Latest news with #OperationStorkSpeed
Yahoo
2 days ago
- Business
- Yahoo
RFK Jr. is investigating infant formula. Here's what's at stake
Operation Stork Speed is underway. Announced in mid-March by US Health and Human Services Secretary Robert F. Kennedy Jr., the initiative charges the US Food and Drug Administration with leading the first comprehensive update and review of infant formula nutrients since 1998. 'We're going to make American infant formula the gold standard for the world,' Kennedy said in an Instagram post about the initiative. The update on formula is long past due, said Dr. Thomas Brenna, a professor of pediatrics, chemistry and human nutrition at the Dell Medical School at the University of Texas at Austin. Brenna is a member of the new FDA review panel on infant formula that is meeting in Washington on Wednesday. The group has met once online, and this will be the first in-person meeting. The FDA's last comprehensive review, released in 1998, 'called for a reevaluation of the fatty acids in infant formula within five years because of all the studies that were going on in the 1990s; I was one of the people doing them,' Brenna said. 'And so here we are in 2025, and much needs to be discussed.' The panel is stocked with experts who have been investigating the nuances of infant formula nutrition for years, said panel member Dr. Roger Clemens, a faculty member in the global medicine program at the Keck School of Medicine at the University of Southern California in Los Angeles. 'I myself have 50 years of experience, and several others are close, so I'm sure we have 500 years of combined experience in this group in areas of genuine significance, such as carbohydrates, fats, proteins and amino acids,' said Clemens, who also served as a scientific adviser to Nestlé USA for over 10 years and is a consultant on medical nutrition. 'We hope the public will comment, as well. All public comments are due on September 11, and we hope hundreds of people will tell us what's on their minds,' he added. A growing backlash against using seed oils to provide fat, one of the 30 nutrients that federal guidelines say must be included in infant formulas, has been building within Kennedy's Make America Healthy Again movement and among some anti-additives food activists and social media influencers. 'Seed oils are one of the most unhealthy ingredients that we have in foods,' Kennedy said in an interview with Fox News last fall, adding that seed oils are 'associated with all kinds of very, very serious illnesses, including body-wide inflammation, which affects all of our health.' However, the reality is much more nuanced than that, especially when it comes to infant formula, said Brenna, a pediatrician who's spent decades studying omega-6 and omega-3 fatty acids. 'A lot of the health concerns stem from how heavily the oils are processed,' Brenna said. 'Some suggest moving to palm oil, which is not from a seed, but in some ways, it's processed more harshly than seed oils. 'All oils must be processed to be used, so I believe we should be focusing on milder ways of extracting all of the oils,' he said. About 47% of calories in infant formula must be from fat, so choosing the right sources and amounts is key, Brenna said. As they currently exist, federal guidelines require minimum levels of 30 nutrients, including key vitamins, minerals and fats, proteins and linoleic acid, an essential fatty acid the body cannot make on its own. Only 10 nutrients have set maximum levels. Important lipids for infant brain development, such as the omega-3 fatty acid docosahexaenoic acid, or DHA, and the plant-based alpha-linolenic acid, or ALA, have never been part of the federal guidelines. (Many formula makers have been adding DHA since 2001 under the FDA's 'generally recognized as safe' or GRAS designation.) 'We're one of the only countries in the world that doesn't require a range of fats in our infant formulas,' Brenna said. 'Everybody else has been updating their standards, and we have been sitting still.' Another area of concern is the types of carbohydrates used in some 'sensitive' or 'gentle' infant formulas marketed to parents concerned about lactose intolerance, said Dr. Michael Goran, a professor of pediatrics and vice chair for pediatric research at the Keck School of Medicine at the University of Southern California, who is also on the review panel. 'Lactose, which is a natural sugar, is the only carbohydrate energy source in human breast milk,' said Goran, who is also program director for nutrition and obesity at the Saban Research Institute at Children's Hospital Los Angeles. However, the 1998 guidelines do not require the carbohydrates added to infant formula to be lactose, nor are the types of carbs required to be listed on the label so parents can choose, Goran said. 'A great many of the infant formulas sold today are made with glucose-based corn syrup solids and not lactose,' he said. 'Which is all based on this myth that (so-called) 'fussy' infants have lactose intolerance, which really is not a concern for most babies.' Although many nutritionists believe corn syrup is processed like sugar by the body, new unpublished research by Goran and his team counters that view. Six-month-old babies wore glucose monitors for three days to see how their blood sugars responded to corn syrup-based formula, compared with babies on breast milk or traditional lactose-sweetened formulas. A brief of that research will be presented during the panel's meeting Wednesday. 'We showed that when you give those babies corn syrup, it just makes their blood glucose sugars go into overdrive,' Goran said. 'But the infants who drank traditional lactose-based formula had glucose levels similar to breast-fed infants.' An analysis of the nutrient component of corn syrup-based and lactose-based formulas by researchers at Children's Hospital Los Angeles found that babies drinking formulas sweetened with corn syrup 'could consume up to 60 grams of added sugar a day — the equivalent of two sodas worth of sugar,' according to a brief on the study. In a separate study published in 2023, Children's Hospital researchers also found that babies fed corn syrup-based formulas were 10% more likely to be obese by age 4. 'High levels of dietary sugar can have an impact on children's brain development and memory and learning performance,' Goran said. When it comes to safety, many parents remember the lack of decontamination at an infant formula manufacturing plant owned by Abbott Nutrition that contributed to severe shortages of baby formula in 2022. The FDA inspection determined that Abbott was at fault after the company recalled several lots of Similac, Alimentum and EleCare baby formula made at its Sturgis, Michigan, manufacturing plant. The recalled formulas were linked to serious Cronobacter sakazakii and Salmonella infections in five infants. Two babies with Cronobacter infections died. There are other safety issues to consider, said Clemens, who is also past president of the Institute of Food Technologists and the International Academy of Food Science and Technology. 'We want to look beyond traditional safety, and a number of topics come to mind,' he said. 'We need to address emerging pathogens in the food supply. I'm going to suggest we look at more than bacterial contaminants and consider viruses and fungi, as well.' Nor has the US set standards for heavy metals, Clemens said: 'Yet tests find arsenic and lead in formula and baby foods.' A recent Consumer Reports investigation found concerning levels of arsenic and lead in some samples from 41 infant formulas, but the majority of the reports on heavy metals have focused on baby foods. In 2021, a congressional investigation found that leading baby food manufacturers knowingly sold baby foods with alarming levels of toxic metals. Keeping up-to-date with advances in infant formula means those changes need to be tested via the scientific process, said review panel member and neonatologist Dr. Steven Abrams, professor of pediatrics at the Dell Medical School at the University of Texas at Austin. 'If we're going to talk about novel ways of putting together oils, novel carbohydrate sources and even novel protein sources, there has to be a more efficient way to get those vetted, such as in clinical trials,' Abrams said. 'Nor has the FDA fully addressed issues of inaccurate labels, false marketing claims and things of that sort in the formula market,' he added. Another issue is providing additional support for the growing number of donor breast milk programs in the US. Breast milk is still best for a baby's health, according to the American Academy of Pediatrics, and mothers who can't or don't want to breast feed should have the option of obtaining that milk from donors, Abrams said. 'Except for one, all of these milk banks are nonprofits and need additional support to grow,' he said. 'There's a lot of donor milk out there, and the US is nowhere near maxed out on its capacity to support the milk banks themselves.' Other concerns will be presented Wednesday by other members of the review panel. Still, parents should not take the review as a sign that the US formula market is in disarray or in any way harmful to infants, Abrams said. 'It's not that there's a danger in the infant formula we're selling today, but our regulations are for formulas from the '80s we no longer sell,' he said. 'We are in dire need of an update.'
CNN
2 days ago
- Business
- CNN
RFK Jr. is investigating infant formula. Here's what's at stake
Operation Stork Speed is underway. Announced in mid-March by US Health and Human Services Secretary Robert F. Kennedy Jr., the initiative charges the US Food and Drug Administration with leading the first comprehensive update and review of infant formula nutrients since 1998. 'We're going to make American infant formula the gold standard for the world,' Kennedy said in an Instagram post about the initiative. The update on formula is long past due, said Dr. Thomas Brenna, a professor of pediatrics, chemistry and human nutrition at the Dell Medical School at the University of Texas at Austin. Brenna is a member of the new FDA review panel on infant formula that is meeting in Washington on Wednesday. The group has met once online, and this will be the first in-person meeting. The FDA's last comprehensive review, released in 1998, 'called for a reevaluation of the fatty acids in infant formula within five years because of all the studies that were going on in the 1990s; I was one of the people doing them,' Brenna said. 'And so here we are in 2025, and much needs to be discussed.' The panel is stocked with experts who have been investigating the nuances of infant formula nutrition for years, said panel member Dr. Roger Clemens, a faculty member in the global medicine program at the Keck School of Medicine at the University of Southern California in Los Angeles. 'I myself have 50 years of experience, and several others are close, so I'm sure we have 500 years of combined experience in this group in areas of genuine significance, such as carbohydrates, fats, proteins and amino acids,' said Clemens, who also served as a scientific adviser to Nestlé USA for over 10 years and is a consultant on medical nutrition. 'We hope the public will comment, as well. All public comments are due on September 11, and we hope hundreds of people will tell us what's on their minds,' he added. A growing backlash against using seed oils to provide fat, one of the 30 nutrients that federal guidelines say must be included in infant formulas, has been building within Kennedy's Make America Healthy Again movement and among some anti-additives food activists and social media influencers. 'Seed oils are one of the most unhealthy ingredients that we have in foods,' Kennedy said in an interview with Fox News last fall, adding that seed oils are 'associated with all kinds of very, very serious illnesses, including body-wide inflammation, which affects all of our health.' However, the reality is much more nuanced than that, especially when it comes to infant formula, said Brenna, a pediatrician who's spent decades studying omega-6 and omega-3 fatty acids. 'A lot of the health concerns stem from how heavily the oils are processed,' Brenna said. 'Some suggest moving to palm oil, which is not from a seed, but in some ways, it's processed more harshly than seed oils. 'All oils must be processed to be used, so I believe we should be focusing on milder ways of extracting all of the oils,' he said. About 47% of calories in infant formula must be from fat, so choosing the right sources and amounts is key, Brenna said. As they currently exist, federal guidelines require minimum levels of 30 nutrients, including key vitamins, minerals and fats, proteins and linoleic acid, an essential fatty acid the body cannot make on its own. Only 10 nutrients have set maximum levels. Important lipids for infant brain development, such as the omega-3 fatty acid docosahexaenoic acid, or DHA, and the plant-based alpha-linolenic acid, or ALA, have never been part of the federal guidelines. (Many formula makers have been adding DHA since 2001 under the FDA's 'generally recognized as safe' or GRAS designation.) 'We're one of the only countries in the world that doesn't require a range of fats in our infant formulas,' Brenna said. 'Everybody else has been updating their standards, and we have been sitting still.' Another area of concern is the types of carbohydrates used in some 'sensitive' or 'gentle' infant formulas marketed to parents concerned about lactose intolerance, said Dr. Michael Goran, a professor of pediatrics and vice chair for pediatric research at the Keck School of Medicine at the University of Southern California, who is also on the review panel. 'Lactose, which is a natural sugar, is the only carbohydrate energy source in human breast milk,' said Goran, who is also program director for nutrition and obesity at the Saban Research Institute at Children's Hospital Los Angeles. However, the 1998 guidelines do not require the carbohydrates added to infant formula to be lactose, nor are the types of carbs required to be listed on the label so parents can choose, Goran said. 'A great many of the infant formulas sold today are made with glucose-based corn syrup solids and not lactose,' he said. 'Which is all based on this myth that (so-called) 'fussy' infants have lactose intolerance, which really is not a concern for most babies.' Although many nutritionists believe corn syrup is processed like sugar by the body, new unpublished research by Goran and his team counters that view. Six-month-old babies wore glucose monitors for three days to see how their blood sugars responded to corn syrup-based formula, compared with babies on breast milk or traditional lactose-sweetened formulas. A brief of that research will be presented during the panel's meeting Wednesday. 'We showed that when you give those babies corn syrup, it just makes their blood glucose sugars go into overdrive,' Goran said. 'But the infants who drank traditional lactose-based formula had glucose levels similar to breast-fed infants.' An analysis of the nutrient component of corn syrup-based and lactose-based formulas by researchers at Children's Hospital Los Angeles found that babies drinking formulas sweetened with corn syrup 'could consume up to 60 grams of added sugar a day — the equivalent of two sodas worth of sugar,' according to a brief on the study. In a separate study published in 2023, Children's Hospital researchers also found that babies fed corn syrup-based formulas were 10% more likely to be obese by age 4. 'High levels of dietary sugar can have an impact on children's brain development and memory and learning performance,' Goran said. When it comes to safety, many parents remember the lack of decontamination at an infant formula manufacturing plant owned by Abbott Nutrition that contributed to severe shortages of baby formula in 2022. The FDA inspection determined that Abbott was at fault after the company recalled several lots of Similac, Alimentum and EleCare baby formula made at its Sturgis, Michigan, manufacturing plant. The recalled formulas were linked to serious Cronobacter sakazakii and Salmonella infections in five infants. Two babies with Cronobacter infections died. There are other safety issues to consider, said Clemens, who is also past president of the Institute of Food Technologists and the International Academy of Food Science and Technology. 'We want to look beyond traditional safety, and a number of topics come to mind,' he said. 'We need to address emerging pathogens in the food supply. I'm going to suggest we look at more than bacterial contaminants and consider viruses and fungi, as well.' Nor has the US set standards for heavy metals, Clemens said: 'Yet tests find arsenic and lead in formula and baby foods.' A recent Consumer Reports investigation found concerning levels of arsenic and lead in some samples from 41 infant formulas, but the majority of the reports on heavy metals have focused on baby foods. In 2021, a congressional investigation found that leading baby food manufacturers knowingly sold baby foods with alarming levels of toxic metals. Keeping up-to-date with advances in infant formula means those changes need to be tested via the scientific process, said review panel member and neonatologist Dr. Steven Abrams, professor of pediatrics at the Dell Medical School at the University of Texas at Austin. 'If we're going to talk about novel ways of putting together oils, novel carbohydrate sources and even novel protein sources, there has to be a more efficient way to get those vetted, such as in clinical trials,' Abrams said. 'Nor has the FDA fully addressed issues of inaccurate labels, false marketing claims and things of that sort in the formula market,' he added. Another issue is providing additional support for the growing number of donor breast milk programs in the US. Breast milk is still best for a baby's health, according to the American Academy of Pediatrics, and mothers who can't or don't want to breast feed should have the option of obtaining that milk from donors, Abrams said. 'Except for one, all of these milk banks are nonprofits and need additional support to grow,' he said. 'There's a lot of donor milk out there, and the US is nowhere near maxed out on its capacity to support the milk banks themselves.' Other concerns will be presented Wednesday by other members of the review panel. Still, parents should not take the review as a sign that the US formula market is in disarray or in any way harmful to infants, Abrams said. 'It's not that there's a danger in the infant formula we're selling today, but our regulations are for formulas from the '80s we no longer sell,' he said. 'We are in dire need of an update.'
Yahoo
3 days ago
- Business
- Yahoo
Else Nutrition Holdings Inc (BABYF) Q4 2024 Earnings Call Highlights: Navigating Challenges and ...
Revenue: $8 million for fiscal year 2024, a decrease of approximately 15% from $9.54 million in 2023. Gross Loss: $1.2 million for fiscal year 2024, compared to $0.1 million in 2023. Inventory Write-Down: $2.2 million recognized in cost of sales during 2024. Adjusted Gross Profit: $1.1 million, representing a 13% gross margin, excluding inventory write-down. Operating Expenses: $13.6 million for fiscal year 2024, a decrease of approximately 20% from $16.9 million in 2023. Retail Distribution: Products available in over 600 Lola stores and nationwide launch in 1,000 Walmart retail stores. Warning! GuruFocus has detected 2 Warning Sign with BABYF. Release Date: June 03, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Else Nutrition Holdings Inc (BABYF) has taken decisive steps to optimize operations and reduce costs, including targeted reductions in headcount and overhead cost reductions. The company is preparing to start manufacturing its powder formula in Europe, which is expected to lower production costs, improve margins, and enhance product quality. Else Nutrition Holdings Inc (BABYF) has expanded its retail distribution, with products now available in over 600 Lola stores and a nationwide launch of kids RTD products in 1,000 Walmart retail stores. The company is actively engaging with the FDA to establish a clear regulatory pathway for its plant-based infant formula, aligning with the FDA's Operation Stork Speed initiative. Else Nutrition Holdings Inc (BABYF) has introduced its first adult ready-to-drink product in Canada, marking its entry into the growing adult nutrition market. Else Nutrition Holdings Inc (BABYF) faced significant challenges in 2024, including limited marketing resources and funding constraints, which impacted revenue growth. The company's revenue for the 2024 fiscal year decreased by approximately 15% compared to the previous year. Else Nutrition Holdings Inc (BABYF) experienced inventory shortages due to insufficient funding for production and packaging. The company's gross loss for the 2024 fiscal year was $1.2 million, with a write-down of inventories amounting to $2.2 million. Funding constraints have led to a decline in shareholder confidence and share price, impacting the company's ability to accelerate growth. Q: When the distribution has significantly decreased, is this because of a more targeted approach to consumer demographics or simply a lack of demand? A: Hamutal Yitzhak, CEO: Some retailers removed our products, but we added important retailers like AGB and Mayer. The demand varies by demographics and product performance. We are optimistic about retail sales growth in 2025, especially with our products now in 1,000 Walmart stores. Funding limitations have led us to focus on high-return marketing channels. Q: Revenue has declined, and the cash burn rate requires ongoing dilution of share value. Why expand instead of focusing on successful core products? A: Hamutal Yitzhak, CEO: Our cash burn rate has decreased due to cost reductions and efficiencies. Gross profitability has improved, and we expect further improvements in 2025. Inventory issues stem from funding constraints, not production capacity. We are addressing these issues and expect improvements soon. Q: With a large market and a healthy product, why can't you attract enough customers to make a viable business? A: Hamutal Yitzhak, CEO: Limited marketing budget restricts our ability to promote products. We have shifted to more cost-effective marketing strategies and expect improvements in 2025 by focusing on high-return advertising channels. Q: When will Else Nutrition start infant formula trials in the US, and can the new HHS expedite this? A: Hamutal Yitzhak, CEO: We have been lobbying the FDA for a response on clinical pathways. Recent FDA initiatives aim to improve infant formula regulations. We believe our new infant formula will be reconsidered by the FDA, and we expect progress in starting clinical studies. Q: As a long-term shareholder, I've seen my investment decline. What changes can management make to improve shareholder value? A: Hamutal Yitzhak, CEO: We understand shareholder concerns. We have taken actions to stabilize and revitalize the company, including cost restructuring, operational efficiency improvements, and expanding distribution. These steps aim to restore shareholder value and rebuild market trust. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Global News
3 days ago
- Business
- Global News
Infant formula is under health review in the U.S. What parents should know
As American health officials vow to overhaul the U.S. food supply, they're taking a new look at infant formula. U.S. Health Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration to review the nutrients and other ingredients in infant formula, which fills the bottles of millions of American babies. The effort, dubbed 'Operation Stork Speed,' is the first deep look at the ingredients since 1998. 'The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,' Kennedy said. About three-quarters of U.S. infants consume formula during the first six months of life, with about 40% receiving it as their only source of nutrition, according to the Centers for Disease Control and Prevention. Formula has been widely used in the U.S. for roughly six decades, feeding generations of infants who have flourished, said Dr. Steven Abrams, a University of Texas infant nutrition expert. Story continues below advertisement The broader scientific community has been calling for a reevaluation of infant formula for years and is 'fully supportive of this idea of a comprehensive look,' he said. Current formula products in the U.S. continue to be safe and nourishing, he said. 'But there's been a lot of science and we want the FDA rules to align with the most recent science from around the world,' he said. Here's what you need to know about Operation Stork Speed: What is infant formula and why do so many babies consume it? Infant formula is a manufactured product, usually made from cow's milk or soy, that is intended to mimic human breast milk for kids up age 12 months. It may be the sole source of nutrition or supplement breastfeeding. FDA regulations require that infant formulas contain 30 specific nutrients, with minimum levels for all and maximum levels for 10 of them. Story continues below advertisement The ingredients vary, but all formulas must have a balance of calories from protein, carbohydrates and fat that mirrors what's found in human milk. 1:50 Rising baby formula prices putting squeeze on B.C. families Federal guidelines recommend that babies be exclusively breastfed for the first six months of life and that parents continue breastfeeding for the first year or more while adding new foods to the child's diet. Get weekly health news Receive the latest medical news and health information delivered to you every Sunday. Sign up for weekly health newsletter Sign Up By providing your email address, you have read and agree to Global News' Terms and Conditions and Privacy Policy Parents use formula when a mother cannot or chooses not to breastfeed for a wide range of reasons, including medical conditions, work conflicts, to allow other family members to help with feedings and other situations. Why is the government reviewing baby formula now? Kennedy announced the review of infant formula in March as part of his 'Make America Healthy Again' agenda for the U.S. food supply. Story continues below advertisement The FDA's review will include increased testing for heavy metals and other contaminants as well as a review of nutrients, the agencies said. U.S. health officials will hold a two-hour roundtable discussion of infant formula on Wednesday. What issues will that cover? The FDA is asking for new scientific data and information about whether required ingredients in infant formula should be added, removed or changed. The deadline for comments is Sept. 11. Scientists say a review is long overdue regarding the most recent data on the composition of human milk and how babies digest and absorb nutrients in breastmilk and formula. 0:41 Woman arrested for allegedly refilling baby formula with other substances, returning to store In addition, they want the FDA to consider how U.S. formulas compare with those made elsewhere, said Bridget Young, who studies infant nutrition at the University of Rochester. Story continues below advertisement 'How do our regulations differ?' she said. 'Maybe it's time for them to relook at their regulations and consider potential international harmonization.' More international alignment might have eased the U.S. infant formula crisis in 2022, when contamination shut down an Abbott factory, leading to monthslong shortages for American parents, Young said. What about specific ingredients? In recent years, some parents have sought out infant formula made in Europe with the belief that products made overseas are healthier options, experts said. Formula regulations in the U.S. and Europe, including requirements for nutrients and testing, differ somewhat, but are generally similar, Abrams said. 'The differences between the U.S. and Europe should not be considered as 'higher' or 'better' or 'greater' in one vs. the other,' he said. Story continues below advertisement Still, iron, for instance, is included at higher levels in U.S. formulas than in those in Europe — and Abrams suggested that U.S. officials may consider lowering iron targets. Other components have been added to formula in recent years. They include docosahexaenoic acid, or DHA, an essential omega-3 fatty acid, and human milk oligosaccharides, complex sugars that are found breast milk but not in cow's milk. Although they may be beneficial, they are not required. 'These have been added to some formulas, but not to other formulas, so we want to take a look,' Abrams explained. 2:02 Breastfed babies less hyper but not necessarily smarter than babies fed formula: study Many parents have raised concerns over formula ingredients such as added sugars and seed oils, which are also being targeted by Kennedy as hazards in the wider food supply. Recent research suggests that added sugars such as glucose and corn syrup solids in infant formula may be linked to weight gain in children. Young said that most experts agree that lactose, the primary type of sugar found in breast milk, is preferred. Story continues below advertisement Infant formulas in the U.S. do contain seed oils, Young said. But that's because there are a finite number of vegetable oils that provide the essential saturated and unsaturated fats that babies require. 'They need to provide the variety of fatty acids that you see in breast milk,' she said. What are the next steps? Done properly, the FDA's infant formula review would take 'at least a year,' Abrams said. And it will require broad input from multiple government agencies, formula manufacturers and consumers. 'No shortcuts are possible and no one review, white paper or even committee report will suffice to do it right,' he said.
Chicago Tribune
3 days ago
- Business
- Chicago Tribune
Robert F. Kennedy Jr. has ordered a review of baby formula. Here's what you should know.
As federal health officials vow to overhaul the U.S. food supply, they're taking a new look at infant formula. Health Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration to review the nutrients and other ingredients in infant formula, which fills the bottles of millions of American babies. The effort, dubbed 'Operation Stork Speed,' is the first deep look at the ingredients since 1998. 'The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,' Kennedy said. About three-quarters of U.S. infants consume formula during the first six months of life, with about 40% receiving it as their only source of nutrition, according to the Centers for Disease Control and Prevention. Formula has been widely used in the U.S. for roughly six decades, feeding generations of infants who have flourished, said Dr. Steven Abrams, a University of Texas infant nutrition expert. The broader scientific community has been calling for a reevaluation of infant formula for years and is 'fully supportive of this idea of a comprehensive look,' he said. Current formula products in the U.S. continue to be safe and nourishing, he said. 'But there's been a lot of science and we want the FDA rules to align with the most recent science from around the world,' he said. Here's what you need to know about Operation Stork Speed: Infant formula is a manufactured product, usually made from cow's milk or soy, that is intended to mimic human breast milk for kids up age 12 months. It may be the sole source of nutrition or supplement breastfeeding. FDA regulations require that infant formulas contain 30 specific nutrients, with minimum levels for all and maximum levels for 10 of them. The ingredients vary, but all formulas must have a balance of calories from protein, carbohydrates and fat that mirrors what's found in human milk. Federal guidelines recommend that babies be exclusively breastfed for the first six months of life and that parents continue breastfeeding for the first year or more while adding new foods to the child's diet. Parents use formula when a mother cannot or chooses not to breastfeed for a wide range of reasons, including medical conditions, work conflicts, to allow other family members to help with feedings and other situations. Kennedy announced the review of infant formula in March as part of his 'Make America Healthy Again' agenda for the U.S. food supply. The FDA's review will include increased testing for heavy metals and other contaminants as well as a review of nutrients, the agencies said. U.S. health officials will hold a two-hour roundtable discussion of infant formula on Wednesday. The FDA is asking for new scientific data and information about whether required ingredients in infant formula should be added, removed or changed. The deadline for comments is Sept. 11. Scientists say a review is long overdue regarding the most recent data on the composition of human milk and how babies digest and absorb nutrients in breastmilk and formula. In addition, they want the FDA to consider how U.S. formulas compare with those made elsewhere, said Bridget Young, who studies infant nutrition at the University of Rochester. 'How do our regulations differ?' she said. 'Maybe it's time for them to relook at their regulations and consider potential international harmonization.' More international alignment might have eased the U.S. infant formula crisis in 2022, when contamination shut down an Abbott factory, leading to monthslong shortages for American parents, Young said. In recent years, some parents have sought out infant formula made in Europe with the belief that products made overseas are healthier options, experts said. Formula regulations in the U.S. and Europe, including requirements for nutrients and testing, differ somewhat, but are generally similar, Abrams said. 'The differences between the U.S. and Europe should not be considered as 'higher' or 'better' or 'greater' in one vs. the other,' he said. Still, iron, for instance, is included at higher levels in U.S. formulas than in those in Europe — and Abrams suggested that U.S. officials may consider lowering iron targets. Other components have been added to formula in recent years. They include docosahexaenoic acid, or DHA, an essential omega-3 fatty acid, and human milk oligosaccharides, complex sugars that are found breast milk but not in cow's milk. Although they may be beneficial, they are not required. 'These have been added to some formulas, but not to other formulas, so we want to take a look,' Abrams explained. Many parents have raised concerns over formula ingredients such as added sugars and seed oils, which are also being targeted by Kennedy as hazards in the wider food supply. Recent research suggests that added sugars such as glucose and corn syrup solids in infant formula may be linked to weight gain in children. Young said that most experts agree that lactose, the primary type of sugar found in breast milk, is preferred. Infant formulas in the U.S. do contain seed oils, Young said. But that's because there are a finite number of vegetable oils that provide the essential saturated and unsaturated fats that babies require. 'They need to provide the variety of fatty acids that you see in breast milk,' she said. Done properly, the FDA's infant formula review would take 'at least a year,' Abrams said. And it will require broad input from multiple government agencies, formula manufacturers and consumers. 'No shortcuts are possible and no one review, white paper or even committee report will suffice to do it right,' he said.
