What Dietary Supplement Brands Must Know When Outsourcing to Contract Manufacturers

In the dietary supplement industry, outsourcing manufacturing is common—but it doesn’t absolve brand owners of regulatory responsibility.

The FDA holds brand owners accountable for ensuring that products manufactured by third parties meet all applicable requirements, especially those under the Supplement Current Good Manufacturing Practices (21 CFR Part 111).

This blog kicks off our dietary supplement series by breaking down what brand owners must do to stay compliant when working with contract manufacturers.

The Regulatory Foundation: Supplement GMPs and DSHEA

The Dietary Supplement Health and Education Act of 1994 (DSHEA) gave the FDA

authority to regulate dietary supplements under a distinct set of GMP standards.

These Supplement GMPs, codified in 21 CFR Part 111, apply to all parties involved in manufacturing, packaging, labeling, and holding dietary supplements.

Even if a brand owner outsources every aspect of production, they are still responsible for ensuring the final product complies with these regulations.

FDA’s Position on Brand Owner Responsibility

The FDA has made it clear: you cannot contract out compliance. If your brand name is on the label, you are responsible for:

• Ensuring the product is manufactured according to the Master Manufacturing Record (MMR)

• Approving or rejecting product batches for release

• Maintaining quality control systems and documentation

• Auditing your contract manufacturer for compliance with 21 CFR Part 111

In numerous warning letters, the FDA has cited brand owners for failing to oversee their contract manufacturers.

The agency expects brand owners to have systems in place to verify that all operations, whether internal or outsourced, meet regulatory standards.

4 Key Compliance Steps for Brand Owners

To protect your brand and meet FDA expectations, implement these four critical practices:

1. Audit Your Contract Manufacturer

• Review their compliance with 21 CFR Part 111.

• Request recent third-party audit reports.

• Ensure they are willing to share batch records, testing data, and SOPs.

2. Establish Finished Product Specifications

• Define clear specifications for ingredients, packaging, labeling, and testing.

• Ensure these are documented in your Master Manufacturing Record.

3. Identify Quality Personnel

• Assign qualified individuals within your organization to oversee product release decisions.

• Ensure they have access to all necessary documentation from the manufacturer.

4. Develop Standard Operating Procedures (SOPs)

• Create SOPs for product approval, complaint handling, and recordkeeping.

• Include procedures for reviewing and approving reprocessing decisions.

Common Pitfalls to Avoid

• Blind trust in certificates of analysis: Always verify with supporting documentation.

• Lack of access to batch records: You must be able to confirm that each batch meets specifications.

• No written quality agreement: Define roles and responsibilities clearly in a formal contract.

  
  

Conclusion

Outsourcing manufacturing doesn’t mean outsourcing responsibility. As a brand owner, you are the final gatekeeper for product safety and compliance.

By auditing your contract manufacturer, establishing clear specifications, and maintaining robust quality systems, you can protect your brand and meet FDA expectations.