FDA Consumer Update - HCG Diet Products Are Illegal

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?

kapeluza

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

If I ever get pregnant again, I'll run a HCG black market...

Grokette

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!

All you have to do is go to your Dr and get a prescription for the REAL HCG and do the injections just as if you were doing infertility treatments, so it will be a smaller dose than what they prescribe for infertility.


All this is, is the FDA forcing people to go get prescriptions written. More money into the hands of the Pharmaceutical companies.

Grokette

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.

Why, when the injections work splendidly as a weight loss aid and also works to line out other hormonal imbalances?

Infertility treatments is not the only use for the REAL HCG that needs to be injected.

Sp1nGoddess

I have a friend who lost weight on this but he looks like a sack of potatoes now. It's pure starvation and not safe at all.

hottottie11

Why, when the injections work splendidly as a weight loss aid and also works to line out other hormonal imbalances?

It works because of the 500 calories diet

Infertility treatments is not the only use for the REAL HCG that needs to be injected.

But it has not been approved for use in weight loss

Grokette

Why, when the injections work splendidly as a weight loss aid and also works to line out other hormonal imbalances?

It works because of the 500 calories diet

Infertility treatments is not the only use for the REAL HCG that needs to be injected.

But it has not been approved for use in weight loss

Whatever you want to say, but it is not the 500 calorie diet. I did the 500 calorie diet withOUT the HCG injections and didn't lose an ounce and was STARVING.


Dr prescribed the HCG injections and I lost weight effortlessly, actually ate more than 500 calories per day and lost fine with no hunger at all. I maintained that loss too after I went back to MY normal way of eating, which isn't close to normal for most other people.

MissFit0101

Why, when the injections work splendidly as a weight loss aid and also works to line out other hormonal imbalances?

It works because of the 500 calories diet

Infertility treatments is not the only use for the REAL HCG that needs to be injected.

But it has not been approved for use in weight loss

Whatever you want to say, but it is not the 500 calorie diet. I did the 500 calorie diet withOUT the HCG injections and didn't lose an ounce and was STARVING.


Dr prescribed the HCG injections and I lost weight effortlessly, actually ate more than 500 calories per day and lost fine with no hunger at all. I maintained that loss too after I went back to MY normal way of eating, which isn't close to normal for most other people.

how much muscle did you lose?

MattGetsMad

I've never heard of this drug, but it sounds kind of hilarious...

I've got an even better weight loss drug though. It's super effective and the FDA doesn't know anything about it either. You just take one pill everyday, and eat 450 or less calories. Works about 10% better than HCG!

Seriously though, how would someone believe that the extreme weight loss has anything to do with anything other than starving yourself???

CorinthiaB

I have very little faith in the FDA and it stamp of approval. After all, it approved Phen-fen.

servilia

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?

Ok fine. I'll assume you're right. If this is the case it's pretty sad how widespread this scam/fraud is, and how many doctors are participating in it.