Posted on 06/22/2007 2:57:37 PM PDT by Dysart
WASHINGTON (Reuters) - Makers of vitamins, herbs and other dietary supplements taken by millions of Americans must meet new government standards to show the products are free of contamination and contain exactly what the label says, U.S. health officials said on Friday. Food and Drug Administration rules, companies in the $18-billion-a-year industry must test the purity, strength and composition of all of their supplements.
"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," FDA Commissioner Andrew von Eschenbach said in a statement.
Congress gave the FDA power to set manufacturing standards for dietary supplements in a 1994 law. The final requirements announced on Friday will not apply to all makers until 2010.
In addition to product testing, the new standards address design and construction of manufacturing plants, record-keeping and handling of consumer complaints.
Inspectors will check plants for compliance, FDA officials said. For less serious violations, the agency may ask a company to fix a problem. Bigger problems could lead to product seizures or other action, said Robert Brackett, head of the FDA's Center for Food Safety and Applied Nutrition.
Some supplements have been recalled in the past because they were contaminated with microbes, pesticides or metal, or because they did not contain the ingredients listed.
The FDA also has warned companies that sold supplements with undeclared drug ingredients for impotence, and others with less-than-advertised levels of vitamins A and C and folic acid.
Sen. Richard Durbin, an Illinois Democrat, said the manufacturing rule was "better late than never. But the requirements do not appear to go as far as they could have."
"The dietary supplement industry will have significant latitude to determine what quality control measures are appropriate, and limited resources will limit FDA's ability to follow up on complaints," Durbin said in a statement.
Supplements do not have to be proven safe and effective before they can be sold, as medicines do, and the new rules will not change that.
The new FDA announcement "not only is 13 years late but will not do anything to ensure that dietary supplements are safe or effective - a critical necessity," said consumer watchdog Sidney Wolfe, head of Public Citizen's Health Research Group.
The FDA said the rules take effect August 24, but they will be phased in so that large companies comply by June 2008, while companies with fewer than 500 employees have until June 2009. Firms with fewer than 20 employees have until June 2010.
Some supplement makers have been following industry manufacturing standards voluntarily while pushing for the government rules in hopes the requirements would weed out unscrupulous firms and boost public confidence.
Industry groups said they were pleased the FDA had issued the final rules but were still reviewing them.
David Seckman, chief executive of the Natural Products Association, said the requirements appeared "strong but more reasonable" than an earlier proposal.
"This will help smaller companies control costs - costs that would have been passed along to the consumer - while still maintaining quality standards," Seckman said in a statement.
Companies can petition to be exempted from having to test 100 percent of their ingredients. They must provide documents showing less-frequent testing would still assure quality.
Any of this apply to imports from China?
I would hope so. Further, I’d like to see requirements for full disclosure of country of origin for all supps or anything else ingestible. Stamping distribution info is useless.
You beat me to it. That's what I want to know. I seriously doubt it though.
Since they don’t seem willing to deal with the Chinese problem, I suppose this is another way to do it.
I suspect drug companies will have to do this anyway, because if it turns out that they are peddling stuff with lead or antifreeze in it, it’s the drug companies that will suffer. The Chinese will shrug and push their shoddy goods under another name, but the drug companies will be driven out of business when the word gets out.
I would also VERY MUCH like to see a requirement that if there are foreign ingredients in foods or medicines, that should be stated on the label. But that will never happen. They need to protect their Chinese friends.
“new government standards” =
Put down your fork...
I manufacture a propolis extract as a byproduct of beekeeping. It seems I have three more years to come up with a different label and sales pitch.
What is a byproduct of beekeeping? their poop?
Propolis is a byproduct of keeping bees. If you want bee poop, though, I can get you some. What’s it worth to you?
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