October 17, 2011
CEO or President
Baby Product Manufacturer
123 Main St
Subject: Baby Products That Claim To Prevent Or Reduce The Risks Of Sudden Infant Death Syndrome (SIDS)
Dear Sir or Madam:
The Food and Drug Administration (FDA) has learned that some manufacturers are continuing to market baby products that claim to prevent or reduce the risks of Sudden Infant Death Syndrome (SIDS) without FDA clearance or approval. Under section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act) and FDA’s regulations, a baby product is considered a medical device when claims to cure, treat, prevent, or reduce a disease or condition, including SIDS, are made in the product’s labeling, packaging, or advertising. Medical devices are regulated by the FDA.
In 2000, the FDA issued a public letter notifying manufacturers and distributors of baby products, specifically baby mattresses and positioners, that these products are considered medical devices under the law if they make medical claims regarding SIDS. More recently, in September 2010, the FDA and the Consumer Product Safety Commission issued a joint warning against using infant sleep positioners because of the suffocation risk these devices pose. The joint warning cautioned manufacturers that marketing these devices with medical claims, such as those related to SIDS, without clearance or approval is a violation of the FD&C Act.
Manufacturers should be aware that the FDA has never cleared or approved any devices to prevent or reduce the risk of SIDS. Additionally, the FDA is unaware of any pre-amendments device (a device that was on the market before 1976) lawfully marketed to prevent or reduce the risk of SIDS, and is unaware of any scientific evidence that has demonstrated that SIDS can be prevented through the use of a medical device. Current research has shown that the safest sleep environment for infants is alone on their backs on a firm sleep surface, such as a crib or bassinet free of pillows, blankets, bumpers, sleep positioners, and other objects. (See the references below.)
- National Institutes of Health. Eunice Kennedy Shriver National Institute Of Child Health And Human Development (NICHD), available at http://www.nichd.nih.gov/publications/pubs/safe_sleep_gen.cfm; or
- National Institutes of Health. Eunice Kennedy Shriver National Institute Of Child Health And Human Development (NICHD) . What Does a Safe Sleep Environment Look Like? 2006. No. 06-5759, available at http://www.nichd.nih.gov/publications/pubs/upload/Safe_Sleep_2009_Eng.pdf; or
- Pediatrics-. Changing Concepts of Sudden Infant Death Syndrome: Implications for Infant Sleeping Environment and Sleep Position. 2000 Mar, 105(3 Pt 1):650-656, available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;105/3/650
The FDA recommends that you review your current labeling, packaging, and advertising for any direct or implied claims that your product can prevent or reduce the risk of SIDS.
If your labeling, packaging, or advertising (including print and online) contains claims to prevent or reduce the risk of SIDS, you are in violation of the FD&C Act.
In order to comply with FDA regulations you must immediately:
- Stop marketing your products with these claims until you have received FDA clearance or approval, or
- Change your labeling, packaging, or advertising to remove all medical claims and ensure your products are not marketed as medical devices
If you are a manufacturer and you are not sure if your baby product is a medical device, please check Device Advice: Device Regulation and Guidance.
If you have questions about what to do in order to seek FDA approval or clearance for your medical device, contact the Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041 or via email at firstname.lastname@example.org.
Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration