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
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
A year ago, the FDA issued draft guidance for lead levels in baby foods. In the year since the FDA issued its draft guidance for lead levels in baby food, two states, California and Maryland, have adopted laws which require...more
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
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
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
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
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
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
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
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
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
A group of 23 Democratic AGs, led by New York AG Letitia James, petitioned the U.S. Food and Drug Administration (“FDA”) to set limits on the permissible levels of heavy metals in baby food...more
The U.S. Food and Drug Administration (FDA) recently released a new action plan designed to further reduce exposure to toxic elements, including heavy metals, from foods for infants and young children. This represents the...more
The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the...more
The U.S. Food and Drug Administration recently announced a new initiative called Closer to Zero, which is an action plan that identifies steps the agency will take over the next three years (and beyond) to reduce exposure to...more
Last week, members of both chambers of Congress announced the introduction of new legislation – the Baby Food Safety Act of 2021 – that would establish limitations on the levels of certain heavy metals in infant and toddler...more
The U.S. Food and Drug Administration (FDA) has announced an investigation into Real Water alkaline water, which is allegedly the link between several cases of acute non-viral hepatitis. The investigation comes amid the...more
On 5 March 2021, the U.S. Food and Drug Administration (FDA) issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice,...more
Are baby foods subject to stricter standards than adult foods? The short answer is, not really. The U.S. Food and Drug Administration (FDA) has specific guidelines for baby formulas, labeling requirements for baby and...more