Supplement company questions GMP proposals
further regulate dietary supplements, suggesting that the agency
should concentrate on the pharmaceuticals industry rather than the
'relatively safe' supplement sector.
A supplement company has questioned the FDA's recent proposals to further regulate dietary supplements, suggesting that the agency should concentrate on the pharmaceuticals industry rather than the 'relatively safe' supplement sector.
Reacting to the recent proposals on GMPs for dietary supplements, Brenda Watson, president and co-founder of ReNew Life Formulas said: "We can not argue the merit of making the dietary supplement industry safer because there is always room for improvement, even in an industry where safety has remained a top priority. However, we have to wonder why the FDA isn't spending more time on prescription drugs, which clearly pose a much greater health threat."
Watson cited a 1998 study in the Journal of the American Medical Association that apparently found prescription medications kill over 100,000 people a year in the US, making it the fourth leading cause of death in the country. The study also reported that over 2 million hospitalized patients suffered serious drug reactions.
The FDA referred to a study which found that the number of adverse events tied to supplements, ranging from headaches to heart attacks, more than doubled from 553 in 2001 to 1,214 in 2002.
But according to Watson: "The FDA cites this statistic as the reason for the need to regulate, yet when you compare that number with the 100,000 plus annual deaths from prescription drugs, I can't help but ask, 'why this and why now?'"
The FDA claims that the new standards should prevent problems by requiring manufacturers to perform certain quality-control steps that include testing ingredients and finished products for contamination.
"The focus here is on making sure that the supplements aren't contaminated and contain the proper ingredients in the appropriate strengths, which is to be commended. The main problem, though, is that the FDA isn't going far enough in making sure that the products are safe and effective. What is the point of regulating if the process is going to be incomplete?" asked Watson.
ReNew Life Formulas produces natural health supplements and therapeutic products for digestive health.
