As Americans increasingly turn to vitamins and herbal supplements to prevent, augment, or replace their prescription drug use, medical professionals and government leaders worry that few realize the implications of taking what they perceive as innocuous, over-the-counter dietary aids.
Unbeknownst to many consumers, vitamins and dietary supplements can have toxic and life -threatening side effects when used in megadoses or combined incorrectly with prescription drugs. They also can contain significant levels of heavy metals or be spiked with prescription drugs. And manufacturers may make illegal claims about their drugs' effectiveness in treating, curing, or preventing disease.
A report released in May by the Government Accountability Office (GAO) and covered by The New York Times found pesticide residues that appeared above the allowable limit in 16 of 40 supplements tested as part of a Congressional investigation. This is a matter for concern, in light of the fact that the number of Americans taking vitamins and herbal supplements seems to be growing. Approximately 50% of adults regularly take vitamin supplements, and approximately 25% take herbal supplements at least occasionally - a figure that has gone up 8% since a 2007 national survey - with annual sales reaching approximately $25 billion, the report said. The dietary supplement industry is expected to continue to grow, along with the aging of the population and an increasing popular interest in personal health and wellness, according to a 2009 GAO report.
Although dietary supplements can have widespread harmful effects, the U.S. government has almost no control over supplement manufacturers. That could change soon, as Congress prepares to embark on what is being called a 'landmark" food safety bill that is likely to require supplement manufacturers to register annually with FDA and allow the agency to recall supplements it deems dangerous.
The loophole gives pharmacists, as frontline healthcare professionals, a unique opportunity to counsel patients on the correct use of vitamins and herbal supplements.
"People pick up [a magazine] and read about Gingko biloba, so they go out and buy Gingko, but they don't realize these kinds of herbal medications can be contraindicated with their own [prescription] medications," said Christine R. Jacobson, RPh, of Wasatch Health Mart, Wasatch, Utah. "Because of the economy, they're not going to the doctor. They read it and say, 'I've got that, I'm going to try it' The public thinks it's smarter; they think they know their bodies more. They don't trust their doctors. But they trust their pharmacists."
Federal regulations governing dietary supplements don't go much beyond requiring manufacturers to follow "current good manufacturing practices" (CGMP) - guidelines ensuring that dietary supplements be processed consistently and meet quality standards. CGMP requirements, published in the Federal Register in 2007, took effect in 2008 for large manufacturers, while those with fewer than 20 employees were expected to begin compliance by last month (June 2010). Also in 2007, dietary supplement companies were required to submit to FDA any report received about a serious adverse event; reporting of moderate and mild adverse event reports was considered voluntary. According to the GAO, FDA has seen a threefold increase in comparison with the previous year's statistics on the number of all adverse event reports it has received since the reporting requirement went into effect in 2007.
While in explanations of its final rule FDA takes great care to say that it does not block consumer access to dietary supplements, it has the authority to enforce compliance with CGMP requirements and truth-in -advertising restrictions. FDA spokeswoman Siobhan Delancey said that the agency may conduct routine and for- cause inspections to ensure that manufacturers are complying with …