Botanicals, herbals and nutraceuticals Statute and regulation Agency guidance Peer-reviewed
The same plant can be sold as a food, a dietary supplement, a drug or a cosmetic; its intended use and claims decide which
What "botanical", "dietary supplement", "nutraceutical", "functional food" and "medical food" mean in law, which claims each category may carry, and which federal rules follow from the choice.
Status. A plain-language map of definitions, quoted from the statutes, regulations and guidance as of October 2026. It is not legal advice; how a specific product is classified is a question for regulatory counsel (see Legal status).
14 · 16 · 7CFR rule sets mapped for one botanical sold as a supplement, a food ingredient or a cosmetic
6terms defined in U.S. statute; "nutraceutical", "functional food" and "herbal" are not among them
4botanical products approved by FDA as prescription drugs: three NDAs and one BLA
30 yearsof medicinal use, 15 of them in the EU, for an EU traditional herbal registration (Directive 2004/24/EC)
Same plant, different rulebook
As a supplement a botanical meets 14 mapped CFR rule sets, as a food ingredient 16 and as a cosmetic 7
A botanical sold as a food ingredient meets GRAS and food-additive parts that a supplement does not; choose a category to compareeCFR counts
Data table: the rule sets for each category
| Rule set | eCFR sections | a dietary supplement | a bulk dietary ingredient sold to manufacturers | a conventional-food ingredient | a cosmetic |
|---|---|---|---|---|---|
| 21 CFR Part 184 Direct Food Substances Affirmed as Generally Recognized as Safe | 215 | – | – | Check | – |
| 21 CFR Part 182 Substances Generally Recognized as Safe | 85 | – | – | Check | – |
| 21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements | 84 | Applies | Check | – | – |
| 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food | 61 | Check | Applies | Applies | – |
| 21 CFR Part 101 Food Labeling | 50 | Applies | Check | Applies | – |
| 21 CFR Part 170 Food Additives | 41 | – | – | Applies | – |
| 21 CFR Part 1, Subpart S Additional Traceability Records for Certain Foods | 33 | – | – | Check | – |
| 21 CFR Part 1, Subpart O Sanitary Transportation of Human and Animal Food | 18 | Check | Check | Check | – |
| 21 CFR Part 1, Subpart H Registration of Food Facilities | 14 | Applies | Applies | Applies | – |
| 21 CFR Part 1, Subpart J Establishment, Maintenance, and Availability of Records | 13 | Applies | Applies | Applies | – |
| 21 CFR Part 700 General | 12 | – | – | – | Applies |
| 21 CFR Part 172, Subpart F Food Additives Permitted for Direct Addition to Food for Human Consumption | 11 | – | – | Check | – |
| 21 CFR Part 7, Subpart C Enforcement Policy | 10 | Check | Check | Check | Check |
| 21 CFR Part 11 Electronic Records; Electronic Signatures | 10 | Applies | Applies | Applies | – |
| 21 CFR Part 701 Cosmetic Labeling | 10 | – | – | – | Applies |
| 21 CFR Part 740 Cosmetic Product Warning Statements | 8 | – | – | – | Check |
| 21 CFR Part 190 Dietary Supplements | 1 | Check | Check | – | – |
| 40 CFR Part 180 Tolerances and Exemptions for Pesticide Chemical Residues in Food | 755 | Applies | Applies | Applies | – |
| 16 CFR Part 1700 Poison Prevention Packaging | 8 | Check | – | – | – |
| 29 CFR 1910.1200 Hazard communication. | 1 | Applies | Applies | Applies | Applies |
| 29 CFR 1910.132 General requirements. | 1 | Applies | Applies | Applies | Applies |
| 29 CFR 1910.147 The control of hazardous energy (lockout/tagout). | 1 | Check | Check | Check | Check |
| Sections in rules that apply / including rules to check | 928 / 1027 | 855 / 1019 | 946 / 1319 | 24 / 43 |
The journey
Classifying the product comes first, because the category decides the studies, tests and documents
Choose a customer to follow its path from the rules to the documents it would receiveProposed service flow
Text version: customers, rules, stages and documents
Customers
- Brands launching a botanical product Need to know which category the product is in and what its label may say.
- Ingredient suppliers selling into several categories Need a status for each use: supplement, food or cosmetic.
- Sponsors of a botanical drug candidate Need characterized material for studies under an IND.
Rules that decide the category
- 21 U.S.C. 321 Definitions of food, dietary supplement, drug and cosmetic.
- 21 CFR 101.93 Structure/function statements on supplements.
- 21 CFR 190.6 New dietary ingredient notification.
- 21 CFR 111 and 117 Supplement CGMP; food CGMP for ingredients.
- 21 CFR 170 Food additives and GRAS.
- 21 CFR 700 Requirements for specific cosmetic products.
- 21 CFR 312 Investigational new drug applications.
Platform stages (proposed)
- Category and claims assessment Intended use, claims and the route for each market, with counsel.
- Identity and composition Species, plant part, markers and contaminants.
- Safety basis for each use Exposure and history of use per category.
- Claim evidence review What the studies on this product can support.
- Batch characterization Fingerprints and multi-batch data for a sponsor.
What the customer would receive
- Category and claims memo For review by regulatory counsel.
- Specification and test methods
- Safety summary for each intended use
- Claim evidence summary
- Characterization package For the sponsor's own regulated studies.
Definitions
U.S. law defines food, dietary supplement, drug, cosmetic and medical food, but not "nutraceutical", "functional food" or "herbal"
Six terms are defined in statute, one only in guidance, three nowhere in U.S. lawStatute
Explanation, details and sources
The FD&C Act's definitions section (21 U.S.C. 321) uses the phrase "herb or other botanical" inside the definition of a dietary supplement and does not define "nutraceutical" or "functional food" (checked October 22, 2026).
| Term | Definition, quoted | Source | Status |
|---|---|---|---|
| Food | "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." | FD&C Act § 201(f), 21 U.S.C. 321(f) | Statute |
| Dietary supplement | "A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients"; it is intended for ingestion, "is not represented for use as a conventional food or as a sole item of a meal or the diet," and "is labeled as a dietary supplement." Except for § 201(g) and § 350f, "a dietary supplement shall be deemed to be a food." | FD&C Act § 201(ff), 21 U.S.C. 321(ff) | Statute |
| Dietary ingredient | "(A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination" of any of these. | FD&C Act § 201(ff)(1) | Statute |
| Botanical | "Products that include plant materials, algae, macroscopic fungi, and combinations thereof." The definition excludes animal and mineral products (except minor components of traditional preparations), single molecules made by genetic modification or fermentation, and "highly purified substances" such as paclitaxel. | FDA, Botanical Drug Development: Guidance for Industry, Revision 1, December 2016, Section II | Final guidance nonbinding; "for the purposes of this document" |
| Drug | Includes "(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "(C) articles (other than food) intended to affect the structure or any function of the body." | FD&C Act § 201(g)(1), 21 U.S.C. 321(g)(1) | Statute |
| Cosmetic | "Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance," except soap. | FD&C Act § 201(i), 21 U.S.C. 321(i) | Statute |
| Medical food | "A food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." | 21 U.S.C. 360ee(b)(3) (Orphan Drug Act) | Statute |
| Nutraceutical | No statutory definition. Stephen DeFelice coined the term from "nutrition" and "pharmaceutical" in 1989; it "is being commonly used in marketing but has no regulatory definition." | Kalra EK. AAPS PharmSci 2003;5(3):E25 | Peer-reviewed marketing term |
| Functional food | No U.S. statutory definition. The concept was developed in Japan, where the government began approving "foods for specified health uses" (FOSHU); the first approval, a hypoallergenic rice, was dated June 1, 1993. | Arai S. Biosci Biotechnol Biochem 1996;60:9–15 | Peer-reviewed marketing term in the U.S. |
How this site uses the words Management proposal
Botanical: plant materials, algae and macroscopic fungi, following FDA's guidance definition, used for ingredients regardless of the eventual legal category. Herbal: used only when quoting a legal text, such as the EU's herbal substances and preparations, or a source's own wording. Nutraceutical and functional food: used only as market terms, never as a claim about legal status; market statistics that use these words are labeled with their publisher (see Market data).
Labels of U.S. dietary supplements must name botanical ingredients as standardized in Herbs of Commerce (1992), followed by the plant part and, when the name is not listed there, the Latin binomial with its author where needed for identification (21 CFR 101.4(h)). The botanical atlas records both the accepted and the trade name for this reason; see the botanical atlas.
How the categories nest
A dietary supplement and a medical food are each legally a kind of food; a botanical drug sits outside both
Where a botanical product can sit under the FD&C ActStatute
Botanical products plant materials, algae, macroscopic fungi (FDA guidance, 2016)
Food § 201(f)
Conventional foodStructure/function claims only from nutritive value; authorized and qualified health claims
Dietary supplement§ 201(ff); "deemed to be a food"; contains a dietary ingredient such as "an herb or other botanical"
Medical food21 U.S.C. 360ee(b)(3); dietary management of a disease under physician supervision
Drug § 201(g)(1)
Botanical drugNew drug application or BLA; four products approved to date
OTC monographFor example psyllium and senna in the OTC drug review
Cosmetic § 201(i)
Appearance claims onlyA disease or structure/function claim makes it a drug
No U.S. statutory definition: "nutraceutical", "functional food", "herbal". A product described with these words still falls into one of the boxes above.
Explanation, details and sources
FDA's botanical guidance puts it directly: a botanical product "may be classified as a food (including a dietary supplement), drug (including a biological drug), medical device, or cosmetic," and which one "depends in large part on its intended use," established by "the product's labeling, advertising, and the circumstances surrounding its distribution."
Claims
Disease claims belong to drugs; a supplement may claim effects on structure or function after notifying FDA and adding a disclaimer
Marketing that accompanies the product counts as labeling.
What each U.S. category may say: structure/function, disease and health claimsStatute and regulation
Text version of the claims table, with links to each pathway
| Category | Structure/function claim | Disease claim | Health claim (disease risk) | Premarket step for a botanical |
|---|---|---|---|---|
| Conventional food | Allowed when the effect derives from nutritive value; no FDA notification or disclaimer is required. | Not allowed; a disease purpose meets the drug definition. | Authorized claims (significant scientific agreement), claims based on authoritative statements, and qualified health claims. | The ingredient must be lawful in food, for example GRAS or an approved additive; see GRAS. |
| Dietary supplement | Allowed with substantiation, notification to FDA within 30 days of first marketing and the disclaimer "This statement has not been evaluated by the Food and Drug Administration…" (§ 403(r)(6); 21 CFR 101.93). | Not allowed: a statement "may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease." | Authorized and qualified health claims; FDA states that health claims based on authoritative statements cannot be used for supplements. | A new dietary ingredient needs a notification at least 75 days before marketing; see NDIN. |
| Medical food | Not the basis of the category. | Dietary management of a disease is part of the definition, under physician supervision. | The § 403(r) claim provisions and nutrition labeling do not apply (21 U.S.C. 343(r)(5)(A), (q)(5)(A)(iv)). | Not assessed here. |
| Drug, including a botanical drug | An article other than food intended to affect structure or function is a drug. | Allowed only as approved in an NDA or BLA, or under an OTC monograph. | Not applicable. | Clinical development and approval; see Pharmaceutical partnerships. |
| Cosmetic | Not available; the structure/function safe harbor covers foods and supplements only. | Makes the product a drug, or a drug and a cosmetic. | Not applicable. | No approval; facility registration and product listing under MoCRA; see Cosmetics and MoCRA. |
- Structure/function notification≠FDA review or approval
- "Nutraceutical"≠a legal category
- EU traditional-use registration≠demonstrated efficacy
- Botanical drug approval≠approval of the plant as a supplement
Other jurisdictions
Abroad the same botanical may be a food supplement, a traditional herbal medicine, a natural health product or a listed medicine
Five systems outside the United States: what each calls a botanical product and who checks the evidenceLegal texts
Text version: the five systems, quoted from the legal texts
| System | How the law defines it | Evidence standard | Source |
|---|---|---|---|
| EU food supplements | "Foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect," marketed in dose form. | The Directive harmonizes vitamins and minerals; botanicals remain under national rules. | Directive 2002/46/EC, Art. 2(a) |
| EU traditional herbal medicinal products | Herbal substances are "all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh"; herbal preparations are obtained by "extraction, distillation, expression, fractionation, purification, concentration or fermentation," including "tinctures, extracts, essential oils, expressed juices and processed exudates." | Medicinal use "throughout a period of at least 30 years," including "at least 15 years within the Community"; the product must prove "not to be harmful" and its effects must be "plausible on the basis of long-standing use and experience." Indications must suit use without medical supervision. | Directive 2004/24/EC, Art. 1 (points 29–32 of Directive 2001/83/EC), Arts. 16a(1), 16c(1)(c) |
| Canada natural health products | A substance in Schedule 1 (item 1: "a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material"), a homeopathic medicine or a traditional medicine, represented for use in "the diagnosis, treatment, mitigation or prevention of a disease," or in restoring, correcting or modifying organic functions. | A product licence is required before sale, with an eight-digit NPN; manufacturers and importers need a site licence. | Natural Health Products Regulations, SOR/2003-196, s. 1(1), 4(1), 27(1), Schedule 1 (current to September 30, 2026); Health Canada, Product licensing |
| Japan FOSHU and Foods with Function Claims | FOSHU claims are approved by the government. Under Foods with Function Claims, a business notifies the Consumer Affairs Agency, before sale, of the scientific basis for safety and function. | For Foods with Function Claims the government does not review the claim; the business is responsible for it. | Consumer Affairs Agency, Foods with Function Claims page (Japanese); Arai 1996 |
| Australia listed complementary medicines | Low-risk medicines listed on the ARTG with an AUST L number, containing only permitted low-risk ingredients and making only permitted indications. | Indications are "not evaluated by the TGA at the time a medicine is listed"; sponsors certify that they hold evidence. Manufacture must follow GMP principles. | TGA, Listed complementary medicines (page dated May 4, 2018) |
Classify the product before you design the study
The legal category sets the claims, the evidence needed and the manufacturing rules. EUTECNIQ would map these early in any development project and bring in regulatory counsel where needed.