[Congressional Record Volume 141, Number 165 (Tuesday, October 24, 1995)]
[House]
[Pages H10640-H10642]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




    THE FOOD AND DIETARY SUPPLEMENT CONSUMER INFORMATION ACT OF 1995

  The SPEAKER pro tempore. Under the Speaker's announced policy of May 
12, 1995, the gentleman from New Jersey [Mr. Pallone] is recognized 
during morning business for 5 minutes.
  Mr. PALLONE. Mr. Speaker, in a few weeks this Congress will begin 
consideration of reform of the Food and Drug Administration, the FDA.
  Now the FDA now regulates 25 cents out of every dollar spent on a 
good or service in this economy, and its impact in our everyday lives 
runs very deep. It performs several important functions such as 
protecting public health and safety.
  Mr. Speaker, on June 29 of this year I added to the debate over the 
FDA reform, and I introduced a bill called the Food and Dietary 
Supplement Consumer Information Act of 1995, and this addresses how the 
FDA regulates food and dietary supplements. I am aware that the issue 
of dietary supplement regulation was considered in the last Congress 
and legislation was enacted, but that legislation fell short in a 
number of areas and also created an unlevel playing field for foods and 
dietary supplements. More importantly, a recent U.S. Supreme Court 
decision has raised the issue whether we ought to clarify the law with 
respect to claims, advertising and important health information to the 
public on this issue.

                              {time}  1300

  One key issue that must be resolved, Mr. Speaker, is whether the 
American public has the right to receive and hear truthful, 
nonmisleading information concerning the potential and proven health 
benefits of food and dietary supplements.
  A recent U.S. Supreme Court decision, Rubin versus the Coors Brewing 
Company, has provided us with guidance on clarifying the law with 
respect to claims and health information. The issue of regulation of 
food and dietary supplements is among the most important to my 
constituents. We must all eat food daily to stay healthy, that is 
obvious. Over 100 million Americans are now supplementing their diets 
on a regular basis.
  There are three important issues raised by the American people and my 


[[Page H 10641]]
constituents that Congress, I think, must act decisively upon when we 
talk about this issue: First, the right to receive and hear truthful, 
nonmisleading information. The American public has been demanding to 
have access to all the scientific information available about food and 
dietary supplements, and Americans have realized the power and 
influence of our health that nutrition plays on our well-being. I think 
the public policy has to respect these objectives.
  I want to emphasize the legislation I have introduced does not affect 
the current statutory and enforcement authority of the FDA to protect 
the public. The FDA will continue to have its present authority to 
prosecute and remove mislabeled and fraudulent products.
  Second, Mr. Speaker, the American public does not want food or 
dietary supplements turned into drugs. They want unhampered, affordable 
access to health-promoting food and supplements. One of the ways the 
FDA uses its power to interfere with our public access to these 
products is by declaring them to be drugs and forcing their removal 
from the market. I think there is an important distinction and 
clarification that should be made. We should enact my legislation to 
make it clear that food and dietary supplements cannot be drugs. In the 
context of health care, we have we created a system where, when one 
classifies something as a drug, a whole new set of regulations befails 
that product. This system is specifically designed for patentable 
products for which industry is given the ability to recover the 
hundreds of millions of dollars required to go through the patent 
approval process.
  Unfortunately, the system is poorly designed for foods and dietary 
supplements which are generally naturally occurring products and are 
nonpatentable. It also creates the unfortunate consequence on the 
public health that there is no low cost medicine. Obviously, the best 
low cost medicine is prevention. Nutrition foods, dietary supplements 
and an overall healthy lifestyle can be good preventive medicine. It is 
therefore important that foods and supplements be kept out of the drug 
category in order to protect their ability to be used economically and 
affordably in the maintenance and presentation of good health.
  Third and finally, Mr. Speaker, the American public has the right to 
make its own health choices. The American people want their health 
freedom. With a $1 trillion sickness-based health care system, people 
are looking for prevention and more treatment options. Let us give the 
people the information and access they want, and let us empower them to 
make responsibility for their own health. Enactment of this legislation 
preserves this principle without sacrificing the role of government to 
be the guardian of the public health.
  There are some other provisions in my bill which will save money and 
help to create uniformity among the 50 States. The legislation will 
ensure uniformity among the States by requiring the same labeling 
definitions and claims standards for food and dietary supplements. I 
think we will all agree on the necessity to make it economically 
efficient for manufacturers and consumers to have uniform standards for 
labeling definition and claims.
  The legislation also acts to resolve what is now no longer needed, in 
my opinion. That is, the Presidential Commission on Dietary Supplement 
Labels. The Commission is unnecessary and would be a waste of 
taxpayers' money. I do not believe, and many of my colleagues would 
agree with me, that we really need another commission to spend the next 
2 years and the FDA another 2 years thereafter to figure out how to 
inform the public.
  As long as the communicated information is truthful and not 
misleading, as outlined by Supreme Court decisions, there should be no 
difficulty in arriving at a cohesive and sensible public policy on 
labeling.
  Mr. Speaker I would urge consideration of this bill.
  Mr. Speaker, in a few weeks, this Congress will begin consideration 
of reform of the Food and Drug Administration. This Agency now 
regulates 25 cents out of every dollar spent on a good or service in 
this economy and its impact in our everyday lives runs deep. It 
performs several important functions such as protecting public health 
and safety.
  Mr. Speaker, on June 29, 1995 I added to this debate and discussion 
by addressing how the Agency regulates foods and dietary supplements by 
introducing the Food and Dietary Supplement Consumer Information Act of 
1995. I am aware that the issue of the dietary supplement regulation 
was considered in the last Congress and legislation was enacted. But 
that legislation fell short in a number of areas and also created an 
unlevel playing field for foods and dietary supplements. More 
importantly, a recent U.S. Supreme Court decision has raised the issue 
whether we ought to clarify the law with respect to claims, 
advertising, and important health information to the public.
  One key issue that must be resolved, Mr. Speaker, is whether the 
American public has the right to receive and hear, truthful, 
nonmisleading information concerning the potential and proven health 
benefits of foods and dietary supplements. A recent U.S. Supreme Court 
decision, Rubin versus Coors Brewing Co. has provided us with guidance 
on clarifying the law with respect to claims and health information.
  The issue of regulation of food and dietary supplements is among the 
most important to our constituents. We all must eat food daily to stay 
healthy. And over 100 million Americans are now supplementing their 
diets on a regular basis. There are three important issues raised by 
the American people that the Congress must act decisively upon:
  First, the right to receive and hear truthful, nonmisleading 
information.
  Mr. Speaker, the American public has been demanding to have access to 
all the scientific information available about foods and dietary 
supplements. Americans have recognized the power and influence on our 
health that nutrition plays in our well being. Public policy must 
reflect those objectives.
  When we passed the Nutrition Labeling and Education Act in 1990 
[NLEA], we authorized the FDA to pre-clear all health claims, claims 
that a food or dietary ingredient could prevent a disease or health 
related condition. Congress wanted the FDA to allow such claims because 
of the overwhelming scientific evidence between disease and nutritional 
status. It also was allowed so that industry could better educate its 
consumers regarding the benefits of their products. The FDA was given 
the discretion to use a standard that they called ``significant 
scientific agreement'' to decide whether to approve a health claim.
  When the NLEA was passed, the FDA was asked to evaluate nine health 
claims for foods and supplements. It approved only two for supplements; 
first was that calcium prevents osteoporosis and second, after 
initially rejecting the claim, that folic acid prevents neural tube 
birth defects for women of child bearing age. It also approved claims 
that antioxidant and fiber rich foods like fruits and vegetables could 
help prevent heart disease and cancer. It refused to approve the same 
claims for supplements of those dietary ingredients.
  The case of the folic acid health claim is most illustrative of the 
problem with the FDA being the censor of truthful, nonmisleading 
information and the terrible price our country pays for being kept in 
the dark. When NLEA was passed, the FDA was asked to evaluate a health 
claim for folic acid preventing certain birth defects. In November of 
1991, the FDA denied the health claim, stating that there was 
no ``significant scientific agreement'' to approve the claim. 
Subsequently in July of 1992, the U.S. Public Health Service published 
an advisory asking all women of child bearing age to get adequate folic 
acid in their diets by foods or supplements to prevent these tragic 
birth defects. Public and scientific outrage finally forced the FDA to 
reverse itself in the fall of 1993 and the claim was approved. But what 
was most outrageous Mr. Speaker, was that the FDA testified in a Senate 
Labor and Human Resource Committee hearing in October 1993 that it had 
been aware of scientific data that folic acid could prevent these birth 
defects for 10 years. They argued that in their opinion, there was no 
``significant scientific agreement'' when the Nutrition Labeling and 
Education Act was first enacted in 1990 until the FDA reversed itself 
in the fall of 1993. In the interim, the American public was kept in 
the dark, and an estimated additional 2,000 children were born with 
birth defects that could have been prevented had the information been 
allowed to reach women in a responsible manner. For 10 years when the 
first scientific data started coming in, women were not allowed to be 
told on food and supplement labels that folic acid might prevent neural 
tube birth defects. In this period of time, these tragic and 
irreversible birth defects struck approximately 20,000 babies. If any 
of my colleagues have ever seen a child born with anencephalopathy or 
spina bifida, then they know the pain and suffering these children and 
their parents face. These are children who are disabled, disfigured, 
and have short life spans. The costs to take care of these children run 
in the millions. Yet the information 

[[Page H 10642]]
was out there that an adequate amount of folic acid had the potential 
to avert these birth defects. The risk to women of child bearing age 
who could have received this information was zero. The benefit 
potential was thousands of birth defects prevented.

  Now the same thing is happening with a class of nutrients called 
antioxidants which scientific research is showing huge potential in 
reducing or eliminating known risk factors for cancer and 
cardiovascular disease. When I introduced this legislation, the June 
21st edition of the Journal of the American Medical Association 
published a study on vitamin E which provides compelling evidence that 
it can reduce the risk of heart disease. This is another study that 
adds to the overwhelming number of scientific studies that antioxidants 
have important contributions to make in the fight against degenerative 
disease that are driving our health care costs into oblivion. And in 
May, scientists confirmed that a mineral antioxidant, selenium, has the 
ability to protect the human immune system and minimize damage from 
viral infections. These studies promise innovation and cost effective 
treatments for people with viral illnesses. But such information will 
never reach the consumer in time under current FDA policies.
  I want to emphasize that this legislation does not affect the current 
statutory and enforcement authority of the agency to protect the 
public. The FDA will continue to have its present authority to 
prosecute and remove mislabeled and fraudulent products.
  Our desire must be to avail ourselves of this information so that the 
public can safely and beneficially use these inexpensive nutrients to 
protect their health. The American people have a right to hear truthful 
and nonmisleading health information about the foods and supplements 
they consume.
  I think the philosophy and public policy objective concerning claims 
should be guided by the sage words of Justice Stevens who recently 
wrote in Rubin versus Coors Brewing Co.

       Any ``interest'' in restricting the flow of accurate 
     information because of the perceived danger of that knowledge 
     is anathema to the First Amendment; more speech and a better-
     informed citizenry are among the central goals of the Free 
     Speech Clause. Accordingly the Constitution is most skeptical 
     of supposed state interests that seek to keep people in the 
     dark for what the government believes to be for their own 
     good.

  Over 100 million Americans consume dietary supplements on a regular 
basis. Americans are getting better educated and familiar about the 
food they eat by reading improved labels for foods. The payoff we 
anticipate is that Americans will use the power of nutrition and a 
healthy lifestyle to prevent or delay chronic disease and achieve 
optimal health.
  Second, the American public does not want food or dietary supplements 
turned into drugs. They want unhampered and affordable access to health 
promoting foods and supplements.
  Mr. Speaker, one of the ways the FDA uses its power to interfere with 
public access to products is by declaring them to be drugs and forcing 
their removal from the market. I think this is an important distinction 
and clarification that has to be made. The Senate passed version of S. 
784 in the 103d Congress made it clear that dietary supplements could 
not be classified as drugs. However, this provision was deleted in the 
House when the final bill was passed. We should enact my legislation to 
make it clear that foods and dietary supplements cannot be drugs. In 
the context of health care we have created a system where when one 
classifies something as a drug a whole new set of regulations befalls 
that product. This system is specifically designed for patentable 
products for which industry is given the ability to recover the  
hundreds  of  millions  of dollars required  to  go  through  the  
approval process.  Unfortunately  this  system  is poorly designed for 
foods and dietary supplements  which  are  generally  naturally 
occurring products and are nonpatentable. It also creates the 
unfortunate consequence on the public health that there is no low cost 
medicine. The best low cost medicine is prevention, Mr. Speaker. 
Nutritious foods, dietary supplements, and an overall healthy lifestyle 
can be good preventive medicine. It is therefore important that foods 
and supplements be kept out of the drug category in order to protect 
their ability to be used economically and affordably in the maintenance 
and preservation of good health.
  Third, the American public has the right to make its own health 
choices.
  The American people want their health freedom. With a $1 trillion 
sickness based health care system, people are looking for prevention 
and more treatment options. Let's give the people the information and 
access they want and let us empower them to take responsibility for 
their own health. Enactment of this legislation preserves this 
principle without sacrificing the role of Government to eve the 
guardian of the public health.
  There are some other minor provisions in the bill which will save 
money and help to create uniformity among the 50 States. The 
legislation will ensure uniformity among the 50 States by requiring the 
same labeling, definitions, and claims standards for foods and dietary 
supplements. I think we all would agree on the necessity to make it 
economically efficient for manufacturers and consumers to have uniform 
standards for labeling, definitions, and claims.
  The legislation also acts to resolve what is now a no longer needed 
result of Public Law 103-417, the establishment of a Presidential 
Commission on Dietary Supplement Labels. This Commission is unnecessary 
and would be a waste of taxpayer money. I don't believe, and many of my 
colleagues would agree with me, that we really need another Commission 
to spend the next 2 years and the FDA another 2 years thereafter to 
figure out how to inform the public. As long as the communication and 
information is truthful and not misleading as outlined by Supreme Court 
decisions, there should be no difficulty in arriving at cohesive and 
sensible public policy on labeling.
  What the American people asked for in the food and vitamin labeling 
debate was clear, cohesive, rational, and sensible public policy with 
the responsible regulatory agency. In the 103d Congress, the U.S. 
Senate enacted legislation which would have accomplished this. However, 
the House amended the legislation to defer the most important issue on 
the information access question. The food and vitamin debate was not 
fully resolved and outstanding questions still remain. That was what 
was enacted into law. This debate will linger and smolder unless we act 
decisively to resolve this issue once and for all now. The U.S. Supreme 
Court has offered its wisdom to guide us to resolving some of these 
issues and I am confident that the 104th Congress will act decisively 
on the subject.
  I am aware that some in this Congress believe that we ought to wait 
and see how the FDA regulates foods and supplements. However, the truth 
is that millions of letters were sent to Congress asking for a 
definitive solution and reform of this agency's regulatory mission. The 
public did not get what it asked for. Rather than tolerate anymore 
delays and foot dragging by this agency in implementing the will of 
Congress, it is time that we act now. I believe this Congress can 
deliver comprehensive and all-inclusive FDA reform. Reform of the Food 
and Drug Administration is one area where Congress can really make a 
difference to improve the lives of our constituents.

                          ____________________