FDA Issues Warning on Weight Loss Supplement Que She

Today the Food and Drug Adminstration (FDA) announced a public warning on the use of weight loss supplement Que She. This herbal supplement contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions. The FDA is advising immediate discontinuation of this product.

Que She is an compound ethnobotanical consisting of eleven Chinese herbs, including kudzu, coix seed, Chinese hawthorn, Chinese wolfberry, Chinese chrysanthemum, Chinese lotus leaf, sea tangle, semen raphani, cassia seed, green tea extract, and gymistemma pentaphyllum. It claims to suppress appetite and increase metabolism.

An FDA analysis of Que She found that it contains:

• fenfluramine – a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage
• propranolol – a prescription beta blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions
• sibutramine – a controlled substance and prescription weight loss drug, sibutramine was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease
• ephedrine – a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.

These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.

It’s certainly not the first time that weight loss supplements have been targeted by the FDA. One of the more prominent supplements to receive such a warning was Hydroxycut, which had significant adverse effects including one death and one person who required a liver transplant. Other problems reported included heart problems and a type of muscle damage that could lead to kidney failure.

Recalls such as this raise the question of whether the FDA has proper authority to regulate the dietary supplement industry to provide consumer protection. The problem is the difference between drugs, by definition products that prevent or cure disease, and dietary supplements, which cannot claim to treat specific symptoms or diseases.

Drug manufacturers are required to provide safety and effectiveness data before they can sell the products, while dietary supplements do not need FDA approval for sale. It is supposed that the manufacturers of dietary supplements are insuring safety and effectiveness of their products. The Food and Drug Administration can act on dietary supplements only when a harmful or adulterated product is already on sale.

Consumers and health care professionals are encouraged to report adverse events  related to the use of Que She to the FDA's MedWatch Safety Information and Adverse Event Reporting Program or by phone at 800-FDA-1088 (800-332-1088).

If you are looking for a weight loss plan that does not include the use of weight loss supplements, visit the HealthNews diet pages and test out our Individual Diet Selection tool, which can help find the right diet for you lifestyle.