The FDA recently published a consumer webpage with updated guidance on clear aligners.
Seven notes:
1. The webpage explains the benefits, risks and appropriate use of clear aligners, including the importance of an in-person examination before treatment and ongoing supervision by a licensed practitioner during treatment.
2. The webpage also clarifies the FDA’s position on direct-to-consumer clear aligners:
“The FDA has not authorized clear aligners that are sold directly to consumers without a prescription and supervision by a dentist or orthodontist,” the webpage states. “Using clear aligners without proper professional supervision may increase the risk of complications.”
3. The new resource comes after years of advocacy from the American Association of Orthodontists at the state and federal levels, according to a Sept. 16 news release.
4. The AAO met with FDA officials in 2024 to share clinical stories related to direct-to-consumer clear aligners, prompting requests for more information from the FDA. The AAO then asked its members to sign a letter to the FDA highlighting the risks and harms related to direct-to-consumer clear aligners. These discussions continued in 2025 and 2026.
5. The FDA committed to further evaluating direct-to-consumer orthodontic appliances through the agency’s oversight of Class II medical devices.
6. The AAO-backed Oversight of Responsible Teledentistry for Healthy Outcomes Act was introduced in July 2026 to establish standards for orthodontic treatment delivered through teledentistry, including the requirement of certain actions before treatment begins.
7. Additionally, the AAO’s advocacy has led to nine states enacting legislation that requires in-person examinations before orthodontic treatment.
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