EUTECNIQ Sciences

See every page on one mapArrow keys move through results · Enter opens · Esc closes

Applications Proposed markets U.S. law checked October 22, 2026

One characterized ingredient can serve several markets, and each market applies its own law

Supplements, foods, cosmetics and drugs share much of the same science. They differ in premarket steps, allowed claims and quality rules; this page maps what carries over.

10application pages
102figures and diagrams
30interactive tools
223evidence labels
294registered claims

Status. EUTECNIQ Sciences is a company in formation. It has no laboratory, customers or products yet, so every EUTECNIQ service in this section is a proposal. The legal statements summarize U.S. federal law as of October 22, 2026. They are not legal advice.

Application pages

Four groups of pages: markets, development and supply, terms, and commercialization

The applications section: groups inside, pages outside; select a group to zoom, a page to open itSite structure
Built from the site navigation; tooltips give each page's figure and tool counts.
Bar on each card: evidence labels on that pageVerified dataPeer-reviewedRegulation or guidanceThird-party estimateProposal, partner or riskSimulation or schematic
U.S. product markets

Dietary supplements

DSHEA, Part 111, NDI notifications and claims.

10 figures3 interactive
Development and supply

Global ingredients

From a qualified international supplier to U.S. buyers.

13 figures2 interactive
Development and supply

For U.S. manufacturers

Documented qualification for U.S. manufacturers.

8 figures3 interactive
What each application page rests on: share of its evidence labels by kind; select a column to sortCounted at build time
Every evidence label printed on each page, counted when the site is built. Label key: insights library.
Data table
Evidence labels on each application page, by family, counted at build time
PageLabelsVerified dataPeer-reviewedRegulation or guidanceThird-party estimateProposal, partner or riskSimulation or schematic
Botanicals, herbals & nutraceuticals121 (8%)3 (25%)6 (50%)0 (0%)2 (17%)0 (0%)
Dietary supplements152 (13%)0 (0%)4 (27%)0 (0%)8 (53%)1 (7%)
Functional foods & beverages212 (10%)1 (5%)9 (43%)0 (0%)8 (38%)1 (5%)
Cosmetics & personal care193 (16%)2 (11%)5 (26%)0 (0%)8 (42%)1 (5%)
Pharmaceutical partnerships194 (21%)0 (0%)5 (26%)0 (0%)10 (53%)0 (0%)
Advanced ingredient development242 (8%)5 (21%)4 (17%)0 (0%)13 (54%)0 (0%)
Global ingredients362 (6%)0 (0%)14 (39%)0 (0%)18 (50%)2 (6%)
For international suppliers151 (7%)0 (0%)2 (13%)0 (0%)12 (80%)0 (0%)
For U.S. manufacturers222 (9%)0 (0%)6 (27%)0 (0%)13 (59%)1 (5%)
Commercialization & licensing406 (15%)1 (2%)10 (25%)0 (0%)15 (38%)8 (20%)
Why one platform

Most of the scientific work on an ingredient is the same whichever market it enters

Safety evidence, permitted claims and manufacturing rules attach to the intended use, not to the material.

Material properties carry across markets; intended use decides everything elseProposed platform work Regulatory requirement
Four kinds of scientific work are properties of the material and carry across markets; the intended use decides the legal category, and with it four things that are decided market by marketCarries across marketsProposed platform workDecided market by marketBotanical identitySpecies, plant part, authentication by orthogonalmethodsComposition and methodsProfile, marker assays, the analytical methodsProcess knowledgeExtraction, enrichment and drying; mass balance;lot-to-lot variabilityPhysical form and deliverySolubility, dispersibility, particle size, emulsionbehaviorPremarket stepWhether anything must reach FDA before sale, andwhat that step means legallySafety standardWhich standard applies, at what exposureClaimsWhich claims are lawful, and what evidence eachneedsManufacturing rule21 CFR Part 111, Part 117, Parts 210/211, or no finalcosmetic rule yetIntended usedecides the legalcategorySupplement · food · cosmetic · drugWhat carries across markets and what is decided per marketCarries across markets (proposed platform work)•Botanical identity: Species, plant part, authenticationby orthogonal methods•Composition and methods: Profile, marker assays,the analytical methods•Process knowledge: Extraction, enrichment anddrying; mass balance; lot-to-lot variability•Physical form and delivery: Solubility, dispersibility,particle size, emulsion behaviorIntended use decides the legal categorySupplement, food, cosmetic or drugDecided market by market•Premarket step: Whether anything must reach FDAbefore sale, and what that step means legally•Safety standard: Which standard applies, at whatexposure•Claims: Which claims are lawful, and what evidenceeach needs•Manufacturing rule: 21 CFR Part 111, Part 117, Parts210/211, or no final cosmetic rule yet
21 U.S.C. 321(ff), 321(s), 321(i), 321(g); 21 CFR Parts 111, 117, 210, 211. The market matrix below gives each category's rules.
Text version of the two lists

Carries across markets Proposed platform work

  • Botanical identity: species, plant part and authentication by orthogonal methods.
  • Composition profile, marker assays and the analytical methods behind them.
  • Extraction, enrichment and drying knowledge, including mass balance and lot-to-lot variability.
  • Physical form and delivery engineering: solubility, dispersibility, particle size and emulsion behavior.

Decided market by market Regulatory requirement

  • Whether anything must reach FDA before sale, and what that step means legally.
  • Which safety standard applies, and at what exposure.
  • Which claims are lawful, and what evidence each claim needs.
  • Which manufacturing rule governs: 21 CFR Part 111, Part 117, Parts 210/211, or no final cosmetic rule yet.
U.S. demand

Six in ten U.S. adults used a dietary supplement in 2021–2023, up from 54% in 2013–2014

Adults aged 20 and over using dietary supplements in the past 30 days, NHANESGovernment data
U.S. adults aged 20 and over who used a dietary supplement in the past 30 days rose from 53.8% in 2013–2014 to 60.2% in August 2021 to August 2023; use of two or more supplements rose from 30.9% to 38.7%. In 2021–2023, 66.1% of women and 53.9% of men used one, and use rose with age to 75.9% at 60 and older.020406080% of adultsAny supplementAny supplement: 53.8%53.8Any supplement: 55.9%55.9Any supplement: 58.5%58.5Any supplement: 60.2%60.2Any supplementTwo or moreTwo or more: 30.9%30.9Two or more: 33.4%33.4Two or more: 35.5%35.5Two or more: 38.7%38.7Two or more2013–142015–162017–Mar 2020Aug 2021–Aug2023Trend, NHANES cyclesAugust 2021–August 2023, any supplementWomenWomen: 66.1%66.1%MenMen: 53.9%53.9%Age 20–39Age 20–39: 46.3%46.3%Age 40–59Age 40–59: 60.3%60.3%Age 60 and olderAge 60 and older: 75.9%75.9%
Source: Stierman B, Couch CA, Gahche JJ, Mishra S. Dietary supplement use: United States, August 2021–August 2023. NCHS Data Brief No. 561, May 2026 (checked October 24, 2026). Self-reported use in the past 30 days; it says nothing about benefit.
Data table
Adults aged 20 and over using dietary supplements in the past 30 days, NHANES (%)
Survey periodAny supplementTwo or more
2013–201453.830.9
2015–201655.933.4
2017–March 202058.535.5
Aug 2021–Aug 202360.238.7
Any supplement use, August 2021–August 2023, by sex and age (%)
GroupAny supplement
Women66.1
Men53.9
Age 20–3946.3
Age 40–5960.3
Age 60 and older75.9

Use measures demand, not efficacy or safety.

Market matrix

Six U.S. product categories, six different sets of rules

The same botanical extract can fall into any of these rows. Its labeling, marketing and intended use decide which.

U.S. federal framework by product category, as of October 22, 2026Statute and regulation
Market matrix: for each U.S. product category, the governing framework, premarket requirement, typical evidence, claim limits and quality regime.
CategoryGoverning frameworkPremarket requirementTypical evidenceClaim limitsQuality regime
Dietary supplements FD&C Act as amended by DSHEA (1994). Definition in 21 U.S.C. 321(ff) includes "an herb or other botanical" and its extracts. Statute No FDA approval of products or labeling. A new dietary ingredient needs a notification at least 75 days before marketing unless the food-supply exception applies. FDA does not approve notifications. Specifications for identity, purity, strength and composition. History of use or other evidence of safety for a new ingredient. Substantiation for every claim. Structure/function statements, notified within 30 days of marketing and carrying the FDA disclaimer. Disease claims make the product a drug. 21 CFR Part 111 cGMP. Final rule
Dietary ingredients sold to manufacturers FD&C Act. FDA treats dietary ingredients as food under Part 117. Importers fall under FSVP (21 CFR Part 1, Subpart L). The ingredient maker or the supplement maker may file the new dietary ingredient notification. A specification and certificate of analysis the customer can confirm with its required identity test (21 CFR 111.75). Promotional material can establish intended use, so ingredient marketing must avoid disease language. Generally Part 117 when sold only to firms that process it further. Part 111 applies when sold to firms that only package or label it, or to consumers.
Conventional foods and beverages FD&C Act food provisions. A substance added to food is a food additive unless it is generally recognized as safe (GRAS), 21 U.S.C. 321(s). Food additive: an FDA regulation issued on petition (21 CFR Part 171). GRAS: notification to FDA is voluntary today; an August 11, 2026 proposed rule would make it mandatory. Proposed rule "Reasonable certainty… not harmful" for the intended use. GRAS through scientific procedures needs the same quantity and quality of evidence as a food additive approval. Nutrient content claims, authorized or qualified health claims, and structure/function claims derived from nutritive value. No notification or disclaimer for food structure/function claims. 21 CFR Part 117. Part 113 or 114 for low-acid canned or acidified foods; Part 120 for juice.
Cosmetics FD&C Act as amended by MoCRA (enacted December 29, 2022). Definition in 21 U.S.C. 321(i). Statute No FDA approval, except for color additives. Facility registration and product listing. Serious adverse events reported within 15 business days. "Adequate substantiation of safety" held by the responsible person. The law prescribes no specific tests and does not require animal testing. Cleansing, beautifying, promoting attractiveness, altering appearance. A claim to affect body structure or function makes it a drug. No cosmetic GMP rule has been proposed, although the statutory deadlines have passed. FDA has a draft GMP guidance. Draft guidance only
Cosmetic-drug products such as sunscreen moisturizers, antidandruff shampoo, fluoride toothpaste, antiperspirants Cosmetic and drug provisions together. OTC monograph drugs under FD&C Act § 505G (21 U.S.C. 355h). Conform to an OTC monograph, or obtain approval of a new drug application. The monograph's conditions for active ingredient, dose and labeling, or the data in an approved application. Drug claims only as the monograph or approved labeling allows. Drug cGMP, 21 CFR Parts 210/211.
Botanical drugs through regulated partners FD&C Act § 505 (new drug application) or a biologics license. Studies under an IND, 21 CFR Part 312. FDA Botanical Drug Development guidance (December 2016). Final guidance FDA approval of the application before marketing. Adequate and well-controlled clinical investigations (21 CFR 314.126). Nonclinical studies under GLP (Part 58). Trials under Parts 50 and 56 and good clinical practice. Only the indications in the approved labeling. Drug cGMP, 21 CFR Parts 210/211.
Summaries, not complete lists of obligations. State law, advertising law and import rules add further requirements. The detailed pages are new dietary ingredient notifications, GRAS and food ingredients, cosmetics and MoCRA and clinical research. Sources: 21 U.S.C. 321(ff), 321(s), 321(i), 348, 350b, 355h; 21 CFR 101.93, 111.70, 111.75, 170.3, 170.30, 171, 190.6, 314.126 (eCFR, current to October 21, 2026); 91 FR 51834 (August 11, 2026); FDA, Small Entity Compliance Guide for Part 111; FDA, "Is It a Cosmetic, a Drug, or Both?" (September 11, 2024); FDA MoCRA page (August 10, 2026); FDA, Structure/Function Claims and Label Claims pages (March 28, 2024); FDA, Botanical Drug Development guidance (December 2016). Full entries on the sources page.
What carries over

Characterization data travel well between markets; claims and stability data do not

Start from one well-characterized botanical ingredient. This grid shows how much of its dossier a second market could reuse, and why.

Reuse of an ingredient dossier across marketsPlanning analysis, not legal advice
Reuse grid. Rows are parts of an ingredient dossier; columns are markets; each cell says reusable, adapt or new work.
Part of the dossierSupplementFood or beverageCosmeticDrug partnerWhy
Botanical identity and authenticationReusableReusableReusableAdaptFDA's botanical drug guidance relies on raw-material control beyond identity.
Composition profile and analytical methodsReusableReusableReusableAdaptTesting of a drug falls under drug cGMP, Parts 210/211.
Process knowledge: extraction, enrichment, dryingReusableReusableReusableAdaptThe science carries over; the manufacturing rule changes with the category.
Contaminant limitsAdaptAdaptAdaptAdaptAcceptable limits depend on dose, route and frequency of exposure.
Oral safety evidenceReusableAdaptAdaptAdaptFood intake can exceed supplement intake, and skin needs local data. For a lawfully marketed supplement with similar prior use, FDA may let initial clinical studies proceed without further nonclinical testing.
Stability dataNew workNew workNew workNew workStability belongs to a formulation in a package, not to the ingredient alone.
Human efficacy evidenceNew workNew workNew workNew workEach claim needs evidence for that product, population, dose and endpoint.
Claims and labelingNew workNew workNew workNew workEach category has its own claim rules and label regulations.
Reusable the work transfers with little change. Adapt a starting point that needs added data or a different standard. New work the market needs its own study or document. EUTECNIQ planning analysis drawing on 21 CFR 170.30(b); 21 CFR Parts 210/211; FDA, Botanical Drug Development guidance (December 2016), sections on therapeutic consistency and on botanicals lawfully marketed as dietary supplements.
Outside the United States

Other jurisdictions draw the lines in different places

WHO Member States reporting each element of traditional-medicine policy or regulation, 2019 reportWHO survey data
WHO Member States reporting each element of traditional and complementary medicine policy or regulation in the 2019 global report: Acknowledged use of T&CM 170; Registration system for herbal medicines 125; Laws or regulations on herbal medicines 124; Legal or regulatory framework for T&CM 109; National office for T&CM 107; National policy on T&CM 98; National research institute for T&CM 75. Earlier survey values are shown where the report gives them.050100150194WHO Member States (of 194)Acknowledged use of T&CMAcknowledged use of T&CM: 170 Member States (WHO 2019 report, p. 10)170Registration system for herbal medicinesRegistration system for herbal medicines: 125 Member States (WHO 2019 report, p. 39)1252012: 109Laws or regulations on herbal medicinesLaws or regulations on herbal medicines: 124 Member States (WHO 2019 report, p. 29)1242012: 116Legal or regulatory framework for T&CMLegal or regulatory framework for T&CM: 109 Member States (WHO 2019 report, p. 18)109National office for T&CMNational office for T&CM: 107 Member States (WHO 2019 report, p. 21)1072012: 89National policy on T&CMNational policy on T&CM: 98 Member States (WHO 2019 report, p. 15)982012: 79National research institute for T&CMNational research institute for T&CM: 75 Member States (WHO 2019 report, p. 25)752005: 58WHO 2019 reportearlier survey value
Source: WHO global report on traditional and complementary medicine 2019 (pp. 10, 15, 18, 21, 25, 29, 39), as extracted for market data; earlier survey values as summarized by the American Public Health Association, September 3, 2019. Counts of countries with a rule, not of what each rule requires.
Before sale, a product may need nothing, a notification, a listing or an authorization, depending on category and countryStatute and regulation
What must happen before sale, in four kinds of step: no approval, notification, listing or registration, and authorization or approval, with the U.S. and other jurisdictions in each; a notification or a listing is not an approvalNo approval before saleU.S. dietary supplementNo FDA approval of products orlabelingU.S. cosmeticNo FDA approval, except coloradditivesNotificationU.S. new dietary ingredientAt least 75 days before marketing;FDA does not approve notificationsU.S. GRAS noticeVoluntary today; a proposed rulewould require itEU cosmeticElectronic notification before saleJapan, Foods with FunctionClaimsNotified before sale; the claim is notreviewedListing or registrationU.S. cosmetic facility andproductRegistration and listingAustralia, listed medicineAUST L; efficacy not evaluated atlistingAuthorization or approvalU.S. food additiveFDA regulation issued on petitionU.S. drugNDA or BLA, or OTC monographconformityEU novel foodAuthorization and inclusion in theUnion listCanada natural health productProduct licence (NPN) and sitelicenceCommon mistake: calling a notification or a listing an approval. Status as of October 22, 2026.Premarket steps by jurisdictionNo approval before sale•U.S. dietary supplement: No FDA approval ofproducts or labeling•U.S. cosmetic: No FDA approval, except coloradditivesNotification•U.S. new dietary ingredient: At least 75 days beforemarketing; FDA does not approve notifications•U.S. GRAS notice: Voluntary today; a proposed rulewould require it•EU cosmetic: Electronic notification before sale•Japan, Foods with Function Claims: Notified beforesale; the claim is not reviewedListing or registration•U.S. cosmetic facility and product: Registration andlisting•Australia, listed medicine: AUST L; efficacy notevaluated at listingAuthorization or approval•U.S. food additive: FDA regulation issued on petition•U.S. drug: NDA or BLA, or OTC monographconformity•EU novel food: Authorization and inclusion in theUnion list•Canada natural health product: Product licence(NPN) and site licenceA notification or a listing is not an approval.
21 U.S.C. 350b, 348; 21 CFR 190.6, 170.205, Part 171; 91 FR 51834 (proposed); MoCRA; Regulation (EU) 2015/2283; Regulation (EC) No 1223/2009; SOR/2003-196; TGA; Consumer Affairs Agency of Japan. Detail in the table below.

Sources: Regulation (EU) 2015/2283, Art. 3(2)(a) and 6(2); Directive 2002/46/EC, Art. 2(a); European Commission food supplements page; Regulation (EC) No 1223/2009, Art. 4, 10 and 13; SOR/2003-196, ss. 4, 8 and 27; TGA, "Listed complementary medicines" (page dated May 4, 2018); Consumer Affairs Agency of Japan, Foods with Function Claims page. Detail on the international market access page.

Explanation, details and sources
Market-entry basics in the European Union, Canada, Australia and Japan.
Jurisdiction and categoryEntry requirementCommon mistake
European Union, novel foods (Regulation (EU) 2015/2283)A food not consumed to a significant degree in the EU before May 15, 1997 needs authorization and inclusion in the Union list.Assuming use outside the EU exempts it. The test is consumption within the EU.
European Union, food supplements (Directive 2002/46/EC)Vitamins and minerals are harmonized. Botanicals and other substances remain under national rules.Calling a botanical "EU-approved." No EU-wide botanical positive list exists.
European Union, cosmetics (Regulation (EC) No 1223/2009)An EU responsible person, a safety assessment with a product safety report, and electronic notification before sale.Calling the notification an approval.
Canada, natural health products (SOR/2003-196)A product licence (eight-digit NPN) before sale, and a site licence to manufacture, package, label or import.Selling under a U.S. supplement label without a product licence.
Australia, listed complementary medicinesListing (AUST L) with permitted low-risk ingredients and indications, made under GMP. The TGA does not evaluate efficacy at listing.Calling it "TGA approved." Listed medicines are listed, not registered.
Japan, Foods with Function ClaimsThe business notifies the Consumer Affairs Agency before sale, including the scientific basis. The government does not review the claim.Calling the claim government-approved.
Precise language

Eight distinctions every application page keeps

Eight pairs the application pages never treat as the same thingRegulatory terms
  • NDI notification acknowledged without objection≠FDA approval
  • GRAS conclusion for a food use≠Authorization for every use or market
  • Cosmetic registration and listing≠FDA approval of the product
  • Supplement cGMP (Part 111)≠Drug cGMP (Parts 210/211)
  • Structure/function notification≠FDA review of the claim
  • "Cosmeceutical"≠A legal category (FDA: no meaning under the law)
  • Traditional use≠Clinical proof
  • Activity in a cell or animal study≠Efficacy in people
Each pair restates the legal distinction cited in the market matrix above (21 U.S.C. 321, 343(r)(6); 21 CFR 101.93, 190.6; FDA cosmetic and GRAS pages); not legal advice.

Have an ingredient and a target market?

Describe the material, the intended use and the market. EUTECNIQ would reply with the questions a feasibility assessment would need to answer.

Start a conversationRegulatory overview