[Congressional Record Volume 156, Number 17 (Thursday, February 4, 2010)]
[Senate]
[Pages S494-S495]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. McCAIN (for himself and Mr. Dorgan):
  S. 3002. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
more effectively regulate dietary supplements that may pose safety 
risks unknown to consumers; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. McCAIN. Mr. President, today I am pleased to introduce the 
Dietary Supplement Safety Act of 2010 with my colleague Senator Dorgan. 
This bill would strengthen the Food and Drug Administration's, FDA, 
regulation of dietary supplements to ensure the safety of the millions 
of Americans who use them daily. The proposed legislation would require 
manufacturers of dietary supplements to register with the FDA and 
disclose a full list of ingredients contained in each supplement. 
Currently, these companies do not have to submit such information 
before their products are offered for sale to consumers.
  A little over a year ago the NFL suspended six players, including two 
players from one of the teams competing this Sunday, for violating the 
league's anti-doping policy. Several of the players were surprised that 
they tested positive for a banned substance because they used a dietary 
supplement they believed to be safe and legal. Additionally, a recent 
GAO study, GAO-09-250, found that a record number of young Americans 
are using dietary supplements naively believing these supplements are 
safe and approved by the FDA for sale. However, FDA does not have a 
pre-market approval process. In a recent article published in The New 
York Times, it was reported that Americans spent almost $24 billion on 
dietary supplements last year. Close to $3 billion of that total is 
estimated to have come from manufactures that frequently advertise 
their products as alternatives to anabolic steroids, which are used for 
increasing muscle mass and strength.
  The current regulatory process does not adequately address the 
problem. Manufactures of dietary supplements are not required to 
demonstrate that their product is safe and effective before it is 
offered for sale to the public. The dietary supplement industry is one 
that is mostly self-regulated. However, manufacturers have failed to 
disclose to their customers key ingredients that may harm a consumer's 
health.
  For this reason, the proposed bill would require manufacturers to 
register the locations they manufacture these supplements, the products 
they are making, and disclose the ingredients found in their products 
with the FDA. Furthermore, dietary supplement companies would be 
required to provide a 75 day pre-market notice to the FDA not only for 
New Dietary Ingredients, but for all products containing steroids, 
including hormones, pro-hormones, and hormone analogues, and must 
establish that the product is safe for its intended use.
  Lastly, the proposed legislation provides the FDA with mandatory 
recall authority if a product is found to be unsafe or harmful. Had 
this provision been in place earlier, the FD might not have taken 10 
years to ban ephedra, a dietary ingredient that accounted for 64 
percent of all adverse reactions in 2001, despite accounting for 1 
percent of all total dietary supplement sales. It has been reported 
that use of ephedra contributed to the deaths of Baltimore Orioles 
pitcher Steve Bechler and Minnesota Vikings player Korey Stringer. 
Sadly and unfortunately, there are numerous stories of amateur athletes 
who took this supplement and experienced serious health problems.
  Legitimate dietary supplement companies should have nothing to fear 
from this legislation. These additional requirements are critical to 
the FDA's ability to evaluate the safety of particular dietary 
ingredients and to quickly identify and notify all dietary supplement 
manufacturers and consumers of ingredients with known safety risks. 
People's lives and dreams have been significantly impacted by 
illegitimate supplements. The purpose of the bill is not to create a 
sweeping regulatory structure, but instead a targeted structure that 
provides for openness, transparency and safety. All Americans should 
know the ingredients of any dietary supplement they use and the FDA 
must have the tools necessary to ensure the safety of all Americans.
  I am proud that this legislation is supported by all the major sports 
leagues, including Major League Baseball, the National Basketball 
Association, the National Football League,

[[Page S495]]

and the National Hockey League. Additionally, the legislation is 
supported by the United States Anti-Doping Agency, the United States 
Olympic Committee, the American College of Sports Medicine, National 
College Athletic Association, NCAA, and the PGA Tour. I hope my 
colleagues will join these organizations in supporting this needed 
legislation.
                                 ______