HAS THE FDA BANNED THE HCG DIET?
WHAT DID THEY ACTUALLY DO ABOUT HCG DROPS?
They ruled against homeopathic hCG.
HOW WILL THIS AFFECT YOU?
It will narrow your choices.
CAN YOU STILL DO THE ORIGINAL PROTOCOL?
Hello, Dr. Dennis Clark here… I’m here, as a professional research scientist, to explain and answer these and other questions about what is currently happening with the hCG diet that Dr. A.T.W. Simeons created in the 1950s. It is supposed to be a simple diet. Unfortunately, it is now so popular that it has become over-hyped and modified in ways that just don’t work. The FDA and the FTC have issued a ruling and have come down hard with cease and desist letters to certain companies who sell products online.
Two caveats… FIRST, before I get started, note that I might come across as a bit wordy here. My excuse is that I am a career research scientist and university professor, so I am used to having a captive audience, hundreds of students at a time. My sweet wife, Eve, bless her heart, also points out that I am accustomed to writing articles for professional journals, so sometimes I get a little too technical for the public. I agree. The information that I have for you is important, though, so I encourage you to wade through it as best you can. (Eve did screen it for you!) SECOND, I have a pretty good book on the hCG diet, already edited and screened by a few non-scientists so you can enjoy it. Not too wordy, not too technical. It is full of advice about what you can and should do before, during, and after doing the hCG protocol. It’s one of those fancy ebooks that you can order and download ‘instantly’ online. I’ll tell you more about it toward the end of this page.
Now about those questions…
Background – The FDA vs. hCG
HCG recently came under fire by the FDA, fueling hysteria that is only partly based on truth. The FDA’s main issue began with the widespread use of health claims for marketing homeopathic hCG products, usually in the form of hCG drops.
Homeopathic hCG Above the Radar
Media reports about a warning by the FDA that retail hCG diet drugs are frauds created mass confusion about the hCG diet. However, two key points should be kept in mind for clarity about this initial warning.
Point 1: The FDA is not a human health agency except in name only. It is a rogue government agency whose main function is to be the enforcement arm of the pharmaceutical industry. In other words, it is a corporate health agency. Warnings by the FDA should therefore always be taken with a grain of salt.
Point 2: Journalists have managed to mangle this warning to include all hCG weight loss products, whereas the FDA specifically directs its ire at homeopathic hCG drops. The key word here is homeopathic.
Truths About Homeopathic hCG
The FDA is correct in pointing out that this type of product contains only traces of hCG, or none at all. In the realm of homeopathic medicine, this is not an issue. In fact, according to the principles of homeopathy, medicines increase their potency the more they are diluted. Indeed, the most powerful homeopathic medicines contain no molecules of the original material whatsoever.
Do the homeopathic dilutions of this hormone also increase in potency as the hormone becomes more diluted? This is an unanswerable question based on scientific research, because there are no peer-reviewed scientific articles on this subject.
One of the claims by the FDA is that there is no scientific evidence to support weight loss claims regarding homeopathic HCG. This is a valid point, although it is an example of the weakest kind of thinking that anyone can subscribe to. Absence of evidence is just that. It merely means that the research has not been done. It does not mean that it does not work. We simply do not know. (Testimonials are not to be construed as experimental evidence. Only a well-designed experiment can provide that.)
Violation of Homeopathic Principle
The kicker in all this is that one of the core principles of homeopathy is violated by homeopathic hCG. This principle holds that treatments for a symptom must be derived from substances that cause that same symptom. A rash, for example, is best treated by a homeopathic preparation made from substances that cause that same rash. This is referred to as the law of similars.
How does the law of similars apply to hCG for weight loss? The symptom is excess abnormal fat. However, hCG is not a substance that causes this symptom, so it is an inappropriate candidate for homeopathic treatment of fat gain. It violates the law of similars.
The Definitive Experiment
Ideally, a well-designed experiment that evaluates a potential change in the percent of abnormal body fat would answer the question of whether the homeopathic treatment works. Unfortunately, no well-designed experiment has been conducted and published. The definitive experiment has yet to be done on homeopathic hCG for the hCG diet.
What You Can Expect
The only legitimate ways that hCG products can be labeled is either with the amount of hCG they contain, in International Units (e.g., 10,000 IU), or with the amount of dilution that they have undergone if they are homeopathic (e.g., 10X). I have to side with the FDA a little here, since I have found that many internet sites offering homeopathic hCG do not provide this information clearly, right up front. The key for you is to see an actual ingredients list, which is often hard to find for online products.
Oh, one more thing that you should be aware of is that some products claim to be herbal equivalents of hCG. There is, of course, no such equivalent in the plant kingdom. They are a scam. Trust an old plant biochemist on this one.
FDA Warning Becomes a Ruling
After sitting on the warning for a few months, our intreped health guardians at the FDA (now joined by the FTC) finally took the step that, if you know anything about how these agencies work, you could see coming for quite some time. They sent letters to certain online companies to order them to stop selling hCG products. All of these companies were selling homeopathic hCG drops.
News reports of this announcement seemed to appear everywhere.
The homeopathic hCG industry brought on the wrath of government watchdogs itself, so this announcement should not surprise anyone. Take a look at the full news release here, then my comments below it.
FDA Yanks HCG Weight-Loss Agents from Market
The FDA and the Federal Trade Commission said over-the-counter weight-loss products containing human chorionic gonadotropin (HCG) are fraudulent and illegal, and the agencies have told seven manufacturers to stop selling them.
Noting that the product labels call for the pellets, liquids, and sprays to be taken in conjunction with a very low-calorie diet, an FDA official said it did not appear that oral HCG offers any extra benefit.
"There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction," said Elizabeth Miller, acting director of the FDA’s fraud unit for OTC products, during a conference call with reporters.
The recommended diets call for daily calorie intake as low as 500 calories, low enough to create a risk of malnutrition, electrolyte imbalance, cardiac arrhythmias, and gallstone formation, Miller said.
The warning letters sent to manufacturers of the products note that HCG has not received FDA approval for any weight-loss indication. The substance is approved as an injectable drug for certain forms of female infertility and is therefore clearly subject to FDA regulation.
HCG weight-loss products are typically sold over the Internet, often promoted with unsolicited "spam" emails, with such claims as "Lose 26 pounds in 26 days" and "Resets your metabolism."
According to one of the letters, sent to HCG Diet Direct of Tucson, Ariz., "The claims made on your product labeling and website … clearly demonstrate that this product is a drug as defined" by federal law.
The companies have 15 days to inform the FDA of the steps they have taken to correct the violations. Theoretically, the firms could seek FDA approval for the weight-loss claims, but the agencies expect that they will simply stop selling the products.
If the companies do not do so voluntarily, the FDA and FTC threatened to forcibly halt their operations.
Many of these products are labeled as homeopathic remedies, but they are illegal whether the word "homeopathic" is used or not, said Richard Cleland, assistant director of the FTC’s advertising practices division.
If the product is marketed or meets federal standards to qualify as a drug, but is not FDA approved, it cannot be sold legally, Cleland said.
Officials from both agencies were unable to estimate how many people have bought HCG weight-loss products, but Cleland said they were the current hot item in the lose-weight-fast category.
"Four years ago, the miracle weight-loss ingredient was Hoodia gordonii, and then it was acai berry, and now it’s homeopathic HCG," he said.
"Almost more than any other, the weight-loss industry is fad-driven," he added. "Unfortunately, all too often, it is also fraud-driven."
The seven companies receiving the warning letters, in addition to HCG Diet Direct, included Nutri Fusion Systems, Natural Medical Supply (doing business as HCG Complete Diet), HCG Platinum, Theoriginalhcgdrops.com, and HCG-miracleweightloss.com.
The FDA and FTC emphasized that the letters were a "first step in halting sale" of HCG weight-loss remedies. Other companies that market such products "should also read these letters carefully and take appropriate action," Cleland said.
Let’s start with the three monkeys at the FDA (i.e., hear no evil, see no evil, speak no evil), who are all wrapped into one person with the following quote from the announcement:
“There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction,” said Elizabeth Miller, acting director of the FDA’s fraud unit for OTC products, during a conference call with reporters.
This statement of course, ignores all of the evidence from the past half century, which is what the FDA does when it has an agenda. This makes sense when you keep in mind that the FDA is the enforcement arm of the pharmaceutical industry.
On the other hand, note the comment in the announcement that the fad-driven nature of the weight loss industry attracts frauds and scams (citing Hoodia and acai berry, which are, indeed, good examples of such skullduggery). A quick look at online hCG diet programs shows plenty of companies who fit right in here.
Weirdness Upon Weirdness
Let me repeat: A key principle of homeopathic medicine is that the more diluted a substance is, the more powerful it is. The best homeopathic medicines are diluted so much that they contain no molecules of the original substance whatsoever! Marketers of homeopathic hCG have failed to make this clear to the public.
The FDA is now bringing the hammer down on a product that should not have any hCG in it in the first place, basing its complaint on unapproved health claims for a prescription drug — that isn’t even in the product!
If you are still looking for logic in all this weirdness, just keep in mind the main role of the FDA that I cited above. Their endgame is, since Big Pharma isn’t making any money on hCG for weight loss, then you will have to see your doctor to get a prescription weight loss drug instead. That’s where the logic is.
The FDA will undoubtedly shut down the entire hCG diet industry as soon at it can. Clinics, doctors, websites, you name it, will all disappear from the U.S. The typical pattern, as illustrated by another alternative (i.e., non-Big Pharma) industry, historically has been natural cancer treatments. The best treatments went into clinics south of the border, where some of them are still available. Weight loss clinics using hCG will probably do the same thing. Or, some clinics will be allowed to use hCG ‘off-label’ – meaning not as approved. (It is still approved as a prescription treatment for other health issues.)
Online ‘Canadian’ pharmacies (which are usually not Canadian at all) will continue to offer hCG. Pressure from the U.S. has already caused some of these to be shut down. They won’t go away completely, since they offer discount prescription drugs of all kinds. You may just have to find one and stick with it as long as you can.
What About the FDA vs. the hCG Diet?
Keep in mind that the official purview of the FDA is to approve definitions of diseases and to approve drugs to treat them.
Obesity is defined as a disease. Any substance that is claimed as a treatment for it, or for overweight, is by definition a drug treatment for a defined disease. This generally does not include diets per se, unless accompanied by a substance that can be defined by the FDA as a drug.
The recent ruling by the FDA was not against the hCG diet, or against the hormone hCG. It was against homeopathic hCG, specifically homeopathic hCG drops. This was based on too many claims that homeopathic hCG causes weight loss, meaning treating overweight or obesity. That is a health claim, and homeopathic hCG is not an approved drug for that claim or any other health claim.
Excuse me if I seem to be repeating myself here. I just want to make it clear what the FDA actually did. The newspaper article that was widely circulated and quoted on this ruling was itself very vague, misleading, and sensationalized, which is typical of modern journalism.
What Does This Have to Do With hCG Drops?
The form of entry – drops, pellets, tablets, gel caps, skin creams or gels, etc. – is irrelevant. Unfortunately, the association of ‘hCG drops’ with ‘homeopathic hCG’ is so common that they seem to be one in the same. However, they are not. Homeopathic medicines can be formulated in any of these forms. Approved drugs can, too. The key target of the FDA was not the form of entry, it was homeopathic hCG regardless of the form of entry. If you are confused, your confusion probably stems from confusion at the FDA itself. We are, after all, not talking about a federal agency that is known for critical thinking and clear expression.
What is Still Available?
Legitimate clinics and other sources of real hCG, as measured in International Units (I.U., not homeopathic dilutions) still offer the hormone for weight loss. Even this is an unapproved use of hCG, though. It is not approved for weight loss. Folks at the FDA choose to ignore all of the evidence that it works, up to and including recent research in molecular biology that is starting to explain how it interacts with leptin receptors in the same areas of the hypothalamus (brain). Leptin is our ‘master fat hormone’ that communicates between fat cells and the brain. It is a fascinating story that continues to unfold.
The position of the FDA on this research leans more toward pharmaceutical companies that are looking for ways to make the leptin pathway work better. This means new drug development, of course. Keep tuned in to this topic, then when the new drug appears, run as fast as you can the other way. The history of FDA-approved weight loss drugs is a lesson in failure, disaster, and danger to human health.
HCG DIET – THE NEW DEFINITIVE GUIDE
The hCG diet has clearly attracted a boatload of misinformation and controversy. Yes, it is a hormone-driven protocol, which is a worry for some people, although unnecessarily so. And it does have an effect on cholesterol, blood pressure, testosterone, and diabetes.
Clearing up the controversy, skewering the misinformation, explaining exactly what you must do to be successful on the hCG diet protocol and why, pointing out the positive side effects as well as the drawbacks to the hCG protocol, and maybe most important of all, explaining what you absolutely must do and must not do for long-term, healthy weight management after you reach your target weight – these are just some of the topics I tell you about in my book, HCG DIET – THE NEW DEFINITIVE GUIDE.
Do you know that the hCG protocol is not necessarily a long-term solution all by itself, that it doesn’t always work for everyone, that it has an effect on testosterone levels, or that women and men respond differently to it? How about the role of hCG in the diagnosis of cancer?
In my opinion, these are important yet largely ignored issues regarding hCG. They are all explained in my book.
The bottom line, though, based on my perspective as a professional research scientist, on my own personal experience using the protocol, and on the experiences of hundreds of my clients, I’d say that the hCG diet protocol is the best approach to getting rid of abnormal fat quickly. However, there are many variables that you have to watch out for in order to reach your target weight and stay there for good.
The Key to Success with hCG
This is just my opinion. The key to success, as always, is good objective information. And that is what my book provides. It offers a uniquely even-handed and modern scientific perspective on the hCG diet, without hype or misinformation. Okay, maybe I am biased about how good it is because I wrote it.
I do, indeed, want you to order it, although I’m not going to stoop to using any high-minded sales language here. I really don’t know how to do that, anyway! I’m going to provide a couple of incentives, though. First, to give you a clearer picture of what is in the book, I’ve provided the entire table of contents below. It is rather extensive, so take your time looking it over.
Second, I’m including two popular recipe books as bonuses with your purchase, at no extra charge. One is my book, HCG Diet Recipes: How to Get the Maximum Flavor and Enjoyment Out of Your HCG Diet Program. The other is, What to Do After HCG Weight Loss: HCG Diet Phase 3 Instructions and Recipes for Success, by Eve Clark (yup, my lovely and brilliant bride).
That’s it for now. Oh, and if you want to go ahead and order it, you can click on the Paypal button here. I put the same button at the bottom of the page, too, after the table of contents. The price is $37 and worth every penny. (Remember, I’m biased!)
By the way, once you get to the ‘payment confirmed’ page, be sure to click on ‘Return to Think and Create, c/o Dr. Dennis Clark’ so you will be redirected to the download page. (If you somehow miss this step, which sometimes happens, just send me an email and I will send you a copy of the book directly – my email address is provided by Paypal.) Thanks!
That’s about all I wanted to tell you about my new hCG diet book for now. Here’s that Paypal button again.
All the best in natural health,