[Congressional Record (Bound Edition), Volume 145 (1999), Part 16]
[House]
[Page 22870]
[From the U.S. Government Publishing Office, www.gpo.gov]



              THE NUTRACEUTICAL RESEARCH AND EDUCATION ACT

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from New Jersey (Mr. Pallone) is recognized for 5 minutes.
  Mr. PALLONE. Mr. Speaker, tomorrow I am introducing the Nutraceutical 
Research and Education Act which I am going to call the NREA. Many of 
my colleagues may recall the debate and vigorous campaign that led to 
the passage of the Dietary Supplement Health and Education Act of 1994. 
With the passage of that legislation 5 years ago, the use of 
alternative medicines, dietary supplements, functional food products, 
and medical foods has exploded.
  Since the Dietary Supplement Health and Education Act was enacted, 
consumers have flocked to their health food stores and most recently to 
their drug stores, grocery stores and the Internet to buy products that 
can keep them healthy. The food and pharmaceutical industries took 
notice hoping to realize the profits gained by entry into this growing 
market. The food industry responded by developing novel food products 
called functional foods. Pharmaceutical and dietary supplement 
companies have begun calling some of their products nutraceuticals, 
reflecting their claims for nutrients with targeted health and medical 
benefits.
  Despite this impressive growth, the true health benefits of dietary 
supplements and functional foods have not been fully explored.
  Congress must, Mr. Speaker, in my opinion, as a matter of public 
policy, encourage the scientific and clinical study of dietary 
supplements and functional foods. Towards this objective we have 
created the National Center for Complementary and Alternative Medicine 
at the NIH and the Office of Dietary Supplements. However, much still 
needs to be done. Many individuals and companies that would like to 
clinically research their products have encountered numerous barriers 
along the way; and the market is such that if I tested and developed a 
product, often a nonpatentable product or difficult-to-patent product, 
someone else who has not invested time and money in clinical research 
can come in and develop an equivalent or similar product to mine.
  The time has come for Congress to step forward and encourage a 
research-based dietary supplement and functional food industry. We must 
do this to protect the people by ensuring these products are safe and 
effective. Congress can help bring order to the marketplace with the 
creation of the proper incentives. The answer is a public-private 
partnership to get these products researched.
  I propose, in introducing this bill, the Nutraceutical Research and 
Education Act, to reward the individuals and companies doing the 
clinical research on these products with an exclusive marketing claim. 
In doing so, we will give the term ``nutraceutical'' a legal definition 
and classification.
  Under the bill, anyone who chooses to engage in clinical research of 
a natural product and determines that a health benefit exists and that 
that product is safe and effective to achieve this health benefit can 
apply to the FDA for a ruling that their product does what they claim. 
The FDA would then determine the merits of the application and decide 
whether the product does, in fact, offer a health benefit at a low 
risk. If so, the person would be rewarded for doing the hard work with 
an exclusive right to use the health claim they have proven for a 
period of 10 years.
  In this way, we can redirect advertising dollars into research, 
encourage private enterprise and provide the public with safe and 
effective, lower-cost and lower-risk nutraceutical products.
  Mr. Speaker, I want to stress to my colleagues that my legislation 
does not supplant the Dietary Supplement Health and Education Act. That 
legislation was a watershed for the natural products industry. It 
protects access to products and permits some claims to be made. My 
legislation just takes us a step further down the road to encourage 
clinical research and the truthful dissemination of the results of that 
research to provide the American people access to these products.
  Until there is a structure in place to investigate and develop 
dietary supplement and functional food products and prove their worth, 
the majority of health professionals will not recommend them, but 
patients will continue to take them. The NREA will make available a 
mechanism whereby these products are tested for quality and safety to 
give the people access to proven health remedies, to enable self-care.
  Ultimately, Mr. Speaker, I believe the result will be cost effective, 
less sickness, more health, more productivity and a healthier 
population and industry.

                          ____________________