FDA Consumer Update - HCG Diet Products Are Illegal

atomiclauren

Just got an email about this -

Anyone who has ever been on a diet—and there are many of us—knows that there are sensible ways to lose weight. These include balanced diets, exercising and realistic goals.

And then there are reckless ways to shed pounds—fads and diet aids that promise rapid weight loss, but often recommend potentially dangerous practices. These include HCG weight-loss products marketed over-the-counter (OTC) that are identified as "homeopathic" and direct users to follow a severely restrictive diet.

The Food and Drug Administration (FDA) is advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight-loss products. They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores.

FDA and the Federal Trade Commission (FTC) have issued seven letters to companies warning them that they are selling illegal homeopathic HCG weight-loss drugs that have not been approved by FDA, and that make unsupported claims.

(For the list of manufacturers, distributors and products—and more information about FDA’s concerns about HCG—visit www.fda.gov/hcgdiet5.)

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

Health_Gal

I am SOOOOOOO glad to hear that the FDA is finally taking some action on this!

The HCG diet is a dangerous scam. The ONLY reason people lose weight on it is the extremely low calorie food plan. HCG in ANY form has been repeatedly proven to do NOTHING to help with your weight loss or make it safe to eat only 500 calories a day.

I know some people that put their faith in the HCG diet, and became very ill from malnutrition as a result. It is NOT safe!

Here are a some good links about the HCG diet that you might want to read before you get any farther into this:

http://www.myhealthnewsdaily.com/hcg-diet-dangerous-1428

http://www.mayoclinic.com/health/hcg-diet/AN02091

http://www.webmd.com/diet/features/truth-about-hcg-for-weight-loss

http://www.webmd.com/diet/features/weight-loss-cure-dont-want-you-to-know

http://www.dietscam.org/reports/hcg.shtml

http://www.tucsonmedical.com/pages/hcg.php

ninerbuff

Bout time.

A.C.E. Certified Personal Trainer
IDEA Fitness member
Kickboxing Certified Instructor
Been in fitness for 28+ years and have studied kinesiology and nutrition

kmbrooks15

I'm so glad they are taking action on this! Unfortunately, though, there will likely be people who get upset about this and find other ways to buy it, even illegally.

jetscreaminagain

Perhaps now we can focus on fitness here and put a kaibosh on hcg threads here?

HMonsterX

Isn't posting a thread about illegal substances not allowed on this forum?

So the good new is any HCG thread will be deleted on sight now!

Finally!

kmbrooks15

Perhaps now we can focus on fitness here and put a kaibosh on hcg threads here?

Wouldn't that be nice?!

Wonder what will happen to the HCG group. I guess they will have to try to do this the hard way, like the rest of us!

kmbrooks15

Isn't posting a thread about illegal substances not allowed on this forum?

So the good new is any HCG thread will be deleted on sight now!

Finally!

Except that the FDA has only said the DROPS are illegal. People can still legally get the HCG injections if they can find a doctor who will prescribe it (personally I think any doctor that does should have their license revoked, but that's my opinion). The ones who are doing the injections will still be "legal"--I really hope the FDA puts the kibosh on that, too. Even the most overweight people can lose with the methods MFP advocates.

lemonadem

Bout time.

A.C.E. Certified Personal Trainer
IDEA Fitness member
Kickboxing Certified Instructor
Been in fitness for 28+ years and have studied kinesiology and nutrition

^^This.

"The FDA is warning consumers that over the counter HCG products marketed as weight loss aids are unproven and illegal. Many HCG products are marketed to be taken in connection with a very low calorie diet -- it's the decrease in calories that accounts for any weight loss. There are currently no FDA-approved HCG products designed to help you lose weight. FDA and the Federal Trade Commission have jointly issued warning letters to companies illegally marketing over-the-counter HCG products labeled for weight loss."

Source: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm282465.htm


It's the decrease in calories accounts for weight loss, hmm? :noway: Haha... good to know :grumble:

Scott613

Time to stock up on pregnant lady piss and sell it on the black market!

Health_Gal

I have written several emails to the FDA in the past few years about this issue, but at the time, they seemed to consider it a low priority.

Thankfully, they have finally taken notice and are doing something about it!

MissFit0101

hallelujah!

hottottie11

FINALLY!

Listen to the podcast

CessGill

Very good to know... OTC is not the same
at the beginning of the year, I did the HCG diet, but it was prescribed by a doctor (not OTC), and with the guidance of the doctor. The doctor was doing a pilot test on the diet. I only did it for 45 days, and was to wait another 45 days and go back on it, but when it was time to go back, the doctor went from $120 to $500. I never did the second round, but did go from 192lbs to 176lbs during the first 45 days, and was able to maintain the weight throughout the year; until I joined MFP and started loosing again. Its a very strict diet, and only recommended for those who have willpower.

CaptainGordo

Time to stock up on pregnant lady piss and sell it on the black market!

Good call, bro. Running to the stores now.

AZTrailRunner

Soon to be replaced by drops of "old man pee". Taking orders now. :-P

MissFit0101

Soon to be replaced by drops of "old man pee". Taking orders now. :-P

:sick: :sick: :sick: :sick:

Health_Gal

I hope that the FDA's next step is to start going after the so-called doctors and so-called weight loss clinics that offer HCG in ANY form as a weight loss aid. ALL the scientific studies say that HCG does NOTHING to help with weight loss, so those people are basically selling a fraud to their patients.

Whether you take real HCG injections or the homeopathic stuff, it does NOTHING for your weight loss at all. The ONLY reason people lose weight is the extremely strict diet.

Anyone want to join me in writing (or emailing) the FDA about that?

MustangAng

I was desperate enough to purchase the HCG drops a few months ago. When I started reading the instructions on how few calories you could have in a day it hit me that the drops probably had NOTHING to do with the weightloss. Anybody eating 500 calories a day would lose weight I was thinking! I tried the drops one time for one day, and I quickly gave up on that. Hearing this, I'm glad I didn't use them!

Jaslyngonz

i did this diet and now i am glad i read this because i was going to start the diet again in January. Thanks for posting this very useful information

Jaslyngonz

chistoso!!! jajaja. thats funny

Lift_hard_eat_big

What does the fda know?

FrenchMob

It's funny that it took the FDA to step in for dummies to realize what they were doing is not good.

It's call educate yourself people. I also don't really give a rats azz if "a doctor gave it to me". 99% of Dr. no less about nutrition then most people that read about it for a day. There's a bunch of clinics up here in Ontario (might even be all of Canada) called Dr. Bernstein Diet & Health Clinics..."supervised by D", and it's basically the same thing. 500-800 cal diet and you have to go in for B12 injections, and discourage exercise. They charge like $500/mth for this and I know a couple of dummies that went for 3-4 months, loss weight, ranout of money, and now they are heavier than ever.

stefonward

Is the FDA just saying the item isn't FDA Approved? I hope the article isn't suggesting just because HCG and HCG promoted substances are not FDA Approved, they are now considered illegal. In that case, most of the supplement driven weight loss market will probably be "iced". From my perspective.

stefonward

..........or are they stating the "claims are illegal"? I think if that is considered illegal (which it probably should)...again where would most of the market be?

kneeki

"If you lose weight while taking these products, it's likely because you're starving yourself."

CaptainGordo

Is the FDA just saying the item isn't FDA Approved? I hope the article isn't suggesting just because HCG and HCG promoted substances are not FDA Approved, they are now considered illegal. In that case, most of the supplement driven weight loss market will probably be "iced". From my perspective.

Check the link: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm

The diet has become popular again and FDA and FTC are taking action on illegal HCG products. “You cannot sell products claiming to contain HCG as an OTC drug product. It’s illegal,” says Brad Pace, team leader and regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch. “If these companies don’t heed our warnings, they could face enforcement actions, legal penalties or criminal prosecution.”

Elisabeth Walther, a pharmacist at FDA, explains that the agency does not evaluate homeopathic drug products for safety or effectiveness, and is not aware of any scientific evidence that supports homeopathy as effective. However, those that meet certain conditions set by FDA can be marketed. A reference document called the Homeopathic Pharmacopoeia of the United States lists active ingredients that may be legally included in homeopathic drug products.

“HCG is not on this list and therefore cannot be legally sold as a homeopathic medication for any purpose,” Walther says.

FDA advises consumers who have purchased homeopathic HCG for weight loss to stop using it, throw it out, and stop following the dieting instructions.

servilia

Very good to know... OTC is not the same
at the beginning of the year, I did the HCG diet, but it was prescribed by a doctor (not OTC), and with the guidance of the doctor. The doctor was doing a pilot test on the diet. I only did it for 45 days, and was to wait another 45 days and go back on it, but when it was time to go back, the doctor went from $120 to $500. I never did the second round, but did go from 192lbs to 176lbs during the first 45 days, and was able to maintain the weight throughout the year; until I joined MFP and started loosing again. Its a very strict diet, and only recommended for those who have willpower.

The only purpose for which doctors are allowed to prescribe HCG is fertility treatment, to trigger ovulation. Any doctors that presribe HCG for weight loss purposes should be reported to the applicable college of physicians and possibly the FDA.

Iceskatefanrn

I know we have many Pro-HCG'ers here on MFP. And I know there are some that have found success in this program. But please, PLEASE read this information with an open mind. It's for your safety that this action is being taken. Please rethink your diet of choice, and find something else that you can stick to that will be equally successful.

Many MFP'rs are successful just by logging on, recording their food and exercise, and sticking with that. Others are using programs with more structure, such as Weight Watchers, Atkins, Jenny Craig, or in my case, The 17 Day Diet. These are all different programs and not one program is for EVERYONE, but you CAN find success with a legitimate program that is NOT harmful to you!

http://news.yahoo.com/feds-crack-down-homeopathic-weight-loss-remedy-155001085.html

"WASHINGTON (AP) — Federal regulators are ordering several companies to stop selling an unproven weight loss remedy that uses protein from the human placenta.

The Food and Drug Administration issued warning letters to seven companies that sell the protein as drops, pellets or sprays. Human chorionic gonadotropin is produced by the placenta and found in the urine of pregnant women. While it is approved for certain infertility treatments, the FDA says there is no evidence it helps reduce weight.

Many of the products cited in the warning letters claim to change "abnormal eating patterns," and help people lose 20 to 30 pounds in as little as a month when used with a low-calorie diet, usually around 500 calories per day.

Health experts say such restrictive diets can be dangerous.

"These products are marketed with incredible claims and people think that if they're losing weight, HCG must be working," said Elizabeth Miller, of FDA's division for non-prescription drugs and health fraud, in a statement. "But the data simply does not support this — any loss is from severe calorie restriction. Not from the HCG."

The products are advertised as homeopathic remedies, or highly diluted drugs made from natural ingredients and sold with medical claims. Many doctors view homeopathic remedies as ineffective but mostly harmless because the drugs in them are present in such tiny amounts.

But the FDA said the products targeted Tuesday could be dangerous when taken as directed.

Homeopathic treatments are based on principles unverified by mainstream science, and often reference mystical-sounding concepts like "vital force" and "healing energy."

In 1938, Congress passed a law granting homeopathic remedies the same legal status as regular pharmaceuticals. The law's principal author was Sen. Royal Copeland of New York, a trained homeopath.

While regulation of the products is minimal, the FDA maintains a list of approved ingredients that can be used for homeopathic drugs. HCG is not among the approved ingredients.

After decades of declining use, homeopathic remedies have revived in recent decades with the burst of interest in vitamins, herbs and other unconventional treatments.

The companies cited by regulators have 15 days to respond and detail how they intend to remove their products from the market. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution."


:drinker: :drinker: :drinker:

Ice

ShapeUpSidney

I've never found an "efficacy" regulatory standard that applies to OTC homeopathic products. They say they can't market HCG as a weight loss drug because there's no evidence of it's efficacy, but what regulation requires this? The only thing I can find are quality, purity, and potency standards in Section 501b, 21 USC 351 (Federal Food, Drug, and Cosmetic Act)

ShapeUpSidney

The only purpose for which doctors are allowed to prescribe HCG is fertility treatment, to trigger ovulation. Any doctors that presribe HCG for weight loss purposes should be reported to the applicable college of physicians and possibly the FDA.

I could be wrong, but I think the law only prohibits the drug company from "marketing" for indications where there is no evidence to support drug efficacy. Even with a black box warning, I think doctors are still legally allowed to prescribe things "off-label." Pretty much, if it isnt on the Controlled Substances list, the doctor can prescribe it for whatever...

Dammit why am I in the IP legal dept!?!?! Where are my RA peeps?