Preparing US and EU market briefs

Create separate market questions instead of assuming one formula and label will serve both the US and every EU destination.

Write the US question precisely

Identify the finished format, intended use, full composition, proposed amounts and claims. Determine the responsible business and the review needed for classification and labeling. An ingredient’s presence in another supplement does not settle the status of an oral pouch.

Identify EU destinations

List the actual countries, category and local language requirements. Review ingredient status, possible novel-food questions and permitted claims in the appropriate framework. A generic Europe brief leaves important implementation and importer decisions unresolved.

Use official starting points

FDA dietary supplement information and the European Commission claims framework are primary reference starting points. They are not approvals of these concepts. A qualified local review should apply the current rules to the exact product and presentation before a commercial commitment.

Record the decision and assumptions

The review file should identify the formula version, intended label, countries, responsible reviewer and outstanding conditions. If the ingredient, use instruction or market changes, reassess the relevant decision. Keep the approved label and manufacturing specification connected.

Put it in your brief

• Product format
• Full formula
• Actual destinations
• Responsible reviewer
• Versioned decision

For each item, record the decision owner, the information needed and the approval that allows the next stage to proceed. Unresolved questions should remain visible in the project brief instead of being replaced by an assumed specification.

Primary reference starting points

• FDA dietary supplements
• European Commission nutrition and health claims

Related project pages: development services, quality planning and sample enquiries.