Blogs

May 22, 2025

Sally Greenberg, Chief Executive Officer, National Consumers League

Obesity Medication Misinformation Crisis Won’t End with FDA Deadline

America is in the grip of a second obesity crisis—while the first one centers around sky-high rates of chronic disease and access to care, the second one ties to truth.

As millions of Americans seek effective treatments for obesity, they are being targeted by a wave of misinformation and exploitation. Bad actors—med-spas, illegal online pharmacies, and others—are marketing non-FDA-approved GLP-1 drugs while making misleading or untrue claims about their safety and effectiveness.

The World Health Organization calls this flood of disinformation an infodemic: a deluge of information, some accurate, most deceptive, designed to mislead, confuse, and exploit. It spreads online at lightning speed and puts patient safety at risk.

As the nation’s oldest consumer organization—now in its 126th year—the National Consumers League (NCL) believes it is our duty to protect Americans from the rampant fraud infecting the weight loss drug market. That’s why we launched The Weight Truth, a national mobilization to combat the falsehoods circulating online about GLP-1s.

The Wild West of the GLP-1 Market

The FDA declared the GLP-1 medication shortage over in April 2025. When the shortage began in 2022, due to high demand and limited supply, the FDA permitted licensed compounding pharmacies to fill the gap by preparing so-called compounded versions of these drugs. This temporary fix, however, opened the door to a sprawling marketplace of both legitimate and illicit non-FDA approved versions of GLP-1s.

While compounding outside of a shortage situation is appropriate for individual patients with unique medical needs such as allergies to specific ingredients in commercial medications, children who need special dosing, or those with difficulty swallowing pills, compounded drugs are not required to meet the high level of safety, efficacy, and good manufacturing processes standards for drugs that have received FDA approval. Simply put, they are not made using the same guardrails as FDA-approved versions and have not been tested in large populations, so they pose more potential risks to patients. They therefore should never be produced on a mass marketing basis except in very limited situations where the FDA has declared a shortage of drugs in high demand.

Hundreds of millions of doses of both legitimate compounded products and illegitimate GLP-1s flooded the market, and many claimed – without any proof – the same or better benefits than FDA-approved versions.

Data shows that consumer health has taken a hit. As of February 2025, the FDA received over 775 adverse event reports for compounded GLP-1 drugs, including reports of 17 deaths and over 100 hospitalizations. Moreover, poison control centers report nearly a 1,500 percent increase in calls since 2019 related to overdosing or side effects of injectable GLP1 usage. Because most compounding pharmacies are not required to report adverse events from compounded drugs, the FDA indicates it is “likely that adverse events from compounded versions of GLP-1 drugs are underreported.”

May 22: A Turning Point for Consumer Safety?

We should be at a turning point — the FDA has stated that as of May 22, companies should no longer mass-produce compounded GLP-1s. If they do, they will be in violation of the Food, Drug, and Cosmetics Act and may be subject to penalties, recalls, and other sanctions.

This FDA-issued deadline should provide clarity for consumers who need GLP-1 medications, since as of that date, only products that are “FDA– approved” and are prescribed by a medical professional should be on the market.

However, NCL is concerned that, as a result of this “infodemic,” the marketing of compounded and other nonlegal weight loss products will continue and will confuse and hide facts from consumers and patients who are trying very hard to manage chronic diseases like obesity. We must ensure compounders abide by these important regulatory rules.

Our concerns are not unfounded. The recent NCL national survey of perceptions of compounded GLP-1 products sold online shows significant confusion about GLP-1 products amongst women. Key findings include:

85% believe the false claims made in online ads for compounded GLP-1s.
71% believe compounded GLP-1s must be tested and proven safe to be sold.
53% think compounded GLP-1s are FDA-approved.
49% believe they contain the same active ingredients as the real thing.

None of these beliefs are true.

A Blueprint for National Action

Both the FDA and consumers have roles to play in addressing this infodemic. We urge the FDA to enforce federal law and its long-standing safety-guided standards for compounded products now that GLP-1 products are no longer in shortage. We also call on consumers to take specific steps to learn the truth about GLP-1s and understand what’s FDA-approved, fake, and what’s at risk. Here’s what consumers can do:

Know that the compounded versions of GLP-1s that were substitutes for the FDA-approved medicines are not permitted on the market after May 22, and if you see them, it’s a red flag.
Educate yourself by going to The Weight Truth website.
Be aware that FDA-approved GLP-1s are not found in gummy, chewable, patch, nasal, or sublingual forms.
Ask the healthcare provider or company selling you the GLP-1 if it’s the brand product.
Report fake GLP-1s to us through The Weight Truth website.

Join us as we seek to spread the word about the weight truth and replace misinformation about GLP-1 medications with the truth.

January 17, 2025

Nancy Glick, Director of Food and Nutrition Policy, National Consumers League

Science Should Drive Obesity Care

Today, over 100 million Americans, or 40.3 percent of adults, are living with obesity. This makes obesity the nation’s most widespread chronic condition, impacting many more people than diabetes, heart disease, stroke, certain cancers, chronic lung disease, and chronic kidney disease.

Yet, the sad fact is obesity still gets short shrift from health professionals and policymakers, even though it worsens the outcomes of more than 230 chronic diseases, is responsible for an estimated 400,000 premature deaths annually, and costs society an estimated $1.72 trillion a year. As a consequence, only 10 percent of people with obesity get help from medical professionals, meaning the disease remains largely undiagnosed and undertreated. This is occurring even though leading medical societies, including the American Medical Association (AMA), agree that obesity is a serious disease requiring comprehensive care.

It doesn’t have to be this way, which is why the National Consumers League worked with the National Council on Aging and leading obesity experts to issue the first Obesity Bill of Rights for the nation, which establishes eight essential rights so people with obesity will be screened, diagnosed, counseled, and treated according to medical guidelines. The goal is to put an end to the prejudice, incorrect beliefs about obesity, misinformation about treatment options, and outdated government policies that keep Americans from getting the same standard of care as those with other chronic diseases.

It will take time for the Obesity Bill of Rights to be incorporated into clinical practice, but specific rights already have significance. This is the case with new “blockbuster” injectable medicines called GLP-1 (glucagon-like peptide-1 receptor) agonists that work by mimicking a hormone produced in the small intestine to reduce appetite and slow digestion. Considered a game-changer in chronic obesity treatment, GLP-1s can help people lose up to 20 percent of their weight in 26 months. Thus, The Right to Coverage for Treatment reinforces calls from obesity specialists and medical societies for an end to exclusionary coverage policies by insurers and government agencies, so GLP-1 medications are a treatment option for adults at higher risk for living with weight-related diseases.

The major challenge has been the Medicare program, which excludes coverage for weight loss drugs due to past safety concerns that no longer exist today. But this could change. On November 26, 2024, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule to allow seniors on Medicare and adults with Medicaid to have coverage for GLP-1s, thereby removing one of the biggest obstacles impeding access to quality obesity care in the country. If CMS’s proposal is finalized, the right to coverage for obesity treatment will become a reality for 7.4 million Americans – a good start in ensuring that people with obesity receive individualized quality care.

However, there is a lot of misinformation about GLP-1 medications, so The Right to Accurate, Clear, Trusted, and Accessible Information is also important, especially because disinformation is raising concerns among health professionals and the public. To date, the Food and Drug Administration (FDA) has approved four GLP-1 drugs based on evidence from large-scale clinical trials that these medicines are safe and achieve substantial weight loss. Yet, critics of these drugs assert these compounds cause severe side effects in all users, claim GLP-1 medications cause depression and suicidal thoughts, and allege the European Union (EU) is investigating this matter.

Responding to these allegations, experts in obesity treatment have assembled the facts from scientific journal articles and government reports. In furtherance of the right of the public to have this information, here is a summary of these findings:

Regarding the potential side effects of GLP-1s, several studies dispute the assertion that GLP-1 drugs cause severe adverse effects in all people. The consensus is that because these drugs slow stomach emptying, they can cause gastrointestinal problems that are usually mild to moderate and often go away within one to two months.
As to GLP-1s causing suicidal ideation, a recent commentary in JAMA Open Network concludes that large-scale studies do not show any increased risk of suicidal ideation while a 2024 study by researchers at Case Western Reserve University School of Medicine found that people taking a GLP-1 drug had a lower risk of suicidal thoughts compared to those taking a non-GLP-1 compound. Similarly, the FDA published a detailed report in January 2024 also finding no association. FDA reached this conclusion after analyzing information on adverse events from the FDA Adverse Event Reporting System (FAERS), reviewing a meta-analysis of GLP-1 clinical trials data, and analyzing post-marketing data in the FDA’s Sentinel System.
Concerning the investigation by the EU’s European Medicines Agency, EMA’s Pharmacovigilance Risk Assessment Committee conducted a review of health records and issued a finding that no causal association exists between GLP-1s and suicidal thoughts or self-injurious actions.

The Rand Corporation coined the term “truth decay” to call attention to the blurring of the line between opinion and fact. It is important that “truth decay” not become a new obstacle to Americans receiving quality obesity care.

December 6, 2024

Nancy Glick, Director of Food and Nutrition Policy, National Consumers League

A New CMS Rule Could Be a Gamechanger for Adults with Obesity

If the story of combatting the nation’s obesity epidemic were a movie, it would be Groundhog Day.

Year in and year out, for over a decade, advocates and obesity specialists worked to get changes in federal policy. They pressed to get bills passed in Congress, drafted white papers, published research findings in medical journals, held roundtables and briefings, and sent letters and emails to policymakers over and over. But, using the Groundhog Day metaphor, the same day would start again.

Until now. Just as the protagonist in Groundhog Day changed his way of thinking and got the girl, the Centers for Medicare & Medicaid Services (CMS) changed its thinking to recognize obesity as a distinct and serious chronic disease requiring treatment. Based on this reinterpretation, CMS published a potentially game-changing proposed rule to establish the treatment of obesity as a medically necessary service under Medicare and Medicaid and allow Part D coverage of FDA-approved anti-obesity medications (AOMs), including new injectable drugs called GLP-1s (glucagon-like peptide-1 receptor agonists), as a result.

However, better obesity care is not a movie, and the proposed rule, while a major development, is not a final action. Before Medicare and Medicaid beneficiaries can get treated with new anti-obesity medicines, the agency must go through a formal rulemaking process to finalize the proposed rule, including receiving and analyzing comments from individuals and organizations concerned about obesity. This process is now underway, and the obesity community is coming out in force to urge CMS to update its Medicare and Medicaid coverage policy for AOMs based on medical evidence that obesity medications treat the disease of obesity and are not merely agents for “weight loss.”

As the organization that partnered with the National Council on Aging (NCOA) and leading obesity specialists across the country to develop and issue the first Obesity Bill of Rights for the nation, NCL submitted comments as the voice of the nation’s consumers and urged CMS to finalize the proposed rules for these reasons:

There Is a Widespread Scientific Consensus That Obesity Is a Distinct Chronic Disease – CMS’s reinterpretation of Medicare Part D policy is grounded in extensive medical evidence that obesity is not a cosmetic condition but a distinct and serious chronic disease requiring treatment. Reinforcing this recognition of obesity as a distinct disease state, major medical organizations now consider obesity a chronic disease due to its complex biological mechanisms and potential for significant health complications. This includes the American Medical Association, American Association of Clinical Endocrinologists, American College of Endocrinology, and all the leading obesity and nutrition organizations.

Obesity Is the Nation’s Most Prevalent Chronic Disease and Is Directly Linked to Numerous Chronic Diseases –Today, obesity affects 41.9 percent of US adults – more than 100 million people – which makes obesity the most prevalent chronic disease affecting Americans, significantly eclipsing the other most prevalent chronic diseases: heart disease, diabetes, chronic kidney disease, cancer, chronic lung disease, Alzheimer’s Disease, and stroke. Even more significantly, more than 230 medical conditions are directly linked to overweight and obesity, meaning these diseases worsen as the degree of obesity increases. Thus, obesity today is responsible for an estimated 400,000 deaths a year.

The Cost of Obesity Is Too High and Everyone Is Paying the Price – Obesity, due to its role in causing or worsening chronic disease, accounted for 47.1 percent of the total direct and indirect costs of treating chronic conditions in 2016. Accordingly, some estimates put the national cost of obesity at $1.7 trillion a year –more than what Social Security paid in retirement benefits in 2022.

Compared to Other Serious Chronic Diseases, Obesity Goes Largely Undiagnosed and Untreated – The Obesity Bill of Rights was issued to transform obesity care in the US at a time when obesity remains largely undertreated with costly repercussions in high rates of obesity-related diseases and preventable deaths. Reflecting this reality, only 30 million of the more than 100 million Americans living with obesity in 2022 received a diagnosis of obesity, and only around 2 percent of those eligible for anti-obesity medications were prescribed these drugs. Although multiple factors are responsible for this pervasive gap in obesity care, the most pernicious are access barriers that keep people with obesity from getting the care they need, whether through the exclusion of obesity treatments in many insurance plans, restrictive insurance practices that delay or deny treatment, or out-of-date government policies.

New Anti-obesity Medications Are Safe and Effective and Result in Savings From Improved Health Outcomes – As noted in the CMS proposed rule, there have been major advances in understanding and treatment of the disease of obesity since the Medicare Part D program went into effect in 2006, resulting in new therapeutic agents, such as GLP-1 drugs that can help people lose up to 20 percent of their weight in 26 months. Calculating the potential savings resulting from better health outcomes when obesity is treated, studies are beginning to project the potential savings to the economy from covering obesity medications. One recent study published December 5, 2024, in JAMA Network Open estimated that a 10 percent weight loss resulting from obesity treatment saved $2,430 in reduced medical expenditures, and for a 25 percent weight loss, the reduction in health expenditures is $5,444 per person.

The comment period for the CMS proposed rule closes soon, and then it will be up to the new Trump Administration to finalize this important rulemaking. It is our hope that the new team at CMS will make this a priority. Simply put, this important change in CMS policy will make a significant difference in the lives of millions of Americans.