Supplement Market Review: Distinguish US and EU Requirements
A generic FDA/EFSA compliant statement is not a documented market-access assessment.
Keep a market-review responsibility matrix
| Decision | Information to request | How to use the answer |
|---|---|---|
| Product facts | Complete formula, material forms and serving basis | Identify the exact version submitted to the reviewer. |
| Classification | Destination and proposed product presentation | Assign the relevant authority and professional review. |
| Ingredients and claims | Supporting information and proposed label wording | Record unresolved status or substantiation questions. |
| Operators | Manufacturing, marketing and importing roles | Identify who supplies and retains required records. |
| Change trigger | New ingredient, serving, statement or destination | Reassess the affected market decision. |
Do not reuse one market label as a second-market approval
Illustrative purchasing exercise, not a customer case, test result or quotation.
A brand wants the same formula sold in the US and an EU market. Keep one formula reference, but create separate review decisions for the ingredient, serving, label and claims in each destination.
- Shared product: Controlled formula, material identities and physical presentation.
- Separate review: Destination, classification, proposed statements and responsible adviser.
- Controlled change: Record any reformulation or artwork revision produced by the review.
Decision output: A US facility registration or a scientific opinion is not a universal finished-product approval. The project record should identify which question each source actually addresses.
FDA explains that dietary supplements are not approved like drugs before marketing. The European Commission’s food-supplement overview describes a distinct EU framework and possible national notification arrangements. These resources are starting points for review, not a universal legal checklist or confirmation that a product can be sold. Keep the basis and limitations of professional advice with the approved formula and label.
Use the relevant project route
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