Regulations for Exporting Dietary Supplements: Compliance Access Checklist for US, EU, ASEAN, JP, and KR

Understanding Global Regulatory Landscapes for Dietary Supplements

Compliance is the most critical hurdle for exporting dietary supplements. Different countries have vastly different regulations regarding permitted ingredients, dosage limits, labeling requirements, and health claims. For instance, the US FDA requires DSHEA-compliant labeling, while the EU has strict regulations on vitamin forms and maximum levels. Japan uses the FOSHU and Food with Function Claims (FFC) systems.

Key Compliance Factors for Major Markets

This guide provides a comprehensive checklist of regulatory requirements for major global markets and explains how Orisen Bio's regulatory support team helps ensure your products are fully compliant before export. We cover ingredient restrictions, heavy metal limits, microbiological standards, and label layout requirements.

United States (FDA/FTC)

In the US, dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Key requirements include:

• New Dietary Ingredient (NDI) Notification: If an ingredient was not marketed in the US before Oct 15, 1994.
• cGMP Compliance: Manufacturing facilities must follow current Good Manufacturing Practices (21 CFR Part 111).
• Labeling: Must include a Supplement Facts panel, ingredient list, and specific disclaimers for structure/function claims.

European Union (EFSA)

The EU has a more harmonized but strict approach:

• Food Supplement Directive 2002/46/EC: Lists permitted vitamins and minerals.
• Novel Food Regulation: Ingredients not used significantly before 1997 require authorization.
• Health Claims: Only claims authorized by the European Commission can be used.

How Orisen Bio Simplifies Your Export Journey

At Orisen Bio, we don't just manufacture; we partner with you to navigate these complexities. Our regulatory affairs team provides:

• Formula pre-audit against target market regulations.
• Label design review for technical compliance.
• Preparation of technical dossiers for registration.
• Assistance with certificates of free sale and other export documentation.

By choosing a partner with deep regulatory expertise, you minimize the risk of customs rejections and legal challenges, ensuring a smooth entry into your chosen international markets.

Whether you are targeting the mature markets of North America and Europe or the rapidly growing ASEAN region, Orisen Bio has the expertise to guide you. We stay updated on the latest regulatory shifts, such as the UK's post-Brexit FSA requirements and China's SAMR filing system, so you don't have to.