Dangerous HCG Diet Claims Upheld, Regulators Say Product Does Not Aid Weight Loss

The HCG diet — known for a "loading" phase, followed by a rapid weight loss regimen on just 500 calories per day — is not backed by the FDA for weight loss, and to date the scientific evidence does not show that HCG itself contributes to the weight loss. Three out of the six enforcement actions went after firms illegally marketing homeopathic HCG products for weight loss, and cited these violators of the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission issued seven warning letters.

Overview of the HCG diet

Following an approved HCG diet protocol involves a combination of injecting a hormone called human chorionic gonadotropin (HCG), and eating a low-calorie diet. The detailed diet protocol taken from the HCG Diet Plan outlines the three phases of the diet.[10]

In the "loading phase," HCG injections begin and dieters are told to over-indulge on high-fat and high-calorie foods for 2-3 days. Next is the "weight-loss phase" — on days 3 to 27 (in a 40-day program), limiting food intake to only 500 calories, consisting of a certain food list like lean protein, specific fruits and vegetables, and limited olive oil. HCG injections continue through both phases, though sources disagree on dose. After the 500-calorie phase, the maintenance phase involves gradually reintroducing high-calorie foods, but not sugars according to the HCG Institute description, as well as continuing the HCG injections.[10][11][12][13]

FDA Take on Human Chorionic Gonadotropin (HCG)

According to the Food and Drug Administration, HCG is:

• Not approved for weight loss[1]
• Not approved for use without a prescription for any purpose[2]
• Not shown to cause more attractive or "normal" fat distribution[4]
• Not shown to decrease hunger associated with calorie-restricted diets[5]

The FDA takes a firm position on HCG for weight loss: it's not approved, and the existing scientific evidence does not indicate it has benefits beyond calorie restriction for weight loss. In fact, the regulators outright state "no substantial evidence" to support any of the key claims made about HCG by diet proponents, linking directly to the FDA-approved HCG drug label.

Clash of Enforcement

Although the FDA's public pages on HCG are clear, conflicted claims for HCG as a weight loss aid have enriched some market players and caught the eye of regulators.

The FDA and Federal Trade Commission (FTC) collaborated on enforcement actions in 2016, issuing seven joint warning letters to firms for marketing over-the-counter human chorionic gonadotropin (HCG) drug products labeled as homeopathic for weight loss. The FTC explained, "The firms were violating the Federal Food, Drug, and Cosmetic Act for selling unapproved new drugs and the Federal Trade Commission Act for making unsubstantiated weight-loss claims." Seven firms were cited.

The agencies' letter to HCG Diet Direct, LLC on November 28, 2011, is a case in point. The warnings included:

• Violating sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act by selling an unapproved new drug, and
• Violating sections 503 and 301 of the Act by misbranding the drug.[8][9]

In short, the evidence from enriched market players has directly led to warning letters from the FTC and FDA, reinforcing that players in this market can't legally make weight-loss claims on the back of HCG. How this story lands in the spiky, popularity-driven online search landscape will be telling.

Where the description comes from

The facts about the HCG diet protocol and its claimed benefits do not appear to come from the FDA's direct sources, but rather commercial sites. Descriptions of the HCG protocol are surfaced from clinics and can vary from source to source: for example, the HCG Institute describes the 500-calorie phase as lasting 20-46 days, while Alladerm describes it as 23 or 40 days. The daily HCG dose also varies from 125-200 IU or up to 235 IU, according to the surfaced descriptions. Sources disagree on the protocol details.

Triple review: sources cited, studies verified, no invention

The claims made about the HCG diet in this article rely on sourcing intersected from a public knowledge base educating on the facts — authoritatively, ultimately, taking guidance from the FDA as opposed to ingestion from hot online sources. The FDA takes the posture that HCG is not approved for weight loss or for use in weight loss programs, and that it is not shown to have added benefit beyond the power of calorie restriction for weight loss. The agency is so confident in this worldview they clearly said so in their published "Avoid Dangerous HCG Diet Products" alert, and the word-for-word FDA-approved drug label itself notes "no substantial evidence" to support any of the 3 key claims market players had long been bragging. That these regulatory insights have been bolstered and backed by warning letters from the FDA and FTC, warning against misbranding HCG away from weight loss, raises the question: who is the authoritative voice? The FTC and FDA. And what do they have to say about HCG weight loss? Don't fall for the claims and risk your safety.

As for how persuasive this is, more fact-finding is needed. If the FDA is considered the authoritative voice we profiled in this piece, then the evidence is clear, as is the stance: HCG dietary supplements have not been approved for weight loss. But because the search landscape is Google's to play with, much is usually left to the imagination. We're only authorized here to cite the facts.