FDA Archives - The Wealthy Dentist

FDA Finally Takes a Stand on Mercury… Sort Of

February 15, 2019 By Jim Du Molin

Agency Promises to Make a Decision Next Year

The Food and Drug Administration (FDA) has long avoided taking a public stand on the safety or danger of mercury in silver dental fillings. However, with a recent settlement in a lawsuit brought by the organization Moms Against Mercury, the governmental health agency has finally agreed to take a stand on the issue. Eventually.

The agreement calls for the FDA to complete its reclassification of dental amalgam by July of 2009. (The agency began that process in 2002.)

Some news articles have heralded this as a major change in the FDA’s attitude toward amalgam, with headlines making grand proclamations about a new post-amalgam era.

Can you guess which of the following is not a genuine headline?

These are attention-grabbing headlines, to be sure! The problem is, they’re not necessarily true per se. (And okay, I made the last one up.)

In the ADA’s response to news of the decision, the dental organization disputes these suggestions. “As far as the ADA is aware, the FDA has in no way changed its approach to, or position on, dental amalgam,” reads the statement.

As part of the agreement, the FDA has updated the consumer information provided by its website on the subject of mercury and dental amalgam.

“Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. FDA’s rulemaking will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses.”
— Questions and Answers on Dental Amalgam (FDA Consumer Information)

What do you think? Is this a new era, or just more of the same?

Filed Under: Dental News, Legal Tagged With: Amalgam, Dental, dentist, dentistry, dentists, FDA, fillings, mercury

Nanotechnology in Dentistry Could Save Us… Or Could Kill Us

February 15, 2019 By Jim Du Molin

We’ve been talking recently about silver nanoparticles and if nanosilver will be the new amalgam. This week, we’ll try to piece together some of the scientific evidence about nanotechnology.

Nanomaterials have been defined by the EPA as “particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.” That’s pretty tiny, given that there are one billion nanometers in one meter.

Why Newly-Discovered Ingredients Do Not Always Belong in Toothpaste

People tend to get enthusiastic about new technologies, but sometimes being an early adopter isn’t a good idea.

Case in point: Doramad toothpaste, manufactured in Germany between 1940-45. The toothpaste contained radioactive thorium.
Doramad radioactive toothpaste
“Its radioactive radiation increases the defenses of teeth and gums,” read the package. “The cells are loaded with new life energy, the bacteria are hindered in their destroying effect. This explains the excellent prophylaxis and healing process with gingival diseases.” (source)

Doramad is not the only radioactive toothpaste to have been manufactured, but the story behind this World War II toothpaste is particularly interesting, involving resourceful German scientists looking for other applications for their atomic research.

The Safety of Nanomaterials

Nanoparticles behave quite differently from their regular-sized counterparts. Their comparatively large surface area increases their biological activity. Moreover, the particles themselves are much smaller than cells. Nanoparticles can be absorbed through the skin, eyes or nose. They can even cross the blood-brain barrier.

For example, although titanium dioxide is biologically inert, nano-titanium dioxide particles have been shown to damage DNA. Nano-titanium dioxide is estimated to be in over 10,000 consumer products today, including cosmetics, medicines and toothpaste.

Another major nanotech invention, carbon nanotubes have amazing strength. Unfortunately, they can also cause more lung damage than asbestos.

Nanomaterials are also ending up in our food. A thin nano coating can extend the shelf life of fruits and vegetables. Nano ingredients can make cake mixes pour more easily. Food scientists say that nanomaterials can enhance flavor, preserve freshness, or even protect the safety of our food supply.

But foods containing nano ingredients aren’t labeled as such, and the FDA isn’t regulating them.

A number of studies have indicated possible negative health effects from nanomaterials, but the scientific evidence is not yet clear. The FDA, for its part, is concerned about things that have been proven to be dangerous, but is more lax when it comes to things that have not yet proven either safe or dangerous.

Nano-Gold Face Cream

It’s not even clear if nano-gold has useful properties, but that hasn’t stopped the marketing folks from cashing in on it.

For the bargain price of only $420, you can get half an ounce of Chantecaille Nano Gold Energizing Cream.
Doramad radioactive toothpaste

This face cream costs only slightly less than actual gold.

Buy it: Barneys New York

Regulating Nano Products

When it comes to consumer products, the Consumer Product Safety Commission and the EPA are in charge. And while the EPA is not quite as laissez-faire as the FDA, their stance on nanotechnology isn’t clear either.

In 2008, the EPA fined a California company a whopping $200,000 for selling keyboards and mouses with a nanosilver coating. According to the EPA, these products should have been registered under federal pesticide law. Notably, the EPA has not issued any such fines since then. (Read more: Science Daily)

What’s the Deal with Nanosilver?

Silver is a known environmental hazard. (In fact, environmental problems were observed when silver was commonly used to develop photos.) Only mercury can be more toxic to aquatic life. And nanosilver is more biologically active than normal silver.

And now we have unregulated nanosilver in hundreds of consumer products, including toothpaste.

Read more from AOL: The Nanotech Gamble

What are your thoughts?

I’m curious as to what you all think about this. Will nanotech and nanosilver be the next dental amalgam?

Filed Under: Dental Editorials Tagged With: EPA, FDA, nano silver, nanomaterials, nanotech, nanotechnology

Dentists: BPA is Back Making Front Page Dental News Again

July 31, 2012 By Jim Du Molin

Bisphenol A (also known as BPA), a chemical used in lightweight plastics, dental sealants and dental fillings is back making news headlines once again.

First, the federal government announced this month that baby bottles and sippy cups can no longer contain BPA.

This was followed by reports from a new study stating that children getting dental fillings made with BPA are more likely to have behavior and emotional problems later in life.

The study, as reported in Pediatrics Online, “makes a strong case that in the short-term, use of BPA-containing dental materials should be minimized,” asserts Philip Landrigan, director of the Children’s Environmental Health Center at Mount Sinai School of Medicine in New York City.

The researchers in the study tracked 534 children with cavities from when each child received their first dental fillings. Over the following 5 years, the researchers noted that those children who had cavities filled with a composite material containing traces of BPA consistently scored 2 – 6 points less on 100-point behavior assessments than those who didn’t have fillings.

As reported in Science News, the researchers never administered clinical diagnostic behavioral tests to the children.

Instead, they periodically administered some widely used checklists to the children or their parents, allowing each to self-assess features such as a child’s attitudes toward teachers or others, depression, self-esteem, attention problems, delinquent behaviors, acting-out or problems with attentiveness.

Since the children were 6-12 years old at the time, these type of behaviors are not uncommon for children living with a variety of circumstances like divorce, bullying, and problems at home.

However researchers argue that the behavior problems being reported seemed to happen more with the children who had BPA fillings, causing them to believe that some dental fillings may start to break down over time, thus exposing these children to the chemical.

The U.S. government is currently spending $30 million on its own BPA research to determine the chemical’s health effects on humans.

As a dentist, what are your thoughts on the use of BPA?

For more on this story see: Putting BPA-based Dental Fillings in Perspective

Filed Under: Dental Editorials, The Wealthy Dentist Tagged With: Bisphenol A, BPA, Dental Amalgam, Dental Editorials, dental fillings, Dental News, dental research, dental science, dental sealants, dentist, dentistry, dentists, FDA, pediatric dentistry

ADA Left Holding the Bag in Dental Lab Controversy

May 21, 2008 By Jim Du Molin

When Scandal Strikes, Some Bury Their Heads in the Sand

Dentists and dental labs have been in the spotlight recently due to the news of lead-tainted dental products like crowns and bridges. Right now, we don’t know if it’s a widespread problem, whose fault it might be, or whose job it is to resolve this whole mess.

Though the story broke a few months ago, there’s been precious little actual information released on the subject. So what’s going on behind the scenes? Let’s examine the paper trail… You have to read between the lines a little, but it’s frightening how no agency seems willing to take responsibility for this public health hazard.

The correspondence starts on March 6, when the American Dental Association (ADA) sent nearly identical letters to both the Food and Drug Administration (FDA) and Centers for Disease Control (CDC). Does this circle of ineptitude remind you of anything?

Here’s what the ADA had to say to the CDC: (PDF)

“Staff members from the ADA… have been in contact with the CDC’s Oral Health Division. We are undertaking our own efforts to study the problem, including random, objective testing of prosthetics from both overseas and domestic labs and will be happy to share that information with the CDC. Of course, any such testing by the ADA is no substitute for the CDC and other government agencies performing their mandated functions to protect the health and safety of the public.

“Although we are not aware of any risk to health based on the small amount of information available, we and our patients are looking to CDC to affirm that this is true or, if it is not, take the appropriate steps to protect the public. Accordingly, we request that the CDC keep the ADA informed of its efforts to identify the extent of the potential contamination and the health effects of lead in dental prosthetics as well as any CDC plans for action.”

The ADA wrote the same thing to the FDA. (PDF)

“Staff members from the ADA divisions of Science and Government and Public Affairs already have been in contact with the FDA’s Center for Devices and Radiological Health Dental Devices Branch…. Of course, any testing by the ADA is no substitute for the FDA and other government agencies performing their mandated functions to protect the health and safety of the public.”

Let me translate: “”The ADA is doing our own research, but it’s really the FDA’s or CDC’s job to determine if this is a problem and what we should do next.”” The ADA’s point is legitimate; a professional organization should not be expected to provide the same public health services as the government.

On March 18, the ADA again wrote to virtually identical letters to both the FDA (PDF) and CDC (PDF).

“Media reports on ‘contaminated’ dental materials produced in foreign dental laboratories have become more frequent. The reports have an increasingly alarming tone and a sense of urgency since we first wrote to you on March 6. As a result, dentists are fielding more inquiries from concerned patients and there are disquieting reports of patients declining recommended treatment because of unsubstantiated fears.

“We are eager to understand the extent of any problems with dental materials, whether they are produced in foreign or domestic dental laboratories. In particular, we ask that you provide some context for claims of possible health impacts of lead in dental prosthesis in the amounts reported in the media. While recognizing that much remains to be learned about this issue, some general information from the CDC/FDA about the likelihood of harm would be of great interest to both dentists and patients and should come from the federal agency whose mission is to protect the public’s health.

“We also look to your agency to reassure patients that recommended dental treatment should not be ignored. The ADA is asking both the CDC and the FDA to consider providing a media update that will reassure the public that government agencies are taking appropriate steps to protect dental patients and that oral health care should not be postponed.”

Let’s translate that again: “Hey, guys, this goes beyond the scope of the ADA’s job… Can the government please offer some guidance?”

On April 14, the FDA responded to the ADA.

“The FDA is taking this report very seriously. FDA’s Center for Devices and Radiological Health (CDRH) is also working to obtain information on the presence of lead in dental prosthetics.

“At this time, FDA will not be issuing a consumer update; however, the agency will consider further actions after careful examination of the scientific evidence.”

Translation: “Sorry ADA, the FDA has nothing to say on the topic. Ask us again later.”

On April 17, the CDC replied to the ADA’s letters.

“Thank you for your correspondence regarding media reports about the lead content in a dental prosthesis made in a dental laboratory in China. The CDC became aware of this issue through conversations with staff at the ADA’s Divisions of Science and Government and Public Affairs and through media interest in this story.

“As you indicated, the FDA has regulatory authority over dental products, including dental prosthetic materials, and for the registration of foreign laboratories that import dental products into the United States. It is our understanding that the FDA is already acting on this information, At this time, CDC has had no formal request for any type of engagement from a state of local health authority.

“Although CDC has no specific information regarding the case to which you refer, we can provide you with some general information on lead exposure. Many consumer products contain lead in trace amounts, and federal regulations limit the amount of lead in consumer products… Certainly, CDC recommends against the unnecessary use of lead in consumer products, including dental crowns.

“The recent media reports of lead in dental porcelain/metal crowns suggest a level of approximately 200 parts per million. Such small amounts of lead as reported, however, are extremely unlikely to cause adverse health effects in adults because the dental products wear out slowly, so the lead would be released in tiny amounts over time. Even at an increased rate, it is highly unlikely that this amount would be a health risk to an adult.

“It is our understanding that testing for potential leaching of lead from these products is being conducted in ADA laboratories. CDC would be happy to assist ADA in interpreting the health impact of the testing of dental porcelains/meals that is currently underway. CDC will also provide any support if requested from the FDA, as that agency conducts further testing of these products.”

Translation: “It’s the FDA’s job, not the CDC’s. Maybe it’s the ADA’s job, but definitely not the CDC’s. And the amount of lead in dental prostheses is probably safe.”

Are you as amazed by what you’re reading as me?!? Here are a few of the most bothersome points:

“It is our understanding that testing for potential leaching of lead from these products is being conducted in ADA laboratories,” writes the CDC, suggesting that it is the ADA’s responsibility to monitor the safety of dental products. The ADA is a private, voluntary professional organization funded by dues from member dentists. Testing and regulation is the government’s job, not the ADA’s.
The ADA points this out in their initial letter, saying that “testing by the ADA is no substitute for the FDA, CDC and other government agencies performing their mandated functions to protect the health and safety of the public.”
“The CDC became aware of this issue through conversations with staff at the ADA and through media interest in this story,” wrote the CDC.
Really?!? Why was the ADA the one to bring this issue to the CDC’s attention? Does the CDC only investigate health threats that receive media attention?
“At this time, FDA will not be issuing a consumer update; however, the agency will consider further actions after careful examination of the scientific evidence,” says the FDA.
The FDA took over a month to respond to the ADA. The organization in charge of regulating dental materials (you know, making sure they’re safe and lead-free) hasn’t offered the public any guidance on this threat.

The CDC’s passing the buck to the FDA, and the FDA doesn’t appear to be doing much of anything. But dentists are worried, patients are panicking, and public is desperate to know more. As the public face of dentistry in the US, the ADA is now forced to stand in for do-nothing government agencies. Doctors, it’s time to put on your hip-high waders… it is going to get really deep before anyone in the government takes action or gives definitive guidance.

Want to catch up on our coverage of this story?