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The best thing you can do to lower the chance of Sudden Infant Death Syndrome (SIDS) is to place your baby on his or her back to sleep, with nothing else in the crib or bassinet.

That’s the recommendation of the Food and Drug Administration (FDA), which is working to prevent manufacturers of over-the-counter sleep products for babies from claiming that their use will prevent or lower the chance of SIDS. These products include infant positioners, mattresses, crib bedding, pillows, crib tents and baby monitors. Baby products that claim to cure, treat or prevent any condition are considered medical devices, and are subject to FDA regulations designed to protect consumers and patients.

The agency has never approved a product to prevent SIDS—the unexplained death of a baby younger than age 1—and is asking manufacturers to stop marketing their products with these claims until they have received FDA clearance or approval, or to change their labeling to remove all medical claims.

“These products are absolutely not necessary and they can be very dangerous,” says Susan Cummins, M.D., M.P.H., chief pediatric medical officer in FDA’s Center for Devices and Radiological Health.

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FDA is aware of 13 infant deaths in the past 13 years associated with sleep positioners, which are used to keep the baby in a desired position. The Consumer Product Safety Commission has received reports of babies found in hazardous positions after being placed in a positioner.

Other products can also be hazardous. Babies can slide down and be trapped by wedges designed to keep them on their back, says Cummins. Blankets, quilts, soft toys and pillow-like crib bedding can smother, she adds.

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