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    Label Claims

    Indications, performance, and other statements approved or cleared for labeling.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Label claims are the statements about intended use, indications, contraindications, warnings, and performance that the FDA has cleared/approved for inclusion in labeling. Off-label promotion is prohibited.

    What this means in practice

    Salesforce training, marketing collateral, and KOL speaker decks must align with cleared label. Promotion outside the label triggers warning letters and DOJ exposure.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    FDA·1AHRMM·1AdvaMed·1
    1. 1
      FDA labeling regs
      Needs review
      FDAfda.gov
    2. 2
      AHRMM - Healthcare Supply Chain
      Verified
      AHRMMahrmm.org
    3. 3
      AdvaMed Code of Ethics
      Verified
      AdvaMedadvamed.org

    Inline markers like [1] jump to the matching reference above.