FDA to review nutrients in baby formula: 3 things for parents to know
The U.S. Food and Drug Administration plans to review the nutrition quality of infant formula sold in the United States, a review the agency says is the first of its kind in over 30 years.
The FDA said Tuesday that the review -- part of its "Operation Stork Speed" initiative -- will look at whether current nutrient requirements need to be updated, including whether additional nutrients need to be considered.
"Every child deserves a healthy start," Health and Human Services Secretary Robert F. Kennedy Jr., whose agency oversees the FDA, said in a statement Tuesday. "By taking a hard, honest look at the nutrients in infant formula, we're ensuring that parents have the tools to give their children the best nutrition from the very beginning."
The FDA's announcement comes three years after a baby formula shortage escalated to a national crisis due to a voluntary product recall of the one of the country's top baby formula producers.
Here are three questions answered for parents and caregivers.
It remains unclear at this time how long the nutrient review and could take.
To begin the review, the FDA issued a request for information, as required by law, on Tuesday.
The FDA also is seeking public input about whether existing nutrient requirements should be revised based on the latest scientific data. As of now, the FDA is accepting information from the public up until Sept. 11.
Moms turn to social media for help amid baby formula shortage
The FDA will then convene a public panel in early June.
Under current law, the HHS secretary reviews the table of required nutrients every four years as appropriate.
Since many organs rapidly develop in the first year of life, infants have special nutritional needs -- missing even a few days of formula can be harmful for an infant's development. Parents are encouraged to talk to their pediatrician about their child's nutritional plan.
How the FDA is responding to critical baby formula shortage
According to ABC News chief medical correspondent Dr. Tara Narula, parents should closely read the label of infant formula and make sure the formula is fortified with iron.
If parents are using a powder formula, they should make sure the water they are adding to the formula is clean, according to Narula.
Both Narula and the American Academy of Pediatrics warn against trying to make your own homemade infant formula using store-bought ingredients.
Homemade formulas "are risky … and may not be safe or meet your baby's nutritional needs," the AAP warns. Going above the maximum dose of a substance can be dangerous -- many nutrients are toxic to infants at high concentrations -- and the FDA reports that some babies fed homemade formula have been hospitalized for hypocalcemia (low calcium), which can cause seizures and heart problems.
The FDA currently specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients, according to the agency.
Among the nutrients currently required are protein and fat as well as Vitamins A, D, E, K, folic acid, iron, magnesium and zinc.
The FDA is the federal agency that oversees the "safety, nutritional adequacy, packaging, and labeling" of infant formula products, according to its website.
When an infant formula is brought to market, FDA investigators are tasked with ensuring it meets federal nutrition and labeling requirements. The FDA is also the agency tasked with conducting annual inspections of facilities that manufacture infant formulas and making sure the water used to manufacture formulas meets federal safety standards.
FDA to review nutrients in baby formula: 3 things for parents to know originally appeared on goodmorningamerica.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 hours ago
- Yahoo
Editorial: Ax to the vax — RFK Jr. continues on his anti-vaccine warpath
It's time for President Donald Trump, despite his own casual relationship with the truth, to stop putting American lives at risk and get rid of his dangerous quack in chief, Health and Human Services Secretary Robert F. Kennedy Jr. In his latest broadside against science, Kennedy is removing all 17 members of the Advisory Committee for Immunization Practices, the CDC's main advisory body, to ostensibly restore 'public trust above any specific pro- or anti-vaccine agenda.' God protect us, as RFK won't. This is how a society becomes undone. Science and reason get stepped on by half-truths and conspiracy theories. Next comes preventable death and disease. The problem is that there is no anti-vaccine side in the legitimate practice of science and medicine. The department's accompanying press release denigrated 'public health ideology' as if the practice of public health wasn't the CDC's only function. Researchers and doctors should be biased in favor of evidence-based therapeutics that save lives. Railing against bias towards vaccines is like a politician condemning researchers biased in favor of seatbelts in cars or keeping lead out of household paint. It's idiotic. We understand that the Make America Healthy Again movement Kennedy leads is all about questioning medical and nutritional practice. On a really abstract level, we are in agreement that no scientific truisms should be entirely above questioning — such a perspective would be anti-science. But there is a specific and long-standing methodology for actually answering those questions, and it is not debate club or who can most incite crowds of followers. It is the scientific method, under which hypotheses can be rigorously tested in ways that are replicable and based on clear and clearly laid out evidence. In that arena — really the only arena that actually matters when it comes to public health — the safety and efficacy of vaccines has been conclusively established. There is no additional discussion necessary or appropriate, particularly when it comes to immunizations that have now been standard-issue for decades and have by all measures radically decreased illness and mortality where they've been successfully deployed. The measles vaccine will always be better for individuals and public health than getting the measles. The same is true for polio, tetanus, COVID and all else. Preying on public skepticism of the pharmaceutical and health industries to hawk alternative approaches that are often unregulated and don't work is damaging it enough. Yet a true believer like RFK is more dangerous, especially now that he stands at the pinnacle of our nation's public health bureaucracy, a position that allows him to substantively impose his own anti-science view on an unsuspecting public and take the choice away from the American people. If RFK's new picks for ACIP — which the secretary falsely promised Sen. Bill Cassidy he wouldn't touch during his confirmation process — step back from recommending various crucial vaccines, this could substantially prevent even those who want to make the informed decision to receive inoculations or have their children vaccinated from being able to do so. As much as Kennedy and his followers emphasize the need for people to be able to make individual choices about their health, they seem hell-bent on taking that choice away entirely, especially given that insurance is not required to cover vaccines that are not CDC-recommended. We wonder what RFK will have to say for himself as once-eradicated diseases begin cutting through the U.S. population again. Is there anything that will get him to veer off this disastrous course? If the answer is no, and we suspect it is, then he must be removed before he can further damage public health. _____
Business Upturn
3 hours ago
- Business Upturn
Bavarian Nordic Initiates Phase 3 Study of Chikungunya Vaccine in Children
First children vaccinated in clinical study seeking to expand the target population for the chikungunya vaccine. COPENHAGEN, Denmark, June 12, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a Phase 3 clinical study of its single-dose, virus-like particle (VLP) chikungunya vaccine, CHIKV VLP in children 2 to 11 years of age. This first trial of CHIKV VLP in a pediatric population aims to expand the target population for the vaccine, currently approved for persons 12 years of age and older in the US, EU and United Kingdom under the trade name VIMKUNYA®. The global, randomized, double-blind, placebo-controlled study (NCT07003984), sponsored by Bavarian Nordic, will evaluate the safety and immunogenicity of CHIK VLP vaccine in 720 children 2 to 11 years of age for two years. Primary results from the study are anticipated in the first half of 2028. Paul Chaplin, President & CEO of Bavarian Nordic, said: 'Upon the successful approvals earlier this year of our chikungunya vaccine for persons aged 12 and older, we are pleased to initiate this Phase 3 study in children for whom there are currently no vaccines available to prevent against chikungunya. This study represents a significant part of our commitment to the further development of the vaccine to help ensure access for people of all ages.' About VIMKUNYA® Chikungunya vaccine (recombinant, adsorbed) VIMKUNYA (CHIKV VLP) is the first and only virus-like particle (VLP) vaccine for the prevention of chikungunya disease in individuals aged 12 years and above. It is designed to induce a robust seroresponse, with protective immunity starting to develop as early as 1 week after vaccination. VIMKUNYA is the only single-dose vaccine against chikungunya disease available in a prefilled syringe. VIMKUNYA does not contain viral genetic material and is therefore non-infectious and unable to cause disease, ensuring a broad range of people can benefit from vaccination. The vaccine was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 20251,2 and the United Kingdom in May 20253. The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65-year-olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12–64-year-old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain4,5. About chikungunya Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years6. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years7. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide8. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile9. About Bavarian Nordic Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Contact investors: Europe: Rolf Sass Sørensen, Vice President Investor Relations, [email protected], Tel: +45 61 77 47 43 US: Graham Morrell, Paddock Circle Advisors, [email protected], Tel: +1 781 686 9600 Contact media: Nicole Seroff, Vice President Corporate Communications, [email protected], Tel: +45 53 88 06 03 1 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. 2 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. 3 Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom. 4 Richardson JS, et al. Chikungunya Virus VLP Vaccine: Phase 3 Trial in Adolescents and Adults. medRxiv 2024.10.11.24315179. 5 Tindale LC, et al. Chikungunya Virus VLP Vaccine: Phase 3 Trial in Adults ≥65 Years of Age. medRxiv 2024.10.10.24315205. 6 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. 7 European Centre for Disease Prevention and Control. Chikungunya virus disease. 8 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. 9 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/ PMID: 38711542; PMCID: PMC11070701. Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Yahoo
6 hours ago
- Yahoo
Breakthrough procedure helps prevent amputations for Sacramento area patients
( — A breakthrough surgery helping save limbs and lives took place in Sacramento on Wednesday morning. The procedure aims to treat people suffering from Peripheral Artery Disease. PAD is a serious and rarely-treated circulatory condition that restricts blood flow to the limbs due to narrowed blood vessels. It kills more people than breast, colon, and prostate cancer combined. 'Plaque that builds up in these arteries causes not only hardening of the arteries but also plaque in these blood vessels,' said Dr. Inder Singh, an interventional cardiovascular specialist at TLC Vascular. When blood can't flow properly, minor wounds can become dangerous. They can lead to infection and, in some cases, amputation. Michaels Distributing Center in San Joaquin County set to close, affecting over 200 jobs 'If they get an injury or they get a wound or they get a scratch, those will not heal because they don't have enough, adequate perfusion to heal those wounds,' Dr. Singh said. Helping to change patient outcomes, Dr. Singh is now performing a first-of-its-kind procedure using a newly FDA-cleared removable stent called SPUR. 'The idea with it is that basically that kind of treatment that deep penetrates into the tissue and treats it, it will prevent future closure or at least prolong the time from when the blood vessels close,' said Dr. Singh. 'Enabling the patients to be able to heal their wounds, which is really the main outcome we're looking for.' is the first in the Sacramento area to use SPUR, designed specifically for the small, fragile arteries below the knee. Unlike a traditional stent, the spur temporarily holds the vessel open and then is removed, leaving nothing behind. Charges filed against former Cal Fire employee in child pornography case 'We can see somebody on an outpatient basis one day and actually fix a problem rather than put a band-aid on, you know, the incorrect problem,' said Shelby Adney, a nurse practitioner at TLC Vascular. It's an innovative procedure now preventing amputations, healing wounds, and maintaining patients' normal lives. 'Once you can preserve that and heal their wounds… they get their life back,' Dr. Singh said. 'They're ambulatory. They can spend time with their family. You can do a lot of things that most people expect to do.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
