Originally surfacing in the 1950s, the HCG diet has been rising in popularity once again, despite concerns about its safety and efficacy. Short for Human Chorionic Gonadotropin, HCG is a hormone that is produced naturally in the body during pregnancy. The US Food and Drug Administration (FDA) has approved some injectable forms of HCG for the prescription-only treatment of infertility and for specific hormone therapies, but it has not approved HCG for weight loss purposes.
The original architect of the HCG diet, British physician Albert T.W. Simeons published Pounds and Inches in 1954. The manuscript outlines the HCG diet protocol, which recommends a diet restricted to very specific foods, no more than 500 calories per day, and daily injections of HCG. Iterations of Dr. Simeons' HCG diet have appeared over the years, and LegitScript has noticed a recent increase in telemedicine providers prescribing HCG and pharmacies promoting compounded HCG for weight loss purposes. While the HCG diet is touted across the internet as a miracle diet solution, subsequent research has continuously failed to reinforce Dr. Simeons' results; experts and regulators tend to agree that HCG has no significant effects on weight loss and could carry some serious safety concerns.
A History of Regulatory Scrutiny
Given the lack of adequate scientific evidence and the presence of potential safety issues, the FDA has not approved HCG for weight loss purposes. In fact, the FDA requires all approved prescription drugs containing HCG (such as Pregnyl) to include the following disclaimer under the product label's Indications and Usage section: "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."
Aside from prescription drug products, HCG is prohibited in over-the-counter (OTC) or homeopathic drugs. The FDA has not approved the sale of any OTC product containing HCG. The FDA and FTC have issued seven joint warning letters to firms marketing OTC HCG remedies for selling "unapproved new drugs and misbranded drugs that make unsubstantiated claims about weight loss." In addition, OTC products containing HCG sold on the internet are generally oral and nasal formulations. According to the American Medical Association (AMA), "there is no evidence to support absorption of HCG via oral or nasal routes of administration." According to the FDA, HCG "cannot be sold as a homeopathic medication for any purpose."
Furthermore, FDA, AMA, the Obesity Medicine Association (OMA), and several state medical boards have all officially come out against the use of HCG for weight loss.
Despite HCG not being approved for weight loss purposes and a lack of adequate scientific evidence to support its efficacy, medical providers are nonetheless permitted to prescribe drugs for unapproved (i.e., "off-label") uses if, in their professional judgment, the drug is medically appropriate for the patient. Addressing this issue, the FDA has stated: "The 'off-label' use of products usually presents greater uncertainty about both the risks and benefits because less information is available on safety and effectiveness. Unexpected adverse events may occur in this context. FDA has received reports of serious adverse events associated with the use of HCG injections for weight loss including cases of pulmonary embolism, depression, cerebrovascular issues, cardiac arrest, and death."
Because medical providers are within their professional jurisdiction to prescribe HCG for weight loss, LegitScript occasionally observes this practice when reviewing applicants for our Healthcare Certification program. Given that multiple authoritative bodies - both in the US and worldwide - have taken unequivocal stances against the practice, LegitScript currently deems entities that prescribe, compound, dispense, or promote HCG specifically for weight loss purposes as ineligible for certification.
As of March 23, 2020, compounding with HCG may violate applicable laws, such as the Food, Drug, and Cosmetic (FD&C) Act and Public Health Service (PHS) Act. The FDA recently reclassified HCG as a biologic product and, as such, it no longer meets the compounding exemptions laid out in sections 503A and 503B of the FD&C Act. In short, lacking a biologics license, both 503A and 503B pharmacies can no longer legally compound with HCG.
Are you a pharmacy, telemedicine provider, or healthcare provider looking to demonstrate compliance? LegitScript Certification is known throughout the online advertising, social media, regulatory, and payment sectors; it is recognized by Visa, Google, Bing, and other major payment service providers. Find out how you can become LegitScript-certified.