new FDA action on supplements?

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DURBIN TO INTRODUCE LEGISLATION DESIGNED TO PROTECT CONSUMERS OF DIETARY

SUPPLEMENTS

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[CHICAGO, IL] - With the use of heavily marketed energy drinks and other

dietary supplements on the rise, more regulation is needed to ensure

that consumers have the information they need to distinguish between

products that are safe and others that contain potentially dangerous

ingredients which haven't been approved by the Food and Drug

Administration, U.S. Senator Dick Durbin (D-IL) said today. This week,

Durbin will introduce the Dietary Supplement Labeling Act to improve the

information available to consumers, and to curb the prevalence of drinks

and foods that are masquerading as dietary supplements as a means of

avoiding reviews and regulation by the FDA.

" At most convenience stores, you can't make it to the cash register

without encountering flashy advertising displays for energy supplements

like Rockstar Energy Drink and 5-Hour Energy. These products, which

market themselves as dietary supplements that offer a boost of energy,

are foods and beverages taking advantage of the less stringent safety

standards for dietary supplements under current law. When consumers walk

down the aisle, they see products that contain potentially unsafe

additives right next to beverages that have undergone FDA approval, but

they aren't easily able to tell the difference, " Durbin said.

Unlike manufacturers of conventional food and beverage products

containing additives, manufacturers of dietary supplements do not have

to prove that their products are safe before selling them to consumers.

The legislation directs the FDA to establish a definition for

" conventional foods, " which would clarify which products are foods and

should be regulated as such and which products are meant to be health

aids and should be regulated as dietary supplements. Under current law,

it is the choice of the manufacturer as to whether a product is

classified as a food or as a dietary supplement. The distinction between

dietary supplements and foods with dietary ingredient additives is not

always clear, leaving room for some food products to be marketed as

dietary supplements in order to circumvent the safety standards required

for food additives.

" My goal is to take the decision about how a product will be regulated

out of the hands of the manufacturer and put it in the hands of the FDA

where it belongs, " Durbin said. " Consumers who don't scour the fine

print on the back of products may never know the difference, but they

will be safer as a result of this bill. "

" It's important to note most products labeled as dietary supplements are

legitimate health aids. I take a daily vitamin just as millions of

Americans do. My gripe is not with the array of vitamins available at

health stores across the nation; my gripe is with products containing

potentially dangerous additives, labeled as 'dietary supplements' and

marketed to young adults who find them on store shelves right next to

conventional food and beverages whose ingredients have been deemed safe

by the FDA. The current system favors the manufacturers of these

products to the detriment of consumers - and that needs to change. "

In January 2010, the FDA issued a warning letter to the manufacturer of

Drank for selling a beverage containing melatonin, an unapproved food

additive which causes drowsiness. The manufacturer responded by changing

the labeling of Drank from a " beverage " to a " dietary supplement. " The

FDA has not yet taken action, because without a clear definition for

" conventional food and beverage " it is difficult to address this kind of

conflict.

In 2006, Durbin led a bipartisan effort to enact legislation requiring

manufacturers to report serious adverse events related to consuming

dietary supplements, enhancing the FDA's ability to identify and respond

more quickly to potential health problems. The Dietary Supplement

Labeling Act would build on that by requiring dietary supplement

manufacturers to disclose the known risks of ingredients and display a

mandatory warning if the product contains a dietary ingredient that may

cause potentially serious adverse events. Labels would also have to

include the batch number, which would help the FDA identify and recall

contaminated product.

" People using dietary supplements have the right to know the potential

risks. Some ingredients may be safe for the general population but

introduce risk for groups like children or pregnant women-or they should

be avoided by people with health condition like diabetes or high blood

pressure. In addition, some of these supplements - such as energy drinks

which are heavily marketed to young adults - are being taken in large

doses by consumers who aren't aware of the potentially dangerous side

effects, " Durbin said.

Durbin's legislation would also require manufacturers to register

dietary supplement products to the FDA, and provide a description of

each dietary supplement, a list of ingredients, and a copy of the label.

This would allow the FDA to know how many dietary supplements are on the

market and how many products contain certain ingredients, increasing

their capacity to inform manufacturers of possible safety concerns.

This is not the first time the FDA has been asked to clarify their

authority to regulate certain dietary supplements and food additives. In

January 2000, the FDA issued a 10-year plan to implement the Dietary

Supplement Health and Education Act of 1994 (DSHEA), which identified

the need to clarify the distinction between conventional foods and

dietary supplements. Moreover, U.S. General Accountability Office (GAO)

reports in July 11, 2000 and January 29, 2009 recommended FDA clarify

the boundary.

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com

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