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Consumer and Public Health Groups Support FDA Proposal to Ensure Accuracy of Lab-Developed Medical Tests

Press Releases, We're In the News

September 29, 2023

A coalition of consumer advocacy groups is welcoming a proposed rule released today by the Food and Drug Administration to regulate laboratory-developed tests (LDTs), a category of diagnostic tests developed and used in a single lab. LDTs are a subset of In Vitro Diagnostics (IVDs) which are FDA regulated, despite the fact that they have been regulated differently for decades. The proposal clarifies that LDTs are medical devices, meaning FDA will ensure they are safe and effective before they are sold to consumers. The tests have long been under “enforcement discretion,” meaning FDA has not enforced premarket approval and other requirements, but stakeholders and regulators alike have been calling for increased scrutiny of these tests for years.

The proposed regulation will take effect 60 days after a final rule is published and contemplates a phase-in over the subsequent four years. As these tests have become more complex and more important to patient care, ensuring their accuracy has become more crucial, according to the coalition, which includes the Center for Science in the Public Interest, the National Center for Health Research, Strathmore Health Strategy, and U.S. PIRG.

False-positive test results could lead patients to believe they have a serious medical condition that they do not have, and false-negative results may cause a patient’s life-threatening condition to be missed. Some tests have falsely diagnosed people with cancer or inaccurately provided results that lead directly to chemotherapy selection. Many of the tests have been found to be inaccurate, including some COVID-19 diagnostic tests, genetic non-invasive prenatal screening tests, and blood tests manufactured by the biotech company Theranos.

The group applauds many provisions of the proposed rule. These include:

  • Including Academic Medical Centers in the regulatory scheme. There is no reason that people treated or tested at one facility should be more at risk for inaccurate results than those tested at another facility. All tests should be evaluated based on the benefits and risks of the tests, not the building in which the test is run. The proposed rule notes that “[r]eview of the underlying science behind an [in vitro diagnostic] is based on what the IVD does and is in no way related to where the IVD is made.” The FDA requests additional information on this topic, but the coalition hopes the agency sticks to its guns.
  • Including tests for rare diseases in the regulatory scheme. Patients with rare diseases should be equally protected from inaccurate tests.
  • Registration and listing requirements for all tests, which exist for all other medical devices. This will allow FDA and the public to know which tests are available. Further, manufacturers are required to publish performance data on IVDs, which will provide much-needed transparency about the clinical and analytical validity of these tests, according to the coalition.

“This rule is a critical step forward for clinical medicine,” said Dr. Peter G. Lurie, President of Center for Science in the Public Interest and a former Associate Commissioner at the Food and Drug Administration where he worked on LDTs, including on a report demonstrating their potential dangers. “It will help ensure that when a patient receives a test, they can rely on the results to make essential decisions for their health. This rule will close a gaping hole in FDA’s current regulatory reach.”

In the absence of FDA oversight, LDTs have been regulated only by the Centers for Medicare and Medicaid Services, which does not require documentation that the test results accurately inform the diagnosis of patients, a concept known as “clinical validity.” CMS only requires laboratories to document the “analytical validity” of their tests, or their ability to reliably detect a biomarker.

Oversight under FDA would be much more comprehensive and would ensure that healthcare providers and patients can rely on results to make medical decisions, particularly the riskiest medical decisions, where inaccurate test results can cause harm to patients. A modern regulatory framework for LDTs will improve patient access to accurate tests and promote innovation in the diagnostic testing industry.

“We strongly support the decision by the FDA to do what is necessary to rectify a situation that has been so harmful to patients,” said Dr. Diana Zuckerman, President of the National Center for Health Research.  “We understand the need for a transitional period but urge the FDA to address problems with existing high-risk LDTs as quickly as possible. We welcome the opportunity to work with FDA and other interested parties to ensure that FDA has the resources it needs to robustly regulate LDTs so that patients can make informed decisions based on test results.”

This comprehensive approach will require resources, including both user fees and Congressional appropriations. The coalition will continue working with all stakeholders, including Congress and the Agency, to ensure that the agency is adequately resourced to fulfill this critical function.

For more information, contact Dr. Zuckerman at dz@center4research.org

Do Heartburn Medications Cause Kidney Disease? Dementia?

Other Cancers, Other Cancers

Diana Zuckerman, PhD and Farzana Akkas, MSc,

In 2016, research was published indicating that people who take popular heartburn medications are more likely to develop serious kidney disease.[1] In 2023, research was published showing that people prescribed these popular medications are more likely to develop dementia. If you take any of these drugs, how worried should you be? And are there safer medications that work just as well?

Prilosec, Nexium Prevacid, Kapidex, Aciphex and Protonix are all a type of drugs called Proton Pump Inhibitors (PPI). There are several other drugs of this type as well.  They are all used to treat heartburn and acid reflux. In a 2016 study lead by Dr. Morgan Grams of Johns Hopkins University, people who use PPI are more likely to develop chronic kidney disease compared to those who take other types of heartburn medication.  The higher the dose or the more often they take these drugs, the more likely they are to develop kidney disease.[1] In the first of several expected settlements, in October 2023 AstraZeneca agreed to pay $425 million to settle about 11,000 lawsuits in the United States that claimed that Nexium and Prilosec caused chronic kidney disease. AstraZeneca did not admit wrongdoing under the settlement, part of broader litigation against makers of PPI that involve several major pharmaceutical companies.

Even more important, the researchers found that most of the 15 million Americans who were prescribed a PPI don’t really need them.  One in four of long-term users can stop taking them without suffering from more heartburn or acid reflux.[1]

Since the research on dementia is more recent, let’s focus on that first. The 2023 study of more than 5,000 people ages 45 and older who did not have dementia at the start of the study concluded that those who take PPI for 4.5 years or longer are more likely to develop dementia.[2] The study compared more than 4,000 people who did not take the drugs to 1,490 adults who took PPI for up to 2.8 years, between 2.8 to 4.4 years, or for more than 4.4 years. During the 30 years of the study, 585 people (10%) developed dementia. Of the people who did not take the drugs, 425 people developed dementia, which equals 1.9% per year. Of the 497 people who took the drugs for more than 4.4 years, 58 people developed dementia, which equals 2.4% per year. THESE numbers seem small but they add up over time (for example, 38 compared to 48 over 20 years). Researchers did not find a SIGNIFICANT increase in dementia for people who took the drugs for fewer than 4.4 years. This study does not prove that PPI causes dementia but it shows an association which could be caused by the drugs or could be caused by an unknown behavior or medical condition that causes both heartburn and dementia. More research is needed to determine whether long-term PPI use actually causes dementia.

The evidence regarding PPIs and kidney disease is more conclusive. Even before the 2016 study, research had shown that people who take these drugs are more likely to have painful kidney problems such as acute kidney injury and acute interstitial nephritis.[3, 4, 5, 6, 7] The 2016 study is important because the patients taking a PPI developed chronic kidney disease, which is more serious.  It means that their kidneys can no longer filter blood effectively, which can cause kidney failure. Those patients will need dialysis.

Do PPI cause these health problems or does overeating cause these problems? To address this question, the researchers compared results of PPI users to people taking a different type of heartburn medication called H2 blocker users (such as Pepcid, Tagamet and Zantac). After statistically controlling for heath factors such as obesity and hypertension, they found that people who used a PPI were still more likely to develop chronic kidney disease when compared to people using H2 blockers.  And, those who took the PPI medication twice a day were more likely to develop chronic kidney disease than those who took it once a day.

Another study, based on more than 190,000 veterans taking heartburn medication came to a similar conclusion. Regardless of their age and health, the PPI users in that study also were more likely to develop chronic kidney disease than the veterans taking H2 blockers.[8]

H2 blockers like Pepcid, Tagamet or Zantac are less expensive and seem to be safer than the PPI medications.  Many of them are available without a prescription.  And of course, a major cause of heartburn and acid reflux is our health habits. Maintaining a healthy weight and quitting smoking helps reduce the chances of heartburn or acid reflux.  If that doesn’t work, some people find it helpful to avoid spicy or greasy food, chocolate, mint, and coffee until the symptoms go away.[9]

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

  1. Lazarus, B., Chen, Y., Wilson, F. P., Sang, Y., Chang, A. R., Coresh, J., & Grams, M. E. (2016). Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Internal Medicine JAMA Intern Med, 238.
  2. Northuis, C., Bell, E., Lutsey, Pm. George, K., Gottesman, R., Mosley, Tom., Whitsel, E., & Lakshminarayan K. (2023). Cumulative Use of Proton Pump Inhibitors and Risk of Dementia: The Atherosclerosis Risk in Communities Study. American Academy of Neurology.
  3. Blank ML, Parkin L, Paul C, Herbison P. (2014). A nationwide nested case-control study indicates an increased risk of acute interstitial nephritis with proton pump inhibitor use. Kidney Int., 86(4):837-844.
  4. Sierra F, Suarez M, Rey M, Vela MF. (2007) Systematic review: proton pump inhibitor–associated acute interstitial nephritis. Aliment Pharmacol Ther.,26(4):545-553.
  5. Antoniou T, Macdonald EM, Hollands S, et al. (2015) Proton pump inhibitors and the risk of acute kidney injury in older patients: a population-based cohort study. CMAJ Open, 3(2):E166-E171.
  6. Klepser DG, Collier DS, Cochran GL. (2013) Proton pump inhibitors and acute kidney injury: a nested case-control study.BMC Nephrol, 14:150.
  7. Leonard CE, Freeman CP, Newcomb CW, et al. (2012) Proton pump inhibitors and traditional nonsteroidal anti-inflammatory drugs and the risk of acute interstitial nephritis and acute kidney injury. Pharmacoepidemiol Drug Saf, 21(11):1155-1172.
  8. Xie, Y., Bowe, B., Li, T., Xian, H., Balasubramanian, S., Al-Aly, Z. (2016). Proton Pump Inhibitors and Risk of Incident CKD and Progression to ESRD. Journal of The American Society of Nephrology, 27.
  9. Kang, J. H., & Kang, J. Y. (2015). Lifestyle measures in the management of gastro-oesophageal reflux disease: Clinical and pathophysiological considerations. Therapeutic Advances in Chronic Disease, 6(2), 51-64.

Are PIP rubber playgrounds safe for Kingston?

We're In the News

Dr. Diana Zuckerman, PH.D, Kingston Wire, October 23, 2023

When I first saw rubber playground surfaces under swings, slides, and children’s climbing equipment, I was impressed.  They seemed very attractive and safe for active young children. I was wrong. As a scientist I learned that children all over the country are being exposed to unsafe chemicals without their parents’ knowledge or consent.  That’s why I recently wrote to Kingston’s mayor, superintendent of schools, members of the Board of Education, and numerous principals to share scientific information about the lead and dangerous chemicals in artificial turf and playground surfaces, hoping it will help them make the right decisions about what is best for Kingston’s children.  I want to share that information with you.

As president of the National Center for Health Research, I have testified about these products to local, state and federal agencies and legislators and met with parents and community leaders from coast to coast. Our nonprofit think tank includes scientists, physicians and health experts who conduct studies and scrutinize research conducted by others. We explain scientific and medical information that can be used to improve policies, programs, services and products.

What’s in those rubber playground surfaces?

In recent years, scientists have learned about the lead, cadmium, PFAS, and other chemicals that are in the rubber playground surfaces called PIP (Poured in Place) and recycled tire mulch (also called recycled rubber, since that sounds even more environmentally friendly).  We now know that the rubber pieces made from recycled tires contain lead and heavy metals, as well as chemicals that increase the chances of developing obesity; early puberty; attention problems such as ADHD; exacerbate asthma; and eventually cause cancer. Although I’m focusing on playground surfaces, recycled rubber is also used as “infill” for many artificial turf fields and also the rubber mulch sold for your lawn at Home Depot and many other stores.  (The plastic grass that makes up artificial turf also has dangerous levels of lead, PFAS, and other toxic chemicals.)

Pediatricians tell us that no level of lead exposure is safe. The solid rubber surface used on playgrounds looks safe, but whether or not the top is made from recycled tires, underneath is recycled tire crumb that causes lead dust on top of the surface. Children breathe that lead dust as they play.  And, after a few months or years, the solid rubber surface wears off or cracks, revealing small pieces of recycled tires that young children (like those at George Washington Elementary School’s Children’s House) may be tempted to put in their mouths, exposing them to even more lead. Blood lead levels for Kingston residents are already higher than in most communities. That makes it especially essential to avoid additional exposures.

The PFAS in tire mulch are also dangerous because they enter the body and the environment as “forever chemicals.” PFAS are not metabolized and won’t deteriorate, accumulating over the years. PFAS can cause liver damage and other serious health problems. That’s why Governor Kathy Hochul signed a law this year banning PFAS from clothing and carpeting (they are used to make them stain resistant), including the plastic grass carpet used in artificial turf fields, such as the one at Dietz Stadium. Unfortunately, PFAS is not banned from rubber playgrounds, such as PIP.

There are also environmental risks from these materials. They retain heat, so that on a warm sunny day when the temperature above the grass is 85 degrees, it is often over 150 degrees for anyone on PIP and artificial turf fields. And, during heavy rains, the tire mulch washes off, contaminating nearby areas and your water supply.

Evidence of Harm vs. Evidence of Safety

Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals (found in tire mulch and artificial turf) can be dangerous at very low levels, and also when they combine with other exposures in our environment.  That is why the U.S. Consumer Product Safety Commission has banned these chemicals from toys, pacifiers, teething toys and other products used by young children.

Companies that sell and install artificial turf and rubber playground surfaces often claim that there is “no evidence children are harmed” or that their products cause cancer.  This is often misunderstood as meaning the products are safe or are proven to not cause harm.  Neither is true.

It is true that there is no clear evidence that an artificial turf field has caused specific children to develop cancer. However, that statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer.

As an epidemiologist, I can tell you that for many years there was no evidence that smoking or 9/11 exposures caused cancer. It took many years to develop that evidence, and the same will be true for products made from recycled tires.

We know that these materials contain carcinogens. When children are exposed to those carcinogens day after day, week after week, and year after year, it increases the chances of our children developing cancer, either in the next few years or later as adults. That should be adequate reason not to install them in your community.

What Should Kingston Do? 

There have never been any safety tests required prior to sale that prove that any of these products are safe for children who play on them regularly. In many cases, the materials used are not publicly disclosed, making independent research difficult to conduct. None of these products are proven to be as safe as engineered wood fiber or natural grass in well-constructed fields.

Officials in communities all over the country have been misled by salespeople and scientists hired to lobby them to purchase these fields and playgrounds. They were erroneously told that these products are safe. In fact, there is clear scientific evidence that these materials are harmful. How much exposure is likely to be harmful to which children? Do you want to take that risk with your children? Don’t our children deserve better?

I am not paid to write this or speak up on this issue. I do so because I care about the health of my family and yours.

This oped is posted on the Kingston Wire website at https://kingstonwire.com/opinions/2023/10/23/opinion-are-pip-rubber-playgrounds-safe-for-kingston/361KUj and you can read a pdf version of the article here.

We Comment to FDA on the Draft Guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act

Legislation

September 12, 2023

Docket No. FDA-2023-D-0559

We appreciate the opportunity to comment on the Food and Drug Administration (FDA) proposed guidance: Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Noncompliance with required post-market studies (PMRs) is a serious problem that undermines FDA’s authority and the public trust in FDA decision-making. We support FDA’s efforts to ensure clarity and transparency regarding situations when noncompliance with postmarket requirements is acceptable.  These situations should be rare; the more exceptions that are made, the more noncompliance becomes harmful to patients and unfair to companies that comply.

The PMRs that are the focus of this draft guidance are typically required following adverse events that have been reported to the FDA resulting in a serious enough event to warrant further examination into the safety and effectiveness of the drug. Any delay in this process places patients at undue risk and it is FDA’s responsibility to ensure that applicants avoid delays.

We understand this guidance document is specifically referencing non-compliance of PMRs which are not required as a condition of accelerated approval. However, we strongly recommend issuing similar guidance for applicants using this pathway.

We agree that applicants should continue to report regular updates to the FDA throughout the completion of the PMRs. The timelines and milestones established are agreed to by both the applicant and the FDA and should be adhered to. We appreciate the detail provided by FDA in the draft guidance stressing the importance of maintaining regular updates and providing multiple opportunities for applicants to inform the agency of missed milestones. These details, along with specific examples of what would or would not be considered good cause for non-compliance, should minimize overall non-compliance with the regulations. Documentation of delays is not sufficient to justify noncompliance, especially if the delays were foreseeable and avoidable and could suggest inadequate efforts to complete the study as was agreed to.

We support the process described in the guidance for applicants to correct circumstances that led to non-compliance with the agreed upon PMRs; however, we urge that the description of the actions taken by the applicant to address these issues be more explicit and less subjective. The guidance document states that the “FDA considers an applicant to have undertaken appropriate action if the applicant promptly develops and implements a reasonable plan to correct the underlying circumstance(s) leading to the PMR noncompliance” (emphasis added). The guidance document describes the term “promptly” as something the FDA will determine on a case-by-case basis. This is too vague; the FDA should clearly define the agency’s standards by providing examples of what could be considered inappropriate delays that will warrant escalation of actions taken by the agency. We also strongly urge that the FDA take into consideration if a company has a track record of delays in satisfying PMRs, regardless of whether the company’s justifications for those delays seem reasonable. The FDA should scrutinize the reasons given to determine if a company’s track record of delays show a pattern of making commitments to the FDA that the company has shown it is unlikely to meet. This would indicate that what might individually seem like justifiable delays may instead be based on a pattern of foreseeable and preventable delays.

As noted above PMRs which are required as a condition of accelerated approval warrant similar guidance. There have been unacceptable delays in postmarket trials for drugs granted accelerated approval status. More than 280 drug applications have been awarded accelerated approval since the program began; at least 100 of those applications still have incomplete confirmatory trials.1 Approximately 35 percent have at least one trial past its original planned completion date.1 A recently published journal article pointed out that Exondys 51, for Duchenne Muscular Dystrophy, was granted accelerated approval in 2016 with the PMR results required in 2020. Instead, that post-market study was not started until 2020 and FDA granted an extension until 2024, while also granting accelerated approval to 3 other drugs made by the same company, none of which have yet submitted their post-market studies.2 As a result of these delays, patients, insurance companies, and the Medicaid program have paid billions of dollars for treatments that have never been proven to work. This is unfair to patients and their families and threatens the financial integrity of Medicaid programs in States that have been subject to these expenses. We strongly urge that the FDA issue guidance about compliance with PMR for drugs granted accelerated approval before the end of 2023.

1.U.S. Department of Health and Human Services: Office of Inspector General. (2022). Delays in Confirmatory Trials for Drug Applications Granted FDA’s Accelerated Approval Raise Concerns. https://oig.hhs.gov/oei/reports/OEI-01-21-00401.asp#:~:text=WHAT%20WE%20FOUND,104%20have%20incomplete%20confirmatory%20trials.

2. Liam Bendicksen, Diana M. Zuckerman, Jerry Avorn, et al. (2023). The Regulatory Repercussions of Approving Muscular Dystrophy Medications on the Basis of Limited Evidence. Ann Intern Med. doi:10.7326/M23-1073

Our Comments on Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination FDA Draft Guidance

Environmental Exposures, Policy

September 11, 2023

We appreciate the opportunity to comment and support FDA’s proposed rule regarding: “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance.”

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Due to the growing rate of Americans getting tattoos and increased reports of infections related to contaminated tattoo ink, we agree this is an important public health issue that needs to be addressed. Microbial contamination of tattoo inks can occur in nearly 50% of inks on the market in the United States, which can include organisms that are known to cause serious infection and are highly resistant to antibiotics.1  We support the FDA’s objectives of ensuring that ink products are unadulterated and holding manufacturers accountable for contaminated products.

While the act of tattooing is primarily regulated by state, local, and tribal public health authorities, the FDA has the authority to regulate tattoo ink. In addition to microbial contamination, pigments have been found to contain potentially toxic chemicals, heavy metals, degradants, printer toner, car paint, and other substances that were not intended to be used on the human body.2  We agree that the FDA needs to provide guidance that will better support state, local, and tribal public health agencies to help address the growing public health burden of unsafe tattoo ink. This is especially relevant as many local tattooing regulations have recently been found to be outdated as well as inconsistent.

Accordingly, we recommend that the FDA provides explicit guidance regarding the labeling of tattoo inks. While tattoo ink manufacturers are required to include ingredient and safety risks as part of the labeling requirements under the Fair Packaging and Labeling Act, these labels are rarely seen by consumers since the ink is often purchased in bulk by tattoo studios.3 We strongly urges the FDA to require that user-friendly labels for tattoo ink be made available online to consumers prior to getting tattoos; preferably, in a consumer checklist that they must sign, so that they have the information they need to make informed decisions on the risks of tattooing.

We also recommend that the FDA include clear, understandable guidance regarding the water and dilution techniques that should be used to achieve color variation in tattoo studios. This is of particular importance as non-sterile dilution techniques were a primary cause of the nontuberculous mycobacterial skin infection outbreak that was referenced in FDA’s draft guidance. A common practice for tattoo studios is to use distilled or reverse osmosis water for dilution. However, these are non-sterile techniques, and the FDA should prohibit such techniques and instead require and explain the importance of sterile dilution techniques.

We are also concerned about the voluntary reporting system of contaminated ink products, which primarily relies on consumers. This places the burden of contamination identification and reporting on the consumer rather than the manufacturer, and also undermines the responsibility of the manufacturer to ensure that their products are unadulterated. In addition, since consumers are rarely aware of existing reporting mechanisms, the FDA should require that tattoo studios educate consumers on how to report adverse events caused by contaminated ink. We also agree with the FDA’s recommendation that tattoo ink and ink components be tested for microbial contamination and that tattoo establishments be required to discard contaminated products. Although we are concerned that the lack of proposed manufacture accountability and enforcement mechanisms, traceability, and regulatory incentives will lead to noncompliance, having such requirements will increase the risk of lawsuits for noncompliance, and that will serve as an incentive to comply with FDA requirements.

It is estimated that nearly one-third of Americans have a tattoo with reports of microbial contamination at a staggering 49%1,4 Thus, there is a great need to better regulate tattoo ink and raise awareness among the public about the risks of unsafe tattoo ink. We support the objective of the FDA in helping manufacturers to identify and discard adulterated ink to better protect public health. However, we recommend that ink labels be made readily available to consumers and sterile dilution techniques are included in the final guidance. We also strongly recommend that the FDA develop an information toolkit to increase consumer awareness regarding contamination reporting systems in tattoo studios, while working to build robust mechanisms for manufacturer reporting, traceability, and accountability.

As noted above, in addition to microbial contamination, pigments have been found to contain potentially toxic chemicals, heavy metals, degradants, printer toner, car paint, and other substances that were not intended to be used on the human body. The rate of ink contamination with unsafe substances that include but are not limited to microbial contamination has been reported as high as 67%.5 Therefore, we strongly urge the FDA to expand the regulation of all types of dangerous substances in this draft guidance or develop a similar draft guidance specifically to reduce the risks caused by these other dangerous substances.

References:

  1. Nho, SW et al. “Microbiological Survey of Commercial Tattoo and Permanent Makeup Inks Available in the United States.” Journal of Applied Microbiology, 124: 1294-1302 (2018).
  2. “NEHA Response to Request from FDA for Good Manufacturing Practices on Tattooing Inks and Pigments.” 2023.
  3. Association of Food and Drug Officials, Body Art Committee. “Tattoo Ink and Permanent Makeup Labeling Guide.” 2019.
  4. Pew Research Center. “32% of Americans have a tattoo, including 22% who have more than one.” 2023.
  5. Bonadonna, Lucia. “Survey of Studies on Contamination of Marketed Tattoo Inks.” Karger. 2015.

Our Comments on the FDA Proposed Guidance Regarding the Registration and Listing of Cosmetic Product Facilities and Products

Policy

September 7, 2023

We appreciate the opportunity to comment on the Food and Drug Administration proposed guidance: Registration and Listing of Cosmetic Product Facilities and Products; Draft Guidance for Industry.

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We strongly support the purpose and requirements included in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which was part of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) related to the regulation of cosmetic products. These regulations are long overdue and an essential first step toward protecting public health through the disclosure of the ingredients in these ubiquitous products and the registration of the facilities that make these products. Research has documented scientific concerns about the presence of endocrine disrupting chemicals in cosmetics and their effect on consumers’ health.[1],[2],[3] Some hormone disruptors such as phthalates and parabens are found in a wide range of cosmetic products. Other hormone disrupting substances are used in specific cosmetics, such as triclosan in toothpaste and mouthwash; this chemical ingredient was previously banned from soap products by the FDA in 2016. It is essential that the public be made aware of the potential for cumulative exposure to substances in many different makeups, creams, and other cosmetic products used every day.

We are very supportive of the requirements included in MoCRA, but have four recommendations to improve the proposed guidance:

  • We are concerned that the FDA does not plan to transfer the voluntary cosmetics registration program to this new system. We agree that previous submissions to the voluntary cosmetics registration program fail to satisfy the registration and listing requirements, since that information differs from the information required to be submitted under MoCRA. However, there is likely to be substantial overlap of information. We recommend that these entities should be required to register their facilities and submit product listings even if they voluntarily provided similar information previously. If information is not transferred, where will previously submitted voluntary information be stored? Will it be available to the public?
  • Regarding the requirements set for a product listing, we strongly urge that all fragrance ingredients be required to be listed. Fragrance ingredients in self-care products such as shower gels, shampoos, body lotions, and shaving creams are often labeled “unscented.” This is because manufacturers are not obligated to label the fragrance in the ingredient list if the amount added is just enough to cover the scent of other ingredients versus giving the product a noticeable scent.[4] This is not an appropriate justification. All fragrance ingredients added to the product, no matter how minimal, should be included in the product listing. It is not enough to simply list the product as containing “fragrance” or “flavor” as is required under section 701.3 of title 21, Code of Federal Regulations. A more detailed ingredient list is essential and would not jeopardize trade secrets since according to the guidance document, brand names will not be disclosed publicly.
  • Regarding the requirements set for a facility registration, we support the requirements listed in the guidance but also recommend the disclosure of the amount of the product manufactured or processed in each facility in the year prior to the initial registration. Production levels should also be included in each renewal of registration biennially.
  • According to the guidance, the “FDA requests that individuals submitting registration and listing information to attest to the accuracy and veracity of the information submitted.” The guidance does not specify how violations or inaccuracies in the registrations and product listings will be enforced.  It is essential the manufacturers comply with the requirements in order to ensure transparency, and enforcement is necessary to achieve that goal.

1. Ejaredar, M., Nyanza, E., Eycke, K., Dewey, D. (2015). Phthalate Exposure and Childrens Neurodevelopment: A Systematic Review. Environ Res 142:51-60.

2. Diamanti-Kandarakis, E., Bourquioqnon, J., Giudice, L., et al. (2009). Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement. Endocr Rev 30(4):293-342.

3. Harley, K., Kogut, K., Madrigal, D., Cardenas, M., et al. (2016) Reducing Phthalate, Paraben, and Phenol Exposure from Personal Care Products in Adolescent Girls: Findings from the HERMOSA Intervention Study. Environ Health Perspect In Press.

4. Sun, A. (2023) Everything you need to know to choose safe cosmetic products. National Center for Health Research. https://www.center4research.org/cosmetics-safety-regulations-law-tips/

Everything You Need To Know to Choose Safe Cosmetic Products

Environmental Exposures

Andrea Sun, MS, Cancer Prevention and Treatment Fund

Do you know how to pick out the right makeup or skincare products for yourself? Cosmetic products are used by everyone of all ages. They include shampoo, shaving products, and moisturizing creams, as well as make-up, nail polish, and anti-aging products. Promotional videos for cosmetic products are popular among influencers on social media platforms like YouTube and Instagram. Some studies show that the revenue in the U.S. Beauty & Personal Care market will exceed an astonishing $92 billion by the end of 2023.[1]

U.S. consumers use an average of 6 to 12 cosmetic products daily, containing nearly 200 chemicals. With so many choices, and so many potentially risky chemicals, it’s essential to know what to look for when buying these products. Current regulations address some safety concerns for cosmetic products, but many gaps remain.

What are some of the regulations that protect us?

The U.S. has some regulations regarding the manufacturing and selling of cosmetics. Let’s look at what makes cosmetics different from drugs and what might be helpful information when you shop or read the label on a product.

The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as articles intended to make the human body more attractive. Lipsticks, nail polishes, perfumes, skin moisturizers, toothpaste, deodorants, and shampoos are especially popular cosmetics. However, there are some topical products that are sold without prescriptions in drug stores that are not considered cosmetics – they are considered drugs. Drugs are defined as products that can cure, mitigate, treat, or prevent diseases or affect the body’s function. For example, products such as hair loss treatment shampoo and acne medications are considered over-the-counter drugs instead of cosmetics. They are regulated by the FDA to make sure that they are safe and effective.

If a product makes you look better and treats your disease or improves your body’s function, it is both a cosmetic and a drug. One example is anti-dandruff shampoos, since they clean your hair and treat dandruff. Other products, such as deodorants containing antiperspirants, moisturizers, and makeup with sun-protection claims, are also drugs and cosmetics. These are also regulated by the FDA to determine if they are safe and effective.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires manufacturers to list products’ ingredients and manufacturing information, report serious adverse events such as life-threatening reactions, and renew registered facility information at FDA. This law will go into effect on December 29, 2023. Another law, the Fair Packaging and Labeling Act (FPLA), works with MoCRA to ensure consumers receive accurate information. It requires clear labeling of essential information, such as the product’s name and manufacturer and sets standards for quantities and measurements to enable easy comparison across different products. The law also protects consumers from misleading information by prohibiting deceptive packaging or labeling and gives various government agencies the authority to enforce these rules.

The effect of cosmetics on environmental pollution is also limited through regulation. The Microbead-Free Waters Act of 2015 prohibits the manufacturing, packaging, and distributing of rinse-off cosmetics containing plastic microbeads. These tiny plastic particles usually appear in personal care products like facial scrubs, toothpaste, and body washes for their exfoliating properties. However, they pose significant environmental problems, since they could easily pass through water treatment facilities and end up in rivers and oceans. Marine animals could mistake them for food, which would endanger the food chain.

Cosmetic substances that cause health concerns

U.S. regulations require the disclosure of ingredients, but do not set limits on what chemicals can be included in these products. That means that ingredients known or suspected to cause cancer could be in cosmetics that are legally sold in the U.S. This includes chemicals like formaldehyde and formaldehyde-releasers, parabens, phthalates, fragrance, diethanolamine (DEA), and other heavy metals.

● Formaldehyde
Formaldehyde is added to many personal care products to prevent bacteria from growing. Customers sometimes find it in nail polish, shampoo, and body washes. Exposure to low levels can irritate people’s eyes, nose, and throat. However, hair stylists and manicurists who are regularly exposed are more likely to eventually develop nose and throat cancers. A 2019 study in Brazil looked at 23 beauty salons to understand the exposure of hairdressers to formaldehyde and its effects. The result shows that 17% of salons had exceeded the formaldehyde level that is considered safe. Over 65% of the hairdressers reported work-related health issues like eye irritation, skin problems, headaches, limb pain, and breathing difficulties. [8]

● Parabens
Parabens are preservatives commonly used in water-based products. Shampoos, conditioners, face washes, toothpaste, and other cosmetics contain low levels of parabens. Studies on animals indicate that parabens can imitate the actions of the hormone estrogen.[3] that paraben exposure may increase the chances of developing breast cancer in women and disturbances in male reproductive systems. [2]

● Phthalates
Phthalates are chemicals that mimic hormones and are linked to birth defects in animals, especially in the male reproductive system, and are also considered a potential cause for early puberty in boys and girls. They also can increase obesity in children. Personal care product manufacturers started to phase out the direct use of phthalates in 2018 when the U.S. Consumer Product Safety Commission restricted six types of phthalates in children’s toys and child care products after learning about its risks in hormone function and fertility impairment. However, phthalates are still in many products, especially those that smell good.

● Fragrances
Fragrance ingredients are common in self-care products such as shower gels, shampoos, body lotions, and shaving creams. They sometimes are even in products labeled “unscented.” This is because manufacturers are not obligated to label the fragrance in the ingredient list if the amount added is just enough to cover the unpleasant smell of other ingredients versus giving the product a noticeable scent. In the U.S., manufacturers can list fragrance and flavor ingredients as “Fragrance” or “Flavor.” The fragrance is usually a company’s “trade secret,” so they do not need to disclose it. Diethyl phthalate, or DEP, is the phthalate commonly used in fragrance products and is not proven to harm people’s health.

● Diethanolamine
Diethanolamine, also called DEA, is an emulsifier in creamy or foamy products like shampoos and shaving creams. Its reaction with other preservatives in personal care products will form nitrosamines, a human carcinogen according to the International Agency for Research on Cancer and the U.S. National Toxicology Program. Europe and Canada prohibit DEA in cosmetics. Why doesn’t the U.S. FDA?

● Heavy metals
Personal care products such as lipstick, whitening toothpaste, eyeliner, and nail polish often contain heavy metals, including lead, arsenic, mercury, aluminum, zinc, chromium, and iron. Exposure to some of these metals can raise health concerns, particularly affecting the reproductive, immune, and nervous systems. Though “plant-source derived” might sound safe to many customers, several ingredients, such as cottonseed oils and rice derivatives, may contain heavy metals such as lead and mercury, which can harm fertility, cause brain damage, and harm breathing. Sometimes metals are deliberately added to cosmetics; for example chromium is commonly found in eye shadows, blushes, and concealers.

Cosmetics and the Environment

Ingredients from cosmetics can harm our environment. Products such as makeup remover wipes, exfoliating scrubs with microbeads, face sheet masks, skin-whitening creams, and sprays and mists contain non-biodegradable ingredients and chemicals that can harm the environment, waterways, marine life, and even the ozone layer. A 2023 study suggested that microplastics, tiny plastic particles between 100 nm and 5 mm, can move up the food chain from small sea creatures to larger ones, carrying harmful pollutants that could end up in humans.[4]

Additionally, triclosan (TCS), an antimicrobial substance that is often in shampoos, detergents, hand soaps, toothpaste, sunscreen, and deodorants, can also damage the environment. A 2020 study shows that people are more likely to have TCS in their blood, urine, and breast milk if they apply personal care products containing TCS.[5] This can harm human health and our environment, causing an itchy rash, decreased sperm production, and tumors. If TCS is in the environment, it becomes highly poisonous during wastewater treatment, accumulating in animals, plants, and algae, disrupting the ecosystem.

Does consistent exposure to cosmetics harm beauticians’ health?

Hair stylists, manicurists, aestheticians, and other beauticians are constantly exposed to chemicals and heat in their working environments. Do they have a higher risk of some diseases due to these exposures? What can they do to protect themselves from these exposures during work?

A 2021 study examined the chemical and physical conditions in hair salons and assessed the health risks of volatile organic compounds (VOCs) for hairdressers.[6] VOCs are organic chemical components in hair spray that carry substances that can cause heart disease, irritation, insomnia, and nerve damage. This exposure also increases the chances of developing cancer. Installing exhaust ventilation is one of the most effective methods to lower the VOC concentration in the salon. Nail professionals in U.S. salons are also frequently exposed to dangerous chemicals in adhesives, lacquers, removers, moisturizers, and other salon items that can cause breathing problems, rashes, liver complications, reproductive issues, and even cancer. Chemicals found in nail products, such as acetone in nail polish remover, formaldehyde in nail polish and nail hardener, and toluene fingernail glue, can cause headaches, dizziness, allergic reactions, and harm the fetus during pregnancy. For that reason, nail salons should be required to make sure products are 3-free (free from toluene, formaldehyde, and dibutyl phthalate) and free from acid. Nail professionals should always review product labels and instructions when using nail products. [7]

So, what can you do to protect yourself while enjoying personal care products?

1. Read ingredient labels and remember that Ingredients appear in order from highest to lowest concentration. Pay attention to ingredients with higher concentration and avoid those you are allergic to or that can cause environmental problems. See ingredients you want to avoid in cosmetics.
2. When it comes to self-care routine, more is not necessarily better. Skin irritation can occur when layering products. Applying daily makeup without adequately removing it might also disrupt the skin’s protective barrier and cause eye infections and premature aging. Therefore, it is important to build a simple yet effective routine that works well for you and stick with it. Read here for more skin care tips.
3. Choose traditional nail polish over gel polish. Acetone is used to remove gel polish. Traditional nail polish is strong and doesn’t require remover made with acetone. If you use a remover made with acetone, soak a cotton ball in it to remove the polish. Read more here.
4. Cosmetic products that are less dangerous are usually better for the environment as well. Products with sustainable packaging such as refillable and reusable cosmetics can reduce plastic pollution.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

1. Beauty & Personal Care – United States. Statista. https://www.statista.com/outlook/cmo/beauty-personal-care/united-states
2. Sheikh, Knvul. Many Personal Care Products Contain Harmful Chemicals. Here’s What to Do About It. New York Times. 2023.
3. Hager, E., Chen, J., & Zhao, L. Minireview: Parabens Exposure and Breast Cancer. International journal of environmental research and public health, 19(3), 1873. https://doi.org/10.3390/ijerph19031873
4. Zhou, Yuwen., Ashokkumar, Veeramuthu., & Amobonye, Ayodeji. Current Research Trends on Cosmetic Microplastic Pollution and Its Impacts on the Ecosystem: A Review. Environmental Pollution. Vol. 320. 2023. https://doi.org/10.1016/j.envpol.2023.121106
5. Bilal, Muhammad., Mehmood, Shahid., & Lqbal, Hafiz. The Beast of Beauty: Environmental and Health Concerns of Toxic Components in Cosmetics. Cosmetics. 2020, 7(1), 13. https://doi.org/10.3390/cosmetics7010013
6. Senthong, P., & Wittayasilp, S. Working Conditions and Health Risk Assessment in Hair Salons. Environmental health insights, 15, 11786302211026772. 2021. https://doi.org/10.1177/11786302211026772
7. Health Hazards in Nail Salons. Occupational Safety and Health Administration. n.d. https://www.osha.gov/nail-salons/chemical-hazards
8. Pexe, M. E., Marcante, A., Luz, M. S., Fernandes, P. H. M., Neto, F. C., Sato, A. P. S., & Olympio, K. P. K. Hairdressers are exposed to high concentrations of formaldehyde during the hair straightening procedure. Environmental science and pollution research international, 2019; 26(26), 27319–27329. https://doi.org/10.1007/s11356-019-05402-9

Everything You Need To Know About The New Weight Loss Drugs

Diet, Habits, & Other Behaviors, Treatment & Management

Farmin Shahabuddin, MPH, Jenny Niwa, and Diana Zuckerman, Ph.D, National Center for Health Research

Weight loss drugs are advertised everywhere and often in the news, especially the newer drugs such as Wegovy, Ozempic, Mounjaro, and Zepbound. All of these drugs are more effective than older weight loss drugs that the Food and Drug Administration (FDA) previously approved (such as Saxenda, Qsymia, Contrave, Xenical, Alli, and Phentermine). Although Ozempic and Mounjaro are approved for diabetes and not weight loss, all these drugs are being used to lose weight. Before you decide whether to take any of them, here are some things you should know.

What are these drugs and how do they work?

The FDA approved Ozempic in 2017 and Mounjaro in 2022, both for type 2 diabetes. For weight loss, the FDA approved Wegovy in 2021 and Zepbound in late 2023. In 2024, Wegovy was also approved to reduce heart attack and stroke risk in overweight or obese adults,[1] which made it more likely to be covered by health insurance policies. Ozempic and Wegovy contain semaglutide, while Mounjaro and Zepbound contain tirzepatide. Despite different ingredients, they all work by mimicking a natural hormone called GLP-1, which slows digestion so people feel full longer and which also helps control blood sugar.

These drugs were originally only available as weekly shots. In December 2025, the FDA approved a pill version of Wegovy, making it the first GLP-1 weight-loss drug in pill form. It has been in pharmacies since January 2026.

Saxenda, which contains liraglutide, is another GLP-1 drug that is a daily shot and generally leads to less weight loss.[2] Foundayo (orforglipron) is another GLP-1 weight loss pill that was approved by the FDA in April 2026. As a newer drug, there is less information about its safety or effectiveness.

What About Cheaper “Compounded” Versions?

During 2022 to 2024, when these drugs were in short supply, the FDA allowed “compounding” pharmacies to make their own versions at lower prices. These compounded versions were not evaluated or approved by the FDA, so their safety and effectiveness were not guaranteed. Ever since the shortage ended in February 2025, the FDA began to take action against these compounded pharmacy versions, such as the widely advertised Hims & Hers versions.[3] The FDA has warned that these compounded drugs are not FDA-approved and their quality and safety cannot be guaranteed.

What are the benefits?

In clinical trials, people who stayed on these drugs for about a year lost an average of 15% of their body weight on semaglutide (Wegovy) and about 21% on tirzepatide (Zepbound), compared to about 2 to 3% for those on a placebo (fake pill). [4] However, in the real world, results are often less impressive because many people stop early or use lower doses. For example, a 2025 U.S. study of nearly 8,000 adults found that those who stayed on the drugs for a full year lost about 12% of their body weight, while those who stopped early lost only about 4 to 7%.[4]

A 2025 U.S. study of more than 30,000 patients with severe obesity found that GLP-1 patients lost about 10% of their weight, while patients who underwent weight loss surgery lost about 28%. Nearly all surgery patients (96 out of 100) kept off at least 10% of their weight, compared to only 46 out of 100 on drugs.[5] Surgery also cost about $12,000 less over two years because there were no ongoing drug costs. However, surgery is a major operation and is not right for everyone.

In 2023, there was major media coverage saying Wegovy reduced heart attacks, strokes, and deaths by 20%. But when we carefully looked at the actual numbers from a 2023 study of 17,500 people with obesity and heart disease, we realized that out of every 100 people, about 8 on a placebo (fake) pill had a serious heart event compared to about 6.5 on Wegovy.[6] Although 6.5 is 20% lower than 8, 1.5% is a very small difference for patients. More recently, a 2026 U.S. study of nearly 300,000 adults with type 2 diabetes found that 1% of patients taking semaglutide or tirzepatide had similar heart outcomes. About 1 out of every 100 people in each group had a heart attack, stroke, or died within one year.[7]

A 2025 study evaluated 2,510 U.S. veterans with irregular heartbeat (atrial fibrillation), diabetes, and obesity for 3 years. Those taking GLP-1 drugs had about 13% fewer hospitalizations and procedures related to their irregular heartbeat, compared to those on other diabetes drugs.[8]

Keep in mind that these studies showing health benefits focused on people who stayed on the drugs for 1 to 3 years, but most people stop within a year and gain most if not all of the weight back. Health benefits are unlikely during the first year, and even less likely after the weight is regained. Also, many studies only included people with diabetes, so the results may differ for those taking these drugs just for weight loss.

Side Effects, Complications and Unknown Risks

The most common side effects are stomach problems like nausea and diarrhea. Some people experience severe vomiting or stomach paralysis, which is why many stop taking these drugs within months. Other possible serious side effects listed on the drug companies’ websites include inflammation of the pancreas, gallbladder problems, low blood sugar, kidney problems, serious allergic reactions, increased heart rate, and depression or thoughts of suicide.[9] However, research on many of these side effects is still limited, and more studies are needed to fully understand how common or serious they are.

There are several rare but serious concerns. People taking semaglutide (Ozempic and Wegovy) can develop a serious eye condition that can cause sudden, painless vision loss that is often permanent, according to a 2024 U.S. study that first found this connection[10], and a larger 2026 study of over 102,000 U.S. veterans confirmed the finding.[11] If you notice any sudden changes in your vision, tell your eye doctor right away.

GLP-1 drugs carry an FDA warning about a possible connection to thyroid cancer, based on animal studies. However, the evidence in humans is mixed. A large 2025 study by Novo Nordisk (the maker of Wegovy and Ozempic) analyzed data from over 100,000 people in clinical trials and found no increased rate of thyroid cancer compared to those on other medications. Other studies have reached similar conclusions. Still, the FDA warning remains, and if you or a family member has ever had a certain type of thyroid cancer (medullary thyroid carcinoma), these drugs should not be used.[12]

There are also concerns about bone health. A 2026 study of over 146,000 U.S. adults with obesity and type 2 diabetes followed them for five years and found that about 4 out of every 100 people on GLP-1 drugs developed osteoporosis (weak and brittle bones), compared to about 3 out of 100 not taking the drugs.[13]  That is a small difference, but to avoid osteoporosis, doctors recommend eating well, exercising, and getting your bone health checked while on these drugs.

Another thing to be aware of is how these drugs affect medical procedures. Since GLP-1 drugs slow how fast your stomach empties, it is best not to take them prior to surgery. Vomiting under anesthesia can be dangerous because food and stomach acid can get into the lungs, and patients taking GLP-1 drugs were much more likely to have food in their stomach than those who stopped the one dose before surgery.[14] However, switching to clear liquids the day before may prevent this problem. If you are scheduled for surgery or a medical procedure, talk to your doctor about your GLP-1 medication beforehand.

In 2026, an article in the New England Journal of Medicine raised concerns about the misuse of GLP-1 drugs by individuals with eating disorders who are not overweight. [15] That is a different type of concern that needs to be considered.

Keep in mind that there are still many unknowns about these drugs. Brain scans show how they affect the brain, so researchers are starting to study the long-term changes that might result. There are many reports of changes in mood (such as depression), concentration, and other reported changes that are sometimes positive (such as less interest in alcohol) and sometimes negative (feeling less motivated).  Research is needed to better understand if these changes are due to the medications or other issues, and if some people are more likely to benefit than others.  Since children’s brains are still developing, the long-term impact on children and young adults is especially important to study.

What happens when you stop taking these drugs?

Many studies, including a 2026 U.S. study of nearly 127,000 adults without diabetes, confirmed that most people taking GLP-1 drugs stopped within a year, usually because of the side effects or cost.[16] Only about 25% stayed on any GLP-1 drug after 12 months. About 20% switched to a different GLP-1 drug during that time.[16]

When people stop, the weight comes back quickly. A 2022 study of nearly 2,000 adults found that people gained back about two-thirds of their weight loss within a year of stopping Wegovy.[17] A 2026 review of 37 studies found that people who stopped these drugs gained back about 22 pounds in a year, compared to just 2 pounds for those who stopped diet and exercise programs.[18] Even those who stay on the drugs usually stop losing weight after about a year.

There is still much that is unknown about these drugs. It is unclear how they affect patients after years of use, or what percentage of people will only benefit if they stay on the drug for the rest of their lives.[16] In short, these drugs work while you take them, but the benefits fade once you stop.

Are you being sold a product or a medical solution?

With so much money being spent on advertising, it is worth considering how that might influence your impression of these drugs. In 2025, Novo Nordisk spent about $487 million advertising Wegovy and Ozempic, which is more than double what Eli Lilly spent on Zepbound and Mounjaro.[19] When drug companies spend hundreds of millions on advertising, it is worth asking: are you being unduly influenced by the hype of ads and media coverage?

How much do these drugs cost?

U.S. list prices run about $1,350/month for Wegovy, $1,000 for Ozempic, and $1,086 for Zepbound.[20] However, most people do not pay full price. In late 2025, drug companies made deals with the government to lower costs.Without insurance, the Wegovy pill costs about $149 to $299 per month, the standard Wegovy shot about $349/month, and a newer higher-dose Wegovy shot (Wegovy HD) costs $399/month, which is about 40% less than the top doses of Zepbound. Zepbound shots cost $299 to $449/month.[21]

With private insurance, you may pay as little as $25/month using a discount card offered by the drug company that lowers your out-of-pocket cost. Medicare covers these drugs for diabetes, heart disease prevention, or sleep apnea, but not weight loss alone. That may change starting in July 2026, where some Medicare patients may get these drugs for weight loss for about $50/month.

Are these drugs right for you?

If you or a family member has ever had a type of thyroid cancer, taking any of the GLP-1 drugs may be dangerous. If you are sensitive to stomach problems, these drugs may not be right for you. These drugs are meant for serious conditions like obesity and type 2 diabetes, not cosmetic weight loss.

The media attention to these drugs makes it seem that they are the only FDA-approved weight loss drugs. They are not. However, all weight loss drugs have unpleasant and potentially serious side effects, and these newer drugs seem to be more effective. If you are eligible and interested in taking these drugs, you should first and foremost make sure to talk to your physician and discuss what to expect, the possible side effects, and your medical history. Keep in mind, as we said earlier, that these are relatively new drugs, they affect the brain, and we don’t yet know all the risks or benefits. Meanwhile, there are other methods available that can help you lose weight and improve your health if you stick with them. These include exercising daily or regularly, developing healthier eating habits, and knowing when to eat.

References

[1] U.S. Food and Drug Administration. (2024, March 8). FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or

[2] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Prescription medications to treat overweight & obesity. https://www.niddk.nih.gov/health-information/weight-management/prescription-medications-treat-overweight-obesity

[3] U.S. Food and Drug Administration. (2026, February 6). FDA intends to take action against non-FDA-approved GLP-1 drugs [Press release]. https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs

[4] Gasoyan, H., et al. (2025). Changes in weight and glycemic control following obesity treatment with semaglutide or tirzepatide by discontinuation status. Obesity. https://doi.org/10.1002/oby.24331

[5] West, S., Scragg, J., Aveyard, P., Oke, J. L., Willis, L., Haffner, S. J. P., Knight, H., Wang, D., Morrow, S., Heath, L., Jebb, S. A., & Koutoukidis, D. A. (2026). Weight regain after cessation of medication for weight management: systematic review and meta-analysis. BMJ (Clinical research ed.), 392, e085304. https://doi.org/10.1136/bmj-2025-085304

[6] Lincoff, A. M., Brown-Frandsen, K., Colhoun, H. M., Deanfield, J., Emerson, S. S., Esbjörnsson, S., Hardt-Lindberg, S., Hovingh, G. K., Kahn, S. E., Kushner, R. F., Lingvay, I., Oral, T. K., Michelsen, M. M., Plutzky, J., Tornoe, C. W., & Ryan, D. H. (2023). Semaglutide and cardiovascular outcomes in obesity without diabetes. New England Journal of Medicine, 389(24), 2221–2232. https://doi.org/10.1056/NEJMoa2307563

[7] Krüger, N., Schneeweiss, S., Desai, R. J., Sreedhara, S. K., Kehoe, A. R., Fuse, K., Hahn, G., Schunkert, H., & Wang, S. V. (2026). Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice. Nature medicine, 32(1), 342–352. https://doi.org/10.1038/s41591-025-04102-x

[8] Heart Rhythm Society. (2025, April 26). New study finds GLP-1 receptor agonists may reduce atrial fibrillation-related events in patients with obesity [Press release]. https://heartrhythm.com/heart-rhythm-media-room/glp1-study-reduces-afib-events

[9] Novo Nordisk. (n.d.). Tips for managing common side effects. Wegovy®. https://www.wegovy.com

[10] Hathaway, J. T., Shah, M. P., Hathaway, D. B., Zekavat, S. M., Krasniqi, D., Gittinger, J. W., Cestari, D., Mallery, R., Abbasi, B., Bouffard, M., Chwalisz, B. K., Estrela, T., & Rizzo, J. F. (2024). Risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed semaglutide. JAMA Ophthalmology, 142(8), 732–739. https://doi.org/10.1001/jamaophthalmol.2024.2296

[11] Heberer, K., Bress, A. P., Cogill, S., Maldonado, A. I., Kim, S. H., Nallamshetty, S., Chen, Y. Q., Shih, M. C., Lynch, J. A., & Lee, J. S. (2026). New-Onset Nonarteritic Anterior Ischemic Optic Neuropathy and Initiators of Semaglutide in US Veterans With Type 2 Diabetes. JAMA ophthalmology, 144(3), 259–264. https://doi.org/10.1001/jamaophthalmol.2025.6262

[12] Vilsbøll, T., et al. (2026). Assessment of thyroid cancer risk associated with glucagon-like peptide-1 receptor agonist use. Diabetes, Obesity and Metabolism. https://doi.org/10.1111/dom.70291

[13] Horneff, J., et al. (2026). GLP-1 receptor agonist use and musculoskeletal outcomes [Conference presentation]. American Academy of Orthopaedic Surgeons Annual Meeting. Reported in: Bernstein, L. (2026, March 8). Bone injury risk weight loss drugs. The Washington Post. https://www.washingtonpost.com/health/2026/03/08/bone-injury-risk-weight-loss-drugs/

[14] Ahmad, A. I., Garg, S., Jacobs, J., Ansari, Z., Al-Din, T. J., Almomani, A., Valencia, S., Vargo, J., Chatterjee, A., Siddiki, H., Hong, L., Nicolas, M. A., Miller, A., & Shah, T. (2026). Holding vs Continuing GLP-1/GIP Agonists Before Upper Endoscopy: The OCULUS Randomized Clinical Trial. JAMA internal medicine, 186(5), 578–584. https://doi.org/10.1001/jamainternmed.2026.0027

[15] Banks A. (2026). GLP-1 Receptor Agonists and Eating Disorders – Cause for Concern. The New England journal of medicine, 394(17), 1665–1667. https://doi.org/10.1056/NEJMp2600300

[16] Xie, L., Anazco, D., Chancay, A. H., Mathew, M. S., Francis, J. M., Almandoz, J. P., & Messiah, S. E. (2026). Glucagon-Like Peptide-1 Receptor Agonist Switching and Treatment Persistence in Adults Without Diabetes. JAMA network open, 9(3), e261272. https://doi.org/10.1001/jamanetworkopen.2026.1272

[17] Wilding, J. P. H., Batterham, R. L., Davies, M., Van Gaal, L. F., Kandler, K., Konakli, K., Lingvay, I., McGowan, B. M., Oral, T. K., Rosenstock, J., Wadden, T. A., Wharton, S., Yokote, K., & Kushner, R. F. (2022). Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes, Obesity and Metabolism, 24(8), 1553–1564. https://doi.org/10.1111/dom.14725

[18] The GLP-1 Agonist Plateau No One’s Talking About. (2023, September 22). https://www.medpagetoday.com/special-reports/exclusives/106464

[19] Varghese, H. M., & Wingrove, P. (2026, January 28). Novo’s Wegovy and Ozempic US advertising spend doubles rival Eli Lilly, data shows. Reuters. https://www.reuters.com/business/media-telecom/novos-wegovy-ozempic-us-advertising-spend-doubles-rival-eli-lilly-data-shows-2026-01-28/

[20] Florko, N. (2023). Novo Nordisk bought prescribers over 450,000 meals and snacks to promote drugs like Ozempic. STAT+. https://www.statnews.com/2023/07/05/ozempic-rybelsus-novo-nordisk-meals-for-doctors/#:~:text=Novo%20Nordisk%20bought%20prescribers%20over,to%20promote%20drugs%20like%20Ozempic&text=WASHINGTON%20%E2%80%93%20Novo%20Nordisk%20spent,weight%20loss%2Dinducing%20diabetes%20drugs

[21] Amin, K., Telesford. I., Singh, R., & Cox, C. (2023). How do prices of drugs for weight loss in the US compare to peer nations’ prices? Health System Tracker. https://www.healthsystemtracker.org/brief/prices-of-drugs-for-weight-loss-in-the-us-and-peer-nations/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=270760455&_hsenc=p2ANqtz-_P2SZN9DLjS_l7fSn8hrgS8xRf4YvJIonV0X-iRtKF3FtcWbgsMJd-K6tDV2u12XNFMEesDCulwlbdwkw74D1S-2WqXQ&utm_content=270760453&utm_source=hs_email#List%20prices%20of%20drugs%20used%20for%20weight%20loss%20in%20the%20U.S.%20and%20peer%20nations

Our Comments on the FDA Notice Regarding Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies (REMS)

Policy

July 19, 2023

We are pleased to have the opportunity to share our views with the Food and Drug Administration (FDA) on their notice regarding Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies (REMS).

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Implementing changes in REMS has the potential to cause significant disruptions in the operations of any REMS program, including the ability for prescribers and patients to interact with the tools necessary to fulfill the various REMS requirements. These disruptions can undermine patients’ ability to access a drug in ways that minimize risks. Since the FDA does not approve third-party REMS administrators, or play a major role in the initial development of REMS with elements to assure safe use (ETASU), it is essential that the FDA closely monitors any changes in REMS plans to make sure they are appropriate and yield beneficial outcomes.

We strongly urge that the FDA require drug sponsors and their REMS administrators to test proposed changes to REMS systems prior to implementation with those that actively engage with the system, including but not limited to physicians, patients, and pharmacists. This will ensure that the REMS program will have the intended impact. A less-than-rigorous approach to studying the efficacy of REMS defeats the purpose of REMS and fails to protect patients from predictable harm. The FDA REMS for Transmucosal immediate-release fentanyl (TIRF) drugs and the REMS for Extended Release/Long Acting (ER/LA) opioids provide important examples of how improper implementation of REMS can harm patients. The HHS IG found numerous failures for both these REMS programs, at a time when these REMS were especially important because of the opioid epidemic.1 For example, manufacturers consistently missed the REMS’ targets for training ER/LA prescribers, and the FDA was blamed for not giving manufacturers sufficient time to respond to FDA’s requests for better data before their next assessments were due. As a result, the REMS for ER/LA opioids was changed to primarily measure voluntary prescriber training to educate about risks, a decision that also failed to adequately protect patients.

We also strongly recommend that the sponsor and/or the REMS administrator conduct a Failure Modes and Effects Analysis (FMEA) to identify and plan for system failures. This includes providing for adequate support services in the event that the system fails to work as intended following full implementation of an altered REMS system. Part of the planning should include provisions for an emergency suspension of the REMS or specific parts of the REMS.

Additionally, beyond testing a REMS modification with stakeholders, FDA should require stakeholder input from prescribers in all stages of developing, implementing, and tracking a REMS modification related to changes to third party vendors. This will require greater transparency between drug sponsors, REMS administrators, and stakeholders.

In numerous REMS, the FDA has faced measurement challenges, such as a lack of baseline data and limited surveillance data. These metrics are essential for the sponsor to include when evaluating whether a REMS system was successfully and efficiently implemented. It is also essential to collect data on which types of health professionals are involved in implementing a specific REMS. For REMS that involve training of health professionals, there must be a record of the percentage of prescribers being trained, the percentage who start training who complete it, and what percentage that complete the training will answer training questions correctly.

Finally, we strongly recommend that all future REMS agreements that the FDA enters into with manufacturers and their vendors, require that deidentified REMS data be made available to appropriate outside stakeholders. The availability of this data will reassure the public, patients, and health care providers that each REMS is accomplishing its intended outcomes and promoting the safe use of drugs while minimizing harm, especially serious harm.

  1. U.S. Department of Health and Human Services Office of Inspector General. (2020). FDA’s Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis. https://oig.hhs.gov/oei/reports/OEI-01-17-00510.pdf

Our Comments on the FDA’s Use of Generally Accepted Medical Knowledge Draft Guidance

Policy

July 24, 2023

We are pleased to have the opportunity to share our views with the Food and Drug Administration (FDA) on their Guidance: Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information.

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We support the efforts of the FDA to remain flexible and provide a more open application of scientific and regulatory judgment when conducting nonclinical studies that determine in vitro safety and efficacy. We recognize that this has the potential to streamline product development as well as avoid unnecessary animal testing, decrease costs, and hasten new drug approval time.  However, we predict that this will result in some sponsors providing insufficient data to show the safety, toxicology, and efficacy profile of a drug.

For that reason, we do not recommend using Generally Accepted Scientific Knowledge (GASK) as the sole source of nonclinical data in New Drug Applications (NDAs) or Biologic License Applications (BLAs). Instead, GASK should only be used to support sponsor data and should not replace the vital research that is needed to create a robust safety and efficacious drug profile.

Permitting GASK as the sole or primary evidence would often create a level of ambiguity regarding a drug’s true pharmacologic, distributive, and toxicologic effects. We support sponsor communication that is clear and data that are unequivocal, so that potential harms are minimized. We strongly encourage that the GASK used be: 1) long-standing, 2) uncontroversial, and 3) scientifically robust.  However, we note that even when the generally accepted scientific knowledge being relied upon is uncontroversial, long-standing, and scientifically robust, the external application of that information by the sponsor may be inappropriate. For example, even when a drug’s mechanism of action or the biologic pathway that a drug acts on is well understood, the drug should still be tested to assure that there are no downstream or unanticipated effects when in vitro to the full extent possible, and not solely rely on GASK.

In conclusion, we appreciate the opportunity to comment and support the efforts of the FDA to streamline product development and avoid unnecessary animal testing, decrease costs, and hasten new drug approval time. However, this must be better balanced with the need for sponsors to provide clear, unambiguous data regarding the pharmacologic, safety, and effectiveness profile of new drugs and not use GASK as a means of replacing vital research. To that end, we strongly urge the FDA to revise the proposed GASK guidance to require comprehensive and precise language on when using GASK by the sponsor is appropriate.