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A comprehensive regulatory risk analysis of marketing claims for the NovaBotanics Immune+ product line, covering FDA, FTC, and DSHEA compliance.
Overall Risk
High
Claims Analyzed
3
Confidence
92%
Processing Time
26s
Claim-by-Claim Analysis
Original Claim
“Our formula is clinically proven to boost immune function by 300%.”
Suggested Rewrite
“Our formula contains ingredients traditionally used to support immune health.*”
Risk Detail
Quantified efficacy claims ("boost immune function by 300%") constitute drug claims under DSHEA unless supported by adequate and well-controlled clinical trials filed with the FDA.
Rewrite Rationale
Removes quantified efficacy claim and reframes as a permissible structure/function statement with required disclaimer.
Original Claim
“Prevents cold, flu, and seasonal illness.”
Suggested Rewrite
“Provides nutritional support during seasonal changes.*”
Risk Detail
Claims to prevent, treat, cure, or mitigate a disease require FDA pre-approval. "Prevents cold, flu" is an explicit disease-prevention claim and violates both FDA and FTC guidelines.
Rewrite Rationale
Eliminates disease-prevention language. "Seasonal changes" is vague enough to avoid disease-claim triggers while remaining meaningful to consumers.
Original Claim
“Contains high-potency Vitamin C and Zinc for daily wellness.”
Suggested Rewrite
“Contains Vitamin C (500 mg, 556% DV) and Zinc (15 mg, 136% DV) to support daily wellness.*”
Risk Detail
"High potency" is a regulated nutrient content claim that requires the product to contain 100% or more of the RDI for that nutrient. Must be substantiated and properly disclosed.
Rewrite Rationale
Replaces vague "high-potency" claim with exact amounts and Daily Value percentages, satisfying FDA labeling requirements.
Supporting Evidence
FDA Warning Letter Database
Warning Letters — Dietary Supplement Claims
The FDA has issued over 120 warning letters in the past 12 months to supplement manufacturers making unapproved disease claims...
Relevance: Directly supports risk classification for Claims 1 and 2.
FTC Enforcement Actions
FTC v. Supplement Health Alliance (2025)
The FTC reached a $2.1M settlement with a supplement company for unsubstantiated immune-boosting claims...
Relevance: Demonstrates enforcement precedent for quantified efficacy claims similar to Claim 1.
PubMed / Clinical Literature
Vitamin C and Immune Function: A Systematic Review
While evidence supports a role for Vitamin C in immune function, no study demonstrates a 300% improvement...
Relevance: Provides scientific context for rewriting Claim 1 as a structure/function statement.
Audit Trail
Report Initiated
Compliance scan requested for NovaBotanics Immune+ campaign.
Claims Extracted
3 marketing claims identified from submitted copy.
Regulatory Matching
Claims cross-referenced against FDA, FTC, and DSHEA databases.
Risk Scoring
Risk levels assigned: 2 High, 1 Medium, 0 Low.
Rewrites Generated
AI-suggested compliant alternatives created for all flagged claims.
Evidence Linked
3 supporting citations attached from FDA, FTC, and PubMed.
Report Finalized
Full compliance report generated and ready for review.
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