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]
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.
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.
"I sent you today this new proposal of declarations. This is the first mail."
— Dubravka Kukic
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.
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.
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.
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.
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.