Navigating the world of dietary supplements can be overwhelming, especially when it comes to understanding the regulations that ensure their safety and efficacy. One critical aspect of this regulatory landscape is the New Dietary Ingredient (NDI) Notification Process. Whether you're a consumer, a manufacturer, or just someone curious about how new dietary ingredients make it to market, this guide will help you understand the NDI Notification Process in a simple, easy-to-read format. What is an NDI? A New Dietary Ingredient (NDI) is any dietary ingredient that was not marketed in the United States before October 15, 1994. These ingredients can include vitamins, minerals, herbs, amino acids, and other substances used in dietary supplements. The NDI Notification Process is designed to ensure that any new dietary ingredient introduced to the market is safe for consumption. Why is the NDI Notification Process Important? The primary goal of the NDI Notification Process is to protect con
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Comparison on Good Manufacturing Practices (GMPs) of FDA’s Drug and Dietary Supplement (21 CFR Parts 211 vs. 111)
By
Shirley C.
Both drug and dietary supplement GMPs ensure the quality and safety of products, but they differ significantly in scope, control systems, personnel requirements, facility standards, production controls, laboratory controls, documentation, complaint handling, and reporting. Below are the key differences between FDA's Drug and Dietary Supplement GMPs (21 CFR Parts 211 against 111). 1. Scope and Purpose Drugs (21 CFR Part 211): Ensures the safety, efficacy, and quality of pharmaceutical products. Applies to all manufacturing stages, including processing, packing, or holding. Focuses on therapeutic drugs, biological products, and certain medical devices. Dietary Supplements (21 CFR Part 111): Ensures identity, purity, quality, strength, and composition of dietary supplements. Applies to manufacturing, packaging, labeling, and holding of dietary supplements. Focuses on vitamins, minerals, herbs, amino acids, and other dietary ingredients. 2. Quality Control Systems Drugs: Requires a ded
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