The Fallout from the Banning of Illegal Homeopathic hCG
Laws banning homeopathic hCG were enforced by the FDA and FTC on November 28th against 7 companies, including the chiropractor who promoted hCG on the Dr. Oz show this past February.
(See http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm)
At MyLovingWorks.com, we wrote about homeopathic hCG being illegal starting in August, 2009. We released
It's now the told truth
extensive research at the Parker Convention in Las Vegas last January to the Chiropractic profession and published an article in the Journal of the Michigan Association of Chiropractors in April, 2010 (because 3 of the top 4 national magazines would not take our article). A past blog in June predicted this action (see http://mylovingworks.wordpress.com/2011/06/23/the-predictable-and-upcoming-purge-of-illegal-homeopathic-hcg/)
HERE’S THE UPCOMING FALLOUT:
1. 7 COMPANIES THAT RECEIVED THE ENFORCEMENT LETTERS ARE GOING TO LOSE MONEY – ALOT- AND MAY HAVE TO SHUT DOWN.
Not only are these 7 companies required to provide an answer to the charges by the FDA by mid-December , they are also required to deal with purchases by all previous customers. Translation? The usual requirement is a complete refund. Alot of money was made. Now a lot is going to be unmade.
2. EVERYONE WHO HAS BEEN SELLING HOMEOPATHIC HCG WILL NEED TO STOP OR THEY MAY BE TARGETED FOR ENFORCEMENT.
This doesn’t apply to just these 7 companies. It applies to all companies, organizations and individuals. And you can bet that more enforcement letters will be forthcoming, especially if they persist in advertising.
3. THERE IS A FIRE SALE ON HOMEOPATHIC HCG, WHICH WILL CONTINUE FOR THE NEXT COUPLE MONTHS.
Current sellers will frantically attempt to recoup some of their inventory costs by posting “Sales” or huge discounts. A customer at GNC reported on Dec. 7 that she was able to purchase one of the products identified in the FDA enforcement letters as being “…half off. What a deal!” Yep. What a deal. That product will be off the shelf by Dec. 15th.
4. SOME OF THOSE COMPANIES WHO WERE THE LOUDEST PROPONENTS WILL DROP THIS LIKE A HOT POTATO.
You can go to certain websites of manufacturers of homeopathic hCG and– surprise– there is not even a link about homeopathic hCG even though they were selling product as recently as 4 weeks ago. No surprise there. It’s all about the enforcement. Even though these same people were well aware the product was illegal, they sold it anyway. The risk then didn’t seem so great. It is great now. So they will attempt to whistle as they skip by– “It’s over. Nothing to see here. Move along…” to quote a typical movie script.
5. THE GENERAL PUBLIC THAT LOVED THE RESULTS HCG GAVE THEM WILL CRY “FOUL” AND WILL INCORRECTLY POINT TO THE PHARMACEUTICAL INDUSTRY. THEY WILL MOUNT PROTESTS AND PETITIONS, TO NO AVAIL.
You can already see this in comments on the news articles pointing to the banning of homeopathic hCG. “It’s all because pharmaceutical companies can’t make any money on hCG…” or “The FDA wants to take away something that really works and replace it with drugs…” or “I didn’t have any side effects when I lost 40 lbs using homeopathic hCG” are popping up. No, it wasn’t Big Pharma this time. Six pharma companies produce hCG and have been making all kinds of money with these huge volumes. And this isn’t evidence of any conspiracy by the FDA to get everyone hooked on pharmaceutical drugs. Nope. It’s simple law enforcement. The FDA/FTC took about 3 years to address the last big boom in using hCG for weight loss in the mid-1970′s. This time, it took about the same amount of time, starting the timer at the success of Kevin Trudeau’s book in 2007 -2008 and ending the timer at the close of 2011. Yet protests will occur and petitions will be signed, especially online petitions. The law won’t change this way.
6. MEDICAL WEIGHT LOSS CLINICS AND MD’S WILL REMIND EVERYONE THAT YOU CAN STILL GET HCG FROM THEM. UNFORTUNATELY, AS THEY ADVERTISE OR PROMOTE HCG, THEY WILL BE BREAKING THE LAW, TOO
Certain licensed doctors and health providers (MD’s, DO’s, ND’s in some states, PA’s, Nurse Practitioners, etc.) can write off-label prescriptions of hCG for weight loss to their patients. But MD’s and their associated clinics cannot promote or advertise hCG for weight loss legally if the drugs come from a compound pharmacy. In addition, if they advertise non-compounded hCG, they must include a label that states the FDA does not approve hCG for weight loss. Try explaining to a state licensing board how, as a MD, you are meeting the standard of care required to support patients yet are promoting something that by definition isn’t proven to work for that use. All someone has to do is complain and you have a sticky problem. We know of a MD from Florida who is outraged that MD’s/DO’s/DC’s etc. are selling hCG for weight loss and has a personal mission to see any licensed health care provider is disciplined or loses their licenses for selling hCG. He’s been successful, as at least 2 of the 7 enforcement letters went to organizations he has or is targeting.
7. COMPANIES WILL SUDDENLY, OUT OF SEEMINGLY THIN AIR, START OFFERING “NON-HORMONE” HCG OR SOMETHING SIMILAR
These new products will be promoted in the same way, with the very low calorie diet, but without the hCG hormone. There are already a number of them on the market. They will claim that there is no “hCG” in them, yet they will follow the Simeons Protocol (highly restrictive 500 cal/day food program). The giveaway will be the 2,4 or 6 week break that you will still need to take in between rounds. If there is no hCG in the product, why do you need to stop taking their products after the first 42 day round? Because there is still hCG in the product, that’s why. If there is no break after the first round, then you have something different that does not have hCG in it. But will it be a proven product or will it be a placebo?
The fallout will continue because millions of people are overweight and will pay to drop pounds, especially quickly. The search for an effective method to help people release weight and keep it off will continue.
I’m so diguested. I’ve dropped almost 60 pounds with this, quickly and safely.
Valerie Rueger
December 9, 2011
Valerie – Congratulations on your success. We understand that people get results with hCG. Yet it is a schedule III drug and requires a prescription.
mylovingworks
December 9, 2011
Two years ago when I started my homeopathic company I contacted the FDA and I was told it was legal to sell but they were looking at it. FDA gave me the quidelines and I followed them. The quide lines were to have the FDA disclosure (had every single client sign the disclosure if they came in my office or purchased on line. Well it has only been in the last two weeks that the FDA coined the term illegal?! I have clients who lost 20- 120 lbs haven’t gained it back, are healthy and feel great. Some are off of medication. The sad part is this is affordable and does work. sign the petition http://www.savethehcgdiet.com
Greg
December 17, 2011
Mr. Thorson – I appreciate your frustration. It seems unfair that homeopathic hCG is being removed from the market. It’s simple though– it’s totally ILLEGAL. The tough truth is that you didn’t do your homework 2 years ago when you started your homeopathic company. If you did, you would know your responsibilities in how to market ALL homeopathic substances in the United States as these laws have been on the books since 1994. It would have been obvious at that time — as it was to us in 2008– that there is no legal way to market hCG over the counter in any form. hCG is a type III, controlled substance and there is no approved homeopathic form of hCG. AND all homeopathic substances must be listed in the US Homeopathic Pharmacopeia for their sale– whether over-the-counter or by prescription (and yes, there are many homeopathic substances that MUST have a prescription to be sold)– or else they are illegal. hCG is not listed there. The FDA doesn’t provide legal advice. You needed to seek an expert attorney, like we did. That you knew something about having your clients sign the disclosure, you should have researched that the “disclosure” was for licensed medical doctors who wanted to write off-label prescriptions for weight loss. It originated in the 1975 FTC/FDA lawsuits against weight loss clinics to stop selling hCG for weight loss, at that time. If you are not a MD or a DO, you are selling misbranded or adulterated substances, no matter how much good intention you may have had. Also, it wasn’t 2 weeks ago that the FDA coined the term “illegal.” Try 1975. If you had done even simple research on hCG, you would have found the FDA/FTC lawsuits against Kevin Trudeau where all of the cases from the mid-1970′s were referenced were easily located. In addition, the FDA stated in January 2011 that homeopathic hCG is totally illegal. You can see our earlier blog on that. That you sold illegal products to your customers puts you in a tough spot. People can still get hCG from doctors, although it will be much more expensive. Signing an online petition, from everything I’ve read, is a total waste of time, but that’s your right. Good luck.
mylovingworks
December 18, 2011
I really don’t need to get into it with you. I will say I did my homework with my attorney and the individual at the FDA. I’m just wondering what your gain is from all this? It never was illegal until recently.
Greg
December 19, 2011
Mr. Thorson – Well, the facts show that you are missing a few things that don’t support your position. For example, just check CPG 400.400 (FDA Compliance Guide) and you’ll see clearly the requirements for marketing any homeopathic substance legally. Homeopathic hCG does not meet these requirements.
My reason for promoting this message is that I was asked by a Chiropractic client to get the word out to protect other chiropractors whose licenses were being put at risk for selling a misbranded drug when they weren’t told of that risk by promoters of homeopathic hCG.
When I told that client that we would be skewered, ridiculed and condemned by those who sell homeopathic hCG, he said so what? At least you’ll be doing a service to help the chiropractic profession. So that has been my main reason for getting this information out.
Thanks for your question.
mylovingworks
December 19, 2011
I am the admin of a site the does not sale HCG but was building a lot of information about HCG and the diet. There are a lot of things that do not seem clear to me.
When talking about banning the diet they are also talking about how people are asked to only eat 500 calories a day. . This does not seem to be about HCG and more about how much people are eating. So why bring it up?
Also I have not really seen anything about what is dangerous about “HCG” it self, again people keep talking about eating only 500 calories a day. There is also a diet that you can only eat 800 calories a day witch may be better for a lot of people.
Another thing that is not clear is, how the diet has been around for SO long and just now the FDA feels the need to say something.
The 3rd thing that I dont understand is, I can go to CVS and find 50 other diet pills that are not at all going to help lose weight but they still sell them everyday. How can the lack of information on HCG get it banned but for other drugs its ok?
Also for my site I would like to suggest a “NON-HORMONE” one to people but have not found any good products, are there any that you be leave worth a shot? Or are they just not going to work the same?
Thank You
James R
James From HCG Diet Team
January 4, 2012
Thanks for your comment.
While you state that you don’t sell hCG, you provide links for someone to order hCG on your website, so that is confusing. Are you an affiliate? A reseller? A distributor? Okay. Your questions are valid so here are some answers that may help you.
You asked:” When talking about banning the diet they are also talking about how people are asked to only eat 500 calories a day. . This does not seem to be about HCG and more about how much people are eating. So why brin it up?”
The FDA banned the sale of homeopathic hCG because it is a misbranded drug and is an illegal substance per the Food, Drug and Cosmetic Act. hCG is a controlled substance and you can’t just sell a watered-down version over the counter. That they said anything about the 500 calorie diet appears to be part of their justification of why they took action. The real reason is that homeopathic hCG is a controlled substance and can’t be sold over the counter.
You asked: “Also I have not really seen anything about what is dangerous about “HCG” it self, again people keep talking about eating only 500 calories a day. There is also a diet that you can only eat 800 calories a day witch may be better for a lot of people.”
THere are numerous places where you can find problems with taking hCG, starting with the Simeon’s “POunds and Inches” document. You have not searched Google well enough. If you read the SImeons protocol, you’ll find the inventor of the program is exceptionally strict with being under a doctor’s care for 500 calories and if you don’t follow the instructions for the diet precisely, you risk problems, even harm. Lots of people have offered crazy things with hCG– cookies, chocolate, 800 calorie diets,etc. etc. These things are not a part of the Simeon’s protocol and create a different program. What testing has been done or tracking of users of these additions? Simeons would obviously reject these things if he were still alive.
You asked: “Another thing that is not clear is, how the diet has been around for SO long and just now the FDA feels the need to say something. “ You may have to dig a little deeper to find the facts. Go to mlw.mylovingworks.com/forum and you’ll see extensive research in how the FDA took action in 1975 and caused the burgeoning hCG weight loss market to collapse at that time. Check the links to the lawsuits against Kevin Trudeau. It’s all documented.
You asked: “The 3rd thing that I dont understand is, I can go to CVS and find 50 other diet pills that are not at all going to help lose weight but they still sell them everyday. How can the lack of information on HCG get it banned but for other drugs its ok?”
CVS sells dietary supplements that do not have diluted controlled substances in them. If they did, the FDA would send enforcement letters (eventually) and require CVS to remove those products from their shelves. If those other wt loss products didn’t work, no one would buy them after awhile and the store would stop selling them. If people keep buying stuff that doesn’t work, companies will keep selling that stuff.
You Wrote: “Also for my site I would like to suggest a “NON-HORMONE” one to people but have not found any good products, are there any that you be leave worth a shot? Or are they just not going to work the same?”
I can’t speak for other products but our all-natural Weight Balancing System is awesome and you can be a distributor if you wish. We’ve had more than 8,000 people use the product in the past 18 months. You can learn more by going to http://www.mylovingworks.com or to the facebook.com/lovingworks page. If you are interested, please contact me. Approximately 70% of people who have used both hCG and our Wt Balancer(r) product prefer the Weight Balancing System for a lot of reasons.
Good luck with your search.
mylovingworks
January 4, 2012
So, I knew you were selling something! BTW, did you know it’s false advertising and against the law to advertise that you have had 8,000 people purchase your (re-branded form of hCG) that is nothing more than a re-label? Did you also know that as a “weight loss” distributor/wholesaler, you must adhere to Federal guidelines on marketing weight loss http://www.ftc.gov/bcp/edu/microsites/redflag/? You have not had 8,000 people buy this product. How do I know this? Because your Alexa score shows your website not ranking whatsoever for keywords http://www.alexa.com. Not only that, you have little knowledgeable about physicians and what types of disciplines can/cannot prescribe. I’m calling foul on your pseudo-law advice, which is nothing more than a cheap ploy to sell your re-branded hCG/weight loss drops!
Derek Gerdes
January 30, 2012
Mr Gerdes: Thank you for your email full of criticism. Permit me to respond to point out the misrepresentation and to comment on your remarks that unfortunately are long on claims and short on support.
You wrote: “So, I knew you were selling something!”
LW: Yes, Loving Works sells health and wellness supplements. Are you implying that being in business is a problem?
You Wrote: “BTW, did you know it’s false advertising and against the law to advertise that you have had 8,000 people purchase your (re-branded form of hCG) that is nothing more than a re-label?”
LW: This is incorrect. It is not illegal to advertise that we have had more than 8,000 people purchase our products when we have the sales records to prove it. Your statement that LW product is nothing more than a rebranded form of hCG AND a re-label are incorrect. There is no hCG in Loving Works products.
You wrote: “Did you also know that as a “weight loss” distributor/wholesaler, you must adhere to Federal guidelines on marketing weight loss http://www.ftc.gov/bcp/edu/microsites/redflag/?”
This is also false. We are not a distributor/wholesaler. We have distributors who sell Loving Works products. Our legal team has reviewed the Federal guidelines and has indicated that we must have data to support our claims. We have statistical data from our customers that support our claims. While the Red Flag guidelines published by the FTC are used to identify potential bogus sellers of weight loss products, they are not “law.” And while they may highlight a potential problem, if a company has evidence to support its claims, it can meet the requirements of the FTC guidelines. Most cannot, which is why these guidelines are used to identify potential problems.
You wrote: “You have not had 8,000 people buy this product. How do I know this? Because your Alexa score shows your website not ranking whatsoever for keywords http://www.alexa.com.”
LW: You seem pretty sure of yourself. Your statements are false. If all of our sales came just via internet leads, you might have a point. But we have more than 400 distributors of our product who sell person-to-person. While I agree we have room for improvement on the website and it is currently being redesigned, we do not use the internet as a primary sales vehicle. You are mistaken.
You wrote: “Not only that, you have little knowledgeable about physicians and what types of disciplines can/cannot prescribe.”
LW: Show the proof that you refer to in order to back your claim. Outside of MD’s and DO’s, the occasional ND (depending on state laws), or a Physician’s Assistant or Nurse Practitioner, who else is eligible to write prescriptions? You fail to back your statement. It’s a criticism without any evidence and hence easily dismissed.
You wrote: “I’m calling foul on your pseudo-law advice, which is nothing more than a cheap ploy to sell your re-branded hCG/weight loss drops!”
LW: There has been extensive research done by our legal team about the illegality of homeopathic hCG before the FDA made their public statements in january, 2011, reinforcing our conclusions. The enforcement letters of Nov. 28, 2011, you can find on fda.gov by searching hcg enforcement letters. You’ll find all of the legal support that the FDA is using to enforce the law. So again, you claim has no merit because you cannot call “foul” on the facts. Where are yours Mr. Gerdes? Finally, we do not sell rebranded hCG weight loss drops. There is no hCG in any Loving Works products.
I don’t know why you are so vitriolic in your criticism, especially since your claims and comments are meritless. What are YOU selling?
mylovingworks
January 30, 2012