Dear Mr. Singh:
Thank you for contacting me regarding your opposition to the Dietary
Supplement Safety Act (S. 722), which was introduced by Senator Richard
According to Senator Durbin, this legislation seeks to protect consumers
from dangerous dietary supplements, such as ephedra and other stimulants,
by requiring manufacturers to submit proof that their product is safe
prior to bringing it to market.
Senator Durbin points out that, unlike drugs, where the manufacturer must
show that its product is safe prior to marketing, current law allows
dietary supplement manufacturers to sell their products without any safety
review. The burden is currently placed on the U.S. Food and Drug
Administration (FDA) to prove that they are unsafe before the agency can
take any action against potentially dangerous dietary supplements.
I understand that millions of Americans take dietary supplements every
day without experiencing any ill effects, and some dietary supplements
even provide consumers with significant health benefits. Senator Durbin
indicates, however, that he has concerns about a small number of dietary
supplement products – primarily stimulants and steroids "masquerading" as
herbal compounds – that have proven harmful and sometimes even lethal to
The Dietary Supplement Safety Act would make several changes to the laws
governing dietary supplements. First, the legislation requires
manufacturers of the most dangerous types of dietary supplements,
stimulants (which speed up a person's heart or affect a person's central
nervous system), to submit proof that their product is safe prior to
bringing that product to market. The bill also expands FDA's authority to
require proof of safety from any dietary supplement maker if the agency
has received information suggesting that the product has caused death or
other serious adverse health effects. If manufacturers fail to show that
their product is safe, then the FDA could take the product off the market.
Second, the measure requires manufacturers to report serious adverse
health events, such as heart attack, seizure, stroke, or death, to the FDA
no later than 15 calendar days after they receive them. According to
Senator Durbin, even though scientific reports have linked ephedra and
similar dietary supplements to 117 deaths and more than 17,000 other
health-related problems, the U.S. Department of Health and Human Services
(HHS) reported in 2001 that the agency had received only ten adverse event
reports from manufacturers for all dietary supplement products.
Finally, the bill would close a "loophole" in current law which allows
anabolic steroids to be sold widely as dietary supplements. The bill
would instead clarify that anabolic steroids are not dietary supplements
and are subject to regulation that restricts their availability under the
Controlled Substances Act.
Ephedra – an herbal dietary supplement also known as ma huang, ephedra,
sida cordifolia, and epitonin – has been promoted as a way to burn fat and
boost energy. In the United States, it is sold over the counter at such
places as grocery stores, drug stores, gas stations, and fitness clubs, as
well as on TV under brand names like Metabolife 356, Stacker 2, and
NaturalTrim. The industry estimates that over three billion "servings" of
ephedra were sold in 1999.
However, some recent medical studies have drawn a strong connection
between ephedra and the risk of stroke, heart attack, and even sudden
death. Senator Durbin points out that the American Medical Association
has called for a national ban of ephedra products. In addition, the
National Football League, the National Collegiate Athletic Association,
and the International Olympic Committee have all banned their athletes
from using any products containing ephedra. Following the recent tragic
death of Baltimore Orioles pitcher Steve Bechler, Major League Baseball
banned ephedra use among minor league players. It is also my
understanding that the U.S. Department of Defense (DOD) prohibits sales at
all base commissaries.
Senator Durbin chaired two Senate Governmental Affairs Committee hearings
on this issue last year and commissioned a report on adverse events from
Metabolife, the first independent review of the largest set of ephedra
adverse events. This particular study found over 2,000 cases of
significant injury, including deaths, heart attacks, strokes, and seizures
associated with consumption of Metabolife among the 14,400 adverse event
reports analyzed by congressional staff.
Please be assured that I will continue to carefully review all aspects of
this legislation, keeping in mind the need to balance consumer access to
safe and effective dietary supplements, while ensuring appropriate
protections to safeguard human health.
I am also pleased to let you know that I have launched an e-mail
newsletter, through my official Senate web site, to keep constituents
up-to-date on my efforts on behalf of Connecticut. You can sign up for
this e-mail newsletter by visiting http://lieberman.senate.gov
clicking on the "Subscribe to E-Mail Newsletter" button under my "Welcome"
message. I hope this service is informative and useful.
Thank you again for letting me know your views and concerns. Please
contact me if you have any additional questions or comments about our work