La Natura — US Dietary Supplements Regulatory Strategy
Overview
This article captures the regulatory framework discussed with [1] for entering the US market with dietary supplement products. The core issues are product classification, factory registration, and FDA-compliant labeling and health claims. These requirements apply broadly to any European food/supplement brand pursuing US market entry.
Call date: 2026-04-05
Attendees: Mark Hope (Asymmetric), Dubravka Kukic (La Natura), Alen Kaltak, Adis Rastoder, sd@ffgrono.ch (ffgrono.ch)
Key Regulatory Framework
1. Product Classification: Fortified Food vs. Dietary Supplement
The single most important threshold decision for US market entry is determining how the product is classified under FDA rules. The two categories carry meaningfully different regulatory obligations:
| Factor | Fortified Food | Dietary Supplement |
|---|---|---|
| Regulatory pathway | FDA food regulations | DSHEA (Dietary Supplement Health and Education Act) |
| Labeling format | Nutrition Facts panel | Supplement Facts panel |
| Health claims | Nutrient content / structure-function claims (limited) | Structure-function claims with disclaimer |
| Factory registration | Food facility registration | Supplement GMP registration |
La Natura's product classification must be determined before any other regulatory steps can proceed. The classification drives every downstream decision.
2. Factory Registration
Regardless of final classification, the manufacturing facility must be registered with the FDA:
- Requirement: Register as a dietary supplement manufacturing plant (if classified as a supplement) under 21 CFR Part 111 (Current Good Manufacturing Practice — cGMP)
- Cost: Registration itself carries no fee in the US. However, if the factory does not meet cGMP inspection standards, remediation costs can be significant
- Implication: La Natura (or their contract manufacturer) should conduct a gap assessment against US cGMP requirements before initiating registration
3. Labeling Requirements
FDA labeling rules are specific and non-negotiable for market entry. Key requirements for dietary supplements include:
- Supplement Facts panel (not Nutrition Facts) listing all dietary ingredients, serving size, and amounts per serving
- Identity statement on the principal display panel (e.g., "Dietary Supplement")
- Net quantity of contents
- Manufacturer/distributor name and address
- Directions for use
- Warnings where applicable (e.g., "Keep out of reach of children")
Fortified food products use a different label format and are subject to standard FDA food labeling rules under 21 CFR Part 101.
4. Allowable Health Claims
The FDA distinguishes between several types of claims, each with different evidentiary and approval requirements:
- Authorized health claims — require significant scientific agreement; FDA pre-approval
- Qualified health claims — permitted with qualifying language when evidence is credible but not conclusive
- Structure-function claims — most commonly used for supplements; describe the role of a nutrient in normal body function (e.g., "Calcium builds strong bones"); must include the disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
- Nutrient content claims — describe the level of a nutrient (e.g., "High in Vitamin C")
Disease claims are not permitted for dietary supplements without going through the drug approval pathway.
Key Decisions
- Product classification must be resolved first. La Natura needs to confirm whether their product is a fortified food or a dietary supplement before regulatory strategy can be finalised.
- Factory registration is mandatory and should be initiated early, as cGMP compliance may require facility upgrades with lead time.
- Health claims must be scoped to permissible categories — structure-function claims are the most accessible pathway for supplements.
Action Items
- [ ] Dubravka Kukic — Thoroughly review Mark's detailed email covering fortified food vs. dietary supplement classification, FDA labeling requirements, and allowable health claims
- [ ] Mark Hope — Resend the regulatory summary email to Dubravka Kukic
- [ ] La Natura — Confirm definitive product classification (fortified food vs. dietary supplement)
- [ ] La Natura — Initiate factory registration process and conduct cGMP gap assessment
- [ ] La Natura — Align product labeling and health claims with FDA guidelines prior to market entry
Notes on Communication
During this call, it emerged that a detailed regulatory briefing email sent by Mark prior to the call had not been fully absorbed by the client contact. The email covered the fortified food / supplement distinction, labeling requirements, and health claims in full. Screen sharing was used during the call to locate and walk through the email in real time.
Pattern to note: For complex regulatory topics, consider supplementing written briefings with a short structured summary or checklist to improve comprehension and reduce re-explanation overhead on calls. See [2].
Related
- [3]
- [4]
- [5]