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Dietary supplements Own Label Distributor (OLD) regulatory responsibilities: six critical items and processes

corresponding

TARA LIN COUCH
EAS Consulting Group, Alexandria, USA

Abstract

The dietary supplement industry incorporates a complex supply chain with the use of contract manufacturers, contract packagers, contract laboratories, and separate distribution warehouses all at the direction of the product owner or Own Label Distributor (OLD).  Regardless of whether the OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the regulatory requirements in 21 CFR 111. The development of critical OLD processes will go a long way to ensure compliance and should include procedures such as qualification of OLD contractors; demonstration that the quality unit is fulfilling obligations of finished product specifications; a complaint system for evaluating all reported consumer concerns for the identification and reporting of Serious Adverse Events (SAEs) to FDA; and change control processes to ensure revisions are tracked and monitored.
It is also highly recommended that a Quality Agreement be established between the OLD and contractors for the assignment of quality responsibilities.


The dietary supplement industry often incorporates a complex supply chain with the use of contract manufacturers, contract packagers, contract laboratories, and separate distribution warehouses. Even more challenging is that these contractors may be internationally located. For distribution of dietary supplement products to the United States (U.S.) consumer, all of the facilities must comply with the Food and Drug Administration (FDA) dietary supplement Current Good Manufacturing Practices (cGMPs) dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well as other applicable statutory requirements such as:

  • 21 CFR 101, Food Labeling 
  • 21 CFR 190, New Dietary Ingredient (NDI) Notification
  • 21 CFR 11, Electronic Records; Electronic Signatures
  • 21 CFR 117, Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventative Controls for Human Food
  • Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) – Serious A ...
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