GMP for Dietary Supplements 21 CFR Part 111
GMP for Dietary Supplements (21 CFR 111) Audits | North America
If you manufacture, distribute, package, hold, or label Dietary Supplements, Eurofins Food Assurance can help!
In the United States, the Food and Drug Administration (FDA) regulates the manufacturing, packaging, holding and labeling of Dietary Supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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, 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.
The US FDA requires persons 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 and to ensure that the Dietary Supplement is packaged and labeled correctly.
Download our GMP for Dietary Supplements flyer for more information
The Amazon Seller Requirements for Dietary Supplements accept Eurofins GMP for Dietary Supplements and SSCI audits, both of which Eurofins Food Assurance can perform.
Eurofins Food Assurance offers the following services:
Auditing |
Training |
Consulting |
Label Review |
| Eurofins GMP for Dietary Supplements Audit – Based on 21 CFR Part 111 | Dietary Supplements 21 CFR Part 111 Training – Understand the history of regulations, registration requirements, 21 CFR subparts | Dietary Supplements Consulting | Dietary Supplements Label Reviews |
| SQF Food Safety Code for Dietary Supplements Certification – (GFSI) FSC 31: Dietary Supplements | Foreign Supplier Verification Program – Provides knowledge to implement the requirements of FSVP for importers, into the United States, of Dietary Supplements per FDA regulations |
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| Supplement Safety & Compliance Initiative (SSCI) Audit – Based on 21 CFR Part 111 | A full list of training courses can be found here | ||
| Please Contact Us for more information on our Auditing options |
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