Supplement Labeling and Compliance

Launch with confidence. APEX CSM helps brands get labels right the first time—Supplement Facts panels, claims vetting, and market-specific requirements—inside an FDA- and cGMP-certified network with fast turnarounds and flexible MOQs.

21 CFR 10121 CFR 111DSHEAFALCPAFTC Claim GuidanceProp 65 (CA)Amazon Readiness
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Regulatory specialist reviewing a printed Supplement Facts label against a compliance checklist at a clean workstation

Built for Accuracy, Speed, and Market Access

We combine seasoned regulatory review with disciplined documentation so your labels pass audits, retailer onboarding, and marketplace checks—without slowing your launch.

Labeling Expertise

Supplement Facts construction, serving size logic, allergen statements, warning language, claims hierarchy, font sizes, and net quantity placement that align to 21 CFR 101.

Fast Turnarounds

Tight review cycles with redlines and checklists. We orchestrate inputs from R&D, QA, and design to compress artwork approvals and get you press-ready faster.

Retailer & Amazon Ready

Documentation packages for onboarding and marketplace verification—COAs, GMP credentials, master labels, and compliant imagery to minimize listing risk.

What We Cover

  • Supplement Facts panel construction
  • Ingredient & common name conventions
  • Structure/function claims & disclaimers
  • Allergen, caffeine, and age warnings

Pre-Market Files

  • Master label & dieline proofs
  • COAs, identity & potency data
  • cGMP facility credentials
  • Stability & shelf-life rationale

Packaging Compliance

  • Tamper-evident statements
  • Lot, expiry, & storage conditions
  • UPC, GTIN, & variable data checks
  • Country-of-origin & contact info

Ongoing Compliance

  • Change control & revision logs
  • Annual label audits
  • Retailer spec updates
  • Marketplace policy changes
Clean lineup of compliant supplement packaging with accurate panels, allergen calls, and lot coding ready for retail

Our Labeling & Compliance Process

Clear checkpoints from concept to sign-off. You’ll know exactly what’s needed, who’s responsible, and when artwork is press-ready.

1

Discovery

Claims, channels, target markets, allergens, and pack sizes—mapped to regulatory scope and timeline.

2

Data & Facts

Ingredient specs, daily values, and serving logic translated into a compliant Supplement Facts framework.

3

Artwork

Designer-ready dielines with hierarchy rules, mandatory statements, and space for variable data.

4

Reg Review

Redlines and sign-off across QA/RA. Optional retailer spec cross-check and Amazon marketplace readiness.

5

Release

Final PDFs, revision control, printer notes, and onboarding docs (COAs, GMP credentials, master label).

Quality manager reviewing label proofs and batch documentation prior to release

Quality, Documented

Expect transparent records that align with retailer and marketplace expectations—reducing relabel risk and keeping listings live.

  • Identity, potency, and purity to specification
  • Microbial & heavy metal screening as required
  • Stability guidance to support label claims
  • COAs and lot traceability on release

Certifications & Channels We Support

We operate within FDA and cGMP frameworks and coordinate with third-party programs by facility to meet channel expectations.

Regulatory Baseline

  • FDA dietary supplements (DSHEA)
  • 21 CFR 101 (labeling)
  • 21 CFR 111 (cGMP)
  • FSMA-aligned practices

Third-Party Programs

  • NSF / USP (by facility)
  • Organic, Kosher, Halal (as applicable)
  • Informed Choice / Sport (by facility)
  • FSSC 22000 (food safety, select sites)

Retail & Marketplace

  • Amazon documentation readiness
  • Major retailer onboarding specs
  • Imagery & content compliance
  • Recall & notification protocols

Labeling & Compliance FAQs

Quick answers for brand owners preparing artwork and documentation.

What goes into a compliant Supplement Facts panel?

Serving size logic, nutrients by declared units, percent daily values as applicable, other ingredients, allergens when required, and mandatory footnotes where relevant.

Can you review structure/function claims?

Yes. We align proposed claims with evidence level, add the standard disclaimer, and check layout so claims are not misleading or disease-forward.

Do you support Amazon listing requirements?

We package COAs, facility credentials, and master labels to align with marketplace verification workflows and reduce risk of listing suppression.

How do you handle revisions?

Tracked redlines and controlled PDFs with version IDs. We maintain a change log and archive prior label iterations for auditability.

Can you advise on Prop 65 warnings?

We assess the need based on formula and exposure assumptions, then implement compliant warning language and placement when applicable.