FDA issues new safety rules for vitamins

[Guest guest]

FDA issues new safety rules for vitamins

 

By Kevin Freking, Associated Press Writer

The Associated Press

Friday, June 22, 2007

 

Washington - For the first time, manufacturers of

vitamins, herbal pills and other dietary

supplements will have to test all of their

products' ingredients. The Food and Drug

Administration said Friday it is phasing in a new

rule that is designed to address concerns that

existing regulations allowed supplements onto the

market that were contaminated or didn't contain

ingredients claimed on the label.

 

Last year, the agency found that some supplements

contained undeclared active ingredients used in

prescription drugs for erectile dysfunction. In

the past, regulators found supplements that didn't

contain the levels of Vitamin C or Vitamin A that

were claimed.

 

If, upon inspection, the FDA finds that

supplements do not contain the ingredients they

claim, the agency would consider the products

adulterated or misbranded. In minor cases, the

agency could ask the manufacturer to remove an

ingredient or revise its label. In more serious

cases, it could seize the product, file a lawsuit

or even seek criminal charges.

 

Dietary supplements — pills, liquids or other

products — are a $22 billion industry.

 

Most companies already test their raw ingredients,

said Steve Mister, president and CEO for the

Council for Responsible Nutrition, a trade

association representing about 65 manufacturers.

 

" This raises the bar so that all have to comply, "

Mister said.

 

The new rule goes into effect Aug. 24 and will

have a three-year phase-in that gives smaller

manufacturers more time to comply. Even the

largest of the manufactures won't have to comply

until June 2008.

 

The rule applies to all domestic and foreign

companies that manufacture, package and label

supplements for sale in the U.S. It requires them

to analyze the identity, purity and strength of

all the ingredients that go into their products

before they are distributed.

 

It also includes requirements for record keeping

and handling consumer complaints.

 

Dr. Sidney Wolfe, who has testified before

Congress on problems with dietary supplements,

said the new rule does not ease his concern that

unsafe supplements are too easy to bring to

market.

 

" You still don't have to show the product is safe.

You don't have to prove it works, " said Wolfe,

director of Public Citizen's Health Research

Group.

 

Consumers Union, publisher of Consumer Reports,

called the rule a good step toward improving

consistency in the ingredients that go into

supplements.

 

" However, consumers still have no idea if a given

product works, or whether it is dangerous, " said

Janell Mayo Duncan, senior counsel for Consumers

Union, publisher of Consumer Reports.

 

Congress limited the Food and Drug

Administration's oversight of vitamins and other

dietary supplements in 1994. The new rule is a

product of that law, meaning that the rule took

nearly 13 years to develop.

 

Under the old regulations, supplements were

governed by the same rules that applied to

producing foods, such as cans of soup.

 

" The final rule will help ensure that dietary

supplements are manufactured with controls that

result in a consistent product free of

contamination, with accurate labeling, " said Dr.

Robert E. Brackett, director of FDA's Center for

Food Safety and Applied Nutrition.

- - -

On the Net:

FDA: http://www.fda.gov/

 

http://news./s/ap/20070622/ap_on_he_me/dietary_supplements

 

 

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