Wednesday, March 7th 2012
Anyone who has ever been on a diet—and there are many of us—knows that there are sensible ways to lose weight. These include balanced diets, exercising and realistic goals.
And then there are reckless ways to shed pounds—fads 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.
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.
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.
(For the list of manufacturers, distributors and products—and more information about FDA’s concerns about HCG—visit www.fda.gov/hcgdiet.)
HCG is a hormone that is produced by the human placenta during pregnancy.
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.
“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 FDA’s 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.”
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.”
HCG is not approved for OTC sale for any purpose.
Living on 500 calories a day is not only unhealthy—it’s 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 body’s muscles and nerves functioning properly, and an irregular heartbeat.
Shirley Blakely, a nutritionist at FDA’s Center for Food Safety and Applied Nutrition, echoes concerns about such restrictive diets. They can be dangerous, she says, and potentially fatal.
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, strict—and constant—medical supervision is needed to ensure that side effects are not life threatening, says Blakely.
Without medical oversight, consumers on very low calorie diets may not be getting enough vitamins, minerals and—most critically—protein.
“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.”
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.
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. It’s illegal,” says Brad Pace, team leader and regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch. “If these companies don’t heed our warnings, they could face enforcement actions, legal penalties or criminal prosecution.”
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.
“HCG is not on this list and therefore cannot be legally sold as a homeopathic medication for any purpose,” Walther says.
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 FDA’s MedWatch program or by phone at 800-FDA-1088 (800-332-1088) and to the consumer’s health care professional.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Consumer Updates - FDA. Dec. 6, 2011
1. What action are the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) taking against human chorionic gondatropin (HCG) drug products marketed for weight loss?
FDA and FTC are issuing seven joint warning letters to firms marketing over-the-counter (OTC) HCG drug products that are labeled as homeopathic for weight loss. The firms are receiving these letters because they are violating the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act by selling unapproved new drugs and misbranded drugs that make unsubstantiated claims about weight loss.
These unapproved “homeopathic” HCG drug products are marketed OTC on websites and in retail stores, and can be in the form of oral drops, pellets, and sprays. FDA has not evaluated these products for safety or effectiveness.
FDA and FTC will monitor the firms’ responses to the warning letters and take further action as needed. Firms that do not correct the violations may face enforcement action, possible legal penalties, or criminal prosecution.
2. What is HCG?
Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved for the treatment of select cases of female infertility and hormone treatment in men. FDA-approved HCG products are only available in injection-form and require a prescription from a licensed medical professional.
There are no FDA-approved HCG products for weight loss.
3. Why is FDA concerned about the use of homeopathic HCG drug products marketed for weight loss?
Currently, there are no FDA-approved HCG drug products for weight loss. HCG has not been demonstrated to be effective therapy in the treatment of obesity. There is no substantial evidence that HCG increases weight loss.
Additionally, the labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet (VLCD). Consumers on a VLCD are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias. A VLCD should only be used under proper medical supervision.
4. Which homeopathic HCG products and manufacturers/distributors are affected?
The following table provides the products and manufacturers/distributors that are the subjects of this action. This is not an all inclusive list of illegal “homeopathic” HCG products currently on the market. At this time, all drug products claiming to include “homeopathic” HCG are illegally marketed.
HCG Diet Direct, LLC HCG Diet Homeopathic Drops
HCG 1234 LLC (The hCG Drops LLC) Homeopathic HCG
HCG Platinum LLC; RightWay Nutrition HCG Platinum
HCG Platinum X-30
HCG Platinum X-14
Nutri Fusion Systems LLC HCG Fusion 30
HCG Fusion 43
www.resetthebody.com Homeopathic Original HCG
www.theoriginalhcgdrops.com Homeoapthic HCG
Hcg-miracleweightloss.com HCG Extra Weight Loss Homeoapthic Drops
Natural Medical Supply Alcohol Free hCG Weight Loss Formula
5. Are prescription HCG products safe and effective for weight loss?
No. FDA-approved uses for prescription HCG products include female fertility and select hormonal treatment in males, and FDA has not approved prescription HCG for any other uses, including weight loss.. Current scientific evidence does not support the claim that HCG is safe and effective for weight loss or for the treatment of obesity. In fact, FDA labeling for the approved HCG drug products requires the following statement about the use of HCG for weight loss:
“HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. 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.”
FDA is aware that healthcare professionals sometimes prescribe prescription injectable HCG for unapproved uses such as weight loss. FDA understands that sometimes approved products are used to treat conditions that the products were not approved for (i.e., “off-label” uses). The “off-label” use of products usually presents greater uncertainty about both the risks and benefits because less information is available on safety and effectiveness. Unexpected adverse events may occur in this context. FDA has received reports of serious adverse events associated with the use of HCG injections for weight loss including cases of pulmonary embolism, depression, cerebrovascular issues, cardiac arrest, and death.
6. What should consumers do?
FDA advises consumers who are using “homeopathic” HCG for weight loss to stop using the product, to stop following any labeled dieting instructions, and to discard the product. Consumers who suspect they have experienced adverse effects as a result of the use of HCG drug products for weight loss should contact a licensed health care professional immediately.
Sourced from the FDA's website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm
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Disclaimer: The health information presented here has been written for the New Zealand health consumer. It is of a general nature and is only intended to provide a summary of the subjects covered. The information is not intended to be comprehensive or to provide medical advice to you. While all care has been taken to ensure the accuracy of the information, no responsibility or liability is accepted, and no person should act in reliance on any statement contained in the information provided. All health ailments should be treated by a qualified health professional.
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