[net-gold] MEDICAL: DIETS AND DIETING : MEDICAL: PHARMACY PHARMACEUTICAL PHARMACOLOGY: DRUG: BANNED: HCG Diet Products Are Illegal
- From: "David P. Dillard" <jwne@xxxxxxxxxx>
- To: Net-Gold -- Educator Gold <Educator-Gold@xxxxxxxxxxxxxxx>, Educator Gold <Educator-Gold@xxxxxxxxxxxxxxxx>, net-gold@xxxxxxxxxxxxx, Net-Gold <Net-Gold@xxxxxxxxxxxxxxx>, NetGold <netgold@xxxxxxxxxxxxxxx>, Net-Gold <net-gold@xxxxxxxxxxxxxxxx>, K-12ADMINLIFE <K12ADMIN@xxxxxxxxxxxxxxxxxxx>, K12AdminLIFE <K12AdminLIFE@xxxxxxxxxxxxxxx>, MediaMentor <mediamentor@xxxxxxxxxxxxxxx>, NetGold <netgold@xxxxxxxxxxxxxxxx>, Net-Platinum <net-platinum@xxxxxxxxxxxxxxx>, Sean Grigsby <myarchives1@xxxxxxxxxxxxxxx>, Net-Gold <NetGold_general@xxxxxxxxxxxxxxxxx>, Temple Gold Discussion Group <TEMPLE-GOLD@xxxxxxxxxxxxxxxxxxx>, Temple University Net-Gold Archive <net-gold@xxxxxxxxxxxxxxxxxxx>, Health Lists -- Health Diet Fitness Recreation Sports Tourism <healthrecsport@xxxxxxxxxxxxxxxx>, Health Diet Fitness Recreation Sports <healthrecsport@xxxxxxxxxxxxxxx>, HEALTH-RECREATION-SPORTS-TOURISM@xxxxxxxxxxxxxxxxxxx
- Date: Mon, 16 Apr 2012 02:13:26 -0400 (EDT)
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MEDICAL: DIETS AND DIETING :
MEDICAL: PHARMACY PHARMACEUTICAL PHARMACOLOGY: DRUG: BANNED:
HCG Diet Products Are Illegal
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HCG Diet Products Are Illegal
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
For Consumers
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm
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HCG Makes Big Claims
A Potentially Dangerous Diet
Story Started Decades Ago
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Anyone who has ever been on a dietand there are many of usknows that there
are sensible ways to lose weight. These include balanced diets, exercising
and realistic goals.
.
And then there are reckless ways to shed poundsfads and diet aids that
promise rapid weight loss, but often recommend potentially dangerous
practices. These include HCG weight-loss products marketed
over-the-counter (OTC) that are identified as "homeopathic" and direct
users to follow a severely restrictive diet.
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The Food and Drug Administration (FDA) is advising consumers to steer
clear of these "homeopathic" human chorionic gonadotropin (HCG)
weight-loss products. They are sold in the form of oral drops, pellets
and sprays and can be found online and in some retail stores.
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FDA and the Federal Trade Commission (FTC) have issued seven letters to
companies warning them that they are selling illegal homeopathic HCG
weight-loss drugs that have not been approved by FDA, and that make
unsupported claims.
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(For the list of manufacturers, distributors and productsand more
information about FDAs concerns about HCGvisit www.fda.gov/hcgdiet5.)
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HCG Makes Big Claims
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HCG is a hormone that is produced by the human placenta during pregnancy.
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Products that claim to contain HCG are typically marketed in connection
with a very low calorie diet, usually one that limits calories to 500 per
day. Many of these popular HCG products claim to reset your metabolism,
change abnormal eating patterns, and shave 20-30 pounds in 30-40 days.
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These products are marketed with incredible claims and people think that
if they're losing weight, HCG must be working, says Elizabeth Miller,
acting director of FDAs Division of Non-Prescription Drugs and Health
Fraud. But the data simply does not support this; any loss is from severe
calorie restriction. Not from the HCG.
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HCG is approved by FDA as a prescription drug for the treatment of female
infertility, and other medical conditions. It is not approved for weight
loss. In fact, the prescription drug label notes there is no substantial
evidence that it increases weight loss beyond that resulting from caloric
restriction, that it causes a more attractive or normal distribution of
fat, or that it decreases the hunger and discomfort associated with
calorie-restricted diets.
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HCG is not approved for OTC sale for any purpose.
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A Potentially Dangerous Diet
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Living on 500 calories a day is not only unhealthyits hazardous, according
to FDA experts. Consumers on such restrictive diets are at increased risk
for side effects that include gallstone formation, an imbalance of the
electrolytes that keep the bodys muscles and nerves functioning properly,
and an irregular heartbeat.
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Shirley Blakely, a nutritionist at FDAs Center for Food Safety and Applied
Nutrition, echoes concerns about such restrictive diets. They can be
dangerous, she says, and potentially fatal.
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Very low calorie diets are sometimes prescribed by health care
professionals for people who are moderately to extremely obese as part of
medical treatment to lessen health conditions caused by obesity, like high
blood pressure. But even then, strictand constantmedical supervision is
needed to ensure that side effects are not life threatening, says Blakely.
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Without medical oversight, consumers on very low calorie diets may not be
getting enough vitamins, minerals andmost criticallyprotein.
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In general, the reference (average) calorie level is 2,000, says Blakely.
If you want to lose weight, reduce your daily intake by 500 calories. Over
the course of a week, that equals 3500 calories, which is the loss of a
pound. Gradual weight loss is the way to do it.
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Story Started Decades Ago
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Miller explains that HCG was first promoted for weight loss in the 1950s.
It faded in the 1970s, especially when it became apparent that there was a
lack of evidence to support the use of HCG for weight loss, she says.
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The diet has become popular again and FDA and FTC are taking action on
illegal HCG products. You cannot sell products claiming to contain HCG as
an OTC drug product. Its illegal, says Brad Pace, team leader and
regulatory counsel at FDAs Health Fraud and Consumer Outreach Branch. If
these companies dont heed our warnings, they could face enforcement
actions, legal penalties or criminal prosecution.
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Elisabeth Walther, a pharmacist at FDA, explains that the agency does not
evaluate homeopathic drug products for safety or effectiveness, and is not
aware of any scientific evidence that supports homeopathy as effective.
However, those that meet certain conditions set by FDA can be marketed. A
reference document called the Homeopathic Pharmacopoeia of the United
States lists active ingredients that may be legally included in
homeopathic drug products.
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HCG is not on this list and therefore cannot be legally sold as a
homeopathic medication for any purpose, Walther says.
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FDA advises consumers who have purchased homeopathic HCG for weight loss
to stop using it, throw it out, and stop following the dieting
instructions. Harmful effects should be reported online to FDAs MedWatch
program6 or by phone at 800-FDA-1088 (800-332-1088) and to the consumers
health care professional.
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This article appears on FDA's Consumer Updates page7, which features the
latest on all FDA-regulated products.
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Dec. 6, 2011
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-For More Information
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Fraudulent HCG Products for Weight Loss8
FDA Drug Safety Podcast for Consumers: FDA and FTC: HCG Diet Products Are
Illegal mp3 (MP3 - 2.7MB)9
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FDA, FTC act to remove homeopathic HCG weight loss products from the
market10
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Very Low-Calorie Diets11
Make Your Calories Count12
Health Fraud Scams13
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--Related Consumer Updates
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FDA Targets Gastric Band Weight-Loss Claims14
Beware of Fraudulent Weight-Loss Dietary Supplements15
Weight Loss Fraud16
Don't Be Fooled By Health Fraud Scams17
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Sincerely,
David Dillard
Temple University
(215) 204 - 4584
jwne@xxxxxxxxxx
http://workface.com/e/daviddillard
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