ADA Sets Record Straight on Status of Petition to FDA Regarding SmileDirectClub
ADA’s pending citizen petition submitted to the FDA about SmileDirectClub’s marketing & direct-to-consumer sales of plastic teeth aligners is active.
The ADA’s pending citizen petition submitted to the U.S. Food and Drug Administration about SmileDirectClub’s marketing and direct-to-consumer sales of plastic teeth aligners is very much active, contrary to inaccurate public statements from SmileDirectClub stating otherwise, according to a statement Oct. 9 from Association President Chad P. Gehani.
SmileDirectClub inaccurately stated in an Oct. 4 news release that the ADA’s petition has been “shut down” and “dismissed.” The news release was apparently based on a May 30 letter from the FDA to the ADA, which stated, “We appreciate the information [the ADA] provided. Such information is often helpful for us to identify problems with marketed products and possible violations of the laws and regulations that we enforce. We take complaints seriously and we will evaluate this matter to determine what follow-up action is appropriate.”
The letter further explains that the FDA does not initiate enforcement actions on behalf of petitioners. Instead, the FDA reviews the submitted evidence and decides for itself what action to take. All substantive issues raised by the ADA’s citizen petition remain fully before the FDA at this time.
The FDA’s MedWatch voluntary reporting form may be used by both consumers and health care professionals to report poor clinical outcomes associated with medical devices, including plastic teeth aligners. The comment period for the public to address the petition and for the ADA to supplement the petition is open until Oct. 22 at 11:59 PM.
People can also provide comments on the petition at https://www.regulations.gov/document?D=FDA-2019-P-2038-0001.
Read More at ADA.org
SmileDirectClub inaccurately stated in an Oct. 4 news release that the ADA’s petition has been “shut down” and “dismissed.” The news release was apparently based on a May 30 letter from the FDA to the ADA, which stated, “We appreciate the information [the ADA] provided. Such information is often helpful for us to identify problems with marketed products and possible violations of the laws and regulations that we enforce. We take complaints seriously and we will evaluate this matter to determine what follow-up action is appropriate.”
The letter further explains that the FDA does not initiate enforcement actions on behalf of petitioners. Instead, the FDA reviews the submitted evidence and decides for itself what action to take. All substantive issues raised by the ADA’s citizen petition remain fully before the FDA at this time.
The FDA’s MedWatch voluntary reporting form may be used by both consumers and health care professionals to report poor clinical outcomes associated with medical devices, including plastic teeth aligners. The comment period for the public to address the petition and for the ADA to supplement the petition is open until Oct. 22 at 11:59 PM.
People can also provide comments on the petition at https://www.regulations.gov/document?D=FDA-2019-P-2038-0001.
Read More at ADA.org
