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FDA raises legal issues re use of HCG for weight loss

By Michael H. Cohen, Esq.

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.

 

Michael H. Cohen is an experienced health care law attorney who has taught health care law and policy at Harvard University and counseled many different kinds of practitioners and businesses, including:

• physicians (MD's and DO's)
• physician groups, hospitals, and clinical facilities
• integrative medicine centers
• professional health care educational institutions and associations
• dentists
• registered nurses and advanced practice nurses
• clinical psychologists
• chiropractors
• acupuncturists
• massage therapists
• homeopathic physicians and homeopaths
• naturopathic doctors and naturopaths
• energy healers, hypnotists, medical intuitives
• dietary supplement manufacturers and distributors
• cosmetics manufacturers
• entrepreneurs and start-ups
• publishers
• wellness clinics
• herbalists
• bio-energy companies
• medical device inventors
• telemedicine enterprises
• many varieties of businesses

As a founding attorney of a law firm at the cutting edge of health care and business law, he represents enterprises whose leaders are conscious and committed to a better world. He also offers the Entrepreneur's Legal Toolkit as a series of legal guides to businesses.

See what clients say about his legal work or visit the Legal Services page for information on business law and health care legal services.

Our healthcare law and business law firm also provides special expertise to attorneys and law firms whose clients are involved in wellness industry projects or who require guidance regarding such legal issues as:

• fee-splitting, Stark and anti-kickback
  
• medical board or other professional discipline
  
• negligence, informed consent, and medical malpractice liability
  
• HIPAA and patient privacy issues
  
• Medicare (including opting out vs. participation vs. non-participation)
  
• professional liability insurance and insurance (billing and coding) issues
  
• telemedicine, tele-psychiatry and telehealth
  
• other legal and regulatory compliance issues.

To speak with a lawyer about health care law issues pertaining to complementary and alternative medicine, or to consult a business lawyer about laws and legal issues for entrepreneurs and new enterprises that are seeking legal advice, contact our law firm today.

 

 

Full post as published by Complementary And Alternative Medicine Law Blog on January 24, 2011 (boomark / email).