Lawsuit Information Center
In the United States, the FDA is responsible for the legitimacy of the claims on product labels. The FTC is responsible for regulation of product advertising. Not many people understand this and the two do step on each other’s toes at times. What the FTC has advertised, approval must be obtained from the FDA in order to make treatment or prevention claims.
People that make weight loss drugs are not scared of the FDA and FTC. The FDA and FTC have issued 7 joint warning letters to companies marketing over the counter (OTC) drugs advertised as homeopathic for weight loss. Warning letters have been issued as the claims are unsubstantiated (thus fraudulent), unapproved and in violation of federal regulations.
The weight loss product at issue contains human chorionic gonadotropin (HCG), a hormone found in the urine of pregnant women, produced by the human placenta. This alone should scare you off. HCG is currently only approved in the US as an injectable drug for the treatment of certain cases of female infertility and hormone therapy in men. The products subject of the current advisory are available as oral drops, sprays and pellets.
Labels state that the products should be taken along with a very low calorie diet (as low as 500 calories per day). The FDA has concerns with this labeling as patients following a very low calorie diet are at increased risk of gallstone formation, electrolyte imbalance, heart arrhythmias and other adverse effects, and should only be following such a diet under medical supervision.
The FDA has posted a list of 7 companies subject of the warning letters, but state that all products currently on the market labeled as “homeopathic” are being sold illegally:
- HCG Diet Direct, LLC Product name – HCG Diet Homeopathic Drops
- HCG 1234 LLC (The hCG Drops LLC) Product name – Homeopathic HCG
- HCG Platinum, LLC Product names – HCG Platinum, HCG Platinum X-30, HCG Platinum X-14
- Hcg-miracleweightloss.com Product name – HCG Extra Weight Loss Homeoapthic Drops
- Natural Medical Supply, LLC DBA HCG Complete Diet Product name – HCG Extra Weight Loss Homeoapthic Drops
- Nutri Fusion Systems, Inc Product names – HCG Fusion 30, HCG Fusion 43
- Theoriginalhcgdrogs.com Product name – Homeopathic Original HCG, Homeoapthic HCG
Currently, HCG drug products for use in hormone treatment and infertility are labeled with the following statement regarding use of HCG for weight loss as the FDA is aware that some health care professionals may prescribe injectables for “off-label” uses:
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.
The FDA is advising that consumers using the HCG products for weight loss stop taking the product, and stop any very low calorie diets they may be following immediately. Consumers should also discard the product. Any harmful effects experienced should be reported to the FDA.
These over-the-counter weight loss pills are really not the answer to any question other than how to make money off desperate people.