Snoring Relief Labs Inc. (Rancho Cordova, CA) tried to become the first company to market a self-fitting, anti-snoring mouthpiece without a prescription. Its SnorBan product required the patient to self-fit the device by placing it in boiling water advancing the jaw forward, and inserting the device. The patient determined how far forward to advance the jaw, and then took a dental impression. Advancing the jaw forward improved the patient's airway and prevented snoring.
Snoring Relief did not seek premarket approval or notification for SnorBan from the Food and Drug Administration. On September 7, 1995, the FDA notified Snoring Relief that it was violating the Federal Food, Drug and Cosmetic Act by selling SnorBan without having submitted premarket notification or receiving premarket approval.
On October 16, 1995, Snoring Relief submitted premarket notification in the form of a letter from Snoring Relief's president together with a journal article about anti-snoring mouthpieces; SnorBan fitting instructions; and a brochure written by Snoring Relief's president.
Snoring Relief contended that its product was substantially equivalent to two other anti-snoring mouthpieces, both of which were available by prescription only. Snoring Relief wanted to make SnorBan available over-the-counter, and compared its self-fitting device to athletic mouth guards. Also, its application contended that there was not an increased risk of undiagnosed sleep apnea.
On April 1, 1996, the FDA denied Snoring Relief's request to market SnorBan over-the-counter. FDA's Dental Devices Branch of the Office of Device Evaluation enlisted Dr. Susan Runner, a doctor of dental surgery and the Senior Regulatory Review Officer, to compare SnorBan to the prescription-only, anti-snoring mouthpieces. Dr. Runner concluded that marketing SnorBan without a prescription raised two new questions about safety and effectiveness: (1) it would require the patient to distinguish between simple snoring and obstructive sleep apnea, a potentially life-threatening condition; and (2) it would require the patient to determine if he or she had any temporomandibular joint (TMJ) disease that would not permit the use of an oral appliance. If the patient advanced his or her jaw too far forward in fitting the device, the patient could suffer TMJ. Dr. Runner concluded that "selection of which patients are appropriate for oral appliance therapy should always be made by the health professional." Based on this evaluation, the FDA denied SnorBan's request for an exemption and found that SnorBan was a device requiring premarket approval before it could be legally marketed.
Before and after the FDA's final decision, Snoring Relief marketed SnorBan without premarket approval. On February 22, 1996, the FDA sent Snoring Relief a warning letter about this continued violation. On April 15, 1996, Snoring Relief responded by asking for a waiver from the premarket notification requirement. Snoring Relief said its product was similar to the Stop Snore Collar, a pillow-like anti-snoring device that only required an apnea warning label. The FDA disagreed, and in a May 9, 1996 letter the FDA distinguished mouthpieces from anti-snoring devices used externally such as pillows or nasal strips.
In a July 8, 1996 letter to the FDA, Snoring Relief dismissed the distinction between intra-oral and extra-oral anti-snoring devices, and offered to provide a warning label about sleep apnea with its product. On July 23, 1996, the FDA rejected Snoring Relief's continued attempts to market SnorBan without a prescription. The FDA also warned against the illegal marketing of SnorBan, but Snoring Relief continued to distribute its unapproved device without a prescription.
On August 14, 1997, the government filed a legal proceeding alleging that SnorBan was an adulterated device under federal law because it lacked premarket approval and because it was misbranded for a lack of adequate directions for use. Following a warrant, the product was seized on August 19, 1997.
Snoring Relief responded by denying the government's claims and counterclaiming that FDA's refusal to exempt SnorBan from premarket notification or approval and its refusal to approve SnorBan were arbitrary, capricious, and contrary to law.
Both sides asked the United States District Court for the Eastern District of California for a ruling.
Judge Levi found that SnorBan was adulterated under federal law. Judge Levi also found that the seized cartons of SnorBan were subject to condemnation and that FDA's decisions refusing to clear SnorBan for non-prescription use were not arbitrary and capricious. He also concluded that FDA articulated rational safety concerns about increased risk of TMJ and undiagnosed sleep apnea.
Snoring Relief appealed to the United States Court of Appeals for the Ninth Circuit, which upheld Judge Levi's findings.
Source: United States v. Snoring Relief Labs Inc., 210 F.3d 1081 (United States Court Of Appeals For The Ninth Circuit) (May 2, 2000).