[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.
____________________