GMP audits according to 21 CFR Part 111 for food supplements

Dietary supplements in compliance with the US Code of Federal Regulations

Aug 2022. Market regulations for the safety and authenticity of dietary supplements are becoming increasingly stringent, and at the same time can vary from country to country. More and more retailers are requiring that their suppliers comply with GMP requirements 21 CFR 111. Eurofins Food & Healthcare Assurance teams offer a 21 CFR 111 GMP audit for dietary supplements to help manufacturers navigate the complex regulatory environment in their target markets.

Current market requirements and regulations of Title 21 of the CFR Part 111

Due to the high number of adulterations and false claims of efficacy in the field of dietary supplements, it is particularly important for producers to be able to prove the integrity and safety of their products to consumers and retailers^[1]. To this end, more and more suppliers require a GMP certificate based on 21 CFR Part 111.

Title 21 is the part of the US Code of Federal Regulations that regulates food and drugs in the United States for the Food and Drug Administration (FDA), among others. Based on this, the FDA requires persons who manufacture, package, label or hold a dietary supplement to implement and follow applicable Good Manufacturing Practices (GMP) to ensure the safety and quality of the dietary supplement. They must also ensure that the dietary supplement is correctly packaged and labelled. Even if a company is GFSI accredited, such as IFS, FSSC, etc., the FDA requires a GMP certificate 21 CFR Part 111.^[2]^[3][4]

Who is the GMP audit 21 CFR Part 111 suitable for?

The audit offered by Eurofins Food & Healthcare Assurance is basically suitable for all parties within the supply chain that manufacture, package and label, store and distribute dietary supplements.

From a product perspective, the scope of the audit includes those food supplements and their components that are taken by mouth and contain a "dietary ingredient". These can be tablets, capsules, powders, energy bars and liquids as well as vitamins, minerals, amino acids, herbs and herbal substances.

Audit procedure and objectives

Our GMP audit according to 21 CFR Part 111 is an on-site audit, which is conducted by one of our professional auditors with industry experience. The audit lasts one and a half days. A successful audit results in a certificate confirming compliance with 21 CFR Part 111 with regard to

safety
quality
correct packaging and labelling

and is accepted by e.g. Amazon as part of the Amazon Seller Dietary Supplement Requirements.

Successful verification with Eurofins companies

Eurofins Food Control Services GmbH, part of the global Eurofins Assurance, is an approved certification body and supports manufacturers with a GMP audit for dietary supplements according to 21 CFR 111. In addition, the Eurofins laboratories for food and feed testing in Germany offer you a comprehensive analytical portfolio for ensuring compliance with product claims, for environmental and hygiene monitoring or for authenticity analyses. If you are interested in a GMP audit or accompanying analysis, please contact your personal account manager or contact our experts for certification and analysis directly. We look forward to your enquiry.

Relevant sources:

[1] European Commission: 2021 Annual Report - Alert and Coopeation Network
[2] U.S. Food & Drug Administration - CFR - Code of Federal Regulations Title 21: CFR-Part 117
[3] U.S. Food & Drug Administration - CFR - Code of Federal Regulations Title 21: CFR-Part 111
[4] U.S. Food & Drug Administration - CFR - Code of Federal Regulations Title 21: CFR-Part 101
[5] Eurofins Food Assurance Global: GMP audits for dietary supplements