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
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
In 1990, Congress enacted the Nutrition Labeling and Education Act (NELA) as an amendment to the Food, Drug and Cosmetic Act (FDCA). Among other things, NELA 1) provided for modernization and standardization of the familiar...more
Among recent trends in consumer product false advertising class actions has been the rise in cases alleging false advertising for products touting ingredients as “all natural” or “100% natural.” These lawsuits often point to...more
The FDA recently launched an updated dietary supplement ingredient directory titled "Information on Select Dietary Supplement Ingredients and Other Substances," replacing FDA’s "Dietary Supplement Ingredient Directory,"...more
As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more
SOI sets new requirements for labels and ingredients, including for minimum dairy amount and bacterial cultures; compliance deadline is January 1, 2024 The U.S. Food and Drug Administration (FDA) announced the availability...more
On Aug. 14, the Ninth Circuit issued its decision in Nacarino v. Kashi Co., providing some much-needed clarity to the FDA’s protein labeling requirements. The decision dealt with two separate cases from the Northern District...more
A potato-chip brand once famously boasted, “No one can eat just one.” And of course, no one can. But according to the Food and Drug Administration (FDA), you aren’t going to eat more than 16 (or 28 grams), because that is the...more
The U.S. Food and Drug Administration (FDA) published a second procedural notice regarding its plans to conduct consumer research on a front-of-pack (FOP) nutrition labeling scheme....more
FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...more
FTC Lays Out Some AI Ad Essentials - But specific guidance isn’t here yet, so...let’s be careful out there....more
FDA recently announced it does not object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular...more
The U.S. Food and Drug Administration (FDA) is requesting comment on the availability of nutrition, ingredient, and allergen information online for packaged foods sold through online grocery shopping platforms. FDA explains...more
FDA recently issued two nutrition-related initiatives regarding dietary guidance statements and the use of salt substitutes in standardized foods. The first initiative, a draft guidance, contains agency recommendations on the...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
When is a food “healthy”? And who gets to decide? A recent decision from the Southern District of New York touched on these questions in the context of an implausible consumer class action—though the court ultimately didn’t...more
In the waning days of 2022, FDA issued an updated Food Code with several important updates. FDA is responsible for more than a quarter of the U.S. economy, and the Food Code impacts virtually every American. Originally...more
The U.S. Food and Drug Administration (FDA) continues to explore the development of a standardized front of package (FOP) nutrition labeling scheme by conducting consumer research....more
The U.S. Food and Drug Administration (FDA) has extended the comment period for its proposed new “healthy” regulations for food packaging. The new deadline for comments is February 16, 2023. The 50-day extension follows...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
Join us on December 14 for a webinar providing a 2022 FDA year-in-review, with a crystal ball look into 2023. Venable Partners Claudia Lewis and Todd Harrison will discuss myriad topics, including a recap of major issues...more
In the November edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries, kombucha creates a buzz, some purported smoked cheese...more
In Short - The Situation: To conform with current nutrition science and federal dietary guidance, the U.S. Food and Drug Administration ("FDA") has proposed updated criteria for when food labels can bear what the FDA...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
The U.S. Food and Drug Administration ("FDA") responds to the Dietary Guidelines for Americans, 2020-2025 directive to "make every bite count" by proposing significant revisions to the implied nutrient content claim....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