Presently, all extracoronal tooth bleaching products remain unclassified by the FDA. This includes all peroxide-based products used in the in-office, dentist-dispensed products for at-home use, OTC (patient-purchased) products, as well as products used in non-dental settings.
In the early 1990s, the FDA proposed regulating the peroxide-based bleaching materials as drugs and sent warning letters to manufacturers.
Tooth whitening products are developed and marketed according to U.S. ―cosmetic‖ regulations. These regulations are more limited than those for drugs or medical devices. This may lead to the perception that the products are innocuous, though they have the potential to cause harm and may result in undesirable effects to the teeth or oral mucosa.
The recent appearance of tooth-bleaching businesses in non-dental settings has led to state dental board decisions, attorney general opinions, and legislation in some states. Some jurisdictions have taken recent action to better limit patient risks associated with tooth bleaching. These include: Florida, Iowa, Massachusetts, Nevada, New Jersey, Tennessee, and the District of Columbia.
Concerns regarding tooth bleaching in non-dental settings have been raised. Non-dental personnel are not educated in the use of disease screening or diagnostic tests (such as radiographs), and are not licensed or qualified to provide dental examinations. Dental and other healthcare workers receive required education and training in infection control procedures to protect patients and themselves from infectious diseases that may be spread by blood or saliva. The staff in non-dental facilities are not licensed and the level of education and training in infection control or other important emergency and safety procedures is unknown.
Tooth bleaching in the United Kingdom (U.K.) emerged in conflict with existing regulations that applied to hairdressers and the use of hydrogen peroxide. Steps toward resolution of this conflict are underway, including an extensive review of tooth bleaching safety data. As noted previously, the Scientific Committee for Consumer Products (SCCP) in Europe supported the safety of tooth bleaching materials containing up to 6.0% hydrogen peroxide for use by dental professionals.38 The FDA’s position was challenged legally, and in alignment with court decisions, the FDA suspended attempts to classify the bleaching materials. To date, the FDA has taken no further action to classify tooth bleaching products. 3 Such adverse effects are generally related to low pH and poor product quality. 13,23 It is expected that this SCCP recommendation will eventually be ratified by the European Council and by the U.K. government. The timeline for these actions is unclear at present.
In the early 1990s, the FDA proposed regulating the peroxide-based bleaching materials as drugs and sent warning letters to manufacturers.
Tooth whitening products are developed and marketed according to U.S. ―cosmetic‖ regulations. These regulations are more limited than those for drugs or medical devices. This may lead to the perception that the products are innocuous, though they have the potential to cause harm and may result in undesirable effects to the teeth or oral mucosa.
The recent appearance of tooth-bleaching businesses in non-dental settings has led to state dental board decisions, attorney general opinions, and legislation in some states. Some jurisdictions have taken recent action to better limit patient risks associated with tooth bleaching. These include: Florida, Iowa, Massachusetts, Nevada, New Jersey, Tennessee, and the District of Columbia.
Tooth bleaching in the United Kingdom (U.K.) emerged in conflict with existing regulations that applied to hairdressers and the use of hydrogen peroxide. Steps toward resolution of this conflict are underway, including an extensive review of tooth bleaching safety data. As noted previously, the Scientific Committee for Consumer Products (SCCP) in Europe supported the safety of tooth bleaching materials containing up to 6.0% hydrogen peroxide for use by dental professionals.38 The FDA’s position was challenged legally, and in alignment with court decisions, the FDA suspended attempts to classify the bleaching materials. To date, the FDA has taken no further action to classify tooth bleaching products. 3 Such adverse effects are generally related to low pH and poor product quality. 13,23 It is expected that this SCCP recommendation will eventually be ratified by the European Council and by the U.K. government. The timeline for these actions is unclear at present.
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