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BMJ 2009; 339 doi: (Published 14 October 2009) Cite this as: BMJ 2009;339:b4165

Light touch regulation of supplements puts the public at risk

More than half of US adults take some kind of dietary supplement. What they want is a good night’s sleep, a better sex life, enhanced athletic performance, or weight loss. What they get is potential exposure to undeclared hazardous substances including active drugs, untested analogues of active drugs, heavy metals, bacteria, and toxic plants, writes one observer.

Legislative changes in 1994 have created a light touch regulatory environment in the US that is putting the public at risk. The Food and Drug Administration (FDA) has identified 140 contaminated supplements, but there are likely to be many more, he writes. The regulatory authority has neither the power nor the resources to protect people from unscrupulous manufacturers who sell dangerous products online and in mainstream US pharmacies. Recent analyses found undeclared overdoses of sibutramine in weight loss supplements, as well as frusemide, benzodiazepines, and antidepressants. More than half of 26 supplements claiming to improve sexual performance contained untested analogues of phosphodiesterase type 5 inhibitors (such as sildenafil).

Both the public and the medical profession are overly optimistic about the safety of dietary supplements and the strength of government regulation, he writes. Doctors should ask their patients up front about supplements, report suspected side effects to the FDA, and be prepared to have supplements tested in clinical laboratories. Contaminants will not be on the label.

Competing interest declarations can be unreliable

The US Department of Justice recently compelled the five leading manufacturers of hip and knee prostheses to declare all payments made to doctors in 2007. Researchers were then able to compare the names with those listed as organising or presenting at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons. They found 344 matching payments. Only 71.2% (245 of 344) of the payments were disclosed on the meeting’s competing interest form. Ninety one doctors at the …

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