Functional Herbal Tea in the US: Conventional Food or Dietary Supplement?

Under functional herbal tea US regulations, a product is not classified only by whether it carries a Nutrition Facts or a Supplement Facts panel. FDA looks at the product’s overall presentation, including its intended use, labeling, marketing, form and how consumers are expected to use it.

A botanical that can be sold as a dietary supplement ingredient is not automatically lawful as an added ingredient in a conventional tea or beverage. Buyers should determine the product category first, then verify the legal basis for each ingredient in that category.

Why Should This Question Be Settled Before Formulation Starts?

A typical private-label request sounds like this: “I want a functional tea for sleep, stress, energy, women’s wellness or focus. Can you make it for the US?”

Before the formula, claims, dosage, packaging or facts panel are finalized, the brand should determine how the planned product is likely to be classified under US law based on its formulation, intended use, labeling, marketing, form and consumption pattern.

That classification can affect ingredient legality, labeling, the claims framework, manufacturing requirements, notification obligations and import responsibilities.

Choosing ingredients before resolving the product classification and the food-use basis for those ingredients can lead to reformulation later.

What Is a Dietary Supplement Under US Law?

Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(ff), a dietary supplement is a defined category, not a label style.

In practical terms, a dietary supplement must:

• be intended to supplement the diet
• contain one or more qualifying dietary ingredients
• be intended for ingestion
• not be represented for use as a conventional food, or as the sole item of a meal or diet
• be labeled as a dietary supplement

Herbs and other botanicals can be dietary ingredients. Amino acids can also be dietary ingredients.

Being a dietary ingredient, however, does not mean the same substance is automatically lawful as an ingredient in a conventional beverage. The two questions are answered under different parts of the law.

Why Doesn’t a Supplement Facts Panel Decide the Category?

Printing a Supplement Facts panel does not by itself turn a conventional beverage into a dietary supplement.

The statutory definition includes a separate condition: the product must not be represented for use as a conventional food.

In its guidance on distinguishing liquid dietary supplements from beverages, FDA states that beverages are conventional foods.

FDA looks at the whole presentation, which can include:

• the product name
• the container or format
• serving size and recommended use
• labeling and marketing
• whether it is described as a tea, beverage or drink
• whether consumers are expected to use it like an ordinary beverage
• where and how it is sold

Tea-like or beverage-like presentation strongly supports conventional-food classification, but classification remains fact-specific.

Can a Tea Bag Be a Dietary Supplement?

There is no blanket yes or no.

Not every tea bag is automatically a conventional food, but ordinary tea presentation strongly supports conventional-food treatment.

This is especially the case when the product is called tea, is brewed and consumed like ordinary tea, uses conventional beverage serving patterns and is marketed as a drink.

The practical takeaway is not to choose a Supplement Facts panel first and assume the classification question is solved. Classification should be reviewed from the complete product concept.

Does Supplement Use Make an Ingredient Lawful in Tea?

No. This is the most important ingredient rule in this article.

A botanical may fit the definition of a dietary ingredient in a supplement. That does not establish a lawful basis for adding it to a conventional tea or beverage.

FDA’s guidance on substances added to foods, including beverages addresses this distinction directly.

For a conventional food, an added substance generally needs an appropriate food-use legal basis, such as:

• an applicable food-additive authorization
• GRAS status for the intended conditions of use
• a prior-sanctioned use
• another applicable legal exception

Where no such basis exists, FDA may treat the substance as an unsafe food additive, and the food may be considered adulterated. Which specific botanicals have a GRAS basis for tea, and which do not, is covered in our ingredient compliance check.

“Common in supplements” is not a US conventional-food regulatory category.

The relevant question is not whether an herb is sold in America, but what the legal basis is for this exact substance, form and intended use in this food category.

What Does GRAS Actually Mean?

GRAS — generally recognized as safe — is not the same as natural, traditional, long-used, supported by a COA, sold online, or common in supplements.

A GRAS conclusion applies to a specific substance under specific intended conditions of use.

Relevant details can include:

• exact botanical identity
• plant part
• powder or extract form
• manufacturing process
• purity
• specifications
• food category
• maximum use level
• expected dietary exposure

A GRAS conclusion for one extract does not automatically cover another plant part, another extraction process, another supplier, another purity, another dose or another food category.

Is a GRAS Notice Mandatory?

Under FDA’s current regulatory framework for GRAS, GRAS notification is voluntary.

A company may reach an independent GRAS conclusion without filing a notice.

That does not mean no evidence is needed. The company must still have an adequate scientific and legal basis for its conclusion, and FDA may challenge an independent GRAS conclusion.

FDA also publishes post-market determinations that a use is not GRAS.

Two terms are often misused.

FDA does not issue “GRAS certificates”.

An FDA “no questions” letter means FDA did not question the notifier’s GRAS conclusion for the specified substance and notified conditions of use. It is not a universal approval of the ingredient.

Are 21 CFR 182.10 and 182.20 a Botanical White List?

No.

21 CFR 182.10 lists certain spices and other natural seasonings and flavorings.

21 CFR 182.20 lists certain essential oils, solvent-free oleoresins and natural extractives.

They are not a complete list of botanicals allowed in US food.

A botanical that is not listed is not automatically prohibited, and one that is listed is not automatically allowed in every form and dose.

In particular, appearing in a seasoning or flavoring context does not automatically authorize:

• high-dose functional use
• concentrated extract use
• active-ingredient positioning
• every beverage application

Intended use and exposure still matter.

What Does China’s “Food and Medicine Homology” List Mean in the US?

China’s food-and-medicine-homology list (药食同源) is a Chinese regulatory concept.

We have not located any official FDA recognition of China’s food-and-medicine-homology list as a US food-use authorization.

It should therefore not be treated as:

• GRAS status
• food-additive authorization
• dietary-ingredient authorization
• a US food ingredient white list

A Chinese supplier or US brand should not use “listed as food-and-medicine homology in China” as the sole legal basis for a US conventional-food ingredient. The Chinese list governs what a licensed food factory in China may produce; what it contains and how we apply it is explained in our guide to China’s food-medicine homology list.

Each ingredient still needs to be assessed under US law for its intended use.

Case Study: Ashwagandha

Ashwagandha is widely seen in the US supplement market. That presence does not establish conventional-food legality.

We did not locate an FDA “no questions” GRAS notice establishing a general conventional-food basis for ashwagandha.

In addition, FDA Import Alert 99-45 contains entries stating that conventional food products containing ashwagandha appear to be adulterated because the use of ashwagandha in those products appears to be an unsafe food additive.

This is an FDA enforcement example and a strong risk signal for conventional-food positioning.

It is not a blanket statutory prohibition covering every conceivable use.

Case Study: Ginkgo Biloba Extract

In a 2012 scientific memorandum, FDA concluded that available information on Ginkgo biloba extract raised safety concerns and did not support a GRAS basis for its use in conventional foods.

FDA identified no applicable food-additive regulation or prior sanction and treated the extract as an unapproved food additive for that use.

The memorandum reviewed Ginkgo biloba extract in conventional foods.

It should not be extended automatically to every ginkgo plant material, every manufacturing form or every possible use, but it is highly relevant to functional tea or beverage formulas that include ginkgo extract.

Case Study: L-Theanine

L-theanine offers a useful contrast.

The FDA GRAS Notice Inventory lists several L-theanine notices that received “FDA has no questions” responses:

• GRN 209: L-theanine
• GRN 338: L-theanine extracted from tea leaves (Camellia sinensis)
• GRN 501: chemically synthesized L-theanine

These should not be described as “FDA approval of L-theanine”.

Each notice covers a specific substance, source, manufacturing route, specification and set of intended uses.

Tea-derived and chemically synthesized L-theanine, for example, rely on different submissions.

Another notice, GRN 1311, was listed as pending as of September 2026 and should not be presented as cleared.

The useful buyer question is:

Which exact regulatory basis applies to this exact L-theanine material and use?

Case Study: Licorice

21 CFR 184.1408 directly addresses licorice and licorice derivatives, including ammoniated glycyrrhizin.

This does not mean licorice can be used without limit in every tea.

Licorice, licorice extract, glycyrrhizin and ammoniated glycyrrhizin need to be distinguished, and the specific uses, food categories and restrictions should be checked against the current CFR text for the intended product.

Licorice sourced from China can also involve separate supply-side considerations; see export-restricted Chinese herbs.

Conventional Tea vs Dietary Supplement: Comparison

Are Food and Supplement Claims Interchangeable?

No.

For dietary supplements, structure/function claims under section 403(r)(6) require substantiation, a statutory disclaimer, and notification to FDA no later than 30 days after first marketing with the claim.

Conventional foods do not use this supplement-specific system.

Adding a Supplement Facts panel and the supplement disclaimer does not solve a claims question for a conventional tea.

Neither conventional foods nor dietary supplements can freely make disease treatment or prevention claims without raising drug issues.

For packaging wording, see herbal tea packaging health claims.

How Do Part 117 and Part 111 Differ?

Conventional foods are primarily subject to 21 CFR Part 117, covering current good manufacturing practice and, where applicable, hazard analysis and risk-based preventive controls.

Dietary supplements are primarily subject to 21 CFR Part 111.

Part 111 includes supplement-specific requirements such as:

• dietary ingredient identity verification
• component specifications
• master manufacturing records
• batch production records
• quality-control responsibilities

These requirements are described in FDA’s small entity compliance guide.

Supplement facilities are not fully exempt from Part 117.

According to FDA’s FSMA FAQs, when the relevant conditions are met, Part 117 Subparts C and G do not apply to certain supplement operations, while other Part 117 provisions can still apply.

FDA also does not issue a generic “Part 111 certificate”.

Part 111 is a set of regulatory obligations.

When Does the New Dietary Ingredient Rule Apply?

For dietary supplements, an ingredient may be a new dietary ingredient (NDI) if it was not marketed in the US as a dietary ingredient before October 15, 1994, subject to applicable exceptions.

Where notification is required, it must generally be submitted at least 75 days before the supplement is introduced into interstate commerce.

An herb being widely sold does not by itself rule out NDI status.

The analysis can depend on:

• exact ingredient identity
• form
• processing
• chemical alteration
• history of use

Who Is the Foreign Manufacturer, U.S. Agent and FSVP Importer?

These roles are often confused in private-label projects.

• Foreign food facility: facilities that manufacture, process, pack or hold food for the US generally need FDA food facility registration.
• U.S. agent: part of the foreign facility’s registration; the agent must reside or maintain a place of business in the US and be physically present there.
• FSVP importer: a separate legal role, usually the US owner or consignee of the food at entry, responsible for foreign supplier verification.

A U.S. agent is not automatically the FSVP importer.

FSVP treatment can also differ between conventional foods, finished dietary supplements and supplement components.

Is California Proposition 65 Part of FDA Rules?

No.

Proposition 65 is California state law requiring clear and reasonable warnings before certain exposures to listed chemicals.

It is not:

• an FDA food-additive rule
• GRAS
• a national FDA heavy-metal standard

Businesses with fewer than 10 employees are generally exempt from the warning requirements.

For lead, the analysis is exposure-based.

A product’s lead concentration in ppm should not be compared directly with a safe-harbor value expressed in micrograms per day.

Exposure assessment can involve:

• concentration
• serving size
• servings per day
• actual consumption
• extraction into brewed tea
• chemical form
• the applicable safe harbor

A laboratory result in ppm does not, by itself, answer the Proposition 65 warning question.

Who Carries Prop 65 Responsibility in the Supply Chain?

Potential roles can include:

• manufacturers
• producers
• packagers
• importers
• suppliers
• distributors
• brand owners
• retailers

Under the warning regulations, primary responsibility is generally placed on upstream businesses, with defined mechanisms for passing warning materials down the supply chain.

Contracts can allocate:

• testing
• warning execution
• indemnity
• California sales restrictions
• documentation

A contract does not, however, automatically erase statutory obligations.

Buyer Workflow Before Developing a US Functional Tea

1. Define how the product will be marketed and consumed.
2. Determine whether that positioning is likely to support conventional-food or dietary-supplement classification.
3. Identify every botanical, extract, amino acid and other active ingredient.
4. Verify the legal basis for each ingredient in the selected category.
5. Check source, plant part, manufacturing process and specification.
6. Check GRAS, food-additive, CFR or NDI status as applicable.
7. Decide between Nutrition Facts and Supplement Facts only after classification.
8. Review claims separately.
9. Confirm Part 117 or Part 111 manufacturing requirements.
10. Confirm facility registration, U.S. agent and FSVP importer roles.
11. Assess California Proposition 65 separately where applicable.
12. Finalize formulation and artwork only after these checks.

Aile Herb’s Approach

For US functional-tea projects, ingredient selection should begin with the intended product category and destination-market regulatory requirements rather than with a list of botanicals commonly used in supplements.

Where a buyer proposes a functional botanical formula, the exact ingredient identity, plant part, processing form and intended US use should be confirmed before the formula is finalized.

Testing and documentation for the ingredients themselves are covered in herbal tea ingredient testing requirements, and route options for tea projects are explained in Private Label Herbal Tea: Stock Blends vs Custom Formulation.

Buyer Checklist

Before developing a functional tea for the US, confirm:

• intended US product category
• product presentation
• Nutrition Facts or Supplement Facts route
• each botanical identity
• plant part
• powder or extract form
• manufacturing process
• conventional-food legal basis where relevant
• GRAS basis matched to the actual substance and use
• NDI questions for the supplement route
• claims reviewed separately
• Part 117 or Part 111 route
• food facility registration
• U.S. agent role
• FSVP importer role
• Proposition 65 if California sales are planned

FAQ

Can I Sell a Functional Herbal Tea as a Dietary Supplement in the US?

Possibly, depending on the full facts.

Format alone is not decisive, and a product represented as a conventional beverage may not qualify as a dietary supplement.

Does a Supplement Facts Panel Make Herbal Tea a Dietary Supplement?

No.

Classification depends on the statutory definition and the product’s full presentation, not on the panel alone.

If an Herb Is Sold in Dietary Supplements, Can I Put It in a Conventional Tea?

Not automatically.

Conventional-food ingredient legality needs its own basis, such as GRAS status, an applicable food-additive authorization or another valid food-use basis for the intended use.

Is GRAS the Same as FDA Approval?

No.

GRAS applies to a specific substance under specific conditions of use.

An FDA “no questions” letter responds to a particular notifier’s GRAS conclusion and notified conditions rather than approving the ingredient generally.

Does Every GRAS Ingredient Need an FDA GRAS Notice?

No.

Under FDA’s current framework, notification is voluntary.

The company still needs a supportable scientific and legal basis for its GRAS conclusion, and FDA can challenge that conclusion.

Does China’s Food-and-Medicine-Homology List Prove an Herb Is Legal in US Food?

We have not located any official FDA recognition of that Chinese list as a US food-use authorization.

US food legality still needs to be evaluated under the applicable US regulatory framework.

Is Ashwagandha FDA Approved for Functional Beverages?

We have not located any general FDA approval for that use.

FDA Import Alert 99-45 contains adverse enforcement language concerning conventional foods containing ashwagandha.

That is a strong risk signal for tea or beverage use, but it should not be described as a blanket ban covering every possible use.

Is L-Theanine FDA Approved?

That wording is inaccurate.

Specific GRAS notices received “FDA has no questions” responses for specified L-theanine substances and conditions of use.

The actual material used in a product should be matched to the relevant regulatory basis.

Is Proposition 65 the Same as FDA Heavy-Metal Regulation?

No.

It is a separate California exposure-warning law.

For lead, the analysis is exposure-based rather than determined by one simple product ppm threshold.

Is a U.S. Agent the Same as an FSVP Importer?

No.

The U.S. agent is a role connected with foreign food facility registration, while the FSVP importer is a separate role responsible for foreign supplier verification.

To develop a US tea product on either route with the ingredient and label checks built in, see our private label herbal tea bags service and send the formula, serving weight and intended claims.