The U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s increased flexibilities.
Company (Product Origin):
- Danone (Ireland)
- The a2 Milk Company (New Zealand)
- Aptamil Care Stage 1, 0-6 months, Infant Milk (800 grams (g) retail container)
- Aptamil Care Stage 2, 6-12 months, Follow On Milk (800 grams (g))
- a2 Milk Company:
- a2 Platinum Infant Formula (0-6 months), 900g (a2MC Stage 1)
- a2 PlatinumFollow-on Formula (6-12 months), 900g (a2MC Stage 2)
Type of Formula: General
Availability: Both products will be sold at major U.S. retail outlets.
The FDA is exercising enforcement discretion for the importation of the infant formula products listed above following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling and additional information about facility production and inspection history.
Ongoing FDA Steps to Increase Availability of Safe, Nutritious Infant Formula
The FDA has been leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition. The agency continues to dedicate all available resources to help ensure that safe and nutritious infant formula products remain available for use in the U.S. Important progress has been made toward improving the infant formula supply in the U.S. and paving the way for a more robust and diverse marketplace for the future.
The FDA issued guidance in May 2022 that outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. This guidance also may provide flexibilities to those who manufacture infant formula products domestically and may be able to further increase the quantity of domestically-produced product for the U.S. market.
Additionally, in September 2022, the FDA announced new guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure the U.S. continues diversifying its infant formula market, and make families less susceptible to shocks in the infant formula market.
The agency continues to advise against making infant formulas at home or diluting formula. Parents and caregivers are encouraged to work with their child’s health care provider for recommendations on changing feeding practices, if needed. The U.S. Department of Health and Human Services also has additional information available at HHS.gov/formula, including information to help families find infant formula.
The FDA also monitors online marketplaces for fraudulent products and works with major online retailers to remove violative and harmful products offered for sale on their sites. Additionally, since many of these fraudulent products originate overseas, the agency targets and examines these products at ports of entry. The FDA also monitors and follows up on various external signals such as consumer complaints about potential counterfeit and fraudulent products.
- Infant Formula Information and Ongoing FDA Efforts to Increase Supply
- Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
- FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)
- Powdered Infant Formula Recall: What to Know
- CDC Information on Cronobacter Infection and Infants
National Poll: Some parents may not be making the most of well child visits
While many parents regularly take children to checkups, some may consider more proactive steps to make them as productive as possible.
Newswise — While most parents and caregivers stay on top of scheduling regular checkups for their kids, they may not always be making the most of them, a national poll suggests.
Most parents report their child has had a well visit in the past two years and two thirds say they always see the same provider, according to the C.S. Mott Children’s Hospital National Poll on Children’s Health at University of Michigan Health. However, fewer parents took all recommended steps to prepare themselves and their kids ahead of time.
“Regular well visits mean guaranteed face time with your child’s doctor and an opportunity to not only discuss specific concerns and questions about your child’s health but get their advice on general health topics like nutrition, sleep and behavior,” said Mott Poll co-director Sarah Clark, M.P.H. “We were pleased to see that the majority of parents regularly make these appointments and maintain relationships with a trusted provider. But they may not always be taking a proactive approach to ensuring they address all relevant health concerns impacting their child’s physical, emotional and behavioral health at every visit.”
In advance of well visits, a fourth of parents say they often prepare a list of questions to ask the provider, while a little over half said they sometimes wrote things down and about a fifth said they never do.
Meanwhile, about a fifth of parents say they often write down information about their child’s health changes while half say they sometimes take this step and three in 10 don’t do this at all.
“Well visits are busy, and in the moment, it’s easy for parents to forget to bring up questions or concerns with a doctor,” Clark said. “Writing them down ahead of time will help prioritize topics and help you get the most out of the appointment.”
Less than 15% of parents say they often research information online to discuss with the provider, while about half sometimes do and 38% never do.
“We are constantly learning new information that may impact children’s health and some recommendations may evolve or be updated,” Clark said. “Many pediatricians and care providers will bring these topics up themselves but not always. It’s always helpful for parents to do some homework ahead of time to make sure they’re aware of any timely topics affecting their child’s age group.”
Preparing children for the visit
Two in five parents say they often take steps to prepare their child for an upcoming well visit by addressing any fears they may have while slightly more than that sometimes do this while a little less than one in five never do this. A fourth of parents often also offer rewards for cooperating while less than half sometimes use such incentives.
For parents of children aged 6-12, a little more than one in five also regularly ask the child to think about questions for the provider.
“As kids approach puberty, their bodies begin changing. A well visit is a great opportunity to have the provider explain why these changes happen,” Clark said. “Having kids think about health topics themselves is also good practice for when they get older and parents become less involved with health visits. Preparing for this transition early will benefit them when they need to take more ownership of their health.”
Most parents also recall completing questionnaires and checklists about their child at well visits. Among these parents, the majority say they understand the purpose but just about three fourths say they receive feedback about how their child is doing.
“Children and their families are more often getting questionnaires at visits to help identify issues like sleep problems, challenges impacting emotional health and behavioral health concerns,” Clark said. “But when time is short, this may not come up during the actual visit. It’s important parents have conversations with providers about any issues that may surface from the child’s or family’s responses.”
Seeing providers familiar with your child’s history
Nearly half of parents say they schedule well visits with their child’s regular provider even if they have a long wait for an appointment. A third of parents also strongly agree their child is more likely to follow advice if it comes from a provider their child knows well.
For their child’s most recent well visit, more than half of parents also rate the provider as excellent for knowing the child’s health history, answering all their questions and giving recommendations that are realistic for the family.
A primary care physician familiar with a child and their specific health history will help them stay healthy, prevent disease and illness by identifying risk factors and taking the right steps to manage chronic disease care, Clark says.
“We know that continuity with the same provider has long term health benefits for children. Parents polled whose child always sees the same provider for well visits are also more likely to rate the provider as excellent,” Clark said. “Nurturing a relationship with a primary care provider means that the health professional who knows your child best is the one providing individualized care and helping your family navigate important decisions impacting their health.”
However, when well visits are scheduled with a different provider, either by choice or necessity, “parents may benefit from different explanations or perspectives on their child’s health,” Clark added.
The nationally representative report is based on responses from 1,331 parents with children aged 1 to 12 years who were polled in August-September 2022.
Five ways to ensure the most productive well child visit, according to Mott experts:
- Build a long-lasting trusted relationship with the same primary care provider who your child always sees for appointments, which may include a pediatrician, other family physician or nurse practitioner.
- Write down questions regarding your child’s physical, emotional and behavioral health in the same place as they come up to review again when a child is due for a well visit.
- Share input from teachers or daycare providers about the child’s behavior or school performance and ask the primary care provider for the need for further assessment or therapy.
- Prepare children for the visit. If there’s a physical exam, talk them through what to expect. For young children who need immunizations or blood draws, prepare them with books ahead of time, consider comfort positions and distractions like cartoons on screens during shots or give them something fun to look forward to after the visit like ice cream. Never promise them they won’t get a shot. More tips here.
- For older children, help them come up with a list of questions to ask the doctor themselves.
FDA Announces Action Levels for Lead in Categories of Processed Baby Foods
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.
- Action Levels for Lead in Food Intended for Babies and Young Children
- FDA Issues Draft Guidance to Industry on Action Levels for Lead in Baby Foods
- Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children
- Lead in Food, Foodwares, and Dietary Supplements
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- Follow @FDAmediaon Twitter
Study Identifies Cause for Mysterious Cases of Epilepsy in Children
International collaboration uncovers mosaicism, a condition in which cells within the same person have a different genetic makeup, as a cause for pediatric seizures
Newswise — Epilepsy is present in 4% of the population, and is among the most common brain disorders in children. Modern medicine can prevent most seizure recurrences, but approximately 20% of patients do not respond to treatment.
In these cases, the reason may originate in patches of damaged or abnormal brain tissue known as “malformations of cortical development” (MCD), which results in a diverse group of neurodevelopment disorders. Surgical resection or removal of the patch can cure the seizures, and epilepsy surgery to improve neurological outcomes is now a key part of the modern medical armamentarium, but what causes the patches has largely remained a mystery.
Writing in the January 12, 2023 issue of Nature Genetics, researchers at University of California San Diego School of Medicine and Rady Children’s Institute for Genomic Medicine, collaborating with an international consortium of more than 20 children’s hospitals worldwide, report a significant breakthrough in understanding the genetic causes of MCD.
Members of the Focal Cortical Dysplasia Neurogenetics Consortium investigated 283 brain resections from children across a range of MCD types, with parental consent, looking for potential genetic causes. Because most brain tissue in these children is normal, the scientists focused on mutations present in a small subset of brain cells, a phenomenon termed genetic somatic mosaicism.
“This was a decade-long journey, bringing specialists together from around the world, to recruit patients for this study,” said senior study author Joseph Gleeson, MD, Rady Professor of Neuroscience at UC San Diego School of Medicine and director of neuroscience research at the Rady Children’s Institute for Genomic Medicine. “Until recently, most hospitals did not study resected brain tissue for genetic causes. The consortium organized a biobank to store tissue for high-throughput mosaicism analysis.”
Previous research by Gleeson and colleagues had shown that genetic somatic mosaicism in the mTOR signaling pathway was a contributing factor, said co-first author Changuk Chung, PhD, a postdoctoral fellow in the Gleeson lab.
“But most patients remain undiagnosed, which hinders treatment. We tested for hidden mutations, detectable only by greatly expanding the cohort size and improving methods so that the results could be meaningful. We collaborated to solve technical and logistical bottlenecks. The pieces fell into place, but it took 10 years.”
The team conducted intensive genomic discovery using state-of-art somatic mosaic algorithms developed by the National Institutes of Health-sponsored Brain Somatic Mosaicism Network, of which UC San Diego is a member.
“We tried our best to detect mutations in as little as 1 percent of cells,” said co-first author Xiaoxu Yang, PhD, a postdoctoral scholar in Gleeson’s lab. “Initially we failed. To solve these problems, we needed to develop novel artificial intelligence methods to overcome barriers in sensitivity and specificity.”
The team ultimately identified 69 different genes carrying somatic brain mutations, the majority of which have never previously reported in MCD.
“We can draw parallels with the cancer field because these mutations disrupt cellular function and need to be resected,” said co-first author Chung. “However, unlike cancer cells, brain cells mostly do not divide so these cells misbehave by stimulating epileptic seizures. The question that arose was whether the newly found gene mutations were sufficient to cause MCD disease.”
Gleeson said the scientists found that the genes converged on calcium signaling, gene expression and synaptic functions, and noted that when the mutations were introduced into a mouse model, abnormalities similar to those seen in patients were observed. The study authors suggest the findings could be used to improve diagnosis and develop cures for MCD disease.
“The MCD genes in patient brains have demonstrated critical roles during cortical development,” said Gleeson. “These findings could lead to new molecular classifications for MCD, and ultimately to personalized therapies for epilepsy.”
For a complete list of co-authors, see full study.
Funding for this research came, in part, from the National Institutes of Health (grants NIMH U01MH108898 and R01MH124890, NIA R21AG070462, NINDS R01NS083823), the San Diego Supercomputer Center and UC San Diego Institute of Genomic Medicine.
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