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U.S. Department of Health and Human Services

About FDA

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Is it true that "OTC ( Over the Counter)" products can prevent SIDS?

No.  Some baby products are being marketed over-the-counter with claims to cure, treat, or prevent a disease or condition. Because of these claims, these baby products are medical devices, subject to FDA regulation. However, the FDA has never cleared or approved a baby product to prevent or reduce the risk of SIDS.

Here is a resource to educate parents and caregivers about the risks of using over-the-counter baby products marketed with SIDS medical claims: