At the end of November, the Food and Drug Administration (FDA) issued warning letters to seven companies marketing diet products containing human chorionic gonadotropin (hCG). The companies in question have been selling these products as “homeopathic remedies” for use in rapid weight loss, often recommending the products be used in combination with a 500 calorie per day diet. Many of the companies claim that these products can curb appetite, speed metabolism, and eliminate fat from specific areas of the body.
Even though companies state that their products are not intended to diagnose, treat, cure, or prevent any disease, the claims made on the products’ websites make it clear that they are intended to affect the structure or function of the body. From the FDA’s perspective, this makes them unapproved new drugs. Furthermore, the FDA points out in its warning letters that homeopathic drugs are subject to the same regulatory requirements as other drugs. According to FDA compliance policy guidelines:
Section 201(g)(1) of the Act defines the term 'drug' to mean articles recognized in the official United States Pharmacopeia (USP), the official Homeopathic Pharmacopeia of the United States (HPUS), or official National Formulary (NF) or any supplement to them; and articles intended for use in the diagnosis, cure, mitigation, treatment, or the prevention of disease in man or other animals; articles (other than food) intended to affect the structure or any function of the body of man or other animals; and articles intended for use as a component of any articles specified in the above. Whether or not they are official homeopathic remedies, those products offered for the cure, mitigation, prevention, or treatment of disease conditions are regarded as drugs within the meaning of Section 201(g)(l) of the Act.
Homeopathic drugs generally must meet the standards for strength, quality, and purity set forth in the Homeopathic Pharmacopeia.”
More importantly, hCG is not even formally recognized as a homeopathic drug.
The FTC also has taken issue with these products, since companies marketing hCG diet products have made unsubstantiated claims about the effectiveness of these products. Under the FTC Act, advertising that a product can prevent, treat, or cure human disease without rigorous scientific evidence to substantiate the claims violates the Act. Richard Cleland, assistant director of the FTC’s advertising practices division, has also suggested that companies manufacturing similar products that have not received warning letters “should also read these letters carefully and take appropriate action.”
Although hCG is available by prescription to treat infertility, there are no circumstances under which it may legally be sold as an over-the-counter product, and certainly not for use in weight loss. The FDA has demanded that the companies in question reply within 15 working days regarding the steps they are taking to address all of the violations noted in its letters, including how the companies intend to address product that they have already distributed. To date, the companies’ responses have not been posted to the FDA website.
All in all, the joint FDA and FTC action makes it clear that attempts to avoid FDA regulatory attention by labeling a product as homeopathic and disclaiming its intent to diagnose, treat, cure, or prevent disease will not change the manner in which the FDA looks at the claims that are ultimately made about a dietary product. Companies should carefully consider the claims made on their products in light of the above definition of drugs.