HQ Cortex
All compliance regimes

DSHEA — Dietary Supplement Labeling & Claims

Structure/function claim rules, mandatory disclaimer, and 30-day post-market notification under DSHEA.

Supported
1(17%)
In progress
2(33%)
Not yet planned
3(50%)
Tracked6

Why this matters: DSHEA (the Dietary Supplement Health and Education Act) governs how supplement labels and marketing copy may describe a product. HQ Cortex's labeling pipeline must keep claims on the right side of the structure/function line and surface the required FDA disclaimer.

This is a core regime in scope for the default product.

Status legend

  • SupportedWe can do this today.
  • In progressPartially in place or actively in development.
  • Not yet plannedNot yet started or not in scope.

Labeling and Claim Controls

  • Supplement Facts panel validator

    Supported

    Check Supplement Facts format, ingredient ordering, % DV calculations, allergen statement, and net contents.

    In HQ Cortex: Daily-value calculations (FDA + Health Canada) and label profiles drive automatic Supplement Facts rendering.

    21 CFR 101.36

  • Mandatory DSHEA disclaimer auto-attach

    In progress

    Automatically attach the FDA disclaimer to every label and page surface where a structure/function claim appears.

    In HQ Cortex: Disclaimer field is supported on label profiles; automatic propagation from claim text to disclaimer placement is in progress.

    21 CFR 101.93(b)

  • Disease-claim lint

    Not yet planned

    Prevent prohibited disease claims (e.g., 'treats', 'cures', specific disease names).

    In HQ Cortex: Not yet implemented. A lint that flags prohibited terms in claim copy is on the roadmap.

    FDCA §403(r)(6); 21 CFR 101.93(g)

  • 30-day post-market notification tracker

    Not yet planned

    For each new structure/function claim, generate the FDA notification packet and track the 30-day deadline.

    In HQ Cortex: Not yet implemented.

    FDCA §403(r)(6); 21 CFR 101.93(a)

  • Claim substantiation file

    Not yet planned

    Required evidence repository per claim: study citations, expert opinions, mechanism rationale; reviewed before publish.

    In HQ Cortex: Not yet implemented.

    FTC/FDA substantiation expectations

  • Label version control with change reason

    In progress

    Every published label is versioned; FDA-relevant changes require regulatory approval.

    In HQ Cortex: Label profiles are versioned; an explicit regulatory-approval gate is being built.

    21 CFR 101 (general); GMP best practice

References

Last reviewed: May 2026.