The new online resource emphasizes the necessity of professional supervision for clear aligner treatment, following years of advocacy by the American Association of Orthodontists.
The US Food and Drug Administration (FDA) has launched a new consumer webpage detailing the benefits, risks, and appropriate use of clear aligners. The resource explicitly states that the agency has not authorized clear aligners for direct-to-consumer sales without a prescription and supervision by a dentist or orthodontist.
The FDA guidance notes that using clear aligners without proper professional supervision may increase the risk of complications, including uneven bites, unintended tooth movement, pain, and tooth loss. It recommends in-person examinations and periodic visits during treatment to ensure safety and monitor progress.
The American Association of Orthodontists (AAO) highlighted the FDA’s announcement as a milestone in its ongoing advocacy efforts regarding mail-order orthodontic models and teledentistry.
“This announcement reflects years of sustained advocacy by the AAO and its members to elevate patient health and safety concerns associated with clear aligner treatment provided without appropriate clinical oversight,” says Mike Durbin, president of the AAO, in a release. “We appreciate the FDA’s recognition of the importance of an in-person examination and ongoing supervision by a licensed practitioner.”
History of Regulatory Engagement
The AAO has engaged with the FDA on this issue for several years, including a July 2024 meeting where the organization shared clinical examples of patient harm linked to mail-order aligners. In September 2025, an AAO delegation delivered a letter signed by 1,745 members documenting complications from direct-to-consumer treatments.
The FDA updates align with recent legislative efforts, including the Oversight of Responsible Teledentistry for Healthy Outcomes (ORTHO) Act (HR 9829), introduced in July 2026 by US Rep Brian Babin. The proposed legislation would establish federal safety standards for teledentistry, requiring an in-person dental examination and a review of diagnostic records, including X-rays, before beginning orthodontic treatment.
In addition to the new clear aligner page, the FDA updated its consumer resource comparing traditional braces with clear aligner options.
“There are many strategic layers behind patient advocacy success like this: regulatory engagement, federal and state legislation, coalition building, clinical evidence, and sustained grassroots outreach,” says Nathan Mick, vice president of advocacy for the AAO, in a release.
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