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 6 – Mitigating Class Action Exposure
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Podcast: Is the Dietary Supplement Regulatory Framework Working? - Diagnosing Health Care
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Business Divorces in the Food and Supplements Space
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...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
On April 15, 2024, in a big win for the continued validity of implied preemption, the Supreme Court declined to hear an appeal of the First Circuit’s preemption-based dismissal of a proposed misbranding class action. The...more
Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more
What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more
On March 5, FDA published its long-awaited Final Guidance on New Dietary Ingredient Notification (NDIN) Procedures and Timeframes (Final Guidance). This new guidance updates and finalizes Section V of FDA’s revised 2016 Draft...more
Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more
MASSACHUSETTS - First Circuit Holds Putative Class Action Claims Alleging Deceptive Practices In Labeling of Lactase Product As Dietary Supplement Instead Of Drug When Product Claimed To Treat Lactose Intolerance...more
This week, the Natural Products Association (NPA) filed a lawsuit against New York State challenging the constitutionality of a new state law prohibiting the sale of over-the-counter diet pills and dietary supplements for...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
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more
The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more
FDA WILL HAVE EXTENSIVE AUTHORITY TO REGULATE COSMETICS- Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321(i), “cosmetics” are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on,...more
Consumers are increasingly interested in incorporating functional or adaptogenic mushrooms into their diets due to their potential health benefits, such as boosting immunity, reducing inflammation, and promoting overall...more
Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labeling for fluoride products that raised a variety of issues with...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more
Hemp was federally legalized nearly four years ago. Since then, the industry has dealt with constantly changing rules, despite being in regulatory purgatory due to snail-paced progress from the U.S. Food & Drug Administration...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
On July 23, 2021, the U.S. Food and Drug Administration (“FDA” or “Agency”) rejected two New Dietary Ingredient (“NDI”) notifications to market full-spectrum cannabidiol (“CBD”) as part of dietary supplements. This move...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
Almost three years since the legalization of hemp production in the United States, the U.S. Food and Drug Administration (FDA) is still in the process of determining the regulatory framework for CBD and other hemp...more
More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”). The Food and Drug Administration (FDA) has...more
The federal Food & Drug Administration (“FDA”) has refused to consider an application by Charlotte’s Web Holdings, Inc. (“Charlotte’s Web”) for a CBD product to be sold as a dietary ingredient. Instead of clarifying the...more
On July 14, 2021, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...more