As Financial Resilience Gap Widens For Gen Z, NCL Calls For Action

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

Washington, DC – The National Consumers League (NCL) is calling for the Trump administration to address a widening generational gap in consumer financial resilience, as highlighted by the July 2026 Financial Resilience Index (FRI). Consumers are struggling to keep up with the cost of groceries, medical bills, gas, and other household expenses. Gas prices have risen by an average of 81 cents per gallon compared to this time last year. Grocery prices have risen by 33% since 2019, the highest jump in over half a century, while over 100 million Americans are facing some form of medical debt. As a result, only 61% of Gen Zers reported feeling in control of their day-to-day finances, 28 points lower than their Baby Boomer counterparts.

“The next generation of consumers is more vulnerable than ever to economic shocks,” said NCL CEO Sally Greenberg. “This Administration has a responsibility to enact policies that protect Americans’ financial stability—which includes considering Americans’ financial needs when making domestic and foreign policy decisions.”

While the FRI rose 1.5 points from June to July (61.6 to 63.1), NerdWallet cautioned that the statistics do not reflect consumer financial stability after the ceasefire in Iran collapsed, which has driven up gas prices, the impact of high tariffs, is renewing concerns about the stability of the US economy.

As prices rise and fears of recession grow, NCL remains committed to protecting and promoting consumer interests. NCL urges federal lawmakers to keep household financial pressures top of mind and enact policies to improve the long-term financial security of all Americans.

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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, Consumer Groups Urge Senate to Vote No on CPSC Nominees 

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

Washington, DC – The National Consumers League, Consumer Federation of America, and 29 other stakeholders sent a letter to Majority Leader John Thune and Minority Leader Chuck Schumer urging Senators to oppose the confirmation of Brien Lorenze and Karen Sessions to serve as commissioners of the Consumer Product Safety Commission (CPSC).  Last week, the Commerce, Science, and Transportation Committee advanced the nominations with a 15 yeas to 13 nays party-line vote.  The Senate may consider the nominations as early as this week. 

“Product safety hazards have no partisan leanings, and neither should the Commission tasked with addressing them,” the letter states. “We are concerned that without balanced representation at the CPSC, this small agency with a big mission will be unable to independently carry out its congressionally mandated duties and provide the public with the transparency it deserves.  Accordingly, we respectfully request that members of the Senate oppose the nominations of Brien Lorenze and Karen Sessions to serve as CPSC commissioners.” 

In May 2025, the Trump administration removed the three Democratic, Senate-confirmed CPSC commissioners.  President Trump has since nominated two individuals of his own political party. This is particularly troublesome given the conflict of interest created by the President’s financial stake and those of his family and supporters in consumer products the CPSC is entrusted to regulate. 

A copy of the letter can be found HERE 

Cosigners (31): National Consumers League; Consumer Federation of America; Access Ready Inc.; Affordable Homeownership Foundation Inc.; Bicycle Alliance of Minnesota; BioInjury, LLC; Center for Auto Safety; Center for Pet Safety; Community Economic Empowerment Network; Consumers for Auto Reliability and Safety; Cribs for Kids; Derrick Stone Safe Sleep; Detroit Greenways Coalition; Earth Action, Inc.; Economic Action Maryland Fund; Housing and Economic Rights Advocates; Just Strategy; Keeping Babies Safe; Kids and Car Safety; Missourians for Responsible Transportation; National Association of Consumer Advocates; National Bicycle Dealers Association; People Power United; Safety Research & Strategies; StopDistractions.org; The Collaborative; The Wisconsin Bike Fed; Together We Thrive, Inc.; Trailnet; Truck Safety Coalition; Dr. Charles Jennissen, Product Safety Advocate. 

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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.   

The National Consumers League Issues a Nationwide Warning About Self-Injecting “Research-Grade” Synthetic Peptides

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

Washington, DC – At a time when a Food and Drug Administration advisory committee recommends loosening restrictions on some widely promoted research-grade peptides, the National Consumers League is going public about the serious health consequences of acquiring and self-injecting peptides that have not been proven through completed clinical trials to be safe and are prohibited for human use in Canada, Australia, the European Union, and by the World Anti-Doping Agency.

Peptides, defined as short strings of amino acids, are the fundamental building blocks of proteins naturally produced in the body and act as cellular messengers to regulate functions like metabolism, tissue repair, hormone production and immune responses. To date, the FDA has approved more than 100 peptide-based drugs, including insulin and GLP-1 medications, to treat conditions ranging from diabetes and metabolic disorders, to osteoporosis, multiple myeloma, and severe chronic pain, based on large-scale human clinical trials demonstrating their safety and effectiveness.

However, today a new threat has emerged. Thousands of consumers are going to an underground market to buy unapproved, unregulated injectable “wellness” peptides directly from online storefronts, med-spas, and wellness clinics without understanding that these peptides are not intended for human use, and without knowing of an FDA warning that these peptides “have not been found safe and effective for any condition.” Moreover, consumers may be buying fake or underground retatrutide, a potent weight loss drug currently undergoing clinical trials and not yet FDA-approved. These counterfeit versions of retatrutide could lead to accidental overdoses and severe adverse events.

What makes this gray market so dangerous is the ease with which consumers can buy unapproved peptides outside of regulatory controls. In this market, consumers often learn about “wellness” peptides through social media platforms, Reddit threads, and podcasts where social media influencers, athletes, celebrities, and do-it-yourself biohackers promote these substances for muscle growth, injury recovery, anti-aging, and cognitive enhancement.

This includes wellness peptides that the FDA advisory committee recommends adding to a list of substances that compounding pharmacies can use to make products to sell to consumers, such as BPC-157 and TB-500 for tissue repair and muscle building and MOTS-c for metabolic enhancement and longevity. Also in this category are growth hormone-releasing peptides, including Sermorelin, CJC-1295, and Ipamorelin, for restorative sleep and daytime energy. Not on the list is retatrutide, which is going through a formal FDA approval process, unlike the wellness peptides, where the FDA will review extensive data from many human clinical trials to determine whether retatrutide is safe and effective for clinical use.

According to global health experts, none of the wellness peptides are backed by sufficient scientific evidence to support their safety and effectiveness.  Yet due to the massive hype surrounding synthetic peptides, consumers who believe the claims go online to buy peptides labeled “for research use only,” which is a way for gray market vendors to sidestep drug safety regulations. Moreover, online vendors with website storefronts use slang, such as “pep” for peptide, to announce what they are selling through informal online channels, such as chat rooms and social media platforms. On these same online marketplaces, users rely on social media tutorials and influencers for advice on how to self-administer peptides, which are supplied as powders or injections in poorly labeled or unmarked vials.

There are serious consequences when consumers self-inject unapproved peptide products. Because many popular injectable wellness peptides are not approved or formally regulated by the FDA, there is sparse evidence to verify the safety and efficacy of these substances. Additionally, unapproved peptides are manufactured mostly in facilities in China and India where quality standards vary, and the peptides may go uninspected, leaving consumers with no assurance of their sterility, potency, purity, dosing consistency, or ingredient authenticity.

Therefore, NCL urges consumers to learn about the safety risks associated with taking unapproved experimental peptides and heed these warnings from the American Medical Association (AMA) and many global bodies:

Because retatrutide has not completed the FDA approval process, products sold online or through clinics are black market drugs and come with no guarantee of quality, purity, or dosing accuracy. Consequently, so-called retatrutide sold through the underground market may contain substituted chemicals, toxic impurities, or completely different active compounds instead of true peptide. Already, CBS News found that health problems reported to America’s Poison Centers about retatrutide surged to an average of 95 cases per month in early 2026, a 265% increase from late 2025. Also of great concern, in January 2026, health authorities in Australia issued an urgent alert after multiple users of black-market retatrutide suffered from acute liver failure, major kidney injuries, and life-threatening changes in heart rate.

Claims that wellness peptides aid in muscle repair, inflammation reduction, and injury recovery are not supported by scientific evidence. The World Anti-Doping Agency (WADA) put BPC-157, TB-500, and MOTS-c on its Prohibited List, banning these substances in athletic competition because there is insufficient data to confirm their safety.

In light of these facts, NCL urges consumers to follow the advice of the AMA and global health bodies, all of which urge consumers not to self-inject research-grade synthetic peptides due to the serious safety risks associated with these peptides, including severe immune reactions and possible organ damage.

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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 Urges Congress — Stronger Protections for Consumers, Ticketing Reform, and Anti-Fraud Collaboration

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

Washington, DC – Today, John D. Breyault, Vice President of Public Policy, Telecommunications, and Fraud at the National Consumers League (NCL), testified before the U.S. House Committee on Energy and Commerce Subcommittee on Commerce, Manufacturing, and Trade. The hearing, titled “Legislative Proposals to Strengthen Consumer Protection in a Changing Marketplace,” addressed key legislation impacting consumer agency authority, marketplace transparency, and fraud prevention.  

In his testimony, Breyault highlighted the urgent necessity of maintaining independent, fully empowered consumer protection regulators like the Federal Trade Commission (FTC) and the Consumer Product Safety Commission (CPSC). Pointing to recent judicial rulings—specifically Trump v. Slaughter—he warned against dismantling the structural autonomy of federal watchdogs.  

“Consumers do not need milquetoast enforcers, weighed down by political considerations. We need robust, independent agencies empowered to follow the law and hold corporate wrongdoers accountable,” said John Breyault, Vice President at NCL. “Regardless of which party occupies the White House or controls Congress, when the independence of the FTC or CPSC is compromised, the ultimate casualties are everyday consumers and fair marketplace competition.”  

NCL urged Congress to exercise its constitutional authority to insulate federal enforcers from political interference, preserve regulatory independence, and restore vital enforcement tools.  

NCL also expressed firm support for two key pieces of ticketing legislation aimed at overhauling an industry long plagued by hidden fees, artificial scarcity, and predatory software:  

  • The BOSS and SWIFT Act of 2026 – Championed by Ranking Member Frank Pallone (D-NJ6) and building on the legacy of the late Congressman Bill Pascrell, this bill sets comprehensive federal standards across both primary and secondary ticketing markets. Key provisions supported by NCL include mandatory upfront “all-in” pricing, mandatory public disclosures of ticket holdbacks, cracking down on deceptive speculative ticket sales, protecting ticket transfer rights, and prohibiting connected insiders from scalping tickets. 
  • The MAIN Event Ticketing Act (H.R. 2713) – Introduced by Reps. Harshbarger (R-TN1) and Carter (D-LA2), this bill modernizes the 2016 BOTS Act. Breyault detailed how dominant ticketing platforms have historically profited from scalper bots via multi-stage fee collection. The MAIN Event Ticketing Act closes operational loopholes by enhancing reporting requirements for bot attacks, establishing a consumer complaint database, and strengthening enforcement coordination between the FTC, state attorneys general, and law enforcement.  

Addressing the unprecedented rise in deceptive schemes, NCL endorsed H.R. 5967, the Strategic Task Force on Scam Prevention Act, introduced by Reps. Menendez (D-NJ8) and Houchin (R-IN9). With Americans losing an estimated $195.9 billion to fraud in 2024 alone, NCL underscored the importance of establishing an interagency task force combining resources from the FTC, Department of Justice, Department of the Treasury, and other federal partners.  

NCL also cautioned lawmakers against measures that weaken consumer safeguards, specifically raising objections to: 

  • The PACK Act of 2025 (H.R. 6832) – Opposed for preempting strong state-level labeling standards—such as California’s Truth in Labeling Law—without setting strong federal baselines to prevent corporate greenwashing. 
  • The Recycled Materials Attribution Act (H.R. 7502) – Opposed for legitimizing “mass balance accounting,” a deceptive framework that allows manufacturers to market products as containing recycled content regardless of the physical composition of individual store items.  

Breyault’s full testimony is available 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 Groups Oppose Confirmation of Lorenze, Sessions as CPSC Commissioners

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

Washington, DC – The National Consumers League, Consumer Federation of America, and 29 other stakeholders sent a letter to members of the Senate Committee on Commerce, Science, and Transportation opposing the confirmation of Brien Lorenze and Karen Sessions to serve as commissioners of the Consumer Product Safety Commission (CPSC).  The committee is scheduled to vote on the nominations tomorrow. 

“Product safety hazards have no partisan leanings, and neither should the Commission tasked with addressing them,” the letter states.  

In 1972, Congress established the CPSC as an independent federal agency led by five bipartisan commissioners exclusively charged with overseeing the safety of household consumer products. Since then, members of Congress from both parties have supported the role of an independent, nonpartisan CPSC.   

“Historically, the agency’s independence has buffered the commissioners from political pressure from the White House and large donors”; the letter continues. “This has ensured that the agency has acted with transparency and a diversity of views, which has benefited the American people.  Further, the presence of minority commissioners provided a layer of oversight and accountability on CPSC actions.” 

In May 2025, the Trump administration removed the three Democratic, Senate-confirmed CPSC commissioners.  President Trump has since nominated two individuals of his own political party. 

“Diverse perspectives and transparency improve safety,” the letter states.  “Silencing the voices of subject matter experts with whom the President politically disagrees or who may not serve his financial interests can have a chilling effect on the CPSC’s functions. This is particularly troublesome given the conflict of interest created by the President’s financial stake and those of his family and supporters in consumer products the CPSC is entrusted to regulate” 

“We are concerned that without balanced representation at the CPSC, this small agency with a big mission will be unable to independently carry out its congressionally mandated duties and provide the public with the transparency it deserves,” the letter concludes.  “We therefore urge you to oppose reporting favorably the nominations of Brien Lorenze and Karen Sessions to serve as CPSC commissioners.” 

A copy of the letter can be found HERE

Cosigners (31): National Consumers League; Consumer Federation of America; Access Ready Inc.; Affordable Homeownership Foundation Inc.; Bicycle Alliance of Minnesota; BioInjury, LLC; Center for Auto Safety; Center for Pet Safety; Community Economic Empowerment Network; Consumers for Auto Reliability and Safety; Cribs for Kids; Derrick Stone Safe Sleep; Detroit Greenways Coalition; Earth Action, Inc.; Economic Action Maryland Fund; Housing and Economic Rights Advocates; Just Strategy; Keeping Babies Safe; Kids and Car Safety; Missourians for Responsible Transportation; National Association of Consumer Advocates; National Bicycle Dealers Association; People Power United; Safety Research & Strategies; StopDistractions.org; The Collaborative; The Wisconsin Bike Fed; Together We Thrive, Inc.; Trailnet; Truck Safety Coalition; Dr. Charles Jennissen, Product Safety Advocate. 

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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 Petitions FTC For Sports Betting, Prediction Market Notification Controls  

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

Washington, DC – The National Consumers League, alongside the Campaign for Fairer Gambling, the National Council on Problem Gambling, the Public Health Advocacy Institute, and Truth in Advertising, Inc. (TINA.org), today filed a petition calling on the Federal Trade Commission to require wagering apps to provide consumers better control over the notifications they receive.  

Specifically, the organizations urged the FTC to require sports betting and prediction market companies to obtain permission before sending intrusive, pop-up advertisements as push notifications to consumers’ phones. Additionally, the organizations advocated for the FTC to allow consumers to opt out of receiving marketing notifications while still receiving other non-advertising notifications, like those related to account security.  

“We deserve meaningful control over what we see on our phones,” said NCL Senior Public Policy Manager Eden Iscil. “By making it harder to avoid ads sent by their apps, gambling companies are increasing the odds that users become addicted. And for online gambling, the associated harms for participants are well documented.” 

Federal law requires minimum consumer protections for marketing sent via email and text message, like the ability for recipients to opt out and for companies to obtain consent before sending advertisements. However, no such requirements explicitly exist for push notifications. NCL’s request would apply the same safeguards that exist for advertisements sent over email and text message to advertisements for sports betting and prediction markets delivered via app push notifications.  

2025 report by NCL found that, in the aggregate, 93% of notifications sent by the three largest sports betting apps contained advertising material. For apps that do not provide the controls NCL advocates for, users must disable all notifications entirely for the app via their phone’s settings. Doing so also blocks important messages a user would otherwise want to receive, like alerts related to account security. 

NCL, CFG, NCPG, PHAI, and TINA.org’s full petition to the FTC can be found here. 

The public can provide comment to the FTC on the petition here.

Additional 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.   

NCL, 14 Other Orgs Oppose X/Twitter Attempt to Escape Privacy Requirements

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

Washington, DC – Today, the National Consumers League and 14 other organizations submitted comments to the Federal Trade Commission (FTC) opposing a petition from X Corp. (formerly Twitter) to discard an order requiring the company to maintain privacy and cybersecurity safeguards. The order—unanimously approved in 2022 by two Republican and two Democratic commissioners—was necessitated after Twitter repeatedly violated a preexisting privacy order it had been under since 2011. The 2011 order was also ratified unanimously at the time by two Republicans and three Democrats.  

“Users on one of the largest social media platforms deserve to have their privacy protected,” said NCL Senior Public Policy Manager Eden Iscil. “The FTC’s privacy order is the best bet Americans have right now to see accountability if X violates the law again. Given X and its predecessor Twitter’s repeated disregard for keeping our data safe, the sensible thing for the FTC to do is to toss this petition in the trash with haste.” 

In the joint filing, the coalition details how X’s petition fails to meet the rigorous legal standard required to lift or modify an FTC consent decree, which demands a clear showing of unforeseen conditions generating a “grievous wrong.” Far from demonstrating a safe corporate transformation, the groups argue that X’s current practices present an escalating threat to user privacy. The comment highlights a recent leak of 2.8 billion records, international investigations into illicit content generated by its “Grok” AI model, and the platform’s ongoing harvesting of hundreds of millions of user posts without explicit consent to train its artificial intelligence systems—proving that strict, independent federal enforcement is more vital than ever. 

The comment was drafted by the Demand Progress Education Fund, the Electronic Frontier Foundation, the Electronic Privacy Information Center (EPIC), and NCL. 11 other organizations signed on: the Center for Digital Democracy, Check My Ads Institute, Constitutional Alliance, Consumer Action, the Consumer Federation of America, Consumers for Auto Reliability and Safety, Oregon Consumer Justice, the Oregon Consumer League, Public Citizen, Travelers United, and the Virginia Citizens Consumer Council. 

The full comments can be found here. 

Additional 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

One Year Later, Health Coverage Is Harder to Get—and Easier to Lose

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

Washington, DC – One year after the enactment of President Trump’s One Big Beautiful Bill Act, the National Consumers League (NCL) warns that millions of Americans will face new barriers to obtaining and maintaining Medicaid coverage.  

“Healthcare is not a privilege reserved for those who can successfully navigate an increasingly complicated bureaucracy—it is a necessity every person should be able to count on,” said NCL CEO Sally Greenberg.“No family should lose coverage because they struggled to navigate red tape or complete confusing forms required to document work hours. Yet these policies move us further away from a healthcare system that puts patients first.” 

Compounding these challenges, the Centers for Medicare & Medicaid Services issued an interim final rule this month that will place additional barriers on patients, including those with serious illnesses, from enrolling in and maintaining Medicaid coverage. 

“At a time when healthcare costs continue to rise, Greenberg concluded, the answer cannot be to make health insurance harder to get or easier to lose. Consumers deserve a healthcare system that works for them, not against them.” 

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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 Last: SCOTUS Erodes Independence of Consumer Protection Agencies

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

Washington, DC – Today, the U.S. Supreme Court ruled against Federal Trade Commission (FTC) Commissioner Rebecca Slaughter and other formerly independent agency heads across the government by allowing the president to fire them at will. This decision reverses nearly a century of Supreme Court precedent and granted President Trump significant and consolidated power.  

“Today’s Supreme Court decision struck down a key barrier to the implementation of this administration’s radically anti-consumer agenda,” said NCL CEO Sally Greenberg. “Never before has a president systematically removed pro-consumer regulators with complete disregard to the letter or spirit of the law. By building the legal framework to support this White House’s firings, the Court has granted President Trump unprecedented power over the administrative state. We’ve already seen this president’s willingness to misuse his authorities for personal and partisan gain. This ruling is a loss for anyone who believes the government works for the people, not just one person.” 

The Supreme Court’s decision supports the removal of some of the best consumer advocates in the nation. For example, FTC Commissioners Rebecca Slaughter and Alvaro Bedoya and Consumer Product Safety Commission (CPSC) Commissioners Alex Hoehn-Saric, Richard Trumka Jr., and Mary Boyle are excellent public servants who worked tirelessly to protect everyday Americans. The president dismissed them all without cause. President Trump himself had nominated Rebecca Slaughter to the agency in 2018. 

In nullifying nearly a century of protections for independent regulators from at-will firing, the Court has taken unprecedented power away from Congress and given it to President Trump. The decision may impact the implementation of laws concerning consumer protection, labor rights, transportation safety, nuclear energy, and more.  

Additional 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.   

The National Consumers League Calls on FDA to Determine No Clinical Need for Continued Mass Compounding of GLP-1 Weight Loss Drugs

NCL’s Comment Letter in Support of FDA’s Proposed Rule to Exclude 3 GLP-1 Drugs from the 503B Bulks List Calls This Action “A Defining Moment” in Regulating Compounded GLP-1s

Washington, DC– At a time when poison control centers report a nearly 1,500 percent increase in calls since 2019 about overdosing and serious adverse events related to injectable compounded GLP-1 weight loss drugs, the National Consumers League (NCL) is calling on the Food and Drug Administration (FDA) to act with a sense of urgency in finalizing a rule that will establish “no medical or clinical need” for continued mass compounding of these medicines.

In a comment letter submitted to the federal docket supporting a proposed regulation to exclude the GLP-1 drugs semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, NCL asserted that the rule, if implemented, would be a “a defining moment” in combatting the exploitative market selling untested, unapproved GLP-1 drugs, despite only covering the large 503B outsourcing facilities supplying compounded drugs to hospitals and clinics. This is because the rule will formalize FDA’s finding of no medical or clinical need for continued mass compounding of GLP-1 weight loss drugs, including so-called “personalized” compounded GLP-1 products with added ingredients such as vitamin B-12; drugs with different strengths and doses, such as microdosing; and GLP-1s with different routes of administration, such as sublingual or buccal, that have not been approved.

Additionally, it is NCL’s position that applying the determination of no clinical need to exclude the three GLP-1 drugs from the 503B Bulks List will change health professionals’ attitudes about recommending compounded GLP-s, drive more clinicians to follow medical treatment guidelines, and improve patient safety by reducing the availability of mass produced compounded GLP-1 drugs that were never intended to be marketed permanently.

“While FDA’s proposed rule is not a complete solution to stopping the deceptive marketing practices of telehealth platforms and other sellers promoting compounded weight loss drugs, a determination by FDA of no medical or clinical need for these products will be a gamechanger,” said Nancy Glick, NCL’s obesity policy lead. “The FDA should act swiftly to protect consumers from potentially serious health problems associated with compounded GLP-1 drugs.”

In support of this viewpoint, the NCL comment letter lays out these arguments, all of which underscore the importance of finalizing the proposed rule to help ensure the safe use of GLP-1 drugs:

  • Compounded drugs are not as safe as the FDA-approved versions because they may contain the wrong ingredient or no active ingredient at all, or they may contain too much or too little of the active ingredient. Additionally, “personalized” GLP-1s mixed with additives like vitamins, or sold as microdoses, have not been evaluated for safety or effectiveness in clinical trials.
  • GLP-1 weight loss drugs require medical oversight, which necessitates having a detailed label with information on eligibility criteria, indications and usages, dosage and administration, dosage forms and strengths, and warnings to ensure safe use. Compounded versions are exempt from this requirement, putting consumers’ health at risk.
  • The supply chain for compounded GLP-1 APIs is unreliable. Patient safety experts have warned that the source of the active pharmaceutical ingredients (API) used in compounded GLP-1s is often from China, where quality standards can vary widely and the API may go uninspected.
  • Because deceptive advertising hinders the ability of consumers to be aware of safety risks, consumers are unprotected from the deceptive marketing of unapproved GLP-1 weight loss drugs. As a result, thousands of Americans have experienced serious health problems related to dosing errors and reactions to harmful ingredients in compounded GLP-1 products.
  • Despite the argument from opponents that excluding the three GLP-1 drugs from the 503B Bulks List will eliminate an affordable alternative for patients, NCL counters that the alarming reports of dosing errors, overdoses, and serious reactions to harmful ingredients in compounded GLP-1 products is evidence that price should not be a factor when implementing rules affecting patient safety.

NCL’s comment letter is available 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