Update on FDA actions against counterfeit HCG products – December 6, 2011
Press Release - The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.
Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as a prescription drug for the treatment of some cases of female infertility and other medical conditions.
The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets, and sprays.
“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low calorie diet should only be used under proper medical supervision.”
Red Mountain Weight Loss response
We’re pleased the FDA is addressing this important issue. There is a monumental difference between authentic medical grade HCG, and the homeopathic versions being called into question by the FDA. They are not the same.
Pharmaceutical HCG is regulated, and approved for medical use with a Doctor’s prescription. Homeopathic or Over-the-Counter HCG is not, and considered unacceptable by the FDA.
Since medical weight loss is our specialty, we've been concerned for quite some time about counterfeit products marketed under the “HCG”, name. These products are fraudulent and dangerous, since the contents of these products do not include any of the actual hormone, and because it's unsafe to follow a very low calorie diet without the benefits of “Medical Grade HCG” and without a doctor’s supervision.
Frequently asked questions - What does these mean to you?
Pharmaceutical grade HCG is regulated, and legal for sale with a doctor’s prescription. Homeopathic or over-the-counter HCG is not, and considered illegal by the FDA.
Companies that sell homeopathic versions over- the-counter that claim to be “HCG,” but do not contain the actual hormone. Most of these supplements are sold at health food stores, vitamin stores, or over the internet.
Red Mountain Weight loss - uses only Medical-Grade HCG, manufactured to U.S. lab standards, which require a doctor’s prescription.
HCG is approved for female infertility and other medical uses, so it is known to be safe. It is considered “off label use” when used for weight loss. This practice is not uncommon. There are a wide variety of medications that are prescribed for conditions other than what they were FDA approved for, such as Coumadin, Lexapro, Zoloft, and Celebrex.
At present, there are no studies that validate the success of HCG for weight loss. That being said, very few studies have been done on this hormone, period. It’s ironic that even without studies to prove the effectiveness of HCG for weight loss, this hormone has emerged as one of the most popular weight loss methods available. Why? Because in spite of the lack of clinical data, people are having amazing results with HCG. At Red Mountain Medical Weight loss, we have prescribed medical grade HCG to literally thousands of people over the past five years. Clinical records of over 30,000 patients seen at Red Mountain point to unprecedented success of HCG for weight loss. In 20 years of practice, we have yet to find a weight loss method that works as well. The fact that our practice has grown due to successful patient outcomes using HCG further validates this point.
The absence of studies doesn’t necessarily mean a drug doesn’t work. One reason there aren’t more studies has to do with U.S. Patent rights. HCG is a hormone, and as such, no one company can control its manufacturing or distribution. So, there’s no incentive for a major pharmaceutical company to commission a study. They couldn’t recoup their investment. Earlier this year, the popular television show Dr. Oz examined this phenomenon. After interviewing a studio full of people and hearing their HCG success stories, Dr. Oz came to the conclusion that even though there are no studies validating HCG, the anecdotal evidence should not be dismissed. Further studies should be conducted (but the difficulty in finding a company to bear that expense remains a critical issue).
Due to the lack of scientific evidence, as an organization, the ASBP does not recommend HCG at this time. It is however, a significant topic at annual meetings, and is prescribed by a growing number of ASBP members in their own practices. Their primary concern stems from the potential dangers caused by a 500 calorie diet. At Red Mountain Weight loss, we do not prescribe a 500 calorie diet in conjunction with our HCG program, and have found great success, without having patients incur such a risk.
This is the number one misconception associated with HCG. While it is true you would lose weight on a 500 calorie diet, you would also lose muscle mass, and experience health risks such as putting your body through ketosis, as well as rapid weight gain once you return to eating normally. So, following a very low calorie diet without proper medication or doctor supervision is not safe or healthy. That’s why Red Mountain Weight loss uses a (higher calorie) modified diet in conjunction with HCG to insure our patients receive the necessary nutrients for safe and healthy weight loss.
There are no medical studies that prove HCG is dangerous or unsafe in any way. Since the female body produces high doses of HCG in pregnancy, you cannot contract a disease from HCG – any more than you could from your own tears. The primary risk associated with HCG is going on a VLCD or very low calorie diet without a doctor’s supervision.
A doctor is the most qualified person to help you lose weight safely. Putting your body under the stress of a VLCD (Very Low Calorie Diet), should only be done under the care of a Physician. At Red Mountain Weight loss, our Medical Director is a Board-Certified Bariatric specialist, who has studied obesity related diseases for over 20 years. Our medical staff is trained to help patients overcome health issues like menopause, hormone imbalance, diabetes, high blood pressure – and a variety of conditions that can prevent people from losing weight. We’ve provided treatment to literally thousands of patients, a large number of them with medical grade HCG. Our patients have experienced amazing results, many of them after years of struggling with failed diets.
Pharmaceutical HCG is regulated, and legal for sale with a doctor’s prescription. Homeopathic or Over-the-Counter HCG is not, and considered illegal according to the FDA. Make sure you only use HCG obtained with a doctor’s prescription.
Need Further Assistance?
If you have further questions or would like to discuss more about HCG and its effectiveness and safety we encourage you to contact us so that we may assist you.