FDA WARNING_LETTER - Summer Infant, Inc.

The FDA issued a Warning Letter to Summer Infant, Inc. on August 12, 2010, regarding the marketing of several sleep positioner products: Mother's Touch® Sleep Positioner, Head-n-Back® Sleep Positioner, Supreme Sleep Positioner with Heartbeat, Resting Up® with Heartbeat Sleep Positioner, and Symmetry Sleep Positioner.

The FDA determined these products are "devices" under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). The company's website describes these products as designed to keep babies centered in the crib, sleeping on their back, aiding digestion, and preventing Plagiocephaly (Flat Head Syndrome) through a TOTS reminding system.

The products are deemed adulterated under section 501(f)(1)(B) of the Act because Summer Infant, Inc. lacks an approved premarket approval (PMA) application (section 515(a)) or an approved investigational device exemption (IDE) (section 520(g)). They are also misbranded under section 502(o) of the Act for failing to notify the FDA of their intent to introduce the devices into commercial distribution, as required by section 510(k).

Summer Infant, Inc. is required to take prompt action to correct these violations. Failure to comply may result in regulatory actions including seizure, injunction, and/or