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

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Last Updated on January 24, 2023 by Daily News Staff

Today, the U.S. Food and Drug Administration is announcing draft guidance for industry on action levels for lead in processed foods that are intended for babies and children under two years of age, to help reduce potential health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said FDA Commissioner Robert M. Califf, M.D. “For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods.”

Foods covered by the draft guidance, Action Levels for Lead in Food Intended for Babies and Young Children, are those processed foods, such as food packaged in jars, pouches, tubs and boxes and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 The draft guidance contains the following action levels: 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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Women's Health

From Pregnancy to Parenthood: How Medicaid Supports Women Across the Maternal Health Journey

When women are planning, expanding or raising families, access to healthcare is a vital source of physical and mental support. For millions of women and families across the U.S., Medicaid provides that support, enabling parents and children to access the reproductive, maternal and pediatric healthcare they need to thrive.

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From Pregnancy to Parenthood: How Medicaid Supports Women Across the Maternal Health Journey

(Feature Impact) When women are planning, expanding or raising families, access to healthcare is a vital source of physical and mental support. For millions of women and families across the U.S., Medicaid provides that support, enabling parents and children to access the reproductive, maternal and pediatric healthcare they need to thrive. It’s there for anyone who needs it, from working adults to families navigating unemployment or disability.

To learn about how Medicaid supports growing families through every stage of the parenthood journey, consider this information from the maternal health experts at Community Catalyst.

Making Family Planning Possible

When people are able to plan and prepare to welcome children into the world, it can remove a lot of stress, uncertainty and complication from their journeys. Medicaid family-planning coverage may include reproductive health counseling, pre-pregnancy screenings, many forms of FDA-approved contraception and other preventive services. Comprehensive access to birth control allows women and couples to make their own decisions about pregnancy timing or spacing between siblings.

Supporting Healthy Pregnancies

Pregnancy is no small endeavor, and a woman with a healthcare team at her side is better prepared to face whatever challenges may arise. Pregnancy often requires frequent appointments for ultrasounds, laboratory testing and monitoring – all of which are made possible and affordable through Medicaid. Since 1 in 4 Medicaid recipients are women ages 15-49, this care can make a difference during their childbearing years.

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Covering Labor and Delivery Costs

Labor and birth can be unpredictable, but being able to afford them shouldn’t be. Without Medicaid, which finances approximately 41% of U.S. births, based on data from the National Center for Health Statistics, the cost of hospitalization and delivery could be financially devastating to young families. Coverage for labor, delivery and NICU care, if needed, gives parents the ability to focus on their new babies instead of overwhelming medical bills.

Providing Postpartum Care

The need for maternal healthcare doesn’t end when mother and child are discharged from the hospital. Physical recovery takes time, especially if there were any complications during the pregnancy or delivery. Beyond that, postpartum women may need mental health support, treatment for chronic conditions, contraception renewals and other health services that Medicaid can provide. Currently, 49 states plus Washington, D.C. have extended postpartum Medicaid coverage to 12 months, which helps new mothers get continuous care without worrying about insurance lapses.

Caring for Growing Kids

Nearly half of all Medicaid recipients in the U.S. are children ages 0-18 – and sometimes kids qualify for Medicaid even when their parents don’t. The program can help new parents stay up to date with well-child visits for infants, immunizations and ongoing preventive care throughout childhood.

To learn more about access to essential services at every stage of life, visit communitycatalyst.org/maternalhealth.

Filling Gaps in Pregnancy and Postpartum Care: Kayla and Tru’s Story

When Kayla found out she was pregnant at 24 years old, she had no idea how she was going to afford all the costs that were coming. Despite having part-time employment and primary insurance through her mother, she faced gaps in coverage for pregnancy care.

Qualifying for Medicaid changed everything. Not only did it cover Kayla’s prenatal visits, labs, ultrasounds and delivery, but once her son Tru was born, both mother and baby required an extended hospital stay. Medicaid made it possible for Tru to get the care he needed in the NICU while Kayla recovered from birth complications.

Afterward, the program continued to cover Kayla and Tru for follow-up appointments and well-child visits. She’s grateful it was there during her time of need and has one simple message to share: If you qualify for Medicaid, apply.

“You never know what’s going to happen,” she said. “I didn’t expect to be in the hospital as long. I didn’t expect for him to be where he was. But it was definitely needed and helpful.”

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Photo courtesy of Shutterstock (mother leaning over hospital bassinet) collect?v=1&tid=UA 482330 7&cid=1955551e 1975 5e52 0cdb 8516071094cd&sc=start&t=pageview&dl=http%3A%2F%2Ftrack.familyfeatures track

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Community Catalyst

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Lifestyle

P.F. Chang’s Partners With Starlight Children’s Foundation for New “Spirit of the Zodiac” Giving Campaign

P.F. Chang’s launches Spirit of the Zodiac, a giving campaign supporting Starlight Children’s Foundation with Bao plush purchases and in-restaurant donations.

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P.F. Chang’s Launches Spirit of the Zodiac Campaign to Support Starlight Children’s Foundation
P.F. Chang’s and Starlight Children’s Foundation

P.F. Chang’s Launches Spirit of the Zodiac Campaign to Support Starlight Children’s Foundation

P.F. Chang’s is launching a new annual charitable initiative designed to bring comfort to children during hospital stays. The Scottsdale-based restaurant brand announced Spirit of the Zodiac, a giving program inspired by the Chinese zodiac, with its inaugural campaign—Year of the Fire Horse: Spirit of Strength—benefiting Starlight Children’s Foundation.

What the campaign supports

Starlight Children’s Foundation serves more than 800 children’s hospitals nationwide, providing programs such as toy deliveries, hospital gowns, gaming stations, and other experiences intended to help kids feel more comfortable, connected, and supported during medical care.

How guests can participate (Sept. 2–Sept. 30)

From September 2 through September 30, 2026, guests can purchase Bao, a limited-edition horse plushie, for $10 through dine-in transactions at participating P.F. Chang’s restaurants (while supplies last). For each Bao purchased, P.F. Chang’s will donate an identical Bao plushie to Starlight for distribution through its hospital network—up to 20,000 donated plushies.

Guests can also support the campaign by rounding up their checks or making a direct donation in restaurant. The overall effort aims to raise $500,000 to support Starlight’s work with children and families.

Bonus offer for donors

P.F. Chang’s says guests who purchase Bao or make an in-restaurant donation of $10 or more to Starlight will receive an offer for a complimentary appetizer with the purchase of an entrée on a future dine-in visit, valid through October 31, 2026 (restrictions apply; participating locations only).

A story component for families

The campaign also includes a storytelling element: Bao’s journey will be featured in a digital story and an original children’s book by author Jenny Liao and illustrator Adriane Tsai, expected to publish later this month.

What to watch for

P.F. Chang’s and Starlight plan to continue the partnership beyond September, including in-hospital catering and plush deliveries in early October.

For more information, visit www.pfchangs.com/offers/spirit-of-the-zodiac. To learn more about the partnership, visit starlight.org/pfchangs.

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Child Health

Pediatric Cancer Goes Beyond a Victory Bell: How Research and Innovation Improve Survivorship Rates

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Pediatric Cancer Goes Beyond a Victory Bell: How Research and Innovation Improve Survivorship Rates

(Feature Impact) For every tear-jerking video found online of a child ringing a bell that signifies a cancer journey victory, there are dozens, if not more, people working behind the scenes. From leading minds in cancer research to doctors, nurses and support staff, a vast network of people and decades of medical advancements make those moments possible.

In fact, in the last 10 years, the FDA approved 10 new immunotherapies and 20 molecularly targeted therapies to treat pediatric cancers, according to the American Association for Cancer Research. Those breakthroughs – and the children they impact – come with a cost, which is why Hyundai Hope on Wheels has served as a pioneer in increasing survival rates by investing $303 million in pediatric cancer research over nearly three decades.

Those funds have supported more than 1,600 grants to 210 institutions, leading to new insights into cancer biology, clinical trials and new drug development while bringing hope at all stages of a child’s cancer journey.

However, there remains work to be accomplished. According to a survey conducted by Atomik Research on behalf of Hyundai Hope on Wheels, 46% of U.S. adults believe that a child ringing a hospital bell after cancer treatment signifies the child is cancer-free and their medical journey is largely over. The reality is more nuanced than that. In fact, more than one-third of respondents said they’re not familiar with the term cancer survivorship or they have heard the term but don’t fully understand what it means.

Many health care organizations define survivorship as beginning at the time of diagnosis and continuing through treatment and beyond. According to the American Association for Cancer Research, children who survive cancer face several long-term physical and psycho-social challenges due to their cancer and treatment, including planned surgeries, additional rounds of radiation or other forms of medical treatment to address common physical challenges stemming from chemotherapy.

Survival rates continue increasing with scientific and technological breakthroughs, up from 75% to 85% in nearly three decades, representing roughly 40,000 more children surviving their diagnoses. More than 3 in 4 U.S. adults are encouraged by that progress.

For survivors, treatment is just the beginning. Research, follow-up care and long-term funding determine what comes next, and every grant funded and every survivorship program backed means more children reaching adulthood.

According to the survey, more than 80% of adults said they’re more likely to support organizations that fund survivorship services, creating opportunities to fund crucial research and support for children facing pediatric cancer. Collaboration among leading minds, made possible by funding from organizations like Hyundai Hope on Wheels, has led to the development of comprehensive approaches to help children thrive during life after cancer, including enhanced medical records, AI integration, socioemotional support and combatting long-term side effects.

Find more information and ways you can join the fight by visiting HyundaiHopeOnWheels.org.

Photo courtesy of Shutterstock collect?v=1&tid=UA 482330 7&cid=1955551e 1975 5e52 0cdb 8516071094cd&sc=start&t=pageview&dl=http%3A%2F%2Ftrack.familyfeatures track

    

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Hyundai Hope on Wheels

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