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FDA Issues Draft Guidance on NDIN Master Files for Dietary Supplements

by Shari Barbanel | April 4, 2024

On April 3, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The draft guidance is the FDA’s response to the dietary supplement industry’s requests for specific guidance on recommendations about master files for new dietary ingredient notifications ...

FDA Releases New Dietary Ingredient Final Guidance, Associations Respond

by Shari Barbanel | March 6, 2024

On March 5, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” According to the FDA, the guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and ...

Trade Associations Respond to FDA’s Denial of CBD Citizen Petitions

by Shari Barbanel | February 1, 2023

The Natural Products Association (NPA), the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) have responded to the U.S. Food and Drug Administration’s (FDA) denial of the associations’ CBD Citizen Petitions on Jan. 26. “This is an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed ...

AHPA Recommends FDA Implement Policies to Support Responsible Innovation

by Shari Barbanel | July 18, 2019

The American Herbal Products Association (AHPA) submitted extensive and specific policy recommendations on July 15 to the U.S. Food and Drug Administration (FDA) to support responsible dietary supplement innovation while preserving and strengthening FDA’s ability to efficiently and effectively protect the public from unsafe and unlawful products. AHPA submitted these recommendations to FDA in response to an ...

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