FDA Shamed in Media for Slow Reaction on Mercury

By Dr. Mercola

Amalgam, typically referred to as "silver fillings," is a consumer fraud perpetuated by those who, through the years, have stood to gain from its continued sale.

This includes the American Dental Association Health Foundation, the non-profit research arm of the American Dental Association (ADA), which held patents on two (now expired) amalgam formulations (patent numbers: US04078921 and US04018600).

By referring to the color of the compound rather than its content, consumers have been kept in the dark about the fact that they're placing a known neurotoxin — mercury — into their teeth.

As noted in a 2010 scientific review¹ on mercury exposure and children's health, there is no known safe level of exposure for mercury.

Ideally, exposure should be zero, so those who insist amalgams — which are 50 percent mercury — pose no threat to health are not acting in an ethical or responsible manner.

Amalgams Release Mercury Vapors

Dental amalgams readily release mercury vapors whenever you chew or brush your teeth, which pass through your cell membranes, across your blood-brain barrier, and into your central nervous system.

Effects can be psychological, neurological, and/or immunological.

One 2012 study² evaluating the effects of mercury on cognition in adults found that mild impairment was evident at blood mercury levels of 5 to 15 µg/L. Above 15 µg/L, cognition was significantly impaired.

Most people are aware that mercury is hazardous to health, but if they don't know that amalgam fillings contain mercury, then they can't object to it in the first place.

FDA Has Failed to Address Amalgam Fraud

In a report titled, "Measurably Misleading,"³ Consumers for Dental Choice, led by Charlie Brown, reveals how the dental industry and the FDA have deceived you about amalgam.

According to a Zogby poll, 57 percent of Americans are unaware that amalgam contains mercury; 23 percent believe amalgam is made of silver.

This is clear proof that the deceptive use of the term "silver filling" has worked as intended. Moreover, according to this poll, only 11 percent of people were informed by their dentist that amalgam contains mercury.

The FDA is responsible for addressing consumer fraud that occurs in medicine and health. But when it comes to mercury fillings, the agency has refused to take corrective action. In fact, the agency has and continues to support the deceptive marketing of mercury amalgams as "silver fillings."

FDA Also Broke Law By Refusing to Classify Amalgam

The FDA also has the responsibility to determine the risk of every medical device and to classify it accordingly. Dental fillings are a medical device. Yet for 32 years the FDA failed to classify mercury amalgam.

The agency broke the law, and in 2008 Charlie Brown sued the FDA over this breach. US District Judge Ellen Huvelle convened a hearing, and subsequently ordered the parties into mediation to set a date by which a classification would be completed.

The FDA agreed to classify amalgam and re-write its website by August 2009. FDA Associate Commissioner Randall Lutter and Charlie Brown negotiated the website language line by line, and, for the first time, the FDA issued this frank and serious warning about amalgam:

"Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."

Conflicts of Interests Likely Influenced FDA Amalgam Rule

But then the long arm of the industry stepped in. Then newly-appointed FDA Commissioner Margaret Hamburg⁴ came straight from Henry Schein, Inc., the largest seller of dental products, including amalgam, where she'd spent five years serving on the company's board.

To get appointed as FDA Commissioner, Hamburg was required to sign an agreement promising to sell her Schein stock and stock options,⁵ and not to participate in regulator matters affecting Schein while owning these options.

However, not only did she retain Schein stock options, she also allegedly continued regular correspondence with Schein's general counsel on her private e mail.

On June 1, 2009 Charlie Brown wrote her, asking her to confirm that she had indeed recused (disqualified) herself from working on the pending amalgam rule. She never answered.

Instead she convened a meeting with FDA's pro-amalgam dentist Susan Runner, and a rule was subsequently created that allowed for the continued concealment of mercury.

At the end of July, Runner unveiled the new rule, and the website language Brown and Associate Commissioner Lutter had agreed upon was replaced. By then, Hamburg had also transferred Lutter to another agency.

After the rule was announced, Schein's general counsel wrote to Hamburg saying that Schein is "indebted" to her for her work as Commissioner.

The FDA's 2009 rule classifies amalgam as a Class II medical device, which spares manufacturers from proving the product's safety. Class III devices, which would have been a far more appropriate classification, are considered more risky, and require proof of safety prior to marketing.

Remarkably, the agency also said that no environmental impact study of dental amalgam was necessary, and while claiming amalgam is an affordable choice for low-income people, it did not take into account the steep environmental costs of amalgam's use...

It took another year before the tide began to turn. In 2010, the international community gathered together in a series of meetings to hammer out a treaty addressing all sources of mercury pollution, including dental amalgams.

As mentioned, the treaty was finalized and signed in 2013, at which point the FDA's outdated stance became even more untenable.

State Department Urged to Press FDA to Curb Dental Mercury

In the summer of 2014, a group of dentists, scientists, and patients filed a lawsuit against the FDA,⁶ claiming  the agency "hasn't done enough to address any potential health hazards of amalgam and that it's low income groups... who often end up with these fillings because they don't have a choice..."

Consumers for Dental Choice also took the issue to the US Secretary of State, John Kerry, who signed the Minamata treaty on mercury in 2013 on behalf of the US government. The Minamata Convention includes a pledge to scale down amalgam use effective immediately.  The FDA's stance on amalgam is in direct violation of the Minamata Convention, as its current amalgam rule actually advocates more mercury fillings, not less!

Following the signing of the mercury treaty, Consumers for Dental Choice created a petition to the Secretary of State, urging him to insist the FDA comply with the treaty, and to disclose the presence of mercury in dental amalgam. Many of you signed this petition, and now the movement got a major boost from 60 American and foreign environmental groups who, in a well-publicized letter⁷ dated September 21, join in the call for the Secretary of State to "take a leadership role in encouraging FDA to reduce amalgam use."

FDA's Stance Sends Embarrassing Message to Treaty Partners

Aside from the health risks of having mercury implanted in your teeth next to your brain, dental amalgams are also a significant environmental polluter. As noted by The Sacramento Bee:⁸

"A 2013 report by the US Geological Survey said dental mercury fillings now account for 35 percent to 57 percent of the nation's end-use mercury products. One study found an estimated 28.5 tons of mercury dental waste had been released to the environment...

The Minamata treaty aims to protect people around the world by limiting environmental emissions and releases of mercury into the environment... Its name stems from a disaster in the 1950s when more than 1,700 people who lived near Japan's Minamata Bay died after eating fish contaminated by mercury-laden wastewater from a chemical plant."

The US was the first of 128 countries to sign the mercury treaty two years ago. Yet embarrassingly, the FDA has not taken a single step toward fulfilling its international promise to phase down amalgam use. Eight other nations have already cut their use of dental mercury by 95 percent. This includes Norway, Sweden, Japan, the Netherlands, Finland, Estonia, Italy and Denmark.

According to Michael Bender, director of the Mercury Policy Project: "Unless FDA's policies toward amalgam phase down are changed, it may undermine mercury reduction efforts in the US. It also could send the wrong message to other Parties to the Minamata Convention."

Congratulations! Your Support Is Paying Off!

Over the last several years, I've repeatedly called on your help to support the work Charlie Brown and Consumers for Dental Choice are doing, and you have consistently delivered — with financial donations and signatures on various petitions. The latest media focus on this issue could not have come without your dedicated support and participation. More often than not, grassroots efforts such as these are tough going. But it is working, and you can pat yourselves on the back for making it happen.

As noted by Charlie in a recent newsletter update:

"The letter from these environmental superstars is a culmination of years of our bridge-building with environmental groups. In the movement to abolish mercury fillings, we hold many cards: amalgam can harm consumers' health, risk dental professionals' health, pollute the environment, violate consumer rights, and inflict social injustice. We will play each and every card needed to win... and we are going to win."

Three Ways You Can Help Make Mercury-Free Dentistry a Reality for All

There are amalgam phase-out campaigns in Europe, Asia, Africa, Latin America, and the US, where efforts are now focused on pressuring the FDA to uphold the promise made by the nation when it signed the Minamata treaty on mercury pollution. It's quite simple. The US made a promise to the international community to immediately begin reducing the use of amalgam, and the FDA is in direct violation of this promise.

It's an embarrassment to the White House and the entire country that the FDA is refusing to take the most basic of steps toward the phase-down of mercury fillings, which is to inform consumers that amalgam is made with mercury, allowing them to make an informed choice. Consumers for Dental Choice has proven itself as an effective and efficient NGO, and your support will allow them to continue working on our behalf to protect human health, especially minorities and the underprivileged, and the health of the environment. There are three ways you can help Consumer's for Dental Choice succeed:

1. Use only mercury-free dentists. If your dentist still offers amalgam as a choice, switch to one who will not put mercury in anyone's mouth. Also be sure to let your dentist know why you're leaving.
2. Join Consumers for Dental Choice's newsletter list on ToxicTeeth.org, or Mercury-Free.org, or write to Charlie at [email protected].
3. Make a donation to Consumers for Dental Choice.