Many Nutracuetical facilities run multiple products in processing areas designed for quick turnaround without unacceptable risk of product exposure (i.e. dust and cross- contamination). The FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers are not required to register their products with the FDA nor get FDA approval before producing or selling dietary supplements.
VTI can help ensure that your processes, facilities, equipment and procedures adhere to GMP requirements (21 CFR Parts 111) and are validated according to regulatory (FDA) standards.