The paperwork most suppliers cannot produce
FDA does not certify packaging, and there is no such thing as an "FDA approved box". What the regulation actually requires is a document chain proving every component is safe for food contact. Here is ours, and here is what each document proves.
Document set
Items 1–5 are what we send with every food-contact quotation. Items 6–9 are available on request or held at company level.
| Document | Issued by | What it proves | Lead time |
|---|---|---|---|
| Board Declaration of Compliance | Paper mill | Substrate complies with FDA 21 CFR 176.170 / 176.180 for its intended food type | On file |
| Ink compliance statement | Ink manufacturer | Inks are on the Swiss Ordinance 817.023.21 positive list and meet EuPIA GMP | On file |
| Adhesive DoC | Adhesive supplier | Glue and laminating adhesive are suitable for indirect food contact | On file |
| Heavy metals test report | SGS / BV / Intertek | Pb + Cd + Hg + Cr(VI) below 100 ppm combined, per TPCH / CONEG model legislation | 5–10 working days |
| Organoleptic test report | SGS / BV / Intertek | No detectable odour or taint transfer to the product | 2–3 weeks |
| Migration test report | SGS / BV / Intertek | Overall and specific migration within limits — required only for direct-contact packs | 2–3 weeks |
| FSC Chain of Custody certificate | SCS / SGS / Control Union | Certified fibre can be traced through our supply chain | Held |
| ISO 9001:2015 certificate | Accredited body | Quality management system audited annually | Held |
| Prop 65 statement | Cartonwright | No listed substances above safe-harbour levels in the finished carton | On request |
What 21 CFR 176.170 actually says
Part 176 covers paper and paperboard components used in food packaging. Section 176.170 deals with aqueous and fatty foods; 176.180 covers dry foods. Neither section approves a finished box.
Instead, they list the substances permitted in the substrate — wet-strength resins, sizing agents, coatings, mineral fillers — and set limits on how much of each may migrate into food. Your obligation, and ours, is to show that every component is either listed or covered by an effective food-contact notification.
The practical consequence: compliance lives in the bill of materials, not in a certificate. That is why we keep a DoC for the board, the ink and the adhesive separately, rather than one generic "food grade" letter.
Why "FDA approved" is a red flag
No US agency issues an approval certificate for a printed carton. A supplier who offers one is either misunderstanding the regulation or hoping you will not check. The correct phrasing is "complies with 21 CFR 176.170", and it should come with the underlying declarations.
Inks and coatings
Ink is the single largest migration risk in a printed carton — larger than the board itself.
- Low-migration offset inks, positive-listed under Swiss Ordinance 817.023.21
- Water-based or solvent-free laminating adhesives
- No recycled fibre in direct-contact layers
- Mineral-oil-free ink systems available for sensitive actives
If your product is a softgel or a powder with high fat content, ask us for the mineral-oil-free option specifically.
What we can and cannot do
Being clear about the boundary saves everyone a wasted week.
We can
- Supply the full document set above with your quotation
- Run migration and organoleptic testing at your chosen lab, at cost
- Produce FSC-certified board and provide the certificate number for your label
- Sign a confidentiality agreement before you share artwork
- Provide a written statement you can forward to your retailer's compliance team
We cannot
- Register your product with FDA — that is the brand owner's obligation
- Approve your Supplement Facts panel content — we set the layout, you own the claims
- Certify that a finished pack is "FDA approved"
- Guarantee shelf life — that depends on your fill, seal and storage