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Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more
On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more
After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the...more
On September 10, the Food and Drug Administration (FDA) Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study...more
In the world of class action lawsuits, damages calculations and whether or not prejudgment interest accrues can become high-stakes battlegrounds. These issues are highlighted in the recent Ninth Circuit decision in Montera v....more
The Ninth Circuit’s recent Whiteside decision complicates the question of when information on the back of a product’s packaging can be used to clarify information on the front of the packaging. As a result, the bar for using...more
Our notable ruling roundup aims to keep our readers up to date on recent rulings in the food & consumer packaged goods space. Candice Bradby v. Bimbo Bakeries USA, Inc., No. 1:23-cv-00522-LKG (D. Md. – April 12, 2024): The...more
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
Our weekly roundup aims to keep our readers up to date on recent notable rulings in the food & consumer packaged goods space. Carol Whyble, et al. v. The Nature’s Bounty Co., No. 7:20-cv-03257-NSR (S.D.N.Y.—October 31,...more
Our weekly roundup aims to keep our readers up to date on recent notable rulings in the food & consumer packaged goods space. - Tara Amado v. The Procter & Gamble Co., No. 3:22-cv-05427-MMC (N.D. Cal. – June 8, 2023): The...more
Earlier this week, FDA issued draft guidance for staff updating the agency’s existing enforcement policy regarding major food allergen labeling and cross-contact prevention. The updated guidance reflects the addition of...more
Last week, we blogged about an environmental ESG NAD challenge brought by an advocacy group; this week features a blog about an animal welfare ESG NAD challenge also brought by an advocacy group. The challenge was...more
The USDA’s wide-sweeping regulatory update may affect your company, even if it is only a small ingredient in the multi-billion dollar organic foods supply chain. On January 18, 2023, the USDA National Organic Program...more
Le 20 juillet 2022, des modifications apportées au Règlement sur les aliments et drogues sont entrées en vigueur, introduisant du même coup un nouveau symbole nutritionnel pour les aliments préemballés. Faisant partie de la...more
On July 20, 2022, amendments to the Food and Drug Regulations came into effect, introducing a new nutrition symbol for prepackaged foods. Part of Health Canada’s Healthy Eating Strategy, these amendments will require the...more
On October 6, 2021, California Governor Gavin Newsom signed AB-45, creating an explicit framework for the manufacture and sale of hemp-derivative products in the state of California. While hemp was legalized at the federal...more
Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary...more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, something something memory...more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, someone moved someone’s smoked...more
Last week the Ninth Circuit concluded that a campaign for class certification brought by dog food purchasers was all bark and no bite. In a memorandum disposition issued on December 9, 2020, the Ninth Circuit affirmed the...more
Historically, neither food companies nor the plaintiffs’ bar have lost sleep over “recyclable” or “recycled content” claims. Over the past year, however, there has been increasing attention to and scrutiny of recyclable...more
On September 18, 2020, the U.S. Food and Drug Administration announced additional flexibility for manufacturers to comply with the agency’s updated Nutrition and Supplement Facts labeling requirements. Those requirements go...more
Join key industry stakeholders to discuss the latest developments affecting the dietary supplement industry. Now in a Virtual Format. American Conference Institute (ACI) together with the Council for Responsible Nutrition...more
FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The agency views master files as a tool to promote better compliance with NDI notification requirements. Ingredient...more
In the ever-evolving world of nutritional guidance, sugar is the new enemy. In the '70s, it was salt; in the '80s it was fat; in the '90s it was cholesterol; and now, it’s sugar. What this shift in the zeitgeist means for...more