MoCRA checklist, row by row

Every row of a product's MoCRA checklist, in the order the checklist shows them, with the regulation's full wording, who does the work, when it applies and each way to record it. The checklist itself keeps only the row's name, its citation and the buttons to record it.

INFO: MoCRA names no particular document — it requires that your product's safety be adequately substantiated and that you hold the records supporting it. Facility registration and product listing are tracked separately.

Adequate substantiation of safety (21 U.S.C. 364d(a), for each product). Records supporting that the product's safety is adequately substantiated — tests, studies, research, or other evidence that qualified experts would consider sufficient. The statute names no particular document.

How it is met:

• Substantiation on file — upload one of: Safety Assessment, Cosmetic Product Safety Report (CPSR), Toxicology Report.

Source: 21 U.S.C. 364d(a) — Pub. L. 117-328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5854 (21 U.S.C. 364d; FD&C Act §608). US Code 2024 Main Edition. Read 2026-08-18.

Adverse event records (6 years) (21 U.S.C. 364a(e)(1), for each product). Records of every adverse event report you receive for this product, kept six years — three if you are a small business. Required only once a report has actually been received.

When it does not apply (21 U.S.C. 364a(e)(1)) — once you record that, the row says: “Aleph does not track adverse events. If you receive a report of a serious adverse event for this product, it must be reported to FDA no later than 15 business days after you receive it (21 U.S.C. 364a).”

How it is met:

• Your recorded confirmation — Confirm you hold records of the adverse event reports received for this product.

Source: 21 U.S.C. 364a(e)(1) — Pub. L. 117-328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5854 (21 U.S.C. 364d; FD&C Act §608). US Code 2024 Main Edition. Read 2026-08-18.

Ingredient declaration in descending order of predominance (21 CFR 701.3(a), for each product). The label must declare each ingredient's name in descending order of predominance. Naming follows a fixed hierarchy: the name FDA has established for cosmetic labeling under §701.30, or absent that, the name from the compendia named in §701.3(c) (the INCI/CTFA Cosmetic Ingredient Dictionary is the first of these), a consumer-recognized name, or a chemical/technical description as a last resort. Fragrance or flavor may be listed generically as "fragrance" or "flavor" UNLESS it serves a second labeled function, in which case it must also be named for that function. An ingredient granted trade-secret exemption under §720.8(a) may be listed as "and other ingredients" instead of by name.

How it is met:

• Ingredient declaration confirmed — Confirm the label lists every ingredient by name, in descending order of predominance, using the required naming hierarchy (or the trade-secret "and other ingredients" phrase where FDA has granted that exemption).

Source: 21 CFR 701.3(a) — 39 FR 10056, Mar. 15, 1974, as last amended at 81 FR 49897, July 29, 2016 — confirmed against eCFR's own citation history at ecfr.gov, cross-read against Cornell LII's current text.. Read 2026-08-28.

Ingredient declaration is legible and correctly placed (21 CFR 701.3(b), for each product). The ingredient declaration must appear on an appropriate information panel, in letters no smaller than 1/16 inch, without being obscured by design elements or crowding — prominent and conspicuous enough that an ordinary buyer is likely to read it under normal purchase conditions.

How it is met:

• Placement and legibility confirmed — Confirm the ingredient declaration appears on an information panel, in letters at least 1/16 inch tall, without obscuring design or crowding.

Source: 21 CFR 701.3(b) — 39 FR 10056, Mar. 15, 1974, as last amended at 81 FR 49897, July 29, 2016 — confirmed against eCFR's own citation history at ecfr.gov, cross-read against Cornell LII's current text.. Read 2026-08-28.

Net quantity of contents, stated correctly (15 U.S.C. 1453(a)(2), for each product). The label must separately and accurately state the net quantity of contents (weight/mass, measure, or count) on the principal display panel, in both customary inch/pound units and SI metric units (limited exceptions apply). This is a Fair Packaging and Labeling Act duty, not a MoCRA one — MoCRA does not require it, and FDA enforces this one for cosmetics alongside MoCRA, not instead of it.

How it is met:

• Net quantity statement confirmed — Confirm the label states the net quantity of contents on the principal display panel, in both customary and metric units.

Source: 15 U.S.C. 1453(a)(2) — Pub. L. 89-755, §4, Nov. 3, 1966, 80 Stat. 1297, as last amended by Pub. L. 102-329, §§1, 3, Aug. 3, 1992, 106 Stat. 847-848 — read directly at Cornell LII's Legal Information Institute.. Read 2026-08-28.

Not required, but worth holding

• Lab Report — Test results are one of the evidence types §608 contemplates.
• Certificate of Analysis (COA) — Supports substantiation for a specific batch.

INFO: This lists what the checklist records. It is not legal advice, and a row recorded in Aleph is not a finding that the product complies.