News & Analysis as of

Dietary Supplements Manufacturers

Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

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On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more

McDermott Will & Schulte

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new dietary ingredient...more

Venable LLP

FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics

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Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Akin Gump Strauss Hauer & Feld LLP

FDA Adds a Dose of Clarity to the NDIN Process

Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification...more

Perkins Coie

Psychoactive Kratom Draws Continued Scrutiny and Legal Action

Perkins Coie on

In recent years, plaintiffs have increasingly set their sights on kratom, a controversial botanical supplement, as a target for litigation. With at least 15 putative class-action cases filed in the past year alone, this...more

Davis Wright Tremaine LLP

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

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

Venable LLP

New York Court Denies Dietary Supplement Trade Association's Motion for a Preliminary Injunction - The New State Law Is in Effect

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As we have previously discussed, a new law from New York State will require companies selling dietary supplements for weight loss or muscle building to pay close attention to consumers' age. This law went into effect on...more

Venable LLP

FDA Finalizes Section V of the 2016 Revised Draft NDI Guidance

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On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more

Epstein Becker & Green

FDA Releases Updated Directory on Select Dietary Supplement Ingredients

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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

Downey Brand LLP

Surprising Surge in Sauces Tops Prop. 65 Food Notices in Third Quarter 2023

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Proposition 65: Quarterly Highlights (October 2023) - Downey Brand’s latest roundup of Proposition 65 Notices of Violation (“Notices”) summarizes Notices filed in the third quarter of 2023. Citizen plaintiff groups filed one...more

Venable LLP

New York State Prohibits Sales of Diet Pills and Dietary Supplements for Weight Loss and Muscle Building to Minors

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A new law from New York State will require companies selling certain dietary supplements in the state to pay close attention to consumers' age. Last week, Governor Kathy Hochul signed into law Assembly Bill A5610D, which...more

Alston & Bird

Class Action & MDL Roundup 2023 Q2 – Ascertainability Lives!

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Welcome back to the Class Action & MDL Roundup! This edition covers notable class actions from the second quarter of 2023. In this edition, essential oils may need therapy, an ever-growing library goes nowhere, and one...more

Perkins Coie

Weekly Notable Ruling Roundup - August 2023 #4

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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

Downey Brand LLP

Proposition 65 Quarterly Highlights - March & June 2023: Prop. 65 Plaintiffs are “Fishing” for More…

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Downey Brand’s latest roundup of Proposition 65 Notices of Violation (“Notices”) summarizes the Notices filed in the first two quarters of 2023. Between the first and second quarters of 2023, citizen plaintiff groups...more

Jackson Walker

Mid-Year FDA Update: What’s New for Dietary Supplements?

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The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more

Epstein Becker & Green

FDA Introduces Dietary Supplement Ingredient Directory

Epstein Becker & Green on

In a March 6, 2023 constituent update, the U.S. Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of...more

American Conference Institute (ACI)

[Event] Legal, Regulatory & Compliance Forum on Dietary Supplements - June 29th - 30th, New York, NY

American Conference Institute in collaboration with the Council for Responsible Nutrition (CRN) are excited to welcome you back to New York for the “return to live” reunion that the dietary supplements industry has been...more

BCLP

Supplemental Information on Dietary Supplements: Federal Proposal Aims to Establish Mandatory Dietary Supplement Database

BCLP on

In an aim to increase transparency in the U.S. dietary supplement industry, Senators Dick Durbin (D-IL) and Mike Braun (R-IN) recently introduced the Dietary Supplement Listing Act of 2022 - a bill that would require...more

Downey Brand LLP

Proposition 65 Notices of the Month – March 2022: Paper Straws and Food Claims Galore

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In March 2022, the number of new Proposition (“Prop. 65”) Notices of Violation (“Notices”) that citizen plaintiff groups issued hovered just above two hundred (200) claims in total. Notably, new claims regarding alleged...more

Downey Brand LLP

Proposition 65 Notices of the Month – February 2022: Cassava Flour and Chips, Hot Cocoa, Ceramics and Glassware, Boots and Shoes,...

Downey Brand LLP on

In February 2022, the number of new Proposition (“Prop. 65”) Notices of Violation (“Notices”) that citizen plaintiff groups issued was approximately two hundred (200) in total. Food and nutritional supplement claims were...more

Downey Brand LLP

Proposition 65 Notices of the Month – January 2022: Lead in Food Products including Dietary Supplements and Spices Remain a...

Downey Brand LLP on

As compared to prior months, the start of the new year was relatively “slow” in terms of the number of Proposition (“Prop. 65”) Notices of Violation (“Notices”) that citizen plaintiff groups issued alleging new Prop. 65...more

Downey Brand LLP

2021 Prop. 65 Roundup: More Than 3,000 Notices for the Usual Suspects Including Lead and Heavy Metals in Various Foods, Alleged...

Downey Brand LLP on

Twenty twenty-one proved to be another busy year in the world of California’s Proposition 65 (“Prop. 65”). Despite the second full year of the COVID-19 pandemic, Prop. 65 citizen plaintiff groups remained highly active....more

Harris Beach Murtha PLLC

New York Medical and Life Sciences: Year in Review 2021

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

Alston & Bird

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

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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

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