CAMLAW: Complementary and Alternative Medicine Law Blog

Weight loss products raise legal issues

As with HCG and other weight loss products in the U.S., weight loss products become the focus of regulation in the Gulf region.

Abu Dhabi is heavily regulating dietary supplements involving weight loss:

Health officials in Abu Dhabi have recommended the removal of 10 weight loss products from the shelves following an inspection to evaluate the safety of supplements on sale in the emirate.

The Health Authority – Abu Dhabi (HAAD), the regulatory body for the healthcare sector, surveyed 82 weight loss supplements at a sample of 18 shops including complementary and alternative medicine shops and direct distributors.

The survey found that 92 percent of the products surveyed were not Ministry of Health registered products.

As a result, HAAD has recommended the removal of 10 products from the Abu Dhabi market.

In the U.S., the federal Food and Drug Administration (FDA), Federal Trade Commission (FTC), and local health care regulatory boards have clamped down on use of HCG, HGH, and other substances as well as weight loss advertising by various health care practitioners.

The figure health care professionals using integrative medicine has jumped:

76 percent of health-care workers reported using alternative or complementary therapy in the preceding year compared with 63 percent of the general population.

Researchers at the University of Minnesota and elsewhere analyzed data from the Centers for Disease Control and Prevention’s 2007 National Health Interview Survey, the most current nationally representative data available on the use of complementary and alternative medicine in U.S. households. The most common reason given by health-care professionals for use of complementary or alternative medicine (CAM) was general wellness (68 percent), while the least common reason was that traditional medical care was too expensive (4 percent).

One nutritional writer is bashing the FDA:

For as long as a hundred years, FDA management has been in a constant revolving door with high-paying Big Pharma jobs and the large agribusiness/food companies it is supposed to be regulating. This corrupt corporate culture pays lip service to actual safety issues while it uses the FDA as a vehicle to secure profits and wipe out competition. It is a flagrant abuse of regulatory power.

The FDA’s “public health” battle front is invariably against those who offer any alternative to the elite “FDA profit club.” In modern times this includes the dietary supplement industry, family/organic farms, and health professionals engaged in complementary and alternative medicine (CAM). Indeed, the dietary supplement industry in the United States is booming, with sales of $28 billion in year 2010. When you add in the natural/organic food industry and functional foods, that figure hits $117 billion.

On the other side, a group is calling for stricter FDA regulation of acid reflux drugs:

The watchdog group Public Citizen is calling for stricter warnings on popular acid reflux drugs called proton pump inhibitors.

In a petition filed today, Public Citizen urged the U.S. Food and Drug Administration to require a black box warning -- the strongest warning possible -- on the drugs' packaging detailing their side effects and potential to cause dependence among users.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he hopes stricter warnings will curb unnecessary use of the drugs.

"These drugs have a use, but they're grossly overused," Wolfe said. "We hope use will go down when doctors and patients know the risks."

Some such risks, including bone fractures, infections and heart rhythm abnormalities, are listed in fine print on the drugs' packaging. But the potential for the drugs to exacerbate acid reflux when patients discontinue use -- a relatively recent observation -- is not.

California's AG is supporting the legality of Obamacare:

California Attorney General Kamala Harris filed a brief on Monday in the United States Court of Appeals for the Eighth Circuit that supports the constitutionality of the Patient Protection and Affordable Care Act.

The brief urged the court to affirm the states' rights to protect the health and safety of their citizens. Harris, joined by nine other attorneys general, asserted that the federal health care law bolsters, rather than usurps, state authority to address issues in the national health care economy that the states cannot solve effectively on their own....

According to the brief, the health care law solves a national problem in a way that strengthens the power of the states by building on a successful cooperative federalism model. The brief also argues that the framework established by the law "empowers states to create enduring solutions to those problems, and to do so with federal support."

Other states joining California in the brief include Delaware, Iowa, New York, Vermont, Connecticut, Hawaii, Maryland, Oregon and the District of Columbia.

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Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets.  As a corporate and regulatory attorney who has also handled litigation matters, Mr. Cohen represents conscious business leaders in a transformational era.

Clients seek Mr. Cohen’s specialized expertise on business structure and entity formation (corporations, partnerships, LLCs); health care licensing matters; employment contracts and independent contractor agreements; dispute resolution; e-commerce; intellectual property issues; informed consent and malpractice liability issues; HIPAA and confidentiality and privacy issues; Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions; dietary supplement labeling; medical device and FDA matters; insurance reimbursement and Medicare issues; website disclaimers; concierge medicine legal advice; telemedicine; and other business law and health care regulatory compliance arenas.  Whether advising start-ups or established companies, he brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges.

Mr. Cohen is admitted to practice in California, Massachusetts New York, and Washington, D.C.  Contact our attorneys at our Beverly Hills, California law firm today.

 

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