HCG - FDA drug approval / legal issues for weight loss

Texas has told weight loss clinics to stop marketing HCG for weight loss.

According to the Texas Attorney General:

Multiple Texas Weight-Loss Clinics Agree To Stop Marketing Prescription Drugs Improperly

Six purveyors of “hCG” to change promotional messages

AUSTIN – Under agreements negotiated by the Texas Attorney General’s Office, several weight-loss clinics and a distributor of a weight loss product in Texas must significantly alter the way they market their services and/or products. The clinics all advertised chorionic gonadatropin (hCG), a prescription hormone, for weight loss – despite the fact that hCG has never been approved by the U.S. Food and Drug Administration (FDA) as a weight loss drug. The distributor advertised and sold a homeopathic version of hCG as a weight loss product, which also is not FDA-approved.

The FDA has never approved the marketing of hCG for human weight loss – and actually requires a “black box” warning on prescription labels clearly stating that it is not approved for weight loss. Although physicians are generally allowed to prescribe products for non-FDA-approved purposes, drugs cannot be marketed or advertised for a medical use unless that purpose has been approved by the FDA. As a result, physicians and weight-loss clinics may not advertise hCG for weight loss in part because the FDA has stated there is no substantial evidence indicating that hCG leads to weight loss, beyond that which stems from severe dieting. There are no approved homeopathic or over-the-counter hCG products. The drug’s FDA-approved uses are primarily for testicular or ovarian abnormalities.

The following businesses have agreed to stop advertising hCG for weight loss: Biohealth of Texas, LLC, which operated in at least a dozen north Texas cities; Weight Control of Texas, Inc., based in San Antonio; Gulf Coast Plastic Surgery, P.A. of Houston; Dragon’s Breath Massage of Keller; and Optimum Health Care, LLC of Pantego. Professional Health Products Southwest of Arlington agreed to stop advertising and distributing homeopathic hCG.

Thanks to My Loving Works for bring this news flash to light.

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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, Michael H. Cohen represents conscious business leaders in a transformational era.

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