FDA raises legal issues re use of HCG for weight loss

Physician use of HCG for weight loss raises legal issues that the FDA has now flagged.

USA Today reported in a story titled, HCG weight-loss products are fraudulent, FDA says.

The article quoted an FDA official as hinting that FDA could step up enforcement actions concerning use of HCG for weight loss.  According to the article by reporter Nanci Hellmich:

HCG weight-loss products that promise dramatic results and claim to be homeopathic are sold as drops, pellets and sprays on the Web, in drugstores and at General Nutrition Centers. They are supposed to be used in combination with a very low-calorie diet of 500 calories a day.

Many of the labels indicate the products contain HCG, or human chorionic gonadotropin, a hormone made by the placenta during pregnancy. The hormone itself is approved as a prescription treatment for infertility and other conditions.

There is no evidence the oral over-the-counter products are effective for weight loss, says Elizabeth Miller, FDA's leader for the Internet and health fraud team. While they may not be dangerous, they're at least "economic fraud," she says.

Because the products do not seem to be "a serious direct health hazard or a serious indirect health hazard," they have been a lower priority for FDA action than other products. Still, Miller says, "they could be subject to enforcement at any time."

One of the issues is the homeopathic label. Homeopathy is an alternative medicine practice of using very small or diluted preparations of medicines or remedies to treat a condition. Miller says, "We are aware of HCG products that claim to be homeopathic, but it is not recognized in the Homeopathic Pharmacopoeia." Therefore, these products "are not recognized by the FDA as homeopathic drugs, so they are unapproved drugs and are illegal," she says.....

FDA's Miller also has concerns about injectable versions of HCG for weight loss. The drug is not approved for weight loss, she says. Dieters getting injections of the hormone from people who aren't licensed to do so run the risk of getting infections and can't be sure what product they're getting.

The FDA has jurisdiction over interstate commerce and thus can go after manufacturers and distributors of HCG with a variety of enforcement tools.  In any legal analysis of FDA issues involving HCG, there are always two questions: one, what does the law say; and two, what are the enforcement priorities and how likely is it that the FDA will take action?

In addition, while the FDA regulates distribution of drugs in interstate commerce, state law governs the practice of medicine and other health care professions.  Physicians and pharmacies dispensing HCG as subject to state medical practice acts and state pharmacy laws.

Under federal law, HCG cannot be dispensed without a prescription and is a controlled substance under the federal Controlled Substances Act.  In addition, HCG would fall within the federal Ryan Haight Act which regulates Internet pharmacies, telemedicine involving prescriptions, and sales of pharmaceutical drugs off the Internet.

              Our law firm represents integrative medicine doctors, clinics, facilities and weight loss centers using HCG for weight loss.  Our legal advice includes both federal and state law, and we advise clients on how to minimize their legal exposure. Given that the FDA may be tightening enforcement in the area of HCG, it pays to get good legal advice from an attorney familiar with controlled substances, medical practice, and pharmacy laws.

 

Healthcare & FDA attorney Michael H. Cohen is a thought leader in healthcare law & FDA law, pioneering legal strategies in healthcare. wellness, and lifestyle markets. As a corporate and transactional lawyer, FDA regulatory attorney who also handles healthcare litigation, healthcare mediation and healthcare arbitration, and international healthcare & wellness law speaker, Los Angeles / Bay Area healthcare & FDA lawyer Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek healthcare & FDA attorney Michael H. Cohen's legal savvy on all aspects of business law, healthcare law, and FDA law, including: Whether advising start-ups or established companies, Los Angeles / San Francisco / Bay Area healthcare & FDA attorney Michael H. Cohen brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges. The Michael H. Cohen Law Group counsels healthcare practices, entities, and companies, such as clinical laboratories, physicians, psychologists, chiropractors, acupuncturists, naturopaths, nurses, healers, medical spas, sleep centers, addiction treatment centers, surgery centers, anti-aging centers, integrative medicine clinics, anti-aging practices, mental and behavioral health counselors, medical service organizations, telemedicine and mobile (m-health) companies, online health ventures, stem cell and cord blood entities; and other health and wellness enterprises. Healthcare and FDA lawyer Michael H. Cohen is admitted to practice in California, Massachusetts, New York, and Washington, D.C. Our clientele is national and international, and we also counsel healthcare and FDA clients in Los Angeles, San Diego, Ventura, San Francisco Bay Area, San Jose, Santa Barbara, Sacramento, San Bernadino, Alameda, Contra Costa County, and other California cities and counties. Contact our Los Angeles, Ventura County, & San Francisco Bay Area FDA & healthcare attorneys today if you need a telemedicine lawyer, concierge medicine lawyer, HIPAA lawyer, FDA lawyer or FDA regulatory consultant (dietary supplements, medical devices, cosmetics, OTC drugs), advertising compliance lawyer, healthcare mediator or arbitrator, concierge medicine attorney, management services organization attorney, or other specialized healthcare legal advice or FDA regulatory consulting.

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