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FDA Announces Action Levels for Lead in Categories of Processed Baby Foods

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Today, the U.S. Food and Drug Administration is announcing draft guidance for industry on action levels for lead in processed foods that are intended for babies and children under two years of age, to help reduce potential health effects in this vulnerable population from dietary exposure to lead. The proposed action levels would result in significant reductions in exposures to lead from food while ensuring availability of nutritious foods. Today’s action is part of Closer to Zero, which sets forth the FDA’s science-based approach to continually reducing exposure to lead, arsenic, cadmium and mercury to the lowest levels possible in foods eaten by babies and young children. 

“For more than 30 years, the FDA has been working to reduce exposure to lead, and other environmental contaminants, from foods. This work has resulted in a dramatic decline in lead exposure from foods since the mid-1980s.The proposed action levels announced today, along with our continued work with our state and federal partners, and with industry and growers to identify mitigation strategies, will result in long-term, meaningful and sustainable reductions in the exposure to this contaminant from foods,” said FDA Commissioner Robert M. Califf, M.D. “For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods.”

Foods covered by the draft guidance, Action Levels for Lead in Food Intended for Babies and Young Children, are those processed foods, such as food packaged in jars, pouches, tubs and boxes and intended for babies and young children less than two years old. The draft guidance contains the following action levels: 

  • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts. custards/puddings and single-ingredient meats. 
  • 20 ppb for root vegetables (single ingredient).
  • 20 ppb for dry cereals.

The FDA considers these action levels to be achievable when measures are taken to minimize the presence of lead and expects that industry will strive for continual reduction of this contaminant. The baby foods have differing action levels, to account for variances in consumption levels of different food products and due to some foods taking up higher amounts of lead from the environment. Action levels are one regulatory tool the FDA uses to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable, for example due to environmental factors. To identify the action levels for categories of foods, the agency considered, among other factors, the level of lead that could be in a food without dietary exposure exceeding the FDA’s Interim Reference Level, a measure of the contribution of lead in food to blood lead levels.

Just as fruits, vegetables and grain crops readily absorb vital nutrients from the environment, these foods also take up contaminants, like lead, that can be harmful to health. The presence of a contaminant, however, does not mean the food is unsafe to eat. The FDA evaluates the level of the contaminant in the food and exposure based on consumption to determine if the food is a potential health risk. Although it is not possible to remove these elements entirely from the food supply, we expect that the recommended action levels will cause manufacturers to implement agricultural and processing measures to lower lead levels in their food products below the proposed action levels, thus reducing the potential harmful effects associated with dietary lead exposures. Although not binding, the FDA would consider these action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.

“The action levels in today’s draft guidance are not intended to direct consumers in making food choices. To support child growth and development, we recommend parents and caregivers feed children a varied and nutrient-dense diet across and within the main food groups of vegetables, fruits, grains, dairy and protein foods,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “This approach helps your children get important nutrients and may reduce potential harmful effects from exposure to contaminants from foods that take up contaminants from the environment.”

As part of our approach, as laid out in 2021 when the FDA released Closer to Zero, the agency is committed to assessing if action levels should be lowered even further, based on evolving science on health impacts and mitigation techniques, and input from industry on achievability. We expect the draft action levels announced today, along with the draft action levels for lead in juice announced in 2022, will result in even lower levels of lead in the U.S. food supply. Moving forward, the agency will continue to gather data and collaborate with federal partners to establish the scientific basis for establishing Interim Reference Levels for arsenic, cadmium and mercury. Additionally, the FDA is considering the more than 1,100 comments it received in November 2021 during the “Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages for Babies and Young Children” public meeting to inform its strategy moving forward for future planned action on contaminants and fostering engagement, education and sharing of public data and information.

The FDA will host a webinar to provide an overview of the draft guidance and answer stakeholder questions. More details on the webinar will be announced shortly. 

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Lifestyle

4 Tips for Summer Water Safety

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(Family Features) Drowning is a leading cause of death for children ages 1-4, according to the Centers for Disease Control and Prevention. During the summer months, when water activities are more prevalent, drowning is more common, according to the National Safety Council.

Extreme heat may increase incidents of cardiac arrest and an average of 33 drownings occur in the U.S. each day, one-third of which are fatal. To protect your loved ones when playing in and around water this summer, keep these tips from the American Heart Association in mind:

Never swim alone. Children always need supervision, but even adults should swim with a buddy so someone can call for help if an unexpected problem arises. Swimmers can get cramps that hinder movement in the water and slips and falls can happen to anyone.

Wear protective devices. U.S. Coast-Guard-approved life jackets provide the best protection for someone who is in the water and unable to safely reach solid footing. When on a boat, all passengers should wear life jackets in case of an accident, and young and inexperienced swimmers should wear one any time they’re near water.

Choose your swimming location wisely. Avoid unknown bodies of water where hazards such as tree limbs or rocks may be hidden below the surface. Also avoid waterways with strong currents, such as rivers, that can easily carry even the strongest swimmers away. Instead, choose swimming pools and locations with trained lifeguards on duty.

Learn cardiopulmonary resuscitation (CPR). In the event of a drowning, no matter the age, the American Heart Association recommends rescue breaths along with chest compressions to keep oxygen circulating to the brain. Only 39% of those who participated in a consumer survey said they are familiar with conventional CPR and only 23% know about Hands-Only CPR.

Consider these ways to learn CPR and join the Nation of Lifesavers as an individual, family, organization or community.

  • Watch online. Learn the basics of Hands-Only CPR by watching an instructional video online. Hands-Only CPR has just two simple steps:
    1. Call 911 if you see someone suddenly collapse.
    2. Push hard and fast in the center of the chest to the beat of a familiar song with 100-120 beats per minute, such as “Stayin’ Alive” by the Bee Gees.
       
  • Immerse yourself. Through a virtual reality app, you can learn how to perform Hands-Only CPR and use an automated external defibrillator (AED) then put your skills to the test in real-life scenarios.
     
  • Learn at home. Learn basic lifesaving skills in about 20 minutes from the comfort and privacy of home with CPR Anytime kits. The Infant CPR Anytime program is for new parents, grandparents, babysitters, nannies and anyone who wants to learn lifesaving infant CPR and choking relief skills. The Adult & Child CPR Anytime Training kit teaches adults and teens Hands-Only CPR, child CPR with breaths, adult and child choking relief and general awareness of AEDs.
     
  • Take a course. Get a group together and find a nearby class to learn the lifesaving skills of CPR, first aid and AED.
     
  • Turn employees into lifesavers. Help make your workplace and community safer one step at a time by committing to CPR training for your employees or coworkers.

Visit heart.org/nation to access more summer safety resources and find a CPR course near you.

Photo courtesy of Shutterstock


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American Heart Association

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Nurturing the Mental Health of Young Children

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(Family Features) The earliest years of children’s lives lay the foundation for their social and emotional well-being, setting the stage for success in school and beyond. For parents, caregivers and educators, it’s crucial to prioritize and nurture the mental health of children in their care.

Dr. Lauren Loquasto, senior vice president and chief academic officer at The Goddard School, and Dr. Kyle Pruett, clinical professor of child psychiatry at Yale School of Medicine and member of The Goddard School’s Educational Advisory Board, share this insight and guidance to support children’s mental well-being.

Understanding Mental Health in Young Children
Mental health influences how everyone – including young children – thinks, feels and behaves, impacting the ability to cope with stress, build relationships and navigate life.

The development of mental makeup is influenced by both nature (inherited genetic and biological factors) and nurture (environmental factors). Each person is a combination of a unique temperament combined with life experiences, including family, culture and education.

In young children, there is no distinction between mental and physical health. The brain and body are growing and developing rapidly. By 6 months, children can begin to feel overwhelmed by negative experiences. It’s vital to understand that the earliest interactions with children can have lasting social and emotional consequences.

Causes for Concern
When it comes to young children’s mental health, there’s no straight line dividing expected and worrisome behaviors. That line is wiggly and can shift. That said, it’s always concerning when children fall off their developmental tracks.

Infants are expected to partake in “serve and return” activities. They provide signals about how they feel or what they need and caregivers respond to those cues. When those signals stop and the child becomes exceedingly passive, that’s a concern.

Toddler troubles are among the most difficult to diagnose. Many are familiar with the concept of the “terrible twos;” deciphering between developmentally appropriate and worrisome behaviors can be challenging. Signs of concern – especially if they occur constantly – include excessive aggressiveness, a consistent lack of control and screaming instead of talking.

For pre-kindergarteners and kindergarteners, tantrums should be over. They should be interested in making friends and mastering their vocabulary and language. If they aren’t displaying interests or are exhibiting a lack of self-regulation, such as hurting others or animals, seeking help is appropriate.

Seeking Help
If concerns are identified, parents should contact their pediatric care provider. In some cases, they may recommend seeking assistance from a mental health provider, such as a therapist. Selecting the right provider – one with training and experience with working with children – is essential. Lean on your network, including your pediatric care provider, friends and family, to identify the best option.

Supporting Early Social and Emotional Development

  1. Understand your child’s behavior – particularly if they aren’t verbal – is their way of communicating. Narrate what your child is experiencing and label emotions. For example, “I see you’re angry. Can I help you put your shoes on?”
     
  2. Model social and emotional self-control. For example, “I’m frustrated. I’m going to pause, take deep breaths then tell you what I need.” This gives children coping techniques they can practice themselves.
     
  3. Be a good example. Model, for instance, how to be a good friend, show respect and use good manners.
     
  4. Partner with your child’s teachers. There should be two-way dialogue presenting potential concerns.
     
  5. Don’t rush to diagnose issues. Remember children save their “toxic waste” – big, negative feelings – for their parents because they trust them. Your experiences with your child may be different than others’ experiences. Be cautious to avoid a quick reaction. Work to understand what your child is trying to convey. Seek information from others.
     
  6. If a child is exhibiting anxious behavior, which is normal when encountering new situations, be present, listen, observe, answer questions, label emotions and provide reassurance. Don’t overreact to fears. Young children are learning to deal with the unknown and, just like learning to ride a bike, it takes time and comfort to develop the skills to manage those emotions.

To watch a webinar featuring Loquasto and Pruett providing additional guidance, and access actionable parenting insights and resources, visit the Parent Resource Center at GoddardSchool.com.

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Child Health

Illuminating Global Landmarks: Make NF Research Visible

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Global landmarks are set to illuminate in a stunning display of support for World NF Awareness Day. The Children’s Tumor Foundation (CTF) has organized the “Shine a Light on NF” campaign, which will see nearly 400 famous buildings, bridges, waterfalls, castles, and architectural icons light up in blue and green, the official colors of the neurofibromatosis (NF) cause.

Global landmark illuminated in blue and green for neurofibromatosis and schwannomatosis awareness, highlighting the importance of NF research visibility.
Young man living with neurofibromatosis type 1 surrounded by NF researchers and clinicians

NF is a group of genetic conditions that affects approximately 4 million people worldwide. It is known as either neurofibromatosis or schwannomatosis, and it causes tumors to grow on nerves throughout the body. The impact of NF can be severe, leading to disabilities such as blindness, deafness, bone abnormalities, disfigurement, learning disabilities, disabling pain, and cancer. Despite the significant challenges it poses, there is currently no cure for NF. However, the “Shine a Light on NF” campaign aims to raise awareness and highlight the crucial need for scientific research funding.

The “Shine a Light on NF” campaign, launched by the Children’s Tumor Foundation, has grown substantially over the years. The foundation works in partnership with NF organizations, medical and research institutions, and corporate and media partners around the world to expand global awareness of this rare set of genetic conditions. The involvement of internationally recognized landmarks is a testament to the campaign’s reach.

Landmarks such as Niagara Falls, the National Theatre in London, The City of Arts and Sciences in Valencia, and The David in Florence are among the many iconic sites that will light up in blue and green this year. This show of unity and support not only raises awareness but also sends a powerful message of solidarity to those affected by NF.

In conjunction with World NF Awareness Day, the Children’s Tumor Foundation is also launching its “Make NF Research Visible” campaign. This initiative focuses on the transformative potential of scientific research in the fight against NF. By highlighting advancements in NF scientific research and clinical care, the campaign showcases the crucial role these efforts play in improving patient outcomes.

As part of the “Make NF Research Visible” campaign, a collection of portraits and stories featuring clinicians, researchers, and patients is being shared. These compelling narratives demonstrate how increased visibility can drive further progress in NF research and provide support to those affected by the condition.

Simon Vukelj, Chief Marketing Officer of the Children’s Tumor Foundation, emphasizes the importance of the “Make NF Research Visible” campaign, stating that it aims to inspire greater support and drive further advancements. By shining a light on the incredible work being done by researchers and clinicians, the foundation aims to brighten the path forward for everyone affected by NF.

Carson McNall, a 16-year-old living with neurofibromatosis type 1, shares his experiences and hopes for a future where NF can be cured. Carson describes the chaos of living with NF at such a young age and dreams of a life free from constant appointments and worries about the future. The “Make NF Research Visible” campaign aims to turn these dreams into reality by amplifying the voices of patients and showcasing how research can transform lives within the NF community.

Neurofibromatosis encompasses a group of genetic conditions that lead to the growth of tumors on nerves throughout the body. The Children’s Tumor Foundation has initiated campaigns like “Shine a Light on NF” and “Make NF Research Visible” to raise awareness and underscore the importance of advancements in scientific research. These efforts highlight the impact of NF on public awareness, diagnosis, clinical care, and ongoing research endeavors towards finding a cure.

As the world witnesses the illumination of global landmarks and engages with the “Make NF Research Visible” campaign, it is a reminder of the power of unity and the potential for scientific advancements to bring hope and transformation to those affected by neurofibromatosis.

For the full, global list of locations Shining a Light on NF, visit ctf.org/shinealight.

For more information about NF Awareness Month and Make NF Visible, visit makenfvisible.org.

For more information about the Children’s Tumor Foundation, visit ctf.org.

About the Children’s Tumor Foundation
The Children’s Tumor Foundation is the world’s leading organization dedicated to funding and driving innovative research that will result in effective treatments for the millions of people worldwide living with NF, a group of genetic conditions that causes tumors to grow on nerves throughout the body. Through collaboration with the scientific community, pharmaceutical and biotech industries, and other key partners, we work diligently to accelerate research and development efforts, ensuring that promising treatments reach those who need them. One in every 2,000 people is born with some type of neurofibromatosis or schwannomatosis, which may lead to blindness, deafness, bone abnormalities, disfigurement, learning disabilities, disabling pain, or cancer. NF affects all populations equally, and while there is no cure yet, the Children’s Tumor Foundation mission of driving research, expanding knowledge, and advancing care for the NF community fosters our vision of one day ending NF. For more information, please visit: ctf.org.

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