Proposed Requirement Highlights

• Consumer product quality complaints related to CGMP's

  • product quality complaint examples include superpotent, subpotent, wrong ingredient, contaminant (e.g., bacteria, pesticide, toxin, glass, lead, drug)
  • review product quality complaints
  • investigate product quality complaint when possible relationship between consumption and an adverse event

  • keep consumer product quality complaints related to CGMP's

• Consumer complaint NOT related to CGMP is related to safety of a particular dietary ingredient independent of whether the product is produced under CGMP's