FDA’s New Dietary Ingredient Guidance: What You Should Know

Updated October 19, 2026

The FDA has released new guidance on the safety of dietary supplement ingredients. But does this mean the supplements you buy are now safer? And what exactly is a new dietary ingredient?

You may already be taking one without realizing it. Nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), and certain forms of astaxanthin are examples of ingredients that have been the subject of FDA new dietary ingredient notifications. On October 19, 2026, the Food and Drug Administration released a 53-page final guidance document explaining the safety information supplement companies should provide when introducing new dietary ingredients.

Although the document is written for manufacturers, it contains useful information for anyone who takes supplements.

Let’s look at what it says, what it doesn’t say, and what it means for you.

New Dietary Ingredients: Quick Answers

• A new dietary ingredient (NDI) is an ingredient that was not marketed in the United States before October 15, 1994.
• New doesn’t mean unsafe. It simply refers to when the ingredient entered the American supplement market.
• The FDA generally requires safety information at least 75 days before a supplement containing an NDI is marketed, unless an exception applies.
• FDA notification is not FDA approval. The FDA does not approve new dietary ingredients through this process.
• Human clinical trials are not always required. Companies may use documented historical consumption or other appropriate safety evidence.
• Safety does not mean effectiveness. An ingredient can be reasonably expected to be safe without having convincing evidence that it improves health.
• The October 2026 document is final guidance, not a new law. It explains the FDA’s recommendations for meeting existing requirements.

What Is a New Dietary Ingredient?

A new dietary ingredient, often called an NDI, is a dietary ingredient that was not marketed in the United States before October 15, 1994.

That date comes from the Dietary Supplement Health and Education Act of 1994, commonly called DSHEA.

The law established the basic framework used to regulate dietary supplements in the United States.

Ingredients marketed before October 15, 1994, are generally considered older dietary ingredients. Those introduced afterward may be classified as new dietary ingredients.

But the word new can be misleading.

For example, a plant might have been used in traditional medicine for hundreds of years in another country. If it wasn’t marketed as a dietary ingredient in the United States before October 15, 1994, it may still qualify as an NDI.

Likewise, an ingredient might have been discovered decades ago but only recently introduced as a supplement.

An ingredient doesn’t stop being an NDI simply because it has been sold for several years or because a manufacturer has submitted safety documentation to the FDA.

New Dietary Ingredient Examples: NR, NMN, and More

Several ingredients in the supplement industry have been the subject of FDA NDI notifications.

Here are some examples.

Important: The FDA has received safety information about these ingredients, but that doesn’t mean it has approved them or confirmed they work. Different forms of the same ingredient may not be equally safe.

Nicotinamide Riboside (NR): An NDI Example

Nicotinamide riboside is a form of vitamin B3 that helps the body produce NAD+, a molecule involved in cellular energy production.

Although NR occurs naturally in small amounts in certain foods, concentrated NR supplements were introduced much more recently.

In 2015, ChromaDex submitted an NDI notification for its nicotinamide riboside chloride ingredient, TruNiagen. (paid link)

NR remains an NDI even after the notification process.

Does that mean the FDA has approved NR for anti-aging?

No.

A safety notification does not establish that NR slows aging, improves memory, prevents disease, or produces other advertised benefits.

Those claims must be evaluated separately using appropriate research.

Is NMN a New Dietary Ingredient?

Nicotinamide mononucleotide, or NMN, is another ingredient promoted for increasing NAD+ levels.

Its regulatory history is more complicated.

Companies submitted NDI notifications involving NMN, but in 2022, the FDA took the position that NMN was excluded from the dietary supplement category because of its investigation as a potential drug.

But, in September 2025, the FDA changed its interpretation and concluded that NMN was not excluded from the dietary supplement definition – so it could be sold to the public as a supplement.

However, the decision did not mean the FDA had approved NMN supplements or concluded that they slow aging.

Consumer takeaway: Just because an ingredient can legally be marketed as a dietary supplement doesn’t mean its advertised benefits have been proven.

What’s New in the FDA’s 2026 Supplement Guidance?

The FDA did not create a new law requiring every dietary supplement to undergo clinical trials.

Instead, it finalized guidance explaining what information companies should provide to support the safety of new dietary ingredients.

The document focuses on three main questions:

1. What exactly is the ingredient?
2. What evidence suggests it is safe?
3. Why should the FDA consider that evidence relevant to the supplement people will actually take?

These sound like simple questions, but they have important implications.

Why Supplement Ingredient Identity Matters

Suppose two companies sell supplements containing the same plant.

One company uses the root. Another uses the leaves.

Or perhaps one uses a water extract while another uses an alcohol extract.

Even though both labels display the same plant name, the finished ingredients may contain different chemicals in different amounts.

The FDA recommends that manufacturers provide detailed information about the plant species, plant parts, extraction methods, chemical composition, and other characteristics that help establish the ingredient’s identity.

Why this matters to you: A safety study involving one version of an herb may not establish the safety of every other version.

Testing Supplements for Heavy Metals and Other Contaminants

The FDA guidance recommends appropriate testing and specifications for substances that could affect supplement safety.

Examples include:

• Heavy metals such as lead, cadmium, arsenic, and mercury
• Pesticide residues
• Harmful microorganisms
• Chemicals left over from extraction and manufacturing
• Potentially harmful substances naturally occurring in certain plants

This doesn’t mean every supplement must undergo every possible test.

The appropriate testing depends on the ingredient and how it’s produced.

For consumers, the larger issue is whether a company has meaningful quality controls and can provide information supporting its claims.

Consumer tip: Ask companies whether they test finished products for contaminants and whether they can provide a recent certificate of analysis (COA). This is a laboratory report describing what was tested and the results.

A COA doesn’t prove a supplement works, and its value depends on what was tested, how it was tested, and whether the report actually applies to the product being sold.

Does Traditional Use Prove a Supplement Is Safe?

Manufacturers sometimes point to hundreds or thousands of years of traditional use as evidence that a supplement is safe.

That’s useful, but the FDA wants companies to consider how the ingredient was actually consumed.

For example, imagine a plant traditionally prepared as tea.

People may have consumed one or two cups a day for generations.

Now imagine a company selling a concentrated extract containing much larger amounts of particular plant chemicals.

Those are not necessarily the same thing.

The FDA recommends examining how much of the ingredient people historically consumed, how often they consumed it, and for how many years.

An interesting detail: the FDA generally recommends at least 25 years of widespread use as a starting point for establishing an adequate history of safe consumption.

Shorter histories may be supported by additional information.

Can High Doses of Supplements Be Dangerous?

Just because an ingredient appears safe at one dose doesn’t mean it is safe at every dose.

For example:

Suppose researchers found that people tolerated 100 mg of an ingredient daily for eight weeks.

Would that establish the safety of taking 1,000 mg every day for five years?

Not necessarily.

The FDA recommends that the safety evidence support the amount, frequency, and duration of use proposed for the supplement.

This also matters when an ingredient occurs naturally in foods.

Just because people consume tiny amounts of a substance in food does not automatically mean that much larger supplemental doses are safe.

What Do We Know About Long-Term Supplement Safety?

Many supplement studies last only a few weeks or months.

These trials may provide useful information about short-term side effects, but they cannot establish everything about long-term safety.

For example, a four-week study may not detect problems that take months or years to develop.

The FDA considers past human use, animal studies, and human research when evaluating supplement safety. If there isn’t enough evidence, more safety testing may be needed.

The important question is not simply whether an ingredient has ever been studied.

It’s whether the available research is relevant to how people are expected to use it.

Does the FDA Require Human Clinical Trials?

Some people may be surprised by this.

The FDA does not automatically require human clinical trials for every new dietary ingredient.

In certain situations, a well-documented history of safe human consumption may provide sufficient evidence.

In others, animal studies, human studies, laboratory research, or combinations of different types of evidence may be useful.

The FDA specifically explains that additional safety studies may not be necessary when adequate historical evidence already supports the proposed use.

This is reasonable. If large populations have safely consumed a particular ingredient at comparable amounts for many years, additional studies may add little information.

However, when manufacturers introduce concentrated ingredients or recommend substantially higher doses, more evidence may be needed.

Why Probiotic Strains Matter for Safety

Probiotics are a good example of why ingredient identity matters.

Many people assume that all strains of a probiotic species produce similar benefits.

But two strains belonging to the same species can have different characteristics.

For example, Lactobacillus casei DN-114001 and Lactobacillus casei Shirota are two strains of the same bacterial species. In one small study involving 60 people taking antibiotics, diarrhea occurred in 6.7% of those consuming a probiotic drink containing DN-114001, compared with 33.3% of those consuming a drink containing Shirota.

The FDA recommends identifying and characterizing microbial ingredients, including investigating potential toxin production and antibiotic resistance.

Antibiotic resistance is particularly important because certain microorganisms may carry genes that could potentially be transferred to other bacteria.

Supplement shopper takeaway: Research involving one probiotic strain doesn’t automatically mean that every strain of the same species is equally safe or effective.

Are Multi-Ingredient Supplements Safe?

A supplement might contain several ingredients that have each been studied separately.

But what happens when they’re combined in, for example, a proprietary blend?

The FDA recommends considering the safety of the finished supplement, not just the individual new ingredients.

The agency also discusses ingredients that can increase the absorption of other substances.

For example, increasing the amount of a compound absorbed into the bloodstream may change its effects and potentially its risks.

This doesn’t mean combinations are inherently dangerous.

It means companies should consider whether the final formula raises safety concerns that weren’t apparent when the ingredients were studied individually.

Does the FDA Approve New Dietary Ingredients?

Not necessarily.

This is where people often get confused.

When required, a company must submit an NDI notification at least 75 days before marketing the supplement.

The notification includes information supporting the company’s conclusion that the ingredient is reasonably expected to be safe under its conditions of use.

But the FDA doesn’t issue formal approvals for NDI notifications.

Even when the agency has no objection to the submitted information, that doesn’t mean it has approved the supplement.

Also, an NDI notification doesn’t automatically cover every supplement containing the same ingredient.

Different products may use different doses, manufacturing methods, ingredient forms, or combinations.

And, an NDI notification also doesn’t guarantee that a particular bottle of the supplement has been independently tested.

How Can You Find Out If an Ingredient Has Been Reported to the FDA?

The FDA maintains a public database of New Dietary Ingredient Notifications.

You can search the records to see whether a manufacturer has submitted information about a particular ingredient.

The records may identify the ingredient, company, submission date, and FDA response.

Here is the official database:

FDA New Dietary Ingredient Notification Database

Keep in mind that the database is not a list of FDA-approved supplements.

It is a record of submitted notifications. Also, a missing notification does not automatically establish that a supplement is illegal, because exceptions to the notification requirement exist.

How to Choose a Safe Dietary Supplement Before Buying

The FDA guidance offers useful lessons for supplement shoppers, even though the document is directed toward manufacturers.

Here are some questions worth asking:

1. Has the exact ingredient been studied?

Look beyond the name of the herb or chemical. Was the specific extract, ingredient form, or probiotic strain investigated in humans?

2. Was the dose comparable?

A study involving 100 mg doesn’t necessarily establish what happens when someone takes 500 mg.

3. How long was it studied?

A two-week trial provides less information about long-term safety than a study involving much longer exposure.

4. Who participated in the research?

Results from healthy young adults may not apply to older adults, children, pregnant women, or people with medical conditions.

5. Does the company test its products?

Look for useful evidence of identity, strength, and contaminant testing, preferably involving qualified independent laboratories.

6. Are safety concerns clearly disclosed?

Reputable companies should be willing to discuss known side effects, precautions, and potential interactions with medications.

7. Is there convincing evidence that the supplement actually works?

This question may be the most important.

A supplement can be safe but provide little or no benefit.

What Many Explanations of New Dietary Ingredients Leave Out

The FDA and other organizations provide useful background information about new dietary ingredients. However, much of that material focuses on definitions, legal requirements, and how companies submit notifications.

Those explanations are important, but the public also needs to understand several important points.

First, a favorable FDA response is not proof that a supplement works. The NDI process concerns safety, not evidence of health benefits.

Second, one extract isn’t necessarily interchangeable with another. Different forms of an ingredient can have different compositions, even when they share the same name.

Third, you must compare historical consumption with the actual supplement dose. Eating a substance in food does not automatically establish the safety of consuming much larger amounts in capsules.

Fourth, the safety of a single ingredient may not tell us everything about a multi-ingredient formula/propriotary blend.

Fifth, being legally permitted to sell an ingredient is different from demonstrating that it improves health. NMN illustrates why that distinction matters.

New Dietary Ingredients: Frequently Asked Questions

Are new dietary ingredients FDA-approved?

No. The FDA does not approve NDIs through the notification process. Manufacturers submit information supporting a reasonable expectation of safety, and the FDA may review and respond to the submission.

Is a new dietary ingredient necessarily unsafe?

No. The word new refers to its U.S. marketing history, not whether it is dangerous.

Some NDIs may have substantial safety evidence, while others may have limited proof.

Do companies have to conduct human clinical trials?

Not always. The FDA permits different forms of evidence to establish a reasonable expectation of safety, including documented historical use.

Does an ingredient stop being an NDI after 75 days?

No. The notification period doesn’t change its classification. An ingredient marketed after the October 15, 1994 cutoff remains an NDI.

Do all dietary supplements require an NDI notification?

No. Older dietary ingredients generally do not require NDI notifications. Certain newer ingredients that qualify for the food-supply exception also may not require one.

Does an NDI notification mean the FDA tested the supplement?

No. Submitting safety documentation does not mean the FDA independently tested the product or every batch.

Does the FDA’s October 2026 guidance make supplements safer?

It may help by clarifying the quality of safety information that the FDA recommends that companies provide.

But the guidance does not guarantee that manufacturers will comply, that every supplement will be tested, or that every product on the market is safe.

Can a supplement contain both old and new dietary ingredients?

Yes. A formula could contain an older ingredient such as vitamin C along with a newer ingredient such as nicotinamide riboside.

The presence of an NDI may trigger notification requirements even when the other ingredients have a much longer history of use.

Final Thoughts: What Does This Mean for People?

The FDA’s October 2026 guidance provides a clearer picture of the information companies should consider when evaluating the safety of new dietary ingredients.

It emphasizes ingredient identity, manufacturing quality, appropriate doses, historical consumption, and scientific safety evidence.

But people should not interpret the new guidance as an FDA guarantee that supplements are safe or effective.

Before buying a supplement, I want to know three things: What’s actually in it? Is there good evidence it’s safe at the recommended dose? And, most importantly, does credible human research show it works?

Those are three different questions, and each deserves an answer.

References

1. U.S. Food and Drug Administration. New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI. Final Guidance for Industry. October 2026.
2. U.S. Food and Drug Administration. New Dietary Ingredients in Dietary Supplements: Background for Industry.
3. U.S. Food and Drug Administration. Submitted 75-Day Premarket Notifications for New Dietary Ingredients.
4. U.S. Food and Drug Administration. FDA 101: Dietary Supplements.
5. National Institutes of Health, Office of Dietary Supplements. Dietary Supplements: What You Need to Know.
6. U.S. Food and Drug Administration. September 29, 2025 response concerning NMN’s dietary supplement status.

Disclaimer: This article is for educational purposes and is not a substitute for medical advice. Talk to a qualified healthcare professional before using dietary supplements, particularly if you take medications or have a medical condition.