In a continuous effort to rid the market of potentially hazardous drugs, the U.S. Food and Drug Administration (FDA) has recently requested numerous companies to halt the production and distribution of an unproven weight loss remedy. Subsequently, a total of seven manufacturers received warning letters from the FDA, demanding that they stop selling homeopathic weight loss remedies that contain human chronic gonadotropin (HCG). The products targeted in the warning letters have not been approved by the FDA and may be dangerous when taken as directed.
The FDA, in association with the Federal Trade Commission (FTC), has issued warning letters to firms marketing over-the-counter homeopathic HCG drug products for weight loss. Selling unapproved and misbranded drugs that make unsubstantiated claims about weight loss directly violates the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act. The unapproved homeopathic HCG drug products can be found on websites and in select stores.
The following is a list of the drugs, and their corresponding companies, that were targeted by the FDA warning letters:
- Nutri Fusion Systems, Inc (HCG Fusion 30 and HCG Fusion 43)
- Natural Medical Supply, LLC DBA HCG Complete Diet (Alcohol Free hCG Weight Loss Formula, hCG Diet Pellets Weight Loss Formula and hCG Diet Drops Weight Loss Formula)
- HCG Platinum, LLC (HCG Platinum, HCG Platinum X-30 and HCG Platinum X-14)
- Theoriginalhcgdrogs.com (Homeopathic Original HCG and Homeopathic HCG)
- HCG Diet Direct, LLC (HCG Diet Homeopathic Drops)
- Hcg-miracleweightloss.com (HCG Extra Weight Loss Homeopathic Drops)
Human chronic gonadotropin, a natural substance produced by the placenta and found in the urine of pregnant women, is the ingredient receiving scrutiny from federal regulators. It is touted by the distributers to have the ability to change abnormal eating habits and help people lose a significant amount of weight. In association with a low-calorie diet, usually 500 calories per day, these products claim that people may lose as much as 30 pounds a month. However, the FDA acknowledges that there is no evidence to support those claims.
Contradictory to what is promised by the homeopathic remedies, are the opinions of several health experts. According to those familiar with the field of dietary supplements, restrictive diets, combined with the drugs in question, may lead to dangerous circumstances.
“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 in question have made significant medical claims through the use of highly diluted drugs made from natural ingredients. Otherwise known as homeopathic remedies, these products are the subject of a much heated debate. The majority of medical professionals believe that homeopathic remedies are ineffective and generally harmless because they contain such a small amount of drugs. Homeopathic treatments are based on principles unverified by mainstream science, rather than scientific evidence.
The companies mentioned in the FDA warning letters have been given 15 days to respond and acknowledge how they intend to remove their products from the market. Failure to do so may result in legal action by the proper authorities, including seizure and injunction, or criminal prosecution.
Do I Have a Dietary Supplement Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in dietary supplement lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one has purchased or used any of the HCG products mentioned above, regardless of injury, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.