A 10-year-tenure-analog regulatory professional, on call. Three workflows, no more. Every output cited to a primary source. Every output gated on a named human. Every output signed.
Discipline beats feature surface. Each workflow has a defined input envelope, a defined deliverable, an audit-footer schema, and an eval gate.
Line-by-line conformance review against 21 CFR Part 101. FALCPA + sesame allergen check. Nutrient-content and health-claim review. Findings tagged PASS / WARNING / BLOCKER with cites and a print-readiness punch list.
Structure/function vs. health vs. drug classification under DSHEA. Required disclaimers. Evidence sufficiency analysis at the labeled dose. Defensible rewrites you can ship today.
State-by-state delta vs. CA (Prop 65 + AB 418), NY, WA, IL, TX. Naturally-occurring exemption analysis with the three-prong test spelled out. Risk matrix + recommended warning approach.
The findings table is the headline. The audit footer is the legal artifact.
| # | Finding | Severity | Cite | Recommendation |
|---|---|---|---|---|
| 1 | "Heart healthy" is an unauthorized implied health claim. | BLOCKER | 21 CFR §101.14 | Remove, or replace with a permissible nutrient-content claim if numeric thresholds met. |
| 2 | "High in fiber" — product reports 3g (11% DV); requires ≥20% DV per RACC. | BLOCKER | §101.54(b) | Reformulate to ≥5g, or downgrade to "Good source of fiber" (≥10% DV). |
| 3 | No CONTAINS: allergen statement; product contains almonds. | BLOCKER | FALCPA / §101.22 | Add CONTAINS: TREE NUTS (ALMONDS). adjacent to ingredient statement. |
| 4 | "Natural Vanilla Flavor" — verify backing per §101.22(a)(3). | WARN | §101.22 | Confirm flavor system is natural under FDA definition; keep supplier docs. |
| 5 | Responsible-party statement present; city/state acceptable. | PASS | §101.5 | — |
{
"agent": "Regulatory Affairs Specialist",
"agent_version": "v1.0",
"model": "claude-opus-4-7",
"run_id": "<uuid>",
"customer": "<tenant id>",
"inputs_hash": "sha256:<hash>",
"tools_used": ["parse_label", "lookup_cfr", "..."],
"citations": [
{ "source": "21 CFR §101.14", "accessed": "2026-06-01" }
],
"human_checkpoints_required": [
"marketing_claim_signoff",
"vp_quality_signoff_before_print"
],
"confidence": "high",
"started_at": "2026-06-01T22:30:00Z",
"completed_at": "2026-06-01T22:32:14Z"
}The agent orchestrates; tools never call other tools. The call graph is reviewable in every audit log.
Extracts structured fields (ingredient statement, allergens, net qty, serving size, claims) from label text or image.
Current text of a 21 CFR Part 101 section or related federal rule (FALCPA, FSMA, DSHEA). Daily delta-crawl in production.
State-level food law (Prop 65, AB 418, NY S213, IL HB 2438, etc.). State-by-state pipeline in production.
Given ingredients + processing, returns Prop 65 chemicals likely present, safe-harbor thresholds, and the naturally-occurring exemption analysis.
Deterministic reconciliation of ingredient order, allergen disclosure, and quantitative reps. Audit-friendly.
Searches FDA health-claim approvals, EFSA opinions, and PubMed for evidence supporting a claim at a given dose.
Not per-seat SaaS. Anchored to 10–25% of a loaded FTE (~$110K–$170K/yr) for a defined deliverable slice.
10 tasks/mo · one workflow · hand-held setup · 2-day SLA.
30 tasks/mo · all three workflows · 2 users · 1-day SLA.
100 tasks/mo · priority queue · Slack channel · same-day SLA.
Codex Reg + Codex Quality, shared per-tenant KB.
Claude (Anthropic). We are a Claude-powered wrapper purpose-built for food and beverage regulatory work. We do not fine-tune in v1. The defensible work is the per-tenant knowledge base, the eval suite, and the workflow contracts.
No. Codex Reg has a defined scope, a tool belt, a signed audit log, and a human checkpoint on every regulated output. The deliverable is a reviewable artifact — a label review with citations, a claims memo, a state-diff matrix.
Per-tenant directories and retrieval from Day 1. Your content is never used to train a shared model and never appears in another customer's responses. We can sign a DPA.
No. Codex Reg produces regulatory analysis with primary-source citations. Anything that crosses into legal advice is flagged and routed to outside counsel. Drug claims trigger an automatic escalation.
Every BLOCKER finding and every claim rewrite is gated on a named human checkpoint in your workflow. The audit footer records who acknowledged what, when. We carry E&O insurance from Month 4 of any paid engagement, and the pilot contract caps liability.
Those are horizontal compliance platforms. F&B Codex sells named role agents that drop into your org chart at FTE-fraction pricing. Different product, different sales motion, different buyer.