A new ingredient is not automatically a “new dietary ingredient” simply because it is new to your company or because it has never been used in your particular product.
Under the FD&C Act, an NDI is generally a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. Determining whether an ingredient meets that definition—and whether an NDI notification is required—can require a detailed review of the ingredient’s history, identity, manufacturing process, and intended conditions of use.
Start With the October 15, 1994 Question
The first question is:
Was this dietary ingredient marketed in the United States in a dietary supplement before October 15, 1994?
If you can adequately document that the ingredient was marketed as a dietary ingredient in a dietary supplement before that date, it may not be an NDI.
However, FDA does not maintain an authoritative list of all ingredients that were marketed before October 15, 1994. The manufacturer or distributor is responsible for maintaining evidence supporting its conclusion.
Useful evidence may include:
- Product labels
- Catalogs
- Invoices
- Sales records
- Trade publications
- Advertising materials
- Other dated commercial documentation
The evidence should demonstrate actual U.S. marketing for use in dietary supplements—not merely that the substance existed or was used somewhere in the food industry.
If It Was Not on the Market Before 1994
If the ingredient was not marketed in a dietary supplement before October 15, 1994, the next question is whether it qualifies as a dietary ingredient and whether an NDI notification requirement applies.
FDA defines dietary ingredients to include vitamins, minerals, herbs or other botanicals, amino acids, dietary substances used to supplement the diet, and certain concentrates, metabolites, constituents, extracts, or combinations of these substances.
This distinction matters because a substance cannot simply be treated as an NDI because it is intended to be placed in a supplement.
You need to establish both:
Is it a dietary ingredient?
and
Is it “new” under the applicable FDA standard?
Manufacturing Changes Can Change the Analysis
An ingredient with a long history may still require closer analysis if its manufacturing process has changed.
FDA’s decision framework asks whether a manufacturing change alters the ingredient’s identity, including its chemical structure or composition. Examples can include:
- Different starting material
- Different part of a botanical
- New extraction process
- Chemical modification
- Significant changes in composition
- Certain changes in particle characteristics
FDA’s decision algorithm specifically distinguishes manufacturing changes that do not materially alter identity from changes that may create a new dietary ingredient.
For example, simply converting an ingredient into a powder may not necessarily create an NDI. But a manufacturing process that changes the chemical composition or produces a chemically different ingredient can require a different regulatory assessment.
Food History Is Not the Same as Supplement History
Another common mistake is assuming:
“This ingredient has been eaten as food for years, so it cannot be an NDI.”
That conclusion is not always correct.
FDA’s framework considers whether an NDI has been present in the food supply as an article used for food and whether it has been chemically altered from its conventional food form. The analysis can become more complicated when an ingredient is extracted, concentrated, chemically modified, or otherwise changed before being used in a supplement.
The important question is not simply whether the source material has a history of food use. You must evaluate the actual ingredient being placed into the dietary supplement.
Does the Intended Dose Matter?
Yes.
FDA’s decision framework considers the conditions under which the ingredient will be used, including intake level.
For certain NDIs that have a history as an article used for food, FDA’s framework considers whether the intake under the intended conditions of use is the same as or lower than the intake from conventional food use. Other situations can require a more detailed assessment.
That means the regulatory analysis should not stop at:
Ingredient identity → NDI or not?
It should also consider:
Ingredient identity + manufacturing + composition + dose + conditions of use
When Is an NDIN Required?
If an ingredient is an NDI and does not fall within an applicable statutory exception, the manufacturer or distributor generally must submit an NDI notification (NDIN) to FDA at least 75 days before introducing the dietary ingredient or supplement containing it into interstate commerce.
The notification must provide the basis for concluding that the dietary supplement containing the NDI will reasonably be expected to be safe under the recommended or suggested conditions of use.
FDA’s required information can include:
- Identity of the NDI
- Description of the dietary supplement
- Amount of the NDI per serving
- Recommended conditions of use
- History of use or other safety evidence
- Supporting published literature and references
- Relevant manufacturing information
FDA’s current submission process uses its electronic submission system, and FDA encourages electronic submission through the Centralized Online Submission Module.
The 75-Day Period Is Not an FDA Approval
One important misconception is that submitting an NDIN means FDA has approved the ingredient.
It does not.
The statutory process requires the notification to be submitted at least 75 days before introduction into interstate commerce. FDA’s failure to respond does not mean FDA has determined that the ingredient or supplement is safe or that it is not adulterated.
The company remains responsible for ensuring that the dietary supplement complies with the law.
A Practical NDI Decision Tree
Before deciding whether an ingredient needs an NDIN, work through these questions:
1. Is the substance a dietary ingredient?
Confirm that it fits within the statutory definition of a dietary ingredient.
2. Was it marketed in a dietary supplement before October 15, 1994?
If yes, collect documentation supporting that conclusion.
If no—or if the evidence is insufficient—continue the analysis.
3. Has the ingredient’s identity changed?
Review extraction, purification, chemical modification, starting materials, botanical parts, fermentation, and other manufacturing changes.
4. Does it have a food-supply history?
Determine whether the actual ingredient, in the relevant form, was present in the food supply as an article used for food.
5. Has the ingredient been chemically altered?
A conventional food ingredient and a chemically altered derivative should not automatically be treated as the same substance.
6. What is the intended intake?
Evaluate dosage, serving size, frequency, and conditions of use.
7. Is there an existing FDA notification relevant to the ingredient?
Review prior notifications and their specific identity, composition, intake level, and conditions of use. An existing notification is not automatically transferable to a materially different ingredient or use.
What Documentation Should You Keep?
An NDI determination should be supported by a written regulatory file.
Depending on the ingredient, that file may include:
- Ingredient specifications
- Manufacturing flowchart
- Certificates of analysis
- Historical labels
- Dated marketing evidence
- Published literature
- Food-use documentation
- Identity comparison
- Manufacturing-change assessment
- Dose calculations
- Safety assessment
- Copies of relevant FDA correspondence or notifications
This documentation is particularly important when the company concludes that no NDIN is required.
A regulatory conclusion without supporting evidence can become difficult to defend during an FDA inquiry or compliance review.
Common NDI Mistakes
Some of the most common mistakes include:
Assuming “natural” means old.
A natural ingredient can still be an NDI.
Using food history without analyzing the actual ingredient.
The source food and the finished dietary ingredient may not have the same regulatory status.
Ignoring manufacturing changes.
Changes in extraction, starting materials, chemical composition, or processing can affect the analysis.
Relying on someone else’s NDIN.
An existing notification may involve a different specification, manufacturing process, dose, or conditions of use.
Waiting until launch to investigate.
If an NDIN is required, FDA requires it at least 75 days before marketing.
Bottom Line
Determining whether an ingredient is an NDI is not a simple “new vs. old ingredient” question.
The better approach is to evaluate the ingredient’s pre-1994 supplement history, identity, manufacturing process, food-use history, chemical form, intended intake, and conditions of use.
If the analysis shows that an NDIN is required, the notification should be prepared and submitted before the product enters interstate commerce. If the company concludes that an NDIN is not required, that conclusion should still be supported by a well-documented regulatory assessment.
JJCC Group can help supplement companies evaluate NDI status, document the regulatory rationale, assess NDIN requirements, and prepare the supporting safety and identity package before commercialization.
