National Consumers League Welcomes the Appeals Court Ruling Backing FDA’s Decision to Remove GLP-1 Drugs from the Shortage List

Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829 

Washington, DC – As an organization focused on the safety of GLP-1 weight loss drugs, the National Consumers League welcomes the August 27 ruling by the US Court of Appeals for the Fifth Circuit affirming the Food and Drug Administration’s (FDA) decision to remove the popular GLP-1 weight loss drug semaglutide from its drug shortage list as lawful and correct.

The Court’s decision, which also applies to the FDA’s action removing tirzepatide from the shortage list, is especially important because it validates the legal framework for how the FDA regulates the sale of compounded drugs during shortage situations. Dating back to the passage of the Food and Drug Administration Modernization Act in 1977, this framework both allows compounders to produce temporary versions of commercially available drugs during shortages, but it also makes it illegal for the continued mass production and sale of compounded versions when the shortage has ended.

Yet, despite being in existence for almost 50 years, the framework for removing drugs from the shortage list was recently challenged, not because there are legal issues, but because the mass-marketing of compounded GLP-1s became big business for compounding pharmacies and direct-to-consumer telehealth platforms while the branded GLP-1 weight loss drugs were in short supply. In fact, in 2024, compounded versions accounted for an estimated 30% of the overall GLP-1 weight-loss market. Thus, the Outsourcing Facilities Association (OFA), an organization representing compounding pharmacies, sued the FDA for declaring an end to the shortages of semaglutide and tirzepatide, claiming the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.”

Among OFA’s arguments were that the FDA ignored evidence that the shortages continued to exist, and that the agency did not give compounders reasonable notice of the planned determinations or allow them to weigh in with comments. But here is the good news: the Appeals Court reviewed the evidence and rejected these arguments, concluding that the FDA “followed the statutory framework, applying the statutory definition of shortage to the evidence before it.”

Importantly, the Court also endorsed FDA’s methodology and its reliance on actual supply data from the manufacturers to make the determination of the end of the shortage. Specifically, the Court declared that pharmacy screenshots, patient reports, articles, blog posts, and form letters submitted by compounders are less probative than “more specific, reliable, comprehensive, and current” data from the manufacturer – codifying common sense and the value of verifiable evidence.

At a time of growing concern over the need to improve the regulation of compounded drugs and restore compounding to its intended purpose, the Fifth Circuit’s ruling represents a line in the sand for policymakers and compounders. FDA’s time-tested regulatory framework for addressing shortage situations works and relies on a thorough review of the evidence that credits specific, reliable, comprehensive, and current information and data—up and down the product supply chain—over anecdotal, isolated, and unreliable reports.

### 

About the National Consumers League (NCL)      

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.   

This Labor Day, Remember the Women Who Fought for the 40-Hour Workweek

By NCL CEO Sally Greenberg

Labor Day 2026 is around the corner, and fittingly, I was asked this week to join an important discussion about “Responsible Purchasing Practices,” hosted by the Fair Labor Association (FLA), on whose board I serve. It may sound like a niche topic, but the issue is anything but: for generations, workers have been pushed into exploitative conditions to meet relentless demand for goods.

Unrealistic deadlines, last-minute changes, low prices, and production demands can put enormous pressure on the factories and workers who make our products. Children too are often exploited in the supply chain, with low wages, forced labor, hazardous work conditions, and human trafficking.

Florence Kelley, NCL’s esteemed first General Secretary appointed in 1899, made responsible purchasing practices an issue early on. One example is her work with Edward Filene of Filene’s Department Store to encourage shoppers to buy not 2 days before the holidays but weeks before. They launched the campaign because workers – often shopgirls as young as 10 and 11 – could typically be required to work 12 hours a day or more behind counters until late in the evenings, especially during holiday crunch season.

The Filene’s campaign was launched decades before the adoption of the U.S. Fair Labor Standards Act of 1938, which Frances Perkins, who was an acolyte of Florence Kelley and in 1932 became the Department of Labor Secretary under FDR, brought to fruition. The FLSA gave us maximum-hours laws, minimum wages, banned child labor, and required overtime pay beyond a 40-hour week. Ten and 12 hour days were not unusual, and often people worked 6-7 days a week. I talked about this fact on the panel this week – for 88 years, American workers – with a few categories unfortunately carved out and still lacking protections – have enjoyed the benefits of a 40-hour workweek. Workers around the world deserve the same.

The FLA’s program on Responsible Purchasing Practices shows that good RPPs remain a critical concern for workers around the globe – especially those who don’t enjoy broad labor law protections. Without limits on the demands manufacturers and retailers can make on workers to produce around the clock, suffering, exploitation, and misery will surely result.

The FLA is distinctive as a multistakeholder 501(c)(3) organization, bringing together universities, manufacturers, civil society organizations, and other stakeholders to advance laws, policies, and practices that promote safe and ethical working conditions. Responsible Purchasing Practices are central to that mission.

Florence Kelley understood that consumers also have a role to play in demanding decent working conditions for the people who make the goods they buy. When Filene’s and the National Consumers’ League launched their campaign, a central goal was to build that consumer awareness.

As significant as the Fair Labor Standards Act was for workers, NCL has spent decades working to close a major gap in its protections: the exemption affecting children who work on farms alongside their parents. In some states, that exemption can result in children working seven days a week without a guaranteed day of rest.

Poverty was—and remains—a major driver of child labor around the world. Early reformers understood that simply removing children from the workplace was not enough; families often depended on their earnings. Philanthropists therefore stepped in to help replace that lost income, making it possible for children to remain in school rather than at work.

That history helps explain why responsible purchasing practices matter today.

Consumers may see only the finished product on a store shelf or delivered to their homes. But behind every product are workers whose time and labor made it possible. Companies therefore have a responsibility to ensure that their purchasing practices do not encourage excessive overtime, unsafe conditions, or the erosion of basic labor standards.

More than 125 years after NCL was founded, the principle that guided Florence Kelley and Frances Perkins remains central to our work: consumers, companies, and policymakers all have a role to play in building an economy that respects workers and their rights.

We should also remember that the protections many workers enjoy today were hard-won. The eight-hour day, the 40-hour workweek, overtime protections, and restrictions on child labor did not simply appear. Generations of workers and reformers fought for them, often in the face of powerful opposition.

That struggle continues around the world. We are encouraged by recent progress in Mexico and Chile. Mexico recently enacted a constitutional amendment reducing the maximum workweek from 48 to 40 hours, with the reduction to be phased in between 2027 and 2030. Chile, meanwhile, is already implementing its own 40-hour workweek law. The maximum ordinary workweek fell from 44 to 42 hours on April 26, 2026, and will decline to 40 hours in 2028.

Labor Day reminds us not only of what workers have achieved, but also of how much work remains. Hundreds of millions of workers around the globe still lack meaningful protections, and Responsible Purchasing Practices are one important tool for addressing persistent labor abuses.

This Labor Day, let us celebrate American workers while remembering Florence Kelley, Frances Perkins, and the modern-day organizations—including NCL and the Fair Labor Association—that continue the fight for decent work, fair treatment, and meaningful protections for workers everywhere.

National Consumers League Urges FDA to Reject Petition Seeking Autism Warning on Children’s Acetaminophen

Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829 

Washington, DC – The National Consumers League (NCL) submitted comments to the U.S. Food and Drug Administration (FDA) urging the agency to reject a citizen petition from Children’s Health Defense (CHD) seeking to remove over-the-counter acetaminophen products for children under two and require boxed warnings linking acetaminophen to autism spectrum disorder (ASD). 

“Parents need safe and effective options when their child is sick or in pain, and deserve reliable information they can trust,” said Lisa Bercu, NCL Senior Director of Health Policy. “Leading pediatric experts have been clear that the evidence does not establish that acetaminophen causes autism.  Removing products from the market or imposing a boxed warning could unnecessarily alarm families, discourage appropriate treatment, and leave parents with fewer options when their children are sick or in pain.”

The American Academy of Pediatrics (AAP) has stated plainly that decades of research support the safety of acetaminophen for children when administered as directed and that studies do not establish a causal link between acetaminophen use in children and Autism.

“Imposing a serious FDA warning, contrary to leading pediatric expert opinion and without sufficient evidence, could also undermine public confidence in the scientific integrity of FDA’s labeling decisions,” Bercu concluded. “For more than 70 years families have relied on acetaminophen to treat children’s pain and fever, and leading pediatric experts continue to recognize it as safe and effective when used as directed.”

NCL’s comments are available here 

### 

About the National Consumers League (NCL)      

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.