What claims are risky for baby care in the U.S., and how do we avoid drug claims?

Quick Answer (for busy buyers)

Here’s the buyer-first summary. If your brand name is on the label, you usually act as the responsible person and must ensure the listing is submitted and kept current.

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• In general, for baby care in the U.S., avoid claims that imply therapeutic effects, such as ‘cures,’ ‘treats,’ or ‘prevents’ specific conditions, as these are considered drug claims and require FDA approval.
• Stick to cosmetic claims like ‘gentle,’ ‘hypoallergenic,’ or ‘moisturizing.’ For MOQ, typical ranges for baby care products start at 3,000-5,000 units per SKU, depending on complexity.
• Sampling can take 4-6 weeks for formulation and packaging approval.
• Necessary testing includes stability, microbial, and safety assessments, with documentation like CPSIA for the U.S. market.
• Packaging must be child-resistant if applicable, and lead times from production to shipping are usually 8-12 weeks.
• Always consult with a regulatory expert to ensure compliance.