Understanding The Dietary Supplement Health and Education Act (DSHEA) of 1994

Resources for Dietary Supplement Manufacturers and Raw Material Suppliers

What Is DSHEA?

DSHEA created a national regulatory framework for dietary supplements. It was passed in response to a massive outpouring of support in favor of dietary supplements from American consumers and the supplement industry.

DSHEA and rules based on DSHEA:

  • define certain foods as dietary supplements;
  • set safety standards for dietary supplements, including Current Good Manufacturing Practices (CGMPs);
  • detail “Dietary Supplement Labeling Exemptions” and limit health claims that can be made about supplements;
  • establish permissible statements of nutritional support (structure/function claims);
  • outline requirements for dietary supplement labeling, including nutrition information; and
  • specify standards that new dietary ingredients must meet to avoid being deemed adulterated.[1]

Vitature®, the Cloud-Based Regulatory Solution, Ensures DSHEA Compliance

Vitature® ensures compliance with DSHEA-required CGMPs by implementing standardized tools that assist in qualifying suppliers and their raw materials. This is achieved largely by building upon the Standardized Information on Dietary Ingredients (SIDI) Work Group’s recommendations, including raw material data-sheet templates for botanic and non-botanic ingredients. These templates make it easy to build and compare raw material specifications and streamline the qualification process, increasing efficiencies for manufacturers and suppliers.

Vitature Supports CGMP Compliance

Vitature helps manufacturers and suppliers adhere to CGMPs by allowing for:

  • Robust digital audit trails
  • Raw material specification management
  • Streamlined, digital qualification of raw material suppliers
  • Raw material documentation management, including expiration tracking
  • Access to proprietary science and regulatory databases that drive formulation and label claim substantiation

Additional Resources

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