Hazardous 500-calorie diets
According to Miller, while the FDA hasn’t received specific reports of harm linked to the use of HCG weight-loss products, its “very concerned because the products instruct users to take them with a 500 calorie per day diet.”
Living on 500 calories a day isn’t only unhealthy—it’s hazardous, FDA experts warn. People who go on such restrictive diets are at increased risk for side effects that include an imbalance of the electrolytes that keep the body’s muscles and nerves functioning properly, an irregular heartbeat and gallstone formation.
“This kind of diet should only be done under medical supervision. The risks of such a diet can include things like dizziness, fainting, gall stones or even heart arrhythmias,” she warns.
Shirley Blakely, a nutritionist at FDA’s Center for Food Safety and Applied Nutrition, agrees with concerns about such restrictive diets. They can be dangerous, she says, and potentially fatal.
Blakely explains that very low calorie diets are sometimes prescribed by healthcare professionals for people who are moderately to extremely obese as part of treatment to lessen high blood pressure and other lessen conditions caused by obesity.
But she points out that these diets have to be done under strict and constant medical supervision just to ensure that side effects are not life threatening. Without this supervision, she says, people on very low calorie diets may not be getting enough vitamins, minerals and—most importantly—protein.
“In general, the reference 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.”
The violators
On its site, the U.S. drug regulator posted a list of products and manufacturers or distributors that are the subjects of its investigation:
• HCG Diet Homeopathic Drops marketed by HCG Diet Direct, LLC
• Homeopathic HCG sold by HCG 1234 LLC (The hCG Drops LLC)
• HCG Platinum, HCG Platinum X-30 and HCG Platinum X-14 marketed by HCG Platinum LLC; RightWay Nutrition
• HCG Fusion 30 and HCG Fusion 43 sold by Nutri Fusion Systems LLC
• Homeopathic Original HCG and Homeoapthic HCG, www.resetthebody.com; www.theoriginalhcgdrops.com
• HCG Extra Weight Loss Homeoapthic Drops from Hcg-miracleweightloss.com
• Alcohol Free hCG Weight Loss Formula sold by Natural Medical Supply
But the list “isn’t an all inclusive list of illegal ‘homeopathic’ HCG products currently on the market,” the agency warns.
FDA wants consumers to know that: “All drug products claiming to include “homeopathic” HCG are illegally marketed.”
While FDA and FTC said it will monitor the firms’ responses to the warning letters and take further action as needed, a quick check by the Health Care Zone shows that some of the seven firms that face enforcement action from the FDA have websites that are still up and running.
Dangerous off-label practice
More frightening is a growing illicit industry practice, among even doctors and healthcare professionals, of using approved prescription injectable HCG for unapproved uses like weight loss.
This “off-label” use of HCG products presents greater uncertainty about both the risks and benefits because less information is available on safety and effectiveness, FDA notes, warning consumers that , “unexpected adverse events may occur in this context.”
Pulmonary embolism, depression, cerebrovascular events, heart attack and even death are among the serious adverse events associated with the use of HCG injections for weight loss that have been reported so far to the FDA.
Homeopathic drug
According to FDA’s Division of Non-Prescription Drugs and Health Fraud director, 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,” Miller says.
Meanwhile, FDA doesn’t evaluate homeopathic drugs for safety and effectiveness, says Elisabeth Walther, a pharmacist with the agency. It’s also not aware of any scientific evidence that supports homeopathy as effective, she says.
But FDA allows some homeopathic treatments to be marketed, for as long as they meet certain conditions set by the agency.
A reference document called the Homeopathic Pharmacopoeia of the United States lists active ingredients that may be legally included in homeopathic drug products.
“HCG isn’t on this list and therefore cannot be legally sold as a homeopathic medication for any purpose,” Walther says.
What should consumers do?
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.
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