Baby Products with SIDS Prevention Claims

The FDA announced that the agency has never cleared or approved a baby product to prevent or reduce the risk of SIDS. The Agency is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS.

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. Additional information may be found on our website, available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SIDSPreventionClaims/default.htm

The purpose of the above mentioned website is to:

• help manufacturers of baby products understand and comply with the FDA laws and regulations for medical devices and
• educate parents and caregivers about the risks of using over-the-counter baby products marketed with SIDS medical claims.

Additional information can be found at the links below:

• Letter to Manufacturers: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm275776.htm
• Consumer Update: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm275847.htm

If you have questions or comments, please feel free to contact Andrea C. Furia-Helms.