21 CFR 101 Every regulation, on every pack — verified, not assumed

The most rigorous label clearance a brand can get.

ClearLabel assembles a documentation-complete label clearance pack — every regulatory element, every required claim substantiation, the retailer policy checklist, the litigation-pattern scan, and the compliance dossier — checked against FDA/FTC rules, retailer policies, and active litigation patterns before a specialist releases it.

Every subsection of 21 CFR 101 & FTC substantiationFive statutory notice elements, gate-checkedFDA · FTC · retailer policy · litigation pattern scansSpecialist release on every pack2-business-day SLA
Why packs fail

A single non-compliant word can cost you your listing or invite a lawsuit.

A brand's label and marketing claims must simultaneously satisfy FDA labeling regulation (21 CFR 101), FTC's substantiation standard, retailer policies (Amazon, Walmart, TikTok Shop), state rules (e.g., Prop 65), and — most expensively — the pattern of what plaintiffs' firms are currently suing over. Miss one element, skip a required claim substantiation, mis-time a compliance deadline, or fail to address a retailer's documentation demand — and the listing can be deactivated, a warning letter issued, or a class action filed.

Most brands run this by hand, from memory, once or twice a year. The regulations have not been read end-to-end since the last time it mattered. That is exactly where compliance gaps hide.

ClearLabel exists to close that gap with a single, exhaustive standard applied identically to every file.

256
food/beverage class actions filed in 2024 — up 58% YoY
The benchmark

Measured against the letter of the regulation — subsection by subsection.

We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 21 CFR 101, FTC substantiation rules, and retailer policies. These are the provisions each pack is held to.

21 CFR 101.9

Nutrition labeling

All required nutrients, format, serving size, and daily values — present and correctly declared, or the pack does not release.

21 CFR 101.13

Nutrient content claims

Claims like 'low fat' or 'high fiber' meet the defined thresholds and are accompanied by required disclosures.

21 CFR 101.14

Health claims

Authorized health claims are substantiated per FDA's significant scientific agreement standard; structure/function claims include the DSHEA disclaimer.

FTC substantiation standard

Claim substantiation

Every express and implied claim is supported by competent and reliable scientific evidence, with a substantiation dossier compiled.

Retailer policy compliance

Amazon & retailer gates

Amazon's supplement compliance requirements (cGMP, COA, documentation) are checked; Walmart, TikTok Shop, and other retailer policies are scanned.

Litigation pattern scan

Active lawsuit risk

Current class-action and demand-letter patterns (e.g., 'natural', 'healthy', 'protein content') are cross-referenced; flagged claims are escalated.

How a pack is built

Intake to specialist release, with deterministic gates the AI cannot overrule.

AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A human specialist signs every release. That order is never reversed.

01

Compliance Gap Scan

Upload the label artwork and claim list. We return a free completeness read: which regulatory elements and substantiation you already have, and which are missing.

02

Evidence & policy scans

As your authorized clerical agent, we order the FDA regulation check, FTC substantiation review, retailer policy compliance scan, and litigation pattern analysis, and build the compliance matrix.

03

Grounded drafting

The label corrections and claim substantiation dossier are drafted from your validated data and the rule pack into field-locked templates — no legal opinions, no invented facts.

04

Deterministic completeness gates

All required label elements are present; claims are substantiated; retailer policies are met; litigation flags are resolved. Any failure blocks release.

05

Specialist release

A regulatory specialist reviews the exception queue and signs the release. High-risk or novel claims route to attorney review first.

06

Delivery

You receive the pack: cleared label, claim substantiation dossier, compliance matrix, retailer policy checklist, litigation risk report, and compliance calendar — ready for the brand to implement.

The bar we hold

Rigor you can measure.

100%
Specialist-released
No pack ships without a human signature.
2 days
Standard SLA
From complete intake to released pack.
<1%
Critical-defect target
Tracked against a gold-standard pack library.
4
Compliance sources
FDA · FTC · retailer policy · litigation pattern, every applicable file.
Why ClearLabel

Built to be the most thorough option a brand has.

Documentation-complete, by design

The deliverable is completeness itself — every regulatory element and substantiation accounted for or explicitly exception-coded. Nothing is left implicit.

Deterministic, not vibes

The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.

In its lane, on purpose

We prepare documentation and run scans as your clerical agent. We never give legal advice, contact retailers, or represent you in any enforcement action.

Engagement

Flat fee, per released pack. No contingency, ever.

Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.

  • A free Compliance Gap Scan before you commit — see exactly what is missing.
  • One flat fee per released Label & Claim Clearance Pack; disclosed pass-through scan fees.
  • Optional fixed-fee attorney review for high-risk or novel claims.
  • Optional Retailer Continuity Add-on for ongoing monitoring of retailer policy changes and litigation patterns.
FAQ

Questions, answered precisely.

Is ClearLabel a law firm?
No. ClearLabel, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for high-risk or novel claims.
Do you contact retailers or regulators?
Never. ClearLabel is not a compliance representative and does not contact retailers, FDA, FTC, or any other party. The brand remains responsible for submitting documentation and responding to any enforcement action.
What makes a pack 'complete'?
Completeness is defined by the regulations: all required label elements present, claims substantiated, retailer policies met, litigation patterns scanned, and compliance dossier compiled. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is two business days from complete intake to a specialist-released pack. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through scan costs. No contingency and no percentage of any recovered amount or sale proceeds.

See what's missing before it costs you a listing.

Start with a free Compliance Gap Scan. Send your label artwork and claim list and we'll return a completeness read against every applicable regulation and policy.

Documentation-completeness service · not legal advice · the brand implements every change.