FDA Import Rules for Functional Food Range — 2026-04-05

Overview

Call with La Natura (Adis Rastoder, Dubravka Kukic) to clarify why the functional food range can no longer be imported into the US under the same terms as before. Mark Hope walked through the FDA regulatory landscape and the three strategic paths available. Final decision deferred to Evald (owner).

Attendees: Adis Rastoder (La Natura), Dubravka Kukic (La Natura), Mark Hope (Asymmetric)

The Problem

A June 2025 FDA rule update — the first since 2010 — has triggered stricter enforcement on food labeling and ingredient standards. Two specific issues affect the La Natura functional range:

1. Non-standard ingredients: Adding botanicals, vitamins, or minerals to a standard food (e.g. coffee) is prohibited under food regulations. Coffee is classified as a standard food; the FDA does not permit it to be reformulated with functional additives.
2. Health claims: Claims such as "longevity," "focus," or "skin" cannot be made on food products. Making such claims requires the product to be classified and registered as a dietary supplement.

Regular coffee, flavored coffee, and iced coffee are unaffected. The issue is limited to the superfood/functional range where claims are made and non-standard ingredients are added.

Key Decisions

• No decision made on this call. Adis will present the three options to Evald, who holds final authority on the US strategy for the functional range.

Three Strategic Options

Option 1 — Full Compliance: Register as Supplement Manufacturer

• Register the production factory as a dietary supplement manufacturer with the FDA.
• Pro: Full compliance; no regulatory risk.
• Con: Requires a 6–9 month audit and registration process. Delays US launch of the functional range.

Option 2 — High-Risk: Import as Food with Aggressive Claims

• Import the functional range as food and make marketing claims anyway, as many Amazon competitors appear to do.
• Pro: No registration delay; can launch immediately.
• Con: High risk of FDA warning letters. If actioned, sales must halt and all affected listings could be pulled — including potentially the broader La Natura brand.

Option 3 — Risk Mitigation: Separate US Entity

• Incorporate a new US company (e.g. "La Natura Supplements") specifically for the functional range. Register that entity's factory with the FDA as a supplement manufacturer.
• Pro: Isolates any FDA enforcement action to the new entity, protecting the core La Natura coffee brand and Amazon account.
• Con: Still requires factory registration (with possible audit). Adds incorporation overhead.
• Estimated cost: ~$1,000–$2,000 for incorporation + ~$200 for FDA registration.

Note: Even under Option 2 (import-at-risk), the factory still needs to be registered with the FDA if the products are to be labelled as supplements. Registration alone is straightforward; the audit is the variable risk.

Action Items

• [ ] Adis — Present the three strategic options to Evald and obtain a decision on the functional range US path. Inform Mark once decided.
• [ ] Adis — Send Mark a consolidated production overview: all ordered SKUs, quantities, package types, and estimated arrival dates — for Amazon listing preparation.

Production & Logistics Update

• All non-functional products are ordered and in production.
• Pre-Christmas demand is causing paper supply delays from suppliers.
• La Natura team is pushing suppliers to expedite.

Key Transcript Excerpts

Mark Hope: "There's a pretty good chance that we could list this stuff as food and say what we want and get away with it. But there's also a possibility that they'll send us a letter and tell us that we have to stop. I just don't want anybody to say later, 'hey, you said it was okay, and now it's not.'"

Mark Hope: "Another idea might be to create a different company so we can separate them. So if we get in trouble, it only affects those products."

Adis Rastoder: "So we have one right solution — register the company as supplement producer. Second way is to take the risk. And the third way is when we want to take the risk, it will be better to have a separate company in USA."

Adis Rastoder: "Me or Dubravka cannot decide on which way we go forward — he decides."

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