FDA Issues Letter Against "SIDS Prevention Claims" for Baby Products
On October 17, 2011, the Food and Drug Administration issued a public letter to corporate CEOs regarding baby products that claim to prevent or reduce the risk of sudden infant death syndrome (SIDS). In addition, on October 18, the American Academy of Pediatrics expanded its guidelines for infant sleep safety and SIDS risk reduction. Both the FDA and AAP state that soft objects should not be in the crib, including pillows, blankets, or bumper pads. FDA also stated that infant sleep positioners should not be used in cribs.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
Highlights of the FDA letter includes the following information:
Baby Products that Claim to Prevent SIDS Are a "Medical Device"
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.
2000 Letter Issued on Mattresses and Positioners
In 2000, the FDA issued a public letter notifying manufacturers and distributors of baby products, specifically baby mattresses and infant sleep positioners, that these products are considered medical devices under the law if they make medical claims regarding SIDS.
2010 FDA/CPSC Warning Issued on Infant Sleep Positioners
More recently, in September 2010, the FDA and the Consumer Product Safety Commission (CPSC) 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.
FDA Has Not Cleared any Devices to Prevent or Reduce Risk of SIDS
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 Shows Crib Mattress Should be Firm and Free of Objects
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.
Current Labeling and Packaging Should be Reviewed, Any Infractions Immediately Stopped
The FDA recommends that the industry review its current labeling, packaging, and advertising for any direct or implied claims that a baby product can prevent or reduce the risk of SIDS. If such labeling, packaging, or advertising (including print and online) contains claims to prevent or reduce the risk of SIDS, the company is in violation of the FD&C Act and must (i) immediately stop marketing those products until FDA clearance or approval for the claim is received or (ii) change the labeling, packaging, or advertising to remove all medical claims and ensure the products are not marketed as medical devices.
Additional FDA information available here.
AAP's expanded guidelines available here.