Archive for September, 2009

The Use of Chewable Fluoride Pretty Much Discontinued

September 19th, 2009 Comments Off

This is the body of an email received today. The information is old to me. It is, however, new to my website. For further information please go to my fluorosis page.

You might also be interested in reading what the Scientific American had to say about the use of Fluoride on children’s teeth.

Neither the European Dental Associations, nor Health Canada recommend fluoride supplements. They cause problems and no evidence of benefit. And further, they are illegal to market because fluoride supplements are not FDA approved.

The Pfizar settlement for $2.3 billion for “off label” marketing pales compared to fluoride supplements and fluoridation which if it goes to court in the same way would be many trillions of dollars. Simply would put any manufacturer out of business.

The science is very powerful not to ingest fluoride.

Let me know if you want more info.

Bill Osmunson DDS, MPH

—–Original Message—–
From: acesthetics@googlegroups.com [mailto:acesthetics@googlegroups.com] On Behalf Of Shirley Gutkowski
Sent: Friday, September 18, 2009 12:18 PM
To: ACEsthetics@googlegroups.com group
Subject: [ACEsthetics] Fwd: [RDH]: chewable fluoride

From the Amyrdh List:

From: []
Date: 09/18/2009 09:53

Subject: chewable fluoride

Listers,

We had a patient come in today who said her pediatrician could no longer prescrbe fluoride vitamins because one the manufactuers stopped making them. Interesting!

This was news to me.

I had to look it up and here is an article

http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=486

What do you all think?

Michele in NY

who told her they found out that the fluoride actually works topically, as in toothpastes and rinses.

Bulletin
Sodium Fluoride Chewable Tablets
19 August 2009

Products Affected – Description

Sodium fluoride 0.5 mg chewable tablets, 1000-count (NDC 52152-0127-05), Actavis – discontinued
Sodium fluoride 1 mg chewable tablets, 1000-count (NDC 52152-0128-05), Actavis – discontinued

Ethedent 0.25 mg chewable tablets, 120-count (NDC 58177-0432-40), Ethex – discontinued
Ethedent 0.5 mg chewable tablets, 120-count (NDC 58177-0433-40), Ethex – discontinued
Ethedent 0.5 mg chewable tablets, 1000-count (NDC 58177-0433-09), Ethex – discontinued
Ethedent 1 mg chewable tablets, 120-count (NDC 58177-0434-40), Ethex – discontinued
Ethedent 1 mg chewable tablets, 1000-count (NDC 58177-0434-09), Ethex – discontinued

Fluor-A-Day 0.25 mg chewable tablets, 120-count (NDC 51817-0602-16), Pharmascience
Fluor-A-Day 0.5 mg chewable tablets, 120-count (NDC 51817-0611-16), Pharmascience
Fluor-A-Day 1 mg chewable tablets, 120-count (NDC 51817-0622-16), Pharmascience

Luride 0.25 mg chewable tablets, 120-count (NDC 00126-0186-21), Colgate – discontinued
Luride 0.5 mg chewable tablets, 120-count (NDC 00126-0014-21), Colgate – discontinued
Luride 1 mg chewable tablets, 120-count (NDC 00126-0006-21), Colgate – discontinued

Pharmaflur 1 mg chewable tablets, 120-count (NDC 00813-0067-12), Pharmics – discontinued
Pharmaflur 1.1 mg chewable tablets, 120-count (NDC 00813-0065-12), Pharmics – discontinued
Pharmaflur 2.2 mg chewable tablets, 120-count (NDC 00813-0066-12), Pharmics – discontinued

Sodium fluoride 2.2 mg chewable tablets, 100 count (NDC 58223-0676-01), Kirkman – discontinued
Sodium fluoride 2.2 mg chewable tablets, 1000 count (NDC 58223-0673-04), Kirkman – discontinued

Reason for the Shortage

Actavis has discontinued their fluoride chewable tablets due to manufacturing problems.
Pharmascience states Fluor-A-Day chewable tablets are on back order due to increased demand.
Colgate has discontinued all its Luride chewable tablets. The company would not provide a reason for the discontinuation.
Pharmics has discontinued Pharmaflur chewable tablets for unknown reasons.
Ethex has discontinued Ethedent chewable tablets for unknown reasons.
Kirkman has discontinued their 2.2 mg tablets due to product formulation issues. The company plans to release a 2.2 mg tablet in the future (NDC number not available yet).

Estimated Resupply Dates

Pharmascience has all of their Fluor-A-Day chewable tablets on back order and the company cannot estimate a release date.
Kirkman has available sodium fluoride 0.55 mg chewable tablets in 100-count (NDC 58223-0675-01) and 1000-count (NDC 58223-0675-04) bottles and 1.1 mg chewable tablets in 100-count (NDC 58223-0674-01) and 1000-count (NDC 58223-0674-04) bottles.
Fluoritab is available as 0.5 mg chewable tablets in 100-count (NDC 00288-1106-01), 1000-count (NDC 00288-1106-10), and 5000-count (NDC 00288-1106-02) bottles; and 1 mg chewable tablets in 100-count (NDC 00288-2203-01), 1000-count (NDC 00288-2203-10), and 5000-count (NDC 00288-2203-02) bottles.
River’s Edge Pharma has available Renaf 1 mg chewable tablets in 120 count (NDC 68032-0384-12) and 1000 count (NDC 68032-0384-00) bottles, 0.5 mg chewable tablets in 120 count (NDC 68032-0383-12) and 1000 count (NDC 68032-0383-00) bottles, and 0.25 mg chewable tablets in 120 count bottles (NDC 68032-0382-12).

Thought the local press and elected representatives would like to see the latest about the FDA working to stuff their own wallets, and not be an ombudsman for the citizens of our nation.

On Oct 1, it will be mandatory that all dental offices in NJ be equipped with mercury separators to remove mercury from office wastewater. You might want to consider an impromptu survey. Dental salesmen in this area tell me that dentists have been loathe to comply. The penalty for not installing is $5000 and mandatory annual surveillance.

In 1997 I equipped my office with a separator, because I recognized that the dental profession was the leading, non-regulated industry in the country. To learn more, I was interviewed years ago on TV. The link is on my site at the bottom of: http://www.cent4dent.com/html/office_info/media.htm

Below, you will read some information that has come to light under the Freedom of Information Act. For more information of how this has evolved be sure to visit the blog on my website (www.cent4dent.com).
Steve Markus
The Centre for Dentistry at Haddon
209 White Horse Pike
Haddon Heights, NJ 08035
856 546 0665
—– Original Message —–
From: Charlie Brown
To: Charlie Brown
Sent: Wednesday, September 16, 2009 8:23 PM
Subject: Hamburg’s Secret Meeting; FDA’s Plan to “End Game” Our Movement

Hamburg’s Secret Amalgam Meeting; FDA’s Plan to “End Game” Our Movement

FDA Commissioner Margaret Hamburg organized and held a staff meeting to work on the mercury amalgam rule on July 1 . . . so we have learned from our freedom-of-information-act request. Indeed, the Commissioner was insistent about it — she had the meeting rescheduled several times to ensure that she could make it. Her executive assistant wrote the Center for Devices, “This meeting really needs to happen next week.” http://www.toxicteeth.org/scheduling%20briefing.pdf That same month, Dr. Hamburg was cashing Henry Schein stock options and contacted Schein directly at least once, and the next month Schein’s CEO was issuing a hale & hearty “thank you” to Margaret Hamburg.

So much for that FDA form letter to thousands of you with those bogus claims that Commissioner Hamburg was “not involved.” Dr. Hamburg enlisted her staff to spread information she knows (and they too almost certainly know) is not true. Dr. Hamburg already conceded she had an ethical problem that required her not to participate in the rule-making — hence the motive to conceal the July 1 meeting from us.

FDA leaders realize that they set off an international uproar with their mercury amalgam policy. Their rule conceals the mercury from American consumers, especially the most vulnerable — pregnant women and young children. FDA’s rule hands corporate giants like Henry Schein Inc. the ability to sell mercury-based dental products without disclosures or warnings, denying consumers the fundamental right to make their own informed decisions about their health. All along, FDA’s top brass has been hoping against hope that we would never find out about Margaret Hamburg’s staff meeting on the amalgam rule.

So is FDA concerned about consumers? No, FDA is working on a plan to silence us.

The “ problem,” said George Strait, FDA Assistant Commissioner for Public Affairs, in an August 14 memo to Commissioner Hamburg, Deputy Commissioner Joshua Sharfstein, and media aide Mary Pepper Long, “is that there will be no end to Brown,” http://www.toxicteeth.org/endgame-email-from-Strait.doc Strait proposes a solution, and it’s this:

“A communications end game re: Brown.”

So FDA wants to silence this movement. FDA wants to stop us from exercising our First Amendment rights to speak out against its heartless action against America’s children

Today I wrote my letter to Congress, which will be posted soon on our newly revised website, www.toxicteeth.org; now it’s your turn.

Here’s how you call and write your Congresswoman or Congressman in Washington: go to https://writerep.house.gov/writerep/welcome.shtml; choose your state, enter your zip, then click “Contact My Representative.”

Talking Points to your Representative (that is, your Congressman/Congresswoman)
* FDA’s rule conceals the mercury in amalgam from consumers.
* FDA’s rule benefits Commissioner Hamburg’s corporate benefactor, Henry Schein.
* Commissioner Hamburg participated despite claiming that she was recused for ethical reasons.
* Dr. Hamburg and her staff are covering up her role in the rule-making.
* FDA proposes to silence critics of the rule via an “end game.”

Tell the Democratic Congresswomen and Congressmen that FDA under Hamburg is a rogue agency defying President Obama’s deep concerns about mercury, even though the President appointed her.

Tell the Republican Congresswomen and Congressmen that FDA under Hamburg is a rogue agency that concealed the website advisories about neurological harm to children and unborn babies put there last year by former Commissioner Von Eschenbach.

FDA hopes you say nothing. FDA hopes you do nothing. Then FDA can accomplish its “end game” — against us.

—Charlie
16 September 2009

Charles G. Brown, National Counsel
Consumers for Dental Choice
316 F St., N.E., Suite 210, Washington, DC 20002
Ph. 202.544-6333; fax 202.544-6331
charlie@toxicteeth.org,
www.toxicteeth.org
Working for Mercury-Free Dentistry

You folks smoked out Hamburg … So now Sharfstein must answer

Congratulations to a great grassroots movement. Your phoning and your
e-mails smoked out FDA Commissioner Hamburg. We now know Margaret
Hamburg’s secret about recusal from the mercury amalgam rule: She
never formally recused herself at all! No recusal date — despite
holding, and trading, stock options in the nation’s #1 seller of
mercury fillings, Henry Schein Inc.

Here is what FDA’s press office=2 0told ace reporter Jim Dickinson of
FDA Webview:

From: Jim Dickinson September 02, 2009 9:06 PM
To: ‘Charlie Brown’
Subject: RE: Hamburg’s secret – phoning by Eastern time zone is
Thursday

Press Office told me today there is no recusal date because she didn’t
file a document about it. It is not required. She simply did not
participate, which is the same thing as a recusal, I was told.
Basically, they’re saying recusals don’t have to be in writi
ng or filed
formally with anyone.
0A

Jim Dickinson, Editor
FDA Webview20& FDA Review (www.fdaweb.com)

My late mother used to say, “Oh what a tale we weave when first we try
to deceive.” Remember when we said Margaret Hamburg profited after
she took office, and she denied it? Then she admitted to cashing Henry
Schein stock options in July. Now her claim made in July of recusing
herself is unmasked in September. She has no proof she ever recused
herself, only a self-serving claim she did not participate. Her latest
defense goes something like this: I didn’t participate, or if I did I
didn’t participate substantially, or if I participated s ubstantially I
didn’t participate personally, and if I did participate I stopped, and
even though I didn’t recuse myself you should have read my mind and
figured it out!

We are apprising the Inspector General and appropriate Members of
Congress of this latest round of chicanery at FDA.

Drip by drip, the evidence mounts against Margaret Hamburg and her
maneuvering to protect her benefactor Henry Schein Inc., and turn her
back on America’s children and unborn babies.

So now the questions shift to Deputy Commissioner Sharfstein – he needs =0
D
to open up. How did child advocate Josh Sharfstein come to be in
charge of a rule that puts our children and unborn babies at such a
grave risk of permanent neurologic
al harm? And keeps American parents in the dark about the existence of
the mercury?
0A

Please call or write Deputy Commissioner Sharfstein at 301.796-5040, or
JMSharf1@fda.hhs.gov Ask this:

1) With Dr. Hamburg never formally recusing herself, how could Dr.
Sharfstein know he was in charge of the rule-making?

2) On what date did Dr. Sharfstein take charge of the amalgam
rule-making?