What is the Origin of New Dietary Ingredient?

This term is a specific legal and regulatory definition established by the U.S. Congress with the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. The legislation created a distinct category for dietary supplements, separate from food and drugs, and the NDI definition serves as a gatekeeping mechanism for new substances entering the market.

What is the Mechanism of New Dietary Ingredient?

The NDI notification mechanism functions as a pre-market safety review, requiring the manufacturer to provide the FDA with evidence that the new ingredient is reasonably expected to be safe under the recommended conditions of use. This process does not involve efficacy review but aims to prevent the introduction of potentially harmful or adulterated substances into the supplement supply chain. The regulatory classification ensures a baseline level of public health protection for consumers of hormonal support products.

New Dietary Ingredient

Meaning

A substance that was not marketed in the United States as a dietary supplement ingredient before October 15, 1994, and is intended for use in a dietary supplement. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, manufacturers must submit a New Dietary Ingredient (NDI) notification to the FDA at least 75 days before marketing the product. This regulatory classification is crucial for ensuring the safety and regulatory compliance of novel compounds in the hormonal health supplement space.