FDA rules on Vitamins

[Guest guest]

I thought this was interesting for people to know. Pauline

 

WASHINGTON, June 22 (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, United States health

officials said Friday.

 

Under the 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, " Andrew von Eschenbach, the commissioner of

food and drugs, said in a statement.

 

Congress gave the agency 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 manufacturing plants for compliance, F.D.A.

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 Center

for Food Safety and Applied Nutrition at the agency.

 

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 drug agency has also 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.

 

Senator Richard J. Durbin, Democrat of Illinois, said the

manufacturing rule was " better late than never, " but he added

that " the requirements do not appear to go as far as they could

have. "

 

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.