Dietary supplements Proposed service Law checked October 22, 2026

A dietary supplement reaches the market without FDA approval, so its specification, safety basis and claim evidence carry the weight

For supplement brands, contract manufacturers and ingredient suppliers: the rules that apply, what FDA investigators cite most, the stages and tests EUTECNIQ proposes, and the documents a customer would receive.

Status. EUTECNIQ is in formation. It does not yet test, make or sell supplements or ingredients. The services below are proposals; legal statements summarize U.S. federal law as of October 22, 2026 and are not legal advice.

1,938Part 111 citations on FDA Form 483s in fiscal 2025, the most in any year from FY2014 (FDA data)

759of them under Subpart E, which holds specifications (§ 111.70) and identity and other tests (§ 111.75)

38CFR rule sets mapped for a supplement maker that imports, tests and uses endorsements

75 daysminimum notice to FDA before marketing a new dietary ingredient (21 CFR 190.6)

The journey

Three kinds of supplement business, one evidence file: the rules, stages and documents each would use

Choose a customer to follow its path from the rules to the documents it would receiveProposed service flow

Rules: eCFR, up to date as of October 21, 2026 (links open eCFR). Stages and documents are EUTECNIQ proposals; EUTECNIQ has no laboratory yet. Documents are described in the deliverables library.

Text version: customers, rules, stages and documents

Customers

Supplement brands Need an ingredient described precisely, a claim they can defend and supplier data their quality unit can verify.
Contract manufacturers Need ingredients that pass identity testing on receipt and run predictably in capsules, tablets, gummies or liquids.
Ingredient suppliers Need a specification, a safety basis and format data that set their material apart from a cheaper extract with the same name.

Rules that apply

21 CFR Part 111 Supplement CGMP: specifications, an identity test on each dietary ingredient, batch records.
21 CFR 101.36 and 101.93 Supplement Facts panel; structure/function notice and disclaimer.
21 CFR 190.6 New dietary ingredient notification at least 75 days before marketing.
21 CFR Part 117 Food CGMP and preventive controls for ingredient-only operations.
21 CFR Part 1, Subpart L Foreign supplier verification by importers; § 1.511 for supplements.

Platform stages and tests (proposed)

Identity and composition Orthogonal identity methods, marker assays, contaminant limits.
Specification and methods Limits for identity, purity, strength and composition; validated methods.
Format development Capsule, tablet, softgel, gummy, powder or liquid prototypes.
Stability program Studies in the final format and pack.
Safety basis and regulatory route History of use, exposure, the NDI decision.
Claim evidence review The substantiation file behind each structure/function statement.

What the customer would receive

Specification and test methods
Certificate-of-analysis template
Format feasibility report
Stability protocol and data
Regulatory route memo With, where needed, a draft NDI safety narrative for counsel's review.
Claim evidence summary

FDA states that "under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed." The firm's specification, safety basis and claim evidence are therefore what buyers and regulators examine. FDA, "Questions and Answers on Dietary Supplements," content current as of August 27, 2026.

Regulatory frame

DSHEA defines the category; Part 111, the NDI provisions and the labeling rules set the obligations

Thirty-eight CFR rule sets touch a supplement maker that imports botanicals, tests them and uses endorsementseCFR counts

Area is the number of sections in eCFR, a measure of length, not of importance. A "*" marks rules that apply only in the circumstances they name. Select a part to open it in eCFR.Applicability as mapped on the CFR atlas (try its part finder); section counts from the eCFR API, up to date as of October 21, 2026. Orientation, not legal advice.

Data table: every rule set in the treemap

CFR parts for a supplement maker: A U.S. supplement maker that imports botanicals, runs a laboratory and uses endorsements (eCFR section counts)
Rule set	What it covers	Agency group	eCFR sections	Level
21 CFR Part 111	Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. CGMP for anyone who makes, packages, labels or holds a dietary supplement, including identity tests of dietary ingredients.	FDA · 21 CFR	84	Applies
21 CFR Part 117	Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. CGMP, hazard analysis and preventive controls for human food, including dietary ingredients.	FDA · 21 CFR	61	Check
21 CFR Part 101	Food Labeling. Food labels: Supplement Facts (§ 101.36), health claims (§ 101.14) and structure/function statements (§ 101.93).	FDA · 21 CFR	50	Applies
21 CFR Part 1, Subpart R	Laboratory Accreditation for Analyses of Foods. Certain food tests, such as tests to support admission of an import, must be run by a LAAF-accredited laboratory.	FDA · 21 CFR	42	Check
21 CFR Part 58	Good Laboratory Practice for Nonclinical Laboratory Studies. Good laboratory practice for nonclinical studies supporting the FDA submissions listed in § 58.3; NDINs are not listed.	FDA · 21 CFR	36	Check
21 CFR Part 1, Subpart O	Sanitary Transportation of Human and Animal Food. Shippers, loaders, carriers and receivers keep food safe during transport; § 1.900(b) lists exempt operations.	FDA · 21 CFR	18	Check
21 CFR Part 1, Subpart L	Foreign Supplier Verification Programs for Food Importers. Importers verify that foreign suppliers produce food safely; § 1.511 modifies the program for dietary supplements.	FDA · 21 CFR	15	Applies
21 CFR Part 1, Subpart H	Registration of Food Facilities. Facilities that make, process, pack or hold food for U.S. consumption register with FDA and renew every two years.	FDA · 21 CFR	14	Applies
21 CFR Part 1, Subpart J	Establishment, Maintenance, and Availability of Records. Keep records of the immediate previous source and the immediate subsequent recipient of food.	FDA · 21 CFR	13	Applies
21 CFR Part 1, Subpart D	Electronic Import Entries. Lists the data FDA needs in each electronic customs entry of an FDA-regulated article.	FDA · 21 CFR	12	Applies
21 CFR Part 1, Subpart I	Prior Notice of Imported Food. Imported food needs prior notice to FDA: at least 2 hours before arrival by road, 4 by rail or air, 8 by water.	FDA · 21 CFR	10	Applies
21 CFR Part 7, Subpart C	Enforcement Policy. FDA's recall policy: recalls are voluntary actions, classified by health hazard, with a recall strategy.	FDA · 21 CFR	10	Check
21 CFR Part 11	Electronic Records; Electronic Signatures. Electronic records and signatures that meet FDA record rules must be trustworthy, reliable and equivalent to paper.	FDA · 21 CFR	10	Applies
21 CFR Part 1, Subpart E	Imports and Exports. FDA import sampling, hearings and relabeling of refused goods, and the records kept for certain exports.	FDA · 21 CFR	9	Check
21 CFR Part 190	Dietary Supplements. A new dietary ingredient needs notification to FDA at least 75 days before marketing, unless the food-supply exception applies.	FDA · 21 CFR	1	Check
19 CFR Part 141	Entry of Merchandise. Entry of merchandise: liability for duties, who may enter, invoices, duty deposits and release.	Trade: CBP, OFAC, FWS	69	Applies
19 CFR Part 113	CBP Bonds. Customs bonds that secure payment of duties and compliance with import rules.	Trade: CBP, OFAC, FWS	53	Applies
19 CFR Part 142	Entry Process. The entry process: entry documents, entry summary, immediate delivery and line release.	Trade: CBP, OFAC, FWS	40	Applies
19 CFR Part 134	Country of Origin Marking. Country-of-origin marking of imported articles or their containers (§ 134.11).	Trade: CBP, OFAC, FWS	33	Applies
19 CFR Part 177	Administrative Rulings. Binding advance rulings from CBP, for example on tariff classification.	Trade: CBP, OFAC, FWS	25	Check
19 CFR Part 152	Classification and Appraisement of Merchandise. Tariff classification and customs valuation of imported goods.	Trade: CBP, OFAC, FWS	21	Applies
19 CFR Part 12 (selected subject groups)	Special Classes of Merchandise. CBP rules for FDA-regulated goods (§ 12.1), plants, goods made with forced labor, and goods under sanctions.	Trade: CBP, OFAC, FWS	16	Applies
19 CFR Part 149	Importer Security Filing. Importer Security Filing for ocean cargo; core data due 24 hours before loading at the foreign port.	Trade: CBP, OFAC, FWS	6	Check
7 CFR Part 319	Foreign Quarantine Notices. Conditions for importing plants and plant products that can carry pests; they depend on the commodity and origin.	USDA · 7 CFR	128	Check
7 CFR Part 330	Federal Plant Pest Regulations; General; Plant Pests, Biological Control Organisms, and Associated Articles; Garbage. Restrictions on moving plant pests, biological control organisms and associated articles, and on garbage.	USDA · 7 CFR	24	Check
7 CFR Part 357	Control of Illegally Taken Plants. Lacey Act plant declaration (§ 357.3): required for tariff codes on APHIS's phase-in schedule; "plant" excludes common cultivars and common food crops (§ 357.2). CFR atlas	USDA · 7 CFR	4	Check
40 CFR Part 180	Tolerances and Exemptions for Pesticide Chemical Residues in Food. Tolerances and exemptions for pesticide residues in food; inert-ingredient exemptions are in §§ 180.910–180.960.	EPA · 40 CFR	755	Applies
40 CFR Part 261	Identification and Listing of Hazardous Waste. Which wastes are hazardous: ignitable wastes (§ 261.21) and listed wastes such as spent solvents (§ 261.31).	EPA · 40 CFR	83	Check
40 CFR Part 262	Standards Applicable to Generators of Hazardous Waste. Duties of hazardous-waste generators, scaled by generator category.	EPA · 40 CFR	66	Check
16 CFR Part 465	Rule on the Use of Consumer Reviews and Testimonials. Bans fake reviews and testimonials, buying sentiment-conditioned reviews, insider reviews and review suppression.	FTC and CPSC · 16 CFR	8	Applies
16 CFR Part 1700	Poison Prevention Packaging. Child-resistant packaging, including supplements with 250 mg or more elemental iron per package (§ 1700.14(a)(13)).	FTC and CPSC · 16 CFR	8	Check
16 CFR Part 255	Guides Concerning Use of Endorsements and Testimonials in Advertising. How the FTC applies Section 5 of the FTC Act to endorsements and testimonials in advertising.	FTC and CPSC · 16 CFR	7	Applies
29 CFR 1910.1200	Hazard communication.. Hazard communication: hazard classification, labels, safety data sheets and worker training.	OSHA · 29 CFR	1	Applies
29 CFR 1910.132	General requirements.. Workplace hazard assessment and personal protective equipment.	OSHA · 29 CFR	1	Applies
29 CFR 1910.134	Respiratory protection.. Respiratory protection programs where respirators are needed.	OSHA · 29 CFR	1	Check
29 CFR 1910.147	The control of hazardous energy (lockout/tagout).. Lockout/tagout of hazardous energy during servicing and maintenance of machines.	OSHA · 29 CFR	1	Check
29 CFR 1910.1000	Air contaminants.. Permissible exposure limits for air contaminants, such as solvent vapors.	OSHA · 29 CFR	1	Check
29 CFR 1910.1450	Occupational exposure to hazardous chemicals in laboratories.. Chemical hygiene plan and exposure controls for laboratory use of hazardous chemicals.	OSHA · 29 CFR	1	Applies
Total	38 rule sets; 20 apply, the rest apply only in the circumstances they name		1737	1213 in rules that apply

Five federal obligations follow a botanical supplement from definition to marketStatute, regulation, final guidance

21 U.S.C. 321(ff) (DSHEA, Pub. L. 103-417, October 25, 1994), 350b; 21 CFR 111.1, 111.70(e), 111.75(a)(1)(i), 190.6, 101.36, 101.4(h); FDA final NDI guidance, docket FDA-2025-D-6501 (October 19, 2026); FDA Q&A on dietary supplements (August 27, 2026); FDA, Food Allergies (March 11, 2026).

Text version of the regulatory frame

Definition Statute: A product "intended to supplement the diet" containing dietary ingredients, including "an herb or other botanical" and "a concentrate, metabolite, constituent, extract, or combination" of such ingredients. It must be intended for ingestion, not represented as a conventional food or a sole item of a meal, and labeled as a dietary supplement. 21 U.S.C. 321(ff), added by DSHEA, Pub. L. 103-417 (October 25, 1994).
Premarket review Statute: No FDA approval of the product or its labeling. The firm is responsible for safety and lawful labeling, and FDA acts after marketing. FDA Q&A on dietary supplements (August 27, 2026).
Manufacturing Final rule: 21 CFR Part 111 applies to anyone who manufactures, packages, labels or holds a dietary supplement. It requires specifications for identity, purity, strength and composition and limits on contamination, and at least one appropriate identity test on each dietary ingredient before use. Part 111 is not drug cGMP. 21 CFR 111.1, 111.70(e), 111.75(a)(1)(i).
New dietary ingredients Statute Final guidance: An ingredient not marketed in the United States before October 15, 1994 needs a notification to FDA at least 75 days before marketing, unless the supplement contains only dietary ingredients present in the food supply as an article used for food in a form not chemically altered. FDA finalized guidance on the identity and safety content of notifications on October 19, 2026. "FDA does not approve NDI notifications." 21 U.S.C. 350b; 21 CFR 190.6; FDA final guidance, docket FDA-2025-D-6501.
Labeling Final rule: A Supplement Facts panel. Botanicals are named as in Herbs of Commerce (1992) and listed with the part of the plant used. Major food allergen labeling, including sesame since January 1, 2023, applies to supplements. 21 CFR 101.36, 101.4(h); FDA, "Food Allergies" (March 11, 2026).

Inspection record

FDA investigators cite production and process controls most, and the count reached 1,938 citations in fiscal year 2025

Part 111 citations on FDA Form 483s by subpart, fiscal years 2014 to 2025FDA data

Subpart E holds § 111.70 (specifications) and § 111.75 (identity and other tests), the two most-cited sections every year. A citation is an investigator's observation, not a final agency finding; counts are not rates, because the number of inspections changes from year to year. Select a column heading to sort.FDA, Inspection observations spreadsheets, Foods tab, FY2014–FY2025 (page content current as of December 16, 2025; files read October 24, 2026); Form 483s from FDA's electronic inspection tools only. Counted by EUTECNIQ by section number.

Data table: citations by subpart and fiscal year

Form 483 citations under 21 CFR Part 111 by subpart and fiscal year (FDA inspection observations, Foods tab)
	FY2014	FY2015	FY2016	FY2017	FY2018	FY2019	FY2020	FY2021	FY2022	FY2023	FY2024	FY2025
Subpart B: Personnel	53	45	55	61	46	44	26	21	28	38	37	53
Subpart C: Physical plant and grounds	72	81	75	90	71	63	24	17	35	27	53	67
Subpart D: Equipment and utensils	85	63	66	83	72	82	42	34	45	46	69	75
Subpart E: Production and process control system	470	385	529	617	545	490	290	260	459	423	614	759
Subpart F: Quality control	160	154	181	197	184	198	112	120	179	169	205	216
Subpart G: Components, packaging and labels received	42	50	57	61	66	45	28	16	18	37	36	43
Subpart H: Master manufacturing record	151	139	140	161	128	117	91	45	101	92	156	188
Subpart I: Batch production record	157	130	161	151	151	116	115	58	100	97	153	163
Subpart J: Laboratory operations	29	21	31	29	19	28	6	13	33	23	33	77
Subpart K: Manufacturing operations	35	24	32	27	26	21	7	10	21	16	30	49
Subpart L: Packaging and labeling operations	44	32	55	40	54	41	29	20	37	29	38	37
Subpart M: Holding and distributing	89	55	86	119	101	76	41	34	63	72	63	72
Subpart N: Returned dietary supplements	58	44	56	84	79	50	21	19	42	53	48	65
Subpart O: Product complaints	96	63	88	112	90	71	35	32	50	48	45	66
Subpart P: Records and recordkeeping	8	8	13	10	8	2	4	5	7	3	3	8
All of Part 111	1,549	1,294	1,625	1,842	1,640	1,444	871	704	1,218	1,173	1,583	1,938

Process controls, quality control and batch records (Subparts E, F, H and I) drew 1,326 of the 1,938 fiscal 2025 citations, 68%.

Formats

Each format sets its own limit on dose, stability and taste

Six supplement formats and the constraint each puts on a botanical extractEUTECNIQ planning view

General formulation engineering. Liquids: 21 U.S.C. 321(ff)(2)(B); FDA, "Distinguishing Liquid Dietary Supplements from Beverages" (final guidance, January 2014, docket FDA-2009-D-0542).

Cross-section of a spherical microcapsule: an oil core holding the active, surrounded by a wall of thickness delta. Two smaller sketches contrast a reservoir capsule with one core and a matrix particle with many small droplets embedded in the wall material. Beside them, the core volume fraction equation and the steady-state diffusion equation for a spherical shell, with a computed curve showing that a thicker wall slows release but leaves less room for the core. — Steady-state diffusion through a spherical shell: Crank J. The Mathematics of Diffusion. 2nd ed. Clarendon Press; 1975. Reservoir and matrix types: Gharsallaoui A, Roudaut G, Chambin O, Voilley A. Food Res Int 2007;40:1107–1121. Worked values are arithmetic. Generated illustration, EUTECNIQ. Full-size SVG

Show the table (6 rows): Supplement formats with what each suits, the main constraint for botanicals, what to watch

Supplement formats with what each suits, the main constraint for botanicals, what to watch in stability, and the work EUTECNIQ proposes.
Format	Suits	Main constraint for botanicals	Watch in stability	Proposed EUTECNIQ work
Hard capsules gelatin or HPMC shells	Dry extracts, powders, beadlets.	Fill volume caps the dose per capsule; low-density or sticky extracts fill poorly.	Moisture uptake; shells turn brittle when dry and soft when humid.	Powder flow and density, excipient compatibility, fill-weight trials.
Tablets	Compressible extracts at moderate doses.	High extract loads compact poorly and may need binders that slow disintegration.	Hardness drift, moisture, slower disintegration with age.	Compaction and disintegration studies, coating selection.
Softgels	Oils, oleoresins and lipid-based fills.	The fill must not attack the shell; water and some solvents migrate.	Oxidation, fill-shell migration, shell aging that slows opening.	Fill design, antioxidant choice, shell compatibility tests.
Gummies	Low-dose, palatable actives.	Cooking heat, the acid needed to set pectin gels, and strong flavors limit the active load.	Active loss during cooking, moisture migration, piece-to-piece uniformity.	Heat-stability screening, taste masking, an assay that recovers the active from the gel.
Powders stick packs, tubs	Higher doses mixed into water or food.	Wetting and dispersion in water, taste, caking.	Caking from moisture, color change, oxidation.	Spray-dried or agglomerated forms; wettability and flow tests.
Liquids and shots	Soluble or emulsified actives at measured doses.	Solubility versus dispersibility, preservation and pH. A liquid represented as a conventional food is not a supplement.	Creaming or sediment, microbial growth, degradation in solution.	Solubilization or emulsion design, preservative system, real-time stability.

Explanation, details and sources

A botanical extract that works in a capsule may fail in a gummy or a shot. The format is chosen early because it changes the specification and the stability program. Emulsion physics is on the emulsions page; drying on the drying and particle engineering page.

Claims

A structure/function claim is lawful only with notification, the disclaimer and evidence behind it

Four steps make a structure/function claim lawful; a disease endpoint needs an IND even to studyStatute and regulation

21 U.S.C. 343(r)(6); 21 CFR 101.93(a) and (f); FDA, Substantiation for Dietary Supplement Claims (final guidance, January 2009, FDA-2004-D-0303); FTC, Health Products Compliance Guidance (December 20, 2022); FDA, IND guidance (September 2013), Section VI.D.1.

Text version of the four steps and the study examples

Substantiate before use.The firm must have substantiation that the statement is truthful and not misleading. FDA's 2009 guidance applies a standard consistent with the FTC's. The FTC calls its standard "competent and reliable scientific evidence" and says health benefits generally "will need to be in the form of randomized, controlled human clinical testing."
Notify FDA.No later than 30 days after first marketing, with the claim text, the ingredient and the product name, signed by a person who certifies the firm has substantiation.
Carry the disclaimer.Exactly as quoted on the left.
Stay out of disease claims.A supplement with a disease claim is regulated as a drug, unless the claim is an authorized health claim for which the product qualifies.

21 U.S.C. 343(r)(6); 21 CFR 101.93(a) and (f); FDA, "Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6)" (final guidance, January 2009, docket FDA-2004-D-0303); FTC, Health Products Compliance Guidance (December 20, 2022).

FDA examples of structure/function endpoints and disease endpoints in human studies of dietary supplements.
FDA example	Kind of endpoint	IND needed for a study?
Guarana and maximal oxygen uptake	Structure or function	No
Fiber and bowel regularity	Structure or function	No
Preventing osteoporosis	Disease	Yes, under 21 CFR Part 312
Treating chronic diarrhea or constipation	Disease	Yes, under 21 CFR Part 312

How the disclaimer attaches to a claimLayout illustration

[Product name]

Dietary supplement

[A statement about a structure or function of the body]^†

^†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.

The disclaimer sits next to the claim or is linked to it by a symbol; it appears on each panel bearing a claim, boxed when not adjacent, in boldface type at least 1/16 inch high. With more than one claim the plural form is used: "These statements have not been evaluated…". 21 CFR 101.93(c) to (e). Text of the disclaimer quoted from 101.93(c).

FDA, "Investigational New Drug Applications (INDs): Determining Whether Human Research Studies Can Be Conducted Without an IND" (September 2013), Section VI.D.1, which is not stayed. More on the clinical research page.

Explanation, details and sources

A structure/function statement describes how a nutrient or dietary ingredient affects the structure or function of the body. It "may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases."

Differentiation

Buyers pay for an ingredient when its differences can be measured and defended

Each step is something a customer's quality unit or a reviewer can check.

Seven measurable differences, from what every ingredient needs to what few achieveEUTECNIQ view

A commercial judgment, not a regulatory requirement.

Text version of the seven steps

Verified identitySpecies, plant part and, where it matters, chemotype, confirmed by orthogonal methods.
A defined compositionA specification with a repeatable identity method and limits on markers and contaminants.
Lot-to-lot consistencyData across lots, not a single certificate of analysis.
A documented safety basisFor the intended daily amount and the intended users.
A form that works in the formatFlow, dispersion, taste and stability shown in the target product.
Human evidence for a specific claimGenerated with this ingredient, at this dose, in the relevant population.
A protectable process or formulationSomething a competitor cannot copy by buying the same plant.

What EUTECNIQ proposes

Laboratory and development work in house; studies, manufacturing and legal review with partners

Laboratory and development work in house; studies, manufacturing and legal review with partnersProposed External partners

EUTECNIQ proposal. See the facilities roadmap and the planned quality system.

Text version of the division of work

In-house, once the laboratory exists Proposal

Identity and composition testing of candidate ingredients.
Specification and test-method development.
Prototype formulations in the formats above.
Stability program design and testing.
Regulatory route assessment and support for NDI dossier preparation.
Scientific review of the evidence behind a proposed claim.

With qualified partners External partner

Toxicology studies at contract research organizations.
Human studies at clinical sites with IRB oversight.
Commercial manufacturing at Part 111 contract manufacturers, or later in EUTECNIQ's planned facility.
Legal review of labels and claims by regulatory counsel.

See the facilities roadmap and the planned quality system.

Evidence levels

Five levels of evidence, and what each can support on a supplement label

Identity and safety evidence are required; human outcome data are what a benefit claim needsRoles per regulation and FTC guidance

21 CFR 111.70, 111.75, 190.6; FTC, Health Products Compliance Guidance (2022).

Text version of the evidence levels

Evidence levels with what each shows, what it cannot show, and its role for dietary supplements.
Level	What it shows	What it cannot show	Role for supplements
1 Identity and composition	The material is what the label says, at a defined strength.	Safety or benefit.	Required: Part 111 specifications and identity testing.
2 Safety	The ingredient is safe at the intended use and exposure.	Benefit.	Required: a new dietary ingredient needs a safety basis notified to FDA; every supplement must not be adulterated.
3 Biological activity	A plausible mechanism, in cells or animals.	An effect in people.	Supports the rationale; on its own it does not substantiate a benefit claim.
4 Exposure	How much reaches the gut lumen or the blood.	Benefit, or safety at the higher exposure.	Guides formulation; a statement about absorption needs data on the product itself in people.
5 Human outcome	The claimed effect in people, under controlled conditions.	Effects outside the studied product, dose and population.	Generally expected for a structure/function benefit claim.

Sources for the supplement column: 21 CFR 111.70, 111.75, 190.6; FTC, Health Products Compliance Guidance (2022). Levels 3 to 5 follow the dose-to-outcome chain on the ingredient development page.

Building or upgrading a supplement ingredient?

Share the ingredient, the format and the claim you have in mind. The first reply would list the evidence gaps and the order in which to close them.

Discuss a supplement project NDIN pathway