for the years that it takes to go through the normal process.”

The question before the court is fundamental: Do elections matter, or do lower-court judges run the country?

Solicitors general from both parties have also objected. Joe Biden’s solicitor general, Elizabeth Prelogar, warned last year that nationwide injunctions cause “substantial disruption” to executive functions. Acting Solicitor General Sarah Harris earlier this year called them an “epidemic.”

The Supreme Court will now decide whether these bipartisan objections reflect genuine constitutional concerns — or partisan convenience. Take Mary McCord, for example. A former Obama White House official and adviser to the January 6 Committee, she co-signed the respondents’ brief defending the nationwide injunctions in this case. But would she have supported them when courts used them against her own administration?

The Supreme Court will hear arguments Thursday in Trump v. CASA, Inc., along with the related cases Trump v. Washington and Trump v. New Jersey. At issue is the Trump administration’s “modest request” to limit the scope of nationwide injunctions issued by district judges in Maryland, Massachusetts, and Washington state. These injunctions blocked enforcement of the president’s day one executive order on birthright citizenship, even before courts ruled on the legal merits.

(Full disclosure: I submitted a brief in the case on behalf of the Claremont Institute’s Center for Constitutional Jurisprudence, urging the court to restore the original meaning of the 14th Amendment — one that excludes both temporary visitors and illegal immigrants from automatic citizenship.)

The case against universal injunctions follows directly from the Constitution. Article III, Section 2 limits judicial power to “cases or controversies,” designed to resolve disputes between parties, not to dictate national policy. Nationwide injunctions go well beyond the plaintiffs and defendants involved.

Article III, Section 1 vests judicial authority in the Supreme Court and “such inferior courts as the Congress may from time to time ordain and establish.” District courts possess geographically defined jurisdictions. A single federal judge in, say, Maryland or Washington state was never meant to issue rulings that bind the entire country.

Nationwide injunctions routinely disrupt government operations. Different district courts can issue conflicting injunctions, creating legal chaos and making compliance virtually impossible. That’s exactly what happened in 2022 after the Supreme Court’s Dobbs decision overturned Roe v. Wade. Judge Matthew Kacsmaryk of the Northern District of Texas issued a nationwide injunction blocking the FDA’s approval of mifepristone, a common abortion drug. Just hours later, Judge Thomas Rice in the Eastern District of Washington issued a competing order — this one prohibiting the FDA from altering its approval of the same drug in half the country.

RELATED: Injunction dysfunction or tyrant disruption? Trump-era judicial paralysis explained

  designer491 via iStock/Getty Images

These injunctions also fuel rampant forum-shopping. Predictably, left-leaning jurisdictions like Massachusetts, Maryland, and Washington state produced most of the nationwide injunctions during the Trump presidency — just as Texas courts served that role under Obama and Biden. Chief Justice Roberts and Justice Kagan have both warned about this manipulation. Members of Congress, legal scholars, the American Bar Association, and even the Judicial Conference of the United States have proposed random judge assignments for cases that could result in nationwide injunctions.

Such reforms might reduce forum-shopping, but they do not fix the underlying constitutional defects.

If the court agrees with the Department of Justice and narrows the injunctions to the actual parties in the case, it must still define who counts as a party. Will that include only the named plaintiffs? Or will it extend to entire state populations listed as plaintiffs — or worse, activist groups claiming to represent all their members?

If the court accepts either of the latter definitions, it effectively reauthorizes nationwide injunctions under a different name. That outcome seems unlikely. The court will likely stop short of endorsing such a sweeping expansion of lower-court power and instead point to the existing class-action mechanism already embedded in federal rules.

Whatever the court decides, the consequences will ripple through the hundreds of lawsuits filed against the president’s executive actions. At stake is nothing less than the legitimacy of the last election — and whether unelected district judges can override the policies chosen by the American people. The question before the court is fundamental: Do elections matter, or do lower-court judges run the country?