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
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
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
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...more
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
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
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
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
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
A group of 21 Democratic AGs wrote a comment letter to the FDA in connection with the agency’s Draft Guidance to Industry on Action Levels for Lead in Food Intended for Babies and Young Children (“Lead Guidance”).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
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
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
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
U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the...more
What formula brands are affected? This recall only relates to the following Similac®, Alimentum®, and EleCare® powdered formula produce at the Abbott Nutrition plant in Sturgis, Michigan...more
The U.S. Food and Drug Administration (FDA) has announced the release of the Interagency Food Safety Analytics Collaboration’s annual report, which provides data on source attribution estimates for 2020 for Salmonella, E....more
This month marks the 20th anniversary of Shook, Hardy & Bacon’s Food and Beverage Litigation and Regulatory Update (FBLU). Since publishing its first edition in October 2002, Shook has continuously covered the legal,...more
The attorneys general of 22 states have submitted a letter to the U.S. Food and Drug Administration (FDA) and Department of Agriculture (USDA) asserting that the agencies “are not sufficiently prioritizing a public health...more
The giant drug maker Abbott and the federal Food and Drug Administration both should hang their heads in shame as more information becomes public as to how they left millions of vulnerable infants hungry and put kids’ health...more
Chambers and Partners has listed Shook’s Food, Beverage and Agribusiness Practice as Band 4 in its USA – Nationwide rankings. According to Chambers, “The Shook, Hardy & Bacon team is respected for its representation of...more
On May 23, 2022, the Federal Trade Commission (FTC), at the prompting of President Joe Biden, announced that it will launch a civil investigation into the ongoing shortage of baby formula throughout the country. The FTC is...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
The U.S. Food and Drug Administration (FDA) has issued guidance indicating that it will not enforce particular provisions implementing the Food Safety Modernization Act (FSMA). “In certain situations the FDA has determined it...more
California AG Rob Bonta reached a settlement with baby food manufacturer Perrigo Company and two of its subsidiaries (collectively, “Perrigo”) to resolve allegations that Perrigo did not warn consumers about the levels of...more