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
On August 2, 2024, the Association of American Feed Control Officials (“AAFCO”) announced that its Memorandum of Understanding 225-07-7001 (the “MOU”) with the U.S. Food and Drug Administration (“FDA”) outlining the AAFCO...more
Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more
After formulating an exciting new healthy food or beverage, the packaging it comes in may feel like an afterthought. It should not be. Food packaging has become an increasingly hot topic among federal and state regulators,...more
As we enter 2024, more and more brands are joining the nonalcoholic beverage space. An increasing variety of nonalcoholic, single-serve, ready-to-drink beverages are marketing the innovative use of indigenous botanicals,...more
Whether formulating a new food or developing a novel ingredient, a critical first step is understanding the regulatory framework for bringing a new ingredient (or a food containing a new ingredient) to the market. This...more
Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more
Within a month of California becoming the first state in the nation to ban manufacturing with, selling, or distributing food items that contain brominated vegetable oil (BVO), FDA has proposed to revoke the regulation...more
The U.S. Food and Drug Administration (FDA) released a public inventory on July 12, 2023, of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally...more
American Conference Institute is hosting the 7th Annual Advanced Summit on Food Law – Regulation, Compliance, and Litigation from April 18-19, 2023, in Chicago! Prepare for the future by examining current controversies,...more
Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more
On December 5, 2022, the Minnesota Board of Pharmacy filed a lawsuit against three affiliated Minnesota hemp companies seeking condemnation and destruction of several million dollars worth of gummy edibles. Ironically named...more
On November 16, 2022, the United States Food and Drug Administration (FDA) issued Warning Letters to five companies that market food and beverage products containing cannabidiol (CBD). FDA takes the position that the...more
On this episode of “Food for Thought and Thoughts on Food,” Ann Begley and Amaru Sanchez join to discuss regulatory and commercialization challenges facing novel foods today. The pair interview Ahmed Khan, Founder and Editor...more
On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products....more
In recent decades, the use of plastics has proliferated. Overall, they have shown to provide a cost-friendly, durable and versatile solution to many consumer needs across virtually all categories of products regulated by the...more
Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more
The U.S. District Court for the Southern District of New York granted the U.S. Food and Drug Administration’s (FDA or the Agency) motion for summary judgment on September 30, 2021, against claims brought by a group of...more
The global cannabidiol (CBD) market size is expected to reach USD 13.4 billion by 2028. And yet a large part of that market—CBD-infused food, beverages, and dietary supplements—consists of unlawful sales. This article...more
FDA’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) in June explaining the agency’s internal procedures for evaluating color additives and flavors in an oral drug product...more
The U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) recently released a list of priority draft and final guidance documents that the...more
The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States....more
If you are trying to navigate the space where hemp products intersects with animal products, it can be unclear as to which authority to turn to for guidance. In the United States, FDA, FTC, DEA and USDA share governance over...more
By now, most of us have seen plant-based “meat” in supermarkets and restaurants. For one of those plant-based meat substitutes, ImpossibleTM Burger, a lawsuit is underway challenging the FDA’s approval of the compound used to...more
Food poisoning is an experience that no one is likely to ever forget. Some of the common bacteria that cause foodborne illness include Listeria monocytogenes (L. monocytogenes), Salmonella (S. enterica), and Escherichia coli...more
What are the benefits and drawbacks of coming to an independent generally recognized as safe (GRAS) conclusion for a novel food ingredient compared to filing a GRAS notification with the FDA? Our Food & Beverage and FDA teams...more