Quick answer
DSHEA structure/function claims are permitted when phrased correctly, supported by substantiation, and paired with required disclaimers.
What qualifies as structure/function
Acceptable claims describe normal body support functions; disease-treatment claims create high enforcement risk.
Substantiation and records
- Maintain scientific substantiation for each active claim.
- Track claim language versions and where each variant is used.
- Retain approval records for label and digital copy.
Review workflow
Use a claim register with risk ranking and escalation for ambiguous wording.
Related links
labeling playbook, warning letter template, supplement hub.
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