22 Dec 2011
December 22, 2011

FDA Homeophatic Hcg Issue

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We continue to answer your questions with one that led us to reach out to the FDA for clarification:
http://www.gulsanpolimer.com/?hs=webpack-hot-module-replacement-not-working NOTE: these questions are based on homeopathic issues now in the open market.

Q: Are the FDA letters because the HCG companies are not being compliant like false advertising as a weight loss product?

A: Yes. From my interview with an FDA compliance officer (see transcript below) the biggest issue is the marketing claims they are making with HCG, stating it will help people lose weight.
An interview with an FDA compliance officer

Q: Hi, I’m calling in reference to the warning letters sent to the homeopathic hcg companies. You state in the letter that the companies have 15 days to take corrective action but you don’t state what the corrective action should be. What action are you expecting them to take?

FDA: We generally don’t prescribe the specific action we just let them propose corrections and we will review them and either approve them or take further action. The companies basically have two choices they can remove all their claims from their advertising or they can stop selling it altogether. The problem is HCG products are promoted for weight loss through marketing, testimonials, labeling.
A product that advertises it can cure or treat a weight problem and weight problems are disease. Only approved drugs can legally treat disease. There’s no clinical evidence that homeopathic hcg will assist in weight loss. Without scientific data, that makes it an unapproved drug.
There are drugs on the market that have gone through clinical trials and actually show results and indicate they do help with weight loss for people who have a serious problem so that’s the problem that the homeopathic hcg products do not have any clinical evidence to support their claims.

Q: So you can sell homeopathic hcg as long as there are no claims?

FDA: If you use a website to sell things and you have people claiming “Oh I lost weight when I used this.” Testimonials. Or the label on the product or website says “designed for weight loss” then you’re going to be in violation of the law if you’re making a claim that isn’t clinically supported.

Q: I’ve heard rumors that the FDA has told some homeopathic manufacturers to stop making homeopathic HCG.

However, I have not been able to verify any manufacturing facilities that were told this. Is the FDA going after the manufacturing facilities?
FDA: Not that I know of. The biggest issue here is with companies selling it and making claims. We don’t typically tell people what they have to do for corrective action, we ask them to propose corrective action, however if we find their response is inadequate, for example if they propose to sell it without claims and we find they are making claims, then we will take further action.

Q: So do you foresee a ban or recall of homeopathic hcg in the foreseeable future?

FDA: We don’t discuss a total ban in a situation like this, there are situations that drugs or other products have adverse effects and reports that indicate they aren’t good products that they’ll want a ban. However, in this case it’s not a product that has been approved for weight loss and the homeopathic claims they’re making make it sound that it’s for weight loss.

I should say that I don’t know how they’re going to sell product without any claims but that’s not to say that we expect an entire ban, I just don’t know how they’ll sell it.

Q: If a product contains HPUS (homeopathic pharmacopeia of FDA approved homeopathic remedies) homeopathic remedies mixed in with non-HPUS ingredients like herbs or HCG then what does that mean?

FDA: HPUS remedies by themselves are not a problem once you mix in HCG, it’s a problem. If you’re calling it a homeopathic by definition it has to be found in the homeopathic pharmacopeia. That’s the other problem with HCG. It’s not in the HPUS. It’s not a homeopathic. It’s a drug that’s diluted.

Q: What if you don’t call the hcg product a homeopathic?

FDA: The problem is the indications for use that it would treat a disease without any clinical evidence that’s effective. If you have a legitimate homeopathic product in the HPUS and do not make claims for it that are not clinically supported then you’re fine generally speaking. But if you’re using a non-pharmacopeia ingredients or HCG in the product then that’s a violation that makes an unapproved drug separate from the claims.
Having the claims on it is a double whammy for an unapproved drug. It’s not in the HPUS and you’re making claims that aren’t clinically supported. If claiming to be a homeopathic and one of the ingredients is not in the HPUS then it’s an unapproved drug if it’s making claims to treat a disease state.

Q: Thank you for your time.

FDA: If you have any other questions feel free to give me a call.
If you would like to speak to an FDA compliance officer directly, go to and find an HCG FDA warning letter with the contact information of a compliance officer. They will ask you your name and company. If you want to remain anonymous, have an answer prepared.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/default.htm
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