Can Dietary Supplements Make Health Claims? A Regulatory Overview

Health claims are a critical compliance topic in the dietary supplement industry. Regulations governing what can and cannot be stated on labels, packaging, and marketing materials vary by region, but all major markets apply strict controls to prevent misleading information.

For brands working with OEM and ODM manufacturers, understanding these rules is essential to ensure products are compliant before entering the market.

At CSK Biotech, we support global supplement brands by aligning manufacturing and documentation processes with applicable regulatory expectations for softgel capsules, hard capsules, tablets, powders, gummies, and liquid supplements.

What Is a Health Claim?

A health claim generally refers to any statement that suggests a relationship between a dietary supplement and:

• Health maintenance or improvement

• Disease risk reduction

• Body function modification

Such claims are highly regulated and often require formal authorization depending on the target market.

Regulatory Approaches in Major Markets

United States

In the US, dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA). While certain statements may be permitted under specific conditions, disease-related claims are not allowed for dietary supplements. All claims must be truthful, not misleading, and properly substantiated.

European Union

In the EU, health claims are governed by Regulation (EC) No 1924/2006. Only authorized health claims listed on the EU Register may be used, and they must follow exact wording and conditions of use. Unauthorized claims are not permitted.

Germany

Germany follows EU regulations but applies strict local enforcement. Claims must comply with the EU authorized list and are closely reviewed by regulatory authorities.

China

In China, dietary supplements (often categorized as health food) are subject to registration or filing systems. Claims are limited to approved functional categories and must be officially authorized before use.

Where Health Claims Appear and Why Compliance Matters

Health claims may appear in:

• Product labels

• Packaging inserts

• Websites and e-commerce listings

• Marketing and promotional materials

Non-compliant claims can lead to:

• Product removal from the market

• Regulatory penalties

• Brand credibility risks

Ensuring compliance across all channels is critical for international brands.

The Manufacturer’s Role in Claim Compliance

While brands are ultimately responsible for claims used in marketing, experienced manufacturers can support compliance by:

• Reviewing product specifications for regulatory alignment

• Advising on formulation feasibility relative to intended markets

• Supporting compliant labeling and documentation preparation

This collaborative approach helps reduce compliance risks.

Best Practices for Brands

To maintain compliance, brands should:

• Understand claim restrictions in each target market

• Avoid implied disease or treatment language

• Use authorized or permitted statements only where applicable

• Seek regulatory review before publication

Careful planning reduces the risk of costly revisions or delays.

Work with CSK Biotech for Compliant Supplement Manufacturing

CSK Biotech provides OEM and ODM manufacturing services for dietary supplements, supporting brands with:

• Softgel capsules, hard capsules, tablets, powders, gummies, and liquid supplements

• Manufacturing aligned with international regulatory expectations

• Support for labeling and documentation coordination

• Quality-focused production systems

For inquiries about compliant supplement manufacturing or regulatory coordination, please contact:

📧 steve@cskbiotech.com

We welcome partnerships with brands seeking transparent, compliant, and responsible dietary supplement manufacturing solutions.