Dietary supplements face stricter regulations

[Guest guest]

Dietary supplements face stricter regulations

For first time, companies must test products for contamination, FDA

says

http://www.msnbc.msn.com/id/19370824/

Sommerfeld

Senior Health Editor

For the first time, makers of dietary supplements, including

vitamins and herbal pills, will be required to test their products,

the Food and Drug Administration said Friday.

Under the Dietary Supplement Health and Education Act, which passed

in 1994, supplement makers were told they must be able to

substantiate the safety of their ingredients. Now, 13 years later,

the FDA's announcement represents the actualization of that

requirement.

The agency is phasing in the new rule requiring supplement makers to

test the purity and composition of their products. Big companies

will have to comply by next June, while small companies have until

2010 to start testing their products.

" 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 von

Eschenbach said in a statement.

If the FDA discovers that supplements do not contain the ingredients

they claim to contain, the agency would consider the products

adulterated or misbranded. In minor cases, the agency could ask the

manufacturer to remove the ingredient or revise its label. In more

serious cases, it could seize the product, file a lawsuit or even

seek criminal charges. The FDA has also announced requirements for

record keeping and handling consumer complaints.

Some are skeptical and concerned that the guidelines are too

general — and too gentle.

Dr. Tod man, president of ConsumerLab.com, a Westchester, N.Y.-

based company that independently evaluates hundreds of supplements

and periodically publishes reviews, says the the new standards leave

too many important decisions to the manufacturers, such as which

type of testing methods are appropriate.

" The problem is manufacturers often rely on tests that aren't very

specific and can be tricked, " man said. His lab has found

instances of lead contamination and wrong ingredients that

manufacturers' own testing methods have not identified. " This won't

ensure the quality of supplements, but it may help improve the

consistency from batch to batch. "

The new rules don't ask companies to do testing to prove any of

their health claims. Still, this announcement is largely seen as a

step in the right direction.

" Supplements have been an exempt industry, so this is a shift that's

important and overdue, " said Art Caplan, director of the University

of Pennsylvania's Center for Bioethics and an MSNBC.com

columnist. " It's not the most vigorous approach but it's better

than nothing. "