Dietary supplements - 21CFR111 GMP audit

Dietary supplements are a way for consumers to complement their diet in order to improve their health, manage their weight, enhance sport as well as sexual performance, etc.

Expectations from the market on their safety and authenticity are increasingly stringent and require manufacturers to stay up-to-date. Also, market regulations may vary from country to country and more and more retailers request that their suppliers meet GMP requirement 21 CFR 111. 

Eurofins Food & Healthcare Assurance experts are offering a GMP audit for dietary supplements according to 21 CFR 111 in order to help manufacturers navigate the complex regulatory environment in the markets they target.

In the United States, the FDA requires companies who manufacture, package, label or hold a dietary supplement to:

• establish and follow current Good Manufacturing Practices to ensure the safety and quality of the dietary supplement,
• hold a GMP 21 CFR Part 111 certificate even if they are GFSI accredited (IFS, BRCGS, SQF, FSSC),
• ensure that the dietary supplement is packaged and labelled correctly.

Eurofins GMP for Dietary Supplements is accepted by Amazon as part of Amazon Seller Dietary Supplements Requirements.

Complete offering to our customers in the dietary supplement production:

• Auditing* to show compliance with 21 CFR 111 requirements,
• Advisory* with industry experts to prepare a GMP audit, review of 21 CFR 111 audit checklist, gap assessment and label review,
• Training to better understand the history of regulations and registration requirements.

Enquiries for certification requests should be sent to GlobalCertification@eurofins.com.

Definition of dietary supplements:

The FDA defines Dietary Supplements as products taken by mouth that contain a “dietary ingredient” in forms such as tablets, capsules, powders, energy bars, and liquids. “Dietary ingredients” include vitamins, minerals, amino acids, bee products (royal jelly, propolis, bee brad, etc.), and herbs or botanicals, as well as other substances that can be used to supplement the diet.

• In addition to being used to add nutrients to your diet, dietary supplements are used for sexual enhancements, weight management, bodybuilding, and sports nutrition.
• Dietary supplements may not contain articles that are approved as new drugs, other undeclared drug ingredients, or make disease claims.

*Our consulting activities are provided by independent companies and separate from certification activities.