FDA Dietary supplement Consulting

In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices http://www.fda.gov/Food/DietarySupplements/default.htm for those who manufacture, package or hold dietary supplement products.

These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.

At Vitas we offer Dietary Supplements Consulting for those who want to enter the US marked.

Are you a manufacturer?

Not sure how to implement the rules of FDA? Vitas quality department has substantial experience in quality control of dietary supplements and drugs. We can provide ourselves or through a partner the following services:

•    establish quality system based on GMP for dietary supplements
•    perform quality control of finished product
•    supplier qualification
•    stability programs - advice, document and perform analytical services

Are you a distributor or a retailer?

Not sure how the rules of GMP of dietary supplements affects your company? Even though you are not a manufacturer, the FDA rules require you to comply with requirements for holding and distribution. In addition, a distributor who sub-contracts the production to a manufacture of dietary supplements, which the distributor then distributes under its own label, has an obligation to know what and how manufacturing activities are performed. So that the distributor can make decisions related to whether the packaged and labeled product conforms to its established specifications, and whether to approve and release the product for distribution.  Vitas can help you with the following services:

•    Establish a quality system based on GMP for dietary supplements for holding and distribution
•    Perform manufacture audits to confirm that the package and labeled product conforms to its established specifications