CO-CURE: NOTICE: FDA issues new safety rules for vitamins [US]

[Guest guest]

Date:    Fri, 22 Jun 2007 17:04:44 -0700

    Melissa O'Toole <m_otoole2

NOTICE: FDA issues new safety rules for vitamins [uS]

 

FDA issues new safety rules for vitamins

 

By KEVIN FREKING, Associated Press Writer

6-22-2007

 

 

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.