FDA launches effort to review infant formulas
The Food and Drug Administration (FDA) announced a new initiative Tuesday titled 'Operation Stork Speed' aimed at reviewing infant formula ingredients and expanding available options.
According to the FDA, the goal of its new initiative is to ensure the 'quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.'
In 2022, the U.S. infant formula supply was hampered following the temporary closure of Abbott Nutrition's Michigan facility due to bacteria contamination. The FDA shut down the facility for months, and a nationwide recall was issued.
'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,' Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement, calling this action 'critical' to his Make America Healthy Again agenda.
The FDA's response to the 2022 infant formula crisis has been scrutinized, with the Office of Inspector General for the Department of Health and Human Services finding that the agency was dangerously slow in responding to complaints about conditions at the facility. The blowback from this led in part to the FDA reorganizing its structure in 2024.
In its announcement Tuesday, the FDA listed a set of actions it says will support nutritional adequacy and supply of infant formula. These include conducting the 'first comprehensive update and review of infant formula nutrients by the FDA since 1998,' increasing testing for heavy metals and extending the personal importation policy.
The agency also said it will be encouraging companies to develop new infant formulas.
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Hamilton Spectator
32 minutes ago
- Hamilton Spectator
Takeaways from AP's report on financial interests of RFK Jr. adviser who runs wellness platform
ASSOCIATED PRESS (AP) — Calley Means has built a following by railing against the U.S. health system, often hammering on alleged financial conflicts within the medical establishment. Means, a top aide to Health Secretary Robert F. Kennedy Jr., was hired as a White House adviser in March. He has used that position to accuse physician groups, federal agencies and government scientists of financial interests that bias their work. Means, however, has his own stake in the sprawling health system. He's the co-founder of an online platform that offers dietary supplements, herbal remedies, exercise equipment, light therapy lamps and other wellness products. The Associated Press found that Means' heated rhetoric against the medical mainstream dovetails with the interests of his company TrueMed, which features vendors who are prominent supporters of Kennedy's 'Make America Healthy Again' movement. Because of his status as a temporary government employee, Means is exempt from publicly disclosing his financial details. The AP reviewed more than two dozen interviews, speeches, articles and podcast appearances by Means both before and after he joined the government. Here are some takeaways from the AP's reporting : Attacking prescription drugs, promoting wellness alternatives Means' company, Truemed, helps users take tax-free money out of their health savings accounts, or HSAs, to spend on things that wouldn't normally qualify as medical expenses, such as meal delivery services and homeopathic products — remedies based on a centuries-old, debunked theory of medicine. As a top messenger for the administration, Means has been promoting a new government report that calls for scaling back prescription drugs for depression, weight loss and other conditions. By criticizing the use of drugs and other rigorously tested products, health experts say Means is furthering the interests of his company, which offers alternatives to traditional medicine. 'It reeks of hypocrisy,' said Dr. Reshma Ramachandran, a health researcher at Yale University. 'In effect, he is representing another industry that is touting nonregulated products and using his platform within the government to financially benefit himself.' In a written statement, Means said his government work has not dealt with matters affecting Truemed and has focused on issues like reforming nutrition programs and pressuring companies to phase out food dyes. 'Pursuing these large-scale MAHA goals to make America healthy has been the sole focus in my government work,' Means said. Undisclosed interests The full extent of Means' potential financial conflicts are unclear because of his status as a special government employee . Unlike presidential appointees and other senior officials, special government employees do not have to leave companies or sell investments that could be impacted by their work. Also, their financial disclosure forms are shielded from public release. 'It's a big problem,' says Richard Painter, former White House ethics lawyer under George W. Bush. 'I think it's a loophole.' Plugging products and business associates While promoting the administration's accomplishments, Means has not shied away from plugging his own brand or those of his business partners. When asked to offer health advice to listeners of a sports podcast, Outkick The Show, in April, Means suggested they read his book 'Good Energy,' which he co-authored with his sister, Dr. Casey Means. He also recommended blood tests sold by Function Health, which provides subscription-based testing for $500 annually. The company was cofounded by Dr. Mark Hyman, a friend of Kennedy and an investor in Truemed, which also offers Hyman's supplements through its platform. Like dietary supplements, the tests marketed by Function Health are not clinically approved by the Food and Drug Administration. 'It ends up favoring these products and services that rest on flimsy grounds, at the expense of products that have actually survived a rigorous FDA approval process,' said Dr. Peter Lurie, a former FDA official who is now president of the Center for Science in the Public Interest. Steering medical dollars into health savings accounts Means says he has not worked on issues impacting HSAs since joining the federal government. Federal ethics laws forbid government employees from taking part in decisions that could impact their financial situation. But before joining government, Means said the mission of his company 'is to steer medical dollars into flexible spending.' 'I want to get that $4.5 trillion of Medicare, Medicaid, everything into a flexible account,' he told fitness celebrity Jillian Michaels, on her podcast last year. Truemed collects fees when users and partnering companies use its platform. Means also founded a lobbying group, made up of MAHA entrepreneurs and TrueMed vendors, that listed expanding HSAs as a goal on its website. Means said in a statement that the group focused only on broad topics like 'health care incentives and patient choice — but did not lobby for specific bills.' Benefits of HSAs questioned Expanding HSAs has been part of the Republican health platform for more than 20 years. The tax-free accounts were created in 2003 to encourage Americans in high-deductible plans to be judicious with their health dollars. But HSAs have not brought down spending, economists say. They are disproportionately used by the wealthiest Americans, who have more income to fund them and bigger incentives to lower their tax rate. Americans who earn more than $1 million annually are the group most likely to make regular HSA contributions, according to an analysis by the nonprofit Center on Budget and Policy Priorities. Most Americans with HSAs have balances less than $500. HSA expansions in Trump's 'One Big Beautiful Bill' are projected to cost the federal government $180 billion over the next 10 years. 'These are really just tax breaks in the guise of health policy that overwhelmingly benefit people with high incomes,' said Gideon Lukens, a former White House budget official during the Obama and Trump administrations. ___ 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.
Boston Globe
an hour ago
- Boston Globe
Takeaways from AP's report on financial interests of RFK Jr. adviser who runs wellness platform
The Associated Press found that Means' heated rhetoric against the medical mainstream dovetails with the interests of his company TrueMed, which features vendors who are prominent supporters of Kennedy's 'Make America Healthy Again' movement. Because of his status as a temporary government employee, Means is exempt from publicly disclosing his financial details. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up The AP reviewed more than two dozen interviews, speeches, articles and podcast appearances by Means both before and after he joined the government. Advertisement Here are some takeaways from the AP's reporting: Attacking prescription drugs, promoting wellness alternatives Means' company, Truemed, helps users take tax-free money out of their health savings accounts, or HSAs, to spend on things that wouldn't normally qualify as medical expenses, such as meal delivery services and homeopathic products — remedies based on a centuries-old, debunked theory of medicine. As a top messenger for the administration, Means has been promoting a new government report that calls for scaling back prescription drugs for depression, weight loss and other conditions. By criticizing the use of drugs and other rigorously tested products, health experts say Means is furthering the interests of his company, which offers alternatives to traditional medicine. Advertisement 'It reeks of hypocrisy,' said Dr. Reshma Ramachandran, a health researcher at Yale University. 'In effect, he is representing another industry that is touting nonregulated products and using his platform within the government to financially benefit himself.' In a written statement, Means said his government work has not dealt with matters affecting Truemed and has focused on issues like reforming nutrition programs and pressuring companies to phase out food dyes. 'Pursuing these large-scale MAHA goals to make America healthy has been the sole focus in my government work,' Means said. Undisclosed interests The full extent of Means' potential financial conflicts are unclear because of his status as a special government employee. Unlike presidential appointees and other senior officials, special government employees do not have to leave companies or sell investments that could be impacted by their work. Also, their financial disclosure forms are shielded from public release. 'It's a big problem,' says Richard Painter, former White House ethics lawyer under George W. Bush. 'I think it's a loophole.' Plugging products and business associates While promoting the administration's accomplishments, Means has not shied away from plugging his own brand or those of his business partners. When asked to offer health advice to listeners of a sports podcast, Outkick The Show, in April, Means suggested they read his book 'Good Energy,' which he co-authored with his sister, Dr. Casey Means. He also recommended blood tests sold by Function Health, which provides subscription-based testing for $500 annually. The company was cofounded by Dr. Mark Hyman, a friend of Kennedy and an investor in Truemed, which also offers Hyman's supplements through its platform. Advertisement Like dietary supplements, the tests marketed by Function Health are not clinically approved by the Food and Drug Administration. 'It ends up favoring these products and services that rest on flimsy grounds, at the expense of products that have actually survived a rigorous FDA approval process,' said Dr. Peter Lurie, a former FDA official who is now president of the Center for Science in the Public Interest. Steering medical dollars into health savings accounts Means says he has not worked on issues impacting HSAs since joining the federal government. Federal ethics laws forbid government employees from taking part in decisions that could impact their financial situation. But before joining government, Means said the mission of his company 'is to steer medical dollars into flexible spending.' 'I want to get that $4.5 trillion of Medicare, Medicaid, everything into a flexible account,' he told fitness celebrity Jillian Michaels, on her podcast last year. Truemed collects fees when users and partnering companies use its platform. Means also founded a lobbying group, made up of MAHA entrepreneurs and TrueMed vendors, that listed expanding HSAs as a goal on its website. Means said in a statement that the group focused only on broad topics like 'health care incentives and patient choice — but did not lobby for specific bills.' Benefits of HSAs questioned Expanding HSAs has been part of the Republican health platform for more than 20 years. The tax-free accounts were created in 2003 to encourage Americans in high-deductible plans to be judicious with their health dollars. But HSAs have not brought down spending, economists say. They are disproportionately used by the wealthiest Americans, who have more income to fund them and bigger incentives to lower their tax rate. Advertisement Americans who earn more than $1 million annually are the group most likely to make regular HSA contributions, according to an analysis by the nonprofit Center on Budget and Policy Priorities. Most Americans with HSAs have balances less than $500. HSA expansions in Trump's 'One Big Beautiful Bill' are projected to cost the federal government $180 billion over the next 10 years. 'These are really just tax breaks in the guise of health policy that overwhelmingly benefit people with high incomes,' said Gideon Lukens, a former White House budget official during the Obama and Trump administrations.
Associated Press
an hour ago
- Associated Press
Takeaways from AP's report on financial interests of RFK Jr. adviser who runs wellness platform
ASSOCIATED PRESS (AP) — Calley Means has built a following by railing against the U.S. health system, often hammering on alleged financial conflicts within the medical establishment. Means, a top aide to Health Secretary Robert F. Kennedy Jr., was hired as a White House adviser in March. He has used that position to accuse physician groups, federal agencies and government scientists of financial interests that bias their work. Means, however, has his own stake in the sprawling health system. He's the co-founder of an online platform that offers dietary supplements, herbal remedies, exercise equipment, light therapy lamps and other wellness products. The Associated Press found that Means' heated rhetoric against the medical mainstream dovetails with the interests of his company TrueMed, which features vendors who are prominent supporters of Kennedy's 'Make America Healthy Again' movement. Because of his status as a temporary government employee, Means is exempt from publicly disclosing his financial details. The AP reviewed more than two dozen interviews, speeches, articles and podcast appearances by Means both before and after he joined the government. Here are some takeaways from the AP's reporting: Attacking prescription drugs, promoting wellness alternatives Means' company, Truemed, helps users take tax-free money out of their health savings accounts, or HSAs, to spend on things that wouldn't normally qualify as medical expenses, such as meal delivery services and homeopathic products — remedies based on a centuries-old, debunked theory of medicine. As a top messenger for the administration, Means has been promoting a new government report that calls for scaling back prescription drugs for depression, weight loss and other conditions. By criticizing the use of drugs and other rigorously tested products, health experts say Means is furthering the interests of his company, which offers alternatives to traditional medicine. 'It reeks of hypocrisy,' said Dr. Reshma Ramachandran, a health researcher at Yale University. 'In effect, he is representing another industry that is touting nonregulated products and using his platform within the government to financially benefit himself.' In a written statement, Means said his government work has not dealt with matters affecting Truemed and has focused on issues like reforming nutrition programs and pressuring companies to phase out food dyes. 'Pursuing these large-scale MAHA goals to make America healthy has been the sole focus in my government work,' Means said. Undisclosed interests The full extent of Means' potential financial conflicts are unclear because of his status as a special government employee. Unlike presidential appointees and other senior officials, special government employees do not have to leave companies or sell investments that could be impacted by their work. Also, their financial disclosure forms are shielded from public release. 'It's a big problem,' says Richard Painter, former White House ethics lawyer under George W. Bush. 'I think it's a loophole.' Plugging products and business associates While promoting the administration's accomplishments, Means has not shied away from plugging his own brand or those of his business partners. When asked to offer health advice to listeners of a sports podcast, Outkick The Show, in April, Means suggested they read his book 'Good Energy,' which he co-authored with his sister, Dr. Casey Means. He also recommended blood tests sold by Function Health, which provides subscription-based testing for $500 annually. The company was cofounded by Dr. Mark Hyman, a friend of Kennedy and an investor in Truemed, which also offers Hyman's supplements through its platform. Like dietary supplements, the tests marketed by Function Health are not clinically approved by the Food and Drug Administration. 'It ends up favoring these products and services that rest on flimsy grounds, at the expense of products that have actually survived a rigorous FDA approval process,' said Dr. Peter Lurie, a former FDA official who is now president of the Center for Science in the Public Interest. Steering medical dollars into health savings accounts Means says he has not worked on issues impacting HSAs since joining the federal government. Federal ethics laws forbid government employees from taking part in decisions that could impact their financial situation. But before joining government, Means said the mission of his company 'is to steer medical dollars into flexible spending.' 'I want to get that $4.5 trillion of Medicare, Medicaid, everything into a flexible account,' he told fitness celebrity Jillian Michaels, on her podcast last year. Truemed collects fees when users and partnering companies use its platform. Means also founded a lobbying group, made up of MAHA entrepreneurs and TrueMed vendors, that listed expanding HSAs as a goal on its website. Means said in a statement that the group focused only on broad topics like 'health care incentives and patient choice — but did not lobby for specific bills.' Benefits of HSAs questioned Expanding HSAs has been part of the Republican health platform for more than 20 years. The tax-free accounts were created in 2003 to encourage Americans in high-deductible plans to be judicious with their health dollars. But HSAs have not brought down spending, economists say. They are disproportionately used by the wealthiest Americans, who have more income to fund them and bigger incentives to lower their tax rate. Americans who earn more than $1 million annually are the group most likely to make regular HSA contributions, according to an analysis by the nonprofit Center on Budget and Policy Priorities. Most Americans with HSAs have balances less than $500. HSA expansions in Trump's 'One Big Beautiful Bill' are projected to cost the federal government $180 billion over the next 10 years. 'These are really just tax breaks in the guise of health policy that overwhelmingly benefit people with high incomes,' said Gideon Lukens, a former White House budget official during the Obama and Trump administrations. ___ 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.
