It's only been 13 years since the FDA mandated dietary supplement makers follow good manufacturing pratices, but better late than never, right? Today, the FDA issued new rules requiring these companies to do tests to confirm the identity of all ingredients used in their products. As a result, you may finally know what's really in that herbal Viagra pill.
"We know that some manufacturers are better than others,'' Robert Brackett, director of the FDA's Center for Food Safety and Applied Nutrition, told reporters today. "As we implement this rule, this will give us an even better idea of how they're doing.'' Under the new rules, the companies must also establish written procedures and keep production records for at least a year. If they don't, their products could get yanked.
The FDA insists the new regs create the practices needed to "ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints."
"This raises the bar so that all have to comply," Steve Mister, who heads the Council for Responsible Nutrition trade group, told the Associated Press.
But not everyone is convinced this will work. "The FDA has no authority to require testing for safety or efficacy of any dietary supplement," says Public Citizen's Sid Wolfe, in a statement. "We saw with the ephedra-related deaths the dangers that dietary supplements pose. Congress should address this enormous deficiency in the law."
In any event, the rules don't start kicking in for another couple of years. So don't get too excited yet.
2 Comments
The FDA can't even assure the safety of prescription drugs....now they're going to oversee vitamins?? Yeah right.
They may not be able to control vitamins . . . but they can sure set themselves to serve their corporate masters. Have you seen all the Bayer Nutraceutical ads . . . just a preview of things to come as Big Pharma will seek to drive out holistic, naturapathic and homeopathic practitioners as well as small natural-compounders. What was pooh-poohed as anecdotal, trivial and unimportant will probably become ammunition for Big Pharma profitability if they can indeed enlist the FDA to serve as their "hitman."