Proposed Laws Highlight Importance of Disclosure
Even though there have only yet been official reports of two dental crowns (from Chinese dental labs) tainted with lead, that’s more than enough to make a lot of people very worried. And the relationships between American dental patients, dentists and dental labs are receiving more public attention than ever before.
The National Association of Dental Labs (NADL) has been campaigning the FDA for years to improve its regulation of dental laboratories. Of course the FDA already has regulations for foreign dental labs that export to the United States. But critics point out that inspections are minimal.
In addition, dental prostheses are in an import class of their own. Unlike virtually everything else, the FDA does not regulate the final products themselves, only the materials used in their fabrication. There’s no data on this point, but many worry that unethical labs may not be using the high-quality materials they report using, instead replacing them with less expensive alternatives. And China is already under the microscope for doing just that with other products such as pet food, toothpaste and cough syrup.
One of the issues this current scandal has highlighted is how little American consumers know about what’s in their mouths. Your shirt has a tag telling you it was made in China. The same message is imprinted on your dishes, stamped on your furniture, written on your user’s guide. But your dental crown that was made in China? No one ever tells you that.
Canadian dental patients have to sign an informed consent form before their dentists can give them a dental prosthetic manufactured outside of Canada. American dentists, on the other hand, aren’t even required to tell their patients where their dental bridge or crown was manufactured.
Now, a wave of new legislation has been proposed to help close that gap.
One such bill was recently introduced before the New York State Assembly. “Consumer protection is very important to me,” said Assemblyman Rob Walker, author of the bill. “If the bill is passed and signed by the governor, dentists will have to notify consumers where the actual prosthetic was made.” Dental patients would also be told what materials were used to make it. (Read more)
A similar bill was also introduced in Alabama. The synopsis of The Alabama Consumer Dental Act of 2008 reads as follows:
This bill would require dentists to provide prior written disclosure to their patients if any fixed and/or removable dental prosthetic device or appliance, whether fabricated in part or completely, including, but not limited to, a complete or partial denture, veneer, inlay, onlay, crown, or bridge, is manufactured outside of the United States and to provide that failure to make such a disclosure would be grounds for disciplinary actions.
South Carolina first introduced dental lab legislation a year ago. It focuses not on doctor-to-patient disclosure, but rather lab-to-dentist disclosure. The bill, which is still in committee and has yet to be approved, would:
- …require a dental laboratory that performs dental technological work outside of this state to employ a person who is registered by the state board of dentistry to authorize such work based on the prescription of a dentist licensed in this state,
- …require the laboratory to provide information on where the work was performed, and
- …require the laboratory to provide a list of the materials used in the work.
Similar legislation has been proposed in Florida in response to the lead scare. “This legislation is proactive and helps the state of Florida protect its citizens in light of recent documented cases of lead contamination in dental work coming into the U.S. from foreign countries.” The bill would:
- …require dental laboratories that operate in Florida to disclose to dentists where a product was manufactured and what materials were used in each restoration, and provide certificates of authenticity if available. (Although, the bill does not address this information going to the patient, under existing patient rights, a patient may request a copy of this information for their records from their dentist.)
- …require dental labs in Florida have a full-time technician who maintains 18 hours of approved continuing education in dental technology every two years.
Within the next month, we should hear the results of more tests, so we’ll have a better handle on the scope of this potential problem. But regardless of what the research reveals, you can bet that more states will be introducing similar legislation. (It’s already in the works in Michigan, Mississippi, Minnesota, Kansas, and California.)