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Latest News on Vioxx
and heart pills.
More Diet Related FDA News
The issue of U.S. consumers buying prescription drugs from foreign sources
is a significant concern for FDA. A growing number of Americans obtain
their medications from foreign locations, often seeking out suppliers
in Canada. But the FDA cannot ensure the safety of drugs bought from these
sources. FDA
Traveler Alerts
FDA approves product for facial wrinkles
The Food and Drug Administration Monday approved an injectable gel designed
for facial wrinkles. Q-Med AB of Sweden, showed the device, Restylane,
is safe and effective for filling moderate to severe wrinkles around one's
nose and mouth. Most patients need one injection to obtain optimal correction
with one-third of patients needing more than one injection. Restylane
is made with hyaluronic acid lasting about six months. The FDA previously
approved two other injectable products for treating wrinkles: collagen
to correct soft tissue deficiencies, such as wrinkles and acne scars,
and botulinum toxin for treating frown lines between the eyebrows. Other
treatments for wrinkles include topical creams, including creme
la mer and Retin A, chemical peels and laser
and electro-surgical resurfacing.
Ten Drugs not to buy from Foreign sources
Accutane (isotretinoin), Actiq (fentanyl citrate), Clozaril (clozapine),
Lotronex (alosetron hydrochloride), Mifeprex (mifepristone or RU-486),
Thalomid (thalidomide), Tikosyn (dofetilide), Tracleer (bosentan), Trovan
(trovafloxacin mesylate or alatrofloxacin mesylate injection), Xyrem (sodium
oxybate)
Some of they following prescription drugs can be purchased by our USA
Pharmacy - we only recommend you buy them from a USA
Pharmacy over pharmacy not in the United States of America.
FDA Takes Stand on Dietary Supplements
WASHINGTON - Millions of users of St. John's wort, calcium and other
dietary supplements may soon know for sure they're getting what they pay
for: The government proposed the first manufacturing standards for the
$19 billion supplement industry Friday in an attempt to cut fraud and
contamination.
There still will be no guarantee that the pills and powders deliver the
health benefits advertised or are even safe to swallow. Unlike drugs,
supplements can be sold without any scientific proof of safety or effectiveness.
But the Food and Drug Administration (news - web sites)'s long-awaited
factory rules aim to ensure that the ingredients and dosages promised
on a supplement's bottle really are contained inside — without dangerous
contaminants like bacteria and brain-damaging lead that have been found
in some.
Today, this is "a buyer-beware market," said FDA Commissioner
Mark McClellan. "Millions of Americans use dietary supplements every
day, and we need to make sure they're getting the products they pay for
... that are accurately labeled and free from contaminants."
There are more than 1,000 makers of dietary supplements, products that
range from mainstream vitamins to herbs to controversial hormones and
stimulants. Ephedra — an herbal stimulant blamed for dozens of heart
attacks, strokes and deaths — is the most notorious, drawing an
FDA warning last week.
Supplement makers are exempt from most safety oversight, thanks to a 1994
law. Nor has there even been federal quality control: Over and over in
recent years, scientists and consumer groups have uncovered fraud when
testing various types and brands.
The FDA cited a bee product found to be contaminated with lead, and a
brand of folic acid — required during pregnancy to reduce birth
defects — that contained only a third of the promised dose, meaning
women consumed too little for protection.
In another example, California researchers tested 12 different bodybuilding
supplements and found only one contained the amount of androstenedione
(news - web sites) or related ingredients promised on the bottle. Far
worse, one brand illegally contained testosterone, a controlled substance
that should be sold only with a prescription.
The new manufacturing standards aim to prevent such problems with, among
other things, certain quality-control steps that require company testing
of ingredients and finished products to verify purity and dose. Also required
are improvements in labeling and ways to handle consumer complaints.
The FDA characterized the rules as a mix of standards now required for
foods and for over-the-counter drugs such as aspirin.
The rules are open for public comment for three months. Final regulations
are expected next year, and manufacturers then would have time to start
complying — up to three years for the smallest companies. McClellan
promised inspections of supplement factories, with special focus on "potential
bad actors," to ensure compliance.
Until now, only a small portion of the supplement industry has followed
voluntary quality standards. Some companies paid for programs, run by
such organizations as the U.S. Pharmacopeia, that did spot-testing to
certify a product contained the ingredients advertised.
Some supplement makers have long lobbied for the standards, required under
the 1994 supplement law, by arguing that less reputable competitors were
harming the whole industry.
"The responsible manufacturers are happy to comply" with FDA's
standards, said John Hathcock of the Council for Responsible Nutrition,
which represents 80 companies that follow voluntary quality standards.
The rules will force bad manufacturers to "get in line or get out
of business," he said.
Consumer groups also welcomed the standards.
The proposal is "a step in the right direction," said Bruce
Silverglade of the Center for Science in the Public Interest, which has
pushed FDA to crack down on fraudulent and dangerous supplements.
But the rules won't ensure a supplement is completely safe, just that
it has no impurities, Silverglade cautioned.
Consumers "can know it has the strength per dose of whatever ingredient
it is they're ingesting, but it could still be harmful to them,"
agreed Janelle Mayo Duncan of Consumers Union, which wants more stringent
regulation to bar risky supplements.
Source: 2003 FDA
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