Reply Received Today From Senator Durbin About His Amendment

[Guest guest]

Here is what he wrote back to my email. If anyone wishes to respond,

just do a search under " Senator Durbin " and find the place to click

that allows you to contact him.

 

June 21, 2004

 

Thank you for your message about dietary supplements. I appreciate

knowing your thoughts about this issue.

 

I am not opposed to dietary supplements. In fact, I take a vitamin

supplement daily. Unfortunately, not all dietary supplements are

safe. I

introduced the Dietary Supplement Safety Act (S. 722) to protect

consumers

from dangerous dietary supplements like ephedra and to prevent

manufacturers from using the term " dietary supplement " for dangerous

steroid precursors like andro.

 

Ephedra's dangers have been well documented. Its use has been

implicated

in more than 100 deaths and thousands of other serious health

incidents.

Before it was banned by the FDA in January 2004, the American Medical

Association and American Heart Association had called for a ban, and

its

use was already prohibited by the state of Illinois, the NCAA, the

NFL,

and the Olympics. Baltimore Orioles pitcher Steve Bechler died in

2003

after taking a supplement containing ephedra, but famous athletes are

not

the only victims. For example, in Illinois, 16-year old football

player

Sean Riggins died in 2002 after taking an ephedra supplement.

 

Currently, natural stimulants and other potentially harmful substances

that act as steroids are exempt from most federal regulation.

Companies

are not required to report serious adverse health events such as

death,

heart attack, stroke, or seizure to the Food and Drug Administration

(FDA), so there is no easy way to know if a particular supplement

turns

out to be dangerous. The Dietary Supplement Safety Act would

establish a

procedure to protect the public from those dietary supplements that,

unlike vitamins, pose a risk to public health.

 

S. 722 would require supplement manufacturers to report adverse events

resulting in serious injury or death to the FDA. This is not a higher

reporting standard than exists for prescription drugs or even for

over-the-counter medications like aspirin and cough syrup. Adverse

health

events related to the use of those medications already must be

reported to

the FDA.

 

For supplements that are not stimulants, such as calcium supplements

and

many herbal remedies, advance review by the FDA would not be required.

However, if the FDA received a report of death, heart attack, or other

serious injury, the FDA would have the authority to investigate

whether

the product is safe and take appropriate action if necessary. Since

this

portion of the bill has been grossly mischaracterized, I would like to

describe its provisions in detail.

 

First, the bill only requires the reporting of serious adverse

events --

specifically, cases in which supplement use results in death, a

life-threatening health condition, hospitalization, disability, or

serious

complications to pregnancy. It does not require reports of

stomachache,

rashes, muscle pain, and the like.

 

Second, if there were a serious adverse event report, the FDA would be

required first to conduct a clinical evaluation of the incident to

determine if the report is valid and credible. If the clinical

evaluation

indicated that there was no reason to believe the serious event was

caused

by the supplement, that would be the end of the matter.

 

Third, if the FDA's clinical evaluation raised questions that the

product

might present a significant or unreasonable risk of illness, the FDA

could

require the manufacturer to demonstrate that the supplement is safe.

The

FDA could not take action before the manufacturer had a chance to

provide

that information.

 

Fourth, after reviewing the manufacturer's submission, the FDA could

only

remove the product from the market if it concluded that the product

is not

safe under ordinary conditions of use.

 

So the idea that a product could be pulled from the market simply

because

of a single report of a bad experience is totally inaccurate. Any

manufacturer whose product does not cause death, life-threatening

health

conditions, hospitalization, or other serious adverse health effects

is

not at risk. Any manufacturer that can demonstrate its product is

safe is

not at risk.

 

The measure does set a high standard for the narrow class of dietary

supplements that are stimulants, because of the heightened health

risks

associated with their use. Manufacturers of stimulants would be

required

to demonstrate that the stimulants they sell are safe before they are

marketed. This is a lower standard than for prescription drugs, for

which

manufacturers must show both safety and effectiveness. And the

measure

would regulate anabolic steroids as controlled substances, due to

their

serious health effects and widespread abuse.

 

Again, this measure is not aimed at vitamins; it is designed to

protect

consumers from dangerous supplements that can cause serious injury or

death. I hope this helps you understand my goals in introducing this

bill. Thanks again for writing.

 

Sincerely,

 

 

 

Richard J. Durbin

United States Senator---