Labeling & Claims
Compliance
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Why Compliance Matters
Misleading or unverified claims can lead to:
🚨 FDA warning letters
🚨 Product recalls & legal risks
🚨 Loss of consumer trust
The FDA and FTC have strict regulations on what brands can say on their labels and in marketing materials, including websites and social media. If your claims aren’t properly substantiated, your product could be flagged as misbranded or adulterated.
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Key Regulation You Need To Know
21 CFR 101
Governs Supplement Facts panel formatting, ingredient listing, allergen declarations, and required disclaimers to ensure consumer transparency. Non-compliance can result in warning letters or product detentions.
FTC Advertising & Marketing Guidelines
Enforces truthful and substantiated advertising claims for consumer goods. Any claim (e.g., "Supports immune health") must be backed by scientific evidence, or your brand risks legal action.
21 CFR 701 and 740
Governs cosmetic labeling including packaging form, ingredient labeling, and warning statements required. Non-compliance can result in costly recalls , warnings, or detentions.
How We Help
With over a decade of experience, we take the guesswork out of compliance by providing expert guidance and "done for you" services.
Product Label Compliance
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FDA-compliant Supplement Facts panel
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Proper ingredient listing & allergen disclosures
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Required disclaimers & formatting
Claims Substantiation & Risk Assessment
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Structure/Function claim review (e.g., “Supports immune health” vs. “Prevents colds”)
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Ensuring claims align with scientific evidence
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Identifying high-risk claims that could trigger regulatory action
Marketing & Website Review
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Ad copy & website compliance audits
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Social media claims risk assessment
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Guidance on influencer & testimonial compliance
