How ArcheSync sources and maintains regulatory checks

This page explains which sources support ArcheSync's labeling checks, how each finding connects to its source, and how unclear cases are reported. Read it alongside the coverage limits for your product category. A citation makes a finding traceable; it does not by itself establish that every applicable requirement has been checked.

Source hierarchy.

When sources disagree, the higher one controls. Guidance never overrides a statute or regulation.

Statutes
The Federal Food, Drug, and Cosmetic Act and related US Code sections, such as the allergen labeling provisions.
e.g. 21 U.S.C. 343(w)
Regulations
Title 21 of the Code of Federal Regulations, read from the current eCFR text.
e.g. 21 CFR 101.9
Final FDA guidance
Used to interpret a requirement and always labeled as guidance in a finding.
e.g. FDA allergen Q&A, Edition 5
Federal Register actions
Revocations and rule changes with their effective and compliance dates.
e.g. 89 FR 55040
Draft or proposed material
Never treated as a requirement.
Labeled separately

What the food rule set covers.

The current rule set for food, supplement-routing and beverage labels has 105 checks, each built on one primary citation. Source text was retrieved between 2026-09-29 and 2026-10-02. Cosmetic checks are not in the rule set yet.

Computed from the rule set at build time. Example citations are the first distinct sources in each group.
Area	Checks	Scope	Example citations
Category-specific rules	25	Standards of identity, juice, water, product-type redirects	21 CFR 108.25(c); 27 CFR 4.10; 21 U.S.C. 321(ff)(2)
Claims	19	Nutrient content, health, structure/function and implied claims	21 CFR 101.54(g); 21 CFR 101.60(b); 21 U.S.C. 321(g)(1)
Ingredients and additives	18	Color additives, preservatives, sweeteners, revoked uses	21 CFR 172.185; 89 FR 55040; 21 CFR 182.1180
Mandatory label elements	13	Identity, ingredients, panels, language, business line	7 CFR 66.100; 19 CFR 134.11; 21 CFR 101.3
Nutrition labeling	12	Nutrition Facts content, format, serving size, exemptions	21 CFR 101.9(c)(1)(i); 21 CFR 101.9(d)(7)(ii); 21 CFR 101.9(j)
Major food allergens	6	Declarations, species, exemptions, advisory statements	21 U.S.C. 321(qq)(2); 21 U.S.C. 343(w)(1); 21 U.S.C. 343(w)
Import and registration context	6	Facility registration, prior notice and related context; mostly needs information beyond the artwork	21 CFR 1.225(a); 21 CFR 1.502; 21 CFR 117.1
Packaging and net quantity	6	Net contents, multipacks, slack fill, food-contact notes	21 CFR 174.5(d); 21 CFR 101.7(s); 15 U.S.C. 1453(a)(2)

Status definitions.

Each finding gets exactly one status. An unreadable field never becomes No issue; a check that could not be completed is reported as Review.

No issue
The supported check did not identify an issue in the available evidence.
Review
A conclusion requires clarification, additional evidence, or human interpretation.
Flag
The available evidence indicates a potential issue against a cited requirement.
Info
Relevant explanatory information. Not an assertion of a violation or a pass.

From evidence to provision.

A traceable example from the sample report, including what the software could not determine.

Evidence
Soup base lists DRIED BONITO EXTRACT; the label reads "CONTAINS: WHEAT, SOY, MILK, EGG."
noodle_cup_label.pdf
Check
Does the "Contains" statement name the food source of every major food allergen in the ingredients?
Allergen declaration
Provision
Major food allergen labeling, with FDA guidance on complete "Contains" statements.
FD&C Act §403(w)(1); FDA allergen Q&A D.6
FlagFinding
"Contains" statement omits Fish (bonito).
Status
Not determined
Whether other allergens enter through shared equipment, which artwork cannot show.
Outside the artwork

Versions, updates and corrections.

Rule-set version
Each report records the rule-set version it was produced with. [TBD: confirm version stamp on reports (WO-05)]
Reproducibility
Update workflow
[TBD: source monitoring cadence, impact triage and release steps; publish only once the practice exists]
Updates
Change validation
[TBD: re-run of affected demonstration cases before a rule change is released]
Validation
Review status
The checks were drafted and cross-checked against source text but have not yet been individually reviewed by a qualified specialist. That is one reason ArcheSync is in Beta.
Beta
Content owner
[TBD: name of the person responsible for regulatory content, and qualified reviewers]
Responsibility
Corrections
Report an error: [TBD: corrections contact route]. Substantive corrections will be logged on this page.
Corrections

Known limits.

What a label review cannot settle on its own: unreadable or missing panels; type sizes and placement that depend on package dimensions; classification questions (food, beverage or supplement); formulation, nutrient and substantiation evidence; and requirements outside the current rule set, including all cosmetic checks until cosmetic review opens.

Questions

Which sources are used?

Statutes and regulations first: the FD&C Act and other US Code sections, and Title 21 of the Code of Federal Regulations (with a few provisions from Titles 7, 9, 19 and 27, and one state law). FDA guidance is used to interpret them and is labeled as guidance. Every check names its source.

How are changes reviewed?

[TBD: the operating update workflow (monitoring cadence, review and release steps)]

How are uncertain or unsupported checks handled?

They are reported as Review, never as No issue. That covers text the software could not read, checks that need information beyond the artwork, and checks that are not automated yet.

Review your label before your next artwork revision.

Upload a PDF or image. Findings come back with the citation attached.

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Independent software. Not affiliated with FDA.