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 July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request...more
On February 23, 2023, the Food and Drug Administration (FDA) announced the issuance of a draft guidance document entitled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry.”...more
On September 28, 2022, the U.S. Food and Drug Administration issued a Proposed Rule to revise the criteria for when foods can be labeled with the nutrient content claim “healthy.” Since 1994, FDA has recognized that when a...more
On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...more
Here is what you need to know about the FDA's recent proposed rule on "healthy" labeling. - On September 29, 2022, FDA proposed an amendment to the existing regulation (21 CFR § 101.65) on when “healthy” or similar terms...more
On September 3, 2021, the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA-FSIS) opened a comment period in advance of a proposed rule on labeling requirements for meat and poultry products comprised...more
The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) recently published an advanced notice of proposed rulemaking (ANPR) seeking public comment pertaining to the labeling of meat and...more
Parties in another false advertising case surrounding the use of the term “natural” have filed for preliminary approval of a class action settlement. On May 7, 2021, the plaintiff in Megan Holve v. McCormick & Company, Inc.,...more
The U.S. Food and Drug Administration (FDA) published a request for information in the Federal Register in connection with labeling of foods made with cultured seafood cells. FDA will use the information received to decide...more
FDA recently issued two nutrition-labeling guidance documents intended to provide restaurants and food manufacturers flexibility during the public health emergency declared by the Department of Health and Human Services. ...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
LEGISLATION, REGULATIONS & STANDARDS - AGs Submit Comment to FDA on Cannabis - A group of 38 state attorneys general have submitted a letter to the U.S. Food and Drug Administration (FDA) in response to the agency’s...more
Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more
Labor and Employment - Jimmy John's Avoids Joint-Employer Finding in Worker Overtime Litigation - In In re: Jimmy John's Overtime Litigation, 2018 WL 3231273 (N.D. Ill. June 14, 2018), a federal district court ruled that...more
The USDA and the Agricultural Marketing Service (AMS) have set forth the National Bioengineered Food Disclosure Standard (“the Rule”) for labeling food products that have been genetically modified. The Rule requires food...more
US, EU Near Agreement on Shellfish Trade - The U.S. Food and Drug Administration (FDA) has proposed to allow the import of raw bivalve molluscan shellfish—including clams, mussels, oysters and scallops—harvested in the...more
GMA Conference Panels Explore Trends in Class Actions, Organic Production - Litigation, increasing online grocery shopping and consumer concerns regarding product ingredients were hot topics at the 2018 Grocery...more
Organic Group Objects to Withdrawal of OLPP - A group of organic food producers, retailers and certifiers has published a full-page advertisement in The Washington Post containing the text of a letter to Secretary of...more
The Trump administration is moving forward with an Obama-era initiative requiring certain food establishments to list calorie information on menus and menu boards, including food on display and self-service food. The FDA...more
On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants and food establishments that are subject to the menu labeling requirements...more
The FDA has announced that it is delaying implementation of the Nutrition Facts and Supplement Facts Label and Serving Size final rules. As we previously reported, the rules were finalized in May 2016 and initially set a...more
On May 1, 2017, FDA announced it was extending the compliance date for the menu labeling final rule from May 5, 2017, to May 7, 2018. The rule requires calorie information to be listed on menus and menu boards of restaurants...more
The Food and Drug Administration (“FDA”) has extended the compliance date for its menu labeling rules just days before the final rules were set to take effect....more
The U.S. Food and Drug Administration (“FDA”) announced in September that it is considering how to redefine the term “healthy” as a nutrient content claim for the labeling of human food products. The FDA issued a guidance...more
FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.” Today, it announced the beginning of the formal process to make changes to the definition of the...more