Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The U.S. Food and Drug Administration (FDA) recently held a public meeting as a part of its Closer to Zero: Action Plan for Baby Foods initiative. This plan identifies steps the agency will take over the next three years...more
On March 4, 2021, we posted “Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers.” Multiple plaintiffs had filed class action lawsuits in jurisdictions around the country alleging that baby food...more