A botanical's legal status is decided by its intended use, its claims and where it is sold, not by the plant itself
The same extract can be a dietary ingredient, a food ingredient, a cosmetic ingredient or a drug. This page sets out the federal and state rules that decide which, and the questions EUTECNIQ would put to counsel.
Not legal advice. This page summarizes public statutes, regulations and agency documents as of October 2026 and applies none of them to a product. EUTECNIQ is in formation, with no products, suppliers, imports, patents or legal opinions; each question here would be decided by qualified counsel.
Academy fundamentals: Course 10, Why no disease claims · Course 2, The untapped botanicals · Lessons learned: substances that are not lawful ingredients
The Federal Food, Drug, and Cosmetic Act defines each category by what the product is intended to do
FDA infers intended use from claims in labeling, advertising and websites, from consumer perception, and from ingredients with a well-known therapeutic use.
Text version: the four statutory definitions, quoted
| Category | Statutory text (quoted) | Citation |
|---|---|---|
| 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." | Statute FD&C Act § 201(f); 21 U.S.C. 321(f) |
| Drug | "(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals" | Statute § 201(g)(1); 21 U.S.C. 321(g)(1) |
| 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" (soap excepted) | Statute § 201(i); 21 U.S.C. 321(i) |
| Dietary supplement | A product "intended to supplement the diet" that contains a dietary ingredient, including "(C) an herb or other botanical" and "(F) a concentrate, metabolite, constituent, extract, or combination" of such ingredients; intended for ingestion; "not represented for use as a conventional food or as a sole item of a meal or the diet"; and "labeled as a dietary supplement" | Statute § 201(ff)(1)–(2); 21 U.S.C. 321(ff) |
The final sentence of § 201(ff): "Except for purposes of paragraph (g) and section 350f of this title, a dietary supplement shall be deemed to be a food within the meaning of this chapter."
21 U.S.C. 321 (Cornell LII, read October 22–23, 2026). Intended-use evidence: FDA, "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)" (content current as of September 11, 2024).
Walk one product through the definitions
Each step cites its provision. The result is a starting point for counsel, not a determination.
Step through one product, with the provision quoted at each answer
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1. Will the product, its label, advertising or website claim to diagnose, cure, mitigate, treat or prevent a disease?
Claims anywhere in labeling or promotion count toward intended use.
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§ 201(g)(1)(B) It is regulated as a drug
For a product marketed as a supplement, 21 CFR 101.93(f): with a disease claim "the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies". Botanical drug development follows FDA's botanical drug guidance; see pharmaceutical partnerships.
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2. Is it applied to the body to cleanse, beautify, promote attractiveness or alter the appearance?
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§ 201(i) It is a cosmetic, unless it also makes drug claims
FDA: "A product can be a drug, a cosmetic or both." Cosmetic rules after MoCRA are on cosmetics and MoCRA.
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3. Is it intended for ingestion, not represented as a conventional food or as a sole item of a meal, and labeled as a dietary supplement?
All three conditions of § 201(ff)(2) must hold.
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§ 201(f) It is a conventional food
An added botanical ingredient needs a food additive approval or a basis for GRAS status; GRAS rules and the August 2026 proposed rule are on GRAS and food ingredients.
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4. Does it contain a dietary ingredient in § 201(ff)(1), such as "an herb or other botanical" or its "extract"?
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§ 201(ff)(1) It cannot be a dietary supplement
A product with no listed dietary ingredient does not meet the definition. Counsel would decide which category applies.
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5. Before it was first marketed as a supplement or food, was the article approved as a new drug, or authorized for investigation as a new drug with substantial clinical investigations made public?
This is the drug-exclusion or "race to market" clause, quoted in full below.
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§ 201(ff)(3)(B) It is excluded from the definition of a dietary supplement
Unless FDA has issued a regulation, after notice and comment, finding the article lawful in supplements.
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Counsel question Establish the dates before going further
FDA may not disclose when an article was authorized for investigation; in the NMN matter it wrote, "we cannot specify the date of authorization". Marketing history evidence and a search of public trial registries would go to counsel.
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6. Was the dietary ingredient marketed in the United States before October 15, 1994, and can that be documented?
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§ 413(d) It is not a new dietary ingredient
A "new dietary ingredient" is one "not marketed in the United States before October 15, 1994". FDA keeps no authoritative list of pre-1994 ingredients, and a changed form or manufacturing process can raise the question again; see NDIN strategy.
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7. Does the supplement contain only ingredients present in the food supply as an article used for food, in a form not chemically altered?
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§ 413(a)(1) No premarket notification is required
The exception applies only when the supplement "contains only dietary ingredients which 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".
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§ 413(a)(2) Notify FDA at least 75 days before marketing
The notification gives the basis on which the notifier concluded the supplement "will reasonably be expected to be safe" (21 CFR 190.6). An acknowledgement is not an approval. See NDIN strategy.
21 U.S.C. 321(f), (g)(1), (i), (ff); 21 U.S.C. 350b (FD&C Act § 413); 21 CFR 101.93(f) and 190.6 (eCFR, current as of October 21, 2026); FDA, "'Cosmeceutical'" (content current as of February 25, 2022).
An ingredient can lose supplement status if a drug developer reaches FDA first; FDA reversed its own reading for NMN in 2025
Text version: the clause quoted in full, and the NMN dates
"[The term dietary supplement] does … (B) not include— (i) an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or (ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter."
- July 28, 2022FDA filed a new dietary ingredient notification for β-nicotinamide mononucleotide (NMN) submitted on behalf of Inner Mongolia Kingdomway Pharmaceutical Limited.
- October 11, 2022FDA wrote to the notifier "stating that NMN is excluded from the definition of a dietary supplement under section 201(ff)", on the view that NMN had not been lawfully marketed as a supplement before it was authorized for investigation as a drug.
- March 7, 2023Date of the citizen petition in docket FDA-2023-P-0872, answered jointly to the Natural Products Association and the Alliance for Natural Health USA.
- September 29, 2025FDA granted the petition in part: "we now conclude that NMN is not excluded from the definition of dietary supplement under section 201(ff)(3)(B)". It cited evidence that NMN was sold as a supplement "as early as 2017", before the drug authorization, and dropped its view that prior marketing had to be lawful.
Explanation, details and sources
The clause turns on dates and public facts a firm may not see, and FDA's reading can change. Before committing to an ingredient, EUTECNIQ would document marketing history, search public trial registries and ask counsel.
A structure/function claim is allowed on a supplement only with notification, a fixed disclaimer, and evidence that would satisfy the FTC
FDA regulates labeling; the Federal Trade Commission regulates advertising. A claim that passes FDA's form requirements can still be unsubstantiated under FTC law.
Text version: what each rule says
What a statement may say
A structure/function statement "may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases" (21 U.S.C. 343(r)(6)). A supplement making a compliant statement "is not a drug under clause (C) solely because the label or the labeling contains such a statement" (21 U.S.C. 321(g)(1)).
Notification and disclaimer
Notify FDA no later than 30 days after first marketing (21 CFR 101.93(a)). The label must carry: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." (§ 101.93(c)), in boldface type of at least 1/16 inch.
Substantiation
FTC's Health Products Compliance Guidance replaced its 1998 dietary supplement guide. As a general matter, "substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing". Animal and in vitro studies alone are not sufficient. "The guide, however, doesn't have the force or effect of law."
Traditional use is not a shortcut
"claims for products based on traditional use are subject to the same requirement of substantiation" as any other product: competent and reliable scientific evidence. The evidence levels used across this site are on clinical research.
- A notified structure/function claim≠an FDA-reviewed claim
- Traditional use≠substantiation of a health benefit
- An in vitro or animal result≠evidence for a claim about people
21 U.S.C. 343(r)(6) and 321(g)(1); 21 CFR 101.93 (eCFR, current as of October 21, 2026); Federal Trade Commission, Health Products Compliance Guidance (published December 20, 2022), sections I, III.B and III.C.2.
Products sold as supplements that contained drug ingredients were recalled as drugs, most of them in Class I
Data table
| Year | Class I | Class II | Class III | Total |
|---|---|---|---|---|
| 2012 | 1 | 0 | 0 | 1 |
| 2013 | 2 | 3 | 0 | 5 |
| 2014 | 24 | 3 | 1 | 28 |
| 2015 | 1 | 0 | 0 | 1 |
| 2016 | 14 | 0 | 2 | 16 |
| 2017 | 13 | 1 | 3 | 17 |
| 2018 | 1 | 1 | 0 | 2 |
| 2019 | 0 | 1 | 0 | 1 |
| 2020 | 3 | 0 | 0 | 3 |
| 2021 | 0 | 5 | 0 | 5 |
| 2022 | 1 | 1 | 0 | 2 |
| 2023 | 1 | 0 | 0 | 1 |
| 2024 | 5 | 1 | 0 | 6 |
| 2025 | 5 | 0 | 0 | 5 |
| 2026 | 0 | 1 | 0 | 1 |
| Total | 71 | 17 | 6 | 94 |
71 of 94 records were Class I; the reasons most often name sildenafil, tadalafil or vardenafil (33 records), sibutramine (21) and phenolphthalein (14).
Explanation, details and sources
Counts are records, one per product in a recall event. Drug names were counted by keyword in the recall reason, so one record can name more than one drug. openFDA states that its data are not validated. Class I means a reasonable probability of serious adverse health consequences or death (21 CFR 7.3(m)(1)).
California and New York add rules that federal compliance does not satisfy
Text version: both statutes, quoted
Warnings before exposure to listed chemicals
"No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual, except as provided in Section 25249.10." Businesses "employing fewer than 10 employees" are outside the definition of a person in the course of doing business.
Lead is listed for developmental, male and female reproductive toxicity (February 27, 1987). OEHHA's safe harbor levels: 0.5 µg/day (MADL, reproductive toxicity) and 15 µg/day (NSRL, cancer).
Cal. Health & Safety Code §§ 25249.6, 25249.11(b) (2025 code); OEHHA, Proposition 65, lead (page modified January 5, 2025). The USP ⟨2232⟩ comparison is on USP, ICH and COA.Weight-loss and muscle-building supplements: no sales to minors
General Business Law § 391-oo prohibits selling or giving such supplements to "any person under eighteen years of age", requires proof of age, and has delivery sellers require an adult signature. Factors include whether the product contains ingredients such as "creatine, green tea extract, raspberry ketone, garcinia cambogia, green coffee bean extract" and whether its labeling or marketing makes weight-loss or muscle claims. Civil penalties of "not more than five hundred dollars" per violation.
N.Y. Gen. Bus. Law § 391-oo (NY Senate, current text revised April 26, 2024).At or below the 0.5 µg/day safe harbor level, before any allowance for naturally occurring lead.
Method, assumptions and limits
What it calculates. Daily lead intake from one product taken as labeled, and its ratio to OEHHA's safe harbor levels for lead: 0.5 µg/day (maximum allowable dose level, reproductive toxicity) and 15 µg/day (no significant risk level, cancer).
Equation. E = C × m × n, with C the lead concentration in µg/g (equal to ppm by mass), m the product mass per serving in grams and n the servings per day. Inputs are clamped to the slider ranges.
What it does not establish. Whether a warning is required. OEHHA's regulations set further rules for estimating exposure, including how naturally occurring amounts are treated, which this calculator does not apply. Measurement uncertainty, lot variability and other sources of lead are ignored. Not legal advice.
Verification. Reference cases in tests/numerics/reg-legal-status-p65.json, computed independently in tests/numerics/ref/reg_p65.py.
At 0.1 µg/g, two 2 g servings a day deliver 0.4 µg of lead, inside the 0.5 µg/day reproductive safe harbor level.
Where a plant was grown, how it was taken, and whether it is protected can make an import unlawful whatever its quality
Text version: each regime quoted, with its status as of October 2026
| Regime | What the text says (quoted) | Status as of October 2026 |
|---|---|---|
| Iran sanctions: imports | "the importation into the United States of any goods or services of Iranian origin or owned or controlled by the Government of Iran … is prohibited" (31 CFR 560.201). Iranian-origin goods include goods "grown, produced, manufactured, extracted, or processed in Iran" and goods "that have entered into Iranian commerce" (§ 560.306(a)). | Final regulation In force |
| Iran: former foodstuff license | Section 560.534 now authorizes only the wind-down of importing Iranian-origin "Foodstuffs intended for human consumption" (HTS chapters 2–23) "from Iran or a third country", "through 11:59 p.m. eastern daylight time on August 6, 2018". | Expired Narrowed by 83 FR 30335 (June 28, 2018) |
| Iran: August 2026 stay | "Effective August 24, 2026, 31 CFR 560.544, 560.550, and 560.554 are stayed indefinitely", with General Licenses F and G. These covered certain educational activities, personal remittances, conference services, sports and academic exchanges. | Final rule; stay 91 FR 54957 (August 26, 2026) |
| Lacey Act (plants) | Unlawful to import or buy in foreign commerce "any plant … taken, possessed, transported, or sold in violation of any law or regulation of any State, or any foreign law, that protects plants" (16 U.S.C. 3372(a)(2)(B)). Importers must file a declaration with "the scientific name of any plant (including the genus and species of the plant)", value, quantity and "the name of the country from which the plant was taken" (§ 3372(f)). | Statute Declaration phased in by USDA APHIS by product code |
| CITES and ESA | Unlawful to "import, export, re-export, or engage in international trade with any specimen of a species listed in Appendix I, II, or III of CITES" unless the requirements of Part 23 are met (50 CFR 23.13(a)); "you must have a valid CITES document" (§ 23.20(c)). The U.S. Fish and Wildlife Service implements CITES "through the Endangered Species Act" (§ 23.1(c)). | Final regulation Species listings change at CITES meetings |
31 CFR 560.201, 560.306, 560.534; 50 CFR 23.1, 23.13, 23.20 (eCFR, current as of October 21, 2026); Federal Register 83 FR 30335 (June 28, 2018) and 91 FR 54957 (August 26, 2026); 16 U.S.C. 3372 (Cornell LII).
Import steps (registration, Prior Notice, FSVP, customs) are on the botanical atlas page.
A plant, or a constituent merely isolated from it, is not patent-eligible; a markedly different product may be, and know-how can stay secret
Text version: the provisions quoted
Patent eligibility
"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor" (35 U.S.C. 101).
Products of nature after Myriad
"A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring." Association for Molecular Pathology v. Myriad Genetics, No. 12-398, decided June 13, 2013.
The markedly different test
Examiners treat as judicial exceptions "nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature". The analysis "compares the nature-based product limitation to its naturally occurring counterpart in its natural state" (MPEP § 2106.04 and § 2106.04(c), revision R-07.2022).
Trade secrets
"An owner of a trade secret that is misappropriated may bring a civil action" if the secret relates to a product or service in interstate or foreign commerce (18 U.S.C. 1836(b)(1)), added by the Defend Trade Secrets Act, Pub. L. 114-153, May 11, 2016.
Disclosure through regulatory filings
An NDI notification becomes public 90 days after filing, minus trade secret and confidential commercial information (21 CFR 190.6(e)). What to file, what to keep secret and when to file patents is a sequencing question for counsel.
Brands and ingredient names
A trademark protects a brand, not the botanical or its composition. Clearance and registration would be handled by trademark counsel before any public use.
EUTECNIQ holds no patents, patent applications or trademarks. Licensing is discussed on commercialization and licensing.
EUTECNIQ would prepare the facts and evidence at each gate; counsel would decide the legal position
A gate is a point after which a decision becomes costly to reverse. This is a management plan; no counsel has been engaged.
Text version: the gates as a table
| Issue | Type of counsel | Gate | EUTECNIQ prepares | Counsel decides |
|---|---|---|---|---|
| Product category and intended use | FDA regulatory | Before formulation is fixed | Ingredient dossier, intended-use statement, draft claim list | Category; whether any claim implies a drug use |
| Drug exclusion | FDA regulatory | Before an ingredient is selected | Marketing-history evidence; public trial registry and approval searches | Whether § 201(ff)(3)(B) applies |
| NDI status | FDA regulatory | Before first sale | Pre-1994 records, identity data, history of use, draft safety narrative | Old or new dietary ingredient position; whether and when to notify |
| Claims and advertising | FDA and FTC advertising | Before any label, website or sales material | Evidence map per claim with evidence levels | Claim wording; adequacy of substantiation |
| State law | California and New York consumer-product | Before sales into those states | Exposure calculations for listed chemicals; marketing review for § 391-oo factors | Warnings; sales and delivery restrictions |
| Sanctions and origin | Sanctions and trade | Before a supplier contract or purchase order | Supply-chain map to farm or collection region; origin documents | Whether the origin is lawful; any license need |
| Import, Lacey Act, CITES | Customs and wildlife trade, with a licensed customs broker | Before the first shipment | Genus and species, country of harvest, product codes, permits | Declaration content; permit requirements |
| Patents | Registered patent attorney | Before any publication, talk or website disclosure | Invention records, prior-art search, data showing differences from nature | Eligibility, filing and timing |
| Trademarks | Trademark | Before a brand is used | Candidate names and goods descriptions | Clearance and registration strategy |
| Trade secrets and data | Commercial contracts | Before data are shared with partners | Data inventory, access controls | Confidentiality and ownership terms |
| GMP regime | FDA regulatory | Before facility design | Process map separating supplement and bulk-ingredient operations | Where Part 111 and Part 117 apply |
Questions EUTECNIQ would put to counsel
Drafted from the provisions above. None has been answered.
Explanation, details and sources
- For each candidate ingredient, is there any public record of drug approval or substantial clinical investigation that predates its marketing as a supplement or food, and how should marketing history be documented?
- Does the planned form (for example a nanoemulsion or a purified fraction) change an ingredient's old or new dietary ingredient status, or its "chemically altered" status?
- Which statements in draft labels, websites and investor materials could be read as disease claims?
- What evidence would substantiate each proposed claim under the FTC's 2022 guidance, and where is a human trial needed first?
- Does any product require a Proposition 65 warning at the planned daily intake, and which exposure assessment method should be used?
- Does any product fall within New York's § 391-oo factors because of its ingredients or marketing?
- For each supplier, is the origin lawful under U.S. sanctions, including for material processed in a third country?
- Which species or products need CITES documents, and what Lacey Act declaration data must the supplier provide?
- Which processes, formulations or data could support patent claims that satisfy the markedly different analysis, and what must not be disclosed before filing?
- What information in an NDI notification or a master file should be claimed as trade secret or confidential commercial information?
- Which operations would fall under Part 111 and which under Part 117 in a facility that makes both extracts and finished supplements?
- Which human studies would need an IND under FDA's 2013 guidance, and which only IRB review?
Planning a botanical product for the U.S. market?
EUTECNIQ proposes to assemble the identity, marketing-history and evidence file that counsel needs to decide the legal path.