National Consumers League and Child Labor Coalition Mourn the Passing of Human Rights Attorney Terry Collingsworth 

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

Washington, DC – The National Consumers League (NCL) and the Child Labor Coalition (CLC) mourn the untimely passing of Terry Collingsworth, a pioneering human rights attorney and tireless advocate for workers, children, and vulnerable communities around the world. 

For decades, Terry dedicated his life to confronting injustice and holding powerful multinational corporations accountable for human rights abuses. As the founder and Executive Director of International Rights Advocates (IRAdvocates), he helped advance a bold vision of a world free from forced labor, child slavery, and exploitation—a world where victims of corporate abuses have meaningful access to justice. 

Terry understood that protecting human rights required more than promises and voluntary corporate commitments. It demanded courageous action, legal accountability, and strong partnerships with workers and communities on the front lines of exploitation. His pioneering approach combined strategic litigation, research, public advocacy, and coalition building to challenge some of the world’s most powerful corporations.  

From representing children trafficked into forced labor on cocoa plantations in West Africa to challenging hazardous child labor in cobalt mines in the Democratic Republic of Congo, Terry was relentless in his pursuit of justice. His work also sought accountability for violence against trade unionists and for the exploitation of workers and communities whose fundamental rights had been denied.  

For the Child Labor Coalition and the National Consumers League, Terry was an important ally in the shared struggle to eliminate child labor and ensure that corporations respect human rights throughout their global supply chains. He recognized the essential role of consumers, advocates, trade unions, and grassroots organizations in demanding change and refusing to accept exploitation as the cost of doing business. 

 Terry’s determination, courage, and commitment to those too often denied a voice leave an enduring legacy. He demonstrated that even the most powerful corporations must be challenged when they profit from human suffering, and that the law can be a powerful instrument for advancing human dignity. 

We extend our deepest condolences to Terry’s family, friends, and colleagues. We honor his extraordinary contributions by reaffirming our commitment to the principles he championed: justice for exploited workers, freedom for children trapped in forced labor, and accountability for those who violate fundamental human rights. 

 

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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.  

Consumers Will Pay the Price if FDA Opens the Door to Six Untested Peptides

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

Washington, DC – At a time of mounting concern that gray-marketed injectable peptides carry severe risks to human health, the National Consumers League is raising alarm bells that an “interim access policy” poised to be issued by the Food and Drug Administration (FDA) will allow compounding pharmacies to make and sell six currently banned peptides – BPC-157, TB-500, KPV, MOTS-c, Epitalon, and Semax – despite FDA’s own scientists warning that the evidence behind these substances consists largely of small animal studies and laboratory experiments, not the rigorous testing Americans expect from the medicines they put into their bodies.

Specifically, NCL cautions that instead of undergoing a full rulemaking process, the interim access policy would put these untested peptide products on the market without the public comment and scientific review that the law intends. In doing so, FDA would allow specific “503A pharmacies” that prepare customized medications and are exempt from the safety and labeling rules required for FDA-approved medicines to compound these peptides for any use a prescriber supports. FDA’s argument is that patients already buy these peptides from illicit sellers, and thus an interim enforcement discretion policy will allow licensed pharmacies to compound higher-quality products under professional oversight.

The harm to consumers from this “might as well” policy is incalculable. The FDA has warned that immune responses to peptides range from silent antibodies to “life-threatening and catastrophic reactions,” which is why the agency placed the six peptides in Category 2 for significant safety risks, precluding their use. Additionally, the American Medical Association, other medical societies and global bodies including Health Canada, Australia’s Therapeutic Goods Agency, and the World Anti-Doping Agency have all warned that inadequately tested peptide products are a growing public health risk. Among the dangers are liver toxicity, cardiovascular stress, potential tumor promotion, and severe allergic reactions, ranging from skin-swelling and hives to life-threatening anaphylaxis.

Beyond the safety risks, the policy of enforcement discretion will give these unapproved peptide products the appearance of government sanction, leading consumers to believe that these substances are regulated and legal. This will be reinforced when the compounded peptides arrive in pharmacy-labeled vials, with a prescription from a licensed pharmacy, looking exactly like the more than 100 FDA-approved peptide medicines, including insulin and GLP-1 drugs, that have earned their place through large-scale clinical trials. A patient picking up a compounded BPC-157 injection will have no visible signal that it was never tested for safety, proper dosing, or long-term side effects. Just as deceptive advertising has left consumers confused about the difference between FDA-approved GLP-1 medicines and compounded copies, this policy would erase the line between proven medicines and experimental substances.

Moreover, NCL joins with numerous patient safety, medical and public health organizations in cautioning that FDA’s interim access policy will entrench an already dangerous market promoting “research-grade” peptides where influencers, podcasters, med spas, wellness clinics, and telehealth platforms promote these substances with sweeping claims about muscle repair, injury recovery, anti-aging, weight loss, and brain performance — assertions that are not supported by scientific evidence. Underscoring this concern, research published June 15, 2026, in the Journal of the American Medical Association finds over 130,000 Instagram posts and over 230 million views on TikTok as of May 2025 promoting synthetic peptides for muscle growth, injury recovery, anti-aging, and cognitive enhancement.

Because the interim policy implies regulation when none exists, consumers will be exposed to and will buy peptides that are unapproved, untested and exist outside of every lawful pathway believing the claims that these substances are “legal,” “pharmacy-grade,” and “doctor-prescribed” when these products are not backed by clinical trials and the FDA-approval process. Thus, consumers will be playing Russian Roulette with their health while FDA acts against its own mission of ensuring drugs are safe based on a regulatory system that requires rigorous pre-approval testing and FDA review, are of high quality based on good manufacturing practices and FDA inspections, and monitored for adverse events once they are on the market.

Recognizing what is at stake for the health of Americans, NCL supports the petition filed by the Partnership for Safe Medicines (PSM), which calls on the FDA to refrain from allowing compounding pharmacies to make and sell peptides that do not meet the conditions necessary to be included in the 503A Bulks List, the list of ingredients that compounders are permitted to use.

Current laws exist so that patients can trust they are getting safe, proven, and tested therapies. NCL therefore urges the FDA to follow its own scientists, reject a shortcut that bypasses the evidence, and require any peptide seeking broader access to go through full rulemaking with genuine scientific scrutiny. Consumers deserve the truth about what they are injecting, and they deserve a regulatory system that protects them rather than one that lends credibility to unsupported health claims.

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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.   

National Consumers League Calls on Congress to Establish a Robust Regulatory System for Hemp-derived Beverages Before Extending Hemp Deadline

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

Washington, DC – A provision in the 2018 Farm Bill removed hemp from the controlled substances list, creating a loophole in federal law that allowed the hemp industry to build a billion-dollar empire where manufacturers extract and concentrate intoxicating cannabinoids from hemp and market them in gummies, vapes, beverages, and other products. Using an addiction-for-profit model, these products are packaged with bright colors and candy-like branding that appeal to minors. Today, the $28 billion industry is enticing vulnerable teens and young adults with THC-infused beverages, edibles and other intoxicating items that they mistakenly view as safe because the products are sold widely in gas stations and convenience stores.

Recognizing the danger, Congress closed the hemp loophole in the November 2025 appropriations bill by setting a deadline for production of these products of November 17, 2026. It recently extended the deadline to December 11, 2026.

Congress should do nothing to alter the closure of the hemp loophole that was enacted in 2025 and is now effective December 11, 2026, unless and until a robust regulatory regime for hemp-derived products is put in place.

Especially as our work relates to the health and safety of children and adolescents, the National Consumers League is deeply concerned about the distinct risks that hemp products pose to teenagers and young adults whose developing brains are highly vulnerable to cannabinoids. As documented in the medical literature, adolescent cannabis use is a pressing public health concern, associated with adverse outcomes in brain development, mental health, and physical health including its effects on the gastrointestinal, cardiovascular, respiratory, and endocrine systems of body.

The consequences have been devastating. Not only are children and teenagers more vulnerable to the harmful effects of THC, but they are also more likely to consume these products accidentally and can develop dependence more quickly than adults. Thus, poison control centers, emergency departments, and addiction treatment providers have reported significant increases in cases involving hemp-derived THC exposure, including severe and sometimes life-threatening outcomes.

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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.     

Nobel Peace Laureate Kailash Satyarthi to Keynote a Conversation on Ending Global Child Labor

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

Washington, DC – Nobel Peace Laureate and global child rights advocate Kailash Satyarthi will join leaders in child labor advocacy, academia, diplomacy, and international development on Monday, October 5, for “Solving Global Child Labor with Compassion,” a public event hosted by the National Consumers League’s (NCL) Child Labor Coalition at American University’s School of International Service. Register here.

Event Details

When: Monday, October 5, 2026, 2:30-4:00 p.m.

Where: Abramson Family Founders Room, School of International Service, American University, 3468 Nebraska Ave. NW, Washington, DC

Keynote: Kailash Satyarthi, Nobel Peace Laureate and Founder of the Satyarthi Movement for Global Compassion

Admission: Free and open to the public; registration required.

The program will open with remarks from Rachel Sullivan Robinson, Interim Dean of American University’s School of International Service, and Sally Greenberg, Co-Chair of the Child Labor Coalition.

Following Satyarthi’s keynote, Judy Gearhart, Research Professor at the Accountability Research Center at American University’s School of International Service, will moderate a panel examining the continuing challenge of global child labor and approaches to addressing it. Satyarthi will be joined on the panel by Tim Ryan, Chairman of the Global March Against Child Labor, and Jon Jacoby, Chief Executive Officer of GoodWeave International.

The event comes as the international community continues working toward the elimination of child labor worldwide. The discussion will explore the role of compassion in confronting child exploitation and consider how advocates, governments, businesses, researchers, and consumers can contribute to protecting children and advancing their rights.

NCL has a longstanding commitment to combating exploitative child labor through its coordination of the Child Labor Coalition (CLC), whose 38 member organizations work to protect children from hazardous and exploitative work in the United States and abroad.

Satyarthi has been a longtime partner in the global movement to eliminate child labor and has previously joined NCL and CLC initiatives to advance children’s rights.

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About the Child Labor Coalition

The Child Labor Coalition, co-chaired by the National Consumers League and the American Federation of Teachers, brings together organizations committed to combating exploitative child labor and protecting the health, safety, education, and well-being of working minors.

Celebrating Champions of Consumer Protection at the National Consumers League 2026 Trumpeter Awards

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Awards to be presented to NAACP President and CEO Derrick Johnson, Congresswoman Debbie Dingell, Ohio Governor Mike DeWine, and Justice for Migrant Women Founder and President Mónica Ramírez 

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

Washington, DC – The National Consumers League (NCL) will host its annual Trumpeter Awards Dinner on Tuesday, October 6, 2026, at the Mayflower Hotel in Washington, DC. The evening begins with a reception at 6 p.m., followed by dinner at 7 p.m.    

“Consumers are facing enormous challenges, from rising costs and weakened protections to threats to the safety and security of their families,” said NCL CEO Sally Greenberg. “At a time when it can be easy to feel discouraged, our 2026 honorees remind us of what strong leadership looks like. They have spent their careers standing up for fairness, accountability, and justice, and we are proud to recognize their commitment to consumers, workers, and families.” 

NCL will honor NAACP President and CEO Derrick Johnson; Congresswoman Debbie Dingell (MI-06); and Ohio Governor Mike DeWine with Trumpeter Awards for speaking out on social justice issues and the rights of consumers.   Justice for Migrant Women Founder and President Mónica Ramírez will receive the Florence Kelley Award, named for NCL’s first general secretary, a pioneering social reformer who fought child labor and exploitative working conditions and championed minimum-wage protections. News4’s Consumer Investigative Reporter, Susan Hogan, will serve as Master of Ceremonies.   

As consumer leaders navigate these unprecedented times in a rapidly changing marketplace, NCL’s 2026 Trumpeter Awards Dinner will serve as both a celebration and a call to action—honoring those who have spent their careers raising their voices for fairness, safety, and justice.    

All press: RSVP to lisam@nclnet.org  

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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.     

NCL Submits Comments Supporting FTC Policy Against Personalized Pricing 

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

Washington, DC — On Friday, the National Consumers League, joined by 26 other public interest organizations, submitted comments in response to the Federal Trade commission’s (FTC) proposed policy regarding personalized pricing, also known as surveillance pricing. NCL supported the FTC’s position that failing to disclose personalized pricing likely violates the law. NCL also urged the FTC to hold businesses accountable for uses of personalized pricing that would seriously harm consumers even if disclosed.  

“The idea that businesses can spy on us without limit, and be financially rewarded for the same behavior, is fundamentally repulsive,” said NCL Senior Public Policy Manager Eden Iscil. “Companies need to focus on competing and improving their product rather than invading our privacy.” 

The FTC cited numerous examples in its proposed policy of possible deployments of personalized pricing, such as charging dying rideshare users higher fares if they are being transported to a hospital or raising grocery prices for mothers taking care of multiple children. These specific examples and many others should be prohibited under the law, even if disclosed. In addition to the FTC Act, these and similar uses of personalized pricing likely violate federal and/or state anti-discrimination laws prohibiting prejudice against certain traits, including having a disability, familial status, and other protected classes.  

In drafting the comments, NCL received assistance from the Center for Consumer Law & Economic Justice at the U.C. Berkeley School of Law, which served as counsel, as well as the National Consumer Law Center and Truth in Advertising, Inc.  

The full comments can be found here. 

Further reading: 

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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.    

Administration’s “Freedom Means Affordable Cars” Initiative is an Assault on Consumers and Common Sense

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

Washington, DC – Today, the Trump administration released a final rule weakening federal fuel economy standards for cars, pickup trucks, and SUVs.  The rule, dubbed “Freedom Means Affordable Cars,” lowers the fleet average fuel economy from 50.4 miles per gallon to 34.9 miles per gallon by model year 2031.

“Today, the Trump administration dealt perhaps its greatest blow to affordability and common sense: gutting federal fuel economy standards in the midst of skyrocketing gasoline prices and an impending energy crisis,” said Daniel Greene, the Senior Director of Consumer Protection & Product Safety.  “A gallon of regular gasoline is nearing $4.50 per gallon.  Diesel prices have never been higher.  Nearly two years of sustained assaults on domestic clean energy and unprecedented weakening of energy efficiency standards have helped get us into this mess.  Doubling down on failed policies that inflict pain at the pump and exacerbate the affordability crisis will not get us out.”

The administration claims the proposed rule will reduce the price of new vehicles and generate tens of billions of dollars in savings for the American people.  The final rule inexplicably projects that regular gasoline will cost less than $3 per gallon from 2026 through 2040.

“Voodoo economics and alternative facts will not make this good policy,” Greene continued. “The administration may be satisfied with the status quo—content to hoist a metaphorical “Mission Accomplished” banner across every gas pump in the nation.  But there is a better path for consumers.  We must ambitiously support clean energy technologies and strengthen fuel economy standards, because costs are low when fuel economy standards are high.  Since 2002, fuel economy improvements save owners of newer pickup trucks and SUVs $9,920 and owners of newer cars $9,100 over the life of the vehicle.  Yet, since 2002, all vehicle equipment upgrades—including changes in fuel economy, comfort, convenience, durability, and voluntary safety improvements—have added just $3,040 to the cost of a vehicle.  No more false choices.  Let’s choose affordability and energy independence, economic vitality, and national security.”

In February, the National Consumers League released Sticker Shock, a report identifying the factors contributing to rising vehicle prices and evaluating the effect on household affordability.

Earlier this month, the National Consumers League and 25 other consumer organizations sent a letter to Congress opposing resolutions that would invalidate robust tailpipe emission standards adopted in full or in part by 18 states and the District of Columbia.

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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.    

National Consumers League to Convene Experts on AI, Fraud, and Healthcare at Two-Day Conference

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Featuring expert panelists from Amazon, TRM Labs, the D.C. Office of the Attorney General, Reset Tech, the Center for Democracy & Technology, Eli Lilly and Company, PhRMA, the Centers for Medicare & Medicaid Services, KFF, AHIP, the National Organization for Rare Disorders, and George Washington University

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

Washington, DC – The National Consumers League (NCL) will bring together policymakers, consumer advocates, healthcare professionals, technology leaders, and innovators for “The Future of Trust: Artificial Intelligence in Fraud & Healthcare,” a two-day conference, September 23-34, examining how artificial intelligence is reshaping two areas with significant consequences for consumers: fraud and healthcare. RSVP here.

Day one is focused on AI and Consumer Fraud with a keynote address from Patrick Coughlin, author of Dark Side of the Boom: How Scammers Hijacked the AI Revolution, and panelist experts from Amazon, TRM Labs, the D.C. Office of the Attorney General, Reset Tech, and the Center for Democracy & Technology, who will examine the rapidly evolving AI fraud landscape and strategies for protecting consumers.

“The spread of AI-enabled fraud is revolutionizing scammers’ ability to reach millions of vulnerable consumers,” said John Breyault, NCL’s VP of Public Policy, Telecommunications, and Fraud. “This conference brings together the brightest minds in technology, consumer protection, and public policy to discuss real-world solutions that can help reduce consumers’ risk to the growing wave of AI-fueled fraud.”

Day two is focused on AI and Healthcare with a keynote address from Dr. Vin Gupta, Senior Medical Analyst at MS NOW, and panelists from Eli Lilly and Company, PhRMA, the Centers for Medicare & Medicaid Services, KFF, AHIP, the National Organization for Rare Disorders and George Washington University, among others.

“AI has the potential to transform healthcare—from accelerating the discovery of new treatments to improving how patients access, navigate, and manage their care,” said Lisa Bercu, NCL’s Senior Director of Health Policy. “But realizing that promise will depend on earning and maintaining consumer trust. As AI becomes more deeply embedded in healthcare, consumers need confidence that these technologies are accurate, their data is protected, and important decisions about their health are made with appropriate transparency and accountability.”

For the full conference program and registration, visit here.

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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.

Consumer Organizations Urge Congress to Protect Robust Tailpipe Emission Standards, Alleviate Pain at the Pump

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

Washington, DC — The National Consumers League, Consumer Federation of America, and 24 other public interest organizations sent a letter to House and Senate leadership urging members of Congress to oppose resolutions that would invalidate robust tailpipe emission standards adopted in full or in part by 18 states and the District of Columbia.

“Costs are low when tailpipe emission standards are high,” the letter states.  “The fewer pollutants that may be emitted, the less gasoline must be consumed.  These savings are substantial, as households spend approximately $2,800, or 3.7 percent of household budgets, on gasoline each year.”

Improvements in clean vehicle technology since 2002 save owners of 2024 light trucks and SUVs $9,920 in avoided gasoline expenditures over the vehicle’s lifecycle, amounting to $834 in annual savings.  Owners’ of 2024 cars save $9,100 in avoided gasoline expenditures over the vehicle’s lifecycle, amounting to $650 in annual savings.

Further, clean vehicle features have had a minimal effect on vehicle prices.  Equipment upgrades—which include changes in clean vehicle technologies, comfort, convenience, durability, and nonmandatory safety improvements—account for only $3,040, or 13 percent, of the increase in average expenditures per new passenger vehicle since 2002.

“Weakening tailpipe emission standards will inflict more pain at the pump and exacerbate affordability challenges,” the letter continues.  “More pollutants result in more avoidable illnesses and deaths, exacerbating healthcare costs.”

The letter also asserts that “[a] cleaner fleet is a safer fleet, helping address the unacceptably high number of automobile fatalities and injuries on our nation’s roadways.”

“The American people do not have to choose between vehicle affordability and fuel efficiency, public health, and environmental stewardship,” the letter states.  “We encourage all members of Congress to oppose these improper CRA resolutions.”

A copy of the letter can be found HERE

Cosigners (26):  National Consumers League; Consumer Federation of America; Affordable Homeownership Foundation Inc.; American Council for an Energy-Efficient Economy (ACEEE); America Walks; American Academy of Pediatrics; American Academy of Pediatrics, Arizona Chapter; American Academy of Pediatrics California Chapter 1; American Academy of Pediatrics, DC Chapter; American Academy of Pediatrics, Florida Chapter; American Academy of Pediatrics, Idaho Chapter; American Academy of Pediatrics, Maine Chapter; American Academy of Pediatrics, Virginia Chapter; Bicycle Alliance of Minnesota; Center for Auto Safety;

Center for Progressive Reform; Citizens Action Coalition of IN; Consumer Federation of California; Consumers for Auto Reliability and Safety; Earth Ethics, Inc.; Kids and Car Safety; National Center for Health Research; National Coalition for Safer Roads; New Jersey Citizen Action; Vision Zero Maine; Whirlwind Wheelchair International

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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.    

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

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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.

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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.