Category Archives: Policy

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

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 yearthey 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

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

Comments on USPSTF Draft Research Plan for BRCA-Related Cancer

February 14, 2024

We appreciate the opportunity to share our views on the United States Preventive Services Task Force (USPSTF) draft research plan regarding “BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing.”

The National Center for Health Research (NCHR) is 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.

The draft research plan is an excellent overview of the questions and issues that need to be addressed and we support those plans. However, we strongly urge the USPSTF’s research plan to also evaluate how to best communicate with patients who are considering testing or who are receiving their test results. In our interviews with patients, we have found that when information is given about the lifetime risks of breast and ovarian cancer for women with BRCA-1/BRCA-2 genetic mutations, most women become frightened.  However, they are relatively reassured when they are also given information about the risks of breast and ovarian cancer in the short-term, such as within next 5 to 10 years. Since the risk of developing breast and ovarian cancer is much lower in the short-term, women are less frightened and less likely to feel that they must urgently undergo surgery that will have major implications on their quality of life or life plans, such as the ability to bear children. All patients deserve information about the short-term, long-term, and lifetime risk of developing BRCA-associated cancers, but this is especially important for younger women.

In addition, communicating risks to patients should include statistics on absolute risks and risk reduction for different interventions compared to no interventions, as well as relative risks.  For example, if a patient with a BRCA mutation has a risk of developing breast cancer during the next X number of years that is twice as high as women without a BRCA mutation, many BRCA positive women will interpret that information differently than being told that their risk of developing breast cancer is 20% instead of a 10% risk for women without a BRCA mutation. Similarly, if the risk of ovarian cancer during the next Y number of years is reduced by 50%, that may be interpreted differently by a patient than being told that her risk of developing ovarian cancer within the next years would be 5% instead of 10%.

Therefore, as part of USPSFT’s research plan for BRCA-related cancers, we urge the USPSTF to evaluate the impact that different ways of communicating risk has on patients’ decisions, satisfaction with their decisions, and their quality of life.

Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators

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

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

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

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

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

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.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

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/

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

July 19, 2023


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

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

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

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

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

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

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

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

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