Dental Sleep Medicine Experts Call on the FDA to Protect Consumers
The American Academy of Dental Sleep Medicine is urging the FDA to educate consumers about the risks of unproven over-the-counter sleep apnea devices and the importance of professionally supervised treatment.
More than 80 million Americans deal with obstructive sleep apnea (OSA) in which the upper airway either partially or completely collapses during sleep.1 Impacting oral, cognitive, cardiovascular, and mental health, OSA requires appropriate diagnosis and treatment by healthcare professionals. This group includes dentists and dental hygienists dedicated to treating OSA and snoring.
The professional group representing such oral health professionals, the American Academy of Dental Sleep Medicine (AADSM), is currently not happy. Collectively, the AADSM wrote a letter to Owen Faris, PhD, the director of the Office of Product Evaluation and Quality for the United States Food and Drug Administration, asking him to create a FDA webpage advising consumers on oral appliances designed to treat OSA. The AADSM asserts that consumers need to know that these oral appliances need a prescription and/or supervision by a license practitioner in order to be effective and to avoid harm.
The AADSM noted that the FDA had a webpage dedicated to clear aligner therapy that emphasized the importance of seeking treatment from a licensed orthodontist. Many over-the-counter options to treat OSA — such as micro-CPAP devices, which fit into the nostrils and purport they cure snoring; “boil and bite” mouthguards; and anti-snoring gadgets — have no evidence of efficacy and may actually hurt consumers. Click here to read more.
Reference
- Sönmez I, Dupuy AV, Yu KS, Cronin J, Yee J, Azarbarzin A. Unmasking obstructive sleep apnea: Estimated prevalence and impact in the United States. Respir Med. 2025;248:108348.
