[Congressional Record Volume 140, Number 113 (Saturday, August 13, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: August 13, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
           TO AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

  Mr. DASCHLE. Mr. President, I ask unanimous consent that the Labor 
Committee be discharged from further consideration of S. 784, a bill to 
establish standards with respect to dietary supplements, and that the 
Senate proceed to its immediate consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report.
  The bill clerk read as follows:

       A bill (S. 784) to amend the Federal Food, Drug, and 
     Cosmetic Act to establish standards with respect to dietary 
     supplements, and for other purposes.

   The PRESIDING OFFICER. Is there objection to the immediate 
consideration of the bill?
   There being no objection, the Senate proceeded to consider the bill.


                           Amendment No. 2562

  Mr. HATCH. Mr. President, I send to the desk a substitute amendment 
on behalf of myself and Senator Harkin, and I ask for its immediate 
consideration.
  The PRESIDING OFFICER. The clerk will report.
  The bill clerk read as follows:

       The Senator from Utah [Mr. Hatch], for himself and Mr. 
     Harkin, proposes an amendment numbered 2562.

  Mr. HATCH. Mr. President, I ask unanimous consent that reading of the 
amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The text of the amendment is printed in today's Record under 
``Amendments Submitted.'')
  Mr. KENNEDY. Mr. President, I am concerned about several provisions 
of S. 784 in its present form. I am hopeful, however, that this action 
by the Senate will bring us closer to enacting the kind of worthwhile 
compromise that is needed to protect the public health while dealing 
with the legitimate concerns of the large numbers of citizens who use 
dietary supplements and who deserve to have them available.
  Recent Federal legislation, especially the Nutrition Labeling and 
Education Act, has created a great deal of concern and uncertainty 
about the status of these products. I believe all of us agree on the 
need to provide consumers with freedom of choice and access to these 
products. I believe we also agree on the need for responsible 
precautions to protect the public against dangerous products and false 
health claims.
  There continue to be differences among us as to how to achieve these 
goals most effectively. For example, the Hatch legislation offers a 
definition of dietary supplements that many feel is too broad. It will 
allow certain products which are treated as prescription drugs in other 
countries, or as unapproved drugs in this country, to be treated as 
dietary supplements and therefore subjected to inadequate safeguards.
  I addition, for safety purposes, I believe the legislation should 
contain a protective safety standard to assure the ability of the Food 
and Drug Administration to act quickly to remove products that are 
dangerous.
  Similar concerns exist with respect to other issues, such as the 
accuracy of health claims made on behalf of dietary supplements, and 
the use of promotional literature in connection with the distribution 
of these products.
  To deal with these concerns about the legislation in its present 
form, Members of both the Senate and the House of Representatives have 
been engaged in numerous bipartisan meetings over the past several 
months. We have made significant progress in refining the issues and 
working out a consensus solution that all of us can support.
  I continue to hope that a reasonable compromise can be reached that 
will protect the public health against dangerous or fraudulent 
products, without interfering with the large number of legitimate 
dietary supplements that are now available or that will become 
available in the future as a result of the remarkable scientific 
progress that is taking place and the greater and greater knowledge we 
are acquiring about diets and health.
  The issues that divide us are not insurmountable. We all have a 
responsibility to ensure a fair resolution of these concerns. I hope we 
can continue to work with our Senate and House colleagues to expedite 
final action on this measure.


              dietary supplement health and education act

  Mr. HATCH. Mr. President, this is a momentous day in the U.S. Senate.
  Today, we honor the wishes of 100 million people, consumers of 
dietary supplements, people who simply want the ability to lead healthy 
lifestyles without the constant intervention of one tiny agency which 
is possessed by a regulatory zeal equaling none.
  It is entirely appropriate that we consider the Dietary Supplement 
Health and Education Act today, as the Senate completes another day of 
debate on the health care reform legislation. For there is no bill 
which can lead to improved health more than S. 784.
  The substitute that I offer today embodies the text of the Dietary 
Supplement Health and Education Act as approved by the Labor and Human 
Resources Committee on May 11, with several important changes 
negotiated by Senator Harkin and myself in response to concerns raised 
by several Senators immediately prior to the markup.
  Our overwhelming consideration in considering this legislation today 
is that the legislative session is rapidly drawing to a close. The 
specter of our all-consuming debate on health care reform hangs over 
us. That debate will surely continue for days, if not weeks.
  In the interim, we have a legislative proposal which is cosponsored 
by 66 Senators, two-thirds of this body, and supported by many, many 
more.
  In the House, the counterpart legislation authored by our esteemed 
colleague, Representative Bill Richardson, has over 250 cosponsors. 
Unfortunately, that bill has not been marked up yet, either in 
subcommittee or full committee.
  Mr. President, Senate staff has been meeting on almost a daily basis 
with the staff of Chairmen Dingell and Waxman; we have made some 
progress, but we have not been able to bring the negotiations to a 
conclusion after several weeks of discussion.
  I am very appreciative of the great amount of time the House staff 
has devoted to this effort, especially at such a busy time in our 
legislative agenda. There is no question they have a strong desire to 
work this out.
  Chairman Dingell's most able counsel, Kay Holcombe, one of the best 
staffers on Capitol Hill in my estimation, and Chairman Waxman's 
counsel, Bill Schultz, a superb food and drug lawyer, have gone out of 
their way to make the time for these negotiating sessions. For that, 
I--and I believe I am speaking for Senator Harkin as well--owe a great 
debt of gratitude.
  Nevertheless, we have to realize that the situation is very different 
in the Senate with a bill which has been reported by the Labor and 
Human Resources Committee on a 13 to 4 vote. I have the greatest 
respect for our House colleagues, but I recognize that they do have 
differing views about the regulation of products which fall under the 
purview of the Food and Drug Administration. The issues surrounding the 
regulation of dietary supplements are tremendously complicated, and 
there are many details we have to work out.

  I want to make very, very clear, that we recognize there will be no 
final bill without the participation and agreement of our House 
colleagues. We are not intending to act unilaterally here, but rather 
to show the Senate's eagerness to move this issue to a conclusion.
  After this amendment passes, as I know it will, I intend that our 
staffs continue negotiations with the House, in an effort to wrap this 
up. I will be available any time, day or night, to meet with our House 
colleagues, as I am sure is the case with Senator Harkin.
  This dialog with the House is one I wish to continue; I want to make 
that abundantly clear.
  As I mentioned, the language we offer today differs from the Dietary 
Supplement Health and Education Act in several crucial ways which I 
will outline.
  As you know, S. 784 makes clear that dietary supplements are not food 
additives or drugs, and that the burden of proof shall be on the FDA to 
prove that a product is unsafe. That basic premise does not change.
  Drafters of the legislation, though, were criticized for a definition 
of dietary supplement which some felt was overly broad. We have tried 
to tighten that up.
  Some then believed that the language would allow drugs such as taxol 
to be marketed in the United States as dietary supplements. Senator 
Harkin and I worked for some time after the markup to resolve that 
issue, and the language we present today addresses that concern.
  Other concerns were raised about the safety standard in the bill; 
that is, the standard which FDA uses to gauge whether a product is 
unsafe and thus should be removed from the market.
  I continue to believe that the safety standard in the law is 
adequate. However, in deference to concerns that FDA may not have the 
authority to remove potentially dangerous products from the market, we 
have inserted a provision giving the Secretary emergency authority to 
act against dietary supplements which pose an imminent and substantial 
public health hazard.
  We took this language from a similar provision in the drug law.
  Some have argued that this new provision would be ineffective, 
because the drug language has been in the statute since 1938 and has 
seldom been utilized.
  I look at it the other way. The reason this emergency authority has 
been seldom used is that the threat of this tool is so effective; it is 
such a powerful enforcer that it doesn't need to be utilized to be 
effective.
  Another issue about which much concern was expressed is health 
claims.
  Under S. 784, as introduced, dietary supplement health labeling 
claims would be allowed as long as they are truthful and not misleading 
and are based on the totality of scientific evidence. Because of FDA's 
bias against dietary supplements and dietary supplement claims, I was 
not, and am not, comfortable in allowing the FDA the power to approve 
claims--simply because they won't approve claims, as history has shown.
  However, in deference to concern raised by several of our colleagues, 
both on and off the Labor Committee, Senator Harkin and I are willing 
to consider a fair claims process, on two conditions: First, that 
consumers will be guaranteed access to information about dietary 
supplements through truthful and nonmisleading third-party literature 
such as journals or newspaper articles; and second, dietary supplement 
manufacturers will be able to make so-called structure/function or 
nutrition support statements, statements about how a nutrient affects 
the structure or function of the body.

  An example of a structure/function claim is, ``Calcium builds strong 
bones.'' Manufacturers have the right to make such statements under 
current law, and our bill clarifies that they continue to have this 
right.
  With respect to third-party literature, the Harkin-Hatch compromise 
states that truthful and nonmisleading information can be provided to 
consumers in connection with the marketing of dietary supplements, 
provided that information does not promote any specific product or 
brand, provided the information is balanced, and provided it is 
maintained in a location which is physically separate from the 
products.
  It should be emphasized that these new provisions allowing the use of 
certain independent third-party literature in connection with the sale 
of dietary supplement products in no way detract from the right of a 
retail health food store or any other business or person to sell 
independently both dietary supplements and books or other literature 
about nutrients.
  The United States Court of Appeals for the Second Circuit ruled in 
United States v. Sterling Vinegar and Honey * * * and an Undetermined 
Number of Copies of * * * Books, 333 F.2d 157--2nd Cir. 1964--that a 
health food store could, properly, sell both a honey-vinegar product 
and, separately, books about the purported health- and disease-related 
benefits of a honey-vinegar combination, without having the books be 
deemed to be labeling when there was no ``integrated use'' of the books 
and the honey-vinegar product by the store. That case remains good law, 
and nothing in this legislation would change it.
  Instead, what the legislation would do would be to permit the use of 
certain types of third party literature in direct connection with the 
sale of dietary supplement products. The literature would need to meet 
certain criteria that would generally establish the independence and 
reliability of the material; that is, the bill would require: First, 
that any such item would need to be ``not false or misleading''; 
second, that it ``not promote a particular brand of dietary 
supplement''; third, that it be displayed or presented so as to present 
a ``balanced view'' of the available information; and fourth, that if 
displayed in a location in an establishment, it be displayed 
``physically separate'' from the dietary supplements.
  Thus, I want to make clear that our language in no way interferes 
with the current ability of retailers to maintain a library or 
literature section in their stores which contain both reference 
materials and materials for sale.
  A major way in which this amendment differs from the original Dietary 
Supplement Health and Education Act is in the treatment of health 
claims.
  This amendment makes clear that dietary supplements will be subject 
to the preapproval process and standard of Nutritional Labeling and 
Education Act for the 2-year period that a new, independent Commission 
determines the most appropriate process.
  This is a major compromise, and I was not totally comfortable in 
agreeing to it. However, I do believe the provision is necessary if we 
are to get a bill signed this year. As long as the authority is time-
limited and Congress has an ability to reexamine it in the future, I 
believe it is reasonable to include it in our compromise.
  Two other changes are important to note.
  At the request of our colleague from Washington, Senator Murray, we 
have included a provision requiring that all dietary supplements be 
labeled with an expiration date. Senator Murray's suggestion is a good 
improvement to our bill.
  After S. 784 was introduced, the food industry expressed some concern 
that the language put them at a competitive disadvantage, since dietary 
supplement claims could be made under a lower standard than those for 
foods.
  That situation is not the case under this substitute, since all 
dietary supplement claims during the 2-year period would be subject to 
the same process and standard as that for foods.
  I am aware that some Members of this body sought additional 
provisions relating to foods in this bill. I sincerely regret that we 
could not bring together consensus on this matter in the Senate. 
Senator Harkin and I tried very hard and we will keep working to pursue 
this in the House.
  Finally, at the suggestion of Chairman Dingell, the substitute 
supports the establishment of appropriate dietary supplement good 
manufacturing practice regulations. Dietary supplements currently are 
subject to the good manufacturing practices [GMP] requirements for 
foods.
  We believe Chairman Dingell raised a valid point that dietary 
supplements may require different manufacturing and quality controls 
and a provision addressing his concern is included.
  The substitute continues other provisions contained in our original 
bill. One of those is the authorization for an Office of Dietary 
Supplements at the National institutes of Health, so that we can 
encourage more focus on research into the health benefits of 
nutritional supplements.
  Another is a provision allowing judicial review of FDA warning 
letters, if the issue giving rising to the letter is not resolved 
within 60 days. The bill makes clear that the provision only allows 
manufacturers to go to court to challenge the findings in the warning 
letter; it does not preclude the FDA from taking any action it finds 
necessary under law to resolve the situation.
  Mr. President, I want to underscore here the wide range of support 
for this amendment.
  Our efforts are supported by groups ranging from Citizens for Health, 
with chapters all throughout the Nation, to the Alliance for Aging 
Research, to the Utah Natural Products Alliance. Our substitute is 
supported by the National Nutritional Foods Association, the 
Nutritional Health Alliance, and the Council for Responsible Nutrition.
  In particular, I want to cite the dedicated efforts of Citizens for 
Health, whose hundreds of members have worked tirelessly and 
unselfishly to make this an informed and successful debate. There is no 
question in my mind that the work of this citizen army makes today's 
victory possible.

  Others have worked very closely with us and I want to recognize their 
special efforts, including the National Council for Improved Health, 
Michael Onstott and the others at the Alternative Treatment Committee 
of the AIDS Coalition to Unleash Power [ACT-UP], San Francisco, Dr. 
Julian Whitaker, a noted physician and president of the American 
Preventive Medical Association.
  Let me also mention the valuable information that has been provided 
to me by several other individuals, including: the late Royden Brown, a 
leader in the alternative medicine community; Claire Farr, president of 
Claire Industries; Ken Murdock, chairman of Nature's Way; Richard 
Bizzaro, president of Wieder Foods; and Jeff Henricks, president of 
Solaray.
  Finally, I want to cite the stellar testimony at our hearing by 
nutritionist and author Patricia Hausman, and by Dr. Michael Janson, 
who is a fellow and member of the board of directors of the American 
College for Advancement in Medicine and the chairman of their 
scientific advisory committee.
  These people and organizations have all done fabulous work in helping 
to bring the bill forward to the Senate floor, and I will be counting 
on them to help Representative Richardson, Representative Gallegly, and 
me move the bill through the House as well.
  These organizations recognize what two-thirds of the Senate has 
recognized: for over 30 years, the FDA has pursued a single-minded 
regulatory agenda which has stifled the ability of consumers to have 
access to safe dietary supplements and information about those 
supplements.
  Despite a voluminous scientific record indicating the potential 
health benefits of dietary supplements, the Food and Drug 
Administration has pursued a heavy-handed enforcement agenda against 
nutritional supplements which has forced the Congress to intervene on 
two previous occasions, and yet again with adoption of this amendment.
  In 1962, the FDA published regulations setting minimum and maximum 
levels for supplements. These regulations were withdrawn in the face of 
strong citizen protest.
  Between 1966 and 1973, the agency issued proposed regulations on the 
labeling and content of dietary food products. FDA tried to classify 
vitamins as over-the-counter drugs if the product exceeded 150 percent 
of the recommended daily allowances [RDA]. Vitamins A and D would have 
been prohibited under most circumstances. Congress negated this action 
in 1976 when it approved the Proxmire/Rogers amendment to the Federal 
Food, Drug and Cosmetic Act.
  Blocked by the Proxmire amendment, later in the 1970's, FDA tried to 
regulate vitamins by claiming they were toxic, and therefore their 
potencies could be regulated. The Federal courts rejected FDA's this 
attempt to end-run the Proxmire.
  In 1980, the FDA issued a proposed over-the-counter drug monograph 
for vitamins and minerals. The document supposedly dealt only with 
potency above the RDA, thereby implicitly placing a potency limit on 
vitamins and minerals. The proposal was withdrawn after strong 
opposition.
  Beginning in the late 1970's, FDA turned from drug potency arguments 
to enforcement attempts utilizing the food additive theory to prohibit 
the sale of supplements which bore no claims. Essentially, the theory 
was that any ingredient added to a capsule or tablet rendered the 
resulting dietary supplement a food additive because the ingredient was 
added to the capsule or tablet. Under this theory, FDA could not lose, 
as it needed only to furnish an affidavit from one of its scientists 
stating that experts generally did not regard the product as safe. The 
actual safety of the product was never at issue.
  Between 1986 and 1990, the FDA issued four health messages documents 
for food products. This reflected FDA's initial policy with respect to 
the ability of good manufacturers to make limited claims about how a 
nutrient might prevent certain chronic diseases, such as fiber and 
cancer, without rendering those drugs products unapproved drugs. FDA 
left a very narrow area for dietary supplement health messages. The 
level of proof required for dietary supplement claims was unrealistic 
in that the degree of scientific consensus and clinical data required 
eliminated almost all existing supplement claims.
  With enactment of the Nutrition Labeling and Education Act [NLEA] of 
1990, Congress directed the FDA to use the significant scientific 
agreement standard when deciding if foods could make claims about the 
relationship of the nutrient to a disease, so-called health claims. The 
statute specifically said that the FDA could recommend a different 
standard and approval procedure for supplements.
  In December, 1991, FDA proposed rules implementing the NLEA, but 
rejected all but one claim for supplements--for calcium/osteoporosis in 
white and Asian women. Only one other claim has been approved since 
that time, the claim for folic acid and neural tube defects, and that 
claim was only approved after intense public pressure on the FDA.
  Twice since 1991, FDA has proposed that it use the same standard and 
procedure for health claims for foods as on dietary supplements. In 
1992, the Congress imposed a 1-year moratorium barring FDA from 
implementing the rule changes for 1 year. In 1993, the Senate 
unanimously adopted a second moratorium, but the House did not act on 
that legislation.
  The FDA's policies on dietary supplements have not been sustained in 
the courts as well. FDA has asserted to Congress that in pursuing food 
additive allegations against dietary supplement ingredients, it is 
simply applying the current law in a reasonable manner and restricting 
its actions to products that present serious safety concerns. Two 
recent Federal judicial decisions, however, show that, in fact, FDA has 
been distorting the law in its actions to try to prevent the marketing 
of safe dietary supplement substances.
  The FDA's efforts to ban the safe dietary supplement of black current 
oil by asserting that it was an unsafe food additive were rejected last 
year by two unanimous decisions of two different three-judge panels in 
two different U.S. courts of appeals (United States v. Two Plastic 
Drums--Viponte Ltd. Black Currant Oil--Traco Labs, Inc., 984 F.2d 814 
(7th Cir. 1993), United States v. 29 Cartons of--an Article of Food--
Oakmont Investment Co., 987 F.2d 33(1st Cir. 1993).
  In both of these cases, FDA asserted that black currant oil [BCO] was 
a food additive because it was added to gelatin capsules. The seventh 
circuit noted that ``FDA has not shown that BCO is adulterated or 
unsafe in any way.'' The court described the FDA's effort as an ``Alice 
in Wonderland'' approach. Further, the decision by the first circuit 
described FDA's approach as nonsensical.
  Despite these two setbacks in the court, the FDA recommended to the 
Department of Justice that petitions be filed to have these cases 
overturned in the Supreme Court. The Solicitor General did not file 
those petitions.
  These examples show how the FDA has tried to protect the public 
against unsafe products for which there is no evidence that the product 
is unsafe. The FDA has also acted to restrict the information that the 
public may receive about dietary supplements. Folic acid is a clear 
example as was brought out at our Labor Committee hearing last October.
  In September 1992, the Public Health Service issued a recommendation 
that all women of child-bearing age have adequate folic acid to prevent 
against birth defects. The Centers for Disease Control had made a 
similar recommendation 1 year before. Despite these two 
recommendations, and despite the fact that the FDA participated in the 
PHS proceedings leading up to the announcement, FDA did not issue a 
regulation proposing approval of a health claim for folic acid until 
October, 1993, 1 week before the committee's hearing on dietary 
supplements.
  Absent approval of a health claim by the FDA, it was illegal for 
manufacturers or retailers to advise the public about the benefits of 
folic acid, even though those benefits had been endorsed by the leading 
Federal public health agencies.
  If that isn't significant scientific agreement, I don't know what is.
  What is ironic about this situation, Mr. President, is that the one 
element of today's health care deliberations on which there is 
unanimous agreement is the need for preventive health care measures and 
efforts to increase health promotion and disease prevention.
  Unfortunately, millions of Americans do not have healthy diets and 
their nutrition deficit places them at risk. Senior citizens, pregnant 
women, infants, children, dieters, and smokers are especially 
vulnerable.
  Debate on health care reform in the 103d Congress makes clear that 
improving the health status of all Americans ranks at the top of our 
national priorities. It is equally clear that good nutrition, which 
clinical research has shown to limit the incidence of chronic diseases 
and reduce health care expenditures, should also be an important 
national objective. Today, more than 100 million Americans supplement 
their diets through the regular or occasional use of vitamins, 
minerals, herbs, amino acids, or other nutritional substances. We have 
all heard from these consumers, and we all know how strongly they 
support this legislation.
  Let us remember why this legislation is necessary.
  It is not one Senator versus another, nor Democrat versus Republican, 
nor the Senate versus the House.
  It is the U.S. Congress versus the Food and Drug Administration.
  It is the majority of the U.S. Senate versus the continual harassment 
by one tiny agency which has constantly misled the American public 
through deliberately false and misleading statements.

  It is the 250 Members of the House of Representatives against 
mindless Government bureaucracy, against continual overregulation, 
against an agency whose guiding principle has always been: One way--
their way.
  Here we are about to enter an unprecedented consideration of the 
Health Security Act, legislation which attempts to restructure one-
seventh of the American economy in the name of good health for our 
citizens.
  Here we are saying we want the American people to be as healthy as 
they can. Here we are meeting virtually round-the-clock to make this 
our top priority.
  And at the same time, we are letting the FDA stand in the way of 100 
million consumers' efforts to make themselves more healthy. It doesn't 
make any sense.
  If we don't pass this bill and correct the situation, we will be 
parties to that charge of gridlock our constituents condemn.
  There is no disagreement among us that consumers must have access to 
safe dietary supplements and to information about those supplements.
  Any concerns that were raised about this bill, Senator Harkin and I 
worked very hard to address, as I have outlined.
  But let us not kid ourselves. We are starting debate on health care 
reform this week, and we will not have the opportunity for protracted 
discussion of the dietary supplement issue.
  The Congress has moved a great deal on this issue since Senator Reid 
and I introduced the original bill last April. All of this progress has 
been made despite the lack of cooperation by the Food and Drug 
Administration, an agency which, in my mind, has lied to the American 
public and the Congress.
  And let us not forget that FDA has all the authority in the world to 
take bad products off the market; they just don't use it.
  Critics say that the industry is misleading the public by predicting 
that the FDA will make dietary supplements prescription drugs, even 
though the FDA published a proposal soliciting comments on whether 
certain amino acids and herbs should be drugs. That regulation has 
never been withdrawn.
  If you are talking about false and misleading statements, Mr. 
President, the FDA has a corner on the market.
  I draw your attention to our Labor Committee hearing last October, 
when Dr. Kessler and I discussed his agency's ``Unsubstantiated Claims 
and Documented Health Hazards in the Dietary Supplement Marketplace.'' 
I think many of us were astounded to learn of all the inaccuracies FDA 
made in the name of informing the Congress.
  The report was so riddled with error, so flawed, that I think it 
calls into question the veracity of the officials who prepared it--34 
of the 528 products on FDA's list simply don't exist, 142 were assigned 
to companies that neither manufactured nor sold the product; and 25 
products were listed more than once.
  At the hearing, I asked Dr. Kessler to withdraw the report; he did 
not.
  After the hearing, Bill Richardson, Elton Gallegly, and I wrote to 
Secretary Shalala and asked her to withdraw the report; she did not. 
She said that the FDA would respond on my specific concerns. They sent 
me a report signed by a junior official which addressed none of my 
concerns.
  At the hearing, I gave Dr. Kessler every opportunity to redeem his 
agency's credibility. I repeatedly asked him for documentation of his 
statements, even though his office had provided me with all the 
documentation which they said existed.
  So, FDA said they would provide it for the record.
  Well, that was October 21, 1993, almost 1 year ago. The record has 
been printed. Every single copy of the hearing has been snatched up by 
eager consumers. And still we have received no documentation. And at 
least 10 items that Dr. Kessler promised to follow up on for the record 
were never supplied.
  Dr. Kessler brought the dog and pony show of bad products before the 
committee. I asked them to leave them so we could examine them and see 
what type of claims FDA thought were a problem.
  Dr. Kessler refused, but said, ``Senator, we would be happy to make 
copies of the labels and give you those.''
  That was almost a year ago and we're still waiting.
  Let me tell you what has happened in those 10 months.
  FDA has issued its final regulations, regulations so flawed that our 
only recourse, I believe, is to see them withdrawn.
  And while the bureaucrats were over in FDA dotting all the i's and 
crossing all the t's on these regulations, what were they doing to 
discharge their authority under the law to protect consumers from false 
and misleading claims?
  What were they doing? Nothing. Zippo. Zip.
  You know how many seizures they have recommended against dietary 
supplement manufacturers since October? Zero.
  You know how many prosecutions they have recommended? Zero.
  And how many recalls? Just two.
  I guess they were expecting us to take action against all those 
little bottles and boxes they brought up to the hearing, because the 
FDA sure didn't have any interest in doing so.
  So, I go back to my original premise, Mr. President.
  I have seen the enemy, and it is not anyone in this Chamber.
  We have all worked long and hard. We have had to make compromises 
that none of us would have liked, but we have done it in the name of 
good public policy.
  I urge that we move this issue forward and that we continue our 
efforts with the House to see a dietary supplement bill enacted as soon 
as possible.
  The PRESIDING OFFICER. Is there further debate? If not, the question 
is on agreeing to the amendment of the Senator from Utah.
  The amendment (No. 2562) was agreed to.
  Mr. DASCHLE. Mr. President, I move to reconsider the vote by which 
the amendment was agreed to.
  Mr. HATCH. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. The question is on the engrossment and third 
reading of the bill.
  The bill was ordered to be engrossed for a third reading, was read 
the third time, and passed, as follows:

                                 S. 784

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Dietary Supplement Health 
     and Education Act of 1994''.

     SEC. 2. FINDINGS AND PURPOSE.

       (a) Findings.--Congress finds that--
       (1) improving the health status of United States citizens 
     ranks at the top of the national priorities of the Federal 
     Government;
       (2) the importance of nutrition and the benefits of dietary 
     supplements to health promotion and disease prevention have 
     been documented increasingly in scientific studies;
       (3)(A) there is a definitive link between the ingestion of 
     certain nutrients or dietary supplements and the prevention 
     of chronic diseases such as cancer, heart disease, and 
     osteoporosis; and
       (B) clinical research has shown that several chronic 
     diseases can be prevented simply with a healthful diet, such 
     as a diet that is low in fat, saturated fat, cholesterol, and 
     sodium, with a high proportion of plant-based foods;
       (4) healthful diets may mitigate the need for expensive 
     medical procedures, such as coronary bypass surgery or 
     angioplasty;
       (5) preventive health measures, including education, good 
     nutrition, and appropriate use of safe nutritional 
     supplements will limit the incidence of chronic diseases, and 
     reduce long-term health care expenditures;
       (6)(A) promotion of good health and healthy lifestyles 
     improves and extends lives while reducing health care 
     expenditures; and
       (B) reduction in health care expenditures is of paramount 
     importance to the future of the country and the economic 
     well-being of the country;
       (7) there is a growing need for emphasis on the 
     dissemination of information linking nutrition and long-term 
     good health;
       (8) consumers should be empowered to make choices about 
     preventive health care programs based on data from scientific 
     studies of health benefits related to particular dietary 
     supplements;
       (9)(A) national surveys have revealed that almost 50 
     percent of the 260,000,000 Americans regularly consume 
     dietary supplements of vitamins, minerals, or herbs as a 
     means of improving their nutrition; and
       (B) nearly all consumers indicate that dietary supplements 
     should not be regulated as drugs;
       (10) studies indicate that consumers are placing increased 
     reliance on the use of nontraditional health care providers 
     to avoid the excessive costs of traditional medical services 
     and to obtain more holistic consideration of their needs;
       (11) the United States will spend over $1,000,000,000,000 
     on health care in 1994, which is about 12 percent of the 
     Gross National Product of the United States, and this amount 
     and percentage will continue to increase unless significant 
     efforts are undertaken to reverse the increase;
       (12)(A) the nutritional supplement industry is an integral 
     part of the economy of the United States;
       (B) the industry consistently projects a positive trade 
     balance; and
       (C) the estimated 600 dietary supplement manufacturers in 
     the United States produce approximately 4,000 products, with 
     total annual sales of such products alone reaching at least 
     $4,000,000,000;
       (13) although the Federal Government should take swift 
     action against products that are unsafe or adulterated, the 
     Federal Government should not take any actions to impose 
     regulatory barriers limiting or slowing the flow of safe 
     products and needed information to consumers;
       (14) dietary supplements are safe within a broad range of 
     intake, and safety problems with the supplements are 
     relatively rare; and
       (15)(A) legislative action that protects the right of 
     access of consumers to safe dietary supplements is necessary 
     in order to promote wellness; and
       (B) a rational Federal framework must be established to 
     supersede the current ad hoc, patchwork regulatory policy on 
     dietary supplements.
       (b) Purpose.--It is the purpose of this Act to--
       (1) improve the health status of the people of the United 
     States and help constrain runaway health care spending by 
     ensuring that the Federal Government erects no regulatory 
     barriers that impede the ability of consumers to improve 
     their nutrition through the free choice of safe dietary 
     supplements;
       (2) clarify that--
       (A) dietary supplements are not drugs or food additives;
       (B) dietary supplements should not be regulated as drugs;
       (C) regulations relating to food additives are not 
     applicable to dietary supplements and their ingredients used 
     for food additive purposes, including stabilizers, processing 
     agents, or preservatives; and
       (D) the burden of proof is on the Food and Drug 
     Administration to prove that a product is unsafe before it 
     can be removed from the marketplace;
       (3) establish a new definition of a dietary supplement that 
     differentiates dietary supplements from conventional foods, 
     while recognizing the broad range of food ingredients used to 
     supplement the diet;
       (4) strengthen the current enforcement authority of the 
     Food and Drug Administration by providing to the 
     Administration additional mechanisms to take enforcement 
     action against unsafe or fraudulent products;
       (5) establish a series of labeling requirements that will 
     provide consumers with greater information and assurance 
     about the quality and content of dietary supplements, while 
     at the same time assuring the consumers the freedom to use 
     the supplements of their choice;
       (6) provide new administrative and judicial review 
     procedures to affected parties if the Food and Drug 
     Administration takes certain actions to enforce dietary 
     supplement requirements; and
       (7) establish a Commission on Dietary Supplement Labels 
     within the executive branch to develop recommendations on a 
     procedure to evaluate health claims for dietary supplements 
     and provide recommendations to the President and the 
     Congress.

     SEC. 3. DEFINITIONS.

       (a) Definition of Certain Foods as Dietary Supplements.--
     Section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321) is amended by adding at the end the following:
       ``(ff) The term `dietary supplement' means--
       ``(1) a product intended to supplement the diet by 
     increasing the total dietary intake that bears or contains 
     one or more of the following dietary ingredients:
       ``(A) a vitamin;
       ``(B) a mineral;
       ``(C) an herb or other botanical;
       ``(D) an amino acid;
       ``(E) another dietary substance for use by man to 
     supplement the diet by increasing the total dietary intake; 
     or
       ``(F) a concentrate, metabolite, constituent, extract, or 
     combination of any ingredient described in clause (A), (B), 
     (C), (D), (E) or (F);
       ``(2) a product that--
       ``(A)(i) is intended for ingestion in a form described in 
     section 411(c)(1)(B)(i); or
       ``(ii) complies with section 411(c)(1)(B)(ii); and
       ``(B) is not represented for use as a conventional food or 
     as a sole item of a meal or the diet; and
       ``(C) is labeled as a dietary supplement.''.
       (b) Exclusion From Definition of Drug.--Section 201(g) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) 
     is amended by adding at the end the following new 
     subparagraph:
       ``(3) The term `drug' does not include a dietary supplement 
     as defined in paragraph (ff), except that--
       ``(A) an article that is approved as a new drug, certified 
     as an antibiotic (under section 355 or 357), or licensed as a 
     biologic (under section 351 of the Public Health Service Act 
     (42 U.S.C. 262 et seq.)) and was, prior to such approval, 
     certification or license, marketed as a dietary supplement or 
     as a food, may continue to be offered for sale as a dietary 
     supplement unless the Secretary has issued a regulation, 
     after notice and comment, finding that the article when used 
     as or in a dietary supplement under the conditions of use and 
     dosages set forth in the labeling for such dietary 
     supplement, is unlawful under section 402(f); and
       ``(B) an article that is approved as a new drug, certified 
     as an antibiotic (under section 355 or 357), or licensed as a 
     biologic (under section 351 of the Public Health Service Act 
     (42 U.S.C. 262 et seq.)) and was not prior thereto marketed 
     as a dietary supplement or as a food, may not be considered 
     as a dietary ingredient or dietary supplement unless the 
     Secretary has issued a regulation, after notice and comment, 
     finding that the article would be lawful under section 402(f) 
     under the conditions of use and dosages set forth in the 
     recommended labeling for such article.''.
       (c) Exclusion From Definition of Food Additive.--Section 
     201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321(s)) is amended--
       (1) by striking ``or'' at the end of subparagraph (4);
       (2) by striking the period at the end of subparagraph (5) 
     and inserting ``; or''; and
       (3) by adding at the end the following new subparagraph:
       ``(6) an ingredient described in paragraph (ff) in, or 
     intended for use in, a dietary supplement.''.
       (d) Form of Ingestion.--Section 411(c)(1)(B) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 350(c)(1)(B)) is 
     amended--
       (1) in clause (i), by inserting ``powder, softgel, 
     gelcap,'' after ``capsule,''; and
       (2) in clause (ii), by striking ``does not simulate and''.

     SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND BURDEN OF PROOF ON 
                   FDA.

       Section 402 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 342) is amended by adding at the end the following:
       ``(f) If it is a dietary supplement that--
       ``(1) the Secretary finds, after rulemaking, presents a 
     substantial and unreasonable risk of illness or injury under 
     conditions of use recommended or suggested in labeling;
       ``(2) the Secretary declares to pose an imminent and 
     substantial hazard to public health or safety, except that 
     the authority to make such declaration shall not be delegated 
     and the Secretary shall promptly thereafter convene 
     rulemaking pursuant to section 701(e), (f), and (g) to affirm 
     or withdraw the declaration; or
       ``(3) is or contains a dietary ingredient that renders it 
     adulterated under paragraph (a)(1) under the conditions of 
     use recommended or suggested in the labeling of such dietary 
     supplement.

     In any proceeding under this section, the United States bears 
     the burden of proof on each element to show that a dietary 
     supplement is adulterated.''.

     SEC. 5. DIETARY SUPPLEMENT CLAIMS.

       (a) Supplement Claims.--Chapter IV of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by 
     inserting after section 403A the following new section:


                ``DIETARY SUPPLEMENT LABELING EXEMPTIONS

       ``Sec. 403B. An article, another publication, a chapter in 
     books, or the official abstract of a peer-reviewed scientific 
     publication that appears in the article and was prepared by 
     the author or the editors of the publication, reprinted in 
     its entirety, shall not be defined as labeling when used in 
     connection with the sale of dietary supplements to consumers 
     when it--
       ``(1) is not false or misleading;
       ``(2) does not promote a particular brand of a dietary 
     supplement;
       ``(3) is displayed or presented, or is displayed or 
     presented with other such items on the same subject matter, 
     so as to present a balanced view of the available scientific 
     information on a dietary supplement; and
       ``(4) if displayed in an establishment, is physically 
     separate from the dietary supplements.

     This section shall not apply to or restrict a retailer or 
     wholesaler of dietary supplements in any way whatsoever in 
     the sale of books or other publications as a part of the 
     business of such retailer or wholesaler. In any proceeding 
     under this section, the burden of proof shall be on the 
     United States to establish that an article or other such 
     matter is false or misleading.''.

     SEC. 6. STATEMENTS OF NUTRITIONAL SUPPORT.

       Section 403(r)(1) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 343(r)(1)) is amended by adding the following 
     new sentence at the end:``For purposes of this subparagraph, 
     a statement for a dietary supplement shall not be considered 
     a claim of the relationship of a nutrient or dietary 
     ingredient to a disease or health-related condition if the 
     statement does not claim to diagnose, prevent, mitigate, 
     treat, or cure a specific disease or class of diseases. A 
     statement for a dietary supplement may be made if the 
     statement claims a benefit related to a classical nutrient 
     deficiency disease and discloses the prevalence of such 
     disease in the United States, describes the role of a 
     nutrient or dietary ingredient intended to affect the 
     structure or function in humans, characterizes the documented 
     mechanism by which a nutrient or dietary ingredient acts to 
     maintain such structure or function, or describes general 
     well-being from consumption of a nutrient or dietary 
     ingredient.''.

     SEC. 7. CONFORMING AMENDMENTS.

       (a) Section 201.--The next to the last sentence of section 
     201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321(g)(1)) (as amended by section 3(b)) is amended to 
     read as follows: ``A food or dietary supplement for which a 
     claim, subject to section 403(r)(1)(B) and 403(r)(3) or 
     section 403(r)(1)(B) and 403(r)(5)(D), is made in accordance 
     with the requirements of section 403(r) is not a drug solely 
     because the label or the labeling contains such a claim. A 
     food, dietary ingredient, or dietary supplement for which a 
     truthful and nonmisleading statement is made in accordance 
     with section 403(r)(1) is not a drug solely because the label 
     or the labeling contains such a statement.''.
       (b) Section 403.--Section 403 (21 U.S.C. 343) is amended by 
     adding at the end the following:

     ``A dietary supplement shall not be deemed misbranded solely 
     because its label or labeling contains directions or 
     conditions of use or warnings.''.

     SEC. 8. ADMINISTRATIVE AND JUDICIAL REVIEW.

       The Federal Food, Drug, and Cosmetic Act is amended by 
     adding at the end of chapter III (21 U.S.C. 331 et seq.) the 
     following new section:

     ``SEC. 311. WARNING LETTERS.

       ``Any warning letter or similar written threat of 
     enforcement under the Federal Food, Drug, and Cosmetic Act 
     constitutes final agency action for the purpose of obtaining 
     judicial review under chapter 7 of title 5, United States 
     Code, if the matter with respect to such letter or threat is 
     not resolved within 60 days from the date such letter or 
     threat is delivered to any person subject to this Act. In any 
     proceeding for judicial review of a warning letter or similar 
     written threat of enforcement under the Act, the United 
     States bears the burden of proof on each element of each 
     alleged violation of law described.''.

     SEC. 9. WITHDRAWAL OF THE REGULATIONS AND NOTICE.

       (a) In General.--The advance notice of proposed rulemaking 
     concerning dietary supplements published in the Federal 
     Register of June 18, 1993 (58 FR 33690-33700), the notices of 
     proposed rulemaking concerning nutrition labeling for dietary 
     supplements and nutrient content claims for dietary 
     supplements published in the Federal Register of June 18, 
     1993 (58 FR 33715-33731 and 58 FR 33731-33751), and the final 
     rules and notices published in the Federal Register of 
     January 4, 1994 concerning nutrition labeling for dietary 
     supplements and nutrient content claims for dietary 
     supplements (59 FR 354-378 and 378-395) are null and void and 
     of no force or effect insofar as they apply to dietary 
     supplements. Final regulations and notices published in the 
     Federal Register of January 4, 1994 concerning health claims 
     for dietary supplements under the Nutrition Labeling and 
     Education Act of 1990 (59 FR 395-426) shall not be affected 
     by this section and shall remain in effect until 120 days 
     after the date of the submission of the final report of the 
     Commission established under section 11 to the President and 
     to Congress, or 28 months after the date of enactment of this 
     Act, whichever is earlier.
       (b) Notice of Revocation.--The Secretary of Health and 
     Human Services shall publish notices in the Federal Register 
     to revoke all of the items declared to be null and void and 
     of no force or effect under subsection (a).
       (c) Issuance of Regulations.--Notwithstanding any provision 
     of the Nutrition Labeling and Education Act of 1990--
       (1) no regulation is required to be issued pursuant to such 
     Act with respect to dietary supplements of vitamins, 
     minerals, herbs, amino acids, or other similar nutritional 
     substances; and
       (2) no regulation that is issued in whole or in part 
     pursuant to such Act shall have any force or effect with 
     respect to any dietary supplement of vitamins, minerals, 
     herbs, amino acids, or other similar nutritional substances 
     unless such regulation is issued pursuant to rulemaking 
     proceedings that are initiated by an advance notice of 
     proposed rulemaking that is published no earlier than 2 years 
     after the date of enactment of this Act, and followed by, at 
     least, a notice of proposed rulemaking prior to issuance of 
     the final regulation, except insofar as the regulation 
     authorizes the use of labeling about calcium, folic acid, or 
     other matters and does not prohibit the use of any labeling.

     SEC. 10. DIETARY SUPPLEMENT INGREDIENT LABELING AND NUTRITION 
                   INFORMATION LABELING.

       (a) Misbranded Supplements.--Section 403 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 
     adding at the end the following new paragraph:
       ``(s) If--
       ``(1) it is a dietary supplement; and
       ``(2)(A) the label or labeling of the supplement fails to 
     list--
       ``(i) the name of each ingredient of the supplement that is 
     described in section 201(ff); and
       ``(ii)(I) the quantity of each such ingredient; or
       ``(II) with respect to a proprietary blend of such 
     ingredients, the total quantity of all ingredients in the 
     blend;
       ``(B) the label or labeling of the dietary supplement fails 
     to identify the product by using the term `dietary 
     supplement', which term may be modified with the name of such 
     an ingredient;
       ``(C) the supplement contains an ingredient described in 
     section 201(ff) (1)(C), and the label or labeling of the 
     supplement fails to identify any part of the plant from which 
     the ingredient is derived;
       ``(D) the supplement--
       ``(i) is covered by the specifications of an official 
     compendium;
       ``(ii) is represented as conforming to the specifications 
     of an official compendium; and
       ``(iii) fails to so conform; or
       ``(E) the supplement--
       ``(i) is not covered by the specifications of an official 
     compendium; and
       ``(ii)(I) fails to have the identity and strength that the 
     supplement is represented to have; or
       ``(II) fails to meet the quality (including tablet or 
     capsule disintegration), purity, or compositional 
     specifications, based on validated assay or other appropriate 
     methods, that the supplement is represented to meet.''.
       (b) Supplement Listing on Nutrition Labeling.--Section 
     403(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 343(q)(1)) is amended by adding at the end the 
     following: ``A dietary supplement may bear on the nutrition 
     label or in labeling a listing and quantity of ingredients 
     that have not been deemed essential nutrients by the 
     Secretary if such ingredients are prominently identified as 
     not having been shown to be essential or not having an 
     established daily value.''.
       (c) Dietary Supplement Labeling Exemptions.--Section 
     403(q)(5) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 343(q)(5)) is amended by adding at the end the 
     following new clause:
       ``(H) The labels of dietary supplements shall not be 
     required to bear the nutrition information under subparagraph 
     (1), but shall be required to list immediately above the 
     ingredient listing the amount of nutrients required by the 
     Secretary to be listed pursuant to clause (C), (D) or (E) of 
     subparagraph (1) or clause (A) of subparagraph (2) that are 
     present in significant amounts in the supplement.''.
       (d) Vitamins and Minerals.--Section 411(b)(2) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350(b)(2)) is 
     amended--
       (1) by striking ``vitamins and minerals'' and inserting 
     ``dietary supplement ingredients described in section 
     201(ff)'';
       (2) by striking ``(2)(A)'' and inserting ``(2)''; and
       (3) by striking subparagraph (B).

     SEC. 11. COMMISSION ON DIETARY SUPPLEMENT LABELS.

       (a) Establishment.--There shall be established as an 
     independent agency within the executive branch a commission 
     to be known as the Commission on Dietary Supplement Labels 
     (hereafter in this section referred to as the 
     ``Commission'').
       (b) Membership.--
       (1) Composition.--The Commission shall be composed of 7 
     members who shall be appointed by the President.
       (2) Expertise requirement.--The members of the Commission 
     shall consist of individuals with expertise and experience in 
     dietary supplements and in the manufacture, regulation, 
     distribution, and use of such supplements. At least three of 
     the members of the Commission shall be qualified by 
     scientific training and experience to evaluate the benefits 
     to health of the use of dietary supplements and one of such 
     three members shall have experience in pharmacognosy, medical 
     botany, traditional herbal medicine, or other related 
     sciences. No member of the Commission shall be biased against 
     dietary supplements.
       (c) Functions of the Commission.--The Commission shall 
     conduct a study on, and provide recommendations for, the 
     regulation of label claims for dietary supplements, including 
     procedures for the evaluation of such claims. In making such 
     recommendations, the Commission shall evaluate how best to 
     provide truthful and nonmisleading information to consumers 
     so that such consumers may make informed health care choices 
     for themselves and their families.
       (d) Reports and Recommendations.--
       (1) Final report required.--Not later than 24 months after 
     the date of enactment of this Act, the Commission shall 
     prepare and submit to the President and to the Congress a 
     final report on the study required by this section.
       (2) Recommendations.--The report described in paragraph (1) 
     shall contain such recommendations, including recommendations 
     for legislation, as the Commission deems appropriate.
       (e) Administrative Powers of the Commission.--
       (1) Hearings.--The Commission may hold hearings, sit and 
     act at such times and places, take such testimony, and 
     receive such evidence as the Commission considers advisable 
     to carry out the purposes of this section.
       (2) Information from federal agencies.--The Commission may 
     secure directly from any Federal department or agency such 
     information as the Commission considers necessary to carry 
     out the provisions of this section.
       (3) Authorization of appropriations.--There are authorized 
     to be appropriated such sums as may necessary to carry out 
     the provisions of this section.

     SEC. 12. GOOD MANUFACTURING PRACTICES.

       Section 402 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 342) (as amended by section 4) is further amended by 
     adding at the end the following:
       ``(g)(1) If it is a dietary supplement and it has been 
     prepared, packed, or held under conditions that do not meet 
     current good manufacturing practice regulations issued by the 
     Secretary under subparagraph (2).
       ``(2) The Secretary may by regulation prescribe good 
     manufacturing practices for dietary supplements. Such 
     regulations shall be modeled after current good manufacturing 
     practice regulations for food and may not impose standards 
     for which there is no current and generally available 
     analytical methodology. No standard of current good 
     manufacturing practice may be imposed unless such standard is 
     included in a regulation promulgated after notice and 
     opportunity for comment in accordance with the Administrative 
     Procedure Act.''.

     SEC. 13. OFFICE OF DIETARY SUPPLEMENTS.

       (a) In General.--Title IV of the Public Health Service Act 
     is amended by inserting after section 486 (42 U.S.C. 287c-3) 
     the following:

               ``Subpart 4--Office of Dietary Supplements

     ``SEC. 486E. DIETARY SUPPLEMENTS.

       ``(a) Establishment.--The Secretary shall establish an 
     Office of Dietary Supplements within the National Institutes 
     of Health.
       ``(b) Purpose.--The purposes of the Office are--
       ``(1) to explore more fully the potential role of dietary 
     supplements as a significant part of the efforts of the 
     United States to improve health care; and
       ``(2) to promote scientific study of the benefits of 
     dietary supplements in maintaining health and preventing 
     chronic disease and other health-related conditions.
       ``(c) Duties.--The Director of the Office of Dietary 
     Supplements shall--
       ``(1) conduct and coordinate scientific research within the 
     National Institutes of Health relating to dietary supplements 
     and the extent to which the use of dietary supplements can 
     limit or reduce the risk of diseases such as heart disease, 
     cancer, birth defects, osteoporosis, cataracts, or 
     prostatism;
       ``(2) collect and compile the results of scientific 
     research relating to dietary supplements, including 
     scientific data from foreign sources or the Office of 
     Alternative Medical Practice;
       ``(3) serve as the principal advisor to the Secretary and 
     to the Assistant Secretary for Health, and to provide advice 
     to the Director of the National Institutes of Health, the 
     Director of the Centers for Disease Control and Prevention, 
     and the Commissioner of Food and Drugs, on issues relating to 
     dietary supplements including--
       ``(A) dietary intake regulations;
       ``(B) the safety of dietary supplements;
       ``(C) claims characterizing the relationship between--
       ``(i) dietary supplements; and
       ``(ii)(I) prevention of disease or other health-related 
     conditions; and
       ``(II) maintenance of health; and
       ``(D) scientific issues arising in connection with the 
     labeling and composition of dietary supplements;
       ``(4) compile a database of scientific research on dietary 
     supplements and individual nutrients; and
       ``(5) coordinate funding relating to dietary supplements 
     for the National Institutes of Health.
       ``(d) Definition.--As used in this section, the term 
     `dietary supplement' has the meaning given the term in 
     section 201(ff) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(ff)).
       ``(e) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $5,000,000 for fiscal year 1994 and such sums as may be 
     necessary for each subsequent fiscal year.''.
       (b) Conforming Amendment.--Section 401(b)(2) of the Public 
     Health Service Act (42 U.S.C. 281(b)(2)) is amended by adding 
     at the end the following:
       ``(E) The Office of Dietary Supplements.''.
  Mr. DASCHLE. Mr. President, I move to reconsider the vote by which 
the bill, as amended, was passed.
  Mr. HATCH. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.

                          ____________________