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The American Dental Association has asked the Federal Trade Commission to “investigate false and misleading claims made by SmileDirectClub, LLC to entice consumers to purchase products and services.” The ADA is concerned specifically with SmileDirectClub’s marketing and direct-to-consumer sales of plastic teeth aligners, which it says do not follow the adequate safeguards required by law.
In a letter sent June 27 to the FTC’s Bureau of Consumer Protection, the ADA outlines what it asserts are SmileDirectClub’s “unfair and deceptive” practices as defined by the FTC.
Founded in 2014, SmileDirectClub, according to its website, “represents 95% of the doctor-directed at-home clear aligner industry.” However, the ADA believes that despite SmileDirectClub’s claim that its customers receive the same level of dental/orthodontic care as dental patients, in fact “SmileDirectClub and its ‘affiliated dentists’ provide virtually no care.” ADA also says that the company’s claim to use teledentistry is false.
ADA’s letter also explains other deceptive practices committed by SmileDirectClub, including a hidden waiver-of rights-clause and a claim to correct certain orthodontic problems but later pointing to contradictory language when customers complain about poor outcomes.
The complaint letter to the FTC follows the ADA’s earlier action of filing a citizen’s petition with the Food and Drug Administration. Distinct from the complaint letter, the petition dated April 25 focuses on SmileDirectClub’s noncompliance with the FDA’s prescription-only requirement with respect to plastic teeth aligners and how such conduct poses dangers to public health and safety.
“The ADA took these actions out of concern for patient safety and to enable consumers to take action when negative treatment outcomes occur,” said Dr. Jeffrey M. Cole, ADA president, in a statement. Dr. Cole went on to describe the harm that can occur – from bone loss to bite problems and jaw pain – when teeth are moved without having a comprehensive picture of a patient’s oral condition.
Dentists and other health care professionals, as well as patients, can use the FDA’s voluntary reporting form to report poor clinical outcomes associated with medical devices. Fillable PDFs are available on the FDA website.
Additionally, after a dentist has evaluated a patient and has determined that the patient may have received past dental services that fall below the standard of care, especially if patient harm has occurred, they should recommend that their patient file a complaint with the dental board. According to the consumer complaint-form instructions, it is important for the patient to identify the dentist or other dental provider who provided the treatment being complained about. Complaints can be filed online or mailed directly by visiting dbc.ca.gov.
Legislation adds consumer protections
CDA is currently supporting Assembly Bill 1519 (Low, D-Campbell), which provides additional consumer protections such as preserving patients’ rights to submit complaints to the dental board, requiring the disclosure of a dentist’s license information prior to treatment and maintaining a uniform standard of care for orthodontic services received in person and through teledentistry.
Dentists can contact their legislator to urge them to support AB 1519. A letter of support is available at cda.org/ab1519.
CDA will keep members updated on the status of the ADA’s complaint with the FTC and with the legislation CDA is supporting.