FDA vs HCG Diet Supplements
Abstract & Commentary
By David Kiefer, MD, Clinical Instructor, Family Medicine, University of Washington, Seattle; Clinical Assistant Professor of Medicine, University of Arizona, Tucson; and Adjunct Faculty, Bastyr University, Seattle. Dr. Kiefer reports no financial relationships relevant to this field of study.
On december 6, 2011, the food and drug administra- tion (FDA) announced that "HCG products marketed as weight loss aids are unproven and illegal."1 Seven letters were sent jointly by the FDA and Federal Trade Commission (FTC) to companies involved in selling products for that indication. The press release details their concerns about weight loss products with human chorionic gonadotropin (HCG), which are labeled as "homeopathic" and sold in oral drops, pellets, and sprays, and usually are paired with a very low-calorie diet (500 calories daily) in order to help people lose 20-30 pounds in 40 days.
The FDA's concerns center on the danger of very low-calorie diets and the significant weight loss that occurs in association with them over such short time frames, especially without medical supervision. Furthermore, HCG is an injectable pharmaceutical, approved for medical conditions such as infertility, but not for weight loss; therefore, an over-the-counter (OTC) use of HCG is illegal. Finally, there is an approved list of homeopathic remedies, and HCG is not one of the constituents on that list, again in violation of the law.
Examples of the companies marketing HCG for weight loss are HCG Diet Direct, HCG Platinum, and Nutri Fusion Systems.2 As of the printing of the article, products from these and other HCG companies were still available for sale through online companies and distributors. Labeling on HCG products includes phrases such as "Appetite Control and Detox," "Weight Loss Protocol Included" (referring to the diet and exercise regimens recommend along with the supplement), and "Weight Loss Formula." Some products contain homeopathic HCG (in strengths of 6X, 10X, 30X, and 60X) combined with homeopathic amino acids, often dosed as 10 drops three times daily. Another has 910 nanograms of a proprietary combination of HCG amino acids isolates in 10 drops and is dosed 10 drops three times daily. There are many other products using various combinations of amino acids, herbal medicines, and other ingredients.
In some cases, the proposed mechanism for HCG on weight loss is mentioned on packaging, but in other cases, manufacturers do not detail the effect. HCG's involvement in physiological changes during pregnancy is theorized to promote mobilization and metabolism of stored fat to produce additional energy, thereby leading to weight loss and a resetting of metabolism.
Commentary
In the realm of dietary supplements, the FDA and FTC become involved whenever there is an infraction of laws related to supplement labeling or safety (FDA), or advertising or Internet information (FTC). As described above there were several aspects of HCG supplements and the HCG diet that crossed over the legal line and led to the December 6, 2011, announcement and reprimand.
The FDA press release mentions concerns about safety related to the use of the HCG products specified. It is interesting that most of the concerns discussed had to do with the problems of rapid weight loss (i.e., precipitation of gallstones) that may occur as a result of the HCG weight loss protocol, not necessarily the HCG products themselves, which the FDA deems to be ineffective; it is the very low-calorie diet that is presumed responsible for the significant weight loss achieved. The focus on adverse effects of dietary supplements is one of the FDA's mandates. Because of the placement of dietary supplements into the category of food (a result of the 1994 legislation, the Dietary Supplement Health and Education Act), it is a company's responsibility to assure safety prior to release into the marketplace, and the FDA steps in only when concerns about safety surface, essentially postmarketing surveillance. A quick perusal of Internet sites for some of the companies selling HCG products reveals their approach to the issue of safety, with disclaimers strongly encouraging involvement of health care practitioners, directing consumers to books for more information (thereby avoiding FTC's concerns about the inappropriate dissemination of online medical information), and, in some cases, no use or mechanistic data whatsoever. It may, therefore, be possible for some companies to claim that they are not providing any protocol, per se, only products that consumers will have to figure out how to use by referencing some other source. It will be interesting to see how this aspect of the FDA's concern plays out.
Any unknowns about implied use and adverse effects as discussed above vanish with the other two parts of the FDA/FTC complaint. First, HCG is a pharmaceutical with approved uses, none of which are for weight loss; any other use, therefore, is illegal. Micromedex, the pharmaceutical database, states that chorionic gonadotropin is approved for use in adults to treat cryptorchidism, hypogonadotropic hypogonadism in males, and ovulation induction, whereas a related, recombinant form, chorionic gonadotropin alfa, is used in "assisted reproductive technology" and, again, ovulation induction. There are well-established contraindications and a detailed mechanism of action for the above-mentioned indications that do not seem to overlap the weight loss genre. This seems to be a cut-and-dried case of marketing and distribution of a pharmaceutical beyond its FDA-approved uses, an illegal act and one that will probably be hard for companies to circumvent.
Unless. Yes, there is an "unless." Companies involved with HCG products may be able to make a case that they are not actually using the pharmaceutical form, an injectable solution that, interestingly, is a topic of conversation between pleading, overweight patients and, sometimes, suspect physicians. Using subcutaneous or intramuscular HCG would certainly be an off-label use of this drug. Instead, HCG products on the market are using homeopathic HCG, hence the labels that mention 6X, 10X, et cetera, a reference to the fact that the HCG is diluted and shaken ("percussed") so much that nary an HCG molecule exists in the remaining solution. Homeopathic medical practitioners, and a few research trials, support the efficacy of these "ultra-dilute" preparations; in theory, homeopathic HCG might still be able to exert an HCG effect, obtaining what consumers want from this hormone, and allowing manufacturers to skirt FDA HCG drug regulations. However, here arises the third part of the FDA complaint: It appears that in the official homeopathic compendium, HCG is not mentioned as an allowable homeopathic treatment. The FDA may have had the last laugh, as it targets the illegality of even homeopathic HCG forms.
So, there are legal technicalities that seem to be the origin behind the current press release and seven certified letters. However, what else might be going on behind the scenes of the HCG diet movement, and whether or not there may be any truth to what these products' manufacturers, and many of our patients, claim, is a whole other matter. It takes some detective work to compile general themes from the wide variety of HCG manufacturers, as well as track down the origin of specific claims and possible role of co-ingredients, which is beyond the scope of this commentary. Stay tuned for the full HCG treatise in an upcoming issue.
References
1. HCG Products Are Illegal. U.S. Food and Drug Administration. For Consumers. Available at: www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm. Accessed December 10, 2011.
2. Fraudulent HCG Products for Weight Loss. U.S. Food and Drug Administration. Drugs. Available at: www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm282465.htm. Accessed December 10, 2011.
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