New Dietary Ingredients (NDIs): When an Ingredient Needs FDA Notification
An ingredient that was not marketed in the U.S. before October 15, 1994 may need an FDA notification before it goes into a supplement. Here is how the NDI rules work and what buyers should check.
Every few months a new ingredient starts trending, and buyers get pitched products built around it. Before that product goes on your shelf or your storefront, one regulatory question deserves an answer: is this a new dietary ingredient, and if so, did anyone notify FDA? The NDI rules are one of the few premarket requirements in U.S. supplement law, and they are easy to overlook.
This guide walks through what counts as an NDI, when notification is required, how "old" ingredients are supported, and what wholesale buyers should reasonably ask a supplier.
What is a new dietary ingredient?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) created the category. Under section 413 of the Federal Food, Drug, and Cosmetic Act, a new dietary ingredient is a dietary ingredient that was not marketed in the United States before October 15, 1994. Ingredients that were on the market before that date are commonly called old dietary ingredients, or ODIs.
To be a dietary ingredient in the first place, a substance must fit one of the statutory categories:
- A vitamin
- A mineral
- An herb or other botanical
- An amino acid
- A dietary substance used to supplement the diet by increasing total dietary intake
- A concentrate, metabolite, constituent, extract, or combination of any of the above
That last category is where many modern ingredients sit, including branded extracts, novel forms of minerals, and specific plant constituents.
When NDI notification is required
A manufacturer or distributor of a supplement containing an NDI must submit a premarket notification to FDA at least 75 days before introducing the product into interstate commerce. There is one statutory exception: no notification is needed if the supplement contains only dietary ingredients that have been present in the food supply as an article used for food, in a form in which the food has not been chemically altered.
The NDI notification must include information, such as history of use or other evidence of safety, showing that the ingredient will reasonably be expected to be safe under the conditions of use on the label. A supplement containing an NDI that lacks a required notification, or lacks adequate safety evidence, is considered adulterated.
How FDA responds
FDA reviews the notification after filing it, and the 75-day period runs from the filing date. The agency may respond with a letter acknowledging the notification without objection, a letter raising safety or identity concerns, or a letter stating the submission is incomplete. An acknowledgment without objection is not an approval. It simply means FDA did not object based on what was submitted. Notifications and FDA's responses are generally made public after a waiting period, with trade secret information redacted.
An NDI acknowledgment is not an FDA approval, and a supplier who describes it that way is overselling.
Old dietary ingredient status and why it is hard to prove
If an ingredient is an old dietary ingredient, no NDI notification is needed. The difficulty is proving it. FDA does not maintain an authoritative list of ingredients marketed before October 15, 1994. Several trade associations compiled lists in the 1990s, but FDA has said those lists are not definitive, and the burden of showing pre-1994 marketing falls on the company.
Acceptable evidence typically includes dated sales records, catalogs, invoices, or labels showing the ingredient was sold in the U.S. as or in a dietary supplement before the cutoff. The form matters too. A pre-1994 botanical does not automatically make every extract of that botanical an old ingredient, especially if the extraction process changes the composition significantly.
| Scenario | Likely status | Buyer action |
|---|---|---|
| Common vitamin form sold for decades | Old dietary ingredient | Standard documentation is usually enough |
| New branded extract with novel process | Possibly an NDI | Ask whether an NDI notification was filed |
| Synthetic version of a botanical constituent | Depends on facts; FDA views some as NDIs | Request the supplier's regulatory rationale |
| Substance first studied as a drug | May be excluded from supplements | Confirm it is lawful as a dietary ingredient |
The drug exclusion to watch for
Separate from NDI rules, the law excludes from the definition of a dietary supplement any article that was first approved as a drug, or first authorized for investigation as a new drug with substantial clinical investigations made public, before it was marketed as a supplement or food. CBD is the most familiar example: FDA has taken the position that CBD cannot be sold as a dietary supplement for this reason. When a trending ingredient has a pharmaceutical history, buyers should ask whether its supplement status has been questioned.
What buyers should ask about a new dietary ingredient
Distributors and retailers are not usually the party filing notifications, but they carry commercial and reputational risk if a product is later found adulterated. A few questions help:
- Is each dietary ingredient in this product an old dietary ingredient or an NDI?
- If it is an old ingredient, what documentation supports pre-1994 marketing in this form?
- If it is an NDI, was a notification filed, and did FDA respond without objection?
- Does the notification cover this ingredient as manufactured by this supplier, at this serving level?
- Is the ingredient subject to the drug exclusion or any open FDA action?
A supplier who has done the work will answer these readily. For the broader regulatory picture, see our overview of dietary supplement compliance basics, and for context on why novel ingredients keep appearing, see our look at nutraceutical market trends.
Why established ingredients still carry most of the category
Most volume in the supplement aisle comes from well-documented ingredients: vitamins, minerals, amino acids, and widely used botanicals and specialty ingredients with long market histories. These ingredients do not avoid scrutiny, but they rarely raise NDI questions. For retailers building a core assortment, that established base is lower risk, while newer ingredients can be layered in once their regulatory status is clear.
Sourcing established formulas through RV Pharma
RV Pharma is a wholesale nutraceutical distributor offering stock gummies, capsules, softgels, tablets, powders, and more to retailers, pharmacies, distributors, and e-commerce sellers. Supplement Facts panels for stock gummies and softgels are published on our product pages, and our team can help you review formulas before you request a quote.
Frequently asked questions
What is the cutoff date for a new dietary ingredient?
A new dietary ingredient is one that was not marketed in the United States before October 15, 1994, the date DSHEA was signed. Ingredients sold before that date are often called old dietary ingredients. The company relying on old ingredient status is responsible for documenting pre-1994 marketing.
How long before launch must an NDI notification be filed?
The notification must be submitted at least 75 days before the supplement containing the NDI is introduced into interstate commerce. The 75-day period runs from the date FDA files the notification. A notification is not required if the ingredient has been present in the food supply in an unaltered form.
Does FDA keep a list of old dietary ingredients?
No. FDA does not maintain an authoritative list of ingredients marketed before October 15, 1994. Trade associations published lists years ago, but FDA does not treat them as conclusive. Companies must keep their own evidence, such as dated labels, catalogs, or sales records.
Is an NDI acknowledgment the same as FDA approval?
No. FDA does not approve dietary ingredients or supplements. A response acknowledging an NDI notification without objection means the agency did not object based on the information submitted. It is not an endorsement or approval, and it may apply only to the conditions of use described in the notification.
Sourcing a program in this category? A distribution specialist can walk through formats, MOQs, and lead times with you.
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