Fda 101 requirements for all product types
By Jake, founder · Published · Updated
fda 101 sets 12 requirements for every product type: 12 documentary (a record must be on file or a property absent), each carrying its primary-source citation below, last verified 2026-09-02.
The requirements
| Requirement | Category | Limit | Unit | Basis | Method | Status | Source |
|---|---|---|---|---|---|---|---|
| Statement of identity on the principal display panel, including the term “dietary supplement”statement_of_identity | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.3(a), (b), (g)verified 2026-09-02 |
| Net quantity of contents declared on the principal display panel, in the lower 30 percent of the panelnet_quantity_of_contents | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.105(a), (f)verified 2026-09-02 |
| Name and place of business of the manufacturer, packer or distributor, qualified where the firm is not the manufacturername_and_place_of_business | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.5(a), (c), (d)verified 2026-09-02 |
| Ingredient list by common or usual name, in descending order of predominance; dietary ingredients not named in the Supplement Facts panel appear in an “Other ingredients” statement beneath itingredient_list | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.4(a)(1), (g); 21 CFR 101.36(d)verified 2026-09-02 |
| A “Supplement Facts” panel bearing the nutrition labelling this product owessupplement_facts_panel | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.36(a), (b), (e)verified 2026-09-02 |
| Serving size and servings per container declared at the head of the Supplement Facts panelserving_size | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.36(b)(1)verified 2026-09-02 |
| Percent of Daily Value declared beside each nutrient for which a Daily Value has been establishedpercent_daily_value | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.36(b)(2)(iii)verified 2026-09-02 |
| Major food allergen declared, either in a “Contains” statement or parenthetically in the ingredient list, naming the food sourceallergen_declaration | label | on file | n/a | n/a | n/a | Mandatory | 21 U.S.C. 343(w) (FALCPA; FD&C Act §403(w))verified 2026-09-02 |
| Domestic address or domestic telephone number through which a report of a serious adverse event may be receivedadverse_event_contact | label | on file | n/a | n/a | n/a | Mandatory | 21 U.S.C. 343(y) (FD&C Act §403(y))verified 2026-09-02 |
| DSHEA disclaimer, printed with every structure/function claim on the labeldshea_disclaimer | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.93(b), (c)verified 2026-09-02 |
| Iron overdose warning on a solid oral dosage form containing iron or iron salts as an iron sourceiron_warning | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.17(e)(1), (e)(2)verified 2026-09-02 |
| Every required statement in English (Spanish in Puerto Rico), and where any other language appears on the label, every required statement repeated in that languageenglish_language_panel | label | on file | n/a | n/a | n/a | Mandatory | 21 CFR 101.15(c)(1), (c)(2)verified 2026-09-02 |
Advisory rows have no authoritative published number, so no value is invented for them. Per-day bases convert to a concentration limit only with a specific product's serving size, so no bare concentration is stated here.
Who is responsible
The brand owner, even when manufacturing is contracted out. A quality agreement can allocate who performs each task; it cannot transfer the responsibility for a correctly documented product that meets these requirements. In practice: the manufacturer runs the tests and holds the records, and the brand must be able to produce them, current and complete, when a platform, retailer, or inspector asks.
What a certificate of analysis (COA) needs to show to clear this review
A COA that clears review against this table has, at minimum:
- Laboratory identity with contact details and an accreditation reference: verifiers contact the issuing lab to confirm authenticity.
- Sample identification: product name and lot code matching the batch, with report, manufacture, and expiry dates that agree with each other.
- One row per requirement above: the analyte as tested, the numeric result with its unit, the method, and the lab's own specification. “Conforms” without a number is not a result a reviewer can accept.
- Detection limits on non-detects: “ND” only demonstrates compliance when the method's detection limit is at or below the required limit.
- Current date: verification programmes cap document age; an expired COA is unusable regardless of its content.
Common questions
- Who is responsible for meeting fda 101 requirements?
- The brand owner. Responsibility for individual tasks can be allocated to a contract manufacturer through a quality agreement, but the responsibility for a correctly documented product that meets these requirements cannot be contracted out. The manufacturer holds the records; the brand holds the liability.
- Where do these values come from?
- Every row carries its own primary-source citation and the date it was last verified (2026-09-02). Nothing on this page is estimated: values marked advisory have no authoritative published number, and no number is invented for them.
- What happens when a value changes?
- The dataset is versioned. When a set is superseded, this page regenerates with the new values and the update date changes, and customers with affected SKUs are told what changed and what is now needed.
- How do I know if my current documents meet these requirements?
- Upload them to the free gap check. It reads each document, compares every extracted value against this table, and names what is missing, with the citation, before any reviewer does.
Would your documents pass against this table?
The agent reads your supplement label or test report against these rows, compares every value, and names what is missing with the citation. Get in touch and we will take you through it on a document of yours.