The mechanism of distribution is important in capturing the attention of the dentist and the office staff so that when the material arrives at the office, it will not be lost among the myriad of bills, magazines, advertising material, and bulk mail. The Regulatory Work Group is not aware of unethical practices by manufacturers regarding bogus claims of toxicity from dental amalgam, and the promotion of amalgam removal and replacement by other materials. Some manufacturers have promoted their products as alternatives to dental amalgam, which they are. There are reports that some individual dentists are promoting this practice to patients in their individual offices. The present assessment of the ADA is that it is difficult to determine the extent of this activity.
Advertising is considered to be labeling.
If individual dentists were participating in false advertising such as claiming that dental amalgams are toxic to humans or causative agents for diseases, and if literature purporting these claims were on the premises of the dentist's office, FDA would have the authority to take legal action against that dentist. However, this situation is unusual in comparison to the more common case of illegal use of a device. In view of this, the Regulatory Work Group feels that it would be more appropriate for this issue to be handled by State licensing and regulating bodies, or by the state professional association, i.e., State dental association. If there does not appear to be a problem, or if the problem is a minor one, States may elect to issue voluntary guidelines. If, however, the problem becomes blatant, and could adversely affect the dental profession as a whole, the State may wish to develop mandatory regulations.