What an allergen statement covers

An allergen statement is a formal declaration that identifies the presence or potential presence of allergens in a dietary supplement. For brand owners, understanding what this statement covers is essential when working with a contract manufacturer. This guide details the components of an allergen statement, the role of the manufacturer versus the brand owner, and how it supports market entry. It also outlines what brand owners need to prepare and clarifies where responsibility lies for final compliance.

What this document or scope covers

This document covers the definition and purpose of an allergen statement in the context of private-label supplement manufacturing. It explains the types of allergens typically declared, such as major food allergens (e.g., milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans) and gluten. It also addresses cross-contact risks and how statements are communicated on labels or certificates.

What the manufacturer provides vs the brand owner

The manufacturer provides the allergen statement based on the ingredients and production environment. This includes disclosing allergens present in raw materials and potential cross-contact from shared equipment. The brand owner is responsible for reviewing the statement, ensuring it aligns with their product claims, and incorporating it into the final label. The manufacturer does not make claims about allergen safety or suitability for specific diets.

How it supports market entry

A clear allergen statement helps brand owners meet regulatory requirements in their target markets, such as FDA labeling rules in the U.S. or EU allergen labeling directives. It also builds consumer trust by providing transparent information. For brand owners using the Make it Yours program, the allergen statement can be customized to reflect ingredient choices, facilitating smoother market entry and compliance.

What to prepare

Brand owners should prepare a list of desired ingredients and any specific allergen concerns (e.g., gluten-free, nut-free). They should also provide target market regulations to ensure the allergen statement meets local requirements. During the product brief, the manufacturer will use this information to generate an allergen statement. Brand owners must review and approve the statement before production.

Where responsibility sits

The brand owner retains ultimate responsibility for the final label, including the allergen statement, and for ensuring compliance with all applicable laws in their market. The manufacturer provides accurate information based on production data but does not assume liability for regulatory approval or consumer claims. Brand owners should consult legal or regulatory experts to validate their labels.