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HCG, the FDA, and You
When you mention the HCG diet to people, you sometimes get this reaction:
Isn't HCG banned by the FDA?
Yes, and no. In December 2011, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to companies selling nonprescription HCG for "selling drugs that have not been approved, and making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss."
The FDA press release went on to say, "The labeling for the 'homeopathic' HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction."
As an informed consumer who wants to lose weight, what does this mean to you? Here are some thoughts to consider.
The FDA ban specifically addresses over-the-counter and over-the-Internet HCG providers. It does not address pharmaceutical quality HCG obtained by prescription from your doctor.
The FDA website, in "Questions and Answers on HCG Products for Weight Loss," has this to say about pharmaceutical HCG, which has been approved for infertility treatment: "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."
The primary issue over the HCG diet protocol appears to be the very low calorie diet (VLCD) phase. As the FDA website further states, "Consumers on a very low calorie diet (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."
Keep in mind that the HCG very low calorie diet phase is relatively brief—three weeks is the recommended length. Careful reading of FDA information shows that the potentially serious side effects stem primarily from long-term VLCD practice.
Consulting your doctor before starting any new diet or exercise program is always a good move, especially if you haven't been dieting or exercising. Every person is different. Your doctor can evaluate your current health, your body composition, your medications if any, and your medical history to help you determine if the HCG diet with its VLCD phase is a good fit for you.
The HCG diet has helped countless numbers of people take unwanted weight off and keep it off. For them, the possible risks were outweighed (so to speak) by the probable benefits.
In the end, that decision is yours as well.
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