FDA Requirements for Mercury Fillings
- The FDA's requirements for mercury fillings are based on the premise that low exposure to mercury is safe.operation dental image by Andrey Kiselev from Fotolia.com
After years of wrangling with anti-mercury protesters over the health concerns of amalgams used in dental work, the Food and Drug Administration issued final requirements on the subject in July 2009. The FDA officially declared that the levels of mercury off-gassed in dental amalgams, or fillings, are not high enough to be harmful to human health, despite a new, more serious Class II designation of risk. With this ruling came regulations and special controls that the FDA has the authority to impose. - The FDA maintains that labeling connected to dental amalgams must provide a caveat that specifically disallows their use in anyone who suffers from a mercury allergy. Also, the label must caution dental personnel that proper and sufficient ventilation be used whenever dental amalgams are handled. Labeling must include language about both the risks and benefits of the use of amalgams, in particular the risk inherent in the inhalation of gaseous mercury.
- The FDA makes recommendations for dental professionals to follow when conveying information about dental amalgams. Dentists should tell patients that mercury off-gassed at high levels is confirmed to deleteriously affect the brain and kidneys, the FDA says. Also, mercury gas levels are at their peak just after insertion or removal of amalgam fillings but recede precipitously soon after.
With respect to mercury exposure and children, it has yet to be proven clinically that amalgams pose a health risk to children older than 6 years of age. In addition, two pediatric studies found no brain or kidney problems in children older than 6. However, fetuses and very young children may be more susceptible to the toxicity inherent in vaporized mercury. - The FDA deems dental amalgams a Class II risk, which places them in a moderate category. The administration had previously considered the mercury component of the amalgam to be of low risk. With the new, more serious classification, the FDA has the authority to place special controls to ensure that amalgams are used in a safe and efficacious way. In dispensing this authority, the FDA issued guidelines with respect to practitioners and patients alike
