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Author Topic: FDA verknackt drei Firmen wegen Natriumfluorid  (Read 1139 times)

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FDA verknackt drei Firmen wegen Natriumfluorid
« on: October 03, 2010, 04:43:33 PM »

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Consumer Health Digest #10-39
September 30, 2010

Consumer Health Digest is a free weekly e-mail newsletter edited by
Stephen Barrett, M.D., with help from William M. London, Ed.D. It
summarizes scientific reports; legislative developments; enforcement
actions; news reports; Web site evaluations; recommended and
nonrecommended books; and other information relevant to consumer
protection and consumer decision-making.

###

Three companies ordered to stop making unproven mouth rinse claims.

The FDA has ordered three manufacturers to stop claiming that their
mouth rinse products remove plaque above the gum line or promote
healthy gums. Warning letters were sent to

Johnson & Johnson (Listerine Total Care Anticavity Mouthwash)
http://www.casewatch.org/fdawarning/prod/2010/johnson.shtml

CVS Corporation (CVS Complete Care Anticavity Mouthwash)
http://www.casewatch.org/fdawarning/prod/2010/cvs.shtml

Walgreen Company (Walgreen Mouth Rinse Full Action).
http://www.casewatch.org/fdawarning/prod/2010/walgreen.shtml

These products contain the active ingredient sodium fluoride, which
is effective in preventing cavities but has not been proven effective
in removing plaque or preventing gum disease.


Under federal law, a company cannot claim effectiveness in treating
a disease unless those claims have been approved by the FDA in a new
drug application or the active ingredient has been generally recognized
as safe and effective for these claims in an over-the-counter (OTC) drug
monograph.


In a press release, the FTC indicated that the products may still be
useful for for cavity prevention without risk of injury but should be
aware that the agency has no data to show that these products can
prevent gum disease.

###

FTC sues pomegranate juice marketer.

As part of its ongoing efforts to stop over-hyped health claims in
food advertising, the Federal Trade Commission has charged the makers
of POM Wonderful 100% Pomegranate Juice and POMx supplements with
making false and unsubstantiated claims that their products will
prevent or treat heart disease, prostate cancer, and erectile
dysfunction. [FTC complaint charges deceptive advertising by POM
Wonderful: Agency proceedings will determine whether health claims
for pomegranate products are false and not supported by scientific
evidence. FTC news release, Sept 27, 2010]
http://www.ftc.gov/opa/2010/09/pom.shtm

The FTC complaint charges that POM Wonderful LLC, sister corporation
Roll International Corp., and principals Stewart Resnick, Lynda
Resnick, and Matthew Tupper violated federal law by making deceptive
disease prevention and treatment claims.
http://www.ftc.gov/os/adjpro/d9344/100927admincmplt.pdf

The ads in question appeared in publications such as Parade, Fitness,
The New York Times, and Prevention magazines; on Web sites such as
pomtruth.com, pomwonderful.com, and pompills.com; on bus stop signs
and billboards; in newsletters to customers; and on tags attached to
the product. The juice is widely available at grocery stores
nationwide with a 16-ounce bottle retailing for about $4. POMx pills
and liquid extract are sold via direct mail, with a one-month supply
costing about $30. The FTC complaint alleges:

**The heart disease claims are false and unsubstantiated because many
of the scientific studies conducted by POM Wonderful did not show
heart disease benefit from use of its products.

**The prostate cancer claims are false and unsubstantiated because,
among other reasons, the study POM Wonderful relied on was neither
"blinded" nor controlled.

**The erectile dysfunction claims are false and unsubstantiated
because the study on which the company relied did not show that POM
Juice was any more effective than a placebo.

In a related case, Mark Dreher, POM Wonderful's former head of
scientific and regulatory affairs and expert endorser, has signed a
consent agreement that bars him from making any treatment or
prevention claims in advertising for a POM Wonderful product unless
the claim is not misleading and comports with FDA requirements for
the claim.

###

Texas court restricts chiropractic diagnosis.

A district court judge has ruled that chiropractors must limit their
diagnoses to biomechanical conditions of the spine and
musculoskeletal system. The judge's reasoning is spelled out in the
decision letter issued in August.
http://www.casewatch.org/civil/mua/decision_letter.shtml The final
order ended a four-year lower-court battle that pitted the Texas
Medical Association (TMA) and Texas Medical Board against the Texas
Board of Chiropractic Examiners (TBC) and Texas Chiropractic
Association (TCA). The TMA initiated the suit in 2006 to block TBC
rules that would permit chiropractors to perform clinical needle
electromyography (EMG) and spinal manipulation under anesthesia
(MUA), which the TMA charged were beyond the chiropractors' lawful
scope of practice. The TMA also challenged whether chiropractors
should have the right to "diagnose" medical conditions. MUA has some
respectable use for treating frozen shoulder or knee problems, but
spinal MUA has none. Aetna's Clinical Policy Guide provides a
detailed discussion of MUA.
http://www.aetna.com/cpb/medical/data/200_299/0204.html

In November 2009, the judge ruled that Texas law prevents
chiropractors from performing EMG or MUA.
http://www.casewatch.org/civil/mua/summary_judgment.pdf The
chiropractors have notified the court that they will file an appeal.
The TCA Web site, which is seeking donations to help pay for the
appeal, claims that the adverse ruling has the potential to wipe out
the entire chiropractic profession.

###

In June, Doctor's Data filed suit against Dr. Barrett because it
didn't like what he wrote about them on Quackwatch and in this
newsletter. The events leading up to the suit are described at
http://www.quackwatch.org/14Legal/dd_suit.html Contributions to his
defense fund can be made by mail or through
http://www.quackwatch.org/00AboutQuackwatch/donations.html

###

Other issues of the Digest are accessible through
http://www.ncahf.org/digest10/index.html. If you enjoy this
newsletter, please recommend it to your friends. To help prevent the
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--
-----------------------------------------------------------------

Stephen Barrett, M.D.
Consumer Advocate
Chatham Crossing, Suite 107/208
11312 U.S. 15 501 North
Chapel Hill, NC 27517

Telephone: (919) 533-6009

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http://www.quackwatch.org/00AboutQuackwatch/chd.html

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[*/QUOTE*]
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Kinderklinik Gelsenkirchen verstößt gegen die Leitlinien

Der Skandal in Gelsenkirchen
Hamer-Anhänger in der Kinderklinik
http://www.klinikskandal.com

http://www.reimbibel.de/GBV-Kinderklinik-Gelsenkirchen.htm
http://www.kinderklinik-gelsenkirchen-kritik.de
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