La Natura USA Ingredient Declarations & Reformulation
Overview
La Natura (ffgrono.ch) is preparing products for USA market entry and requires ingredient declaration reformulation to comply with US food regulations. This article captures the process, decisions, and coordination patterns involved in getting declarations right for the US market.
The core challenge: at least one ingredient in an existing product line is not permitted under US regulations, requiring supplier-level reformulation and new declaration drafts before packaging can be finalized.
Related meeting: [1]
Client: [2]
Context
La Natura is a Swiss-based lifestyle brand (ffgrono.ch) launching products in the USA. Their product range includes flavored coffees and coffee-mushroom blends. The USA regulatory environment (FDA) imposes stricter ingredient restrictions than European markets, requiring a full review of existing formulations before US-facing packaging and declarations can be finalized.
Reformulation Process
Trigger
A supplier ingredient was identified as non-compliant with US regulations. Rather than seeking an exemption or substitution at the declaration level, the supplier was directed to reformulate — removing the problematic ingredient entirely.
Declaration Drafting Workflow
- Supplier confirms reformulation — supplier commits to producing a version without the non-compliant ingredient.
- New proposal submitted — Dubravka (La Natura) prepares and sends a revised ingredient declaration draft reflecting the reformulated product.
- Regulatory review — Mark Hope (Asymmetric) reviews the declaration for US compliance.
- Confirmation and finalization — Once approved, declarations are locked and packaging proceeds.
"I sent you today this new proposal of declarations. This is the first mail."
— Dubravka Kukic
Key Principle
Declaration drafting can proceed in parallel with awaiting formal confirmation, provided the drafter is confident in the direction. In this case, Dubravka prepared the mushroom product declaration ahead of Mark's explicit sign-off, anticipating approval based on prior knowledge of the ingredient category.
Product-Specific Notes
Coffee Mushroom Blend
- Compliance check required for mushroom ingredients under US regulations.
- Working assumption: mushroom ingredients are likely permissible (not a restricted category under FDA rules).
- Declaration to be drafted proactively; Mark to confirm or flag issues.
- Status at time of call: Awaiting Mark's confirmation; declaration being prepared in parallel.
Flavored Coffee
- Final packaging design completed the week prior to the call.
- Dubravka reviewed and sent two rounds of comments to designer (Matt).
- Matt finalized based on feedback.
- Status at time of call: Ready for print file creation pending sticker spec confirmation.
Packaging & Sticker Specifications (USA)
Confirmed sticker approach for secondary packaging:
| Element | Specification |
|---|---|
| Sticker count | One sticker per product set |
| UPC code | Required; placed on bottom sticker |
| Address | Required on sticker |
| Product description | Required on sticker |
| Food regulations | Do not apply to secondary packaging |
"There's no food regulations on the secondary packaging."
— Mark Hope
This is an important distinction: the primary product packaging must meet FDA labeling requirements, but secondary/gift-set packaging (e.g., a box or sleeve grouping multiple items) is not subject to the same food labeling rules. The sticker on secondary packaging needs only address, UPC, and product description.
Action Items (from source call)
- [ ] Mark Hope — Review new ingredient declaration proposal (email 1); provide feedback
- [ ] Mark Hope — Confirm mushroom ingredients are permissible for US market (email 2)
- [ ] Mark Hope — Review finalized flavored coffee packaging (email 3); provide comments
- [ ] Dubravka Kukic — Prepare mushroom product declaration draft (proceeding without waiting for full confirmation)
- [ ] Matt (designer) — Create print files for packaging stickers
Generalizable Insights
Parallel-Path Declaration Drafting
When a regulatory reviewer has a known backlog, declaration drafting can proceed on a "likely compliant" basis for low-risk ingredients (e.g., common food mushrooms). This avoids bottlenecks while keeping the reviewer in the loop for final sign-off.
Secondary Packaging Regulatory Scope
In the US market, secondary packaging (gift sets, outer boxes, multi-unit sleeves) is not subject to FDA food labeling regulations. Only the primary product packaging requires full nutrition facts, ingredient declarations, and allergen statements. Stickers on secondary packaging need only: importer/distributor address, UPC code, and product description.
Supplier Reformulation vs. Declaration Workarounds
When an ingredient is outright prohibited (not merely restricted or threshold-limited), the cleanest path is supplier reformulation rather than attempting to re-characterize the ingredient in the declaration. This avoids compliance risk and simplifies the declaration itself.
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