Review desk · signal room

AllergentrueFdaScope

Executive summary AllergenTruth Clear is a done-for-you allergen-declaration truth service for U.S. FDA-regulated packaged-food brands and co-packers. The customer does not operate software; they receive a SKU-level Allergen Truth Binder that reconciles the bill of materials, supplier allergen statements, and draft label artwork against FALCPA/FASTER Big-9 requirements, with a print-go / print-hold decision memo released by a human food-label specialist. 34% FDA recalls undeclared allergens (2025) 57 Q1 2026 undeclared-allergen FDA events ~$10M Avg direct recall cost (GMA/industry) $349–$799 Per-SKU Truth Pack 55%+ Gross-margin path by day 90 Beachhead: independent specialty CPG brands and co-packers with 5–80 SKUs and no dedicated regulatory labeling FTE.

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Who this is for

A precise operating owner, not a generic audience.

Responsible buyer

FDA-regulated packaged-food brand or co-packer, 5–80 SKUs, $2M–$80M revenue, no full-time labeling regulatory specialist. Economic buyer: Founder/CEO, VP Quality/Food Safety, or Head of R&D/Regulatory. Champion: QA manager, PCQI, or brand ops lead who owns label artwork freeze.

Cost of the gap

Painful problem Undeclared allergens drove ~34% of FDA food recalls in 2025 and 57 FDA events in Q1 2026 alone. Label errors (mostly undeclared allergens) were estimated to cost the industry ~$1.92B in 2024 direct recall expenses (Loftware/FDA Enforcement Report analysis using ~$10M average direct cost). Small brands still reconcile Excel BOMs, PDF supplier sheets, and Illustrator proofs manually — and miss sesame/sub-ingredients/Contains completeness.

Outcome

The outcome we sell Print-release-ready allergen declaration truth for each SKU — a specialist-released Allergen Truth Binder stating go or hold, with a Big-9 matrix, Contains/ingredient reconciliation, defect list, and evidence citations.

Decision rule

Proceed only when the source record, service boundary, responsible reviewer, and release criteria can be named before work begins.

Method

The work moves through visible states.

  1. ScopeService delivery workflow Sales: Gap Scan → Truth Pack quote.
  2. CollectKickoff checklist: BOM version, supplier statement dates, artwork PDF, prior Contains language.
  3. NormalizeAI draft matrix + defects within 24h.
  4. ValidateSpecialist review same day or next.
  5. ResolveClient Q&A on holds (async).
  6. ReviewFinal binder delivered; optional Continuity Desk enrolls SKUs for change watch.
  7. ReleaseRelease the final pack with an audit trail and correction path.

Engagement

Buy the reviewed outcome, with boundaries written down.

Pricing evidence and proposed pricing Offer Price Unit Free Allergen Gap Scan $0 1 SKU (≤15 ingredients) Allergen Truth Pack $349–$799 Per SKU (complex / multi-component $799–$1,200) Portfolio Truth Pack $2,500–$8,000 10–25 SKUs Change-Control Continuity Desk $499–$1,999/mo Up to N SKUs monitored; overage $99–$199/SKU change Retailer/Audit Evidence Export $250–$600 Per request pack Never hourly. Never contingency on avoided recall value (creates misaligned liability optics).

Release package

  • The outcome we sell Print-release-ready allergen declaration truth for each SKU
  • a specialist-released Allergen Truth Binder stating go or hold, with a Big-9 matrix, Contains/ingredient reconciliation, defect list, and evidence citations.
  • An exception queue with owner, next action, due state, and resolution evidence.
  • A human-released operating pack with version history and a correction channel.

Proof standard

Operating evidence: No verified cycle-time result is published yet. The first result will be calculated from accepted intake through qualified-human release.

Client evidence: No client identity or case narrative is published. A reference may appear only after written permission and factual review.

Volume evidence: No completed-client count is claimed. Counts will be published only after the delivery ledger and provider records reconcile.

Evidence room

Authority comes from traceable sources, not decorative claims.

Open the full canonical blueprint dossier

Service boundary

Automation prepares. A qualified human releases.

AllergentrueFdaScope is an operational documentation and processing service operated by Your Deputy, Obuke LLC. It is not a law firm and does not provide legal, tax, medical, financial, or other licensed professional advice. Consumer and personal debt matters are not accepted. The client retains its licensed professionals and decision authority. Automation may organize and check records, but a qualified human must review and release every client deliverable. Minimum-necessary data handling and professional review apply.

  • Unsupported facts remain unresolved, never inferred into a client deliverable.
  • Jurisdiction-specific or licensed questions are routed to the client's professional.
  • Every correction retains the source, reviewer, version, and reason for change.

Questions

Know the limits before intake.

Is this legal or professional advice?

No. This is bounded operational documentation and processing support. Licensed judgment remains with the client and its professionals.

Does automation make the final decision?

No. It can organize records, run declared checks, and prepare an exception queue. A qualified human reviews and releases every deliverable.

Is a client portal or CRM already active?

This public site does not claim an active portal integration. Portal access is provisioned only after the relevant backend is configured and independently verified.

What happens when evidence conflicts?

The item is placed in an exception state with its sources and owner. It is not silently resolved or presented as verified.

Fit diagnostic

Send enough context to scope the next conversation—no sensitive files.

Do not submit protected health information, personal financial data, credentials, or confidential client records through this public page.