Category Archives: Policy

NCHR Comments on Public Access to Federally Funded Research

National Center for Health Research, May 6, 2020


National Center for Health Research Public Comments on
OSTP’s Request for Information: Public Access to Peer-Reviewed Scholarly
Publications, Data and Code Resulting From Federally Funded Research

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

Our research center has long advocated for making federally funded research publicly available. As a think tank focused on research and data related to human health, we have supported data sharing and other efforts to make research results more freely available, particularly for research that was funded by federal agencies or submitted to federal agencies as part of application materials to the FDA and other federal agencies. Research data and results that are partially or fully funded by or conducted by the federal government should be freely available to the public.

In this comment, we will focus on two issues: 1) Access to peer-reviewed scholarly publications and 2) Access to data for analysis.

Despite efforts to make articles in scholarly publications freely available to the public, most are not. All journal articles based on research funded by the federal government should be freely available to the public, and that should not require the authors to pay thousands of dollars for each article to be available through open access. We understand the financial needs of scholarly publications, but U.S. taxpayers should not be required to pay to read an article based on research that they also paid for. Since journals depend on high quality data to succeed, the government should require that journals have an open access policy for federally funded research results; authors either should not be required to pay anything, or should be offered a greatly discounted rate that the federal government requires the researcher to pay using the research funding that supported the work.

Unfortunately, ClinicalTrials.gov has not fulfilled its goal of making research results publicly available in a transparent and timely fashion. Despite Congressional pressure, too often study results are not reported on the ClinicalTrials.gov website or are greatly delayed, and neither FDA nor NIH has enforced the requirements or penalized those who failed to comply. In addition, results reported on ClinicalTrials.gov are often subjective summaries rather than objective charts and graphs that present the aggregate data. The information most often provided is insufficient for other researchers or medical providers to scrutinize.

In addition, research conducted partially or entirely with federal funds is not always published in a timely manner, or at all. In some cases, the authors have submitted manuscripts that have been rejected by journals; in some cases, there are competing pressures that make it difficult for the researchers to finish writing and submitting manuscripts, and in other cases, the only journals willing to publish a specific article charge thousands of dollars for publication that the authors can’t afford. We strongly urge that PIs of federally funded studies be required to make the raw data available to other U.S. researchers if it hasn’t been published within 3 years of completion of the initial study. Such data sharing between researchers is essential for ensuring that federal agencies have not wasted taxpayers’ money on research that never becomes available to potentially benefit the public.

Even when federally funded research results are published, the results may be biased or inaccurate. Sharing of raw data after publication is an invaluable tool for confirming the accuracy of reported research findings and enabling other researchers to replicate results and understand any conflicting findings.

U.S. taxpayers deserve to have the government maximize the usefulness of the funds they’ve invested in research by making that research publically available. Efforts to improve public access to federally funded research will benefit the scientific community, the medical community, public health, and the public.

National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

NCHR’s Public Comments on FDA’s Proposed Inclusion of Older Adults in Cancer Clinical Trials

May 4, 2020


National Center for Health Research’s Public Comments on FDA’s Proposed Inclusion of Older Adults in Cancer Clinical Trials Guidance for Industry

[FDA-2019-D-5572-0002]

We are writing to express our views on the FDA Draft Guidance on Older Adults in Cancer Clinical Trials. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We have long urged the FDA to require older adults in clinical trials of drugs for the treatment of cancer and other diseases that are likely to be used by people over 65. When our Center’s president served on CMS’ Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), she pointed out at every meeting that there were few if any patients over 65 who had been tested in clinical trials for the drugs and devices that were seeking to be covered by Medicare. As a result, it was impossible for the MEDCAC members to determine if the likely benefits outweighed the risks of any of those products, including cancer diagnostic tests and treatments.

We strongly support FDA’s efforts to improve the diversity of clinical trials and analyses of demographic subgroups, but have been disappointed that these efforts have not been enforced in a meaningful way. Subgroup analyses of safety and efficacy are essential for new drugs and devices so that patients and clinicians can make informed treatment decisions. New medical products should only be approved for populations for which there has been sufficient testing to determine that the benefits outweigh the risks. This is of particular importance for older adults in cancer trials. Moreover, if the FDA refused to approve cancer drugs for patients over 65 or over 70 when those age groups were not adequately studied, it would provide a substantial incentive for sponsors to be more vigilant about recruiting and studying patients in older age groups.

As stated in the guidance, it is not sufficient to only study the safety and efficacy of treatments among younger adults and assume that the results would be the same for older adults as well. We also strongly support the recommendation to evaluate smaller, discrete age groups (such as ages 65-74 and 75 and up), as well as the recommendation to collect additional safety measures for older adults, such as cognitive functioning. However, there are additional aspects of subgroup analysis that must be taken into consideration.

Subgroup analysis must determine the unique benefit to risk ratio for each subgroup, rather than determine whether the benefits of a treatment differ between younger and older patients. Older adults are more likely to have comorbidities that can affect how drugs are absorbed, metabolized, or eliminated, which may impact the safety and efficacy of a particular treatment. Therefore, there must be an assessment of the unique risks and benefits for older adults. It is not important to know that a medical product is more or less safe or effective for older patients compared to younger patients; what matters to older patients is whether the benefits outweigh the risks for patients in their age group.

In addition, it is not necessary that the proportion of older patients studied is consistent with the proportion of older patients with the particular type of cancer. What matters is that there be sufficient numbers of older adults so that subgroup analyses can be conducted to assess the benefits and risks of treatment for patients in several older age groups. Subgroup analyses are not meaningful if the numbers of older patients in the trials are small.

Since older adults are likely to be more frail and to have other serious comorbidities, it is imperative to determine the adverse effects and the efficacy of new drugs for older adults prior to FDA approval. All too frequently, post-market research, even if required, is delayed, follow-up is inadequate, or for other reasons the results are not as informative as had been expected.

The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

 

NCHR Comments on CPSC Priorities for FY2021/2022

National Center for Health Research, April 2020


Diana Zuckerman, Ph.D., President of the National Center for Health Research

Comments on the U.S. Consumer Product Safety Commission
Agenda and Priorities for FY2021/2022

April 2020

The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and public health experts who analyze and review research on a range of health issues. Thank you for the opportunity to share our views concerning the Consumer Product Safety Commission’s (CPSC) priorities for fiscal years 2021 and 2022. We greatly respect the essential role of the CPSC, as well as the challenges you face in selecting the most important priorities.

We want to start by emphasizing two issues involving chemicals in products that affect our and our children’s health, (1) artificial turf and playground surfaces and equipment, and (2) organohalogen flame retardants. We will also briefly discuss sport and recreational helmets, sleep-related products for infants, furniture stability, home elevators, and liquid nicotine packaging. All these issues should be CPSC priorities.

Artificial Turf and Playgrounds: Risky Chemicals and Lead

We expressed our concerns about artificial turf and playgrounds last year. Our concerns are even greater this year because of increasing evidence of lead exposure from these products, as well as from playground equipment.

Requiring testing for artificial turf, playground surfaces, and the paint used for playground equipment needs to be a priority, because children are exposed to these synthetic rubber and plastic fields and playground surfaces as well as playground equipment – and the lead and harmful chemicals they contain – day after day, year after year.

A new issue that arose in the last year is research indicating that the paint used on outdoor playground equipment contains lead. Professor Alexander Wooten from Morgan State conducted studies in Maryland that indicate that paint with lead is widely used on playground equipment, such as climbing structures, in some cases at very dangerous levels.1 We have learned that there are no federal restrictions on lead used in outdoor paint, even for products used exclusively by young children. CPSC should investigate this issue immediately.

The rubber and plastic that make up turf and playground surfaces contain chemicals with known health risks, which are released into the air and get onto skin and clothing. Crumb rubber – whether from recycled tires or “virgin rubber”– includes endocrine disruptors such as phthalates, heavy metals such as lead and zinc, as well as other carcinogens and skin irritants such as some polycyclic aromatic hydrocarbons (PAHs) and volatile organic compounds (VOCs).2,3,4,5,6 Other plastic or rubber surfaces used in playgrounds also contain many of these chemicals.7 Moreover, the plastic grass in artificial turf also has dangerous levels of lead, PFAS, and other toxic chemicals as well. PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks.

Tire crumb is widely used as infill for artificial turf fields and also used for colorful rubber playground surfaces. In addition to the chemicals noted above, these playground surfaces contain lead and create lead dust on the surface that is invisible to the eye but that children are breathing in when they play.8

The CPSC is well aware that no level of lead exposure is safe for children, because lead can cause cognitive damage even at low levels. Some children are even more vulnerable than others, and this vulnerability can be difficult or even impossible to predict. Since lead has been found in tire crumb as well as new synthetic rubber, it is not surprising that numerous artificial turf fields and playgrounds made with either tire crumb or “virgin” rubber have been found to contain lead. However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or other materials also contain lead. Whether from infill or from plastic grass, the lead doesn’t just stay on the surface – it can get into clothes, on the skin, or into the air that children breathe.

While one-time or sporadic exposures are unlikely to cause long-term harm, children’s repeated exposures, especially during critical developmental periods, raise the likelihood of serious harm. There are few activities that children engage in for as many hours in their early years as those on playgrounds and playing fields.

We appreciate the CPSC’s ongoing efforts to investigate the safety of crumb rubber on playgrounds and playing fields. As your study using focus groups to examine children’s use of playgrounds and exposure to playground surfaces has shown, children who use playgrounds with artificial surfaces could be exposed to the chemicals in these surfaces.9 It is unfortunate that the EPA report on artificial turf (which did not include playground surfaces or playground materials) did not provide the scientific evidence needed to support their assumptions that the likely levels of exposure to dangerous chemicals was low enough that it was not likely to harm children. The EPA did not study the actual impact of the exposure to endocrine disrupting chemicals on children and did not study lead exposure from synthetic playground surfaces, leaded paint used on playground equipment, or artificial turf.10

Meanwhile, we have repeatedly heard the companies that make these products and those that install them make erroneous claims at the state and local government levels, falsely stating that CPSC and other federal agencies have concluded that these materials are proven safe. As we all know, that is not correct.

We encourage you to closely evaluate the research that has been done, focusing on independently funded research of short-term and long-term safety issues. We need information that can protect our children from harm. In addition, we strongly urge you to convene a Chronic Hazard Advisory Panel (CHAP) to examine the short-term and long-term risks of different types of artificial turf used in playing fields and children’s playgrounds, including surfaces and lead paint used on climbing equipment and other materials.

In addition to the risks of lead and the long-term risks of cancer and other health problems caused by hormone disruption, these fields can cause short-term harms. Artificial turf generates dust which may exacerbate children’s asthma.11,12 Fields heat up to temperatures far higher than ambient temperature, reaching temperatures that are more than 70 degrees warmer than nearby grass; for example, 180 degrees when the temperature is in the high 90’s and 150-170 degrees on a sunny day when the air temperature is only in the 70’s.13,14 We have measured the temperatures ourselves and been shocked by the results. These temperatures can cause heat stress and burns.

Fields made of crumb rubber have been marketed as reducing injuries compared to grass. However, research has shown that this is not the case. We have spoken to students terribly harmed by turf burn, and studies have indicated increased risk for some types of injuries, including joint, foot, and brain injuries.15,16,17 That is the reason that only two Major League Baseball parks use artificial turf and why the men’s soccer World Cup is now always played on grass.  In response to the demands of women soccer players, the Women’s World Cup will require grass in 2023.

Organohalogen Flame Retardants

The National Academies of Sciences, Engineering, and Medicine issued their scoping plan to assess the hazards of organohalogen flame retardants (OFRs) last year.18 The report concluded that OFRs can be divided into subclasses on the basis of chemical structure, physicochemical properties, and predicted biologic activity. As noted in their summary of the report:

The committee identified 14 subclasses that can be used to conduct a class-based hazard assessment and concluded that the best approach is to define subclasses as broadly as is feasible for the analysis; defining subclasses too narrowly could defeat the purpose of a class approach to hazard assessment.

We encourage you to convene a CHAP to use this scoping plan to evaluate OFRs and to develop regulations to address OFRs in children’s products, upholstered residential furniture, mattresses/mattress pads, and the plastic casing of electronic devices. In addition, it is essential to consider current flammability standards to determine if there are changes that would improve their safety from chemical exposures as well as exposures during a fire.

OFRs are not bound to products to which they are added, so they migrate out of products and into dust. This allows them to get onto our skin and food and into the air. Because of their widespread use and the long-lasting nature of OFRs, consumers are continuously exposed to OFRs19 and many bioaccumulate in our food supply.20,21 As a result, OFRs are present in nearly all people in the U.S.22,23 For these reasons, CPSC should focus on the potential for hormone disruption, altered brain development, reduced ability to get and stay pregnant, and the timing of puberty.24,25 While not all OFRs have been adequately studied to determine whether all are unsafe, those that have been sufficiently studied have proved to be harmful to health.

We share the Commission’s concerns about fire hazards as well, but there is evidence that these flame retardants may not be effective at preventing deaths in real world situations.26,27 When the chemicals burn during a fire, the inhaled smoke is more toxic to humans, and exposures could result in serious harms, including death.

Helmets for Sport and Recreational Activities

There are up to 3.8 million concussions reported each year related to sport or recreational activities, with most reported for children and adolescents.28 This number is likely an underestimate.29 We urge the CPSC to focus greater attention on the need to ensure the effectiveness of helmets intended to protect against brain injuries during athletic activities. Currently, CPSC only provides guidelines for bicycle helmets, even though many organized sports and recreational activities use helmets to reduce the risk for severe head injuries, including baseball, football, snow sports, skiing/snowboarding, and climbing. Unfortunately, these helmets are not necessarily designed to prevent mild concussions.30 We encourage CPSC to consider how design changes could improve the ability of helmets to prevent severe head injuries as well as mild concussions, and to develop guidelines for helmets that reduce these risks without interfering with vision or hearing or other safety concerns.

Baby Products and Products Posing Risks to Young Children

The CPSC is the major safeguard to protect infants and young children from unsafe products that are widely sold and inadequately studied. Crib bumpers and infant sleepers are two examples that have received CPSC attention but CPSC has not adequately protected families from the tragedies of infant deaths caused by these products.

There is nothing more tragic than when an infant or young child dies due to a product in the home that families or loved ones purchased because they erroneously assumed they were tested and found to be safe. The standard for these products should not be based on the number of deaths per year, but rather the 1) risk to benefit ratio of the product and 2) whether regulations or restrictions would make the product safer. In the case of crib bumpers, they have no benefit. In the case of inclined infant sleepers, products were sold that were promoted as superior to other available products but in fact had no comparative benefits and were less safe.

Furniture that tips over and home elevators are two other examples of products that have resulted in deaths of young children. In both cases, CPSC should do more to prevent the sale of products that can be redesigned or modified to make them safe.

Liquid Nicotine Packaging

We agree with other public health and consumer organizations that have urged CPSC to immediately remove from the market dangerous liquid nicotine products lacking the child-resistant packaging and flow restrictors required under the Child Nicotine Poisoning Prevention Act of 2015. The law requires the CPSC to enforce a mandatory child-resistant packaging standard for liquid nicotine containers, including the use of flow restrictors.

Liquid nicotine is a highly toxic product that can seriously harm or kill children. Since liquid nicotine can be quickly absorbed through the skin, flow restrictors are an essential safeguard to reduce the risk of nicotine poisoning in children.

Effective CPSC enforcement measures to remove noncompliant products from the market are long overdue, and that enforcement should be an immediate priority.

Final Thoughts

CPSC is the only federal agency whose mission is to protect children and adults from harmful products used in their daily life. Flame retardants and lead and many different chemicals in artificial turf and playground surfaces and equipment get into the air and dust and thus into our bodies. These chemicals tend to have greater risks for fetuses and children. There are large gaps in our knowledge about the chemicals in the products on the market, because the companies do not provide that information to the public. Ideally, the potential health impact of all of these chemicals would be evaluated in the final product before it was sold. If that doesn’t happen, CPSC must do more to identify the health risks as soon as possible after children and adults have been exposed.

Too often, the lack of independently funded and publicly available research has been used to mislead the public. Claims that “there is no evidence of harm” are misunderstood to mean “there is no harm.”

While reducing exposures to dangerous products is key, there will always be some potential for harm. Whether those harms are from the intended use of a consumer product or an unintended but foreseeable use, CPSC has a very important role to play in reducing harm. Improving the timeliness and targeting of information campaigns to warn parents and children about harmful products is also a key task of the CPSC.

References

  1. Wooten, Alexander, Lead and Playgrounds, Presentation at the Takoma community forum in Washington, DC, July 29, 2019.
  2. California Office of Environmental Health Hazard Assessment (OEHHA). Evaluation of Health Effects of Recycled Waste Wires in Playground and Track Products. Prepared for the California Integrated Waste Management Board. 2007. https://www2.calrecycle.ca.gov/Publications/Details/1206
  3. Llompart M, Sanchez-Prado L, Lamas JP, et al. Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 2013;90(2):423-431. https://www.ncbi.nlm.nih.gov/pubmed/22921644/
  4. Marsili L, Coppola D, Bianchi N, et al. Release of polycyclic aromatic hydrocarbons and heavy metals from rubber crumb in synthetic turf fields: Preliminary hazard assessment for athletes. Journal of Environmental and Analytical Toxicology. 2014;5(2):1133-1149. https://www.hilarispublisher.com/open-access/release-of-polycyclic-aromatic-hydrocarbons-and-heavy-metals-from-rubber-crumb-in-synthetic-turf-fields-2161-0525.1000265.pdf
  5. 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://link.springer.com/article/10.1007/s11270-018-3711-7
  6. Perkins AN, Inayat-Hussain SH, Deziel NC, et al. Evaluation of potential carcinogenicity of organic chemicals in synthetic turf crumb rubber. Environmental Research. 2018;169:163–172. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396308/
  7. KimS, Yang JY, Kim HH, et al. Health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environmental Health and Toxicology. 2012;27:e2012005. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278598/
  8. Baca, N. Parents demand answers on playground lead in DC. wusa9.com. October 2, 2019. https://www.wusa9.com/article/news/local/dc/parent-forum-lead-playgrounds/65-45401b01-3371-436a-8f55-a364be0c07d3
  9. Consumer Product Safety Commission. Summary of Playground Surfacing Focus Groups. 2018. https://www.cpsc.gov/s3fs-public/Playground_Surfacing_Focus_Group_Report_2018.pdf
  10. National Center for Health Research. Children and Athletes at Play on Toxic Turf and Playgrounds. Center4research.org. http://www.center4research.org/children-athletes-play-toxic-turf-playgrounds/
  11. Shalat, SL. An Evaluation of Potential Exposures to Lead and Other Metals as the Result of Aerosolized Particulate Matter from Artificial Turf Playing Fields. Submitted to the New Jersey Department of Environmental Protection. 2011. http://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf
  12. Mount Sinai Children’s Environmental Health Center. Artificial Turf: A Health-Based Consumer Guide. 2017. http://icahn.mssm.edu/files/ISMMS/Assets/Departments/Environmental%20Medicine%20and%20Public%20Health/CEHC%20Consumer%20Guide%20to%20Artificial%20Turf%20May%202017.pdf
  13. Serensits TJ, McNitt AS, Petrunak DM. Human health issues on synthetic turf in the USA. Proceedings of the Institution of Mechanical Engineers, Part P: Journal of Sports Engineering and Technology. 2011;225(3):139-146. https://plantscience.psu.edu/research/centers/ssrc/documents/human-health-issues-on-synthetic-turf-in-the-usa.pdf
  14. Penn State’s Center for Sports Surface Research. Synthetic Turf Heat Evaluation- Progress Report. 2012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  15. Theobald P, Whitelegg L, Nokes LD, et al. The predicted risk of head injury from fall-related impacts on to third-generation artificial turf and grass soccer surfaces: A comparative biomechanical analysis. Sports Biomechanics. 2010;9(1):29-37. https://www.ncbi.nlm.nih.gov/pubmed/20446637
  16. Balazs GC, Pavey GJ, Brelin AM, et al. Risk of anterior cruciate ligament injury in athletes on synthetic playing surfaces: A systematic review. American Journal of Sports Medicine. 2015;43(7):1798-804. https://www.ncbi.nlm.nih.gov/pubmed/25164575
  17. Mack CD, Hershman EB, Anderson RB, et al. Higher rates of lower extremity injury on synthetic turf compared with natural turf among national football league athletes: Epidemiologic confirmation of a biomechanical hypothesis. American Journal of Sports Medicine. 2019;47(1):189-196. https://www.ncbi.nlm.nih.gov/pubmed/30452873
  18. National Academies of Sciences, Engineering, and Medicine; Division on Earth and Life Studies; Board on Environmental Studies and Toxicology; Committee to Develop a Scoping Plan to Assess the Hazards of Organohalogen Flame Retardants. A Class Approach to Hazard Assessment of Organohalogen Flame Retardants. Washington (DC): National Academies Press (US). 2019. https://www.ncbi.nlm.nih.gov/books/NBK545458/
  19. Allgood JM, Vahid KS, Jeeva K, et al. Spatiotemporal analysis of human exposure to halogenated flame retardant chemicals. Science of the Total Environment. 2017;609:272-276. https://www.ncbi.nlm.nih.gov/pubmed/28750230
  20. Lupton SJ, Hakk H. Polybrominated diphenyl ethers (PBDEs) in US meat and poultry: 2012-13 levels, trends and estimated consumer exposures. Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment. 2017;34(9):1584-1595. https://www.ncbi.nlm.nih.gov/pubmed/28604253
  21. Schecter A, Colacino J, Patel K, et al. Polybrominated diphenyl ether levels in foodstuffs collected from three locations from the United States. Toxicology and Applied Pharmacology. 2010;243(2):217-224. https://www.ncbi.nlm.nih.gov/pubmed/19835901
  22. Centers for Disease Control and Prevention. Fourth National Report on Human Exposure to Environmental Chemicals, Updated Tables. 2019. http://www.cdc.gov/exposurereport/
  23. Ospina M, Jayatilaka N, Wong LY, et al. Exposure to organophosphate flame retardant chemicals in the U.S. general population: Data from the 2013-2014 National Health and Nutrition Examination Survey. Environment International. 2017;110:32–41. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6261284/
  24. Dishaw L, Macaulay L, Roberts SC, et al. Exposures, mechanisms, and impacts of endocrine-active flame retardants. Current Opinion in Pharmacology. 2014;19:125-133. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4252719/
  25. Kim YR, Harden FA, Toms LM, et al. Health consequences of exposure to brominated flame retardants: A systematic review. Chemosphere. 2014;106:1-19. https://www.ncbi.nlm.nih.gov/pubmed/24529398
  26. Shaw SD, Blum A, Weber R, et al. Halogenated flame retardants: Do the fire safety benefits justify the risks? Reviews on Environmental Health. 2010;25:261-305. https://www.ncbi.nlm.nih.gov/pubmed/21268442
  27. McKenna S, Birtles R, Dickens K, et al. Flame retardants in UK furniture increase smoke toxicity more than they reduce fire growth rate. Chemosphere. 2018;196:429-439. https://www.ncbi.nlm.nih.gov/pubmed/29324384
  28. Halstead ME, Walter KD, Moffatt K, et al. Sport-related concussion in children and adolescents. Pediatrics. 2018;142(6):e20183074. https://pediatrics.aappublications.org/content/142/6/e20183074
  29. Baldwin GT, Breiding MJ, Dawn Comstock R. Epidemiology of sports concussion in the United States. Handbook of Clinical Neurology. 2018;158:163-74. https://www.ncbi.nlm.nih.gov/pubmed/30482376
  30. Consumer Product Safety Commission. Which helmet for which activity? https://www.cpsc.gov/safety-education/safety-guides/sports-fitness-and-recreation-bicycles/which-helmet-which-activity
  31. Perry, C. Why Inclined Baby Sleepers Are So Dangerous. Parents.com. November 8, 2019. https://www.parents.com/baby/sleep/basics/why-inclined-baby-sleepers-are-so-dangerous/

CPTF Statement Supporting Maryland House Bill to Ban State Funds for Artificial Turf and Playgrounds

Diana Zuckerman, PhD, National Center for Health Research, March 5, 2020


CPTF Statement Supporting Maryland House Bill 1098
To Ban State Funds for Artificial Turf and Playgrounds
March 5, 2020

Diana Zuckerman, PhD, President

Thank you for the opportunity to express our strong support for of HB 1098, to restrict the funding of additional artificial turf fields and playground surfaces in Maryland.

As a long-time resident of Montgomery County and president of the National Center for Health Research (NCHR), I am hoping that this bill will finally get the support it deserves.  NCHR is a non-profit public health organization which analyzes and explains scientific and medical information that can be used to improve policies, programs, services, and products.

Our organization has been testifying and writing about the dangers of synthetic turf and playground surfaces for several years, and we’ve testified before state, local and federal legislative bodies and regulatory agencies.  Our scientific staff has reviewed all publicly available scientific studies pertaining to the health impact of the lead and toxic chemicals that are in artificial turf and playground surfaces, compared to natural surfaces such as grass and engineered wood fiber.

In the last year, scientists have reported finding potentially dangerous levels of lead in artificial turf fields and playground surfaces.  In addition, plastic and synthetic rubber are made with different types of hormone-disrupting chemicals, some of which are known to be particularly harmful to growing children.  Scientists at the National Institute of Environmental Health Sciences, which is an institute of NIH, have concluded that these chemicals can be threats to health even at low levels.  According to research at Yale University, 20% of the 96 chemicals they found in samples at five different synthetic turf companies were classified as probable carcinogens.[1]

Manufacturers and advocates for synthetic turf often state that artificial turf has been declared safe by federal authorities.  That is completely untrue.  It is essential to understand that there are no federal requirements for safety testing of these synthetic turf products before they are sold.   Although the EPA and the federal Consumer Product Safety Commission are jointly studying the chemicals used in these products, they have not released any data on studies of children exposed to these fields and playgrounds day after day and week after week.

We commend you for considering how to reverse the dangerous trend of replacing natural fields and playground surfaces with materials that are dangerous to our children’s health, potentially dangerous to adult fertility and health, and bad for our environment.  In the last year, we’ve learned new information about lead and PFAS in artificial turf, as well as the risks of some of the newer infill materials that turf companies are using to replace tire crumb.

Tire crumb, used as infill for artificial turf fields and also used for colorful rubber playground surfaces, has well-known risks, containing lead as well as chemicals that have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer.  However, the plastic grass itself has dangerous levels of lead, PFAS, and other toxic chemicals as well.  PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks.

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products.  Despite claims to the contrary, none have demonstrated that artificial turf is safe.  Although the Trump Administration’s EPA stated that there was no conclusive evidence that the levels of chemicals in artificial turf was harmful to children, they made it clear that their research was based on assumptions rather than scientific research on children.

Lead

The American Academy of Pediatrics states that no level of lead exposure is safe for children, because lead can cause cognitive damage even at low levels.  Some children are even more vulnerable than others, and that can be difficult or even impossible to predict.  Since lead has been found in tire crumb as well as new synthetic rubber, it is not surprising that numerous artificial turf fields and playgrounds made with either tire crumb or “virgin” rubber have been found to contain lead.  However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or some other materials also contain lead.  Whether from infill or from plastic grass, the lead doesn’t just stay on the surface.  With wear, the turf materials turn to dust that is invisible to the eye but that children are breathing in when they play.

Why are chemicals that are banned from children’s toys allowed in artificial turf and rubber playground surfaces?

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals (also called EDCs) and other toxins.  There is very good evidence regarding these chemicals in tire crumb, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA).

The California OEHHA conducted three laboratory studies to investigate the potential health risks to children from playground surfaces made from tire waste.1 The researchers created a chemical solution that mimicked the conditions of a child’s stomach and placed 10 grams of tire shreds in it for 21 hours at a temperature of 37°C.  One study mimicked a child touching the tire shreds and then touching her mouth by wiping recycled tire playground surfaces and measuring chemical levels on the wipes.  To evaluate skin contact alone, the researchers tested guinea pigs to see if rubber tire playground samples caused any health problems.  Results of the OEHHA studies showed that five chemicals, including four PAHs, were found on wipe samples.  One of the PAHs, “chrysene,” was higher than the risk level established by the OEHHA, and therefore, could possibly increase the chances of a child developing cancer.

A 2018 report by Yale scientists detected 92 chemicals in samples from 6 different artificial turf companies, including unused bags of tire crumb. 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 found in rubber and plastic 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 artificial turf or 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, EDC 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 beginning 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 Serious Harm

It is essential to distinguish between evidence of harm and evidence of safety. Like the Trump Administration’s EPA, companies that sell and install artificial turf 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 no clear evidence that an artificial turf field has caused specific children to develop cancer. However, the 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 evidence that smoking or Agent Orange caused cancer.  It took many years to develop that evidence, and the same will be true for artificial turf.

I have testified about the risks of these materials at the U.S. Consumer Product Safety Commission, as well as previous Maryland hearings.  I am sorry to say that I have repeatedly seen and heard scientists paid by the turf industry and other turf industry lobbyists 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).

However, we know that the materials being used in artificial turf and 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 your community.  That’s why I have spoken out about the risks of artificial turf in my community and on a national level.  The question must be asked: if they had all the facts, would Maryland families choose to spend millions of taxpayer dollars on fields that are unhealthy and unsafe rather than well-designed natural grass fields?

Dangerously Hot and Hard Fields

Summers in Maryland can get hot.  Even when the temperature is a pleasant 80 degrees Fahrenheit, artificial turf and playground surfaces can reach 150 degrees or higher.  Obviously, turf and playground surfaces are likely to be even hotter than 150 degrees on a sunny 90 degree day.  That can cause “heat poisoning” as well as burns.

Artificial turf fields get hard as well.  Turf companies recommend annual tests at 10 locations on each turf field, using something called a Gmax scores.  A Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk.  However, the synthetic turf industry and ASTM (American Society for Testing and Materials), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field.  Are Maryland communities paying to have these tests conducted on all public artificial turf fields?

The hardness of natural grass fields is substantially influenced by maintenance, rain and other weather; if the field gets hard, aeration water will make it safe again.  In contrast, once an artificial turf field has a Gmax score above 165, it needs to be replaced because while the scores can vary somewhat due to weather, the scores will inevitably get higher because the turf will get harder.  Gmax testing involves testing 10 different areas of a playing fields, to make sure all are considered safe.  Some officials average those 10 scores to determine safety; however, experts explain that is not appropriate.  If a child (or adult) falls, it can be at the hardest part of the field, which is why safety is determined based on each area tested.

Environmental Issues

In addition to the health risks to school children and athletes, approximately three tons of infill materials migrate off of each synthetic turf field into the greater environment each year.  About 2-5 metric tons of infill must be replaced every year for each field, meaning that tons of the infill have migrated off the field into grass, water, and our homes.  The fields also continuously shed microplastics as the plastic blades break down.[4,5] These materials may contain additives such as PAHs, flame retardants, UV inhibitors, etc., which can be toxic to marine and aquatic life; and microplastics are known to migrate into the oceans, food chain, and drinking water and can absorb and concentrate other toxins from the environment.[6,7,8]

Synthetic surfaces also create heat islands.[9,10]  In contrast, organically managed natural grass saves energy by dissipating heat, cooling the air, and reducing energy to cool nearby buildings.  Natural grass and soil protect groundwater quality, biodegrade polluting chemicals and bacteria, reduce surface water runoff, and abate noise and reduce glare.[11]

Envirofill and Alternative Infills

Envirofill artificial turf fields are advertised as “cooler” and “safer,” but our research indicates that these fields are still at least 30-50 degrees hotter than natural grass. Envirofill is composed of materials resembling plastic polymer pellets (similar in appearance to tic tacs) with silica inside. Silica is classified as a hazardous material according to OSHA regulations, and the American Academy of Pediatrics specifically recommends avoiding it on playgrounds. The manufacturers and vendors of these products claim that the silica stays inside the plastic coating.  However, sunlight and the grinding force from playing on the field breaks down the plastic coating. For that reason, even the product warranty admits that only 70% of the silica will remain encapsulated. The other 30% can be very harmful as children are exposed to it in the air.

In addition, the Envirofill pellets have been coated with an antibacterial called triclosan.  Triclosan is registered as a pesticide with the EPA and the FDA has banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use.  Research shows a link to liver and inhalation toxicity and hormone disruption.  The manufacturer of Envirofill says that the company no longer uses triclosan, but they provide no scientific evidence that the antibacterial they are now using is any safer than triclosan.  Microscopic particles of this synthetic turf infill will be inhaled by children, and visible and invisible particles come off of the field, ending up in shoes, socks, pockets, and hair.

In response to the concerns of educated parents and government officials, other new materials are now being used instead of tire crumb and other very controversial materials.  However, all the materials being used (such as volcanic ash, corn husks, and Corkonut) have raised concerns and none are proven to be as safe or effective as well-designed grass fields.

Conclusions

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

I have cited several relevant scientific articles on artificial turf in this letter, and there are numerous studies and growing evidence of the harm caused by these synthetic materials.  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 of artificial fields on our children.  Your decisions about artificial turf and playground materials will directly and indirectly help educate parents throughout the state, making it even more important that your decision is based on scientific evidence, not on sales pitches by individuals with conflicts of interest.

Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe.  But 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.

Please pass HB 1098 and thank you for addressing this critical public health issue.

 

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/
  4. Magnusson K, Eliasson K, Fråne A, et al. Swedish sources and pathways for microplastics to the marine environment, a review of existing data. Stockholm: IVL- Swedish Environmental Research Institute. 2016. https://www.naturvardsverket.se/upload/miljoarbete-i-samhallet/miljoarbete-i-sverige/regeringsuppdrag/utslapp-mikroplaster-havet/RU-mikroplaster-english-5-april-2017.pdf
  5. Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. International Journal of Environmental Research Public Health. 2017;14(10):pii: E1265. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  6. Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018,13(4): e0194970. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895013/
  7. Oehlmann J, Schulte-Oehlmann U, Kloas W et al.  A critical analysis of the biological impacts of plasticizers on wildlife. Philosophical Transactions of the Royal Society B. 2009;364:2047–2062. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  8. Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philosophical Transactions of the Royal Society B. 2009;364:2153–2166. https://royalsocietypublishing.org/doi/full/10.1098/rstb.2009.0053
  9. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014;72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
  10. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  11. Stier JC, Steinke K, Ervin EH, Higginson FR, McMaugh PE. Turfgrass benefits and issues. Turfgrass: Biology, Use, and Management, Agronomy Monograph 56. American Society of Agronomy, Crop Science Society of America, Soil Science Society of America. 2013;105–145. https://dl.sciencesocieties.org/publications/books/tocs/agronomymonogra/turfgrassbiolog

NCHR’s Testimony to FDA on TOOKAD to Treat Low-Risk Prostate Cancer

Diana Zuckerman, National Center for Health Research, February 26, 2020


Thank you for the opportunity to speak today.  I am Dr. Diana Zuckerman, president of the National Center for Health Research. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.

Although active surveillance is recommended for many patients with low-risk prostate cancer, some patients prefer treatment and that can be a reasonable choice as long as the treatment has a meaningful benefit and does not increase patients’ harms. However, the clinical data for TOOKAD that we are discussing today do not clearly demonstrate that its benefits outweigh its risks – efficacy is uncertain, particularly for U.S. patients, and the drug has the well-known very negative side effects typical of prostate cancer treatments.  

There are 5 major problems with the data, and the FDA did an excellent job of expressing their concerns:

#1.  There was only 1 clinical trial. Replication is the key to science, and effective treatments are available for prostate cancer, so the FDA should not approve a new treatment based on just one study.

#2.  This one trial took place in Europe, and 99.8% of participants were white.  Five patients – not 5% but only 5 men — were not white. Given the higher percentage of African American men who die of prostate cancer, this lack of diversity should not be considered acceptable, unless the FDA is considering approving this product for white men only.

#3. The accuracy of detecting cancer is one major problem. The data showed a high false negative rate. 13.5% of those in the active surveillance arm had a negative biopsy after 2 years. Since it is unlikely that the cancer would spontaneously disappear, this probably reflects false positives in the original diagnosis or false negatives in the post-test. This high false negative rate raises major concerns about the accuracy of biopsies in the treatment arm and at baseline. 

#4. Further, there was a large amount of missing data regarding biopsies at 24 months. Unfortunately, 18.4% of the patients in the treatment arm and 41.5% of those in the active surveillance arm were missing these crucial pieces of information regarding efficacy.  That makes it impossible to draw conclusions based on this one study. 

 #5. The trial was open-label, meaning patients as well as those collecting the data knew whether a particular patient was receiving the treatment or active surveillance. The decision to pursue definitive therapy  — such as surgery — was a subjective decision. Wouldn’t active surveillance patients be more likely to choose treatments later. Also, when biopsy results were uncertain, pathologists may have been biased by their knowledge of whether or not a patient was assigned to the treatment group. 

The FDA held a workshop in September 2018 to discuss issues related to clinical trials of novel treatments for localized prostate cancer.  They concluded that treatment endpoints might be clinically meaningful only if 1) the patients using the new therapy were less likely to undergo subsequent treatment (such as surgery), 2) there was an overall reduction in adverse events, and 3) there was no reduction in long-term cancer control.  However, in this trial, these criteria were not met. 95% of those treated with TOOKAD had adverse event in the weeks after treatment compared to 55% of the men on active surveillance. For many men these problems continued 2 years after treatment, when 34% continued to have urinary problems compared to 16% with active surveillance. Two years after treatment, 38% of patients treated with TOOKAD had erectile dysfunction, compared with 12% of those assigned to active surveillance. In other words, erectile dysfunction was 3x as prevalent among those treated with TOOKAD.

The long-term complications of the treatment that are unclear.  In addition to the urinary problems and ED that might be worse for those who are subsequently treated with surgery, it may be more difficult to obtain accurate biopsies. 

The American Urological Association recommends active surveillance as the best available treatment for low-risk prostate cancer patients, and the data clearly support that recommendation.  We understand that the fear of cancer can persuade men to seek treatment, but if so they should not be bamboozled by ads to choose a product that may have no benefits for them but that does have clear risks of erectile dysfunction and urinary problems. If the FDA thinks this product might have a useful benefit, they should require at least one double-blind study – preferably two – since the treatment does not involved surgery and is therefore easier to blind.  The studies should also include a patient population that represents the diversity of men with prostate cancer. There is no need to rush to approve this particular treatment based on a single, open label trial with endpoints of questionable clinical relevance and problems with inaccurate diagnoses. Better research needs to be completed before approval because the sponsor did not comply with FDA’s recommendations for the study and was even less likely to do so after the product is approved.   

The Oncologic Drugs Advisory Committee voted 13 to 2 against approval of TOOKAD to treat low-risk prostate cancer.

NCHR’s Comments on FDA’s Notice on the Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks

National Center for Health Research, February 24, 2020


National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Applications  for IQOS System With Marlboro Heatsticks

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks submitted by Philip Morris International.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We strongly oppose the approval of this modified risk application by Philip Morris International. According to the FDA, a modified risk tobacco product needs to demonstrate that it (1) significantly reduces harm to smokers and (2) promotes public health. However, there is insufficient evidence to support the claim that these products significantly reduce harm for smokers. Further, there are potential risks to public health because these products may be appealing to non-smokers, particularly adolescents.The products do contain nicotine, which is addictive.

The applicant claims that “switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.” They also claim that it delivers tobacco taste and nicotine satisfaction, which could promote IQOS use as an alternative to smoking cigarettes. However, there is not sufficient data that cigarette smokers would switch to complete IQOS use instead of continuing to smoke traditional cigarettes and thus engage in dual use. The study designs, for example, do not show that consumers’ actual use of the product would significantly reduce the use of traditional cigarettes or result in them switching completely from cigarette use. Without that scientific evidence, there is no proof to support the applicant’s claim that this product leads to a substantial reduction in toxicity.

Nearly 90% of smokers smoked their first cigarette before the age of 18,1 yet adolescents were not included in any of the studies provided by the applicant. The vaping epidemic among adolescents illustrates why we should be concerned about lack of data on teenagers. Research has shown that over half of 12th graders who vape reported that they do so “in order to “see what it’s like,” and one-third report that they vape “because it tastes good.”2 The interest that adolescents show in vaping suggest that adolescents who previously did not consume tobacco products may be interested in trying a novel form of smoking, particularly one with a flavor, such as menthol. Since the applicant has failed to provide any research on the likely impact on adolescents, we can’t assume that adolescents would not be enticed to try the product.

The main reason why we oppose a risk mitigation claim for these products is that they have not been proven to reduce risk. In addition, previous studies have demonstrated that adolescents are likely to perceive products with risk-mitigation claims as less harmful, and Philip Morris International has failed to demonstrate that this would not be the case for their IQOS system. To add to the public health concerns, the effects of the risk mitigation claims in advertising and marketing were not tested, despite the fact that some tobacco advertisements can increase use among youth. The increase in vaping among youth has demonstrated that adolescents are swayed by advertising, and that once they begin a habit such as vaping or smoking, they are unlikely to stop.

In summary, the data provided do not adequately support the claim that the IQOS systems 1) significantly reduce harm for smokers and 2) promote public health. A modified risk statement may encourage people, particularly adolescents, who do not smoke to begin using this tobacco product. At the same time, such a statement could lead to more dual usage among current smokers thinking that this is a safe alternative.

The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

References

  1. Youth and Tobacco Use. CDC.gov. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/. Updated December 10, 2019.
  2. National Institute on Drug Abuse. Monitoring the Future Survey: High School and Youth Trends 2019. National Institute on Drug Abuse; National Institutes of Health; U.S. Department of Health and Human Services; 2019. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/drugfacts-mtf.pdf

National Center for Health Research Written Statement to Greenwich Board of Education

National Center for Health Research, February 19, 2020


Written Statement to Greenwich Board of Education

Diana Zuckerman, PhD, National Center for Health Research

February 19, 2020

Dear Chairman Bernstein and Members of the Greenwich Board of Education:

I am disappointed that I was unable to be there in person for your meeting on February 20, but I wanted to update you on the latest research about the health risks of artificial turf for children and adults.

As President of the National Center for Health Research, I want to share the information we have provided to Members of Congress, state and federal agencies, state and local legislators, parents, and others who want to ensure that our children are not exposed to dangerous chemicals or metals when they play on artificial turf or playgrounds. Our nonprofit think tank is 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.

We commend you for considering the possible risks of replacing grass fields with artificial turf. In the last year, we’ve learned new information about lead and PFAS in artificial turf, as well as the risks of some of the newer infill materials that turf companies are using to replace tire crumb. Tire crumb 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. However, the plastic grass itself has dangerous levels of lead, PFAS, and other toxic chemicals as well.  PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks.

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products. Despite claims to the contrary, none have concluded that artificial turf is safe. Although the Trump Administration’s EPA stated that there was no conclusive evidence that the levels of chemicals in artificial turf was harmful to children, they made it clear that their research was based on assumptions rather than scientific research on children.

Lead

As you know, the American Academy of Pediatrics states that no level of lead exposure should be considered safe for children, because lead can cause cognitive damage even at low levels. Some children are more vulnerable than others, and that can be difficult or even impossible to predict. Since lead has been found in tire crumb as well as new synthetic rubber, it is not surprising that numerous artificial turf fields and playgrounds made with either tire crumb or “virgin” rubber have been found to contain lead. However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or some other materials also contain lead. Whether from infill or from plastic grass, the lead doesn’t just stay on the surface. With wear, the turf materials turn to dust that is invisible to the eye but that children are breathing in when they play.

Why are chemicals that are banned from children’s toys allowed in 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, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA).[1]

A 2018 report by Yale scientists detected 92 chemicals in samples from 6 different artificial turf companies, including unused bags of tire crumb. 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 found in rubber and plastic 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 artificial turf or 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, EDC 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 beginning 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. Like the Trump Administration’s EPA, companies that sell and install artificial turf 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 no clear evidence that an artificial turf field has caused specific children to develop cancer. However, the 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 evidence that smoking or Agent Orange caused cancer. It took many years to develop that evidence, and the same will be true for artificial turf. 

I have testified about the risks of these materials at the U.S. Consumer Product Safety Commission as well as state legislatures and city councils. I am sorry to say that I have repeatedly seen and heard scientists paid by the turf industry and other turf industry lobbyists 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). 

However, we know that the materials being used in artificial turf and 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 your community. That’s why I have spoken out about the risks of artificial turf in my community and on a national level. The question must be asked: if they had all the facts, would Greenwich or any other community choose to spend millions of dollars on fields that are less safe than well-designed natural grass fields?

Dangerously Hot and Hard Fields

I lived in Connecticut for several years while on the faculty at Yale and Vassar, and I know the climate well. When the weather is warm and/or sunny, it is usually quite pleasant to be outside – as long as you aren’t on artificial turf or an outdoor rubber surface. Even when the temperature above the grass is 80 degrees Fahrenheit, artificial turf can reach 150 degrees or higher. Obviously, a 90 degree day is likely to be even hotter than 150 degrees on turf. That can cause “heat poisoning” as well as burns.

Artificial turf fields get hard as well. Turf companies recommend annual tests at 10 locations on each turf field, using something called a Gmax scores. A Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk. However, the synthetic turf industry and ASTM (American Society for Testing and Materials), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field. Is Greenwich paying to have these tests conducted on all your public artificial turf fields?

The hardness of natural grass fields is substantially influenced by rain and other weather; if the field gets hard, rain or watering will make it safe again. In contrast, once an artificial turf field has a Gmax score above 165, it needs to be replaced because while the scores can vary somewhat due to weather, the scores will inevitably get higher because the turf will get harder. Gmax testing involves testing 10 different areas of a playing fields, to make sure all are considered safe.  Some officials average those 10 scores to determine safety; however, experts explain that is not appropriate. If a child (or adult) falls, it can be at the hardest part of the field, which is why that is the way safety is determined.

Environmental Issues

In addition to the health risks to school children and athletes, approximately three tons of infill materials migrate off of each synthetic turf field into the greater environment each year. About 2-5 metric tons of infill must be replaced every year for each field, meaning that tons of the infill have migrated off the field into grass, water, and our homes.[4] The fields also continuously shed microplastics as the plastic blades break down.[5,6] These materials may contain additives such as PAHs, flame retardants, UV inhibitors, etc., which can be toxic to marine and aquatic life; and microplastics are known to migrate into the oceans, food chain, and drinking water and can absorb and concentrate other toxins from the environment.[7,8,9]

Synthetic surfaces also create heat islands.10,11 In contrast, organically managed natural grass saves energy by dissipating heat, cooling the air, and reducing energy to cool nearby buildings. Natural grass and soil protect groundwater quality, biodegrade polluting chemicals and bacteria, reduce surface water runoff, and abate noise and reduce glare.[12]

Envirofill and Alternative Infills

Envirofill artificial turf fields are advertised as “cooler” and safer, but our research indicates that these fields are still at least 30-50 degrees hotter than natural grass. Envirofill is composed of materials resembling plastic polymer pellets (similar in appearance to tic tacs) with silica inside. Silica is classified as a hazardous material according to OSHA regulations, and the American Academy of Pediatrics specifically recommends avoiding it on playgrounds. The manufacturers and vendors of these products claim that the silica stays inside the plastic coating. However, sunlight and the grinding force from playing on the field breaks down the plastic coating. For that reason, even the product warranty admits that only 70% of the silica will remain encapsulated. The other 30% can be very harmful as children are exposed to it in the air. 

In addition, the Envirofill pellets have been coated with an antibacterial called triclosan. Triclosan is registered as a pesticide with the EPA and the FDA has banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use. Research shows a link to liver and inhalation toxicity and hormone disruption. The manufacturer of Envirofill says that the company no longer uses triclosan, but they provide no scientific evidence that the antibacterial they are now using is any safer than triclosan. Microscopic particles of this synthetic turf infill will be inhaled by children, and visible and invisible particles come off of the field, ending up in shoes, socks, pockets, and hair.

In response to the concerns of educated parents and government officials, other new materials are now being used instead of tire crumb and other very controversial materials. However, all the materials being used (such as volcanic ash, corn husks, and Corkonut) have raised concerns and none are proven to be as safe or effective as well-designed grass fields. 

Conclusions

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

I have cited several relevant scientific articles on artificial turf in this letter, and there are numerous studies and growing evidence of the harm caused by these synthetic materials. 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 of artificial fields on our children. Last year, I told members of the BET that their decision about artificial turf can save lives and improve the health of children in Greenwich.  You owe it to your community to make sure you know the risks of artificial turf and do all you can to protect Greenwich children from the known risks and also the suspected risks.  Because of Greenwich’s reputation as a well-educated and affluent community, your decisions about artificial turf in Greenwich will be cited by other communities, making it even more important that your decision is based on scientific evidence, not on sales pitches by individuals with conflicts of interest.

Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe. But 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.

Sincerely,

Diana Zuckerman, Ph.D.

President

The PDF of this letter can be found here.

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/
  4. York T. Greener grass awaits: Environmental & fiscal responsibility team up in synthetic turf. Recreation Management. February 2012. http://recmanagement.com/feature_print.php?fid=201202fe02
  5. Magnusson K, Eliasson K, Fråne A, et al. Swedish sources and pathways for microplastics to the marine environment, a review of existing data. Stockholm: IVL- Swedish Environmental Research Institute. 2016. https://www.naturvardsverket.se/upload/miljoarbete-i-samhallet/miljoarbete-i-sverige/regeringsuppdrag/utslapp-mikroplaster-havet/RU-mikroplaster-english-5-april-2017.pdf
  6. Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. International Journal of Environmental Research Public Health. 2017;14(10):pii: E1265. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  7. Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018,13(4): e0194970. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895013/
  8. Oehlmann J, Schulte-Oehlmann U, Kloas W et al.  A critical analysis of the biological impacts of plasticizers on wildlife. Philosophical Transactions of the Royal Society B. 2009;364:2047–2062. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  9. Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philosophical Transactions of the Royal Society B. 2009;364:2153–2166. https://royalsocietypublishing.org/doi/full/10.1098/rstb.2009.0053
  10. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014;72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
  11. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  12. Stier JC, Steinke K, Ervin EH, Higginson FR, McMaugh PE. Turfgrass benefits and issues. Turfgrass: Biology, Use, and Management, Agronomy Monograph 56. American Society of Agronomy, Crop Science Society of America, Soil Science Society of America. 2013;105–145. https://dl.sciencesocieties.org/publications/books/tocs/agronomymonogra/turfgrassbiolog

NCHR Testimony on Low Nicotine Cigarette Claim

Nina Zeldes, National Center for Health Research, February 14, 2020


Thank you for the opportunity to speak here today. My name is Dr. Nina Zeldes and I am here as a senior fellow speaking on behalf of the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from drug and medical device companies or tobacco companies, so I have no conflicts of interest.

We strongly oppose the approval of this modified risk application by the 22nd Century Group for their low-nicotine combusted filtered cigarette tobacco products. According to the FDA, a modified risk tobacco product needs to demonstrate that it (1) significantly reduces harm to smokers and (2) promotes public health. Unfortunately, evidence is lacking to support the claim that this product significantly reduces harm for smokers. At the same time, it is likely to entice people who have never smoked, especially adolescents, to start smoking.

As the applicant has pointed out, this low nicotine cigarette poses similar risks of tobacco-related disease as conventional cigarettes. Its only advantage is that it contains much less nicotine, and could therefore be less addictive. However, the claims of reduced harm seem to be based entirely on the assumption that people would smoke less often – an assumption that was not adequately supported by the applicant’s data. For example, this product was rated as less satisfying than smokers’ usual brand of cigarettes and less likely to be used again compared to nicotine gum, raising questions about whether smokers would switch completely to this product and ultimately quit smoking.

The FDA briefing document points out that nicotine is often perceived as causing smoking-related health risks. That means that a claim of a product having “95% less nicotine” will be misunderstood as being less likely to cause cancer, when in fact it just means potentially less addictive. Although the applicant provided a voluntary warning that “less nicotine does NOT mean safer”, study participants who were shown this warning still perceived this product as safer than conventional cigarettes. Additionally, the applicant only tested the claims on packaging and not how they would be used in ads and social media. We’ve all learned that the context and imagery in these ads can vastly alter how these claims are interpreted. Tobacco companies have learned how to make very persuasive ads that go beyond the specific claims that they make.

And as we all know, smoking is a habit that is very difficult to break, and addiction to nicotine is only one of the reasons that quitting is so difficult.

Most smokers start smoking as children and adolescents, and yet adolescents were not included in any of the studies provided by the applicant. Previous studies have demonstrated that this group is likely to perceive products with a risk-mitigation claim as less harmful, but that is not proven in this case.

In conclusion, while the claim that this product contains 95% less nicotine may be factually correct, the company’s claims of health benefits are based on the implied assumption that this product would help smokers quit. If that is supposed to be the benefit, their product should have sought to market this product as a cessation aid. Moreover, the packaging does not explain how to achieve this health benefit. Because of such claims, smokers interested in reducing smoking-related health risks might start using this product, instead of quitting or using available FDA-approved cessation products. Meanwhile, non-smokers, particularly adolescents, might start using this product, thinking it is a safe alternative to other tobacco products.

If we’ve learned anything from the vaping epidemic, it is that adolescents are easy to influence, and once they start a habit like smoking or vaping, they are unlikely to stop. We encourage you to let the FDA know that you do not believe that would be an acceptable outcome.

Thank you.

Coalition Letter Urging Support for the Reversing the Youth Tobacco Epidemic Act

February 4, 2020


See PDF: Coalition Letter Urging Support for HR 2339 2.4.20

U.S. House of Representatives
Washington, DC 20515

Dear Representative:

We are writing to express our strong support for H.R. 2339, the Reversing the Youth Tobacco Epidemic Act of 2019. This legislation will address the current youth e-cigarette epidemic that is undermining the progress made in reducing youth tobacco use.

Use of e-cigarettes by youth has escalated rapidly in recent years, placing a new generation at risk of nicotine addiction and tobacco use. Between 2017 and 2019, e-cigarette use more than doubled among high school students (from 11.7% to 27.5%) and tripled among middle school students (from 3.3% to 10.5%). More than 5.3 million middle and high school students used e-cigarettes in 2019, an alarming increase of more than 3 million in two years. Use of other tobacco products, including cigarettes, cigars and hookah, is also a serious problem. Tobacco use remains the leading preventable cause of death in the United States and is responsible for approximately $170 billion in health care costs each year.

The Reversing the Youth Tobacco Epidemic Act provides a much-needed response to this serious public health problem. Its prohibition on flavored tobacco products, including flavored e-cigarettes, flavored cigars, and menthol cigarettes, is needed to stop tobacco companies from targeting and addicting kids with enticing flavors, such as gummy bear and cotton candy. Flavors mask the harsh taste of tobacco and make it easier for kids to start to use a tobacco product and to become addicted.

The bill’s prohibition on flavored e-cigarettes is all the more important because the Administration’s recently released policy on flavored e-cigarettes will leave thousands of flavored e-liquids and devices on the market. Flavors are a key reason for widespread youth use of e-cigarettes. Ninety-seven percent of current youth e-cigarette users have used a flavored e-cigarette in the past month, and seven out of ten said they used e-cigarettes “because they come in flavors I like.”

The bill’s prohibition on menthol cigarettes, flavored cigars, and other flavored tobacco products will also help protect kids and public health. More than half of youth smokers – and seven in ten African American youth smokers – smoke menthol cigarettes. As a result of decades of pervasive tobacco industry marketing, 85 percent of African-American smokers smoke menthol cigarettes, and menthol is a likely contributor to the higher rates of tobacco-caused death and disease experienced by African Americans. A 2013 Food and Drug Administration (FDA) analysis concluded that menthol cigarettes increase youth initiation, increase nicotine addiction, and make it harder for smokers to quit. Cigars are also available in a wide variety of flavors that make them more attractive to kids. More than one million high school students smoke cigars.

In addition to its prohibition on flavored tobacco products, the Reversing the Youth Tobacco Epidemic Act includes a number of other provisions that will help to reduce youth use of e-cigarettes and use of other tobacco products, including prohibiting online sales of most tobacco products, addressing inappropriate marketing and advertising, and ensuring that FDA will promptly implement the graphic health warnings on cigarette packs and advertising that are required under the 2009 Tobacco Control Act.

Youth use of e-cigarettes and other tobacco products is a problem that will not resolve itself. It will require action by Congress. The Reversing the Youth Tobacco Epidemic Act provides the comprehensive response that is needed. We urge you to support this important legislation when it comes to the House floor.

Sincerely,

AASA, The School Superintendents Association
Academy of General Dentistry
Action on Smoking & Health
African American Tobacco Control Leadership Council
American Academy of Oral and Maxillofacial Pathology
American Academy of Oral and Maxillofacial Radiology
American Academy of Otolaryngology-Head and Neck Surgery
American Academy of Pediatrics
American Association for Cancer Research
American Association for Dental Research
American Association for Respiratory Care
American Cancer Society Cancer Action Network
American College Health Association
American College of Cardiology
American College of Occupational and Environmental Medicine
American Dental Association
American Federation of School Administrators
American Federation of Teachers
American Heart Association
American Lung Association
American Medical Association
American Public Health Association
American School Counselor Association
American School Health Association (ASHA)
American Society of Addiction Medicine
American Thoracic Society
Americans for Nonsmokers’ Rights
Association of Educational Service Agencies
Association of Maternal & Child Health Programs
Association of School Business Officials International
Association of Schools and Programs of Public Health
Association of State and Territorial Health Officials (ASTHO)
Association of Women’s Health, Obstetric and Neonatal Nurses
Asthma and Allergy Foundation of America
Big Cities Health Coalition
Campaign for Tobacco-Free Kids
Catholic Health Association of the United States
Children’s Wisconsin
ClearWay Minnesota
Common Sense Media
Community Anti-Drug Coalitions of America’s (CADCA)
Eta Sigma Gamma – National Health Education Honorary
First Focus Campaign for Children
International Association for the Study of Lung Cancer
March of Dimes
Mesothelioma Applied Research Foundation
NAACP
National African American Tobacco Prevention Network
National Association of County and City Health Officials
National Association of Elementary School Principals
National Association of Pediatric Nurse Practitioners
National Association of School Nurses
National Association of Secondary School Principals
National Association of Social Workers
National Black Nurses Association
National Center for Health Research
National Coalition for Cancer Survivorship
National Education Association
National Hispanic Medical Association
National Medical Association
National Network of Public Health Institutes
National Rural Education Advocacy Collaborative
National Rural Education Association
Oncology Nursing Society
Parents Against Vaping e-cigarettes (PAVe)
Prevent Cancer Foundation
Public Health Solutions
SHAPE America
Society for Cardiovascular Angiography and Interventions
Society for Public Health Education
Students Against Destructive Decisions
The Society of State Leaders of Health and Physical Education
The Society of Thoracic Surgeons
Trinity Health
Trust for America’s Health
U.S. PIRG

 

NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut

National Center for Health Research, January 21, 2020


National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen® Snuff Fine Cut

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We strongly oppose the approval of this modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer” for the following reasons:

  • This safety claim could result in a higher number of dual users, and there is not sufficient evidence to suggest that dual use would reduce the risk of lung cancer. 
  • Even if an individual’s complete switch from combustible tobacco products to this product reduces a user’s risk of lung cancer, we agree with the FDA’s own website, which indicates that the use of smokeless tobacco products increases the risks of other types of cancers, such as oral, esophageal, and pancreatic cancer, as well as other diseases.
  • Because snuff has risks, data are needed to ensure that the marketing of this product as a modified risk product would not increase the number of non-smokers who would start using tobacco products. Increased use is likely, especially among teens and young adults, because, as with vaping, when people hear claims that a product is “safer,” they often misinterpret that to mean the product is “safe.”
  • Research has already shown that individuals who start using smokeless tobacco products, such as this product, are more likely to start using combustible tobacco products.
  • The modified risk statement could be interpreted as suggesting that Copenhagen Snuff Fine Cut can be used as a smoking cessation strategy. However, the sponsor has not provided scientific evidence that using this product helps people stop smoking. 
  • Although smoking and lung cancer deaths have both gone down in Sweden and Norway, the company has not provided evidence that these “favorable public health outcomes” are due to smokeless tobacco products. In addition, there is no evidence that additional reductions would occur in the U.S. market if this modified risk reduction application is approved, because the healthcare system, tobacco reduction campaigns, popular products and cultural influences are different than they are in Sweden and Norway.

In summary, a modified risk statement may encourage people who do not smoke to begin using this tobacco product and could lead to more dual usage, therefore, this product would not reduce the health risks for lung cancer.

For questions or more information, please contact Nina Zeldes, PhD at the National Center for Health Research at nz@center4research.org or at (202) 223-4000.

References

  1. US Food and Drug Administration. Executive Summary of USSTC MRTP Application for Copenhagen® Snuff Fine Cut. Silver Spring, MD: US Food and Drug Administration; 2020. https://digitalmedia.hhs.gov/tobacco/static/mrtpa/Copenhagen/2.3-executive%20summary%20_Redacted.pdf