Report DTC Issues to FDA

Report issues with direct-to-consumer dental laboratory products and read about ADA efforts to address concerns.

Patients and dentists are urged to report issues with medical devices to the U.S. Food and Drug Administration, including any problems they have had with devices related to direct to consumer, or DTC, dental laboratory products.

MedWatch Reporting Form

ADA Contacts Federal Agencies About Business Practices & Patient Safety

The American Dental Association sent a complaint letter to the Federal Trade Commission’s (FTC) Bureau of Consumer Protection raising concerns over aspects of SmileDirect Club, L.L.C.’s (SDC) marketing and direct-to-consumer sales of plastic teeth aligners.

The letter was sent approximately two months after the ADA filed a citizen’s petition with the U.S. Food and Drug Administration (FDA) in April stating that SmileDirectClub is placing the public at risk by knowingly evading the FDA’s “by prescription only” restriction the agency has placed on teeth aligning materials.

The ADA took these actions out of concern for consumer safety and customer recourse when negative outcomes from this direct to consumer dentistry product occur.  For more information, read the ADA’s online news release.