HCG Diet- FDA Bans- Finally

There is always another “fad” diet out there- and the HCG diet hopefully died when the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued letters to companies warning them that selling “homeopathic” HCG weight-loss drugs was not FDA approved and that there was no evidence of the claims, thus violating FTC rules.

HCG is a hormone that is produced by the human placenta during pregnancy. Clinically HCG is used as a fertility treatment, and can lead to increase in progesterone and testosterone, which have consequences of their own including deep vein thrombosis (a clot in the veins of the lower extremity) leading to pulmonary embolism and even death. This is not a benign hormone, and should only be used under the strict supervision of a physician – who knows what they are doing, not a naturopath or homeopath, or chiropractor. HCG is also elevated in some cancers, and we follow HCG levels to determine how effective our cancer therapies work with some tumors. This is also the hormone most use to determine if a person is pregnant.

 

This fad diet started in the 1950’s when Albert Simeons, a physician working in India, noted that pregnant women on a low-calorie diet lost fat rather than muscle and the fetus was protected. He hypothesized that the HCG reprogrammed the brain to lose fat rather than muscle, thus protecting the body against loss of muscle. Simeons went on to become an entrepreneur founding weight loss clinics, manufacturing centers, and having widespread use of his product. There was no evidence for HCG working and the diet died in 1976 after an article in JAMA showing that there was no difference between patients who received HCG and those who received a placebo. In 1976 the FTC ordered the Simeon Weight Foundation and HCG Weight Clinic Foundation to stop claiming the HCG was safe and effective, and the FTC has required labeling and advertising of HCG to state:

Albert Simeons- went from working in India to making a fortune in 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

HCG was reborn in 2007 with the book, “The Weight Loss Cure They Don’t Want You to Know About,” by Kevin Trudeau (if you watch infomercials you have seen him – the infomercial guy). Shortly after the FTC charged Trudeau with violating a court order and misrepresenting the contents of the book on his infomercials. He was ordered to pay 37 million dollars for violating their order.

This silly book resurected a bad diet

Still, that started a new industry with companies manufacturing products that could be sold out of major drugs stores, injections given in drive-by diet centers, and lots of people touting this as the cure to obesity. The manufacturers decided if they would slap the “homeopathic” label on it, they could get by with selling this over-the-counter and make even more money off consumers. The FDA stopped this nonsense- not only because this is a potentially dangerous hormone, often given without strict medical supervision, but because the very low calorie diet that goes with it should be done under the supervision of a physician also.

The reason we won’t see the HCG end is because physicians can still prescribe injections of HCG – even though this is not a diet that will work. There are still unfortunates who think getting an injection of this hormone will work- and as PT Barnum once said “there is a fool born every minute.”

The HCG proponents are filled with confirmation bias.  They lose weight, so they assume it is the HCG that suppresses appetite – although there is no evidence it does.  They then will cite articles in non-peer reviewed journal  such as Dr. David Bryman, an osteopath from Scottsdale, who published a non-randomized study with a higher protein low calorie diet- showing the HCG had more weight loss (The Bariatrician – 2010 Vol 25, page 11) . The problems with this study are several: first there is no randomization, second there is no control, third there is no blinding, and fourth there is a clear bias.  To put this in perspective- this study has less validity to it than a noted expert opining.  This study does not rise to acceptable levels of Evidence based medicine. Sadly, the HCG proponents, including health care professionals, do not understand the value of the evidence based medicine that clearly demonstrated no efficacy of HCG in any study in a peer reviewed journal.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm

The action of chorionic gonadotrophin in the obese. Simeons ATW. Lancet 2:946-947, 1954.

Chorionic gonadotropin in weight control. A double-blind crossover study. Young, Fuchs, and Woltjen. JAMA. 1976 Nov 29;236(22):2495-7.

Dr. Terry Simpson About Dr. Terry Simpson
Dr. Terry Simpson received his undergraduate and graduate degrees from the University of Chicago where he spent several years in the Kovler Viral Oncology laboratories doing genetic engineering. He found he liked people more than petri dishes, and went to medical school. Dr. Simpson, a weight loss surgeon is an advocate of culinary medicine. The first surgeon to become certified in Culinary Medicine, he believes teaching people to improve their health through their food and in their kitchen. On the other side of the world, he has been a leading advocate of changing health care to make it more "relationship based," and his efforts awarded his team the Malcolm Baldrige award for healthcare in 2011 for the NUKA system of care in Alaska and in 2013 Dr Simpson won the National Indian Health Board Area Impact Award. A frequent contributor to media outlets discussing health related topics and advances in medicine, he is also a proud dad, husband, author, cook, and surgeon “in that order.” For media inquiries, please visit www.terrysimpson.com.

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  2. COLIN says:

    Hello Dr. Simpson, I could not locate a contact us page, so I writing you in the comment section. The image you are using on this page came from one of my websites, and the book being shown in the image was written by me. I respectfully request that you remove this image from your website. You are in titled to your opinion with regards to the HCG diet protocol, however the information in your video and on this page pertains to the sale of Homeopathic HCG for which I do not sell or promote. The use I my image on your site was not grated by me, and implies that I promoting the illegal sales of homeopathic HCG for which I am not. Your immediate response to my request would be greatly appreciated.

    Regards,

    Colin F Watson

  3. The Doc says:

    I am uncertain as to which image you refer but HCG is not a matter of opinion- it is a matter of fact, that has been tested in double blinded and randomized studies. You are correct Homeopathic HCG is not only silly, but a complete fraud. I gather your HCG is prescribed by a physician who sees the patient, does a complete history and physical on the patient, and then prescribes the drops, shots, or whatever — . I suspect which image it was, but am happy to remove it if I didn’t get it. Please clear your cache and see if we have removed yours — and yes, I would not wish to imply that you are selling homeopathic if you are not, and my apologies for that confusion.

  4. sue morgan says:

    I am a living example that HCG low calorie diet DOES work. Doctors are scared they will lose money when patients no longer want gastric by pass surgery or anything from doctors. HCG is harmless. The female body produce hundreds of thousands of units of HCG for 9 months. Does she get cancer or elevated testosterone or anything else? No she gets a perfectly healthy baby (all else being equal). I suffer from under active thyroid and although taking levothyroxine, going on the treadmill for one hour a day 6 days a week and doing other excersices I did not lose any weight. I had, due to the thyroid problem not being diagnosed early enough put on from 10 stone to 16 stone. Once I got treatment wegith increase stopped but I didnt, and coujldnt lose. I ate very healthily, excersised well but nothing would get the wieght down more than a couple of pounds which soon went back on again. So I heard about hcg. I purchased it from a reputable source and in 40 days I lost 38lbs. I was never hungry on 500 calories, I felt the healthiest I had ever felt for years. I followed through with the 6 week stabilisation and what is also so amazing is my dose of levothyroxine has now had to be cut right down to 25mcg before it was 125mcg. Somehow the HCG ahs kick started things and got me working better. I a a living example of how it works.

    The Doc … have YOU actually done double blinded and randomized studies? Or are you going by the ones already done that were HCG only not with a 500 calorie diet. HCG on its own WILL NOT WORK. There has to be a deficit for it to work. When pregnant the baby is the deficiti getting nourishment etc from the mother’s body. With losing weight the low calorie intake is the deficit and it does indeed work. I am not under any doctor but I am part of an australian research study into HCG low calorie diet. For people like myself where every single weight loss diet, healthy eating regime, excersice programme etc has not worked, HCG does work. My own doctor who I saw after I lost the wieght was amazed as she has been trying for the past 5 years to help me lose wieght having sent me to a dietician and all sorts of people with no lasting success and only a few lbs being lost. When I told her that I had taken HCG low cal diet she did solme research and said it couldnt work, all the research showed it did not work. So I put her right, and said on its own no it does not work with low calorie yes it does as I am living proof. My twin sister who also suffers from under active thyroid and put huge amounts of weight on bought some HCG also and she too is losing the weight now. The research center I belong to is not run by a doctor at all also they are in australia and I am in the UK. I get drops in a bottle.

    So to recap … HCG does NOT lose the weight. It only loses the weight in conjunction with a low calorie diet. You may say a low calorie diet would lose you the weight anyway. Yes it would BUT. the HCG forces the “locked in fat” to be lost not the essential fat. Essential fat is the fat that pads out your organs that fills your face and body to cover the bones. Normally if one was to hhave a low calorie diet only then you start looking gaunt after a while and are constantly hungry and you dont have as much energy as you should. Once tyhe diet is over the weight can gradually go back on because the wrong fat has been lost. With HCG and low calorie, the fat that is lost is the excess fat not the fat we need to protect our body. We do not feel hungry at all. I had more energy than I ever had with my thyroid problem. My skin cleared up from spots and my hair started to shine. Now I can eat normally included occasionally fried foods or luxury foods and I wont put on weight. The one day I did have a binge I puyt on a couple of pounds and that is when one has a high protein day preferably a steak day and the weight dropped off. All those years with thyroid problem and doing low calorie diets which just made me ill as they robbed me of energy and took the fat from my ribs and face and my whole wellbeing suffered. Not so on HCG and low calorie. I suggest people read Dr. Simeons book from cover to cover (its a free download just do a google for pounds and inches by dr simeons) and you will see about the studies that have been done which make people say HCG does not work. No it doesnt, unless you have a low cal diet with it. Go to thyroid UK forum and search about HCG diet you will find people who were bedridden with “fibromyalgia” and other very painful illnesses that doctors had not been able to get under control at all. They had put on wieght cos of lack of excersise. After the diet their fibrmyalgia (maybe wrongly diagnosed I dont know) was cured as was some rheumatism and some thyroid people stopped taking their thyroid medication altogether as their blood tests showed the were high and were fine once they stopped. This does NOT happen with everyone, those people are in the minority, but it shows that hcg does do something to help the body apart from being part of a weight loss programme. I sugges The Doc that you do your own research on HCG PLUS low calorie diet according to dr. simeon then say it doesnt work, as you will be totally surprised that it does work IF people follow the diet exactly. Slight deviations could affect the amount of weight lost. I agree there should be some regulation on the sale of HCG to make sure it is sold correctly and not just water from the tap. But please do not rubbish this diet until you have tried it yourself or done your own researdh as the research you have seen is flawed greatly. I assume you have read cover to cover Dr. Simeons book? if not please do so. I will stand testimonly to the diet in that it does work. Yes one should be under a doctor with any diet. My private doctor who I eventually saw for my thyroid has not only heard of the diet but approves of it. HCG is not harmfull. If it was then god help pregant women as they get a dose daily thousands times that ofthe HCG diet which is only a few units of it daily. IO have another 2 stone (28lbs) to lose which I will be doing after Easter using HCG and 500 cal diet but EXACTLY according to Dr. Simeon which includes no makeup unless mineral based, no mint toothpaste, no oil at all in shampoos or body lotions etc etc, plus only eating the foods he says, no deviation at all. The only down side of this hcg low calorie diet is that I found it boring. That was such a small price to pay for permanent wieght loss that in over 5 years has been impossible because of my thyroid. The added bonus was that my medication is cut down. My NHS doctor was amazed and when I told her how I lost the weight etc, yes she was sceptical and could not approve or back me cos it was not part of NHS, but off the record she applauded me and asked to be kept informed. I also put her in contact with the research study group I originally got the HCG from and put her in touch with my Private doctor who did back me on this diet.

  5. thedoc says:

    There have been double randomized studies done, and they show that placebo and hCG work just as well.
    In terms of your argument that hormones are ok because women produce them during pregnancy is like saying because one aspirin is good one can take the entire bottle. Estrogen is also produced, but if you have estrogen receptive breast cancer you will find that you will get more breast cancer.
    There are always people who will provide their testimonial about how HCG works- but that is an anecdote– science has been done. If you follow the diet exactly you will lose the same weight as if you follow the diet with HCG

  6. thedoc says:

    You are correct – people will end up at the weight that their calorie intake, and type of calorie intake, will lead them too. A diet rich in fruits and vegetables works for some and not for others- and fruits and vegetables are carbohydrates.

  7. thedoc says:

    It is the diet, and not the HCG that does this – and if someone can eat less calories, they will lose weight. We physicians do not recommend these low calorie diets, instead a lifestyle change

  8. LC says:

    Actually, to be quite honest, I’ve also tried the hcg a number of times, it does work!!! Unfortunately, this is an example of how commonly held “knowledge” or “science” can be shown to be inaccurate. I am not very disciplined, I did not cut back to 500 calories, but i did stick to the types of foods that are allowed on the diet, your negative calorie fruits and vegetables (foods that use more calories for digestion than the amount of calories taken in). I also stuck to the meats and carved out the carbs and fatty foods. I did also exercise while using the drops and even though my weight loss wasn’t always 2 lbs per day, I did usually drop at least a 1lb per day. Unlike when I did all of the same things without the use of hcg. Weight loss has been a frustration for me, while using the hcg I dropped from 220 to 178, over the last 1 1/2 years I’ve slowly put back on 20 of those pounds. But it took a long time before I even began to regain.

    One thing that I’d like to mention is that there are soooo many distributers of HCG with all the same claims and all with different levels of homeopathic concentration. With that comes so many possibilities that some people will fall victim to money making schemes and it is sad. The HCG homeopathic drops that I used did not come from a MD as it is common that the MD’s usually aren’t fans of the HCG, but rather from an NP who also ran a bariatic support group of which she saw first hand how well the drops worked for her patients.

    One other thing that is unfortunate is that we do have a capitalist society and everyone is out to make a buck off of the backs of the mentally, spiritually, emotionally and financially poor. This also includes many doctors, health care workers and so on and so forth. So please make sure the companies that you are thinking of using for obtaining hcg are reputable. Compare and contrast the concentrations, the prices, the amounts, etc. etc. Check the BBB for complaints and most importantly be safe.

    As if is a fad diet, if you go back to your formal lifestyle, you will eventually regain the weight. I personally think that instead of always pointing a finger at the protocol, I think that the more health care workers should just monitor the health and weight loss of their patients on the protocol instead of writing it off as rubbish because of this study or that study. We still prescribe the liquid diet and it’s the same principle. Think of how long it took for people to realize that the earth wasn’t the center of our galaxy or that the earth wasn’t flat.

    I do believe that research and statistics are important, but, I don’t believe that they are the “end all, & be all” on every topic, we are still learning new things about our universe every day. So if you’re morbidly obese with all the different co morbidities (sleep apnea, high blood pressure, high cholesterol and diabetes) what kind of significant harm can hcg do to you that a gastric bypass or gastric band won’t?

    Live, learn, grow and love!

  9. thedoc says:

    The double blinded randomized studies are clear – HCG shows no difference. There has not been a double-blinded randomized study that shows it works, but there are a lot of patient testimonials. The question always is– if they didn’t know what they were taking, then would they lose- the answer is – yes.
    Supplements are not regulated by the FDA – so someone can sell HCG to anyone, in any concentration, or state it is a concentration, and it isn’t. There is no regulatory agency that monitors the dosage of HCG you receive, or even if you receive that at all.
    I’ll stick with science on this one – but as a weight loss surgeon, I agree with some of what you say:
    (a) If you don’t change lifestyle it doesn’t matter if you have a gastric bypass or do HCG – you will regain weight
    (b) If you can lose weight and change lifestyle, go for it
    (c) The statistics are clear, that most people cannot lose and maintain weight loss, and the studies are clear that so far the most effective method is surgery.

    That being said – as a weight loss surgeon, I look forward to the day when I can put down the knife, and say “this is what you should do”- but that has not happened. However, I spend more time teaching patients how to cook, how to change their lifestyle, than I do performing surgery

  10. Dawn says:

    I love how there is scientific evidence that it’s a placebo and people still argue with you. Some are just so desperate. I can’t believe people think that eating 500 calories a day is healthy. You should have a minimum of 1200 and most people need more based on age/height/activity/weight. Yeah, you’ll lose weight fast, but it’s starving your body and as soon as you eat like a normal human, it’s going to come right back. Ugh. So many diet fads, but this HCG is one of the more obnoxious ones.

  11. Heather says:

    As a person who has hypoglycemia, I was very concerned about the very-low-calorie diet of hCG. Then I met someone who has done severa rounds of this diet. She informed me of everything others have stated and that the diet resets your metabolism. I found this very difficult to believe, however, I saw this topic covered on an episode of Dr. Oz and his concerns were the same as mine: does the caloric intake have to be SO low? I exercised my due diligence and researched by speaking to over 20 people who had done the hCG diet with much success and no side effects. So I decided to try this diet and if I did not feel well I would stop. After 7 days of being on the diet I was still feeling ‘off’ and having difficulty focusing and thinking clearly. When I contacted the clinic, I was told my dosage would be increased from 25 cc’s to 50 cc’s. The very first day I injected 50 cc’s I felt completely NORMAL and all side effects I was experiencing completely subsided. I did 3 rounds of this diet over a 6 month period and lost 45 lbs of fat WITHOUT feeling deprived or hungry (had I attempted this eating plan without the hCG injections I would have been very ill). My metabolism had been reset as well as my eating habits adjusted so that I could no longer consume the foods leading to weight gain. The loss of weight aleviated much of the pain I was feeling in my body after a serious car collision and weight gained from muscle relaxants & pain killers.

    Due to my own experience with this diet, I am completely convinced the FDA and FTC banning this effective diet is due solely from the dollars not going to Big Pharma and people getting well enough that they no longer need prescription drugs for diabetes, bood pressure, cholesterol, etc. etc. etc.! While the FDA approves many drugs that are harmful to the very patients they are meant to assist, I see this organization pulling anything that is safe and effectively reverses or cures the ailments of many IF it is something the major pharmaceutical companies are not selling an unable to make a profit.

    I agree a medical professional who is licensed and qualified to order labs and interpret the results is imperative (and I have my own doubts about the homeopathic version, yet I have never tried them), however, I disagree with this option for weight loss being banned by the FDA and FTC. There is no ‘one’ method that will work for everyone that the FDA and the FTC will allow – especially since an organic diet is nearly impossible in this country due to all the FDA approved chemicals and GMO that are making their way into our refrigerators.

    Bottom line: The hCG diet is effective and can be done safely under the supervision of a medical professional (M.D., D.O. or L.P.N.) as long as the patient doing the diet understands the purpose of this diet is the beginning of permanent changes that are intended to be life long.

  12. thedoc says:

    It is not due to dollars going through big Pharma- it is due to there is NO difference if you had placebo or HCG – the studies are clear. You could have had placebo.
    Confirmation bias — what we experience is not always reality – but we are convinced by it

  13. DianaH says:

    I have done the protocol and I say you’re full of it. I even experimented with trying to eat 500 cal/day without the HCG injections and I was so hungry I wanted to gnaw my arm off. I also know what I’m taking is not a placebo. You can test it by buying a pregnancy test and testing a few drops of the mixture. Shows I’m having a baby!

  14. thedoc says:

    The effect on hunger is a placebo- and anecdotal evidence based on confirmation bias is not proof. The proof is when it is blinded and done with large groups of people- which has been done. So, yes, it has no effect on hunger- it was propagated and promoted by two different scam artists, and when tested by real science found to not work. Still – people believe in its effect and with their own confirmation bias feel it works.

  15. Kim Cox says:

    Why don’t you guys wake up and smell the coffee? This is the only diet that has ever worked for me – Weight Watchers etc is a load of crap! Look – serious dieters – the hcg diet really works and works quickly, do not take any notice of these ‘so called bloody do-gooders (doctors). This is just total bulls**t and they are worried about losing money! I have never felt so healthy and energetic than on this diet, the UK sucks – they ban everything without looking into it in greater depth.
    In 1 month I lost 24lbs – tried it without the drops – no success – I will leave it to your decision!

  16. thedoc says:

    Confirmation bias is the hardest bias to solve. When this was looked at with many people, with placebo vs. HCG both worked equally well.

  17. ed hazan says:

    I have done HCG and lost 30 lbs in 30 days. I am split half n half. Yes, I lost the weight but I can lose that much without HCG shots too. The question is, why did I feel that energy that I had?
    Without HCG, I can’t even go 6 hours on such low cal diet. Surgeon: do you really think it was my psychology that I am taking shots and feeling full?
    I am truly not sure? what do you think? And what are the side effects in a man?

  18. thedoc says:

    We call that placebo effect. When studies – where people didn’t know if they got the HCG or if they received saline, the results were the same. There is nothing in HCG that makes one feel “full.” In fact, since your stomach is empty most of the time on the 500 cal diet, you are not full. Then think about it- most pregnant women gain weight, they don’t loose it. Energy level: physicians for years have been giving B12 shots telling patients they will feel more energy, and many swore by it — even though it doesn’t happen.
    Side effects: if a tumor is growing that is hormone dependent, HCG could stimulate it.

  19. Lotus flower says:

    I am currently on the protocol for about 15 days now. I have lost about 12lbs so far. Now Doc, seriously, get off your high horse. I have known about the diet for about 2 years and have seen lots of my friends lose lots of weight, but I was very reluctant. I even tried doing the 500 calorie diet without the shots. Guess what? I lasted about 4 days! I was lethargic, I couldn’t focus, I felt as though I was dying of hunger. Now, I am on the exact same diet, along with my shots and I have not gotten hungry even once! As a matter of fact, I find myself unable to tolerate the smell of high fat foods while my body is detoxing. From my experience with “science”, you claimed the earth was flat at one time didn’t you? Eventually, you will catch on, like you always do, when some new “study” PROVES that it actually works. For now, you can’t stop us. And I will be rejoicing every pound I lose!

  20. Dr Simpson says:

    Funny thing about placebo isn’t it. And happy for your weight loss- but the studies are clear and the science is clear: HcG is just a placebo – and in terms of not focus for four days– well, happens initially with any low calorie diet.
    But I am happy for your weight loss- here is the key – not how you do it- but what will you do differently. you cannot go back to your old style, you cannot go back to the same foods that got you overweight and kept you there – you have to change, you have to learn to cook and appreciate great food.

  21. EMC says:

    I laughed when I read the opening statement to this article. It’s quite a “fad” you’re vilifying. Thank God there are doctors out there to save us from becoming a healthy weight; and rescue us from the side effects of eating normal portions of healthy foods. Read: Sarcasm. Don’t tell me and a whole group of family and friends who’ve successfully used the hCG diet to lose weight and stay slim and healthy that this is a dangerous fad diet. Speak for the trillion-dollar weight-loss community who will lose a livelihood should, heaven forbid, folks actually lose weight and keep it off. Delusional.

  22. EMC says:

    Oh, now I get it. I read the tiny print at the bottom that says you encourage “your” lap-band surgery. It’s not delusional blindness; it’s willful.

  23. Dr. Terry Simpson says:

    I guess science just isn’t as good as your personal experience. So lets test this: we take a bunch of people- some we give saline to and some we give HcG to and we see what happens on the same diet. Answer – saline does a bit better. To spell this out for you: if a person is blinded and the doctor is blinded to whether you get saline (salt water) or HcG there is NO DIFFERENCE in weight loss. So why the HcG – do you know the dose you are getting, do you know if it is purified by some standard, do you know if the ingredients that it is kept with are safe, do you know if it is mixed in with known weight loss drugs (sometimes it is) or amphetamines? Do you know that- because do you have an agency that is testing it? No? Ok- personal experience or science — give me science every time.

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