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Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators

Policy, Testimony & Briefings

November 7, 2023

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. So I have no conflicts of interest.

In addition to my current work, my perspective reflects my post-doctoral training in epidemiology and public health, my training in bioethics, previous policy positions at HHS and a Congressional Committee with oversight over FDA, and as a faculty member and researcher at Yale and Harvard. I am also a founding board member of the Alliance for a Stronger FDA, which is a coalition of industry and nonprofit organizations that work to ensure that the FDA has sufficient appropriations to fulfill its important mission.

Thanks for the opportunity to speak today. Since you have such impressive medical expertise on this panel, I will focus on policy issues that have important implications for patients – a goal that we all share.

The FDA has spelled out their concerns about these devices in their written summary and will talk about them today, so I will focus on the big picture.

  1. These devices have been treated as 510k devices since 1976 and that has resulted in limited scientific data — in fact, FDA found very few studies of either safety or effectiveness, none of which were randomized controlled trials and none that evaluated a specific device used to prevent cancer metastasis.
  2. Most importantly, no studies indicate that the use of blood irradiators improves patient outcomes.

So given the lack of evidence of benefits, what are the risks?

  • There are few adverse event (AE) reports to FDA’s Medical Device Reporting (MDR) system. But that may be because the devices aren’t used frequently and MDR reports are voluntary and everyone agrees that AEs are under-reported. We all know that surgeons are very busy and do not have strong incentives to report AEs, especially when it isn’t clear if a problem was caused by the device vs. human error.
  • Even so, the FDA has identified numerous potential serious risks, including incorrect or improper dose of radiation, damage to blood components caused by the radiation, and radiation causing an immune response that is harmful to cancer patients. Device malfunction or poor design could result in unintended radiation exposure of the operator or the public, or electrical shock or burn.
  • Several papers reported that blood irradiation took additional time, 15-20 minutes, and that can sometimes be harmful.
  • Perhaps most important, most patients and surgeons assume that these products are proven safe and effective. Would they choose to use them if they knew how little scientific evidence there is regarding safety or effectiveness?

THE BOTTOM LINE: These devices fit FDA’s definition of Class III

  1. “Insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness.”
  2. “The device is for a use which is of substantial importance in preventing impairment of human health.”

The FDA is asking if special controls would be sufficient instead of a PMA.  They don’t specify which special controls, but the problem here is we don’t know if the products have any benefits regardless of how they are used.

Would FDA impose special controls requiring evidence of effectiveness, and if so, why not require a PMA instead? We don’t know if either of the current products are safe and effective, and we don’t know if one is better than the other. That is why I encourage you to urge the FDA to categorize these as Class III and require a PMA, so that we will finally have well designed clinical trials to determine safety and effectiveness.

Would registries be as good as clinical trials to study blood irradiators that are already on the market? Registries can collect important information.  But registries do not provide a control group, and this is especially problematic for a device that is not widely used, since those who use blood irradiation to prevent metastasis may differ in important ways from those who do not.

Our Comments on the FDA Draft Guidance for Industry Concerning Dietary Guidance Statements in Food Labeling

Policy

September 25, 2023

We appreciate the opportunity to comment on the Food and Drug Administration (FDA) draft guidance for industry concerning questions and answers about Dietary Guidance Statements in food labeling.

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 use of Dietary Guidance Statements to improve dietary patterns, reduce the burden of nutrition-related chronic diseases, and advance health equity. Dietary Guidance Statements provide important nutrition information to consumers, and are especially important to consumers with poor nutritional habits. They also encourage industry to reformulate products to improve nutritional standards.

We recommend the following to improve this guidance:

  • Revise the recommendation that manufacturers may use Dietary Guidance Statements on products that exceed recommended limits on saturated fat, sodium, or added sugar.

Manufacturers should not be allowed to use Dietary Guidance Statements on products that exceed recommended limits on saturated fat, sodium, or added sugar, even with an added disclosure statement explaining the nutrient levels the product may exceed. This would be confusing and potentially misleading to many consumers. If the FDA insists on this confusing strategy, the agency should clearly describe which recommended nutrient level is exceeded, and should be designed to grab the attention of consumers, similar to that of a black box warning on medical products.

  • Provide an explicit definition that includes examples of a “consensus report.”

In this draft guidance, FDA defines a “consensus report” as: “A report that represents the consensus produced by a group of qualified experts whose bias and conflicts of interest have been minimized and that are convened to study a specific issue. The consensus report conveys agreed-upon recommendations that reflect widely accepted, objective views of current scientific evidence.” This definition does not specify what FDA considers a “minimized” conflict of interest. This definition needs to be explicit to ensure that inappropriate sources are not included and that Dietary Guidance Statements do not conflict with recommendations in the Dietary Guidelines for Americans released every five years by HHS.[1]

We recommend that FDA provide a list of which published reports from U.S. Federal government agencies, U.S. scientific bodies, or U.S. health organizations outside the Federal government are appropriate to serve as the basis for Dietary Guidance Statements. The list should be updated at least every five years, and be in agreement with the release of updated Dietary Guidelines for Americans.

  • Amend the use of Dietary Guidance Statements related to juice and reduce misleading claims about fruit drinks.

The FDA guidance recommended that products should contain at least ½ cup equivalent of fruit per Reference Amount Customarily Consumed (RACC), which can also be ½ cup of fruit juice per RACC. However, a Dietary Guidance Statement on a product that contains fruit only in the form of juice would be misleading to consumers, because the Dietary Guidelines for Americans place an emphasis on the importance of whole fruits. FDA should amend the guidance to clarify that Dietary Guidance Statements involving fruit should emphasize the benefits of whole fruit over fruit juice, as well as the benefits of fruit juice compared to fruit drinks.

  • Amend the use of Guidance Statements regarding whole grains.

Consumers are often misled by claims of products that “contain whole grains” despite whole grains constituting a small amount or small proportion of the total grains. The Dietary Guidelines for Americans recommend a diet including “grains, at least half of which are whole grain.” As an example guidance statement, the FDA provides a label saying, “Make half your grains whole grain.” This should be amended to recommend that “at least half” your grains should be whole grain. Additionally, for products that contain high amounts of grain, the FDA should recommend at least 50% of the total grains be whole grains.

  • FDA should provide guidelines for Dietary Guidance Statements on alcohol.

Evidence regarding the harmful effects of alcohol, including moderate amounts of alcohol, is well documented and we therefore urge that the Dietary Guidance Statement should include that information.  That would require amending the definition of Dietary Guidance Statements to include those that “represent or suggest that a food or food group may or may not contribute to or help maintain a nutritious dietary pattern. ” Dietary Guidance Statements regarding alcohol should emphasize the recommended limits as well as established evidence about the impact of alcohol consumption on health.

[1] https://www.dietaryguidelines.gov/about-dietary-guidelines/purpose-dietary-guidelines

Our Comments On FDA’s Requirements for Tobacco Product Manufacturing Practices

Policy

October 6th, 2023

We appreciate the opportunity to comment on the FDA’s proposed guidance regarding tobacco product manufacturing practice requirements: “Requirements for Tobacco Product Manufacturing Practice.”

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.

Overall, we support FDA’s proposed rule for regulating tobacco manufacturing practices. Prior evidence suggests that the absence of agency established tobacco regulations may expose consumers to unnecessary hazards, addictive products, and risks associated with tobacco products.1 While this proposal will not make tobacco products safe, it will help to limit health risks that are not normally associated with the use of tobacco products. Tobacco consumers will still remain at higher risk for cancer, stroke, heart and vascular disease, and chronic obstructive lung disease compared to non-tobacco users. Thus, NCHR urges the FDA to make it clear that this rule will not make tobacco products safe or protect consumer health, but rather is intended to reduce the risks.  We also strongly urge the FDA to put more emphasis on implementing explicit policies that protect the public health as much as possible, rather than emphasizing the agency’s willingness to be flexible in how companies implement this rule.

We agree with the FDA’s proposed requirement that each manufacturer maintain a master manufacturing record (MMR) so that the FDA is able to hold manufacturers accountable and is able to track whether the tobacco products conform to packaging and labeling specifications. Further, as part of the MMR, it is imperative to require tobacco manufacturers to make products that consistently and accurately reflect the nicotine concentration printed on the label. This is essential for e-liquids and e-cigarettes, as they have been shown to range from having anywhere from 35% less nicotine to 52% more nicotine than is printed on the label.2 Moreover, younger e-cigarette users frequently misinterpret the concentration and strength of nicotine in e-cigarettes and many are uncertain about whether some e-cigarettes even contain nicotine.3 When the amount of nicotine consumed is unclear, it has the potential to increase the chances of consumers becoming addicted. Therefore, in addition to requiring manufacturers to accurately and clearly specify the nicotine concentration contained in the product, we also recommend that the FDA require clear, user-friendly labeling to help consumers better understand and calculate their nicotine consumption.

We also strongly agree with the FDA’s proposed regulations to restrict flavor additives, reduce hazardous contamination, and impose maximum nicotine levels in order to mitigate unnecessary health risks. These standards are essential for everyone, but may be especially likely to decrease tobacco initiation among younger consumers, as well as reduce the duration of use and risk of tobacco addiction. E-cigarettes have been shown to contain hazardous contaminated substances such as volatile organic compounds, metals, glass, and plastics and so we support FDA’s proposal for a Quality Management System (QMS), to help reduce contamination, hasten recalls, and prompt regulatory action for contaminated or misbranded tobacco products.

While we agree with the FDA’s proposed approaches for measuring and imposing tobacco standards, we find the enforcement mechanisms and corrective actions against manufacturers who violate these proposed regulations to be inadequate. The incentive for compliance is low, the FDA’s responses to noncompliance have not been sufficiently rigorous, and prior corrective actions have not been commensurate with the gravity that violations pose to the public. For example, the civil monetary penalties that have been previously issued for past e-cigarette violations are relatively rare and not sufficient to improve compliance. As of August of this year, the FDA had sought injunctions against only six companies and filed monetary penalty complaints against only 21 companies for illegally selling e-cigarettes, which pales in comparison to the scope of the problem.4 Thousands of unauthorized and illegal e-cigarettes remain on the market, posing a major threat to public health. NCHR recommends that the FDA enforce more violations and implement more stringent and aggressive enforcement strategies for each violation. For example, when there are multiple violations, rather than charging manufacturers with a single violation in one proceeding, which results in a maximum fine of $19,192, we urge that the manufacturer be charged for each violation, since the FDA has the authority to charge a manufacturer with multiple violations up to $1.2 million in a single proceeding.5 Incentives for compliance would be much greater if the statutory maximum is issued for each violation of the Family Smoking Prevention and Tobacco Control Act. Charging manufacturers with a single violation is not having the desired impact; stiff monetary penalties are needed to increase compliance among manufacturers that repeatedly market flavored e-cigarette products, produce tobacco products with hazardous foreign material, or are non-adherent to regulatory and label requirements.

We are very concerned that in each of the injunctions filed by the FDA, there was a delay of over a year between the time the FDA sent a warning letter to the companies in violation and the commencement of injunction proceeding. Throughout this period, these companies continued to profit from the sale and distribution of illegal products, including menthol flavored cigarettes and all types of flavored e-liquids that are especially attractive to children and teenagers. This substantial delay between the FDA’s identification of violations and initiation of injunction proceedings has clear adverse effects on public health, making it especially likely that children and adolescents will try these products and become addicted to them. We strongly recommend that the FDA streamline the process, more quickly imposing corrective actions in order to reduce harm to individuals and to public health.

In conclusion, we appreciate the opportunity to comment on the proposed rule to regulate tobacco manufacturing practices. We strongly recommend requiring manufacturers to accurately reflect the nicotine concentration contained in the product on the label using clear, plain language in large font. Further, we support the proposed regulations to restrict flavor additives as required by law, reduce hazardous contamination, and impose maximum nicotine levels. Even more important, the FDA should exercise its full authority when imposing monetary penalties for violations to improve incentives for manufacturer compliance. Although tobacco products are inherently unsafe, these proposed regulations, if properly enforced, will be more effective at reducing health risks related to tobacco consumption. 

References:

  1. Lange, T et al. “Regulating Tobacco Product Advertising and Promotions in the Retail Environment: A Roadmap for States and Localities.” Journal of Law and Medical Ethics. 2015.
  2. Raymond et al. “The Nicotine Content of a Sample of E-cigarette Liquid Manufactured in the United States.” Journal of Addiction Medicine. 2018.
  3. Morean et al. “Adolescents’ awareness of the nicotine strength and e-cigarette status of JUUL e-cigarettes. Drug and Alcohol Dependency. 2019.
  4. FDA, Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products. August 10, 2023.
  5. Zuckerman Spaeder. “Effective Use of Civil Monetary Penalties to Control Illegal Marketing of E-Cigarette Products. 2023. Link: Federal Register :: Requirements for Tobacco Product Manufacturing Practice

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

Uncategorized

Andrea Sun, MS

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