News & Analysis as of

Food and Drug Administration (FDA) Baby Products

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - July 2025

A report arguing for raising taxes on alcohol and sugar-sweetened beverages, a law requiring labels to disclose if an animal was harmed during production, a lawsuit calling grain alcohol "inherently dangerous," and more. It...more

Hogan Lovells

FDA issues letter to industry on recall communications for infant and baby foods

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On July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a letter from Commissioner for Human Foods Martin Makary and Deputy Commissioner for Human Foods Kyle Diamantas to industry members involved in the...more

Cozen O'Connor

AGs Renew Call for FDA Guidance on Toxic Heavy Metals in Baby Food

Cozen O'Connor on

Arizona AG Kris Mayes and D.C. AG Brian Schwalb submitted a letter to the FDA in support of other state AG’s 2022 petition for reconsideration of a multistate petition seeking FDA actions on toxic heavy metals in food...more

Holland & Knight LLP

Holland & Knight Health Dose: May 20, 2025

Holland & Knight LLP on

The budget reconciliation package is expected to be considered by the full U.S. House of Representatives as soon as May 22, 2025. The House Committee on Rules is scheduled to meet on May 21, 2025, at which time additional...more

Venable LLP

Operation Stork Speed Update: FDA Issues RFI for Infant Formula Nutrition Review

Venable LLP on

On May 14, as part of Operation Stork Speed (the Operation), the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) to begin its review of infant formula nutrition requirements. FDA’s last...more

Venable LLP

FDA Launches Operation Stork Speed to Make Infant Formula Healthy Again

Venable LLP on

On March 18, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the launch of Operation Stork Speed “to enhance [FDA’s] efforts to ensure the ongoing quality, safety,...more

Troutman Pepper Locke

FDA’s New Lead Guidelines: A Milestone for Safer Baby Foods

Troutman Pepper Locke on

In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to...more

Hogan Lovells

FDA Issues Final Guidance Setting Action Levels for Lead in Food Intended for Babies and Young Children

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) issued a final guidance for industry titled Action Levels for Lead in Processed Food Intended for Babies and Young Children (Final Guidance). The final action levels apply only to...more

Womble Bond Dickinson

FDA Sets Action Levels For Lead

Womble Bond Dickinson on

A year ago, the FDA issued draft guidance for lead levels in baby foods. In the year since the FDA issued its draft guidance for lead levels in baby food, two states, California and Maryland, have adopted laws which require...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

DLA Piper

Food and Beverage News and Trends - January 2025

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FDA issues final guidance on lead in baby food. FDA has issued its Final Guidance on Action Levels for Lead in Processed Food Intended for Babies and Young Children as part of its Closer to Zero initiative to reduce dietary...more

DLA Piper

Food and Beverage News and Trends - November 2024 #2

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA seeks input on human food export certification program. Companies that...more

Venable LLP

Maryland Requires Baby Food Manufacturers to Test for Toxic Heavy Metals

Venable LLP on

We want to inform you of a new law in Maryland, effective January 1, 2025, that mandates baby food manufacturers to test for toxic heavy metals, excluding infant formula. Known as Rudy’s Law, this legislation was inspired by...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Cozen O'Connor

The State AG Report – 2.22.2024

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •FTC, California DFPI Team Up Against Mortgage Relief Scams...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update

LEGISLATION, REGULATIONS & STANDARDS - 20 State AGs Ask FDA to Act on Lead, Metals in Baby Food - Citing a wave of childhood lead poisoning connected to recalled applesauce pouches, a group of 20 state attorneys general...more

Cozen O'Connor

Democratic AGs Continue Urging FDA to Issue Guidance on Toxic Metals in Baby Food

Cozen O'Connor on

A group of 20 Democratic AGs wrote a comment letter to the FDA urging it to act on prior AG petitions asking the FDA to issue strong, specific guidance to the baby food industry on testing for lead and other toxic elements....more

Foley & Lardner LLP

FDA Issues Tip Sheet to Shore-up the Supply Chain for Infant Formula and Critical Food

Foley & Lardner LLP on

In the effort to enhance product quality and the integrity of the infant formula supply chain after contamination resulted in the 2022 baby formula shortage, Congress and the FDA took steps to ensure that infants and parents...more

Morris James LLP

How Do I Report an Injury to a Baby from Infant Formula?

Morris James LLP on

Baby formula has sadly made headlines in recent years as a result of shortages, plant closures, contamination, and lawsuits. A major infant formula class action lawsuit is ongoing against manufacturers Enfamil and Similac for...more

Shook, Hardy & Bacon L.L.P.

FDA Outlines Strategy for Infant Formula Market

The U.S. Food and Drug Administration has released a national strategy outlining actions it will take immediately to help increase the resiliency of the U.S. infant formula market and supply. The Food and Drug Omnibus Reform...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - April 2023

FDA Proposes Changes to Standards of Identity for Foods Including Salt- The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would change the standards of identity (SOIs) for foods that include salt to...more

Cozen O'Connor

FDA Draft Guidance on Lead in Baby Food Earns AG Support

Cozen O'Connor on

A group of 21 Democratic AGs wrote a comment letter to the FDA in connection with the agency’s Draft Guidance to Industry on Action Levels for Lead in Food Intended for Babies and Young Children (“Lead Guidance”). The letter...more

Venable LLP

FDA Infant Formula Updates: New Labeling Guidance, Call for Enhanced Safety Measures, and Draft Protein Efficiency Ratio Testing

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Infant formula manufacturers should be aware of several recent actions taken by the Food and Drug Administration (FDA). In total, these actions reflect FDA's dedication of resources to the infant formula industry....more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - March 2023 #3

LEGISLATION, REGULATIONS & STANDARDS - California Lawmakers Introduce Legislation to Ban Five Food Additives - California lawmakers have introduced first-in-the-nation legislation seeking to ban five food...more

Womble Bond Dickinson

Ramifications of FDA’s Proposed Action Levels for Heavy Metals in Baby Food

Womble Bond Dickinson on

On March 4, 2021, we wrote about lawsuits concerning alleged high levels of heavy metals in baby foods (“Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers”). A precipitating factor was a staff report...more

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