Latest news with #infantformula
The Independent
18 minutes ago
- Business
- The Independent
Kennedy 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: 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. 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. 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. 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. 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. 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. 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. 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. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
RNZ News
9 hours ago
- Business
- RNZ News
How pulling out of a long-planned new infant formula standard left the government with an expensive problem
Photo: RNZ Creating a stand alone infant formula food standard for New Zealand would be "complex", "costly" and "require significant resources", the government was warned. The warning was issued to Cabinet ministers by Food Safety Minister Andrew Hoggard as the government considered opting out of tougher trans-Tasman baby formula rules last year. It is revealed in a newly released Cabinet paper from Hoggard. Despite the warning, Cabinet decided to opt out anyway, and Hoggard announced New Zealand would create its own standard. But since then, the government has been looking at how it could opt back in with Australia if exemptions to the labelling issues opposed by industry could be negotiated. The heavily redacted Cabinet paper shows Hoggard warned there would be "cost implications" if New Zealand chose to go it alone. "Significant resources will be required to develop the standard," Hoggard wrote. "Should New Zealand opt out, we will require a process to review industry applications for new ingredients for infant formula including food safety risk assessments and management. This is essential to ensure we maintain the assurance of our export partners and equivalence of our food safety system. Andrew Hoggard Photo: RNZ / Angus Dreaver "This work requires a specialist team with expertise in food science, nutrition, risk assessment, toxicology, genetic modification, dietary assessment and social science." The minutes of that Cabinet decision also noted the "potentially significant negative economic impacts" on formula companies if the standard was adopted. Ministers also agreed to "continue discussions" with Australia to allow New Zealand to opt into the standard in the future, the minute noted. Hoggard's warning about the cost of opting out of the trans-Tasman standard was echoed by others Photo: RNZ Just days before the Cabinet decision, Fonterra, which was in favour of adopting the proposed new standards, had raised concerns with MPI officials about the "complexity" of creating a New Zealand-alone standard. Fonterra questioned whether the ministry had the resources to implement and monitor such a standard. "We would be concerned if resource was diverted away from other dairy sector priorities," it wrote to an MPI official on July 31. MPI officials themselves were also concerned. An internal memo from late August warned that developing a New Zealand standard would be "complex" and require input from a host of specialists to assess "composition and labelling requirements." An RNZ investigation has previously revealed how a handful of formula companies, led by Danone, The a2 Milk Company and an industry lobby group, intensely lobbied the government against adopting the new trans-Tasman infant formula standards, which were more than 11 years in the making. The lobbying included bombarding senior ministers with emails, letters, surveys and legal advice, as well as having at least six meetings with Hoggard in the six months leading up to the decision. Newly released documents from MPI show industry representatives met with MPI officials 18 times over the issue between May 2023 and July 2024. Fonterra attended two meetings, Danone, which strongly opposed the standards, had three, including one where it brought seven executives. Fonterra and a2 typically brought only two executives to the meetings. The a2 Milk Company met with officials four times, as did the industry lobby group Infant Nutrition Council. The Dairy Companies Association of New Zealand (DCANZ), headed by Hoggard's sister , also had two meetings with MPI. Two of the 18 meetings were regular MPI Dairy Product Safety Advisory Council meetings, attended by multiple dairy companies. They are included in the total count because the infant formula standards were discussed at these meetings. Representatives from INC, Danone, Fonterra, DCANZ and Synlait attended. MPI told RNZ that DCANZ "has advised that they did not take a position on the options in these meetings." In addition to the many meetings, emails showed that the INC had at least two phone calls with MPI staff in July, though these were not officially recorded as meetings. MPI also held "targeted stakeholder engagement" with a handful of formula companies in October to discuss how infant milk should be regulated. It met with Danone, a2, Fonterra, Nestle, INC, and the Ministry of Health and the Ministry of Foreign Affairs and Trade. Fonterra, Nestle and the Ministry of Health supported New Zealand opting into the FSANZ standards. In a statement, MPI said the consultation was part of its process to explore next steps. "This engagement informed a wider and ongoing process to develop options for the Minister to consider. These types of engagements are common practice and allow those who are affected by Government regulations to provide expert feedback," New Zealand Food Safety Deputy Director General Vince Arbuckle said. New Zealand "remains committed" to the joined food system with Australia, he said. In a statement, Hoggard's office said the situation with infant formula had not "materially changed" recently and he had nothing to add.
New York Times
3 days ago
- Business
- New York Times
She Built a Cult Baby Formula Business. Then R.F.K. Jr. Came Calling.
The photo posted on X in March by the Department of Health and Human Services seemed innocuous. Secretary Robert F. Kennedy Jr. stands in the center, surrounded by Robert Ford, chief executive of Abbott Laboratories; Kris Licht, the chief executive of Reckitt; Patrick Lockwood-Taylor, chief executive of Perrigo; and Laura Modi, the founder and chief executive of Bobbie. The post was paired with an announcement that H.H.S. would work with these leaders to update the country's nutrition guidelines for infant formula, which have remained unchanged since 1998. But that photo set off an animated debate among fans of Bobbie, which has made its name over the last several years as an ingredient-conscious and science-based brand. Some cheered on Ms. Modi for being the only woman there and the only one representing a newcomer to an industry dominated by old gatekeepers. When Bobbie shared the photo on its Instagram page, many of its followers threw fire and heart emojis all over its comments. Others wondered if she should have been there at all, meeting with Mr. Kennedy, who they say is antithetical to everything they thought the Bobbie brand stood for. That the other chief executives in the photo didn't receive this kind of scrutiny illustrates the difficulty of being a business leader who has been vocal about their company's purpose during the current administration, when every decision about a company's values can become politically charged. Want all of The Times? Subscribe.
Globe and Mail
6 days ago
- Business
- Globe and Mail
Else Nutrition CEO Highlights Urgent Need for Infant Formula Alternatives in The Washington Times Op-Ed
VANCOUVER, BC , May 28, 2025 /CNW/ - ELSE NUTRITION HOLDINGS INC. (TSX: BABY) (OTCQX: BABYF) (FSE: 0YL) ("Else" or the "Company"), a pioneer in wholefood, Plant-Based nutrition for babies, toddlers, children and adults, is pleased to announce that its CEO and Co-Founder, Hamutal Yitzhak , authored a featured op-ed published in The Washington Times on May 25, 2025 . Titled " Operation Stork Speed will ensure babies get the nutrition they need," the piece highlights the urgent need to modernize the infant formula regulatory environment and emphasizes the importance of increasing access to safe and innovative nutrition options—particularly for infants with dietary restrictions or allergen sensitivities. The Washington Times has a substantial readership in Washington, D.C. , particularly among Congress and the Administration. "Our mission has always been to deliver a safe, plant-based infant formula that supports healthy development and gives families—especially those with dietary or dairy/soy allergen concerns—greater access to trusted nutrition," said Hamutal Yitzhak , CEO and Co-Founder of Else Nutrition. "Operation Stork Speed is an excellent initiative designed to expand access to these types of formulas, and as noted in the Washington Times op-ed, we look forward to continuing to collaborate with the White House, policymakers, and the FDA as we look to bring our unique solution to market in a swift and responsible manner." Regulatory Pathway and Status Else Nutrition has developed a clean-label, whole plant-based infant formula intended as an alternative to dairy- and soy-based products. In 2023, the Company successfully concluded the pre-clinical studies required and received Institutional Review Board (IRB) approval for its infant growth clinical study protocol—marking a key step toward U.S. Food and Drug Administration (FDA) compliance. At present, the Company is awaiting final authorization from the FDA to initiate its clinical trial in the United States , pending regulatory modernization that the company believes may be accelerated through Operation Stork Speed. Several Congressional Appropriators recently called on the FDA to accelerate this effort, as directed through an oversight letter. Policy Advocacy and Operation Stork Speed The op-ed coincides with the recent launch of Operation Stork Speed, an initiative by the Trump administration and Health and Human Services Secretary Robert F. Kennedy Jr. , aimed at improving the regulatory review and safety of infant formula in the United States as well as encouraging innovation and transparency in formula composition to serve unmet needs. Ms. Yitzhak's commentary lends industry perspective to this national conversation and urges regulatory authorities to accelerate the path to market for scientifically supported, non-traditional formula options. Else Nutrition is actively engaged in this effort through direct outreach to policymakers, bipartisan advocacy on Capitol Hill, and consumer education. The Company continues to advocate for updated infant formula guidelines that recognize the validity and safety of plant-based, non-soy, allergen-friendly alternatives. About Else Nutrition Holdings Inc. Else Nutrition Holdings Inc. (TSX: BABY, OTCQX: BABYF, FSE: 0YL) is a food and nutrition company in the international expansion stage focused on developing innovative, clean, and Plant-Based food and nutrition products for infants, toddlers, children, and adults. Its revolutionary, Plant-Based, non-soy formula is a clean-ingredient alternative to dairy-based formulas. Since launching its Plant-Based Complete Nutrition for Toddlers, made of whole foods, almonds, buckwheat, and tapioca, the brand has received thousands of powerful testimonials and reviews from parents, gained national retailer support, and achieved rapid sales growth. Awards and Recognition: "2017 Best Health and Diet Solutions" award at Milan's Global Food Innovation Summit #1 Best Seller on Amazon in the Fall of 2020 in the New Baby & Toddler Formula Category "Best Dairy Alternative" Award 2021 at World Plant-Based Expo Nexty Award Finalist at Expo West 2022 in the Plant-Based lifestyle category During September 2022 , Else Super Cereal reached the #1 Best Seller in Baby Cereal across all brands on Amazon To delve deeper into Else Nutrition's offerings and its revolutionary approach to nutrition, visit TSX Neither the TSX nor its regulation services provider (as that term is defined in the policies of the TSX) accept responsibility for the adequacy or accuracy of this release. Caution Regarding Forward-Looking Statements This press release contains statements that may constitute "forward-looking statements" within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as "will" or similar expressions. Forward-looking statements in this press release include statements with respect to the anticipated dates for filing the company's financial disclosure documents. Such forward-looking statements reflect current estimates, beliefs, and assumptions, which are based on management's perception of current conditions and expected future developments, as well as other factors management believes are appropriate in the circumstances. No assurance can be given that the foregoing will prove to be correct. Forward-looking statements made in this press release assume, among others, the expectation that there will be no interruptions or supply chain failures as a result of COVID-19 and that the manufacturing, broker, and supply logistic agreement with the company does not terminate. Actual results may differ from the estimates, beliefs, and assumptions expressed or implied in the forward-looking statements. Readers are cautioned not to place undue reliance on any forward-looking statements, which reflect management's expectations only as of the date of this press release. The company disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Daily Mail
12-05-2025
- Health
- Daily Mail
Urgent warning to parents about new Aussie formula after a baby boy suddenly fell ill and was rushed to hospital
The parents of a seven-month-old baby claim his health deteriorated and became malnourished after switching to new plant-based baby formula. The Melbourne family turned to Coco2 - an Australian company which claimed to be 'the world's first coconut-based infant formula' - after learning their little boy was lactose intolerant. The parents claimed their son began showing worrying symptoms a few weeks after he started on the formula. 'He wasn't reaching any of his seven-month milestones, he wasn't sitting up,' the father told 7News. 'He'd look sick, he'd get up, he'd drink, he'd go to sleep and then wake up again in half an hour because he's hungry and we'd feed him again.' By February, the baby was lethargic, losing weight and had 'lost all his colour'. 'His lips started to crack. He was rashing all around his nose and eyes and so we just went to the GP and he suggested some blood tests,' the father said. However, the tests did little to ease the family's panic and they went to the Royal Children's Hospital in their desperate quest for answers. Their worst fears, including blood cancer, were ruled out but doctors struggled to narrow down what was wrong. Eventually, they recommended the family try a new formula and the baby quickly recovered. Doctors don't believe the baby will suffer any long-term issues. An official report from doctors at The Royal Children's Hospital suggested the baby's illness was likely caused by the formula. 'The Coco formula they were previously consuming had made an error in their scoop size and was not delivering adequate nutrition per feed — this is the likely cause for their significant weight loss and malnutrition,' the report stated. Coco2 recently updated its serving recommendations after detecting an error in its scoop size. 'We're reaching out with an important update regarding the Coco2 Baby Formula batch you purchased,' an email to customers stated. 'Due to natural variations in bulk density, we discovered that the included scoop holds slightly less powder than usual.' The company recommended parents add 50 per cent more formula to their baby's bottle. Coco2 has recently updated its serving recommendation to add 50 per cent more formula to each bottle (stock image) 'This adjustment is simply to ensure that your baby receives the proper serving size and all the nutrients they need,' it said. 'We sincerely apologise for any confusion or inconvenience this may have caused.' A sticker with the updated serving recommendation has also been added to in. Coco2 emphasised that the product is safe and 'there have been no medically confirmed reports of babies becoming seriously ill due to Coco2 formula'. The company also insisted a recall was not required as the issue was dosage related. Daily Mail Australia has contacted Coco2 for further comment. Developed in Queensland, Coco2 was hailed as the world's first coconut-based formula and 'a breakthrough in plant-based nutrition for babies' when it was launched seven months ago. The new product prompted a warning from experts for parents to check with their GP before switching to the plant-based formula 'I would be waiting, as a professional, for [a] growth study to come out before I went out and recommended this formula to a family who wanted to feed that to their baby,' paediatric allergy dietitian Ingrid Roche said. 'Some babies have really high nutrition needs and we know (certain) formulas are good for growth for some children who have really high nutrition needs.'
