What an NDI is
Under the 1994 supplement law (DSHEA), a 'new dietary ingredient' is one not marketed in the U.S. before October 15, 1994. For these, a manufacturer is generally required to submit a safety notification to the FDA before marketing — the NDI notification — providing evidence the ingredient is reasonably expected to be safe [1]. This is part of the broader framework in how the FDA regulates supplements.
What it is — and isn't
- It's a safety notification, not approval. The FDA reviews the submission but does not 'approve' the ingredient the way it approves drugs [2].
- It focuses on safety, not effectiveness. An NDI notification doesn't address whether the ingredient works.
- Many ingredients are exempt. Ingredients present in the food supply (and not chemically altered) can be exempt, and ingredients sold before 1994 don't need one.
Why compliance is uneven
In practice, not every new ingredient that should have an NDI notification gets one — this is a known enforcement gap, and some novel or 'designer' ingredients reach the market without the required filing. So a shopper can't simply read 'NDI-notified' off a label, and the process isn't a consumer-facing seal.
Why it still matters to you
The NDI concept explains why brand-new, exotic-sounding ingredients deserve extra caution: a truly novel ingredient may have limited safety data, and the system meant to vet it is imperfect. It's part of why adulterated and 'designer' ingredient products are a real concern.
Practical guidance
- Treat novel, heavily marketed ingredients with more caution than long-used nutrients.
- Don't assume a new ingredient was vetted just because it's for sale.
- Favor established ingredients and reputable, [third-party-tested](/learn/supplement-certification-seals-compared) brands, and report problems to the FDA (see [reporting a supplement problem](/learn/report-supplement-adverse-event)).