CLA-2-39:OT:RR:NC:N4:421
Mr. James Fallon
Apnea Sciences
27071 Cabot Road, Building #118
Laguna Hills, CA 92653
RE: The tariff classification of mouthguards
Dear Mr. Fallon:
In your letter dated October 9, 2012, you requested a tariff classification ruling.
Two samples were provided with your request and are being returned. One is marketed as SnoreRx®; the other is marketed as ApneaRx®. The products are mouthguards made of injection molded plastics. They are non-prescription devices that assist in keeping airflow open to the mouth, thus alleviating snoring. The mouthguards may be adjusted by the consumer to achieve a better fit inside the mouth.
The SnoreRx is described in the most prominent print on its packaging as “Clinically Proven Mouthguard Stops Snoring” and the ApneaRx as “New easy to use micro-adjustable mouth piece to treat snoring and sleep apnea.” The ApneaRx is further described on a side panel as an “aid for the reduction/alleviation of snoring and mild to moderate sleep apnea.” There is no indication that either is ever used for the level of sleep apnea which is usually treated with a CPAP (continuous positive airway pressure) device for artificial respiration. As you state, “Both products are designed the same, they are just labeled differently.” Both are intended for direct use by consumers at home. Headquarters Ruling Letter 966521, dated September 10, 2003, determined that a device “registered with the United States Food and Drug Administration (FDA) as a snoring preventative medical device” was not classified as a medical device for tariff classification purposes.
The applicable subheading for the SnoreRx and ApneaRx mouthguards will be 3926.90.9980, Harmonized Tariff Schedule of the United States (HTSUS), which provides for other articles of plastics, other. The general rate of duty will be 5.3 percent ad valorem.
The rate of duty provided above is the rate applicable to these products when manufactured in a country with which the United States has Normal Trade Relations.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Joan Mazzola at (646) 733-3023.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division