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CPTF Testimony at the FDA Listening Session on Advisory Committee Meetings

Policy, Testimony & Briefings

June 13, 2024

Hello, my name is Laura Lytle. I am the Health Policy Director for the National Center for Health Research (NCHR), a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies, treatments, and products 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.

I am grateful for the time today to share NCHR insights on the composition of FDA Advisory Committees. It’s crucial to ensure that these committees are composed of individuals who can provide objective, science-based recommendations. Here are our key areas of concern:

Consumer Representatives: Some consumer representatives lack the necessary scientific expertise to effectively analyze data and critique research design. Additionally, some may have affiliations with industry or products under review, which could lead to conflicts of interest. It’s essential to ensure that consumer representatives truly represent the consumer perspective and possess the required scientific competence. According to FDA guidance, candidates for these positions should meet two criteria: the ability to analyze scientific data and critique research design, and an affiliation with and active participation in independent consumer and community-based organizations, or a history of advocating for the public interest. Many consumer representatives selected would be better suited for positions as patient or industry representatives because they lack the necessary ability to analyze scientific data and critique research design, and many have strong ties to industry or the products they are reviewing. This can lead to conflicts of interest or an inability to make decisions in a scientifically neutral manner.

Financial Conflicts of Interest: The current FDA policy on conflicts of interest is too narrow, allowing individuals with recent financial ties to the industry they are reviewing to serve on Advisory Committees. Transparent disclosure of all financial ties to the company whose product is crucial to maintaining objectivity and trust.

Thank you for your dedication to this important issue and for your time today.

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FDA Brings Lab Tests Under Its Oversight

News Stories & Editorials, We're In the News

Judy George, MedPage Today, April 29, 2024

The FDA issued its final rule to regulate laboratory-developed tests (LDTs), the agency said Monday.

LDTs are in vitro diagnostic products (IVDs) designed, manufactured, and used within a single clinical laboratory. They can be used to measure or detect markers like proteins, glucose, cholesterol, or DNA to help provide information about a patient’s health, including diagnosing, monitoring, or determining treatments.

Historically, the FDA has generally exercised enforcement discretion for most LDTs, meaning it has not enforced applicable requirements. LDTs were certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and regulated by the Centers for Medicare & Medicaid Services, which did not require the tests to show clinical validity.

The final rule amends existing regulations and makes explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. It phases out the agency’s enforcement discretion so IVDs manufactured by a lab largely would be treated the same as other IVDs.

“LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s,” FDA Commissioner Robert Califf, MD, said in a statement. “The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work.”

A growing body of evidence indicates that some LDTs raise public health concerns because they don’t provide accurate test results or don’t perform as well as FDA-authorized tests, said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a press conference.

[….]

Comments posted on the agency’s proposed rule helped shape the FDA’s thinking, leading to a 4-year phase-out period of the FDA’s general discretion approach, Shuren pointed out. “After this phase-out, the FDA generally will expect IVDs manufactured by either a non-laboratory or laboratory to meet the same requirements, though certain IVDs manufactured by a laboratory may fall within one of the agency’s target enforcement discretion policies,” he said.

Those discretion policies extend to LDTs that were marketed before the final rule was issued, certain tests that may help meet an unmet need, and LDTs approved by the New York State’s Clinical Laboratory Evaluation Program (CLEP).

The FDA’s final rule was met with mixed reviews. “We strongly support FDA’s decision to regulate lab-developed tests because it is unconscionable that thousands of tests are being used by patients and consumers that have never been evaluated by independent experts to make sure they are accurate,” said Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, D.C.

“Unfortunately, this final rule has compromised on a crucial issue: it ‘grandfathers’ the thousands of tests — some dangerously inaccurate — that are already on the market, rather than requiring them to be proven to accurately diagnose serious medical conditions or genetic vulnerabilities,” Zuckerman told MedPage Today. “The previously proposed version of this LDT rule did not have that giant, deadly loophole — a loophole that was also in the VALID Act that Congress had considered on lab-developed tests.”

Last month, several speakers at a House subcommittee hearing voiced concerns that, if the FDA proposed rule passed, labs would incur significant costs to meet compliance.

[….]

Others saw the final rule today as a step forward. “The FDA is putting patients first by beginning to make many lab test developers prove their tests are accurate and clinically reliable before they are offered for use on patients,” said Patricia Kelmar, JD, of the public advocacy group U.S. PIRG.

[….]

To read the entire article in MedPage Today, click here.

Testimony of Dr. Diana Zuckerman at the Tobacco Products Scientific Advisory Committee Meeting on General Snus

Policy, Testimony & Briefings

June 26, 2024

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center is a nonprofit public health think tank that scrutinizes the safety and effectiveness of medical and consumer products, and we don’t accept funding from companies that make those products. Our largest program focuses on cancer prevention and treatment.

Thank you for the opportunity to share my views today. My expertise is based on my current work as well as my post-doc training in epidemiology and public health, and as a former faculty member and researcher at Yale and Harvard.  I’ve also previously served as professional staff in the US House of Representatives and US Senate, at the Dept of Health and Human Services, and the White House.  I’m a founding Board member of the nonprofit Alliance for a Stronger FDA, which educates Congress about the need to financially support the essential work of the FDA.

The question today is whether General snus should continue to be labeled as safer than other tobacco products.  I will focus on the scientific evidence, which I personally found challenging due to lack of some key information. So, I will raise the questions that weren’t a focus of the FDA review, and I respectfully encourage you to try to get the answers to these questions today. Several panel members and previous speakers have already asked some of these questions.

  1. We all know the risks of smoking, including cancer, lung disease, and cardiovascular diseases.
  2. Equally important: Most smokers start smoking as children or teenagers and most of these diseases are diagnosed decades later – usually in the patients 50’s or 60’s or even later. That’s more than 30 years later—often 40 or 50 years later, or even later.

In contrast, the data being discussed today found:

  1. A significant increase in several serious cardiovascular diseases, and these were diagnosed in studies that followed relatively young white men. For example the Araghi et al. study published in 2022 included 9 million person years of study, which sounds impressive, but averaged 22 years, including some men that were followed for only 5 years
    • Those results indicate some serious risks are evident apparently at a younger age than found with cigarettes.
  1. There was no increase found in oral cancers, despite previous evidence that smokeless tobacco can cause oral cancers. However, oral cancers usually develop in people in their 50’s or older, and many of the individuals in these studies were younger.  My question is whether the follow-up for these individuals in any of these studies is long enough to draw conclusions about oral cancer.  In addition, information provided in previous research indicate that snus in Sweden differs from snus sold in the U.S. and therefore the data provided on Swedish consumers may differ from the impact on U.S. consumers.  I hope you will ask that question.

Bottom line:

  1. How good is the evidence that using the General snus sold in the U.S. is safer than smoking cigarettes in either the shorter term (10 or 20 years) or longer term (30, 40, or 50 years)?
  2. How often do General snus users also use other tobacco products or switch to other tobacco products? Apparently the answer is often, so does the nicotine in General snus make it more difficult to quit tobacco use and instead result in continued use of snus and other tobacco products?
  3. Can the information available be understood by teenagers or adults who consider using snus if it has a modified risk claim – which will be perceived as a seal of approval by the FDA? If the lack of information makes it so difficult for me to make sense of the risks of snus, I have to assume they will too.

Thank you for the opportunity to share these views.  I encourage you to ask these questions and make sure the answers make sense.

 

Feds declare turf, rubber playgrounds “generally safe’

News Stories & Editorials, We're In the News

Ellie Borst, Politico E&E NEWS, April 18, 2024

Toxic heavy metals or associated air pollutants from recycled tire crumbs used for synthetic turf and rubber playgrounds “generally” do not put people at risk of illnesses, according to a long-awaited federal report.

A joint effort by EPA, the Centers for Disease Control and Prevention, and the Consumer Product Safety Commission, the report is the first comprehensive study on the risks of harmful chemical exposure on turf fields or rubber playgrounds and comes more than eight years after the three federal agencies first teamed up.

“Although chemicals are present in the tire crumbs, as expected, and exposures can occur, those exposures are likely limited,” Annette Guiseppi-Elie, national program director for EPA’s Chemical Safety for Sustainability research program, said during a webinar Wednesday.

Researchers studied 25 participants, both adults and children, playing on three synthetic turf fields over different durations and temperatures to see if they would be exposed to dangerous levels of chemicals well-known for human health harms.

The report reinforces EPA’s long-held stance that turf or rubber play areas are safe.

Concerns over the issue surfaced decades ago when researchers found the recycled tire crumbs, also a popular infill material for turf fields, contained traces of neurotoxic metals such as lead and zinc. Those concerns ballooned in 2016 following a “60 Minutes” report that aired the stories of former high school football players who said their cancer diagnoses could be traced back to turf fields.

Diana Zuckerman, president for the National Center for Health Research, said the report was “very disappointing” and “not a credible response” to concerns.

“I had hoped this report would be more cautious in saying this is what we know, this is what we don’t know,” Zuckerman said. “When they said this was generally not a problem … it means that most people won’t have a problem, but it doesn’t mean that nobody will have a problem. And it doesn’t mean that hardly anybody will have a problem. We don’t know how many people are playing on these fields that may be vulnerable.”

Melanie Taylor, president and CEO of the Synthetic Turf Council, said the council was “pleased to see it reaffirms what other research has shown: synthetic turf and its system components are safe.”

The report did not measure exposure to “forever chemicals,” or PFAS, a recent point of controversy in the “turf wars” due to the chemicals’ connections to cancer and other serious health effects.

[….]

To read the entire report, click here.

Guest Lecture by Diana Zuckerman for Georgetown University Grad Students

Environmental Exposures

April 10, 2024

Today I will talk about Chemicals and Heavy Metals in Artificial Turf, Playgrounds, and Neighborhood Lawns: Policies vs. Scientific  Evidence.

I’m Dr. Diana Zuckerman and I’m president of the National Center for Health Research. Our nonprofit research center and think tank is staffed by scientists, medical professionals, and public health experts. We conduct and explain research that can improve the health and safety of adults and children. We do not accept funding from companies whose products we evaluate, so we have no conflicts of interest.

Artificial turf and rubber tiles, mulch, and rubber playground surfaces contain lead, PFAS and other risky hormone-disrupting chemicals (EDCs) and heavy metals. Crumb rubber is used for turf infill and rubber mulch and tiles and contain lead and EDCs. When we look at the beautiful rubber playground surfaces, such as the one pictured here, they look very inviting. They feel spongy and that seems especially safe when small children fall. But what happens when children are exposed day after day, week after week, and year after year? This is especially true for playgrounds used daily by daycare centers and elementary schools.

Some playground surfaces are covered with recycled tire mulch or “virgin rubber.” contain lead? They vary in color. None are tested for metals or chemicals before they are sold.

Poured in Place (PIP) is a very popular type of surface for playgrounds, and consists of what looks like a solid rubber surface, but underneath the surface is recycled tire mulch. Sometimes the top surface may be virgin rubber, but sometimes it is also made of recycled tire mulch. Testing has shown chemicals and heavy metals, even in dust on the surface.

Rubber playground surfaces contain hormone-disrupting chemicals that can cause or exacerbate:

  • Attention deficits
  • Early puberty (and infertility in adults)
  • Obesity
  • Asthma and allergies
  • And eventually cancer

Don’t be fooled by how they look when they are new

These photos show what happens to these very attractive rubber surfaces after a few years.  The rubber surfaces deteriorate, especially where children are most active. Some examples are at the foot of a slide, where children land when they go down the slide.  But the top layer also wears off in other areas where children play or when the top layer cracks due to the weather. The black you see is recycled tire mulch.  I’m not sure what the gray color on the ground is – probably the tire mulch washed away and left the hard surface underneath.

What’s below the rubber surface? Recycled tire mulch can be on the top layer of a playground surface or just below the top PIP (poured in place) solid layer.  You can see that in these close-up photos.  The surface on the left is made of pieces of rubber of different colors, whereas the top layer surface on the right looks orange from a distance but is actually from pieces of rubber that are yellow and red.  But look at what is under the surface.  The black is recycled rubber mulch. It looks a bit like licorice.  You can also see some color pieces of rubber that are mixed in with the black.  That looks like candy.  And small children like to play with it, and put it in their mouths.

From the ground into the air

When lead dust is found on the surface of playgrounds, officials often try to solve the problem by power washing the dust off the surface.  But where does the lead dust go when it is washed away?  The lead goes onto the dirt and sometimes into streams and ground water.  And of course, new lead dust will form on the surface after the previous dust is washed off.

In this photo you can see black specks which is tire crumb used as infill in an artificial turf field.  Did any of you watch the Superbowl this year?  That field used artificial turf, and although the plastic grass was nice and green, you could see black areas where the tire crumb infill was very visible.  And you could also see some of that infill flying around the feet of the players during the game.

Whether we’re talking about playgrounds or artificial turf fields, children and athletes breathe in the lead, chemicals, and particulate matter when they play. And small children eat pieces.

In a study of aerosolized particulate matter from artificial turf, a University of Georgia faculty member found particulate matter that contained arsenic, cadmium, chromium, and lead.1

Safety Tests

This photo of a new playground in Maryland shows the surface is made of recycled tire crumb that was dyed green.  Given the chances of tire pieces containing lead ending up in children’s clothes, on their hands, and in their mouths, this is probably the most unsafe playground possible.

No tests on human health were conducted prior to this product getting on the market.   Fortunately, several of us were invited by families in that community to speak at their town forum, and I’m glad to say that all these playground surfaces were replaced with a safe alternative called engineered wood fiber.   But meanwhile, we learned that there is a playground at NIH where very sick children play – kids that are so sick that they are undergoing treatment at NIH – that were also made with loose tire crumb similar to this.

U.S. government agencies restrict lead and some phthalates in numerous other children’s products. Agencies are starting to restrict PFAS. But these substances, VOCs, and other heavy metals are not restricted in artificial turf, rubber tiles, mulch, or playgrounds.

Here’s a sign that the D.C. government put up at artificial turf fields using recycled tire mulch as an infill.  It’s in English and Spanish.  If only toddlers could read!

The Consumer Product Safety Commission has warnings on their website that says:

  • Avoid mouth contact with playground surfacing materials, including mouthing, chewing, or swallowing playground rubber. This may pose a choking hazard, regardless of chemical exposure
  • Avoid eating food or drinking beverages while directly on playground surfaces, and wash hands before handling food.
  • Limit the time at a playground on extremely hot days.
  • Clean hands and other areas of exposed skin after visiting the playground, and consider changing clothes if evidence of tire materials (e.g., black marks or dust) is visible on fabrics.
  • Clean any toys that were used on a playground after the visit.

These are very clear and important warnings, but how realistic are they.  Will busy parents and caregivers of young children really immediately wash children’s clothes and toys after going to a playground?

Another issue is how hot artificial turf and playgrounds covered with rubber can get. You can see from this photo that on a warm and sunny day in the Washington, DC area, when the air and grass were about 90 degrees, the artificial turf and playground were 180 degrees!  That is unusually hot, but I’ve frequently measured temperatures of 150 or 160 degrees when the air is less hot or the weather is less sunny, which is also dangerously hot.

 

Where does tire mulch infill go when it rains? Or when they can no longer be used?

In this photo, a heavy rain caused the recycled tire infill to wash off the artificial turf field onto other play areas nearby.  I’m glad to say that the father who took this photo got his kids off the tire crumb right after the photo was taken.  But this gives you an idea of how much tire mulch infill there is, and it has to go somewhere.  And it can’t be recycled, and in many cases it eventually gets into streams and ground water.  And by the way, when the infill washes off like this, the entire artificial turf field has to be replaced.  They can’t just replace the infill that has washed off.  Since these fields cost about $2 million dollars, this is a very expensive problem, because the fields don’t last 10 years as is often promised.

 

 

The companies claim that the old synthetic turf and tire crumb are recycled, but most of these materials can’t be recycled. As you can see, it often ends up in a dumpster, and from there to a landfill. They still contain lead and toxic chemicals.

 

Recycled Tire Crumb at Home

As you can see in this photo, recycled tire crumb is now being sold directly to consumers for use in their yards.  One company calls its product “PlaySafer Rubber Mulch” because they advertise it as being safe if your child falls.  They don’t mention the chemicals or heavy metals in their products, and how unsafe they can be.  And of course, rubber mulch to put around trees and shrubs has become so popular at places like Home Depot that many if not most bags of mulch that they advertise are not natural products made of wood or pine – they are rubber.
In this photo, you can see floor tiles made of recycled rubber, which are also widely available at Home Depot and other stores. They are proudly described as recycled rubber and therefore environmentally friendly, but if you want to find out that they are made of recycled tires you need to check the manufacturers’ websites to find that information. I don’t mean to pick on Home Depot – I mention it because these stores are in communities across the country. We are especially concerned about these tiles when used in daycare centers, playrooms, exercise rooms, or basements, because those rooms may have no windows or windows that are not usually opened.

Myth, reality and alternatives

  • Does artificial turf need watering? YES.
    • If you don’t water it regularly, the warranty will be voided.
  • Does it use pesticides and herbicides? YES.
    • Many assume that artificial turf doesn’t need pesticides, but actually many such fields are treated with pesticides when they are being made, before they are installed. Think of it like wall-to-wall carpeting, which looks like one enormous piece of carpet but is actually made up of many smaller pieces that are sewn together. To prevent weeds from destroying the artificial turf, pesticides are needed to prevent weeds from growing along the seams of the carpet.
  • Does it pass all required safety tests?  YES
  • Are there any required safety tests?  NO

Engineered wood fiber, which is what is shown in this photo, feels as spongy as rubber when installed correctly on playgrounds and has no lead or any other dangerous chemicals. It does not cause splinters, even though it is wood.  And it is ADA compliant.  Here’s a photo of a playground covered with engineered wood fiber.

  • And of course, the alternative to rubber mulch around plants is the natural wood mulch that is used around shrubs, flowers, and other plants.  And yet rubber mulch is increasingly popular at stores like Home Depot.
Challenges to Safeguards
There are many reasons why there are so few regulations protecting children and adults from these materials.
  • Recycling tires is big business
  • Artificial turf is big business, with each field costing at least $1 million, and often $2 million or more
  • There are thousands of PFAS chemicals and companies that claim there is “no PFAS” in their products have tested only a few – perhaps 3-6 of the thousands of PFAS chemicals
  • Testing some PFAS in liquid is well established but testing PFAS in materials is more controversial. In addition, safe limits have not been established for some heavy metals for childhood exposures or in some cases for adults, making policies difficult to implement.
  • Voters like convenience and choices and they don’t like government telling them what to do.
I’d be glad to answer any questions.
References

1. Shalat, S.L. (2011). An Evaluation of Potential Exposures to Lead and Other Metals as the Result of Aerosolized Particulate Matter from Artificial Turf Playing Fields, Final Report. Submitted to NJ Department of Environmental Protection, July 14, 2011. https://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf

Why journalists should scrutinize the FDA’s accelerated drug approval process

In the News, News Stories & Editorials, We're In the News

Association of Health Care Journalists
Mary Chris Jaklevic
March 7, 2024

Last month, the FDA withdrew its approval of multiple myeloma drug Pepaxto, three years after the medication was okayed under the agency’s accelerated approval program.

Although the move didn’t get much notice, it marked the FDA’s first use of its new authority to stamp out instances in which drugs can maintain their marketing authorization despite little evidence that they help patients.

That nagging problem of ineffective and potentially harmful drugs lingering on the market factored into the intense backlash against the FDA’s greenlighting in 2021 of Aduhelm, a pricy Alzheimer’s drug with worrisome side effects and very weak evidence of clinical benefit.

Reform legislation passed in late 2022 addressed flaws in the accelerated approval pathway, which has been in use since 1992 and accounted for 16% of new drug approvals in 2023. Still, some experts say the new law doesn’t do enough to protect patients.

The upshot is that journalists still need to be diligent about covering the limited evidence on which accelerated approvals are often based.

What the new law does

In exchange for earlier market access for products for serious conditions that address an unmet need, drugmakers promise to conduct post-approval confirmatory studies, with the aim of ultimately converting to traditional approval.

But too often manufacturers fail in their obligation to promptly complete confirmatory studies or get a negative result, resulting in what’s been termed a “dangling” approval.

Until now, it has been difficult for the FDA to rescind an approval, although some drugs are voluntarily withdrawn from the market by their manufacturers.

The new law established clear procedures for the FDA to withdraw accelerated approvals and empowered the agency to require that a confirmatory trial be underway before accelerated approval is granted.

The law also added transparency. If the FDA does not require a post-approval study, it must publish its rationale. Sponsors must submit progress reports on confirmatory research, which the FDA must post online.

[….]

How Congress fell short

The law didn’t take steps to strengthen the evidence base that is required for accelerated approvals, which many advocates would like to see. Opponents of such measures contend that looser standards amount to a trade-off that benefits patients with severe or life-threatening diseases.

[….]

Although the FDA can do some of these things on its own, codifying them in law would protect against legal challenges that are likely if the Supreme Court decides to limit the regulatory powers of federal agencies.

What journalists can do 

It’s up to journalists to inform the public about the quality of evidence on which a drug is approved.

For example, accelerated approvals are typically based on improvement of a biomarker or other surrogate endpoint, but that surrogate may not have been proven to reliably predict a clinical benefit. Such was the case with Aduhelm, which was approved based on its ability to reduce beta-amyloid plaque in the brain, which is not associated with improved cognitive function.

Other problems to highlight in your reporting:

  • The FDA may allow a sponsor to use a surrogate market as its primary endpoint in a confirmatory trial, which means that patients and physicians may never know whether a drug really helps patients live better or longer.
  • The FDA in recent years has largely abandoned the gold standard of two large randomized controlled trials, and may allow trials with no control arm or a small number of patients.

Big-picture issues to follow

The FDA continues to face industry pressure to expand accelerated approvals into areas such as neurological disease and gene therapy.

[….].

News coverage can also focus on how forcefully the FDA wields its new power to jumpstart confirmatory research and rescind approvals.  

The recent withdrawal of Pepaxto was a relatively easy call, said Diana Zuckerman, Ph.D., of the National Center for Health Research, a not-for-profit think tank that focuses on patient safety. By the time the FDA acted, the manufacturer had already pulled Pepaxto off the U.S. market. The reason: confirmatory research showed that rather than helping patients, it shortened their lives. 

Zuckerman said it’s worrisome that Pepaxto was okayed for patients, only to prove dangerous a few months later. With accelerated approval, she said, “There are too many loopholes that have harmed patients.”

To read the entire article, click here Journalists need to scrutinize the FDA’s accelerated drug approvals | Association of Health Care Journalists (healthjournalism.org)

What’s the Deal with Keratin Treatments and Other Hair Straighteners?

Cancer Prevention

Have you ever gotten a keratin treatment? A Brazilian Blowout? Maybe you’ve heard that they make hair silky smooth and relaxed and are expensive. Or maybe you’ve heard that they can cause cancer. Are the risks greater than the benefits?  And what products are the FDA planning to ban in April 2024?

What is a Keratin Treatment?

Keratin is a protein found in the hair, nails, and skin. Keratin affects your hair texture and whether it is straight, wavy, or curly. Using chemicals to change the molecules in coiled or curly hair to make it straight or wavy is known as relaxing the hair. In a keratin treatment, cream containing formaldehyde, or methylene glycol (a chemical that releases formaldehyde when used in hair straightening) is brushed into the hair, which is then blown dry and flat-ironed. The combination of formaldehyde, heat, and compression causes straight keratin in the cream to bind to the keratin in the hair, making curly or wavy hair more relaxed.[1]

Why is Formaldehyde a Problem?

Formaldehyde is a colorless, strong-smelling gas that causes health problems when inhaled, sprayed into the eyes, or absorbed through the skin. It can irritate the eyes, nose, and throat, cause coughing and wheezing, and trigger a severe allergic reaction of the skin, eyes, and respiratory tract.[2] Some people have also reported that it caused headaches, dizziness, nausea, chest pains, vomiting, and rashes. [3] [14] Repeated exposure at high levels has been linked to various cancers, including leukemia, uterine cancer, and ovarian cancer. [4] [5][14] Formaldehyde is released at highly concentrated levels when it is heated, so stylists that perform keratin treatments and customers that repeatedly get them are at a greatest risk for these health problems.[4] That’s why the FDA has been raising alarm as early as 2010 and has plans to ban hair smoothing products with formaldehyde in April 2024.[14][15] 

Which Products and Ingredients are Dangerous?

The New York State Department of Health list the following as some of the companies that sell one or more products that contain formaldehyde: Brazilian Blowout Solution,Cadiveu Brazilian Thermal Reconstruction, Coppola Keratin, QOD GOLD Solution and many more. See the full list of products here. Many of these products have been banned in the E.U. and Canada due to their health risks.[8]

All of these treatments contain either formaldehyde or another chemical that releases formaldehyde when heated. The following chemicals are all considered formaldehyde by OSHA: methylene glycol, formalin, methylene oxide, paraform, formic aldehyde, methanal, oxomethane, oxymethylene, or CAS Number 50-00-0.[6] There are also other hair products, such as conditioners and hair sprays, that contain keratin but do not contain any form of formaldehyde, and do not require heat activation. They just leave keratin on the outside of your hair, rather than binding the molecules together. So, it’s best to read the ingredients label before taking any product home, to make sure that you aren’t exposing yourself to formaldehyde, whether it’s listed as formaldehyde, methylene glycol or by one of these other names.

It’s important to know that Keratin is not the only hair straightener that is dangerous.  A 2022 study indicated a possible link between the use of chemical hair straighteners and uterine cancer. Researchers found women who applied chemical straightening products on their hair at least four or more times a year were more than twice as likely to develop uterine cancer compared to those that did not, and that Black women were at higher risk.  [9] [14]  Following the 2022 NIH study, a lawsuit was filed against L’Oreal and other beauty companies for selling chemical hair straightening products. [10]

Isn’t a Brazilian Blowout “Formaldehyde-Free”? No!

Brazilian Blowout is one of the most common brands of keratin treatments. As a result of the 2010 controversy over formaldehyde in keratin treatments, Brazilian Blowout created a formula that they advertised as “formaldehyde-free.” While there is no formaldehyde listed in the ingredients, the main chemical used is methylene glycol, which releases formaldehyde when it is heated during the treatment process. Because of this, the FDA issued a warning letter to Brazilian Blowout in 2011 saying that the product is “misbranded” because the “formaldehyde-free” label is false or misleading.[11] [15] Brazilian Blowout is actually one of the most dangerous treatments because almost 12% of the product is basically formaldehyde hiding under another name, and contains three times as much formaldehyde as most other keratin treatments.[6] Five other keratin treatments labeled “formaldehyde-free” were also found to contain formaldehyde levels up to five times the recommended amount.[12]

In response to the FDA’s letter, Brazilian Blowout changed the labeling on their original formula to warn consumers about health risks, and created an alternative product called Brazilian Blowout ZERO+, which does not contain any formaldehyde.[15] But according to a company representative, the new product does not leave the hair as smooth as the original.[1]

Risks to Stylists and Customers

Because stylists are at greatest risk for formaldehyde exposure, the national Occupational Safety and Health Administration (OSHA) set a standard for the amount of formaldehyde allowed in the air. [16] If workers have been exposed to more than a specified amount of formaldehyde, their health must be monitored and they must be reassigned to a job with significantly less exposure. The salon is required to install ventilation systems, use lower heat settings on blow dryers, and monitor formaldehyde levels at all times using a Consumer Sampling and Analysis Kit.[3] Other workers should also be trained annually to safely handle chemicals and be provided personal protective equipment, including gloves, aprons, and eyewash stations.[2] Learn more about OSHA’s recommendations for formaldehyde exposure here.

If you are a hairdresser who wants to protect your workers from the health risks of formaldehyde, don’t offer keratin treatments at your salon. If you just thinking of getting regular keratin treatments for yourself (Brazilian Blowout recommends getting treatments every 12 weeks), remember that will put yourself and others at greater risk for irritation, allergic reactions, and even cancer. Regardless, with the FDA’s announcement to ban hair-smoothing products that contain formaldehyde, products that contain or create formaldehyde as an ingredient will not be legally available soon. [14][15]

If you want to straighten your hair, remember that using a flat iron releases water vapor, which is much safer for your health. Of course, any form of straightening will damage hair and should be used sparingly, alternating with protective hairstyles that don’t require altering hair’s natural texture, such as braids or gentle twists. These will give your hair (as well as your skin and sinuses) a break from harsh chemicals and heating elements.

We agree with other experts who say that the FDA should have prohibited the use of formaldehyde in hair straightening products years ago.  The FDA started to do so in 2016, but for reasons that are not clear, that decision was blocked until 2024! [14] We also urge the Federal Trade Commission to crack down on false advertising by products labeled as “formaldehyde-free.”

 

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

  1. Environmental Working Group. Best options for straight hair, Hair Straighteners. ewg.org. http://www.ewg.org/hair-straighteners/our-report/how-to-get-straight-hair-whats-the-best-option/. April 2011.
  2. Occupational Safety and Health Administration. OSHA Fact Sheet: Formaldehyde. Osha.gov. https://www.osha.gov/OshDoc/data_General_Facts/formaldehyde-factsheet.pdf. April 2011.
  3. S. Food & Drug Administration. Hair-Smoothing Products That Release Formaldehyde When Heated. Fda.gov. https://www.fda.gov/cosmetics/cosmetic-products/hair-smoothing-products-release-formaldehyde-when-heated#:~:text=A%20hair%20straightening%20or%20smoothing,the%20air%20as%20a%20gas. Updated August 24, 2020.
  4. National Cancer Institute. Formaldehyde and Cancer Risk. Cancer.gov. https://www.cancer.gov/about-cancer/causes-prevention/risk/substances/formaldehyde/formaldehyde-fact-sheet#what-has-been-done-to-protect-workers-from-formaldehyde Updated June 10, 2011.
  5. Schwilk E, et. al. Formaldehyde and leukemia: an updated meta-analysis and evaluation of bias. Journal of Occupational and Environmental Medicine. 2010;52(9):878-886. https://journals.lww.com/joem/Abstract/2010/09000/Formaldehyde_and_Leukemia__An_Updated.5.aspx.
  6. Environmental Working Group. Brands that hide formaldehyde. ewg.org. http://www.ewg.org/hair-straighteners/our-report/hair-straighteners-that-hide-formaldehyde/. April 2011.
  7. New York State Department of Health. Consumer Health Alert: Hair Straightening Products and Formaldehyde. health.ny.gov. https://www.health.ny.gov/environmental/chemicals/formaldehyde/docs/consumer.pdf. Updated Feb 2024.
  8. Women’s Voices for the Earth. Hair Straightening Products Containing Formaldehyde. womensvoices.org. https://www.womensvoices.org/safe-salons/brazilian-blowout/hair-straightening-products-containing-formaldehyde/. Updated January, 2018.
  9. National Institute of Health. Hair straightening chemicals are associated with higher uterine cancer risk. https://www.nih.gov/news-events/news-releases/hair-straightening-chemicals-associated-higher-uterine-cancer-risk. 17 October 2022.
  10. Melillo, Gianna. Lawsuit against L’Oreal, beauty companies alleges hair straightening products cause uterine cancer. The Hill. October 25th, 2022. https://thehill.com/changing-america/well-being/prevention-cures/3703073-lawsuit-against-loreal-beauty-companies-alleges-hair-straightening-products-cause-uterine-cancer/
  11. S. Food and Drug Administration. Warning Letter: Brazilian Blowout 8/22/11. College Park, MD: U.S. Food and Drug Administration; August 22, 2011. https://www.fdalabelcompliance.com/letters/ucm270809.
  12. Maneli MH, Smith P, Khumalo, NP. Elevated formaldehyde concentration in “Brazilian keratin type” hair-straightening products: A cross-sectional study. Journal of the American Academy of Dermatology. 2013;70(2):276-280. https://www.jaad.org/article/S0190-9622(13)01135-3/fulltext#back-bib7
  13. Rabin RC. The FDA Wanted to Ban Some Hair Straighteners. It Never Happened. The New York Times. October 21, 2020. https://www.nytimes.com/2020/10/21/health/brazilian-blowout-formaldehyde-fda.html.Rabin, R. C., & Jewett, C. (2023, October
  14.  F.D.A. Plans to Ban Hair Straighteners With Formaldehyde. The New York Times. https://www.nytimes.com/2023/10/16/health/hair-straighteners-black-women-fda.html
  15. Nutrition, C. for F. S. and A. (2022). Hair Smoothing Products That Release Formaldehyde When Heated. FDA. https://www.fda.gov/cosmetics/cosmetic-products/hair-smoothing-products-release-formaldehyde-when-heated
  16. 1910.1048—Formaldehyde. | Occupational Safety and Health Administration. (n.d.). Retrieved February 15, 2024, from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1048

CPTF Testimony in Support of HB1147 for the Maryland House of Delegates Environment and Transportation Committee

Policy, Uncategorized

February 28, 2024

Dear Chair Korman, Vice Chair Boyce and Committee Members:

Thank you for this opportunity to express the views of the National Center for Health Research (NCHR) in strong support of HB1147.

I have lived in Montgomery County for over 30 years and been president of NCHR for 25 years.  I am a scientist trained in epidemiology and public health, and NCHR is a nonprofit think tank located in Washington, D.C. Our scientists, physicians, and health experts conduct studies and scrutinize research. Our goal is to explain scientific and medical information that can be used to improve policies, programs, services, and products.

I am writing to share scientific information about the risks posed by certain playground surfaces that I have provided to Members of Congress, federal agencies, state and local legislators, parents, and others who want to ensure that our children are not exposed to dangerous chemicals when they play on playgrounds.

We understand that these issues are hotly debated, but some information is more accurate than others. For example, although PIP (poured in place) playground surfaces are attractive and seem safe if children fall, they are made with recycled tire crumb. After a few years, the top layer of rubber will wear off (especially in places where children are most active, such as the bottom of a slide or swing).  The material underneath the top layer is typically granular and will seem quite interesting to small children, who will play with it and put it in their mouths and pockets – sometimes even up their noses.

In the last few years, scientists have learned more about lead, other heavy metals, and PFAS in various playground surfaces. Playground surfaces of loose tire crumb is especially dangerous, but the tire crumb beneath the top PIP rubber layer as well as the synthetic rubber surface has well-known risks, containing chemicals that have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer. When PFAS is in playground surfaces that is of particular concern because they enter the body and the environment as “forever chemicals,” which means that they are not metabolized and do not deteriorate, instead building up in a child’s body over the years. Recent research indicates that PFAS can cause liver damage and other serious health problems. PFAS from playground surfaces can also get into ground water, streams, etc. and from there into drinking water.

Federal agencies such as the Environmental Protection Agency (EPA) and the U.S. Consumer Product Safety Commission have been investigating the safety of these products, and I was recently a featured speaker at a national meeting of the Centers for Disease Control and Prevention (CDC) in Atlanta (https://www.center4research.org/zuckerman-speech-cdc-clppp-2023-meeting/ ) talking about the lead and other chemicals in tire crumb and PIP.

Lead

Lead can cause cognitive damage even at low levels. I’m sure you know that the American Academy of Pediatrics warns that no level of lead is safe, and the lead in tire crumb and lead dust on playgrounds is especially unsafe because it will get on children’s hands and clothing, and they will breathe it in their mouth and lungs when they play.  Some children are more vulnerable than others, and that can be difficult or even impossible to predict. Since lead has been found in recycled SBR rubber, it is not surprising that numerous playground surfaces made with either tire crumb or PIP have been found to contain lead. However, the lead doesn’t just stay on the surface. With wear, the materials turn to dust containing lead and other chemicals that is invisible to the eye and is inhaled by children when they play.

Hormone-Disrupting Chemicals

Why are chemicals that are banned from children’s toys allowed in areas used by children such as artificial turf and rubber playground surfaces?  Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals (also called EDCs). There is very good evidence regarding these chemicals in tire crumb used in PIP and artificial turf, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment.[1] Rubber playground surfaces like EPDM contain many of the same dangerous chemicals as tire crumb, since they are very similar materials, all made from petroleum.

A 2018 report by Yale scientists detected 92 chemicals in recycled tire crumb samples from 6 different companies. Unfortunately, the health risks of most of these chemicals had never been studied. However, 20% of the chemicals that had been tested are classified as probable carcinogens and 40% are irritants that can cause asthma or other breathing problems or can irritate skin or eyes.[2]

There are numerous studies indicating that endocrine-disrupting chemicals (also called hormone-disrupting chemicals) found in rubber cause serious health problems. Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals can be dangerous at very low levels, and the exposures can also be dangerous when they combine with other exposures in our environment.

That is why the Consumer Product Safety Commission has banned numerous endocrine-disrupting chemicals from toys and products used by children. The products involved, such as pacifiers and teething toys, are banned even though they would result in very short-term exposures compared to playground surfaces.

A report warning about possible harm to people who are exposed to rubber and other hormone disrupting chemicals at work explains that these chemicals “can mimic or block hormones and disrupt the body’s normal function, resulting in the potential for numerous health effects. Similar to hormones, endocrine-disrupting chemicals can function at very low doses in a tissue-specific manner and may exert non-traditional dose–response because of the complicated dynamics of hormone receptor occupancy and saturation.”[3]

Studies are starting to demonstrate the contribution of skin exposure to the development of respiratory sensitization and altered pulmonary function. Not only does skin exposure have the potential to contribute to total body burden of a chemical, but also the skin is a highly biologically active organ capable of chemical metabolism and the initiation of a cascade of immunological events, potentially leading to adverse outcomes in other organ systems.

Scientific Evidence of Cancer and Other Systemic Harm

It is essential to distinguish between evidence of harm and evidence of safety. Companies that sell and install PIP often claim there is “no evidence children are harmed” or “no evidence that the fields 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 a PIP playground has caused specific children to develop cancer. However, the industry’s 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 also tell you that for decades there was no publicly available evidence that cigarettes or Agent Orange caused cancer. It took many years to develop that evidence, and the same will be true for playground surfaces.

We know that the materials being used in rubber playground surfaces contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after year, they increase 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 Maryland. That’s why I have spoken out about these risks in my community and on the state and national level. The question must be asked: if they had all the facts, would Maryland communities choose to spend millions of dollars on playgrounds that are less safe than those made with engineered wood fiber?

I have testified about the risks of playground surface materials at the U.S. Consumer Product Safety Commission, the CDC, and EPA as well as state legislatures and city councils. I am sorry to say that I have repeatedly seen and heard scientists and lobbyists paid by the recycled rubber industry say things that are absolutely false. They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true). They also claim that the products do not contain PFAS or lead, but independent researchers find those claims are also false.

Dangerously Hot

Children enjoy playing in warm and sunny weather –but even when the temperature above the grass is 80 degrees Fahrenheit, we have found that rubber playground surfaces in Maryland can reach 150 degrees or higher. A sunny 90-degree day is likely to be even hotter than 160 degrees on these surfaces. These temperatures can cause “heat poisoning” as well as burns.

Alternative Playground Surfaces

Engineered wood fiber products are a safe material for playground surfaces and are ADA compliant. Don’t be fooled by other wood products, such as BrockFILL, which has been scientifically tested and found to contain PFAS, the “forever chemicals.” In addition, the Brock shock pad also tested positive to PFAS.

Conclusions

There have never been any safety tests required prior to sale that prove that synthetic playground surfaces 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.

I would be happy to provide additional information upon request  (dz@center4research.org). I am not paid to write this statement. I am one of the many parents and scientists who are very concerned about the impact on our children of chemicals and heavy metals in currently used playground surfaces.

Your support for this legislation can save lives and improve the health of children in communities throughout Maryland.

Officials in communities all over the country have been misled by the hype around tire crumb and related products. They were erroneously told that these products are safe. On the contrary, there is clear scientific evidence that these materials are harmful. The only question is how much exposure is likely to be harmful to which children? We should not be willing to take such a risk. Our children deserve better.

That is why we urge this committee to give HB1147 a favorable report.  Thank you for considering our views.

Sincerely,

Diana Zuckerman, Ph.D.

President

References

  1. State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007.http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf
  2. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64.https://doi.org/10.1007/s11270-018-3711-7
  3. Anderson SE and Meade BJ. Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals. Environmental Health Insights. 2014; 8(Suppl 1):51– 62.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/

 

Our Written Testimony in Support of HB 457 for the Maryland House of Delegates Environment and Transportation Committee

Testimony & Briefings

Bill Title: Environment – Synthetic Turf- Chain of Custody

February 16, 2024

I am writing in enthusiastic support of HB457 on behalf of the National Center for Health Research (NCHR), as the president of the Center and as a long-time resident of Maryland’s District 16. The bill would establish a simple chain of custody for synthetic turf. NCHR is a nonprofit think tank the conducts, scrutinizes, and explains research with important public health implications for adults and children. We are nationally respected as a source of unbiased information and do not accept funding from entities with a financial interest in our work.

This is an important bill to the public health of Maryland residents because it would require transparency regarding synthetic turf and turf infill.  By enabling the public to be informed about the chain of custody from the time of installation; use; possible reuse; recycling; and disposal, the bill would ensure that individuals, policy makers, and communities could make informed decisions that are essential to the health of adults and children in Maryland.  The National Center for Health Research is not an environmental organization, but we are very knowledgeable about the scientific issues pertaining to synthetic turf and infill and how inappropriate disposal of those products can affect the health of Maryland residents.

We urge the immediate passage of this bill, because the lack of transparency regarding the chain of custody of synthetic turf and infill has made it impossible for families, communities, and government officials to make informed decisions that affect the health of adults and children.  I speak from experience on this matter: synthetic turf became popular locally while my children were playing soccer while growing up in Maryland, and like most parents I was unaware of the environmental or health issues involved.  As I became knowledgeable, I was shocked by the widespread misinformation regarding the disposal of these materials.

As the legislators representing our families, you can improve transparency and help communities, families, and government officials determine how synthetic turf and infill are being used and what happens to those products when they are removed.  We strongly urge your favorable report on HB457.

Respectfully submitted,

Dr. Diana Zuckerman
President