TCB DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

**DIETARY SUPPLEMENT STAKEHOLDER MEETING**

**PUBLIC MEETING**

Tuesday, June 8, 1999

10:00 a.m.

Cohen Auditorium

330 Independence Avenue

Washington, D.C

FDA PARTICIPANTS

[Meeting Chair]{.underline}

JOSEPH A. LEVITT, Director, Center for Food Safety and Applied Nutrition
(CFSAN), FDA

[Panel]{.underline}

MARGARET JANE PORTER, Chief Counsel, Office of the General Counsel, FDA

WILLIAM HUBBARD, Acting Deputy Commissioner for Policy, FDA

ELIZABETH A. YETLEY, Ph.D, Director, Office of Special Nutritionals,
CFSAN, FDA

DEBRA L. BOWEN, M.D., Deputy Director, Office of Drug Evaluation V,
CDER, FDA

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[PAGE]{.underline}

**OPENING REMARKS**

Joseph Levitt, Director, CFSAN 5

**PANEL I: TRADE ASSOCIATIONS**

APhA, Luncinda Maine, Ph.D., Senior V.P. Professional

Affairs 17

CHPA, William Soller, Ph.D., Senior V.P. and Director,

Scientific Technology 22

NFPA, Regina Hildwine, Director, Food Labeling and

Standards 26

CRN, Annette Dickinson, Ph.D., V.P. Scientific and

Regulatory Affairs 30

RDIA, Maureen Mackey, Ph.D., Director, Applied

Nutrition 35

NNFA, Michael Ford 40

FDA Panel Questions 43

**PANEL II: NUTRITION PROFESSIONALS; FOOD INDUSTRY**

SNE, Paul Thomas, Ed.D., Secretary 68

ADA, Tracy Fox, MPH, RD, Senior Regulatory Federal

Manager 71

IFT, Mary Ellen Camire, Ph.D., Associate Professor 76

USP, Joseph Valentino, Senior V.P. and General

Counsel 79

FDA Panel Questions 82

**PANEL III: CONSUMERS**

National Woman\'s Health Network,

Adrian Fugh-Berman, Ph.D. 101

Citizens for Health, James Turner,

Chairman of the Board 106

CSPI, Ilene Heller, Senior Staff Attorney 110

FDA Panel Questions 113

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(Cont\'d.)

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**PANEL IV: NUTRACEUTICALS**

ANA, Gary Huber, M.D., V.P. Scientific

Communications 129

Rexall Sundown, Steven Dentali, Ph.D.,

Senior Director 134

Neutraceutical Initiative, Antonio Martinez,

Government/Public Affairs Counsel 138

FDA Panel Questions 141

**PANEL V: CONSUMERS**

DAAIR, Fred Bingham, Executive Director 160

AARP, Richard Johnson, AARP Delaware State President 164

FDA Panel Questions 168

**PANEL VI: LAWYERS; DIETARY SUPPLEMENT INDUSTRY**

Emord & Associates/Burke Professional Center,

Claudia Lewis Eng, Attorney 182

Patton Boggs, Jim Prochnow, Attorney 186

Hyman, Phelps, McNamara, Steve McNamara, Partner 190

Emord & Associates/Burke Professional Center,

Steven Allis, Attorney 194

FDA Panel Questions 199

**ADDITIONAL COMMENTERS**

Anne Fonfa, Annie Appleseed Project 218

Maury Silverman 222

CONCLUDING REMARKS 226

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MR. HUBBARD: Good morning. I\'m Bill Hubbard from the Commissioner\'s
Office at FDA. We\'re running a little late because Joe Levitt, who is
going to chair this, is caught in traffic. He should be here
momentarily. We might be able to do some initial housekeeping things,
however, that we were going to do anyway, to prepare for him.

So, with that, let me first introduce Margaret Porter, our General
Counsel, and Beth Yetley, the head of our dietary supplements office\--

DR. YETLEY: Office of Special Nutritionals.

MR. HUBBARD: Excuse me.

\[Laughter.\]

MR. HUBBARD: And Dr. Debra Bowen, from our Center of Drug Evaluation and
Research.

Perhaps the first thing to do is to give you a brief run-through of what
we\'re going to do today and how we\'re going to organize the meeting.

Beth, could you do that?

DR. YETLEY: Joe Levitt does have some opening remarks, so when he gets
here we\'ll let him go ahead and do that, although I think that would
probably between Panels I and II.

What we have done is try to organize this by panels that appeared to
have somewhat common interests. We have six panels scheduled, and then
at the end of the day we will have some concluding remarks.

The first panel is primarily trade associations, then we have nutrition
professionals. A third panel will be consumer groups; fourth panel
nutraceuticals. A fifth panel is consumer groups, and the six panel is,
again, industry and industry representatives.

We will ask the entire panel to come up as a group. We will ask each
member of that panel to give their remarks. We\'ve asked them to keep
this to five minutes or less. And then once the entire group has given
their remarks, we will try to have a dialogue between those of us on the
FDA side, and the members of the panel. This is as much information
gathering, from our prospective, as we can make it. And so we wanted to
have as much dialogue as we could.

The first panel, we have APHA, Lucinda Maine\--I\'ll have you start up
and wind yourself around the table\--CHPA, Bill Soller; NFPA, Regina
Hildwine; CRN, Annette Dickinson; RDIA, Maureen Mackey, and we also
asked NNFA, Michael Ford to join this panel.

If they could come forward?

\[Pause.\]

MR. HUBBARD: Could I speak to Lynn Larsen to a minute?

DR. YETLEY: Lynn, we\'re looking for the timer. I understand we have a
timer so people stay on schedule.

Okay, Ellen, down here, is going to\--what?\--hold up cards. Yellow
means caution, I presume, and red means\' you\'re time is up.

Okay. We have a very full schedule, so we are going to be a little bit
hard-nosed about sticking with the schedule.

APHA\--Lucinda Maine.

MR. HUBBARD: Lucinda, let me interrupt you. Joe Devitt is walking in
now. Perhaps it would be best to go back to the original schedule.

Joe, you need to come around. Sorry about that.

\[Laughter.\]

MR. LEVITT: Good morning, everyone. Let\'s see if this microphone is
working. It sounds like it is.

I apologize to everyone, including the panelists up here, for my late
arrival. You know what they say: the best laid plans. If you need to get
here quickly, you will find the traffic jam in Washington\--at least is
what I\'ve found.

At least I can tell you that it is cooler in here than it is out there.
As the day goes on, we hope the air conditioning holds. If it does not,
I would encourage people to freely\--whether you\'re up here on the
panel or not, to take off your jackets, or whatever is needed, so that
we have a comfortable day.

What I would like to do\--if we can get the slide projector going\--is
to set the stage for the speakers that we have today. And Lynn is
telling me\--I\'m just going to use the mike here, because I don\'t
think I could get there. The only question is will it at all affect how
I move the slight. Pardon me. I just couldn\'t quite figure out how to
get from here to there.

\[Pause.\]

We\'ll start off again with a welcome. We\'ll welcome the members of the
FDA panel; the folks from the industry; consumers; health professionals;
and everybody that is here in the audience.

I hope this will be a useful day. We would like to try and do three
things. I\'ve got to remember my rules here.

Number one is\--most importantly\--we want to share views. We at the FDA
want to hear what all the stakeholders have to say about dietary
supplement strategy.

Number two, really, is a goal. Sometime in this area it feels like a
dream. But to the extent that we can build consensus, obviously that is
good. In order to do that\--and I said this at an earlier meeting\--I
really ask all the speakers\--I make you this deal. I\'ll listen to each
of you, as will my colleagues, if you\'ll listen to each other. Because
we will hear, I have no doubt, differing points of view on this subject.
And it\'s important that everybody understand the different points of
view if we have a chance and a hope of building consensus. And even
without consensus, we need to prioritize the work we have to do.
There\'s a lot of important work to be done in this area. We recognize
and are becoming more, if you will, humbled by the scope and depth and
breadth of what we need to do. And so one absolute goal I have out of
this process is to prioritize.

Now, in terms of background, this meeting really has its origins in a
meeting in this room just about year ago, when we had a general
stakeholders meeting of CFSAN. We had a number of oral and written
presentations, and we really focused on the central question: where do
we do the most good for consumers?

That developed into the CFSAN program priorities document for
1999\--what I finally referred to as the \"Yellow Book.\" And one of the
main features under dietary supplements there was to say: we need to
take a step back. We need to recognize that we\'ve had four years of
experience since DSHEA, but we need to take a step back and really
develop an overall strategy for how we\'re going to implement this law.
And, as you see, there are a long list of things that are listed, and
all those are relevant.

Now, Dr. Henney, when she testified before Congress earlier this spring,
I think made a number of key statements that will help frame our
discussions for today.

Number one, she said FDA is aware that Americans place great faith in
dietary supplements to help maintain and improve their health, and that
the scientific evidence documenting the benefits of a number of
supplements is increasing. So there\'s value here. We need to recognize
that.

But, number two, the challenge to FDA is to strike the right balance
between preserving consumers\' access to both products and information,
while assuring the safety and proper labeling of all these products. So
we have access on the one hand; we have safety, proper labeling on the
other hand, and we need to achieve both.

Now, we\'ve also made a considerable set of progress to date. Attached
to Dr. Henney\'s testimony was a list of the [Federal
Register]{.underline} documents that have been published since DSHEA on
dietary supplements. We took a short little poll in FDA. Nobody outside
of the Office of Special Nutritionals thought there were more than ten.
But as we counted them all up, indeed there were 25 [Federal
Register]{.underline} documents already, which shows there has been a
lot of work but, also, we realize a lot more to be done.

In addition to the [Federal Register]{.underline}, you see we receive
large numbers of 30-day notifications, as well as a number of
scientific-based new dietary supplement ingredient notifications that we
have dealt with.

Dr. Henney then continued, therefore, \"It is clear, with the benefit of
hindsight, that we still have a way to go, both in achieving full
compliance with DSHEA, and in developing a workable regulatory
framework.\" I really hope that today is the day that starts us
vigorously along that path.

Now, we also\--this is part of a broader outreach effort\--again, I
talked about the meeting a year ago. We had a meeting in January dealing
with international scheduling. Dr. Henney had an agency-wide stakeholder
meeting in April. We held one here in the Center, on health claims on
dietary supplements\--and I see some of the same speakers on the first
panel that I was able to hear then. We have today\'s meeting on overall
strategy, and we are repeating this same meeting on the West Coast on
July 20th.

Now, we put out a [Federal Register]{.underline} notice, which you all,
no doubt, got, or you wouldn\'t be here today. Again, reinforcing the
statements I already read, FDA\'s objective in developing this strategy
is to ensure consumer access to safe dietary supplements that are
truthfully and misleadingly labeled, following a process of openness,
flexibility, efficiency and commitment to public health.

We propose four criteria in setting priorities: number one, consumer
safety; number two, health-related labeling; number three, efficiencies
in the process; and number four, closure on unresolved issues. And those
familiar with my general priority-setting process will see a clear
similarity there.

We posed seven questions in the [Federal Register]{.underline} notice,
and I will run through those briefly, that we hope people will be
addressing.

Number one: in addition to ensuring consumer access to safe dietary
supplements that are truthfully and not misleadingly labeled, are there
other objectives that an overall strategy should include?

Number two: are the criteria that I just went over\--are the criteria
for prioritizing the tasks within the supplement strategy appropriate?
What specific tasks should FDA undertake first?

Number three: what factors should FDA consider in determining how best
to implement the tasks; i.e., the use of regulations, guidance,
etcetera\--what approach should we take?

Number four: what specific tasks should be included under the various
dietary supplement program elements in the CFSAN priorities
document\--and I went through those earlier\--claims, boundaries, CNPs,
GMPs, etcetera.

Number five: are there current safety labeling or other marketplace
issues that we should address quickly? We sometimes talk about the
difference between something that is important and something that is
urgent. And some things are both, but some things are more urgent than
others, and some things are important over the long haul, but not
necessarily something that has to be done first, or right away. So are
there things that FDA should address quickly through enforcement actions
to ensure, for example, that consumers have confidence that the products
on the market are safe and truthfully and not misleadingly labeled.

Number six: what type or area of research on dietary supplements should
FDA allocate its resources; so, focusing on research.

And, finally, how we can leverage. Given FDA\'s limited resources, what
mechanisms are available or should be developed to leverage FDA\'s
resources to meet effectively the objective of the strategy.

Now, I\'ll share with you our current thinking as we\'ve been talking
and meeting as we\'ve led up to this meeting, too, and I would take
those earlier long lists and really put them under three broad headings.

Number one: what are the boundaries? If we\'re going to have a set of
rules for regulating dietary supplements, I think the first step is,
what is a dietary supplement? What falls within those rules, and what
falls within other sets of rules; whether it\'s food additive, drug,
conventional food, or whatever.

Number two is safety, and I would put this in both acute safety issues,
such as adverse even reporting, as well as longer term things that will
help promote safety, like GMPs.

And third is the whole area of labeling and claims.

Now, meeting logistics\--I think this has been gone over, but just to
reiterate briefly\--we have a series of panels. The first one is sitting
up here already nicely. We will ask each speaker in the panel to go over
and give their presentation. I would ask you not to follow my
lead\--you\'ve already been here before me. We do have to focus on
timeliness if we\'re going to allow everybody a chance to speak. We have
asked everybody to try and limit your remarks to five minutes, and we
will accept any additional comments, written, for the record.

We will then go through out side quickly and pose questions from FDA,
and then will proceed from one panel to the next with some limited
breaks and so on and so forth.

Let me just see if\--there were some notes that I wanted to be sure we
got to. Did you do the logistics, such as where the restrooms are and
those sorts of this?

MR. HUBBARD: No, we didn\'t do that.

MR. LEVITT: Well, let me do\--If you\'ll allow me one more minute,
we\'ll get to the really important stuff.

The rest rooms are on the left and right of the main corridor. When you
go out, turn right when you leave the auditorium to get to the main
corridor.

Number two: food. Some people will get hungry today. There is an express
cart with coffee and snacks that is located right out there. I saw it
just when I ran in. That will be available until noon. Just before noon
we\'ll talk about luncheon arrangements.

Number three: panelists for the morning should be seated in the reserve
section in the front of the podium over there. So, hopefully, the other
people sitting over there are the people who are going to speaking later
this morning. In the afternoon, the same way. That will help us as we
try to get up and down. And, as you see, the logistics for just getting
up and down are challenging in and of themselves.

As I said, we\'ll allow five minutes per speaker. We do have somebody
who\'s going to help us in timing. Ellen? Show us where Ellen is, thank
you. We will have a one-minute warning, and a still friendly orange
time, which is a nice way of saying time is done. And we would ask you
to respect that. I know I was giving a speech yesterday,and all of a
sudden\--it was a 25 minute speech, and the 5-minute sign went up, and
said, \"Holy smokes,\" and I had to adjust myself a little bit, but was
able to finish. So we all need to live with that.

As I said, we do have a full agenda, and we need to deal with that.

I\'ll talk about luncheon later.

Finally, a couple of concluding remarks. And, again, if this was covered
before, I apologize. We made a mistake in the [Federal
Register]{.underline} notice on the closing date for comments. We meant
to say August 20th for the date for comments due, instead of the earlier
date. That was clearly as mistake.

Number two: the slides I just showed are available in today\'s handouts
and on our Web site.

Number three: if you want written requests for the meeting transcript,
the meeting is being transcribed. You can ask FDA\'s FOI office. Give us
two weeks, please, or 15 days, it actually says here. And the address of
the office is on the back of the [Federal Register]{.underline} notice.
And I mentioned the similar meeting in California.

Now, somebody also handed me something here that I think I\'m supposed
to say, so let\'s see.

\[Pause.\]

Okay. I think these items have essentially be covered.

With that, I will take a deep breath, try and sit back and relax, and if
we can figure out the lights and the logistics, we will proceed to the
first panel. And my list says that Dr. Lucinda Maine, Senior Vice
President Professional Affairs, APhA is our first speaker, and she is
standing at the podium, ready.

Thank you. If we can turn this off, we can focus attention on you. Thank
you very much.

Please, Dr. Maine.

**PANEL I - TRADE ASSOCIATIONS**

DR. MAINE: Yes. Thank you for the opportunity to provide input to the
Center on how you can best develop an overall strategy for achieving
effective regulation of dietary supplements.

I do represent the American Pharmaceutical Association, the national
professional society of pharmacists, with over 210,000 pharmacists,
scientists, students and technicians.

I\'ll briefly address your key questions, first by sharing where the
Association finds itself with respect to policy development on what we
believe is one of the most profound examples of consumerism in health
and wellness. Then, drawing on the results of recent focus groups held
with pharmacists, I\'ll share our perspective from a key health care
provider that hopefully will guide the agency as you struggle with these
important questions.

We are respectful of the constrains on the agency from public pressure
to keep dietary supplements in a largely unregulated environment. I
personally had begun to wonder whether a contributor to this consumer
opinion is the fundamental belief held by consumers that an acceptable
threshold of regulation on these products currently exists. These
products appear on the shelves of our nation\'s pharmacies where many
other categories of traditionally regulated products are found. Consumer
belief would be supported by the history of strong regulation by this
agency for the full range of products currently and clearly in your
jurisdiction.

Our association initiated policy development on these products in 1997,
per the request of both our practitioner and science members.
Ultimately, five suggested policies came before our house, and that
related to the need for informed decision-making pharmacists and public;
the need for additional sources of quality education and publication for
practitioners; suggestions that manufacturers provide evidence of the
use of good manufacturing practices; and the adherence to standards and
quality control sufficient to ensure that only quality products are
available for sale to the public.

I believe reflective of the evolution in pharmacists at the time, the
house overwhelmingly adopted the policy stating that informed
decision-making should be the basis what pharmacists and consumers do,
and that APhA needed to provide pharmacists assistance, in terms of
education and publications to facilitate their counseling of patients on
proper use, indications, safety and interactions between these and other
products. Deferred were the policies on what the profession should
require from manufacturers and suppliers of these products in terms of
standardization and assurance of quality.

TWo years later pharmacists find themselves increasingly called upon to
provide consumers information regarding the use of these products.
APhA\'s education and publications efforts have expanded during this
timeframe in response to great demand from our members to provide the
most credible information possible. A continuing challenge to the
Association and to pharmacists is the lack of information on efficacy,
safety, standard dosage, side effects and interactions with traditional
therapies and conditions. This information is that which pharmacists and
other health care providers have come to use and find easily available
for traditionally regulated products. APhA will again be focusing on the
development of meaningful policy specific to the regulation of these
products over the next nine months, and we welcome input from FDA and
key stakeholders as we embark on this path.

Findings from two focus groups of pharmacists recently conducted by APhA
provide additional guidance to your key questions. Pharmacists are using
a variety of terms to define this category, and their terms do differ
from those used by consumers, in many cases. The key issue for
pharmacists is determining the quality and efficacy of a supplement.
Pharmacists that all types of consumers are approaching them seeking
information regarding the purchase of these products. Often it appears
that the consumer is seeking to establish credibility to a decision that
they have reached based on advertising, consumer media and word of mouth
recommendations from friends, family and others.

Pharmacists do want manufacturers to prove the quality of their products
using means similar to the trusted approach for
pharmaceuticals\--controlled clinical trials with results disseminated
and peer reviewed in reputable publications. And pharmacists want to see
standards established for this category of products.

The current scientific and regulatory environment for dietary
supplements is clearly insufficient. One area for research that the FDA
could embark upon would be the ability of these products to actually
deliver the intended substance. Recently publish research in our journal
[The Journal of the American Pharmaceutical Association]{.underline},
has indicated problems with, for example, dissolution. The product
was\--the publication was entitled \"The Comparison of Melatonin
Products against USP\'s Nutritional Supplement Standards,\" and we did
find that not all products dissolved according to the USP
specifications.

I will close with my recommendations, and there are four.

There is a need to establish what consumers believe is the current
regulatory framework for dietary supplements. I think this speaks to
your \"boundaries.\"

There is a need to clarify the nomenclature and criteria for
classification of products.

A systematic process for aggregating and applying the most credible
evidence is required.

And I believe adverse event reporting for these products should be
integrated into existing systems and systematically analyzed, with that
information being fed back to consumers.

Thanks again for the opportunity to participate in today\'s panel.

MR. LEVITT: Thank you very much.

Our next speaker is William Soller, from CHPA. And, Bill, I won\'t take
this out of your time, but as you\'re standing up there and getting
ready\--I neglected\--I saw you over there, and I just assumed you were
on the list\--but Michael Ford is not on the written agenda, but he\'s
sitting up here and will be one of the speakers of this panel, and we
certainly welcome you here, too.

Please, Dr. Soller.

DR. SOLLER: Good morning. I\'m Dr. Bill Soller, Senior Vice President
and Director of Science and Technology for the Consumer Health Care
Products Association, which represents producers of quality dietary
supplements and non-prescription medicines, including over 200 member
companies across the manufacturing, distribution, supply and service
sectors of the self-care industry.

We have detailed written comments that supplement these oral remarks and
have been put into the record today.

In setting its priorities, CFSAN should place safety first; that is,
enforcement, GMPs, and AERs, as well as the development of a three to
five year detailed strategic plan or gaps analysis. While activity in
the claims area may proceed as priority is given to safety issues, its
completion should be targeted farther in the future than that for
resolving the safety-related issues, and I have six points.

First, in passing DSHEA, Congress intended that consumers would use
dietary supplements for health promotion, health maintenance, and
disease risk reduction. Consumer confidence is essential to product use.
Allegations that the dietary supplement industry is unregulated or that
FDA does not have sufficient enforcement powers, which it does, acts to
undermine consumer confidence. Therefore, foundational to CFSAN\'s
overall strategy for dietary supplements is an effective enforcement
policy that removes unsafe products from the marketplace and that
ensures truthful, not misleading, and substantiated claims on dietary
supplements. Because of the complementary jurisdiction of FDA and FTC in
this area, the two agencies must coordinate closely, and a public
workshop on this matter would be helpful for all stakeholders to
understand the current relationship between these agencies.

Second, the dietary supplement industry has maintained that specific GMP
regulations would be helpful for ensure that dietary supplements are
safe and not adulterated or mis-branded; have the identify and provide
the quantity of dietary supplement ingredients declared in the label;
and meet the quality specs that the product is represented to meet. We
recommend that FDA make the publication of proposed GMPs a top priority
in 1999, and consider the additional comments that we have developed and
appended to our written comments.

Third, as outlined in our remarks to the House Committee on Government
Reform on May 27, we recommend that CFSAN prepare a written plan for,
and adopt a systems approach for AERs similar to that recommended in
FDA\'s May 1999 \"Managing the Risks for Medical Product Use: Creating a
Risk Management Framework.\" We think the system should be grounded in
the Agency\'s current safety policy and have specific refinements to
CFSAN\'s current AER surveillance of dietary supplements, such as
defined protocols for consistent handling of AERs, training and
re-examining AER listing on the CFSAN Web site, etcetera.

Fourth, boundaries between different types of products\--drugs,
conventional foods, dietary supplements, and cosmetics\--should be based
on a product\'s claim which defines the intended use of the product. In
this way, a product may have more than one intended use which should not
be considered an overlapping situation, but rather one that is
coexistent. Importantly, because the two major confounding issues in
FDA\'s structure/function proposal related to the overly broad
redefinition of \"disease,\" and the intricate interrelationship between
health promotion maintenance and disease prevention, we recommend that
FDA re-propose its structure/function proposed rule as a focused,
regulatory statement that closely incorporates the intent of DSHEA,
amends FDA\'s proposed redefinition of \"disease,\" as we proposed in
our comments; omits the confusing and ambiguous proposed criteria; and
addresses implied claims by the statutorily required disclaimer on
structure/function claims.

We also recommend development of a guidance on structure/function claims
for dietary supplements consistent with DSHEA, and modeled after the FTC
advertising guidance to industry.

Fifth, we don\'t recommend\--we do not recommend that CFSAN move forward
at this time with the appointment of a formal dietary supplement
advisory committee. CHPA considers the priorities of safety, an overall
strategic plan or gaps analysis and claims policy of sufficient
potential resource intensity that the appointment of another special
advisory committee, in a formal sense, would detract at this time from
the needed refinements in CFSAN\'s operations and activities. The
operational mechanism of special working groups, as needed, on the Foods
Advisory Committee appears to be working, given the nature and extent of
the agenda for dietary supplements at this time.

And, finally, industry has an interest in helping to ensure that FDA is
appropriately staffed and funded to meet its statutory obligations of
promoting and protecting the public health. Only if we know and
contribute to the three to five year plan or gaps analysis for CFSAN are
we able to knowledgeably pursue appropriations requests to build the
CFSAN infrastructure needed for dietary supplements, hence the
importance of what comes our of today\'s meeting.

Thank you very much.

MR. LEVITT: Thank you very much.

Our next speaker is from the National Food Processors Association,
Regina Hildwine, Director, Food Labeling and Standards.

MS. HILDWINE: Good morning. I\'m very grateful for this opportunity to
present NFPA\'s views.

NFPA\--National Food Processors Association, is the principal scientific
trade association representing the food processing industry. There are
copies of my remarks out on the desk. We are going to file written
comments at a later date.

Today I\'m very briefly going to discuss issues related to safety and
labeling claims, and I\'m going to bring in some things relative to
other classes of foods.

NFPA is interested in dietary supplements because they are foods. NFPA
supports a regulatory policy which is consistent for all foods with
respect to safety and label claims. NFPA also believes that safety comes
first. NFPA is aware that the law makes different provisions for the
burden of proving safety of ingredients for dietary supplements and for
other foods. While, by law, dietary ingredients of dietary supplements
are no longer deemed to be food additives, NFPA believes that this does
not absolve the dietary supplement industry from responsibility for
safety of their products and ingredients. Dietary supplement companies
should continue to assess the safety of their products and ingredients
prior to market, monitor safety after market introduction, and have
procedures in place in the event a recall is necessary. Dietary
supplements are not exempt from voluntary recall provisions.

To assist the dietary supplement industry in assuring the safety of its
products, NFPA believes that FDA should proceed promptly with the
rulemaking of good manufacturing practices\--that is, GMPs\--for dietary
supplements. We see this as a top priority. The experience of the food
industry is that FMPs serve as a useful outline for those production and
processing procedures which result in safe and high quality food
products.

The dietary supplement industry should also be encouraged to notify FDA
that key dietary ingredients of their products are generally recognized
as safe\--that is GRAS\--especially dietary ingredients with some
history of use. We see this as another objective that should be
considered. Using GRAS notifications for dietary ingredients with a
history of use would complement the current pre-market notification
procedures for new dietary ingredients or dietary supplements. GRAS
substances are not food additives by legal definition, so dietary
supplement ingredients would not be excluded from consideration under
GRAS provisions. Ingredients of dietary supplements should be help to
the same GRAS standard as conventional food ingredients.

Consideration under GRAS provisions should address current levels of
consumption and conditions of use for dietary ingredients, including
herbals and botanicals. Current uses may be very different from
historical uses.

We note that some botanical ingredients have utilized the new GRAS
notification process, however their notified as \"flavors.\" To assist
the dietary supplement and, indeed, all sectors of the food industry,
NFPA recommends that FDA should promptly finalize its proposed GRAS
notification process. The supplement industry should then be encouraged
to use this provision to ensure that the users of supplement
ingredients, including herbal and botanical ingredients that there is no
question of the safety of these substances.

NFPA believes that the dietary supplement industry should carry the
burden of ensuring its products are safe, and FDA should provide a
regulatory environment, through GMPs and GRAS, to assist the industry in
its endeavors.

Regarding label claims of health benefits, conventional foods and
dietary supplements enjoy similar, if not always identical, regulatory
approaches\--and I talk a lot about this all over town. In the area of
health claims, both conventional foods and dietary supplements should be
subject to the same provisions, and this includes extending FDAMA health
claims provisions ultimately to supplements. NFPA also believes that the
recent court decision in [Pearson v. Shalala]{.underline} ultimately
will exert equal force on claims labeling rules for both dietary
supplements and conventional foods.

With respect to structure/function claims, NFPA commented last year that
FDA\'s unfortunate proposed rule would have as much of an adverse effect
on claims for conventional foods as it would on dietary supplements. The
proposed redefinition of disease would adversely affect health claims
and structure/function claims across the board.

NFPA has urged FDA to withdraw this proposal and we repeat our request
today. We also ask FDA to take to heart the arguments we put forward
with respect to nutritive value.

It\'s imperative that all types of claims on all foods, including
dietary supplements be well substantiated or fairly carefully and
explicitly qualified. We believe that FDA needs to be aggressive in its
enforcement posture against any poorly substantiated, poorly qualified
or otherwise misleading claims. And we also urge FDA to work in
cooperation with the Federal Trade Commission.

All these reforms\--safety and claims\--are needed not only to ensure a
level playing field between dietary supplements and conventional foods,
but to prepare a positive environment for new types of foods being
designed to provide health benefits beyond those of basic nutrition.
Whether these novel foods or dietary supplements in the form of
conventional foods, or traditional foods enhanced with properties or
components associated more with dietary supplements, NFPA believes that
the course to a barrier-free regulatory environment lies in correcting
the flaws in current rules and a strong enforcement approach, rather
than embarking on a new regulatory scheme.

Thank you very much.

MR. LEVITT: Thank you.

Next we\'ll hear from Dr. Annette Dickinson, Council for Responsible
Nutrition.

DR. DICKINSON: The Council for Responsible Nutrition is a trade
association of the dietary supplement industry, representing
approximately 100 member companies, ranging from suppliers of raw
ingredients to finished product manufacturers; manufacturers of national
brands as well as store brands; and manufacturers of products which are
marketed through all channels of distribution, including mass market,
health food stores, direct sales and mail order.

We are encouraged by FDA\'s state commitment to an open and
participatory process, but we hope\--and, in fact, we have
confidence\--that that process will, in fact, go beyond what is possible
in this meeting which was, unfortunately, announced with less than 30
days\' of notice, and permits only five minutes per presentation. So we
look forward to additional discussions in the future.

FDA indicates that the two primary objectives for its dietary supplement
strategy are to assure consumers of safe dietary supplements, and to
assure consumers that labeling is truthful and not misleading. We fully
support these two objectives, but we would urge FDA to add a third
overall objective to this plan, and that is to fully implement DSHEA.

FDA may currently be of the opinion that this is implicit in its
strategy, but we believe it needs to be made explicit and, in fact, we
believe the most critical issue facing FDA and the industry today is the
perceived failure to implement DSHEA, which leads to the inappropriate
conclusion that FDA lacks authority to regulate these products when, in
fact, the issue\--as has been mentioned already\--is more enforcement
and implementation.

We believe that all of the elements of the overall strategy can be
encompassed in three headings: one for safety, which actually is not a
current heading in the proposed outline\--one for safety and one for
GMPs. Under the issue of safety, FDA needs to address\--continue to
address\--the issue of new ingredients of dietary supplements and also
adverse event reporting. We fully support FDA\'s continued review and
action on new dietary ingredients notifications, and have supported FDA
action that has been taken earlier this year. However, we have been
disappointed that in one case involving GBL FDA\'s action was based on a
new drug\--unapproved new drug theory, rather than relying on the
provisions of DSHEA directly as the basis for enforcement action.

We also support the need for prompt and effective adverse event
reporting, and the current system needs improvement, because it is not
prompt and it puts companies at a risk of having a product falsely
associated with an adverse event.

We have suggested a number of specific modifications to the adverse
event reporting system in our written statement provided today, and we
will expand on that in our final statements before this is over. This
include involving companies directly in evaluating adverse events;
evaluation reports with regard to the strength of association;
correcting errors that may have appeared in public reports; and
carefully considering whether there is, in fact, a role for specific
identification of companies and products. In looking at some previous
FDA adverse event reporting systems on food additives and other
ingredients, in general, specific company and product name is not
included in the overall report.

On the issue of claims, FDA has a number of issues facing it, including
statements of nutritional support, NLEA health claims, and FDAMA health
claims. We encourage FDA to rely specifically on DSHEA for the
definition of statements of nutritional support and to recognize that
the only dividing line provided by DSHEA between statements of
nutritional support and disease statements is the specific mention of a
disease condition. We would urge the agency to withdraw the proposal
that was published last year, and to implement\--simply proceed with
implementing DSHEA on this point.

On NLEA health claims, we would encourage FDA\'s review and approval of
four new petitions that have been filed or will be filed in the next
week or so, and to implement the requirements of the
[Pearson]{.underline} decision, if necessary, in evaluating those
petitions.

We also encourage FDA to fully implement the FDAMA health claims
provisions, using the criteria that are specified in the Act, and
without adding new requirements which are not included in the law
itself.

On the issue of GMPs, we join the previous speakers in urging that FDA
make the completion of the GMP process a very high priority. We and our
members who prepared and submitted the drafts on which the current
proposal is based stand ready to provide any additional assistance that
we can provide in moving that process forward.

My final two points regarding leveraging of resources and stakeholder
involvement: FDA needs to leverage its resources, and we believe that
one of the ways to do that is to appoint a dietary supplement advisory
committee to help review important issues relating to this product
category. In the meantime, FDA needs to continue to rely on working
groups to supplement the existing Food Advisory Committee, which does
not have the expertise in our product category. At this time, we call on
FDA specifically to appoint dietary supplement industry liaison members
to the existing Food Advisory Committee, and also to any dietary
supplement advisory committee that may ultimately be established.

The industry wishes to be involved with FDA as a major stakeholder in
regulating this product category. We believe in the importance of
private-public partnerships, and we are prepared to work with FDA to
improve mutual communication and action. Often, when serious issues
arise, we learn about it only hours before a public announcement is
made. We want to be a more meaningful partner with you in resolving
solutions to those problems, whenever possible.

Thank you.

MR. LEVITT: Thank you very much.

Next, we have Dr. Maureen Mackey from RDIA.

DR. MACKEY: Thank you for the opportunity to speak today on behalf of
the Research-based Dietary Ingredient Association, which is an
association of companies including Cargill, Galogen, Monsanto and
Novartis, committed to championing the role of science in the
development of functional food ingredients and related products.

Our comments today are directed towards the agency\'s request for input
on its objectives to ensure consumer access to safe dietary supplements
that are truthfully and not misleadingly labeled. We also will address
the agency\'s request for guidance in developing implementation
strategies that leverage its limited resources.

RDIA urges FDA to develop a regulatory framework for foods and dietary
supplements that, first, has consistent and transparent standards for
safety and claims substantiation; has timely and predictable processes
for regulatory acceptance; and, thirdly, rewards investment in research.
I\'ll first talk about standards for safety.

As we would all agree, consumers have the right to know that the foods
and dietary supplements they consume are safe. These products should
meet a common safety standard that their consumption will not pose a
significant or unreasonable to health when used as intended. Meeting
this standard may require a scientific process that includes original
research. For example, if the safety assessment of a new dietary
ingredients in a dietary supplement indicates that the safety standard
articulated above cannot be met through experience based on common use
and published literature, then safety research will be required. We
believe there is a need for uniformity of understanding in the industry
as to what the safety standard means, and what information is required
to be assured the standard is met. While DSHEA does not prescribe the
specific safety-assessment process, neither does it excuse any company
from determining that its products are safe for the target population at
the specified level of ingestion. We urge FDA to work with industry to
help assure uniformity in understanding what information and science are
required to meet the safety standard as indicated under the law.

Second, standard for claim substantiation. RDIA believes that foods and
dietary supplements whose benefits to health have been demonstrated via
sound scientific research to a reasonable certainty should be able to
describe these benefits on labeling, whether a structure/function claim,
NLEA health claims or FDAMA health claims. The nature of the science
needed to support a claim likely will vary, depending on the type of
claim made, but the same standard of reasonable certainty that the claim
is truthful and not misleading should be required. We encourage FDA to
apply this standard evenly to all types of claims on both foods and
dietary supplements.

One of the obstacles to developing responsible claims for products is
the lack of clarity regarding the nature and extent of evidence
constituting adequate substantiation. We realize it is not feasible or
even desirable to prescribe a set of studies needed to substantiate
every claim. However, we believe it is appropriate to establish a
process for gathering, evaluating and weighing the evidence that may
substantiate a claim, and to require that this process be applied
consistently. We would bring your attention to the Functional Foods
Technical Committee of the International Life Sciences Institute, which
is developing a proposal for such a process, and is seeking scientific
input and acceptance. RDIA supports this effort and believes it will
help assure that claims are evaluated according to a consistent,
scientifically sound process.

Third, I\'ll talk about timely and predictable processes for regulatory
acceptance. RDIA believes there should be mechanisms in place to assure
that claims made on foods and dietary supplements do, in fact, meet a
standard of reasonable certainty, and that they can be used by
manufacturers within a timely manner after their data evaluation is
complete. RDIA believes it makes sense for industry to participate
actively in its own monitoring. For example, industry could develop
guidelines that would help its members perform appropriate and adequate
studies to assure reasonable certainty. In addition, an independent
expert review process could be established to verify that claims are
substantiated. This option would take much of the burden of data
evaluation off the FDA. These measures, however, are not meant to
replace FDA\'s role and authority in taking action against claims.
Rather, they would limit the number of situations in which FDA would
need to act.

And, lastly, incentives for investing in research. RDIA believes the
regulatory system should be designed and implemented in a way that
encourages research and development of products that benefit people. For
example, suppose a manufacturer of a dietary supplement invests
significantly in well-conducted clinical studies to demonstrate its
product reduces blood cholesterol consistently in subjects with
moderately elevated cholesterol, when taken as part of an overall
dietary plan. The current petition and approval process for health
claims under NLEA is too uncertain and time-consuming, and the
provisions that data supporting a health claim be publicly available,
and that any company can use an approved claim, are strong deterrents to
research investment. Instead, the manufacturer should be rewarded for
its investment by having the freedom to make a labeling claim, such as
\"When taken as part of an overall dietary plan, this product can help
lower moderately elevated cholesterol levels.\" Such a claim should be
allowed, because that is what the data truthfully and not misleadingly
showed. We realize some of our proposed objectives require legislative
change. In the meantime, RDIA urges the FDA to step back from its
current view on claims and generate discussion within the scientific and
public health communities and industry on how the results of scientific
studies about products should be presented appropriately to consumers.

Thank you.

MR. LEVITT: Thank you very much.

And, again, our final speak on this panel is Michael Ford from NNFA.
Again, I apologize for not having your name on the written agenda.

MR. FORD: Okay. Well, thank you very much for accommodating me. I do
appreciate it, and we appreciate this series of hearings.

We agree with the three identified themes of maintaining a credible FDA
program, and maintaining a science-based program with highly qualified
scientists, and maintaining FDA\'s importance to consumers in the
regulated agency, but we want you to act. We need you to get off of the
thematic and on to the schematic, so to speak.

With the issues that you have identified, with respect to claims, we
would agree with you. While maybe you haven\'t stated this publicly, but
we believe there\'s a great deal of fraud in the claims in the
marketplace. And the only answer that there is for dealing with that
fraud is enforcement of DSHEA. It is your only course.

We believe that structure/function statements, as described in the law,
are quite broad in scope and there is not a need to make medical-style
claims. We believe that the structure/function statements afford the
industry ample opportunity to expand their markets. But you must
enforce\--you must see the substantiation for these claims, because if
you don\'t, then the fraud will continue. And DSHEA gives you the tools
that you need to take care of business.

As far as defining the boundaries\--all the -ceuticals that are out
there: the neutriceuticals, the cosmeceuticals\--you have a lot on the
table to deal with. And we suggest that you consider the appointment of
expert advisory group\--not necessarily, perhaps, through the Advisory
Committee Act, but more of an ad hoc but standing group that could
combine the best from academia, consumer groups, industry, congress and,
of course, the FDA, to help you through some of these issues where I
think that you do need assistance.

I agree with what\'s been stated today that GMPs are extremely
important. We believe the ANPR that came out was a little more drug-like
than perhaps intended, even though it came substantially from the
industry. I believe the industry has moved along, the technology has
moved along. We are moving along, also. And yesterday NNFA completed its
first inspection of a member company. As I\'ve said here before, we now
have mandatory GMP compliance\--GMPs that we have put together\--for
continuing membership in the Association. And we hope to have the
opportunity to sit down with you and talk with you more about that, and
even invite you on some of the inspections and see the process that we
are using.

With the adverse event reports, obviously there\'s a lot of improvement
needed. I want to stress here today that NNFA has not supported any of
the arbitrary efforts budgetarily or legislatively to undermine the AER
safety issues. We want to work with you to get the AER program the way
it needs to be but, let\'s face it, when we\'re talking AERs\--we\'re
talking ephedra\--you truly need to move, again, on your regulation. We
believe that perhaps you didn\'t go the right way with your regulation.
We have suggested a guidance. But if you feel strongly that you went the
right way, based on your AERs, then go ahead and finalize it. If the
industry believes that you\'ve not met your burden of proof, then I
guess it will be worked out in court. But I think that would be a
reasonable move at this point, rather than continuing with what kind of
tends to be a rope-a-dope strategy, that the fraud in the industry, and
the injuries in the industry are just going to do the industry in
ultimately if you stand by. Don\'t stand by. Act.

I think that the responsible part of this industry wants rules, and they
just want to know what they are. They want to play by them if they know
what they are.

As far as the research needs, I think the FDA has mighty research needs.
We support a science-base for claims and for regulations. Hopefully,
there\'s room for collaboration with the Office of Dietary Supplements
and the Center for Complementary and Alternative Medicine when it comes
to the products in our area.

My main message\--well, I do want to get to resource needs. We think the
industry is trying to help you out with some meaningful self-regulation
but obviously you need more dough to serve the public well on the safety
issues, and to enforce against the outliers. And that\'s what I suggest
that you do to use your money wisely is stop trying to get most of the
mainstream companies that are in the sort of a gray area, go after the
outliers\--I think we all know who they are; they\'re making outrageous
claims\--you could use your resources better. If we knew what an
adequate budget would be for you to enforce DSHEA adequately, we would
probably advocate for that on the Hill for you, which would be an
unusual situation but something we would jump right into.

Please use your authority\--base your decisions on law and science. You
will find that you do have industry support.

MR. LEVITT: Thank you very much.

What we\'ll now do\--and this will be our first try at this, so we thank
you for being the test\--the focus group for us. What we\'re going to
try to do is, I think, as each of the FDA panelists to ask one question,
and then we\'ll see where we are on time. But we\'ll probably then be
moving to the next panel.

So, I\'ll go first and the others can be sitting here thinking of what
your question is.

My question relates to the general issue of how we get outside advice
into the process. CRN has been very forceful and consistent in
advocating a separate advisory committee, and has recently submitted a
written proposal on that subject. CHPA thought that that was not the
right approach, and has an alternative. Over here we had yet a third
alternative. There was a fourth idea for leveraging outside help. How do
we make sense of this? You\'ve all each other. You talk to each other.
Just kind of quick thoughts down\--or is this just something\--FDA
should hear all the views, make a decision and move on, kind of based on
your last point?

MR. FORD: Well, we\'ve been talking\--

MR. LEVITT: You need to speak into the mike, and we can pass the mikes
down the table, as needed.

MR. FORD: Okay. We\'ve been thinking about this advisory committee issue
for a long time, and we\'re probably more in agreement with CRN than
with other groups, that there needs to be a group you can turn to. But
our thinking has progressed somewhat, and wonder if the bureaucracy and
expenditures that would be associated with appointing a committee
through the Advisory Committee Act is necessary, in terms of getting the
expertise that you need. I think that\'s what you really need is the
expert advice, more than something\--a body to make regulatory decisions
for you. So we\'re looking at the idea of a voluntary group that would
have some substance, from a variety of sectors, that could help you
through a lot of the bumpy roads ahead.

DR. MACKEY: We like the GRAS notification process quite a bit; the
assembling of private experts to evaluate your data product by product.
We also think that a similar process could be developed for claim; if
you wanted an extra measure of credibility behind your claim, that an
independent body\--we\'ve suggested something like the Life Sciences
Research office\--could be commissioned to undertake this kind of thing.
It would be voluntary, but you could distinguish your claim somehow on
labeling.

DR. DICKINSON: We think the priority is for FDA to have access to the
right experts as it goes about making these decisions. As you say, we
have supported a formal dietary supplement advisory committee. In the
process of developing that\--and we understand that it can sometimes
take a year or more to develop\--in the process of developing that, or
even if you decide not to develop that, we think that the immediate
priority is to get that kind of expertise available to you through the
Food Advisory Committee, which you are already using to refer many of
these questions to, by outside working groups such as those you have
already convened, but possibly by additional ones of those, and by
incorporating into that committee representatives of the affected
industry and other interests who are involved in the dietary supplement
business. I think that\'s the immediate priority for purposes of dealing
with issues that are on the table right now today as you move forward in
considering the value of a separate committee.

MR. LEVITT: Okay. Thank you.

Regina?

MS. HILDWINE: Well, we didn\'t talk about this in our prepared remarks.
Certainly, NFPA believes that any point at which FDA interacts with
outside organizations has to be publicly transparent. And we believe
that that is the protection afforded by the Advisory Committee Act. The
exact mechanism that you use\--I think you\'re going to have to figure
out what works best, but I believe that the APA is going to give
protections relative to transparency and public process, and that\'s
very much needed in this area.

MR. LEVITT: Bill?

DR. SOLLER: Yes, just a quick comment.

Our thought here really is on the operant word \"at this time.\" And we
look at this in regards to priorities that you have, and as we\'ve kind
of looked at this landscape, we see enforcement GMPs and AERs as being
the top priority issues, and then over a longer term, probably the
claims situation playing out. So, you know, the operant word being \"at
this time.\"

MR. LEVITT: Excuse me, Bill. Does that mean that you see the proposal
for an advisory committee as relating primarily to claims, and not to
GMPs, AERs, etcetera?

DR. SOLLER: I was just getting into that.

What I was saying is that as we look at this and think about the sort of
building the infrastructure within Special Nutritionals and CFSAN,
versus some sort of claims review\--and let me just return to that in a
moment.

The infrastructure on AERs and GMPs, just given my experience with
advisory committees, both on the RX and the OTC side, is that you\'re
not necessarily going to get the expertise out of academia that has
dealt with GMPs and AERs in a particular product category. And that\'s
building the basic infrastructure. So the kind of working group approach
that\'s been used with the Food Advisory Committee, that has very heavy
industry input when you look at it, compared to other types of working
groups, is more along the lines of what Michael Ford was saying as
something other than a formal advisory committee.

Now, as you get into the claims area, and you think about botanical
drugs and the sorts of things that are going to come out of NIH, and
potentially go for either an RX, and RX to OTC switch, or and OTC drug
type of claim\--and that is a possibility\--we have, of course, the
Nonprescription Drug Advisory Committee that, under its purview, does
have botanical drugs\--senna, cascara, sagrada, and psyllium and so
on\--so it\'s not foreign to that area. But you made need special
botanical expertise as you explore that in the initial period.

I think, as you get into DSHEA type claims and structure/function
claims, that could be a morass, in terms of a formal advisory committee,
and could be less productive than going after the outliers, as was
suggested by Michael Ford earlier. And I think that is how, in looking
at an advisory committee, you have to think about where your priorities
are, and then what type of groups do you really need in to give you
advice. And on AERs I would ask: would not CDER be a very important, and
perhaps the primary focus that you want to work with, particularly with
respect to Jane Henney\'s May \'99 publication, which is a very, very
important document for you to look at in the AER sector. And I would say
maybe you don\'t need that much input from outside groups on some of
these issues.

MR. LEVITT: Do you have anything to add?

DR. MAINE: Just very quickly\--we don\'t have a formal position on an
advisory committee. I think what you\'d needed to do, though, is set as
efficiently as you can, a table that brings together the broadest
community of interest, with the credible scientists, the provider
community, the industry and consumer interests reflected, so that the
dialogue that needs to occur can occur, but again in a way that doesn\'t
hamper the agency from moving forward on its priorities.

MR. LEVITT: Okay. Let me turn to Margaret Porter.

MS. PORTER: The question I have relates to safety and ADRs, and I know a
number of the panel has indicated the importance of an adequate ADR
system in assuring the safety of dietary supplements. And I now that
several of you have said you\'re going to submit additional comments for
the record on this. But I\'d be interested just in this context, if any
of you would address sort of what you see as the relative
responsibilities and abilities of various stakeholders in the system,
whether it\'s consumers, manufacturers, retailers, health professionals,
the Agency, in terms of identifying information on adverse events,
reporting that information and monitoring it?

DR. MAINE: I would just start with identifying the fact that I think we
have no good model for adverse event reporting in the full range of
products that I would classify as pharmacotherapies, and I include these
in that.

I am respectful\--tomorrow there\'s an excellent meeting, for instance,
that\'s being held on this topic specifically. And I think that the
reporting mechanisms have to be evolved so that simple reporting, but
meaningful reporting, is available from everyone: consumers, providers,
and all other stakeholders, but that it has to go into an intelligent
system that will analyze that information so that it is not spurious,
it\'s not misleading, and that it can really be fed back, particularly,
from our perspective, to the provider community that needs to use it in
the course of constructing meaningful plans for patient health and
well-being in the course of integrating both traditional and
non-traditional approaches to care.

MR. LEVITT: Margaret, just a point on definition. If we can call it AER,
and not ADR, then we\'re ;in the right realm here. If that\'s fair
enough.

I think the sources that we have, in terms of spontaneous
reporting\--the medical literature, the medication error system of USP
tests, the toxic exposure surveillance system of the American
Association of Poison Controls Centers, NICE out of CPSC\--and I may
have missed one or two others.

As we look at that, and our experience in consumer products, that the
sources are there and they are available in terms of bringing in
signals. And we\'ve picked up, you know, on a handful of reports on
anaphylaxis and a voluntary program for a warning on neosporin, by way
of example, and it was only a handful of reports over a fairly long
period of time, and therefore very rare reaction. You can get those
kinds of signals out of what we currently get, and our experience is
that those are\--we don\'t need to look for other sources.

I would encourage that you look at our comments\--the detailed comments
on page 4\--as well as what we did last month which the Burton hearings
on dietary supplements to get an idea as to where we are coming from,
and a broader perspective on AER reporting. And I would also encourage
looking at the May \'99 report, because it goes to what Lucinda was
saying earlier that what needs to happen on the CDER side, as well as
the CFSAN side\--remember, we\'re going to have new dietary supplement
ingredients come out; we\'re going to have new drugs that will come out
and will be used in a much broader population of people. And the
potential for rare interactions in that regard, although they would be
rare, and at probably at a low exposure setting, if you will, still need
to be tracked. And so we need that integration. And what is outlined in
that May \'99 report to CDER on medical products I think is the
foundational setting for CFSAN to move forward.

What we are working on right now is a much more detailed type of plan on
AER reporting, in terms of the specifics as to when do you share things,
who do you share them with, how are they reported on the Web site? A
table of contents as it appears is simply not something that is very
helpful and, in fact, potentially misleading, and there may be another
way of thinking out of the box on that one to meet the need of being
FOI-able, but also meeting the need of being complete, valid and so on.
And that\'s what we\'re struggling with right now, to get the right kind
of thing before August and into the system through our comments.

MS. HILDWINE: Again, this is one that we didn\'t cover in our prepared
remarks, but I think it was a year ago\--a little more than that\--we
did present to the Food Advisory Committee relative to safety of dietary
supplements on the subject of surveillance.

Dietary supplements are foods. We believe the models that have been in
place for a long time for foods are very useful here, and those models
essentially put the burden for surveillance\--the first line of
reporting\--on the industry, because it is, after all, the industry
that\'s providing products that go into the mouths of consumers. And
there is a long history on the food side of FDA-industry cooperation
relative to adverse events; a long history of voluntary compliance with
the industry; a long history of voluntary recall preparation, which NFPA
has been a longstanding part of. We would encourage FDA, keeping in mind
that dietary supplements are legally classified as foods, to look to the
food models for adverse event reporting and safety surveillance issues
in the marketplace, because I think that that\'s going to be very
helpful as you go forward with this process.

DR. DICKINSON: We would support this call to look to the food models. We
do think the adverse event reporting system has been demonstrably
effective in pointing out\--signalling\--errors, problems that need to
be corrected. I think some of the problems that we\'ve had in the
ephedra area which is the one, of course, that we\'re all struggling
with most greatly at this moment, comes from trying to over interpret
the adverse reaction reports and to draw from that the kinds of
information that FDA\'s own preamble to the adverse reaction list
indicates cannot be done: that is, identifying a particular dose that is
safe or unsafe; identifying what the denominator is or even, in some
cases, what the numerator is. I think the system as it\'s currently
operated has the capacity to work if we apply intelligent analysis to
it, as Lucinda was suggesting. And what we\'re going to be struggling
with in our further comments is ways of doing that more effectively.

But then you\--you know, as in Dr. Levitt\'s\--Mr. Levitt\'s iceberg
that he shows as an example that AERs are really just a signal\--just
the tip of the iceberg\--you really need to go to the underlying science
and to other issues, probably, for defining what is a safe dose, and
what kind of regulatory action needs to be taken once that signal is
sent up.

DR. MACKEY: I would simply second Regina\'s comments. There are
certainly examples\--published articles in the literature\--documenting
how adverse events for food additives has been conducted. And, you know,
there\'s some experience there to look into.

MR. FORD: I would agree substantially with Dr. Dickinson\'s comments. I
think you need, when looking at dietary supplement, and particularly
botanicals, you need a little bit of different criteria as to determine
which of these reports make it into your final report as you look
through\--and as Annette says, you know, this always comes back
with\--AER seems to come back to ephedra. The reports in there are just
all over the place. We have no idea, many times, what the recent
history\--medical history\--of the person is, what else they may have
taken, what pre-existing conditions they may have, and that\'s, I think,
important information with botanicals, and I don\'t know exactly how you
always get at that information. I do understand, though, we\'re talking
about a list that has a\--as I\'ve said here before\--complaint about
SlimFast that it had an off taste. Well, you know, so does Drano but I
think it would probably produce a much greater adverse event.

So there needs to be some criteria about how these reports get in. There
was conversation awhile ago among the trade associations and FDA about a
consistent 800 number of some kind on the label. That would probably get
you more reports, but I\'m not sure it would necessarily improve the
quality.

MR. LEVITT: Thank you very much.

Mr. Hubbard?

MR. HUBBARD: I actually was going to ask about AERs as well.

As you know, with the drug and device model, we rely principally on
physicians\--the so-called \"learned interveners\"\--and manufacturers
for information.

Dr. Dickinson, you suggested we could rely more on the manufacturers.
Were you thinking of more the drug model, where manufacturers have an
obligation to seek out data and report to FDA?

DR. DICKINSON: No, I was thinking of a food-based model, but in which
the reports, once FDA receives them, would be referred to the
manufacturer so that the manufacturer can be involved, both in
determining that the actual\--the product has been correctly identified;
the manufacturer\'s been correctly identified; provide some additional
information to you regarding the ingredients and the nature of the
product; and be actively involved in determining the likely association
between that report and the product.

MR. LEVITT: Bill?

DR. SOLLER: Yes, I don\'t think that a mandatory AER system would
necessary be the way to go here, given the overall safety and what we
know from the sources of AER reporting. I think we\'re really talking
about refinements to the system.

It\'s true that manufacturers are going to have the sincere motivation
of making sure that that AER is as accurate as possible. One of the
things that\'s difficult here is that FDA may not release the name of
the voluntary reporter, under MedWatch. And you can understand, it would
probably undermine the system. But part of some of the discussions that
we\'ve had focus on whether FDA is able to encourage the voluntary
reporter to also notify the company, particularly of the serious AERs,
because that\'s what we\'re really interested in. And I think as you
look at the AER system, focus in on the serious ones, recognizing that
the broad perspective of all these products is that they\'re very safe.
And if there can be some kind of linkage there, then I think you\'re
able to\--linkage between FDA, the voluntary reporter, and then the
voluntary reporter also telling the company on the serious AERs\--then
you\'re helping to partner, in your follow-up process, by having the
company also work in terms of identifying what is a valid report, what
may have changed in the report, etcetera.

MR. LEVITT: Dr. Yetley?

DR. YETLEY: Thank you.

Some of you have mentioned the high priority for GMP regulations for
dietary supplements. If you were to describe the overarching philosophy
that FDA should follow in dealing with GMP regulations, what would it
be? And what should it not be\--for dietary supplements?

MR. FORD: We have approached out GMPs\--we believe in the old rising
tide lifting all boats. And we have a very inclusive and consultative
type of approach. We don\'t want to intimidate companies. We think that
most of them, with a little ratcheting, will do just fine with GMPs. So
I think they need to be realistic. But just to cut to the chase, to me
the most important elements of our GMPs is that raw material needs to be
tested for safety and identity on the loading dock when it\'s received,
and finished product, lots and batches need to be tested for safety and
identity as far as label integrity is concerned. And everything else in
the middle is important, but that\'s the heart and soul. Because I think
that\'s the question that keeps getting raised when I pick up the
newspaper, is about the safety and identity of the products, and that\'s
what the GMPs, in my view, should be there to guarantee.

MR. LEVITT: Let\'s go down to Annette, and then Bill.

DR. DICKINSON: I would agree that the overarching principle for GMPs is
to assure that products have the identity and quality that there are
represented to have so that consumers have confidence that what they see
on the label is what they actually get in the product. And I think
that\'s the direction that the GMP working groups have been going toward
as they work through the Food Advisory Committee to refine the proposal
that has been discussed.

I think one of the things that they are not\--at least in our view\--is
that they are not HACCP; that the nature of this product category is
such that GMPs are really the answer to regularizing the products in
this category, and that they don\'t, by and large, represent the kind of
microbial or other challenges that have made HACCP FDA\'s choice in some
other product areas.

MR. LEVITT: Bill?

DR. SOLLER: Yes\--generally in agreement. And moving beyond the
identity-quality-potency and purity types of goals of GMPs, our
experience in GMPs has been that as an overarching philosophy\--now,
setting that aside from objectives of identity, potency, purity and so
on\--is that GMPs are best when they specify the goal, and don\'t
over-engineer how to get there. And that is probably the most important
overarching philosophy for any product GMP that would fall within FDA\'s
bailiwick.

Now, there will be specifics within GMPs, and I don\'t mean to say that
you are totally devoid of those. But it\'s quite clear that you need to
build in the kind of flexibility into GMPs that allow technology
advancements, and basically specify: this is your expectation for what
identity, quality, potency and purity would be, allowing the flexibility
for companies to get there.

The second is\--and just a brief point\--if you had to think about the
one area in GMPs that is most sensitive for this industry\--and that\'s
the supplier side of this\--and ensuring that what comes into the
manufacturer, distributor, re-packager and so on is of high quality and
known element is extremely important.

DR. MAINE: The only other new thought that I would add to that is that
they have to be enforceable. That\'s what the people who are in the
distribution channels are\--

DR. SOLLER Here, here.

DR. MAINE: \--interested in seeing.

MR. LEVITT: Thank you.

Just before I move on to Dr. Bowen, I think after we deal with Dr.
Bowen\'s question, I\'m going to ask one final one. I\'m going to tell
you what it is now, so you can also be thinking of it\--which is just to
go down the panel, rapid fire\--looking ahead a year from now\--and
I\'ll be asking all the panel this\--looking a year ahead from now, if
FDA could accomplish one thing in this area, what would it be? So you
can be thinking of that as Dr. Bowen asks her question. I don\'t mean to
distract from that, but I didn\'t want to hit you with that cold.

DR. BOWEN: Okay. I think this will be an easier one for you, compared to
what you have already been asked, and it\'s about, again, the safety
issue, and the adverse event reporting.

I heard that what you want is a prompt and complete notification system,
and clearly we also want that; and that want you want is an intelligent
system, once we have those AERs reported, in terms of feeding back what
we receive. What I\'m interested in knowing from you is: does industry,
since you prefer a voluntary kind of system\--does industry have general
SOPs in place that facilitate picking up adverse event reports and would
include something like literature reports and screening and surveillance
of not only your direct reports but anything else that you could find
out?

MR. LEVITT: Who would like to start? Dr. Soller?

DR. SOLLER: I\'m not going to represent that the industry is necessarily
consistent across all sectors, but at least my experience is that the
larger companies\--obviously, those with the resources for the
infrastructure\--follow AERs as a matter of survival in a litigative
world. That\'s a very clear driving force. And if you then say what
about, perhaps, smaller companies, or companies that are starting up and
so on, our experience on the OTC side has been as we have had to compile
AERs for your Non-Prescription Drug Advisory Committee over these many
years, is that we generally can account for the very large exposure of
the American public to a particular product. And if you\'re looking at
the inherent toxicity of a particular ingredient, that\'s what you
really need to drive for, as you think about whether it\'s voluntary or
mandatory; that you can really use a system that is able to derive from
the large exposure base, but not the entire exposure base necessarily.

I\'m not sure whether that helps in some of the thinking on where you
were going with this\--

DR. BOWEN: I think that helps somewhat from the OTC drug perspective,
and some of the people that are now moving into dietary supplements on
that side. But maybe from the food side\--the three in the middle\--the
four, I guess.

MS. HILDWINE: The food industry certainly has SOPs in place\--most
companies do. NFPA helps them\--helps set them up. We help educate staff
as to what to be looking for. And I would say that operations staff in
food company, as well as staff further down the chain, are very vigilant
in monitoring problems. A lot of food companies, as you know, have
consumer response centers, where they receive all kinds of responses
from consumers, including, in some instances, complaints and adverse
event reports\--at which point science kicks in. Because like all other
foods, the adverse events associated with dietary supplements may be
somewhat distal to ingestion. And so, at that point, it\'s very much
necessary to determine that the suspect is, in fact, associated with the
adverse event. Science does this. NFPA has been doing this for decades
to determine that, in fact, an adverse event is associated with the
suspect product, at which point companies then\--assuming a positive
finding\--companies then kick into their process to withdraw the product
from the market, or engage in a recall, and then if the Agency isn\'t
already involved, involve the Agency.

This is\--it\'s very clearly drawn out at NFPA. We have a publication
that helps companies set this up, and certainly we\'d be happy to make
that available to the Agency. I think you probably already have it, as a
matter of fact.

DR. DICKINSON: If I understood your question to go somewhat beyond,
perhaps, what the individual companies may do in the way of SOPs and
follow-up, I don\'t believe there is, on a larger, industry-wide basis,
or even on an association basis, the kind of tracking, perhaps, that
I\'m just hearing that NFPA has in place. And I think this is something
we could learn from NFPA\'s model to do that better.

DR. MACKEY: Certainly NutraSweet had an active adverse event reporting
process back in the \'80s that involved reaction to consumer call-ins.
We had physicians on staff to evaluate the claims, get back to the
callers personally. This is how some of our studies were\--on, for
example, whether aspertame caused headaches\--this is how some of our
studies were initiated; people who claimed that they had an adverse
headache after consumer our product.

Other companies certainly would do this for fat substitutes as well. We
have what we call adverse event reporting. We also have post-marketing
surveillance as to how much exposure are getting from our product; is
that within the safety that we\'ve established for the product? I think
that\'s another aspect that, in some instances, it makes sense to
undertake: just how much are people actually eating, versus what do the
data say is the safe level.

MR. LEVITT: Thank you.

Michael?

MR. FORD: Well, I\'m not sure I have a lot to add at the end here, but I
would agree with the assertion of inconsistency, at least, across the
industry. There is sort of an informal system out there that when the
distributors come to the health food store every week or two, and if
product has been brought back with a complaint, that complaint usually
will be voiced by the health food store retailer to the distributor. It
gets back to the company, and I think the companies do respond when they
see a problem with a product out there; they\'ll pull the product, or it
might affect the way the use directions show up on the label.

But it\'s very inconsistent, and it\'s quite informal.

MR. LEVITT: Okay. Thank you.

Well, in the spirit of us all trying to learn something from the meeting
today, I hope you\'ll take back the\--certainly\--feeling that\--the
example in the food industry, there is quite systematic approach that
maybe could be looked at by members from industry, too.

Okay. My last pop-quiz question: one thing a year from now. Rapid-fire,
please.

DR. MAINE: Id have to say that it is the\--whatever would\--it will take
to translate credible science related to these products into accessible
and meaningful labeling for consumers and health care providers.

DR. SOLLER: When I was growing up my dad always asked me \"What do you
want for your birthday?\" and I always said, \"Can I have two things?\"

But number one\--drawing from that\--and you wouldn\'t dis my dad, I
hope\--drawing from that, I would say an enforcement policy that removes
unsafe products from the market place and ensures truthful, not
misleading, and substantiated claims on dietary supplements. And,
secondly, because it will set up what you\'re going to do for the next
three to five years, a strategic plan, or a gaps analysis, that really
defines your resource needs.

MR. LEVITT: Thank you.

Regina?

MS. HILDWINE: A lot of what I mentioned had implications for
conventional foods, so I\'m going to rule all that out, and I\'m going
to say that a year from now I would really like to see that we\'ve
reached the close of a comment period on a proposed role on good
manufacturing practices for dietary supplements.

MR. LEVITT: Thank you.

Annette?

DR. DICKINSON: I would endorse the GMP as one of those but, like Bill,
I\'m going to take the opportunity to have a second one, and the second
one is a visible FDA presence, in terms of implementation and
enforcement, so that we deal with the outliers, and so that the
impression is not given that there\'s a vacuum.

MR. LEVITT: Thank you.

Maureen?

DR. MACKEY: Yes, I would say that there were consistently applied
standards; guidance from the Agency as to how to do that; how to affirm
the safety of your product and to substantiate it\'s claims.

MR. LEVITT: Michael?

MR. FORD: I want to read in the [Washington Post]{.underline}:
\"Year-long FDA Moratorium on DSHEA Regulation Promulgation Works.\" The
bill\--\"\'The Act is a good one when we enforce it,\' Levitt says.\"

\[Laughter.\]

MR. LEVITT: Okay. Very good.

Listen, I want to thank this panel very much. And if we can, I guess, in
an orderly way\--I wasn\'t here when you\--I don\'t know what you had to
do to get up here\--

\[Laughter.\]

\--but if we could exit that way and allow you to get off before the
next group tries to come up. But our next group is composed of Paul
Thomas, Tracy Fox, Mary Ellen Camire, Joseph Valentino.

\[Pause.\]

MR. LEVITT: Okay. While we are on logistics\--I mean, while we\'re
moving back and forth, let me do a couple of logistical things. I will
repeat this just before lunch, but in case anybody wants to leave before
I get to say this\--attendees who are not government employees, which,
looking around the room, is most of the people in the audience, who did
not get visitor\'s passes when you went to the building, if you want to
get back in after lunch you need to pick up a pass from the staff on
your way out from lunch. There are going to be only just the correct
number of passes for the non-government folks who signed in with the
guards. So if you want to get back in, you need to get your guest pass
so when you come back in it\'s an easier process. I will repeat that
later. But it certainly did serve a purpose, and allow our next group of
speakers to be seated. So I\'ll get a two-fer out of that.

Thank you. I suspect most of you were here at the beginning but, if not,
we\'ll ask to go five minutes per speaker. We have somebody sitting
right up here that will give you a one-minute warning and final,
friendly \"Time is up;\" and ask speakers to adhere to that as much as
possible.

Then we\'ll go down the list. Each of us will ask one question, and then
afterwards I give you a chance\--the \"year from now\" question, or what
do you want from your birthday a year from now, to use the Sollerism.

Okay. With that, our first speaker is Paul Thomas, Secretary of SNE.

**PANEL II - NUTRITION PROFESSIONALS; FOOD INDUSTRY**

DR. THOMAS: Okay. Well, thank you and good morning.

The 1,400 members of SNE acknowledge the growing role that supplements
play in American life. We also recognize the need for more authoritative
information about them so consumers can make more informed, sensible
decisions about supplement use. But we think that making such decisions
can be hard in today\'s environment. It\'s only natural that so many
people are confused about supplements, given the large number of
products available and the plethora of information from advertising,
product promotions, media reporting of single studies, and word-of-mouth
from sellers. It\'s hard even for experts to separate from the
pseudo-science without a good bit of digging.

SNE recommends that FDA consider adding a strong consumer research and
information component to its overall strategy on regulating supplements,
and we have three specific suggestions.

Number one, FDA should take the lead in conducting and encouraging
others to conduct high quality consumer research on supplement use. Last
year, FDA asked its Food Advisory Committee to help identify questions
to ask consumers about supplements in future surveys and focus groups.
FDA\'s Alan Levy stated that while half the population takes
supplements, very little is known about consumer understanding and use
of product labeling. He added that FDA\'s current research on
supplements focuses on who uses them, how many are used and reasons for
use, in a relatively simple kind of way: \"What do you take? What are
you using it for?\" \"I take echinacea for colds.\" \"Thank you.\" Dr.
Levy acknowledged that more research is needed where consumers are asked
their thoughts about supplements.

Now, we agree. Clearly more research is needed on how the labeling,
advertising and various promotions of supplements shapes consumer
perceptions of them and their willingness to try such products. We need
detailed studies, both qualitative and quantitative, and theory-based,
that explore how consumers come to decision about whether or not to
supplement, and details of the decision-making process itself. Do
consumers make meaningful distinctions between health claims and
nutritional support claims? Do they evaluate advertising copy and label
information in the same way or differently? What do consumers recommend
that FDA do to regulate supplements? The research needs to move beyond
simple surveys and a few focus groups.

FDA might use its Food Advisory Committee to help define the questions
that need to be asked, and do what it can to stimulate the needed
research. FDA might also develop a workshop or conference to get advice
from the scientific community on developing a more consumer-focused
research agenda on supplements, and we can, of course, provide you the
names of some Society for Nutrition Education members who might want to
participate.

Now, suggestion two. At present, supplement manufacturers do not have to
provide FDA with substantiation of their claims of nutritional support
for their products, even though DSHEA says the manufacturer must have
that substantiation that the claims are truthful and not misleading. We
believe that FDA should require that the evidence on which the
manufacturer is relying be provided to the agency and be made publicly
available. Then more claims of nutritional support might be investigated
by scientists, journalists and perhaps even FDA itself. The results, we
think, would help consumers become more savvy users of supplements.

Suggestion three. Consumers and health care professionals need easily
accessible and authoritative information about supplements without
having to search too many diverse sources, or to conduct their own
literature reviews. The Office of Dietary Supplements, for example, is
preparing fact sheets on some supplements. U.S. Pharmacopoeia has
produced short monographs on various botanicals. And recently, the
American Society of Anesthesiologists issued a warning about using
certain herbs before surgery. Authoritative information such as this
should be accessible from a single source that is very frequently
updated. The FDA or ODS Web site might be the right source. But
irrespective of placement, FDA could do more to encourage the
development of a central source of authoritative statements regarding
supplements, and then promoting it.

And, again, on behalf of the Society for Nutrition Education, I want to
thank you for the opportunity to comment on FDA\'s efforts to develop an
overall strategy for regulating supplements. Consumers need easy access
to good, authoritative information to make sensible decisions about
these products and more consumer research is needed to develop better
policies and regulations that will allow the dietary supplements
industry to thrive, but not at the expense of consumer misunderstanding
and confusing about the benefits and limitations of its products.

Thank you.

MR. LEVITT: Thank you very much.

Our next speaker is Tracy Fox, American Dietetic Association.

MS. FOX: Good morning. My name is Tracy Fox. I\'m a registered dietician
and a senior Federal regulatory manager with the Government Affairs
Office of the American Dietetic Association.

With over 70,000 members, ADA\'s mission is to serve the public through
the promotion of optimal nutrition health and well-being. ADA supports
the need for consumers to have access to dietary supplements as long as
their opportunity to choose is made in the context of a fully informed
choice and assured public safety measures. To this end, we continue to
stand behind the need for stricter regulation and oversight of the
dietary supplements, and applaud the efforts of FDA.

We congratulate FDA for holding this open meeting and soliciting input
from various organizations on the complex issues surrounding the
regulation of dietary supplements. We also urge FDA to look closely at
the recommendations made by the Presidential Commission on Dietary
Supplement Labels in November of 1997 to ensure that these
recommendations are incorporated effectively into FDA\'s overall
strategy.

In my oral testimony today, I\'ll highlight some of the key issues that
ADA urges FDA to consider as you proceed through developing a strategy.
My written comments provide much more detail in a number of areas,
including adverse event reporting, good manufacturing practices, and
significant scientific agreement. Copies of the testimony are out front
as well.

FDA has asked whether there are other objectives in addition to ensuring
consumer\'s access to safe dietary supplements that are truthful and not
misleadingly labeled that should be addressed in an overall dietary
supplement strategy. Frankly, if FDA accomplishes this and this alone,
given the relative limited authority it has under DSHEA, then the
strategy should be considered an enormous success. However, ADA
recommends that that statement\--\"ensuring consumer access to safe
dietary supplements that are truthful and not misleadingly
labeled\"\--should be the overarching goal of FDA\'s supplement
strategy. This goal would then drive the development of more specific
and measurable objectives to coincide with elements of the Center for
Food Safety and Applied Nutrition\--the elements that they have already
identified in the 1999 program priorities document\--as well as the
recommendations that were made by the Presidential Commission on Dietary
Supplement Labels. We also urge FDA to consider establishing an advisory
committee on dietary supplement comprised of multi-disciplinary,
well-respected experts to provide on-going counsel and guidance.

ADA agrees with the need to define boundaries between the various
categories of products in order to provide industry with a more
structured approach to marketing and labeling, and to provide consumers
with accurate information. The proliferation of claims on a variety of
products has created an environment of confusion and distrust among
health professionals and consumers.

Within the dietary supplement definition, we urge FDA to consider an
approach that delineates those supplements that occur naturally in
commonly eaten foods, and those that do not. Under this approach,
vitamins and minerals for which some form of requirements or formulation
standards have been established, such as by the Institute of Medicine,
or United States Pharmacopoeia, and about which there is a considerable
research base, would be in one category along with other known nutrients
or components of body function. Botanicals, like St. John\'s wort,
echinacea, as well as hormones, like DHEA and melatonin, of which less
is known, and therefore present unknown or potentially greater risk,
would be in a different category. The components in the latter category
would require more scrutiny or limits. This would also help the Center
in allocating resources and focusing on supplements that could present a
greater risk.

ADA continues to believe that health and nutrient content claims, as
well as structure and function claims on foods and dietary supplement
should be based on the totality of publicly available scientific
evidence, including results from well-designed studies conducted in a
manner that is consistent with generally recognized scientific
procedures and principles. DSHEA, as well as the 1997 Food and Drug
Administration Modernization Act, did not change that overarching public
health need. To this end, we urge FDA to expeditiously outline criteria
on characteristics for significant scientific agreement. This will help
the public, consumers, researchers and certainly the industry itself.
And my written comments go into much more detail about the components of
significant scientific agreement and some ideas.

ADA, like the Society for Nutrition Education, supports the need for the
contents of manufacturers\' substantiation files to be more readily
available\--to FDA as well as health professionals, researchers and
consumers. How can consumers make informed choices, or health care
professionals be knowledgeable about products, if the only information
available is what\'s contained on the supplement label\--equivalent in
size to a 3x5 inch index card. In addition, when claims are made for
supplements and the research base includes a particular formulation,
then the product making the claim must use the same formulation. That\'s
common sense.

I see my time is up. I think some of the other areas, including
communicating to consumers as well as research needs and the research
area, we would certainly support more research into basic supplement
research itself, in terms of the bioactive components and the mechanisms
underlying the action of the supplement. We also support the need for
additional consumer research. We need to understand their attitudes,
purchase decisions, usage behaviors, and sources for dietary supplement
information.

Again, thank you for the opportunity of allowing ADA to testify, and we
certainly urge FDA, as they struggle with developing a strategy, to
think of consumers first and foremost in implementing a strategy and,
again, to take a look at the recommendations by the Presidential
Commission. And we look forward to working with FDA, other government
agencies, the private industry\--food industry, supplement industry\--in
reaching the ultimate goal of providing safe supplements to consumers.

Thank you.

MR. LEVITT: Okay. Thank you very much.

Our third speaker on this panel is Dr. Mary Ellen Camire,
IFT\--Institute of Food Technologists.

DR. CAMIRE: I\'m Mary Ellen Camire, and I\'m an associate professor in
the Department of Food Science and Human Nutrition at the University of
Maine, and I\'m speaking here on behalf of the Institute of Food
Technologists, which is a non-profit scientific society with about
28,000 members working as food scientists, food technologists and in
related professions, in academia, industry and government positions. We
will be submitting written comments later in more detail; particularly
academicians like myself like to take a little break in the summer. But
we\'d like to make three main points today.

We think that some clarifications that will be key to FDA\'s overall
strategy will be making clear distinctions between foods and dietary
supplements. There is a great deal of confusion I think, both for
manufacturers and consumers at this time. You can walk into stores and
see soups and teas that are clearly marked \"Herbal Supplement\" on
their front package panel. They contain a supplement facts panel
containing nutrition information. Is this enough information for
consumers to know if it\'s a food or a supplement, when it looks and it
appears in every other respect like a food. It\'s not clear. And this is
what the consumer research will be very important.

Many food products, and particularly we\'re seeing this in snack foods
and beverages, are adding botanicals and other dietary supplement
ingredients to conventional foods, but maintaining that food identity,
keeping the nutrition facts panel. So you may have a tea which is a very
traditional way of taking botanical ingredient, but add St. John\'s wort
or another herb, and then it\'s up to the manufacturer to decide are
they inclined to market it as a dietary supplement or as a food. In some
cases the packaging is the only distinction that the ingredients may be
exactly the same. And I think that\'s very confusing to people,
particularly small food manufacturers like we have in Maine.

In order to prevent unnecessary research and development expenditures
which may be exceeding possibly millions of dollars at this point for
food products that contain added dietary supplement ingredients, it
would be very helpful for FDA to issue a talk paper or similar vehicle
to explain to food manufacturer how these ingredients can be
incorporated, and what the distinctions between foods and dietary
supplements are.

The second issue we\'d like to address is to urge FDA to assign priority
to finishing up unfinished business; that final rules or to let people
know rules will be issued on issues that have come up in the past and
need to be taken care of. In particular, the advance notice of proposed
rule-making for ephedra-containing supplements was issued over two years
ago, and IFT strongly made comments over four years ago regarding the
safety of ephedra supplements.

In addition to working on that one, which I think is important in terms
of preventing any additional deaths, while maintaining access for the
people who are using these supplements responsibility and do use it in
the traditional fashion, we also need to make sure that there\'s rules
coming out\--forthcoming\--on good manufacturing practices and though we
don\'t totally agree maybe with some of the proposed ideas regarding
structure/function claims and the definition of disease, that closure
needs to be brought to that subject as well.

Finally, we\'d like to recommend formation of dietary supplement
advisory committee, though I\'m going to amend my remarks, given the
discussion we\'ve had this morning that some form of advisory group is
needed, maybe not in the traditional sense; scientists with expertise in
botanicals, particular, but also other dietary supplement ingredients,
could provide very important and valuable assistance to FDA in what has
become a great deal of research burden for FDA scientists. The Food
Advisory Committee thus far has done an excellent job working with ad
hoc groups, but we think additional assistance is needed, and this may
help reduce some of the workload involved with dietary supplements. And
although the formation of such a committee was not outlined in the CFSAN
priorities, I think perhaps it should be added.

Thanks.

MR. LEVITT: Thank you very much.

Our final speaker on this panel is from the USP, Joseph Valentino.

MR. VALENTINO: Thank you for this opportunity.

The United States Pharmacopoeia is a unique organization. We\'re a
non-profit standard-setting body, and we publish the USP\--the [United
States Pharmacopoeia National Formulary]{.underline}\--and these are the
only non-governmental pharmacopoeia in the world. It\'s because of this
uniqueness that I never know where we\'re going to be placed on a panel.
So today, I guess, either I\'m a nutritional professional or a member of
the food industry.

Because of time constraints, I\'ll address the questions posed in the
[Federal Register]{.underline} in our written, but I\'ll try to use my
time today to focus on a specific area that we believe needs attention
by the Agency.

The United States Pharmacopoeia promotes the public health by
establishing and disseminating officially-recognized standards of
quality for the use of medicines and other health care technologies. In
1995, based on concerns about the safety, quality and use of dietary
supplements, USP members\--about 400 organizations\--adopted a
resolution to provide standards for these products. Over the past four
years USP has begun developing monographs in the National Formulary for
those botanical-based dietary supplements that account for about 90
percent of U.S. retail sales. This is approximately 24 botanicals, and I
have a chart in my handout which indicates the status of the progress
we\'ve made.

These monographs contain standards of identity, strength, quality and
purity, and there\'s even a chapter on manufacturing practices for
nutritional supplements. Compliance with standards in the official
compendia the USP and NF would help eliminate the reported problems
involving potency variations and product contaminations.

The Federal Food, Drug and Cosmetic Act indicates that dietary
supplements purporting to conform to the standards of the official
compendia must do so, or they will be considered misbranded. FDA should
take regulatory action against those products which purport to meet USP
or NF standards on their label and that fail to do so. Further, the FDA
should take advantage of this provision regarding dietary supplements
and the USP-NF recognition in the drug provisions of the Food and Drug
Act, by recognizing USP standards and NF standards and methods of
analysis in their regulations, and encourage their use by industry to
ensure the potency and purity and ultimately the safety of dietary
supplements. We would also welcome the participation in the development
of these standards and analytical methods by FDA.

Compliance with USP or NF standards would provide for uniform
designations of identity and strength on labels, and would allow
consumers to make meaningful selections of products and be assured of
their performance.

Now, in order that consumers not be misled, USP recommends that FDA also
carefully review labeling that inaccurately implies compliance with USP
or NF standards, or contains statements that are false or meaningless,
or designed to mislead consumers as to the quality of the product.
Included among these statements are\--quote\--\"standardized\" or
\"meets laboratory standards,\" or some that even say \"meet USP
dissolution standards.\" The first two statements do not provide useful
information to consumers. And even the third may be misleading if the
product is not in the USP or NF; or, if it is, and it meets the USP
dissolution standards but it fails to meet the other quality standards.

In conclusion, let me say that USP looks forward to working with the FDA
to assure the quality of dietary supplements in the marketplace.

MR. LEVITT: Thank you very much.

Again, we\'ll go through the same process we did before. I\'ll start
with a question and we\'ll proceed right down the row.

My question is on the issue of substantiation of claims. A couple of
speakers addressed that to some degree, and my question is where would
you put, in an overall priority, the substantiation issue on claims,
compared to some of the safety issues that have gotten also a lot of
comment already today\--primarily the enforcement; the AERs, the GMPs
and so forth. I think everybody agrees substantiation is needed, but
where do you think that fits in the hierarchy, in terms of urgency?

Please?

DR. CAMIRE: Well, I think we have to maintain safety as the number one
priority, but substantiation is important, particularly given the NPR
survey that came out this year that said more than half of Americans
surveyed didn\'t feel that the claims that were on dietary supplement
labels were really accurate, to paraphrase them.

So I think that\'s important to consumers that hey have some confidence
in what\'s on the label. But I think we don\'t have the framework yet to
be able to make those recommendations and that may be a longer-term
goal; within the next three to five years.

MR. LEVITT: Good. Thank you.

Tracy?

MS. FOX: Again, I would have to agree\--we can\'t say safety is going to
be second, and substantiation first. However, I do think that
substantiation is absolutely critical. If there can be two top goals it
would be safety, clearly, and substantiation. Because if FDA is going to
adhere to the strategy of making sure that consumers are not misled,
then that is substantiation, and that is also safety. And I think that
is absolutely critical.

There are many claims out there, on many different types of products,
and I think we need to rein that in and really get a feel, as health
professionals, what we can be telling consumers.

MR. LEVITT: Thank you.

Anybody else want to address\--it\'s optional.

MR. VALENTINO: I was just going to say that I\'ll limit my remarks to
the standards aspects, and I think that the\--it\'s important that the
claims being made regarding the standards and the quality of the product
be substantiated, and that FDA take a separate look at that.

DR. THOMAS: And I would just concur, as well, that safety probably
first, but substantiation of claims is a very close second. And, let\'s
face it, consumers are deciding whether or not to take particular
supplements largely on the basis of hoping for some kind of effect. And
what is on the label is probably\--and also in advertising\--is probably
a major source of information for them in their decision-making process.
And, unlike with foods that you might eat because they taste good,
they\'re crunchy\--you know, that sort of thing\--you\'re taking dietary
supplements for specific health-related types of effects, and here the
labeling and the information that is available about them is critical.

MR. LEVITT: Okay. Thank you very much.

If I could pass the microphone over to Margaret Porter.

DR. PORTER: My question is a follow-up to something that I think I heard
Tracy Fox say, which is suggesting in that as we tray\--the Agency tries
to figure out how to set priorities, that we may want to consider
looking at the universe of dietary supplements and drawing distinctions
among the categories. And I think I understood you to say that with
respect to dietary supplements that might be naturally occurring in
commonly eaten foods, perhaps we ought to consider giving a lower
priority, or a lower attention to those products; and that with respect
to botanicals and hormones, that we might apply a higher scrutiny. And I
was wondering if I heard you right and, if so, if you might elaborate on
the basis for that recommendation, and also what the other panelists
might care to comment.

MS. FOX: You did hear me correctly, in terms of\--within the definition
of dietary supplement as FDA undertakes the very difficult task of
defining the boundaries, I think because we all recognize there are
limited resources. We also all recognize that there are very safe
products out there, and very\--with a very good research base. And I
think you need to draw the line somewhere. This is just a consideration.
It\'s clearly very preliminary; it\'s something that as we were
struggling with trying to identify, within our own minds, the boundaries
and the definitions, that this is one approach that I think is worthy of
further discussion; not necessarily drawing the line very clearly. I
don\'t think that\'s going to happen. But I think it\'s at least a
gradation approach, in terms of trying to identify those products that
we really don\'t know much about but for which\--are out there in the
marketplace, consumers are purchasing them and taking them, and we
don\'t have a strong research base for them.

So that is one approach that I think is worthy of consideration and
further discussion.

DR. PORTER: Is there anybody else who\'s interested in commenting on
that?

DR. CAMIRE: I\'d just like to say that in regards to the research
priorities, I think it ties in that this is an area we need more
research, and I agree that we have a little bit more comfort level with
things that are derived from foods and culinary herbs, but we\'re not
sure how processing many of these components: when we do an alcohol
extract, when we freeze-dry, when we isolate individual components. And
we don\'t know how that effects the efficacy and the safety of those
isolated materials. And that certainly could be something for CFSAN to
consider as a research area.

MR. VALENTINO: I was going to say, from our perspective, we\--obviously,
if there\'s an inherent toxicology problem with a substance we\'ll try
and set standards for it. But we say items are \"safe.\" They\'re safe
if what we think they are. But if you can have something with not an
inherent adverse effect but yet if it\'s contaminated with pesticides or
some other impurity, or it\'s transformed somehow, that article is no
longer safe. So what we have done is we\'ve given priority to attempting
to cover as many products on the market\--the largest percentage on the
market that the people will be taking\--with this in mind.

DR. THOMAS: And I would agree with both Tracy\'s recommended protocol
and Joe\'s statement, as well, that you take into account the\--perhaps
the naturalness, the familiarity of the different types of supplements
as a set of criteria, but also, probably, as important, is the number of
people that are taking particular kinds of supplement, as perhaps
measured by sales volume is one measure.

MR. LEVITT: Okay. Thank you very much.

Bill Hubbard.

MR. HUBBARD: As you know, one of the provisions of DSHEA differentiated
so-called structure/function claims from disease claims.

The earlier panel was fairly critical of the proposal we did on that
issue recently, but yet they were also urging us to act against
unsubstantiated claims.

Do you have any views on that proposal? The structure/function proposal?
Are you familiar with it?

MS. FOX: Yes.

DR. THOMAS: Well, I\--I\'m sorry.

MS. FOX: Go ahead.

DR. THOMAS: I\'m familiar with it personally, but as far as the Society
for Nutrition Education goes, probably most of its members and its Board
has not evaluated it, so I wouldn\'t be comfortable in speaking for them
on that particular proposal.

MS. FOX: ADA did provide comments on the proposed structure/function
claim rule, and I believe we\--I think we generally support the
definition that FDA proposed of disease. And, certainly, while we agree
with the need for guidance in the area of structure/function claims, I
think that is one of the most difficult undertakings in terms of trying
to really grapple with the complex issue of what is a structure/function
claim and what is a disease claim. And I frankly think that that\'s
where the consumer research is needed, because I don\'t think consumers
really know the difference between\--or really\--not that they don\'t
know the difference between it, but I really think they can easily
extrapolate from the structure/function claim to\--perhaps
inappropriately, to a disease claim. And I think the consumer research
base is probably going to need to be there much more strongly in order
to really handle that issue effectively.

Any other reactions to that?

Okay. Dr. Yetley?

DR. YETLEY: Either explicit or implicit in many of your comments was the
need for research and sound science to back up a lot of the issues.
You\'re all members of professional associations. What ways can your
associations help us leverage research expertise and actual funding for
research projects?

DR. CAMIRE: Well, I\'ll address that, since I\'m incoming chair of
IFT\'s research committee and nutrition division.

I think that IFT, in particular, because we have people working in the
food industry, in the dietary supplement industry, and food scientists
as well as nutritionists, we\'d be happy to provide expertise and to
help point out individuals who may have expertise that FDA does not
have. I think it\'s also important for us to make sure that you have
adequate funding, and I think the last panel addressed the need for FDA
to tell us what you\'re going to need in order for us to help get
funding so that you\'re able to adequately do your research.

MR. VALENTINO: In April of next year the USP convention will be meeting,
and they will be electing an expert committee on dietary supplements.
And it may be that we should explore ways on how the FDA can utilize and
get opinions or decisions or whatever from this expert committee more
than they do now. Right now you have an ad hoc reviewer that sits in at
the meetings and learns from their deliberations, but there may be
something more formal that we can do with the Agency so that you can
take advantage of this expert group.

MS. FOX: I think also as FDA establishes kind of its research agenda in
terms of the types of research needed, it would be beneficial to
establish, or to really closely look with industry, with scientists,
with researchers, to look at creative funding mechanisms as well;
funding mechanisms that can take advantage of, I think, the experts and
the resources in the industry arena, and tap into that to focus
research, as well as develop strategies, that it can be very
complementary in terms of being as objective as possible, yet still
tapping into the resources and the expertise of the industry.

MR. LEVITT: Okay. Very good.

Dr. Bowen.

DR. BOWEN: Okay. This is a somewhat more directed question about
research.

Three out of four of you mentioned consumer research should be an FDA
priority. And I\'d like for you to comment\--each of you\--on FDA\'s
role, what that should be. Should it be to encourage the research? To
ask for it? To actually do the research? And, in your opinion, what do
we need to know from consumers?

DR. THOMAS: Well, I think I presented some of those research needs in my
statement, but I certainly think that FDA needs this kind of research;
at the very least, should be asking for it; certainly should be
encouraging it; and, to the extent that it can, given its limited
resources, actually undertaking it. And, certainly, under Alan Levy, you
have made some good moves in that direction and have raised some
interesting issues with the focus groups and questions that prompt
additional kinds of questions and research needs.

I think we need more knowledge of consumer behavior regarding
supplements in terms of the sources of information that they use; their
evaluations of labeling information and advertising claims, and how that
affects their decision-making process\--their general sense of the
potential usefulness of dietary supplements.

I also think it\'s probably a good idea that more effort be made,
actually, to find out what consumers think FDA\'s role should be in the
area of dietary supplements and its regulation. And probably this isn\'t
for FDA alone, but also for consumer input related to decisions
regarding policies within the Federal government as a whole, including
Federal Trade Commission, for example. And I think this kind of
information is really very critical for FDA and other agencies to
develop effective public policies in this area that respond to perceived
consumer needs, and that are likely then to be better liked and
appreciated because of having had the opportunity of input rather than
what is often, typically, the case, where we have a variety of, you
know, industry, professional societies, etcetera\--the usual group of
people that generally comment in forums such as this and to proposed
regulations. They need to be asked more directly.

MR. VALENTINO: I was going to say that the USP just recently conducted a
study as to what is considered \"useful information\" for patients,
relative to the patient inserts for medications. And this was done in
conjunction with Duke in North Carolina. And it may be that we could
develop another program which could tack onto that, and would be
considered useful information relative to dietary supplements.

MS. FOX: I think also there\--since the use of dietary supplements is
growing so rapidly, some of the government survey instruments have also
been modified, or I know there are plans for modifying some of those
large-scale instruments to capture this important information from
consumers. And I think efforts in that direction should be increase as
well. There might be some opportunities with CDC behavior factor
assessment survey. There might be some really good opportunities to,
across the board, capture some very basic information, even just on
usage; how consumers\--what they view the label as, in terms of dosing
requirements.

There was a recent article in the [Journal of the American Dietetic
Association]{.underline} that found the majority of high school students
exceeding dosage on a very regular basis for supplements, of course,
that were recommended by their coaches. And I think this is the kind of
information that we really need, and we need more of. And I think there
are some opportunities in existing survey instruments. UPS does one. ADA
does a trend survey. These are really good avenues to take a look at, as
well as government surveys.

DR. CAMIRE: And I\'d like to echo Tracy comment that I think it\'s
important to encourage collaboration on this issue. USDA and ODS, CDC;
FTC has done some excellent work in this area\--their study on how
consumers responded to qualified health claims and advertising. It could
very easily be reworked into looking at structure/function claims on
dietary supplements.

But I think it would be also important to look at how consumers respond
to that disclaimer, and to see if that is really helpful or not, because
that does take up, you know, valuable space on the package label, and to
find out really\--my personal sense is that people disregard the
disclaimer and they are, indeed, using the supplements to treat or
prevent a disease. And if, in fact, that is how the public is using
them, then we may need to re-think about how we provide these claims on
the package labels.

DR. BOWEN: Thank you. I think those suggestions are very helpful.

MR. LEVITT: For our one last final question\--you heard before\--a year
from now, if there was one thing that could be accomplished, that would
be?

Dr. Thomas\--we\'ll move right down the row.

DR. THOMAS: Well, again I think that we will have significantly more
knowledge of consumer behavior regarding supplements, and maybe a
workshop or a conference with a broad group of people to help set a
research agenda.

MR. LEVITT: Mr. Valentino?

MR. VALENTINO?: I think I\'d like to see a joint USP-FDA committee
formed, and that they be charged with three things: one, that we develop
an active working relationship in the standards area, where you comment
and we develop standards, not only for the materials but for the
extracts, and for the dosage forms, and the development of reference
standards. That\'s very important in this area.

Two, I think the committee should be charged with exploring with USP
cooperating with our practitioners reporting programs. We do operate
practitioner reporting programs in which we make information available
to the FDA and the industry now, and we may be able to work off of these
programs and cooperate with you on that.

And then the last point was the one I made previously. I think that
they\'d be charged with exploring how the FDA could utilize the
decisions of the USP advisory panels in their decision-making.

MR. LEVITT: Thank you.

Tracy?

MS. FOX: To not have to testify at any more FDA hearings\--

\[Laughter.\]

MS. FOX: \--on this issue, because it\'s all been resolved.

Actually, I think probably the two main areas are\--I\'d have to say
safety first, to make sure that the system in place in this country
provides assurances to health care professionals and consumers\--and I
think it\'s important to say \"provides assurances,\" because I believe
for the most part the system is safe, in terms of the manufacturing of
supplements, but I think more importantly, consumers need to feel
comfortable, and so do health care professionals.

And I think the next phase would be claims substantiation. I think
that\'s a critical first step in educating consumers, and educating
health care professionals on the effective, ineffective, appropriate,
inappropriate uses of supplements.

MR. LEVITT: Thanks.

And Mary Ellen.

DR. CAMIRE: I\'d obviously like to see final rules on the
ephedrine-containing supplements, and I\'d also like to see more
supplement companies feeling comfortable putting contraindications on
their product labels.

MR. LEVITT: Okay. Thank you very much.

Before I let you go down, let me just take a couple minutes on
logistics.

First, not to scare anybody, but we\'re on schedule.

\[Laughter.\]

Before people leave, there are three quick announcements that I need to
make. One is, as I said before, if you\'re not a government employee,
and you did not get a visitor pass, on the way out, if you want to get
back in easily, please get a visitor pass on your way out. That\'s
number one.

Number two is that in your package you do have a green sheet that looks
like this, that lists some convenient places for lunch that you can get
to an back in an hour.

And, number three\--and I\'ll repeat this again after lunch, but in case
there\'s some people that are not coming back\--with regard to the
meeting in July in California, we had provided a contact in the [Federal
Register]{.underline}: our public affairs specialist, named Janet
McDonal, and we had provided a phone number and a FAX number. Under
Murphy\'s law, some people have had trouble getting through on the phone
and/or the FAX, and I would like to provide, in addition, an e-mail
contact, which is JMcDonal\--without the D at the end, for some
reason\--so that\'s JMcDonal@ORA.FDA.gov. Again, that\'s
JMcDonal@ORA.FDA.gov for interest in the California meeting. And again
what we\'re hoping is we\'ll get different speakers. The goal is not to
see if the same speakers can fly out to California and repeat the same
presentations.

\[Laughter.\]

MR. LEVITT: No word that Tracy will do that\--but we\'re hoping to get a
different mix of people so they didn\'t have to fly east.

My watch, it says that it is 12:20, so we will begin\--try to begin
promptly at 1:20 back in this room.

I thank you very much. Thank you to the speakers. And, Tracy, thank you
especially for coming back twice in a month.

\[Luncheon recess.\]

MR. LEVITT: It being 1:20, we are able to get going. I actually looked
around and said, \"Oh, we can\'t start yet, the next panel isn\'t up
there.\" I just hadn\'t invited them up yet.

So, again, for those that were not here this morning, my name is Joe
Levitt. I\'m Director of the Center for Food Safety and Applied
Nutrition, and we are part way through out open public meeting on
looking at an overall framework for the regulation of dietary
supplements.

I have a couple of announcement\'s that I\'ll either repeat or make for
the first time, while we have everybody back and attention.

Number one, at the end of the day\--at the end of the day, we will
provide some time for members of the public who did not have an
opportunity to schedule time in advance\--if you want to speak, we ask
you to sign up outside at the registration desk. We do have a couple of
people that have signed up. We would try to limit these presentations to
about three minutes each, as the hour will be late by then but we do
want to give you an opportunity, if you\'ve traveled specifically
because you wanted to make a presentation. So you sign up for that
outside the door at the registration table. And we will come back to
that later.

Second, I just want to repeat that for those that are interested in
having information about the meeting in California on July 20th, again
it\'s a repeat meeting. We\'re asking the same speakers not return and
make the same statements again, but the [Federal Register]{.underline}
notice does provide a contact in California. Her name is Janet McDonal.
She\'s actually here\--or was here a second ago\--right up here in the
back. The [Federal Register]{.underline} has her phone and FAX number.
In addition, her e-mail address\--because the others have been so
difficult in getting through\--is JMcDonal\--it\'s like JMcDonald
without the D at the end. If you include the \"D\" you\'re going to have
trouble\--@ORA.FDA.gov\--and the ORA is because our field offices are
under the Office of Regulatory Affairs at the FDA.

I also need to make an announcement for one person that we\'re not sure
we can find in the audience, from our Chief Counsel\'s Office. Alexis
Barnett, if you\'re here, you have a conference call at 1:30.

\[Laughter.\]

Sorry to have an embarrassment if that occurred, but I was handed a
note, so I thought maybe I should read it.

With that, let me welcome everybody to the afternoon session. For those
who were not here this morning, we are engaging in a public dialogue on,
really, how to stake a step back, four years after DSHEA and say \"How
are we going to develop a long-term blueprint to make this law work and
fully implement it?\"

We\'ve talked about a lot of issues so far. We have divided the day up
into several panels. There is an agenda that is orange that all of you
have out here, and I think, without further ado, we will invite the next
panel up.

We have three people on this. The first is a representative from the
National Woman\'s Health Network, Adrian Fugh-Berman. Second is Citizens
for Health, James Turner. And the third is Center for Science in the
Public Interest, Ilene Heller. If the three would please come up and
join us at the table, we will go through and ask each speaker to make a
five minute presentation in the order that I\'ve just described. It
looks a little different when you\'re up here, but we have a young lady
sitting in the front row who will give you a one-minute warning and a
final time. And we do ask you if would adhere to that. We had terrific
compliance this morning with that, and it\'s very helpful in moving
along.

We will then go through and each member of the FDA panel will ask one
question, and at the end of which I\'ll ask one final question, which I
have telegraphed in advance, which is: A year from now, if there was one
thing that you would like to see occur, it would be\--blank.

And, with that, let me invite Dr. Adrian Fugh-Berman\--if I have
pronounced your name correctly. If not, please correct it for me\--from
the National Woman\'s Health Network.

**PANEL III - CONSUMERS**

DR. FUGH-BERMAN: Good afternoon. Pleasure to be here.

My name is Adrian Fugh-Berman, and I\'m Chair of the National Woman\'s
Health Network, which is a national consumer advocacy group that takes
no money from drug companies, medical device manufacturers or dietary
supplement companies for that matter. I also integrate herbal medicine
into my practice, and am a consultant to the Federal Trade Commission on
dietary supplement issues, and a member of the ad hoc panel on
botanicals for the U.S. Pharmacopoeia. And I teach about botanicals all
over the country.

It\'s a women\'s health issue because more women than men use
alternative therapies. And there is a plethora of dietary supplements
that are specifically marketed to women. They\'re very popular with
consumers. They\'re also very popular with physicians. I\'ve just come
from Columbia\'s Botanical Conference last week, where it\'s a whole
week-long course\--CME course\--where we teach physicians about
botanicals.

The current available of unregulated products that are widely divergent
in quality, safety and evidence of efficacy really raises a number of
public health concerns. Consumers have no tools or guidelines with which
to assess a product\'s quality. Labeling is very vague;
contraindications aren\'t\' listed; drug interactions aren\'t listed.
And there are some dietary supplements that should just not be on the
market at all. I have\--comfrey contains pyralizidine alkaloids with
proven hepatotoxicity. There is no reason for this herb to be on the
market. DHEA and melatonin are very potent hormones that are not part of
any sort of traditional medicine. They shouldn\'t be considered dietary
supplements. They shouldn\'t be on the market.

I would disagree with the speaker this morning who would put together
herbs or botanical medicines with these hormones. They\'re very
different things. And the National Woman\'s Health Network would
definitely support having an advisory committee on dietary supplements.
I would emphasize, however, that it would be very important to have at
least half of those members be conversant with botanical medicine. Herbs
are quite different from other sorts of dietary supplements, and really
need to be regulated differently. They span the whole spectrum, from
foods to drugs, and it\'s really important to integrate people who are
familiar with these.

I\'ve forgotten to say that this testimony was prepared by myself and
Dr. Varro Tyler, who is one of the most eminent pharmacognicists in the
country. And it\'s one of the expertise\--it\'s\--FDA needs to integrate
pharmacognicists into this discussion. There are very few
pharmacognicists working in the FDA, and those that are there are mainly
sort of banished to the laboratories, and they really need to be
incorporated into all levels of these.

Even\--science supports the use of many alternative\--of many dietary
supplements: St. John\'s wort to treat depression; garlic to lower
cholesterol; folic acid to reduce the risk of neural tube defects, but
even in these cases, labeling these to reflect caution. Garlic can
inhibit platelets and can cause bleeding; folic acid shouldn\'t be used
with certain drugs; St. John\'s wort can cause photosensitivity. It
shouldn\'t be combined with certain anti-depressants. So it\'s really
very important that labels be accurate, be understandable and have
adequate warnings on them.

It\'s really important not to ignore work that\'s already been done.
There\'s quite a lot of research on botanicals. There\'s quite a lot of
research on chemical characterization of botanicals; on quality-setting
for botanicals. Much of this has been done in other countries, but
there\'s no need for us to reinvent the wheel. And I think one of the
systems that we could use as a model is the Commission E, which is the
body in Germany, an independent panel, that assessed more than 300
botanicals and determined whether there was evidence of efficacy and
safety. Those monographs have recently been published in English.

So FDA\'s first priority should be safety, quality and efficacy of
dietary supplements. Unsafe dietary supplements should be removed from
the market. And, really, the quality issue is the most important one
besides\--the next most important thing besides safety. The limitations
of structure and function claims have been extremely confusing to
consumers. It\'s caused manufacturers of both worthy and unworthy
products to really resort to subliminal messages and word games.
There\'s no reason that people should not be able to make a claim when
there is adequate evidence, but there is a lot of misleading labels out
there, and we feel it\'s really important for FDA to go after labels
that are already out there on the drug store shelf.

This is \"Brain Gum,\" which \"improves name and face recognition; helps
in recalling telephone numbers, and improves recalling the locations of
misplaced objects.\"

\[Laughter.\]

There is a number of these \"breast health\" formulas; this is
\"Women\'s Breast Health,\" \"Everywoman\'s Breast Basics.\" These do
everything except make a specific claim for preventing breast cancer.
This, for instance, has a picture of a pink ribbon on it, and says \"A
portion of these proceeds goes to support cancer research.\"\--\"Breast
health is the number one concern of women. This formula contains the
patented compound glucurate which has been shown to enhance the major
cleansing pathways in the body, helps the body rid itself of pollutants
and foreign elements not conducive to breast health.\"

This company gives money to the \"Breast Health Project\" \--

\[Laughter.\]

\--and says that \"Our herbal extracts are potency
assured\"\--trademark. Potency is one of the many terms that really
needs to be regulated\--that these terms on these labels really need to
be regulated. \"Standardized\" can be used for anything; \"potency\" can
be used for anything.

I\'m out of time, but I just wanted to say that you do have a lot of
power on the labeling right now, and there\'s a lot to do on products
that are currently marketed. We want to get unsafe products off the
market and products with misleading claims should also be off the
market. Thank you.

MR. LEVITT: Thank you very much.

Mr. Turner?

MR. TURNER: My name is James Turner, and I\'m Chair of the Board of
Citizens for Health.

Citizens for Health was very much involved in t\\passage of DSHEA;
generated a significant number of the million signatures that were sent
to Congress, and has been one of the contributing plaintiffs in the
[Pearson]{.underline} case; and also generated 175,000 comments to FDA
on its structure/function proposal.

We felt very strongly that changing the definition of disease was not
contemplated by DSHEA, and we also feel very strongly that that
regulation should be withdrawn, and suggest that any difference between
the definition of disease prior to the passage of DSHEA and now would
consider to be something worthy of further legal action.

Citizens for Health is committed to the four basic rights of consumers
that were announced by President Kennedy in 1962: safety, choice,
information and participation or access. We believe that the construct
of the issue for dietary supplements is that choice and safety are in
tension, and information is the primary tool that can help us balance
those in an effective way.

And so in virtually all instances where Citizens for Health has
participated in a public debate, it has been about enhancing the
information available on a product\--in this case, the product category
of dietary supplements. So we believe that the number one thing to do is
to work vigorously on information issues.

I\'ve been involved in FDA issues since 1968. I\'ve been involved with
the Food Safety Council, which was a group of consumer and industry
people, to work on food safety questions in the NANDA dietary supplement
area, and I was involved with the nutrition dialogue that was set up
between industry and consumers on nutrition labeling. We believe
strongly that that kind of a process would be extremely useful
here\--again, focused on information\--to help us work our way through
the choice-safety dichotomy, or the choice-safety tension.

Specifically, we are extremely concerned that FDA\--we would like FDA to
refrain from arguing that it does not have authority over regulating
dietary supplements. It has a lot of authority that has not yet been
used. We are strongly in support of working on good manufacturing
practices regulation. We believe that\'s very important. We think that
the adverse reaction report on dietary supplements needs to be greatly
improved. And we would like very much to see a process like the ones
I\'ve mentioned be used to do that. There is a major role for all of the
stakeholders to be involved on an ongoing basis in working out what we
believe are the crucial issues here: information strategies.

Specifically, we feel\--and urge\--that the FDA not appeal the
[Pearson]{.underline} case. We don\'t see any need to do that. We
believe that you could move forward and do the definition of
\"significant scientific agreement\"\--again, in the kind of process
I\'m suggesting, and develop a caveat program; something that will say
the kinds of comments about the use of information that is not
definitive, as the court suggested. We think it\'s an important aspect
of working out how information can be used in this field.

In the 30 years or so that I\'ve been working on these issues, I\'ve
heard repeatedly, from day one, the concept that everything is not black
and white; that FDA, or anyone else, can\'t draw a line and say \"all
the things on this side are good for everybody, all the time, and all
the things on this side are bad for everybody all the time. It can\'t be
done.\" There\'s an area where some things fall\--they\'re always good
for everyone. And there\'s an area where some things fall, and all
things are bad for everyone. But there\'s this large area in the middle.

In my experience and observation, both in studying the history of FDA,
and being involved with it specifically since 1968, there has been a
tendency on the FDA in dealing with dietary supplements to group all
questions that are in the gray area\--and to treat all questions that
are in the gray area as if they were in the black area. That is the
source of almost all of the difficulty that has gone on, actually, since
at least 1962, and perhaps before, in the FDA\'s activities. It\'s been
a\--it\'s an enormous, costly, unpleasant social battle that\'s been
under way.

And I\'m going to take\--I\'m going to answer your last question right
now and say what I think I would like to see as the outcome of the
year\'s worth of work. And that is that the contentious battle that has
been going on between a segment of the public and the FDA be moved away
from the courts, and away from the Congress, and into processes where
all of the balancing of choice and safety can be worked through, and a
process that will allow all the stakeholders\--consumers, producers,
health groups, individuals\--to be involved in shaping how we are going
to talk about this category. And as Dr. Fugh-Berman has said, the
category contains all kinds of things in it. So we may have to do a lot
of different kinds of modulating and so forth.

But we believe very strongly that an information strategy that preserves
choice and preserves safety is the goal that we should work toward. And
the courts and the Congress are refined enough to make those kinds of
subtle choices without the help of the kind of process that I\'m talking
about with the participants I\'ve mentioned.

Thank you very much.

MR. LEVITT: Thank you.

Irene Heller, from CSPI.

MS. HELLER: The Center for Science in the Public Interest appreciates
this opportunity to present our views on developing an overall strategy
for achieving effective regulation of dietary supplements under DSHEA.

CSPI is a non-profit consumer organization supported by more than one
million members, that has worked since 1971 to improve national health
policies. My presentation will highlight recommendations which are
explained in more detail in our written statement.

First, the FDA should ask Congress to establish a research program at
the National Institutes of Health to evaluate the safety and efficacy of
dietary supplement ingredients.

Second, the results of the research should be used as the basis for FDA
determinations that particular supplements are safe or pose a
significant or unreasonable risk, and specify appropriate and
inappropriate labeling claims.

Third, the research program should be funded by an industry user-fee.

We also urge the FDA to take enforcement action to ensure that foods or
drugs are not being marketed as dietary supplements to avoid regulatory
controls that apply to those products.

The recent flurry of consumer warnings on dietary supplement
ingredients, such as GBL, and herbal Fed-phen, and the proposed rule on
ephedra, underscore the need for FDA to have solid safety and efficacy
data prior to the time a dietary supplement ingredient is marketed. We
there urge the FDA to request that Congress mandate a research program,
paid for by the industry, that would systematically review the safety
and efficacy of dietary supplement ingredients. Vitamins and minerals
known to be generally recognized as safety and effective, and whose role
in maintaining health is not the subject of controversy within the
scientific community could be exempted from such review.

The results of the review will alert both the FDA and manufacturers to
dietary supplements that should not be marketed, or that should only be
marketed subject to certain regulatory controls. The results of the
review could also be used to support health claim petitions under the
NLEA. The review could be modeled on elements of the over-the-counter
drug review, which determined whether particular ingredients within a
given class of drugs are generally recognized as safety and efficacy, or
the GRAS review of food additives. While those reviews were slow and far
from perfect, they nevertheless demonstrated that comprehensive reviews
of entire product categories are feasible.

The NIH would be the best entity to conduct and supervise this research.
It is the premiere research institution in the United States dedicated
to helping prevent, detect, diagnose and treat disease and disability.
It both conducts research in the laboratories of its 24 separate
entities, and supports research of non-Federal scientists in
universities, medical schools, hospitals and research institutions.

The specific NIH institute that has expertise relating to a particular
dietary supplement ingredient should either test or supervise the
testing of that substance. For example, the National Institute on Aging
is currently working on a research project on the effect of ginkgo on
memory. The National Institute of Arthritis and Musculoskeletal and Skin
Diseases would be the appropriate agency to test dietary supplement
ingredients designed to promote healthy bones.

The Office of Dietary Supplements, which was established DSHEA, should
be given sufficient funding to coordinate dietary supplement research;
at least the five million that Congress authorized, but which has never
been appropriated. Under DSHEA, ODS has been designated as the principal
advisor to FDA on dietary supplement issues, including safety and
claims. Congress specifically directed ODS to compile a data base of
scientific research on dietary supplements and individual nutrients, and
to coordinate NIH funding concerning dietary supplement research.

The research program itself would be funded through fees assessed on
dietary supplement manufacturers. These fees would be based on an
appropriate criterion, such as market share or annual sales, and waivers
and fee reductions would be available for small businesses. The funds
collected would be distributed in the form of research grants.

This is an exciting time in the dietary supplement and food industries,
as new discoveries offer the promise of significant health benefits. But
consumers need scientifically sound information about supplement
ingredients if they are to make informed purchasing decisions. We
therefore recommend the creation of an NIH research program that will
study the safety and efficacy of dietary supplement ingredients and
issue findings on which the government, industry and the consumer can
rely.

Thank you.

MR. LEVITT: Thank you very much.

I wonder if I could pick up on\--Irene, your comment, and ask the other
two if they have additional or different ideas on how we could get the
research that\'s needed on a lot of these products done and evaluated so
the results can be available to consumers.

DR. FUGH-BERMAN: Well, I think the first thing is to be aware of how
much research has already been done. There is a huge amount of research
that\'s already been done on botanicals, for instance. And people have
already noted that vitamins and minerals, there\'s also been a huge
amount of research done. So, it\'s really important to have\--to
evaluate, to have access to and to evaluate that data. You have to know
what\'s out there before you can identify gaps.

MR. LEVITT: Mr. Turner?

MR. TURNER: I think that an approach such as been suggested makes a lot
of sense. I think there are some things to think about carefully. Both
the examples that were cited dealt with generally recognized as
safe\--generally recognized as safe standard. That standard is a clear,
defined standard to build a program around. It would be very important
if there was going to be a review in the NIH, that a standard of a
similar nature, and what, would argue, would spell out \"significant
scientific agreement\" as a standard, and do something of that kind of
review might make sense.

The problem is, however, more than just the research. The context of how
the research is evaluated is equally important. So that\--you know,
we\'ve strongly argued that \"significant scientific agreement\" should
be made concrete so that everyone understands what it means.

If that were done, and there were such a program, the second problem is
that the outcome of that program should not be, in my opinion\--and part
of our argument\--should not be a yes-no program; \"if you don\'t have
enough science, you don\'t get on the market.\" That isn\'t an
appropriate way to do it. The appropriate way to do it is to evaluate
the relationship between the science that exists, create the
risk-benefit ratio dynamic that we\'re talking about in all of these
issues, and then decide how you want to proceed.

Again, that means\--we feel strongly, from Citizens for Health, that
those things which pose a serious problem should be the most severely
restricted, and those things which don\'t pose a serious problems should
be the least seriously restricted\--even if we don\'t have firm, clear
evidence of efficacy.

MR. LEVITT: Thank you.

Margaret?

MS. PORTER: Yes. Dr. Fugh-Berman, you, in addressing the
structure/function rule\--if I understood you correctly, I understood
you to suggest that the least the lines that the Agency attempted to
draw, and the proposal\--you were concerned that they were not workable
and would lead to subterfuge, I think was your word.

I\'d be interested in the comments of any one of the panelists on sort
of alternative ways of addressing the variety of claims if the Agency\'s
structure/function proposal has the concerns that you had identified.

DR. FUGH-BERMAN: Well, I think for products for which there actually is
evidence of efficacy, that there should be an independent expert panel
that determines what level of evidence there is, but that there\--you
should be allowed to make a claim if there really is good evidence for
it. But you can\'t extricate that from determining the quality of
products; that right now, you know, if you put \"ginseng\" on the
product label, you don\'t know if it\'s ginseng root, ginseng leaf;
often Latin names aren\'t on it, let alone any other sort of
information. And I think there\'s a real role for the Agency in spot
checking products that are on the market; that other countries that
regulate botanical medicines, particularly, do check products. IT\'s
very important to see, you know, what the level of active ingredients
are in them.

But\--I\'ve had a patient, for example, who was taking St. John\'s wort
every day, and I asked her why she was taking it\--it\'s indicated for
depression. She wasn\'t depressed, but because the label claim says
\"Supports emotional well-being,\" \[laughs\] she just thought it was a
good, sort of general tonic. So it can be very confusing to consumers.

MS. HELLER: I\'d like to follow up on some comments that were made this
morning, as well as now. And I think there\'s a real need for consumer
perception study to determine how consumers view these claims; whether
the consumer really can distinguish between a structure/function claim
or a health claim, because there are different consequences and
regulatory requirements for each of those. And if a consumer thinks that
the amount of scrutiny that a product that undergoes a health claim
procedure is the same as something that\'s a structure/function claim,
the consumer is greatly misled. And I think we really need to do this
survey. I think it would also help in light of the [Pearson]{.underline}
decision, if that sticks, because to the extent FDA can document that
disclaimers don\'t work; that consumers are very confused, then FDA will
have more authority, I think, to just regulate things so that consumers
can understand them. And that\'s the point of what FDA should be doing.

MR. TURNER: The problem of drawing the line between structure/function
claims and health claims is a problem of categorization. And I\'m not
sure that it helps actually solve any of the regulatory problems that
we\'re facing\--that distinction. It happens to be where the law settled
out in the last round.

But what\'s happening is, in a general societal way, we\'re going from
very broad, clearly understood categories\--basically, originally, food
and drug, and moving systematically through a differentiation. So that
things that were clearly one or the other of those concepts, are now
confused, or partake of both of those. Some things are both foods and
drugs. And the distinction that first was used to distinguish those was
the claim made. So lots of energy was brought in on what are the claims.

But it seems to me that we\'re going to go through a series of
categorizations, and I think that the disclaimer piece is one of the
tools that\'s available. That\'s why Citizens for Health supports it. If
something is not harmful, and there is some evidence supporting its
efficacy, we are arguing that there should be a disclaimer that says,
\"FDA has not yet established that this is effective\"\--it would be
safe, but \"this is effective for the claim. However, preliminary data
suggests that it might be.\" And that\'s the three-tier label that
we\'ve petitioned for, and we\'ve argued for in [Pearson]{.underline}
and so on.

The idea is that in the societal moving of things, things are breaking
out into sub-categories. Once we get into the dietary supplement
category, really, it makes relatively little difference about a hormone,
whether it\'s making a structure/function claim, or a health claim. It
poses the same safety problem. So that that distinction doesn\'t help us
a whole lot.

MR. HUBBARD: I\'d like to keep going with this. Dr. Fugh-Berman has
suggested that these products, while they may have efficacy, also have
safety issues. And I assume you\'re not saying that those safety issues
rise to the level of being a significant or unreasonable risk that would
require FDA to ban them, but rather \--

DR. FUGH-BERMAN: Some of them absolutely do. Comfrey should be banned;
herbs containing pyralizadine alkaloids should be banned.

MR. HUBBARD: And do you think we at FDA\--there\'s enough evidence out
there that comfrey should be banned?

DR. FUGH-BERMAN: \[Nodding affirmative\].

MR. HUBBARD: But you did\--I think you said that St. John\'s wort and
others have some use. And so are you suggesting that they, in fact, be
regulated as drugs, with a risk-benefit analysis?

DR. FUGH-BERMAN: No. Botanicals need to have their\--they need to have a
separate kind of regulation. They span the spectrum from food to drugs,
and\--well, just to use an example, for instance\--soybeans have
endocrinological effects. There are many soy-based foods. Then there are
soy foods that are enriched with genestein, which is an isoflavone
that\'s derived from soy. Then you can also go into a health food store
now and buy genestein 100 milligram capsules. We have no long-term
safety data on taking purified, isolated isoflavones over long periods
of time.

We do have pretty\--we have indirect, but pretty substantial indirect
safety data on eating soy food. So they should be in different
categories. Tofu should be in a different category than purified
genestein capsules.

With botanical products, they have to be regulated as botanicals and,
you know, I think that we should take some lessons from other countries
that have a lot of experience doing this. But they\'re their own
animal\--or their own plant, and they really have to be regulated
differently. Because some of them are drugs. You can isolate drugs from
plants. Some of them are ground up plants. And there\'s a whole spectrum
in between. And right now there\'s no regulation of even what the terms
are. So that when a manufacturer puts \"standardized\" on a product, it
can mean \"We say there are 50 capsules in the bottle, and there are 50
capsules in the bottle.\" It doesn\'t really mean anything.

MR. HUBBARD: Well, let me ask Mr. Turner, then\--if some of these
products, in fact, have some health use, and structure/function or other
sorts of health use, but are not universally safe, how does FDA go
about\--is that a labeling issue?

MR. TURNER: The issue\--when you say\--there\'s a serious problem about
things which are essential for some people and unsafe for others. And
it\'s not a problem that is only in dietary supplements, it\'s in a lot
of areas.

Our argument is, first of all\--first of all, from Citizens for
Health\'s point of view, we think FDA should put substantial amounts of
its resources in this area on figuring out the categories. I think I
agree with what Dr. Fugh-Berman has said: that there\'s a series
of\--there\'s a whole bunch of things in this category that are
different, and require a different way of being looked at. And I think
that that\'s an important step that we need to go through.

The first step that I think FDA researches are useful for is safety
questions. I think those are the most important single questions that
need to be dealt with. So that if we look at safety questions, and we
find things where there are safety problems\--and they could be small
safety problems to large safety problems, FDA needs to look at that and
figure out, for example, where there is enough evidence to create an
opportunity to take something off the market that shouldn\'t be there.
That is more important as a first step in working this all out than
figuring out the efficacy piece.

The labeling part of it is: for those things which are not in the
category that say we can show that these things are unsafe\--in that
category\--those things\--I don\'t think FDA has the authority to take
them off the market. But I do think it has ample authority to guide
people toward the proper use of these substances, again if words that
are there are given some kind of a meaning that everybody can share as
being the meaning of what those words are. And I agree with the
statement, for example, about \"standardized.\" Those kinds of words
need to be useful to help people work their way through a set of
categories that have\--that are safe but we don\'t know how effective
they are.

The policy problem is that if you say anything that doesn\'t have a full
scientific evidence of efficacy that meets the FDA definition as it
currently stands; if you say anything that doesn\'t meet that category
is going to be regulated more strictly by either being kept off the
market, or being confined to what it can say, the result is that many
things are dumped into the same category which have all kinds of
different meanings. So that you end up with people not being able to
work their way through the market. And I\'m arguing\--we are
arguing\--that FDA has the ability to help shape that\--taking out those
things which are unsafe\--it has the ability to shape the way consumers
balance safety and choice around whatever issue that they particularly
are looking at.

MS. HELLER: I\'d just like to add one more thing. I think in the
discussion of safety and efficacy we\'ve forgotten that there are some
safety issues under the rubric of \"efficacy.\" For example, if
someone\'s taking a dietary supplement to prevent breast cancer and they
actually have breast cancer and should be seeing someone for that, and
they\'re not seeing someone because they\'re relying on this dietary
supplement, that\'s really a safety issue, because it\'s preventing
people from going to get the treatment that they need, and it\'s causing
them to make unsafe decisions.

So perhaps that, in considering efficacy issues, there should be a
categorization as to products which are used for very serious
diseases\--let\'s say cancer or heart disease\--and products which, if
they have no effect, it\'s not going to hurt anybody; you know, they\'re
designed to make you\'re fingernails grow longer.

So I think there needs to be a distinction there.

MR. LEVITT: Dr. Yetley?

DR. YETLEY: You\'ve all discussed safety as one of your priorities that
you think the Agency should focus on. Given the range of tools and
approaches and resources that the Agency has available to it, how should
the AGency proceed in terms of dealing with safety issues? We can do it
by regulation. You can do guidance. You can do other means. Do you have
some particular advice for us on how to approach safety issues?

DR. FUGH-BERMAN: Well, I think\--well, yes, it has to be\--the Agency
has to be familiar with the literature so that it knows what to go
after. I think that its\--one of its roles should be to set quality
guidelines. I don\'t know whether those should be regulations or
guidelines\--but to set standards of quality for various dietary
supplements. It\'s really important, especially in the botanical area.
And there\'s quite a lot of research in that area.

But the main thing is going out into the stores, buying products and
analyzing them, and publicizing the results. I don\'t think it should
just be up to [Consumer Reports]{.underline}, and CSPI, and some of the
other groups that have done independent analyses to determine that a
number of ginseng products on the market contain no active ingredient,
or some of them actually contain ephedra instead of ginseng\--that sort
of thing. There\'s a lot of misidentification of plants; there\'s a lot
of contamination. There\'s a big problem with mixing drugs in with
herbs, particularly in preparations that are imported from Asia.

There\'s a lot of different issues out here, and there are safety issues
in products that are on the shelves now.

MR. TURNER: In addition to going out to the market, the FDA\--it seems
to me, again, following the basic point that we are pushing from
Citizens for Health, which is a dialogue process, there is a lot of
information available in the dietary supplement community which people,
if they had confidence in FDA would be willing and happy to share. It\'s
very difficult, however, if the agency is looked upon as an agency which
is constantly going to after whatever it can put in jail, or some
comparable thing. It would be much better if we could have an open flow
of information. It\'s not only products that have ginseng that has
ephedra, but there\'s ephedra that has amphetamines. I mean that\'s
another issue.

It would be useful for the FDA to organize an ongoing communication
system. Two things would help develop that possibility, I think, very
strongly. One would be the development of good manufacturing practices,
and I think those could be expanded to some extent to include some of
the standard ideas that Dr. Fugh-Berman has been mentioning. You could
create potency and name of source and so forth as part of that.

And then, secondly, it is very important that the Agency seriously look
at the adverse reporting system, because it\'s coming in now in a way
that is very undifferentiated, very unclear; it\'s being used by
competitors to fight out marketplace battles. And it\'s really,
frankly\--to be very honest with you\--it\'s an embarrassment. And it
would be useful if\--and we, of course, and I\'m sure these groups and
the ones that were here this morning, would be more than happy to
participate in a dialogue about how to make a system like that work. So,
for example, if we got the adverse reporting system working effectively,
and everyone had confidence in it, we, and I believe others, would
encourage all of the people,e that we are involved with, in terms of
practitioners and sellers and other people in the community, to
participate in that, and to make information available. The way it\'s
coming in now, however, it\'s undermining confidence rather than
building confidence.

MS. HELLER: I think it might be useful to publish a [Federal
Register]{.underline} notice that lists the dietary supplement
ingredients with which FDA has concerns, and to allow the public to
comment on those particular substances, and FDA can then evaluate the
evidence. And it would be helpful if down the road FDA could publish a
book that would be available in health food stores so at the point of
sale, consumers could see what type of rating a product had; you know,
if it\'s safe but possibly effective; safe but definitely effective;
unsafe.

MR. LEVITT: Thank you.

Dr. Bowen.

DR. BOWEN: Dr. Fugh-Berman, you mentioned in the context of botanicals
that Commission E could be used as a model. Would you further elaborate
on that comment?

DR. FUGH-BERMAN: Do you want me to explain what Commission E is, or \--

DR. BOWEN: No. I know what Commission E is, but you could explain it
briefly, and then tell us how you think that could be used as a model.

DR. FUGH-BERMAN: This was an independent group that was set up by part
of the German federal health agency that was composed of physicians,
pharmacologists, pharmacists, members of the industry and consumers to
evaluate information on herbs, about\--more than 300 herbs and herbal
mixtures were evaluated and monographs were written which were used as
product labels in Germany.

They have\--they\'re sort of like consensus-conference kinds of
documents. They\'re not referenced, but they are based on a huge amount
of clinical and scientific data. And I\'m not saying that we should
adopt them wholesale, but it\'s a useful model, putting together a group
that is familiar with botanical research, etcetera, to evaluate
information; they come up with either positive or negative assessments
based on the benefits\--known benefits and known risks of botanicals,
and to publish those. I think it\'s something that we could, if not
exactly duplicate, but do in a more scientifically referenced way with a
group that\'s familiar with the research. And I think it could be really
useful.

Because there\'s a lot of benefits in dietary supplements, and there is
quite a lot of studies showing benefits for some of these. But right now
there are so many products on the market that are entirely ineffective
because we have no regulation as to quality. So I really think
it\'s\--you know, there\'s a dual issue around safety and around
quality, and we need to address it in a pretty comprehensive way.

MR. LEVITT: Okay. Thank you.

On my one question of \"a year from now,\" I think some of this has
already been answered, but I\'ll et everybody go down one more time and
amplify, or say you\'ve already said it.

Ms. HELLER: Okay. Basically, repeating what I said before, we need to
have a systematic review of the safety and efficacy of the various
dietary supplements.

MR. TURNER: I think that a substantial amount of progress could be\--you
know, I\'ve already said about moving it out of\--moving it into a
dialogue and out of a confrontational forum\--but a very substantial
amount of progress could be made if the agency put energy into working
through the quality questions. A lot of the issues would become much
clearer if that were to be done.

DR. FUGH-BERMAN: Clear, accurate, comprehensive labeling of every
dietary supplement on the market, and periodic analyses by FDA.

MR. LEVITT: Thank you. What would we do in the second year?

\[Laughter.\]

MR. LEVITT: Okay. Thank you all very much.

As we\'re moving between panels, we have\--the next panel we have Dr.
Gary Huber of ANA. We have Dr. Steven Dentali of Rexall Sundown. And we
have Antonio Martinez of Neutraceutical Initiative.

On your agenda you have an additional name of Paul Simmons. My notes
tell me that his views were\--he is not appearing\--that he\'s not here
today. Is that right?\--but that some of his views were covered this
morning.

Thank you. Well, an efficient group. Let\'s go right to Dr. Huber.

**PANEL IV - NUTRACEUTICALS**

DR. HUBER: Thank you for the opportunity to be here today on behalf of
the American Nutraceutical Association, whose members are health care
professionals and consumers.

The American Nutraceutical Association is a non-profit alliance of
individuals with a shared interest in the science, technology, marketing
and production of nutraceutical products. The ANA was established to
develop and provide educational materials and continuing education
programs on nutraceuticals for health care professionals and for
consumers.

We want to emphasize that we believe we currently stand at a most
serious confluence of important forces coming together in the
nutraceutical world. This is a critical crossroad for the consumers of
nutraceuticals. What are these critical factors that we should consider?

First, unprecedented numbers of Americans are now consuming
nutraceuticals and other dietary supplements. There is every reason to
believe that they will continue to do this in the future. For the most
part, they are doing so with a blind trust in those who manufacture and
distribute these products.

Second, United States\' health care delivery systems are changing. They
are not stable. They remain in enormous flux as we search for a means of
health care that will work and that is affordable. In this period of
change, increasing numbers of Americans are searching for more control
over their destiny of their own health. They also want more freedom to
control their own health care. One way that Americans at all levels are
fulfilling their quest of these objectives is to turn to nutraceuticals
and dietary supplements. In doing so they want to achieve as much good
health as possible. They want to live as long as possible, and they want
to be free of the rages of chronic illness, physical disability and
mental impairment for as much of their life as possible. Faced with a
medical care system and a pharmaceutical industry that has focused on
disease, not on prevention, they are turning to nutraceutical products
and dietary supplements in their quest to fulfill these needs.

Third, those who manufacture and distribute nutraceuticals and dietary
supplements can now market their products without adequate levels of
external accountability for quality or safety.

Fourth\--and finally\--a major force adding momentum to the potential
conflict resulting from the confluence of these movements is the fact
that the unremitting growth of the nutraceutical industry seen over the
past few years appears to be slowing and in some cases plateauing. As a
consequence, the nutraceutical market is becoming, each and every day,
more competitive. Without control, and without accountability for
quality or safety, the opportunity to follow the first rule for those
who care about the health of the people they serve\--to do no harm\--has
a potential to be diminished and lessened under these circumstances. We
need a reliable, independent and intelligent adverse event reporting
system.

In the perspective of these considerations, we need therefore to ask
some important questions. Can nutraceutical products be manufactured
under current good manufacturing practices? Does a nutraceutical product
contain a standardized extract that has been validated by scientific and
clinical studies? How do the consumers know that the products they take
actually contain the required dosages of ingredients required to produce
the desired results as promised in marketing materials provided by the
manufacturers and distributors? Most importantly, is the product safe,
and does the product have integrity? Without clear and acceptable
answers to these questions, the safety and integrity of the
nutraceutical products and the dietary supplements will be compromised.

What can we do? The pathways of responsibility leading to a good
solution must be shared. The American Nutraceutical Association
recommends attention be given to the following priority issues
concerning the consumer\'s safety.

One, quality assurance. Manufacturers and distributors of nutraceuticals
and dietary supplements need guidelines for current good manufacturing
practices and production standards to protect the consumer. The FDA is
the logical source to develop these guidelines and with help from the
manufacturers of supplements and from the trade associations who
represent their interests. Ideally, the nutraceutical industry should be
responsible for somehow regulating itself through a third-party
validation mechanism. If the nutraceutical industry does not
satisfactorily self-regulate, regulation must come from without.

Two, standardization. This is a complex challenge, but nutraceutical
products must be standardized. Both the consumer and the manufacturer
will benefit from products that are standardized, reliable and
dependable. Nutraceutical products must have a reliable consistency.

Three, product stability. Most nutraceuticals are derived from natural
sources that are prone to degradation. Once active components are
standardized, their stability and shelf-life can be determined.
Nutraceuticals of the future must be labeled with expiration dates and
recommended storage instructions.

Four, bioavailability. What are the pharmakinetics of nutraceuticals?
What are their interactions with diet and with medications?

Five, clinical validation is an essential and critical priority for
nutraceuticals. Safety and clinical efficacy are definite consumer
concerns.

People are going to continue to buy and consume nutraceuticals \--

MR. LEVITT: Excuse me\--if you could try to summarize, please?

DR. HUBER: The consumer needs to be able to trust health care
professionals to whom those nutraceuticals most want to turn and with
reliable knowledge about nutraceutical products.

In summary, the consumer and health care professionals need to know that
nutraceuticals are safe, and that they are produced and marketed with
integrity.

Thank you.

MR. LEVITT: Thank you very much.

Next would be Dr. Dentali:

DR. DENTALI: Thank you, and thank you for having this forum here today.

I guess I should say a little bit about my background; that I was
trained as an herbalist, a pharmaceutical scientists and a
pharmacognicist. I\'ve served on several\--a few GRAS committee efforts
regarding botanicals, and I was a member of the special working group on
ephedrine safety in foods.

My position at Rexall Sundown is a new one. I\'ve been there two months.
My understanding is that Rexall Sundown is the largest supplier to the
mass market of dietary supplements and also botanical products.

I want to thank Dr. Fugh-Berman and Mr. Turner for making the point that
botanicals are different. Because, really, when you look at dietary
supplement categories, there\'s basically two: botanicals and all
others. That\'s because there are special concerns that are brought up
when you\'re dealing with botanicals, and that\'s really what I\'m going
to speak about today.

Although DSHEA will help in providing consumers of information on and
access to safety and efficacy dietary supplements, it really does not
adequately address many, if not most, when dietary supplements are of
botanical origin, in my opinion. Indeed, the DSHEA
Presidentially-appointed commission on labeling spent a considerable
amount of time and effort attempting to resolve issues surrounding the
labeling of dietary supplement of botanical origin.

Many assumptions regarding dietary supplements really don\'t fit. It is
a\--as they are themselves a huge mixture of components\--dietary
supplements span many different categories, you can draw the line pretty
much anywhere. If you want to take different examples, you can make
whatever case you would like as food, dietary supplement or drug.

The World Health Organization recognizes that most of the world\'s
population relies on botanical products, or what are known as
\"traditional remedies\" for much of the health needs of the world. In
fact, recognizing this importance, they published a guideline on their
assessment, and this guideline helps to ensure the safe use and
manufacturing of botanical materials used as traditional remedies. So
really what I\'m suggesting here is the category of \"traditional
remedies,\" or something such as that.

In the green handout that was out front was a headline, \"FDA is
Considering a New Category.\" I apologize, I don\'t have it up here to
refer to. It\'s not within CFSAN, but that idea is obviously receiving
more and more attention for a good reason.

While many developing and developed countries have an extensive
monograph system for traditionally-used botanicals, we in the U.S.
cannot, in conjunction with a product, educate consumers as to the most
basic of western concepts\--honorable action. Indeed, practically all
the modes of action that I was taught regarding traditional uses of
North American herbs cannot be used without the corresponding product
being considered a drug.

Although traditional remedies are often understood to have a broad range
of actions appropriate for a myriad of conditions, the present structure
limits what manufacturers can share regarding what is considered common
knowledge among many peoples. This traditional remedy category\--this
establishment\--I feel falls into the long-haul category but, however,
its implementation brings into focus many of the issues that you deal
with, such as boundaries, safety and labeling issues\--those that are of
immediate concern regarding botanical preparations. In other words, this
or a similar category is needed for a rational and effective regulatory
foundation for dietary supplements of botanical origin.

The solution resides, I believe, in part, to a well-developed monograph
system created by expert committees, the members of which are uniquely
qualified to assess the botany, historical use, chemistry, pharmacology,
safety and efficacy of herbal materials. The best I\'ve seen in this
regard is the American Herbal Pharmacopoeia, not to dis the USP. And, by
the way, the American Herbal Pharmacopoeia is a non-governmental
pharmacopoeial system, so there actually must be two.

Botanicals are a special case requiring special botanical expertise and
treatment. This issue deserves expert advice input from botanical
experts, both inside and outside the industry. In fact, I don\'t think
you can do it well without it. So I think there\'s an area where it will
continue to appear as something that deserves attention and I believe
that the traditional medicines category is one way to address that.

Thank you.

MR. LEVITT: Thank you very much.

Mr. Martinez.

MR. MARTINEZ: Thank you very much, and good afternoon.

I\'m happy to be here on behalf of the Nutraceutical Initiative, which
is an outreach project that\'s collaborating with the Foundation for
Innovation in Medicine in Cranford, New Jersey, which is headed by Dr.
Steven DeFelice, the gentleman who actually coined the term
\"nutraceutical.\"

I\'m also here as someone who was intimately involved with the
development and passage of DSHEA, and I\'m happy to see my colleagues
Mr. McNamara and Mr. Turner here also\--individuals who were intimately
involved with the formulation and the development of that legislation.

We are at a state where the confusion that exists in the marketplace
really begs a question as to whether the AGency has the right kind of
tools in order to address them. At its most basic level, we\'re really
talking about safety and information questions. What we have now in the
marketplace is a condition where price is driving the marketplace when
it comes to dietary supplements, nutraceuticals, functional
foods\--whatever you want to call them\--should be research-driven
marketplace.

Unfortunately, there are not the kinds of incentives that promote the
development of good research-driven marketplace. Also, we have a new
aspect to this whole question\--and I can speak to this because I
represent\--in addition, I was an attorney in a managed care
organization that would like to cover these kinds of products, but have
great difficulty due to the fact that there is not yet any mechanism
that critically evaluates these kinds of products, short of going the
drug route, which is not a practical matter for most of these products.

I know we don\'t have a lot of time, so I\'m going to jump a little bit.
One other point I want to get in before my five minutes is, when it
comes to enforcement, we\'d like to see the Agency begin some type of
proportional enforcement, where if there are labeling problems with a
company out there with a product with bad labeling, the Agency should
take action to take care of that; act quickly to remove unsafe products.

What the Nutraceutical Initiative would like to envision as a solution
to this problem is unlike what is suggested by the Center for Science in
the Public Interest, which is a government-driven, research-based
approach, we would like to see, very similar to an Orphan Drug Act
enacted by Congress, but dealing with functional foods and dietary
supplements. In fact, there is draft of that legislation that is
circulating on Capitol Hill, and while we had hoped that this
legislation would have been introduced this springtime, it is my belief
that it should be introduced in the Congress by the summer. But it will
not be introduced without consulting with the Agency, and we will be
moving along those channels shortly.

But ultimately what we want to see is the company that does the research
ought to get a reward, and they ought to be tell the whole story\--the
whole truth\--about their products, and they should be able to do that
exclusively for a time\--set period under the law. One of the conditions
in return for that would be that the manufacturer would engage, and be
responsible for post-marketing surveillance of its products, and that
way you would have a phenomena going on in the marketplace where you
would have a tested product, with a\--and with its ingredient, and its
formulation, and you will be able to actually get the kind of data that
will answer safety-related questions and at the same time the
marketplace will change because if there is at least one approved
product out there, the competitors\--sort of like a generic
situation\--will try to come as closely and match the tested product.
Thus we\'ll have a situation where the bad products\--the junk that\'s
out there\--will not be able to withstand the market forces there, plus
you\'d be able now to have a situation where the mainstream health care
professionals will now be able to look to something; and patients and
people at risk\--there are different types of sub-groups of consumers.
And we need to have the right kind of public policy that accomplishes
that.

So we look forward to working with the Agency; working with the public,
working with industry to accomplish this. It\'s quite impressive to see
how this whole process has matured, and we certainly expect to be in the
middle and involved with this.

Thank you very much for your time. I\'ll take your questions.

MR. LEVITT: Thank you all very much.

Let me begin with just kind of a nomenclature question. Two of the three
speakers, as well as the title we assigned is called \"nutraceuticals.\"
I think if we all read through the act, we wouldn\'t find that term.

Help me understand, within the legal terms within the statute of dietary
supplement, conventional food, food additive, drug\--within those terms,
where does nutraceuticals fit?

DR. HUBER: Unfortunately, I don\'t think there\'s an agreed-upon
definition, so one gets a whole series of definitions, and that really,
I think clouds the issue.

MR. LEVITT: Okay. But in your mind, when you stood up and said, \"I\'m
here to speak about nutraceuticals,\" what were you referring to?

DR. HUBER: A naturally-occurring product that has some biological
activity that will affect health.

MR. LEVITT: Okay.

MR. MARTINEZ: As we are looking at \"nutraceutical,\" I\'ll work off of
Dr. DeFelice\'s definition, and also what is being looked at on paper
from a legislative standpoint. It would be anything that\--a substance
that is found in food, or food as itself, that can provide a health
benefit that we have further defined as\--that can be used for the
prevention of disease, the reduction of risk factors associated with
disease, and for the management, from a dietary standpoint, of disease.

DR. DENTALI: I\'m really glad I didn\'t mention the word.

\[Laughter.\]

MR. LEVITT: And just following up to the first two speakers\--not that
that wasn\'t clear\--what\--give me some sense of proportion of the
products you\'re talking about with the dietary supplements? 50 percent?
20 percent? 100 percent? 90 percent? Versus foods?

MR. MARTINEZ: I would argue that both\--you could apply this definition
to either.

MR. LEVITT: No, no\--you\'re misunderstanding my question.

MR. MARTINEZ: I\'m sorry.

MR. LEVITT: Of the universe of products you\'re talking about \--

MR. MARTINEZ: Mm-hmm.

MR. LEVITT: \--how many of them are dietary supplements?

MR. MARTINEZ: Oh\--I would say at least more than half, to two-thirds.

MR. LEVITT: Okay.

MR. MARTINEZ: The dietary supplements have been further out there\--I
mean, functional foods are now just coming into play.

MR. LEVITT: Would you agree with that

DR. HUBER: Without a clear definition I don\'t think you can have
precise numbers.

MR. LEVITT: Okay. But what\--you would say a large proportion are
dietary supplements?

DR. HUBER: \[Simultaneous discussion\].

MR. LEVITT: Yes? Okay.

Margaret.

MS. PORTER: Yes. This is a question for Dr. Dentali, but others would be
welcome to address it as well.

I heard you say very clearly \"botanicals are different,\" and that
under certain circumstances botanicals could be foods, or dietary
supplements, or drugs. But I think I also heard you to recommend that
claims not be used as the basis for deciding whether a botanical is a
drug or a dietary supplement.

If I understood you correctly, I\'d be interested in what other criteria
you would use to draw those kinds of distinctions?

DR. DENTALI: I don\'t know if claims itself can work well enough the way
are using them right now, without a traditional medicines category. I
think that\'s one solution it provides\--it may allow a vehicle to make
claims and set them off so the consumer understands the distinction, if
indeed consumers would.

The other answer is it would have to be done on a case-by-case basis.
And I\'m not trying to dodge the question. I\'ve written\--I\'ve
extensively reviewed the literature and written on safety on three
botanicals; on Kava, on ephedra and on ginkgo\--with a popular book
being on ginkgo. And they\'re three completely different situations.

Kava, in fact, completely defines the cultures where it is still
traditionally used. So I don\'t know if you can say if it\'s food, drug
or whatever, but it\'s\--and ephedra has a discrete traditional uses and
not others. Ginkgo, the product that has been the most\--the research
has done on, is a semi-purified extract. So looking at uses\--looking at
historical use\--intended use is certainly part of that. But I think you
have to take it on a case-by-case basis and look at the totality of the
information on what it is\--what the historic use is and how it\'s being
used.

MS. PORTER: Would either one of the other panelists care to comment on
that question?

Thanks.

MR. HUBBARD: Dr. Dentali, your description of the monograph system
sounds very much like the way we regulate over-the-counter drugs; and,
of course the President\'s commission a couple of years ago recommended
that we consider regulating botanicals because they are somewhat
different in that way. Are you saying, then, that that over-the-counter
drug model is more appropriate for those products?

DR. DENTALI: It\'s possible, if it\'s modified. I think that there
are\--I think you have\--what we don\'t want to do is live in a world
we\'ve got to prove everything scientifically before we can use what we
know by common sense works\--unless there is common sense or science
that shows us that we should treat it otherwise. Comfrey\'s a good
example; comfrey root should probably not be taken internally in
products. We have enough good science there for internal use of
pyralizadine alkaloids that there\'s a serious question for safety.
However comfrey leaf, the levels are much less; comfrey externally,
I\'ve found very little that helps for bruises and contusions as a
poultice of comfrey.

So, if we have an intelligent monograph system that takes into account
all the variety of\--all the different\--the word isn\'t coming that
I\'m looking for\--something of that nature, but you would have to then
expand it. I think we must not try and shove botanicals into an existing
framework, but design one that is designed for them.

MR. LEVITT: Dr. Yetley.

DR. YETLEY: Well, Dr. Dentali just answered the question I was going to
ask, so I\'ll have to think of another one quickly.

I think all three of you are suggesting that you want to find a way for
many of these products to be marketed so that they are either useful in
disease treatment or management of diseases. Do you see this as being
under DSHEA? Do you see this as having to need another category, and why
aren\'t you interested in existing categories? I\'m thinking explicitly
of Dr. Martinez\'s example of wanting something similar to orphan drug
law. Why do you see that orphan drug law as it exists now would not
work?

MR. MARTINEZ: Just simply because it\'s almost like if you look at the
products that are on the market, they tell half a story. They don\'t
tell the whole story. And manufacturers\--it\'s a big semantical game
with the Agency. I can tell you that as a private attorney, when I work
with supplement companies, we\'re all\--it\'s all about semantics, and
coming up with a way that tries to stay within the boundaries which were
set within the law when, really, I know what the\--if a company acts,
has done the research and know that its product can have a benefit for a
particular disease risk factor, let\'s say hypothetically, they would
like to have a functional way to communicate that information to the
public. And that\'s what\'s missing. And we need to have something in
place that would give an incentive for the companies to do that knowing
that, hey, if I spend the money to do the kind of research, then my
competitors aren\'t coming to come out the next day working off of my
research, and come out with the same kind of product. There would be
some kind of protection.

In exchange for that for a period of time there would be, you know, the
kind of post-marketing surveillance and other things. I think this is
something that we will sit down and further discuss with the Agency. I
know there\'s interest on this in Congress about this, because I think
we all want to resolve the controversies with dietary supplements,
because they promise so much. You know, we\'ve just got to come up with
the right framework for that. And certainly the Orphan Drug Act is an
example where incentives work; 5,000 orphan drug conditions. Before the
Orphan Drug Act there were very orphan drugs. Since the passage now,
over 15 years, we have over\--almost 200 now, new orphan drugs to help
people with orphan diseases. So that system does work.

MR. LEVITT: Excuse me. Just to clarify, if I may\--and I know I\'m
violating my own rule. There\'s got to be some advantage to being the
chair\--is the Orphan Drug Act analogy, I clearly understood the idea of
if you put the money and do the testing, you ought to get some
exclusivity in marketing. That part I got. The Orphan Drug Act, of
course, also works within a system of pre-market review for that. Do you
envision that as part of the system you\'re thinking of?

MR. MARTINEZ: Well, in the draft that is out there there will be an
actual\--there will be an actual commission set
up\--established\--that\'s overseen by FDA, but established out of the
NIH. This commission would set up\--working off of similar stuff that\'s
been FDAMA\--to basically, if a company does the clinical research, it
puts together its best evidence, presents it to this body, the body will
make a judgment on it, and that judgment would be reviewed by the agency
and the agency can add things to it\--additional information,
etcetera\--conditions for the claim, and that claim would be exclusive
to that holder for a time certain. And we believe that this will
actually start shifting resources to research, which ultimately is what
we need to resolve the controversies with dietary supplements and
functional foods.

MR. LEVITT: Okay. Thank you.

Dr. Bowen.

DR. DENTALI: Could I follow up on that first?

MR. LEVITT: Please. Because we\'ve got lot\'s of time.

DR. DENTALI: I want to say that I think we need to use all the existing
categories, to whatever extent that they are useful and that they\'ll
serve the purpose. And I still think outside of that we may still
find\--indeed, I believe we will find cases where it doesn\'t work. And
I think we need to balance the strength of the substantiation on the
claim that\'s being made. If someone wants to sell a product that
they\'re saying cures migraines, and that product is feverfew, I expect
no less than drugs out there that have that same claim for that to be
sold.

However, if there\'s a substantial body of traditional information\--of
which there is\--to say that \"many people report using feverfew helps
prevent their migraines,\" and this is how it\'s used\--and that happens
to be true\--that may be useful information for a consumer, if there\'s
no safety issues, you know, of any type being involved.

So, you know, we have to balance the consumer information with the risk
of using the product. Now, feverfew is a good example because it\'s the
only product in North America that\'s used as a raw botanical for a drug
indication\--and that\'s in Canada. Dried feverfew leaf, 90 percent leaf
material of a certain percentage perthenolide is approved for treating
migraines. And it\'s under a traditional medicines category\--excuse me,
it\'s not. But Canada is another example of also traditional medicines
category which has good and bad parts to it.

The unfortunate situation is that you need to look at what is\--if
you\'re going to use those clinicals in Canada for that indication, then
what you\'re selling needs to be closely comparable to what was used in
the clinical trials. So that\'s Canada\'s situation for that drug
identification.

We may have a third situation here where maybe those\--we don\'t think
those trials are good enough to establish it as a drug here; indeed, we
may not have that type of mechanism. But for consumers to be aware that
maybe we want to just allow the Internet\--but do manufacturers play a
part in that? Does the FDA play a part in that? Is there a risk
involved? Should this be useful information for consumers that people
have traditionally reported this as effective, and let people try it.

We may find that a traditional category could be a good vehicle for
providing information to consumers to increase access to safe, effective
remedies.

So that\'s pretty much\--it\'s the claims that\'s important that we
balance that. I had another point, but I don\'t remember what it was.

\[Laughter.\]

MR. LEVITT: Okay.

Dr. Bowen.

DR. BOWEN: Well, I think the whole discussion here in the last little
bit has raised a lot of questions for us, and I guess what I had heard
was that you\'re thinking of some of the existing systems that we have
to manage some of the issues around botanical drugs\--drugs, food,
dietary supplement, whatever part of that continuum they\'re on\--and
that potentially raises the question of is a separate system needed for
that? And then, if so, would some of the review be pre-market for
certain claims? Would some of the review for those products that are
already used in traditional medicine\--wherever\--and then what those
products were for those claims. And it\'s very interesting, and I don\'t
think I have a question here, but it\'s interesting. It raises a lot of
those issues.

MR. LEVITT: Does anybody want a further comment?

MR. MARTINEZ: I just think there\'s going to be sort of an amalgam of
what you\'re outlining, where hopefully we\'ll have policy in place that
will allow this kind of basic information to apply in general, much like
what Dr. Dentali suggests. But for companies go the\--you know, the
extra distance here, that they would be\--and that\'s going to be
ultimately to the whole marketplace\'s benefit. Because once we have
products out there that have been tested, and have been critically and
scientifically evaluated, you will see the marketplace will change,
because you cannot\--if you know that you have something that works, the
junk that\'s going to be out there will not stay out there, and you will
then see an embracing and a utilization of this by the mainstream
medical community. I mean, the bottom line is, the public is far ahead
of the Agency, of the\--you know, the marketplace is ahead of the
regulators here, and we need to kind of bring this now into some kind of
coordinated fashion from a public policy standpoint.

And there was some\--there are tools in place, but of course we\'ve seen
the limitations, I think, of\--for example, with DSHEA, with
structure/function claims, and this\--obviously we would need to go now
to what the next step is. I mean, bottom line is people want to be able
to tell the story about their products, but the whole truth. And we
would look forward to working with the Agency in that regard.

MR. LEVITT: Very good. You folks are stimulating thinking.

Margaret Porter has one follow-up question. I have one follow-up, and
then we\'ll do the run-down of \"one item.\" This is following up on Dr.
Dentali\'s point that, yes, we still have some time.

\[Laughter.\]

You were courageous enough to stick your neck out and suggest that the
traditional medicine system in Canada has\--I think you said both good
and bad parts to it. And since, obviously, you\'re suggesting that we
look at those kinds of alternative systems to try to see whether
there\'s something that we could learn from them.

I\'d be curious as to what you would venture to say you think are the
good parts, and what you think are the bad parts.

DR. DENTALI: Well, I think the good part is that it allows, basically,
the familiarity that an herbalist has with traditionally used materials
to be shared with the public, and to make those available.

One of the bad parts, and this\--again, it goes back to how you\'re
implementing things. If someone has a serious heart condition, they
probably shouldn\'t be running off to take hawthorn. Now, there\'s very
good\--well, you know, we can talk about what\'s very good, and what
research is available to show that hawthorn has discrete effects on
improving cardiac function over a long period of time. It\'s effects are
more, indeed, dietary supplement/nutritional in nature. Many of the
compounds now that are falling under \"the active compounds\" of dietary
supplements fall into very broad categories\--sub-categories of
flavanoids. So that hawthorn cannot be recommended for heart conditions
maybe prevents the population from including it as part of their diet,
which would possibly prevent a lot more heart disease from arising.

So, you know, whatever system we come up with, or philosophy we come up
with\--whether it be of medicines or regulations\--there\'s always going
to be outliers. So the more points of view we can have on a topic, the
more likely we are to come to an enlightened regulations on it.

This comes to, also, with the issue of standardization\--we tend to
assume that standardization is a simple thing and beyond that awe tend
to assume that it\'s measuring the amount of constituents. It is not.
And the examples in the industry are a good way of how you can
completely miss the point.

Standardization is the complete body of information and controls that
guarantee a consistent product. And in many cases, not only do we not
know what to measure, we don\'t even know how to measure it. What you
guarantee is that you had the correct plant, it was grown properly, it
was harvested properly, it was dried properly\--which is the single most
important part in determining the quality of the crude botanical
material\--and it was manufactured and processed properly. And again,
indeed, these are the issues that the industry is grappling with in
coming up with definitions.

Use of the word \"potency,\" is one that\'s been raised before, and
deserves proper attention.

So\--but gaining the basic familiarity that\'s, I think, the benefit of
a Commission E-type approach, that these things\--these assumptions that
we have of how to regulate and apply to botanicals oftentimes don\'t
hold true when the details start being raised. What are we exactly
talking about when we try to imply a pharmaceutical on to it that it
doesn\'t fit. Not always, but a lot of the time.

So, again, wherever what we have works, we need to use it. But if
there\'s areas where it doesn\'t work, we need to be open for creative
endeavors on how to deal with that.

MR. LEVITT: I thank you\--oh, you want to \--

MR. MARTINEZ: Yes, one thing\--just as a historical footnote, I find it
kind of fascinating and sort of we\'ve come full circle here is one of
the factors that actually led to DSHEA was the fact that when the
botanical industry requested establishing a botanical ingredients review
panel, the Agency refused to do that. And that was one of the factors
that led to the development and passage of DSHEA. Here we are now\--here
can see that the Agency is actually contemplating here, now what are we
going to do have a handle with botanicals. So it\'s good that
we\'ve\--there\'s sort of a listening now to that. So\--just\--it was a
comment.

MR. LEVITT: Thank you. And I congratulate Dr. Dentali for not only
answering Margaret\'s question but mine at the same time.

Why don\'t we then go through our last rapid-fire wrap-up. Again,
looking a year from now, if I could ask people to try to focus in
narrowly on one thing that could be accomplished a year from now, what
would that be?

DR. DENTALI: The establishment of a category, and the expertise to
provide us and the populace with a greater familiarity of botanicals so
that we can use them in all appropriate ways.

MR. LEVITT: Mr. Martinez.

MR. MARTINEZ: A year from now I\'d like to see a Nutraceutical Act being
debated and under full consideration by the U.S. Congress.

MR. LEVITT: I guess that means there\'s nothing we have to do in the
next year.

DR. HUBER: And what\'s been said all day long\--safety, safety and
safety.

MR. LEVITT: Yes\--Bill Hubbard wants to make one quick comment.

MR. HUBBARD: I\'d just like to say that your comments sound very much
like these\--you\'re not talking about these things as foods. I mean,
DSHEA is for foods. You know comments very much lead one into
the\--trying to find a category that\'s appropriate for these products,
that they have medicinal properties, they have some risks, they need to
be properly used, potency needs to be established. And I guess I go back
to my earlier discussion with you, Dr. Dentali, about OTC. Maybe the OTC
model\'s not perfect or not, but somehow, you know, your comments don\'t
lead me in the direction of saying these are food products that should
be treated that way. These are a particular kind of product that should
have some regulation, but also have benefits and usefulness and need
their niche. And I think that\--that\'s what\'s you\'re saying, right?

DR. DENTALI: No.

MR. HUBBARD: Okay.

DR. DENTALI: Only because there are perfect examples where they clearly
are foods. Chickweed is an excellent example. I used to\--as an
undergraduate student I made salads pretty much where chickweed was half
of it on a regular basis. So clearly that\'s a food. It\'s recognized as
a food, it\'s used as a food. I don\'t know about claims for it\'s being
used in weight-loss. Certainly any claims along that nature, they\'d
have to be evaluated. Dandelion greens\--food. The list goes on and on.
If we want to look at that category, there\'s a huge amount.

So it is a continuum, completely, where we could find examples and win
an argument on either end of the story, and every place in between.

MR. LEVITT: Okay. Well, listen, I thank this panel very much again.
Before you go down, let me just make a couple of announcements. We are
going to take a 15 minute break and reconvene at three o\'clock.

Before everybody runs out to do that, I have a message\--or there is a
message for Mrs. Joy Joseph. If you\'re in the audience, if you could
Naomi Kulicob in the back of the auditorium\--she\'s standing with her
hand like this\--she\'ll be happy to give you that message.

And, finally, if there are people who want to make a statement at the
end of the meeting, please register outside and then afterwards I\'ll
have the next speakers come to the front of the room over here.

Thank you very much. We\'ll see you at three o\'clock.

\[Recess.\]

MR. LEVITT: Well, if I could ask for people\'s attention. If people
could take their seats.

We are in danger of being on time.

\[Pause.\]

MR. LEVITT: We\'re ready to start the final segment of the day; what
we\'d like to call the homestretch.

We have two panels, and a small number of individuals who also have
asked to speak. I believe that on our Consumer panel, unless somebody
has just walked into the room in the last couple of moments, that one of
the listed people, Phil Howry, is not here at the moment. If he\'s able
to get here later in the afternoon we will definitely fit him in,
because I know he\'s traveling from some distance.

But let me welcome up to the podium Fred Bingham and Richard Johnson,
and we\'ll be happy to hear your presentations.

10:25 As they come up\--we\'ll continue, as we\'ve done before, with
each speaker making a five-minute presentation. AGain, once you\'re up
here I can focus your attention in the front row, and you\'ll see a
little sign that will come up with \"one minute left,\" and a little
sign that will come up when your time has expired.

We\'ll then subject you to hopefully friendly and constructive
questioning.

\[Laughter.\]

And as this group is smaller, I hope it does not look like an unequal
distribution of energy. But I\'m sure you have very interesting things
to contribute. And please step right up to the podium.

**PANEL V - CONSUMERS**

MR. BINGHAM: I\'d like to thank you for allowing me to be here today.
I\'m delighted that this process is proceeding.

My name is Fred Bingham. I\'m the Executive Directive of DAAIR. We\'re
the largest HIV-AIDS Virus club in the United States. We supply low-cost
and sometimes no-cost nutritional supplements to people with HIV and
AIDS and other chronic illnesses. We have about 5,000 members.

This statement has also been co-authored by Michael Onstott, who is
Executive Director of the National AIDS Nutrient Bank, based on the West
Coast. And he\'ll be giving testimony out there on July 20th, I believe.

All right. All consumers of dietary supplements, including people with
HIV and AIDS, have a right to expect that the products we use are pure
and safe, and that they contain the substances claimed on the label in
the amounts specified. Guaranteeing the safety of supplements and the
accuracy of labels with regard to contents is the responsibility of the
manufacturers and Food and Drug Administration.

Consumers also have a right to accurate, clear and non-misleading
information about dietary supplements. Currently, however, there are
only a handful of informative claims with which the FDA agrees. Totally
unsubstantiated health-related claims are essentially undifferentiated
with those that are backed by specific, well-designed clinical studies.
The practice of following virtually all manufacturer-driven label claims
with FDA\'s statement that these claims have not been evaluated by FDA
does not provide enough information for most consumers\--definitely not.
FDA\'s disclaimer may, in fact, mislead people to believe that all
claims not evaluated by the FDA are more or less equivalent.

With all the above factors in mind, we would like to address five
interrelated areas of concern regarding the regulation of dietary
supplements.

Labeling information. As indicated below, dietary supplements should
contain sections, or boxes, that provide the following information:
supplement facts; active ingredients, etcetera; health claims and FDA
disclaimers to health claims; a safety profile\--safety and purity; and
GMP\--good manufacturing practices.

Safety profile\--and I\'ve gone into some of this\--this statement will
be substantially elaborated on by the 20th of July. The system for
reporting adverse events associated with dietary supplements should be
enhanced and made consumer friendly. Outreach and education to those who
use supplements must become a high priority. Product safety should be
evaluated using standardized and objective criteria to determine if
adverse effects are likely to occur, or if they have occurred. If
adverse events have been identified, then it should be further
determined if they rise beyond an objective threshold past which FDA
action is required. Once verified, the current mechanisms for FDA
response are adequate.

Dietary supplement labels should indicate if a product may be associated
with historically known or reported adverse effects and
contraindications. This information should be\--would be contained in
the \"safety profile\" section of the label. Labels for formulas
containing new biochemical ingredients would also indicate that the
product was associated with a very limited history of use.

All dietary supplement labels should be required to devote a small but
prominent section to inform consumers if a product is manufactured under
a credible standard of GMP. This standard, as proposed by various
manufacturers\' associations, should be higher than the standard for
food, but not as onerous as that which is required for pharmaceutical
drugs. The FDA would supervise verification of a manufacturer\'s
compliance with GMP for a selected product. The Agency would also
periodically check for contaminants in a variety of dietary supplements
to assure their purity.

Health claims. If a manufacturer or distributor of a dietary supplement
makes a health or disease related claim, that claim must be evaluated
under an objective standard to determine the degree to which the claim
is valid. Once evaluated, claims would be rated on a scale of 1 to 4.
The lowest rating, level 1, would be associated with the absence or
extreme paucity of scientific evidence, while the highest rating, level
4, would indicate that there \"significant scientific agreement\" and
that FDA agrees with the claim. Levels 2 and 3 claims would require
varying degrees of scientific proof and/or verification of long-term
history of use, and would be accompanied by an FDA disclaimer.
Appropriately, level 2 would require a higher standard of proof than
level 2, while level 3 would represent a considerable body of scientific
studies and other specific evidence that clearly placed it above level
2.

Consumer outreach and education. The goal in implementing the proposed
label additions and changes is to benefit consumers and assist us in
making informed choices. This requires extensive consumer outreach,
media campaigns, as well as educational seminars and public meetings. A
collaborative effort that includes input form a broad range of consumer
groups, scientists, FDA officials and representatives from the dietary
supplement industry must be mounted in order for labeling information to
become genuinely useful for those who use supplements.

Assisted by others in the collaboration, consumers should take the lead
in determining how best to approach the goal of comprehensive,
user-friendly labels to avoid consumer deception and fraud.

And funding and resource allocation\--I\'d just like to say that we
propose that Congress authorize the allocation of some additional funds
to assure that the FDA can monitor the safety and content of dietary
supplements, but we also further propose that funding for necessary
improvements in labeling and evaluation of label claims, as well a
portion of the consumer outreach efforts be substantially obtained
through a nominal surcharge on each unit of dietary supplement sold in
the United States.

Thank you.

MR. LEVITT: Thank you very much.

Mr. Johnson, please.

MR. JOHNSON: Good afternoon. My name is Richard Johnson, and I am the
AARP Delaware State President.

AARP is interested in the regulation of dietary supplement because lots
of our members and other older persons use supplement products. In
recent years, we have commented on FDA proposals regarding the
regulation of supplements and claims made on product labels.

At the outset, we\'d like to commend FDA\'s work in standardizing the
label supplements. Clear, readable supplement product labels regarding
nutrient content and ingredients, with uniform standards for claims are
essential to providing consumers the information they need to make wise
choices. Ironically, consumers are not getting adequate assurance that
the products they choose are safe. Without proof of product safety, the
supplements that people take to improve their health may actually cause
harm.

We believe that the Agency\'s number one priority in the area of
supplement regulation should be to ensure the safety of these products.
We understand that the Dietary Supplement Health and Education Act
significantly hampers FDA\'s ability to remove dangerous supplements
from the market. We also recognize that the Agency has limited resources
to dedicate to this issue. However, we urge the Agency to think
creatively about what it can do to address supplement safety. A major
obstacle to supplement safety is a lack of scientifically sound
research. There has been some research on vitamins and minerals, however
research is needed on many other dietary ingredients.

Without a requirement for FDA review and approval before marketing
products, manufacturers have no research incentive. The inability of
manufacturers to patent many of their products and recoup safety
research costs is another disincentive to research.

Given FDA\'s limited research funds, it should consider alternative
funding avenues. One possible source could be a user-fee program. Every
supplement manufacturer could be assessed an annual fee based on some
appropriate criterion. The monies collected would be distributed as
research grants. Under such a program the Agency could establish an
advisory council to develop research priorities. One issue of concern to
our members is the possibility of serious interaction between certain
supplement products and prescriptive medicines.

Implementing a user-fee research program may be challenging, however.
Some interests may believe it more appropriate to implement such
research through the National Institutes of Health\--the NIH. AARP urges
the FDA to work with other Federal agencies like the NIH, and with
Congress, the supplement industry, and interested consumer groups like
AARP to establish a supplement safety research program.

A second issue of concern to us is the problem of product
classification. A product labeling standards and safety requirements
depend on whether it is classified as a drug, a food or a dietary
supplement. But classifications are not always clear, and are less clear
when products can cross the lines of definition. For example, Benecol
and Take Charge are two margarine products that contain an added
substance which lowers cholesterol. Calling these products something
other than drugs or foods\--functional foods, or nutraceuticals\--is
confusing. We urge that product classifications be structured such that
manufacturers cannot use them to skirt appropriate regulations. FDA must
ensure that the products are appropriately classified and conform to
proper standards.

Finally, we\'d like to mention our concern about the efficacy of
supplement products. If sufficient funds were available, we would like
both the safety and efficacy of supplement products to be researched.
Some of the research is already being done. For example, the Office of
Complementary and Alternative Medicine at NIH is currently funding
research in conjunction with the National Institute on Aging, on the
effects of ginkgo on memory. Clearly, more of this type of research is
needed.

At the same time, we believe that the agency could be doing a better job
of reviewing the adequacy of scientific support for the claims on
product labels. AARP members are especially concerned about the claims
on products marketed to older persons, such as those that claim to
improve memory, promote prostate health, and reverse the aging process.
Our concern is not just that these products may be worthless, but also
that they may not be harmless. Such claims may lead a person to forego
proven treatments, and select alternative remedies that are based on
unsubstantiated promises.

AARP appreciates the opportunity to present our views on an FDA approach
to supplement regulations. We would welcome and opportunity to
participate in the development of a sound regulatory system that
protects consumer health and safety in this rapidly expanding area of
health promotion products.

Thank you.

MR. LEVITT: Thank you very much.

Again, what we\'ll do is we\'ll go right down the row here, and try to
do one question each, and then at the end, I\'ll ask you to just
summarize: if there was one thing that you could have a year from now,
what would that be?

My question relates to safety. Both of you have emphasized that as an
important area. The law talks about what\'s called \"unreasonable or
significant risk.\" Without dwelling too much, from a lawyer\'s point of
view but just from a consumer\'s point of view, for this category of
products, what\--how should we go about deciding what\'s a reasonable
risk and what\'s not a reasonable risk? You know, what benchmarks, or
from a consumer point of view\--you know, would you want to be assured
of?

MR. BRIGHAM: I think that anything that might affect your health that
you unknowingly might take because it\'s not specified or not proven to
be safe is unreasonable.

MR. LEVITT: Okay. Thank you.

Would you like to\--

MR. JOHNSON: Well, no\--that\'s really a tough question. I don\'t know.
All I know is that you need to establish some kind of objective criteria
for\--

MR. LEVITT: Mm-hmm.

MR. JOHNSON: \--for establishing this definition, and that there really
hasn\'t been up to this point. I don\'t know if it\--it would involve
industry and obviously health care professionals and consumers
perhaps\--

MR. LEVITT: Mm-hmm.

MR. JOHNSON: \--and some kind of working group or panel. I mean,
I\--there are so many dietary supplements sold that in some way can be
dangerous. I mean our catalog is littered with warnings on the things
that we sell. We do quite a lot of research on them. But\--and I think
that safety is the number one priority here, for sure.

But also I think that the health benefits that are gained from these
supplements is significant and needs to be recognized and regulated
appropriately.

MR. LEVITT: Thank you.

Margaret?

MS. PORTER: My question is about consumer research. The second panel
this morning, I think, really stimulated us to look at issues about
doing more research, or having more research done on how consumers
actually use supplements, what they really understand or don\'t
understand from the labels that are there; whether they follow the
dosage restrictions, etcetera, etcetera. And as representatives of major
consumer organizations, I\'d be interested in your perspective on
whether that kind of research is appropriate; whether your organizations
ever do that kind of research into the behavior and attitudes and
preferences of your consumers, or how you think the agency would go
about getting such research done.

MR. BRIGHAM: I think that it\'s a very necessary thing. I would strongly
encourage you to formalize that and proceed in some way.

DAAIR is a relatively small organization, with limited funding, and we
really haven\'t taken an objective look at\--I mean,
intuitively\--because I know so much about my organization, I can kind
of answer that on an intuitive level, but on an objective, measured
level, I can\'t. And I\'m sure AARP might be able to do a little bit
better with some sort of funding.

But I think that that may be one of the first steps that might be taken
in order to structure the label. I mean, these different\--well, we\'re
proposing these different boxes on the label, to see just exactly how
they are being used, and what are the limitations and understandings,
and limitations of understanding. I think that would be one of the first
things I would do.

MR. JOHNSON: AARP is, as you know, a large organization, and in addition
to having 33 million members, there are probably about 600,000
volunteers within that structure, plus the staff members that give
guidance. All of the feeling is that this is very important, to have
consumer education. And in many of the fields, the major activity of
these volunteers with AARP is information and education. And we have
various things that are very important to AARP, such as Social Security
and Medicare solvency and that type thing. And I\'m sure that, as a
function of that, we would really advocate the information and education
as to what is necessary to make consumers more informed about these
items, and what is the proper of these things, and such as that.

Consumers, left to themselves, I think would tend to go in the direction
of if one pill is good, two may be better. And so there needs to be some
information to be disseminated that would help to counter that.

MR. LEVITT: Bill Hubbard?

MR. HUBBARD: Do you believe that your constituencies are more vulnerable
to unsafe dietary supplements than the general population, and do you
have any objective data of injuries or adverse events from supplements
in your various members?

MR. JOHNSON: What was your first part of your\--

MR. HUBBARD: Do you believe that your members, or your constituencies,
are more vulnerable to unsafe dietary supplements than the general
population?

MR. JOHNSON: Speaking for AARP, we represent, generally, the older
people in our society, and I think that they are probably more
vulnerable because they are the ones that are taking a lot of
prescriptive drugs. And the problems arise where some of these
supplements may actually interfere or cause difficulty if you\'re taking
a prescriptive drug.

I was surprised, in reading some of the literature in preparation for
this, that garlic is a blood thinner\--

MR. HUBBARD: Mm-hmm. Right.

MR. JOHNSON: \--and yet there\'s a lot of advertising of garlic to be
used. And if you\'re on, such as I am, a medication which already thins
your blood\--and many adults, or many seniors may be in that
category\--that would be an area of a severe problem. So I think\--yes,
the AARP members are probably more prone to have this difficulty than
others.

MR. BRIGHAM: Interestingly enough, my answer is very similar. I mean,
people with HIV and AIDS are also on a great deal of pharmaceutical
drugs. I mean, speaking personally for myself, with kava kava, I used it
at a\--about a year ago, and then re-challenged myself with it. I
actually ended up in the emergency room. I was on hamilor and
nortriptyline\--a tricyclic anti-depressant. And trying to manage some
anxiety before I went on to a prescription drug, I took kava kava. And
then I re-challenged\--the first time, I was admitted to the emergency
room. The second time, I just went to the emergency room because I was
taking a lower dose, and I just wanted to see if it really did it. But I
nearly passed out. I mean, I went through waves of passing out.

And, you know, and then there\'s\--the historical use of kava kava
can\'t extend past three months anyway. You develop quite a substantial
rash\--skin rash\--and dermatitis, it\'s known, if it\'s used
consecutively. And we have warnings throughout our catalog on blood
thinning agents\--many of the coumarins and stuff, and different herbs
and botanicals.

MR. LEVITT: Bill, if I could just follow up with you briefly on
that\--so, in your mind, the remedy for that problem is labeling on
products? I mean, everybody\--

MR. BRIGHAM: Yes.

MR. LEVITT: \--doesn\'t necessarily have the catalog that you\'re
referring to.

MR. BRIGHAM: Right. No. I think there needs to be some labeling
on\--definitely there needs to be some labeling, some safety\--you know.
And even if it means a label which opens up. You know\--I mean, I know
we\'re getting into OTC and things like that\--I mean, that goes into
these contraindications. You know\--and, I mean, they certainly do
exist. And to ignore them\--it\'s really, really needed.

MR. JOHNSON: And expanding a little bit on what the gentleman said, as
we talked of these needs for information on labels, I could envision a
label that would stretch across the table on a small bottle. But I think
it\'s necessary, and if it can\'t be done on a label, it has to be done
somehow, that the people are aware. I\'ve heard garlic advertised many
times over television and radio, without ever hearing any of the adverse
or possible adverse effects. And, again, it surprised me to find that
that was a side effect.

MR. LEVITT: Okay. Thank you.

Dr. Yetley?

DR. YETLEY: You both indicated that you would like to see FDA get more
input from consumers, particularly your consumer constituencies in
designing label information.

What mechanisms do you suggest that would facilitate that process?

MR. BRIGHAM: Well, the establishment of maybe a bi-coastal
group\--working group or panels or something\--to meet on a regular
basis to establish a framework of what to achieve, and goals to achieve.
I mean, and actually having some, you know, regular timely meetings with
consumers throughout a process, you know, that establishes a process and
objective goals within a period of time, I mean, and on a regular basis,
and is more formalized.

DR. YETLEY: Would you see this as separate from an advisory committee
that was discussed earlier, or would you see that this could be
incorporated into that process?

MR. BRIGHAM: I wasn\'t here for the advisory committee, but I think I
might see it separate.

MR. JOHNSON: If we\'re talking about getting input from consumers, it
might be possible with some of the AARP publications. We have a
publication called [The Bulletin]{.underline} which goes to all AARP
members, and the [Modern Maturity]{.underline} magazine. And I\'m not
sure if this could be accomplished in a very quick fashion, but if there
were such a thing as a questionnaire that would ask what are your inputs
that you might have as to the needs on labeling for the various consumer
issues, that might be something that could be done through the
publications that we have.

The other question that you had as to should this be in addition to an
advisory council, I\'d say yes, they should be separate entities; one
being from an advisory council, and then any other input you can get
from consumers directly.

MR. LEVITT: Thank you.

Dr. Bowen?

DR. BOWEN: My question is do you have any data from your groups of
consumers who use these drug products, are they using it in concert with
what is actually listed on the label, or are they using it differently.
And, in specific, could you talk about the disclaimer\--the FDA
disclaimer\--about the information. What purpose do you think that
serves, or if that helps?

MR. JOHNSON: I don\'t have any information that we have knowledge of
specific instances. Now, the disclaimer you\'re mentioning is the one
that says the FDA does not recommend\--I think that\'s very valuable,
and I think\--and, again, some of these things I wasn\'t aware of until
I read this literature on this subject, but in reading that, it seemed
that that would at least give people pause if they would read something
that was making some claims, and then they would see that this was not
something that FDA would sanction on the basis of the words in that
disclaimer.

I think it\'s very valuable.

MR. BRIGHAM: I actually\--I think the opposite. I think that there
is\--it\'s a wild, wild west show out there right now, as far as I\'m
concerned. I mean, I can\'t believe I\'m sounding as conservative as I
am\--

\[Laughter.\]

\--but\--since FDA knows which side of the fence\--I\'ve been before you
before on a number of occasions, in Congress and whatever. But it
is\--it\'s a wild, wild west show out there, and I think that the
statement is becoming essentially meaningless at this point. It\'s just,
you know\--and there is a substantial amount of deception and fraud
going on. I\'m not\--you\'re kind of focusing on health and safety
issues, which are certainly there\--certainly not as much as OTC drugs
or pharmaceutical drugs. But with the health\--related to health claims
and health benefits, I think that it\'s pretty\--it\'s a disaster.

So\--and there needs to be some more formalized standard of objectivity
and\--I mean, I know FDA is going through the process of redefining, or
defining what scientific agreement is or is not or whatever. But, I
mean, even aside from that, just trying to at least tier these health
claims a little bit to try and more inform the consumer, you know. And
then it\'s amazing how small they put that disclaimer\--the FDA. I have
to look for it, and it\'s like\--when I\'m looking at one of the ads, or
whatever. It\'s really\--you should at least require it to be in 10
point type.

\[Laughter.\]

MR. BRIGHAM: But, again, someone who has been involved with this for a
long time may find that it\'s something that you overlook. But for a
novice, or someone that\'s not that involved in these use of dietary
supplements, I think it would cause me pause at least.

MR. LEVITT: Okay.

Margaret, did you say you have a quick follow-up?

MS. PORTER: Yes\--I really did understand you not to think that the
disclaimer was very helpful, Mr. Bingham.

I\'m interested in your suggestion\--and I know you said your written
comments are going to more fully elaborate this\--

MR. BRIGHAM: Right.

MS. PORTER: \--or your comments on the West Coast next month, but I
understand you to be advocating a several- tier system that evaluates
various levels of evidence with respect to the varying degrees of
efficacy of particular claims. And, as you know, the more levels one
has, the more\--shall we say\--complex a system can become. And I\'d be
curious as to whether you are going to be advocating whether we would go
to a\--some sort of a monograph system, or whether you\'ve got some
models that you would have us examine if we were to try to look at that
kind of a system?

MR. BRIGHAM: I think I need to think about that a little bit further.

MS. PORTER: Sure.

MR. BRIGHAM: But, I mean, I don\'t know about going to a monograph
system. That may ultimately be necessary. But I think that this\--I
mean, if the public can understand the food pyramid I think they can
understand a four-tiered health claim system. And\--

\[Laughter.\]

\--I mean, and other things, including safety profile and GMP.

MR. LEVITT: Thank you.

Dr. Yetley, you have a quick follow-up?

DR. YETLEY: Yes, I was just going\--I think your comment\--I was going
to ask you about how well you thought consumers would understand a
tiered system, in terms of the shades of qualification. I think there
are questions as to how well consumers understand the food pyramid, so I
don\'t know about the analogy\--

\[Laughter.\]

\--but if either one of you had any comments, in terms of how consumers
understand various shades of qualification to a message?

MR. BRIGHAM: Well, I think it\'s really a matter of outreach and
education, and you should be given the funds for this, either through
congress, or through some kind of tax\--or, well, let\'s not use that
nasty word\--user-fee on dietary supplements\--per unit of dietary
supplements. And we obviously want you to dramatically increase your
role and expand it in this area. And it\'s going to take substantial
funding, and it\'s going to take a lot of consumer outreach and
education. But I think it can be done. And I think getting together this
working group, or bi-coastal working group of consumers is a good way to
start as well, you know, in addition to industry and other groups.

MR. LEVITT: Mr. Johnson, do you care to comment how you think your
constituents would respond to a four-tiered\--

MR. JOHNSON: I don\'t have any idea.

MR. LEVITT: Okay. Thank you.

With that, then, we\'ll give you one last opportunity to look ahead a
year from now and say to us, FDA, if I could see one clear
accomplishment a year from now, that would be\--

MR. JOHNSON: Safety. And, again, as I said, if we had two that we could
talk about: safety and efficacy. But safety is the primary concern.

MR. LEVITT: Thank you.

Mr. Bingham?

MR. BRIGHAM: Make some stop-gap\--I hate to use that work, because I
know the process is going to be long and tedious to work through this
enormously complicated issue of dietary supplements and the functional
foods and\--but some stop-gap safety assessment of various
nutraceuticals, vitamins, supplements and herbs that might pose a
potential risk to the public health that are out there. And have them
placed in some way that\--on the bottle, in a box, or whatever. I mean,
I don\'t know, but, you know\--I mean, I can list, you know, about 15 of
them off the top of my head, just, you know, right now.

You know, and getting at least that.

MR. LEVITT: Okay. Thank you. And if in your written comments you would
identify those 15 or so, we\'d be happy to know specifically which ones
you thought needed attention.

MR. BRIGHAM: Right.

MR. LEVITT: Listen\--I thank both of you very much.

That concludes this panel. We have one final panel, four lawyers.

\[Laughter.\]

And we have Claudia Lewis-Eng, we have Jim Prochnow, Steve McNamara,
Steve Allis. If you could kind of figure out how to sit in that order,
it makes it a little easier. From either end.

\[Pause.\]

Okay. Again\--although I think you all have been watching the
proceedings\--what we\'ll do is each speaker will have five minutes. It
looks a little different when you\'re up here. Right down here we have
the one-minute warning, and the \"time as expired\" sign. If we could
try to adhere to that. People have been very good\--I want to compliment
all the speakers, who have been very good about trying to stick within
that. And then we\'ll go down and ask some questions.

Please, first speaker, identify yourself and where you\'re from. And in
the case of the lawyers, please, if you could talk about who you are
representing here today.

**PANEL VI - LAWYERS & DIETARY SUPPLEMENT INDUSTRY**

MS. LEWIS-ENG: Certainly.

Good afternoon. I\'m Claudia Lewis-Eng, and I\'m an Associate with Emord
and Associates. And today I\'m here on behalf of our clients Pure
Encapsulations, American Preventive Medical Association, Dr. Julian
Whitaker, Mycology Research, and Weider Nutrition International.

I would like to thank the FDA for hosting this public meeting and
providing us with an opportunity to have this oral presentation.

In announcing the meeting, CFSAN made references to its 1999 priorities
document for regulating dietary supplements. While I agree with many of
the Agency\'s priorities, I must say there was a glaring omission. On
January 15th of this year, the U.S. Court of Appeals for the D.C.
Circuit made a decision in [Pearson v. Shalala]{.underline}. And that
decision stands for the general proposition that the government may not
suppress outright commercial speech that is only potentially misleading,
as opposed to inherently misleading.

In that case, the petitioners submitted four health claim petitions to
the FDA, together with the scientific information, and the FDA rejected
all four health claims. Those health claims were: omega-3 fatty acids in
reduction of heart disease; anti-oxidant vitamins in reduction in the
risk of certain kinds of cancer; consumption of fiber in reduction in
the risk of colorectal cancer; and 8 milligrams of folic acid in dietary
supplement is more effective in reducing neural tube defects than in
common food form.

In the [Pearson]{.underline} case, the U.S. Court of Appeals stated that
the fact that FDA found the scientific evidence submitted by the
petitioners inconclusive was not good enough to reject the claims and,
instead, that the FDA should impose the use of disclaimers to balance
the potentially misleading speech. And that\'s what I am here today to
urge the FDA to make as its number one priority: to authorize those four
health claims submitted by the petitioners, and include the use of
disclaimers to balance the potentially misleading speech if the
disclaimers are necessary.

I also urge the Agency to employ the use of disclaimers in the case of
other health claim petitions presented to the Agency, as opposed to the
outright suppression of speech. In fact, our firm just recently
submitted three health-claims petitions to the Agency.

The first health-claim petition was merely seeking a clarification from
a rule that we already feel applies to dietary supplements, and that is
psyllium husk seeds in the reduction of coronary heart disease. But the
second two we think that the Agency should really take a good look at
the science that we submitted and, if necessary, attach disclaimers to
balance any potentially misleading speech the Agency might find. And
those are folic acid, B-6 and B-12, and the reduction of cardiovascular
disease; and Saw Palmetto and the reduction of BPH\--benign hyperplasia.
The firm at this time also intends to submit one more health-claims
petition, and that would be vitamin E and the reduction of heart
disease.

And so I would urge the Agency, upon looking at those petitions to
really look closely and try to develop some disclaimers that could be
used, as opposed to rejecting the health claims, finding that the
scientific information is inconclusive.

And just a gentle reminder to the Agency: we strongly believe that the
[Pearson]{.underline} case governs every instance in which the FDA would
choose to regulate health claims. The case and its Constitutional impact
should really be a priority with the Agency, and we look forward to
seeing the use of disclaimers, as opposed to the rejection of the health
claims.

And since I still have some time, I would like\--have one other point
that I would like to touch on briefly, and that is the AER system.
Currently, FDA has a system of collecting adverse event reports. And it
doesn\'t seem that there\'s much organization or a systematic method of
collecting that data. For example, there are some instances where people
don\'t really inform the Agency of the products they were using, how
much they were using, what other types of medications they were taking,
what other things that might have gone into causing the adverse
event\--yet the Agency relies on this information for promulgating
proposed rules. And that was the case in ephedrine.

So we think that the FDA should take time to restructure its AR system
and perhaps have a separate system for dietary supplements as opposed to
combining with the food information. So we also want the FDA to take
time to confirm that the information put on the Web is accurate, and do
as much background checking as the Agency can in order to make sure that
information that\'s posted on the Web does not adversely affect innocent
companies.

Thank you very much.

MR. LEVITT: Thank you.

Next speaker\--from Patton Boggs, Jim Prochnow. Help me with the name,
because I\'m not sure\--

\[Pause.\]

MR. PROCHNOW: Jim Prochnow, from the wild, wild west\--from Denver,
Colorado.

Our law firm is based in Washington, D.C., but I am the chairman of the
Denver segment of the office, that deals with dietary supplements, both
from the standpoint of FDA, Federal Trade Commission, state regulators,
product liability suits, and all the other forces that help to regulate
dietary supplements in the marketplace.

And, basically, we represent a variety of manufacturers,
distributors\--whether by mail order catalog, by multi-level marketing,
by health food stores, mass merchandisers, things like this. And in
preparation for this meeting, what we did was we sent out an e-mail to
virtually all of our clients asking for their input about the questions
that were raised in the [Federal Register]{.underline} about the
importance of dietary supplement regulation in the future.

We\'ve gotten, to date, about a third of those responses back, but we
will tabulate them by the time that the comments are over. And,
actually, quite a few of them are going to\--at lengths to describe what
they think are\--their opinion of how dietary supplements and dietary
supplement companies should be regulated in the future, and we\'ll be
making a very intricate matrix of that information and passing it along
to the FDA, and make it available to others who are interested in that
information.

Today, with the very restricted time element here, I\'m going to make
only three points. One is this: in our judgment, DSHEA, which was
passed\--that magic date in October of 1994\--we think already is a very
comprehensive framework for governing the dietary supplement industry.
If there\'s going to be any tinkering with DSHEA, it should be with the
expansion of benefits to consumers and the industry, and not with any
restriction of DSHEA by regulation or otherwise. That\'s the first
point.

Secondly is this: we think that the way that the FDA can best give input
from the American public is actually keying off something that one of
the last panelist members said, and that\'s \"go to the people more.\"
It\'s okay to have these types of meetings, and it\'s okay to deal with
the major trade associations, who have a very important role to play.
But like the FDA has done in the area of medical devices, our clients
believe, and I believe that what they should do is hold a series of
meetings in Colorado, where there\'s a lot of dietary supplement
companies of every nature; in Utah, perhaps the hotbed of dietary
supplement companies; in California, New Mexico, and places like
that\--have one representative from the FDA in Washington, if they have
the resources, otherwise have the local district office; invite the
folks in for a three-hour meeting, and sit down and talk with them. And
then you can really find out, on a local basis what\'s going on. It\'s
the best way to get the most information in a cost-effective way.

The other comment that I wanted to make today\--and my biggest
comment\--is this: the FDA has good folks that are sitting here, but
they probably aren\'t going to get much funding than they have now to
carry out their duties. So I hear all of these people saying a lot of
good things about what these good folks should do, but the fact of the
matter is they\'re going to be able to do very little more than they\'re
doing now without a lot of increased Federal funding, and that\'s
unlikely to happen in today\'s political atmosphere\--and in the
atmosphere of the dietary supplement industry.

So what I\'m proposing today is that everybody here should think about
something that actually was raised by one of the last people to speak,
but I\'m going to raise a more specific thing, and that\'s this: and
that\'s an industry-funded check-off program. For those of you that know
what check-off programs are all about, basically it\'s where the
industry itself has Federal legislation that enables monies\--not a
tax\--but monies to be collected on a per-unit basis, whether it\'s a
half-cent per bottle, or whatever\'s agreed upon\--the money is not
spent by the Federal government. The money is\--it\'s a check-off
program that\'s spent by the industry. The industry itself elects
members to a council. It\'s a very intricate thing. It\'s been done very
successfully in the cotton industry, in the beef industry, in the
propane industry, now the heating oil industry. It\'s a very effective
thing. People can disagree with different aspects of it. But the
important thing is, it would be industry-controlled as opposed to the
FDA controlled.

When DSHEA was passed, I remember the fighting that went on beforehand,
and the fight was to have less FDA regulation, not more. And the reason
for that is this: it was thought that historically the FDA was at odds
with the industry and with the American public over health. I think that
attitude is shifting somewhat. Still, the regulators are never going to
know as much about your industry as you know about the industry. And
unless you want more regulation, the industry itself, either through a
check-off program, or through some other mechanism, is going to have to
develop an effective means to regulate itself.

Personally, I\'m not in favor of any more regulation. The marketplace is
a powerful regulator itself. Product liability suits, claims,
insurance\--things like that. But if there\'s going to be more
regulation, let\'s let the industry do it, and not the FDA and the
government.

Thank you.

MR. LEVITT: Thank you very much.

Next is Steve McNamara:

MR. McNAMARA: Good afternoon. I\'m Steve McNamara. I\'m with a law firm
that generally limits its practice to matters of food, drug, medical
device and cosmetic regulation. And I\'m here today specifically on
behalf of one of our clients\--Starlight International, headquartered in
the lovely location of Monterrey, California, where some of us would
like to be more often. Starlight is a manufacturer and distributor of
dietary supplement products.

I\'ve been asked to address today and issue that, interestingly, does
not appear to have been raised at all at this meeting up until now.
It\'s an issue that goes to the heart of FDA\'s authority in certain
respects; for example, I heard Mr. Levitt earlier ask one of the prior
speakers, \"Would you recommend that we use regulations or guidelines or
what?\" It\'s also an issue that could save FDA a lot of resources if
approached appropriately, I believe.

And basically, this is the point. And I should say here, we have a
detailed paper that discusses the citations and quotes the supporting
authority for all of this. I\'m just going to try and hit the high
points in an oral summary.

The basic point is this: I\'ve spent about 50 hours going through the
legislative history of the Dietary Supplement Health and Education Act
over the last two weeks, at the request of the client, to look at this
particular issue. It brought back a lot of memories. As some of the
FDAers will recollect, I testified both in the House and the Senate for
the coalition of Utah companies that asked Senator Hatch to introduce
and sponsor the Dietary Supplement Health and Education Act. So I\'ve
been rather thoroughly involved with this for the past five years.

Having refreshed my memory, and having looked at the facts, it seems to
me that\--it would be pretty clear that because of certain unique
provisions in the Dietary Supplement Health and Education
Act\--provisions that were specifically considered during the
legislative process\--and because of provisions that do not apply to any
other parts of the Food, Drug and Cosmetic Act, it appears to us to be
the case that FDA does not have the authority to issue a regulation that
has binding effect with respect to the adulteration or safety provisions
of the law that have been discussed earlier today.

Let me just, for purposes of oral summary, and recognizing that many of
you are not lawyers, go to the essence of some of the key points.

First of all, on the face of the law itself, Section 402(f)(1) of the
Food, Drug and Cosmetic Act, as amended by the Dietary Supplement Health
and Education Act, there are a series of provisions to the effect that a
dietary supplement will be deemed to be adulterated \"if\"\--and these
have been referred to by FDA representatives today, including Mr.
Levitt, and summarized at one point accurately as, a dietary
supplement\'s adulterated if it presents a \"significant or unreasonable
risk of illness or injury\" etcetera.

At the close of this section, however, after all of these adulteration
provisions are provided, there is the following unusual provision: \"In
any proceeding under this subparagraph, the United States shall bear the
burden of proof on each element to show that a dietary supplement is
adulterated. The Court shall decide any issue\--\" any
issue\--\"\--under this paragraph on a de novo basis\--\" i.e., all over
again, from scratch, not relying on a conclusion that has already been
reached in the past by the FDA.

I believe on the face of the law that says that if FDA goes to all of
the work to publish a regulation, and then marches into court with a
regulation that says a particular section\--particular dietary
supplement is adulterated because it contains a certain amount, for
example, of ephedra that exceeds the level that the regulation allows,
and that therefore the supplement is adulterated, the Agency will not be
able to rely on the regulation but will instead need to prove its case
from scratch that that particular supplement is adulterated under the
statutory standard, and that the company would be free to offer data to
show that its product, as evaluated by it, with its own marketing
history is, in fact, safe for use and not adulterated. And the
regulation would not establish the outcome.

I am reassured in my conclusion about this by looking at the legislative
proceedings. It happens that this very section of the law originally had
a provision in it for FDA to issue regulations, but that that
provision\--that authorization for regulations\--was explicitly deleted
before the final section of the law was passed. Furthermore, the earlier
provision did not have the section that said that a court shall decide
any issue on a de novo basis. And, in fact, that was added when this
section was put in and when the explicitly provision for a regulation
was deleted.

There\'s more in the legislative history. It\'s discussed in some
detailed in the paper. We will welcome other dietary supplement
companies focusing on this issue in taking a good hard look at it,
because we believe it establishes a point that many in the industry will
have a common point of view about: that FDA itself, when it moves to
articulate what it believes the law requires with respect to safety or
efficacy under Section 402(f)(1) should be relying on guidelines, not
regulations. And if it spends all the money\--time, money and effort
that are necessary to issue a regulation, the regulation won\'t have any
more effect in court than a guideline anyway. So why not creatively
shift to guidelines, rely upon guidelines, and the agency can get a lot
more guideline work done in a shorter amount of time and with less
resources than would be taken by regulation.

Thank you, Steve.

Steven Allis\--last speaker on this panel.

MR. ALLIS: Thank you.

As the last speaker, I\'m sure I\'m\--everyone\'s got the same thought
right now. So I\'ll try to just hit a few key points and then move on to
the next phase.

My name is Steven Allis, and I\'m an associate at the Firm of Emord and
Associates. I represent a company called Biogenics, which does business
as Eola International. They manufacture a variety of dietary
supplements, including dietary supplements containing ephedra.

When I first saw the notice for this meeting it, to me, summarized that
FDA was looking for comment on how to identify where to proceed; how to
prioritize its tasks and to put those tasks into effect, or to
accomplish those tasks. I\'m not asking in the comments to really do
much of a change. I\'m not really focusing so much on that, I\'m
focusing more on how to go about that change; not exactly what should be
changed, but the processed involved with that.

There are three points I\'d like to focus on.

The first is that in the decision that the agency is going to make, it
should rely on sound science, which is a very obvious statement. And
I\'m sure your scientific staff would agree with that, because that\'s
their bread and butter. The sound science standard, the standards used
to evaluate that have been recently affected by the
[Pearson]{.underline} decision, recently mentioned by Ms. Lewis-Eng. And
in that decision, the court, as part of it, said that the FDA needs to
define a scientific standard that would be applied to dietary
supplements. And the language, of course, involved \"significant
scientific agreement.\"

And what I want to point out is, as far as the procedure used for
defining the scientific standard here\--the point that what I want to
refer to\--a duality I\'ve noticed with the agency, not only working as
an attorney but as a former scientific reviewer in the Office of Device
Evaluation\--I have seen that when a company wants to petition the FDA,
as with the recent health-claims petitions that my firm submitted, the
standard, of course, there is scientific evidence that demonstrates
significant scientific agreement. And in that, it\'s not really clear
where that lies, especially after the [Pearson]{.underline} decision.

Some science like well controlled randomized studies, of course, fall
under the category of good science. Things such as anecdotal evidence
are usually\--are almost totally rejected, and they should be, because
they\'re not really good science. They\'re little cases here\--someone
had this affect, and someone had this other effect. So in that situation
a company is asking FDA to do something and the reaction is, well you
have to reach a certain level of science. Some science is bad, some
science is good\--we\'re going to draw the line somewhere in the middle.

Now, when the opposite happens\--when FDA is seeking to take action, as
in the case with ephedra, these anecdotal reports all of sudden become
valuable. They\'re used as a basis for saying, \"Okay, we have
something\--some information, scientific or not, that is going to be
used to base our regulations on\--to base our regulatory decisions on.\"
And as in the case of ephedra, a number of adverse event
reports\--AERs\--were used as a primary basis for prompting the
regulation which is currently pending of ephedra.

The problem, of course, with AERs is that they are just cites\--or one
moment in time where someone had an effect from a product, and that\'s
just kind of floating out there. There\'s no real reference to put that
in. It\'s not a study where you had a certain population, or we can
derive a percentage from: how many people had a bad result. And not only
that, but the AERs also are flawed because they\--sometimes you don\'t
know what product they took, how much they took of it, what other
conditions they had. And I just bring up these\--this duality. We have a
situation where FDA\--where someone\'s asking FDA to do something and
the standard is a strong scientific standard. And when FDA is trying to
do something that involves an industry or a company, that standard gets
kind of ignored. It\'s kind of made a little bit over inclusive. And
I\'m just asking that whatever the Agency decides, to stick with sound
science in its procedures.

The second theme is to ask the agency not to overregulate. Now, that\'s
another overstatement, but what I\'m getting at with that is\--again, I
can use ephedra as a good example. That\'s a product where there are
some bad actors out there. The product has been tied to a possible
illicit use for some manufacturers. There\'s also problems that might be
attributed to the labeling claims, or over\--too high of a concentration
of ephedra.

Now, what I would hate to see is where a few bad actors ruin it for the
whole industry. And that\'s particularly alarming when you consider that
the existing statute and regulations could allow effective regulation to
get these bad actors from ruining it for the rest of the industry.

There are already regulations in place to prevent claims that aren\'t
supported by science. There are various other tools already in place
that could be used to stop these bad actors. There\'s no reason to put
another layer of regulation to restrict ephedra, particularly when that
regulation is based on, like I said before, the faulty science of the
AERs.

And as a last point, I want to refer to\--whatever the Agency does, to
be fair. And that\'s another overbroad statement. Here, I have to refer
to what Texas has recently done, or is trying to do with ephedra, and
that would be passing regulations saying that \"we\'re going to regulate
botanical ephedra a certain way, and synthetic ephedra another way.\"
There\'s no real justification for treating the two differently if it
comes from a plant source or a chemical source. There is no science that
I could find out there, or that anyone I relied on could find out there,
saying that there is\--the body recognizes the difference between the
two.

I\'m just using Texas as an example of an agency that is saying,
\"We\'re going to treat these two versions of the product differently\"
with no apparent rationale.

So I just ask for the Agency to keep fairness in mind when they\'re
applying any of the regulations of industry.

Thank you for your time.

MR. LEVITT: Thank you very much.

For my first question I\'d like, if I may, take advantage of the fact
that we have four very knowledgeable lawyers up here, and while not
picking up necessarily on the particular points you made, you\'re all
familiar with DSHEA.

One of the things that has struck me in learning more about it is there
is a long litany of issues that might benefit from definition,
clarification, throughout that statute. In your experience, could you
each list, just in your mind, one or two legal definitional kinds of
issues that would really us paying attention to, giving clarification
to?

MR. PROCHNOW: This is Jim Prochnow. The question that I get asked the
most frequently by clients is what does \"substantiation\" mean? Usually
I say, the FDA has refused to define substantiation in its comments to
various rules, and said it\'s kind of like pornography; we recognize it
when see it.

But substantiation is a huge issue, because people do want to comply
with the law. And, as you know, as a quid pro quo for making
structure/function statements, you have to have substantiation for what
you say is true. So I would say in the clarification arena, more
clarification about what\'s \"substantiation\" would be helpful.

And I want to say I agree with Steve. And I say use of guidance
documents is the way to get this done, as opposed to regulation. It will
take too long for regulations, and you need the industry to buy in on it
from a voluntary basis anyway. So I\'m all in favor of substantiation,
and the use of guidance documents to accomplish what the FDA needs to
accomplish in this area.

MR. LEVITT: Thank you.

Who else would like to comment?

Steve?

MR. McNAMARA: Well, I do think there\'s a fundamental problem over the
so-called \"disease\" definition, but that goes even broader. I mean,
part of it goes to the issue that several people referred to earlier:
the FDA\'s proposal from April of a year ago. And we all, I trust, are
aware of the volume of response, and the strongly felt disagreement.

But there seems to be a belief on FDA\'s part, held closely and deeply,
that somehow disease-related claims are not appropriate for things that
are foods, and dietary supplements are a sub-category of food. In fact,
the definition of \"food for special dietary use,\" which has been in
the FDA regulations since the 1940s, and which includes among the
defined categories \"dietary supplement products\" as a type of food for
special dietary use, has recognized that claims of special dietary
usefulness for a food may include claims about providing usefulness with
respect to physical, physiological, pathological or other conditions
including, but not limited to, the conditions of disease. I\'ve more or
less got that verbatim. And that\'s in Part 105\--I guess .3, somewhere
along that line, in the definitional section.

I would submit to you that there are perfectly appropriate dietary
supplement uses with respect to disease, and to say that something is
\"disease-related,\" to use the conceptual dividing line that FDA often
uses, is not an appropriate divider for deciding whether something
ceases to be an appropriate food or not; and that there are very good
cases to be made, which will be made\--and I hope they don\'t need to
eventually be thrashed out in litigation\--to the effect that
disease-related claims are indeed appropriate in certain circumstances,
for certain products, for things that are dietary supplements or,
indeed, foods for special dietary use.

And I think that if we are to avoid that black hostility that I believe
Jim Turner talked about earlier, that this is an apt time for the Agency
to reflect on some fundamental instincts about what\'s acceptable for a
food and a supplement, and a food for special dietary use, insofar as
that\'s an appropriate umbrella term for supplements.

And I personally believe that there\'s a very good legal argument, as
well as a good policy argument, that there\'s number of disease-related
representations that deserve to get in\--appropriately, properly\--and
that the Agency\'s instinct is so resistent to that, and its proposals
are so resistent to that, its courtesy letters are so resistent to that,
that we find ourselves dealing with these issues always in conflict
situations. It\'s regrettable.

I mean, one of\--you asked earlier about advisory committees, whether
they\'re advisory committees, or however they\'re set up. It really will
be advantageous to the industry and to the FDA, I think, if you can find
ways for some of these issues, which have been dealt with in contentious
contexts to be dealt with in non-contentious contexts.

MR. LEVITT: Thank you.

Yes.

MS. LEWIS-ENG: I do have one comment that I would like to make.

I don\'t really have a clarification comment under DSHEA that I would
like to ask, but I do have one under FDAMA. Since the agency is really
looking at priorities at this time, I think that we should have a clear
definition of what an \"authoritative statement\" is. I think there has
been lots of upheaval in the industry\--dietary supplement industry in
terms of what exactly constitutes an authoritative statement, and the
agencies such as NIH and the FDA and others who are approved under FDAMA
don\'t seem to agree what an authoritative statement is. And I think
that really should be clarified.

MR. LEVITT: Okay. Thank you. I think that counts.

\[Laughter.\]

Steve, do you have anything you\'d like to add?

MR. ALLIS: Your question related to where we could establish or improve
on definitions that you rely on?

MR. LEVITT: Yes.

MR. ALLIS: All I can really do is reiterate my point is that looking at
this from a legal perspective, or regulatory perspective, it\'s easy to
ignore the science side of it, which is what I was trying to stress in
my talk, which is that it\'s pretty easy to define what\'s good science
and what\'s bad science most of the time. And as far as a definition
goes, just, like I said in my speech a minute ago was that if it\'s
going to be bad science for use for someone to apply to the Agency, it
should still be bad science when the Agency wants to rely on it for
passing regulations.

MR. LEVITT: Okay. Thank you.

Margaret.

MS. PORTER: Well, I have several questions I\'ll try to discipline
myself and start with one that I actually asked the earlier panel.

I was pretty stimulated by this morning\'s second panel really urging
the Agency to find ways of doing consumer research or having others do
consumer research that really looked intensively at how dietary
supplements are actually used; whether consumers really follow the
labeled indication, follow the dosage indicates; whether they use
supplements for purposes that are not advised by the manufacturers, and
whatever, on the labeling and otherwise.

And I was interested in any comments that you might want to make on
behalf of your clients about the appropriateness of that kind of
research; the usefulness for which it could be used. I know that in the
[Pearson]{.underline} context there is a strong suggestion that the
Agency look at that in the context of disclaimers. I\'m acknowledging
that, but also asking some broader questions, and I\'d be interested in
any comments you might have.

MR. PROCHNOW: In my judgment, I think it\'s a very important component
to the resolution of all of these issues. I mean, consumers are the ones
that are to benefit from taking dietary supplements. They probably drove
the enactment of DSHEA. The question always is: how do you pay for this
and get it done in a reasonable period of time.

Now, although I respect what the FDA has done in the past, still it
seems its efforts with respect to the ephedra rule, and
structure/function rule not get too far. So I think that if there\'s
going to be some research in this industry, again it has to somehow
be\--the industry has to, I think, carry the water on that issue, with
input from the FDA.

I think the industry wants to do some of these things, and is looking
for a mechanism of how to carry this out. I think there\'s got to be a
partnership involved here, and I think Annette Dickinson talked about a
partnership this morning. I just happen to think\--I\'m trying to be
creative and think about our clients, or about a program that the
industry can buy into to fund some of these things. Because of this
requires a lot of money. And without that happening, I don\'t see it
being done.

But we use consumer research on trademark issues in this industry all
the time, and for other things. So I think it\'s imperative that
something like that should be done.

MR. McNAMARA: I trust the assumption is that it\'s not being done in all
cases. I mean, there are some substantial companies\--I would assume,
but I don\'t know that I have the right to make the assumption\--often
the larger ones, that have, I know, spent a great deal of money on
appropriate research of various kinds. I think the first focus tends to
be on the substantiation of the health-related structure/function
statement, but there\--it\'s not appropriate to name brand names up
here, but there\'s a major line of products out there now with a
clinically-proven representation on the front panel. I think you\'ll
find that people who are making those kinds of claims have done a lot of
work to substantiate those, at least certain of the companies that are
larger companies, that I\'m familiar with are, in fact, doing that.

And\--so I wouldn\'t reach the quick and cavalier assumption that things
are not being done, or at least that it\'s any materially different than
perhaps you find with respect to other industries that FDA regulates,
where there\'s a variety of performance. But you should also not judge
companies that do comply by those that don\'t. And I think that there
are many out there who feel that sometimes they\'ve put in the work to
defend what they\'ve got, and then they\'re tarred by generalizations
that are made about others.

One of the other factors that I really think is important here that no
one has raised yet, and that I know that Dr. Yetley and Mr. Levitt have
heard me raise in other contexts, has to do with insofar as you\'re
worried about a definition, or insofar as you\'re\--you know a product
is a supplement or a drug, or insofar as you\'re worried about whether a
claim is an appropriate claim or not; insofar as the Agency expresses an
opinion, it ought to be willing to follow through on that opinion.

And one of the negative impacts right now that we are all living with,
if we\'re honest, is that the Agency is issuing letters that express
opinions that nobody pays attention to; or that the addressees have paid
no attention to. I\'ve mentioned one that I know\--again, I\'m not going
to mention a brand name up here, but anyone out there in the industry\'s
probably familiar. I mean, the Agency sent at least five letters
expressing the view that a particular name and claim are illegal and
inappropriate for a particular product that\'s quite successful. And it
has been increasingly successful, notwithstanding the FDA\'s repeated
letters. And the Agency\'s done nothing, and the product is just booming
in the marketplace.

Now, believe me, when other companies come and consult with you about,
\"Well, can we make the following claim or not,\" and you say, \"Well,
you know the agency issued a letter about that point last year.\" And
they say, \"Tell me about something other than an FDA letter. I know
what happened to the letter that FDA wrote that other company. They
didn\'t do anything to follow through on it. The people that withheld
from meeting the competition lost lots of money. And I have no
confidence in FDA paper.\"

And whatever structure you come up with\--earlier commenters this
morning, I noticed, were talking about enforcement. I\'m not up here to
ask you to go out and have enforcement actions. I\'m here to defend
companies. But I believe that the wrong way to have the railroad run is
for the Agency to express views that it does not follow through upon.
You\'re wasting your money if you\'re sending that kind of a letter.
You\'re not only getting no bang for the buck out of it, but you\'re
undermining the respect for the agency in other contexts.

And a fundamental question should be going through the head of the
Agency, whenever it expresses an opinion in writing, and that is: do we
mean it enough that we mean it? Or are we just putting it out there, and
if people ignore it, we\'ll do nothing. And\--enough to say on that.

Others?

MS. LEWIS-ENG: Whenever it comes to scientific substantiation, the
question of money always arises. And I represent a number of clients who
wouldn\'t be afraid or unwilling to spend a substantial amount of money
to submit scientific substantiation to the Agency if they had faith that
the Agency would take an objective view of the scientific
substantiation.

In the past, when I sort of encouraged this type of clinical trials and
whatnot, to take place, the most\--the response I received most often is
that, \"I\'m not certain that the FDA is going to take this scientific
evidence that I produced seriously, based on its past actions that the
Agency has taken.\"

So I would submit to the Agency that perhaps until the industry has more
faith in the Agency, in terms of being objective and not having biases,
if you will, that perhaps the Agency could team up with universities, or
private contractors, if you will, to come up with some scientific
information that everyone could pull from, and they get a grasp of what
the Agency is actually looking for, and what will work with the Agency.
And they might be willing to spend their own dollars on the scientific
substantiation.

MR. LEVITT: Thank you.

Did you want to say something? Please.

MR. ALLIS: Like what I\'ve stated before is that the companies do
want\--for the most part, do want to do the science. The clients that I
represent with Ms. Lewis-Eng, they have an interest in having the
science and putting the investment into the product. Of course, there\'s
something you should keep in mind, which is that there\'s a risk not
only that the other guy in the market won\'t have to be meeting the same
burden, also, as I\'ve seen in dealing with science and submission to
the Agency, there\'s very little guidance sometimes, or access to people
who will be reviewing the science, to find out whether a little flaw is
going to be a fatal flaw later on when you come to the end of your
study. That could be a huge expense, especially for the smaller
companies that predominantly are found in this industry.

Another thing I would want to bring up is that the health-claims
petitions that we filed recently\--adopting health claims such as that
might alleviate the need for some of the dietary supplement claims that
are being generated by individual manufacturers, if they could rely, or
fall back on a health-claims petition\--or, I\'m sorry, an approved
health-claims petition. Maybe that statement might forego the need to
come up with, maybe, some more extravagant claims or objectionable
claims.

MR. LEVITT: Thank you.

Before we move on to Dr. Yetley, let me note that Mr. Hubbard needed to
leave. And I\'m sure, Margaret, Bill would want to have yielded his time
to you. And so, when we finish, if you\'d like to have another couple of
questions, I\'m sure this group is eager to answer them.

Beth.

DR. YETLEY: Some of the previous panels had urged the FDA to take
stronger action relative to safety and substantiation of claims.

How would you recommend that the FDA deal with the recommendations that
hey were making to us?

MS. LEWIS-ENG: Well, I wasn\'t here this morning. But, of course, safety
is of the utmost concern. As a consumer myself, I wouldn\'t advise the
Agency to just put products on the market because there was some
inclusive scientific evidence that wasn\'t really\--didn\'t substantiate
the claim at all.

What I\'m looking for is that very rarely in the scientific is there a
total agreement, and I\'m just looking for some balance that the Agency
can put on the health claims and substantiation requirement so that the
small actors, as well as the large actors in the industry, can compete
effectively in the market\--with safety, of course, being the number one
concern.

MR. PROCHNOW: In my judgment, the biggest thing that you could do for
safety right now, I think, is to either adopt the GMPs that have been
proposed by the industry in a guidance document, or issue a regulation
for them. It will send a signal to the industry that this GMP process,
and other processes, can have an end to them, and that the FDA can bring
to finality certain things.

It\'s important, not only for the substance of them, but for the fact
that they are actually issued, in the form of a guidance document or
regulation. Because right now, whether it\'s in the context of just
manufacturers and distributors wanting to be able to have safe products,
but people will conform to a\--whether it\'s a quasi-regulatory document
like a guidance document or a regulation\--but I believe there\'s got to
be some finality to the GMP process, and that\'s the single biggest
thing at the present time.

The second thing, I think, is selective\--maybe sending out more warning
letters and then, as Mr. McNamara suggested, taking some action with
respect to some of the warning letters, because that makes a difference
and an impact in the industry as well.

MR. LEVITT: Okay.

DR. BOWEN: I\'m tempted to yield my question, but I guess I\'m very
curious, so I\'m going to ask it.

Mr. Prochnow, you mentioned that you thought that FDA could get a lot of
mileage out of holding meetings across the country in areas where
consumers use dietary supplements pretty extensively. If that were
possible, how would you envision those meetings to happen? The forum of
those meetings?

MR. PROCHNOW: How do I envision them to happen in what? I\'m sorry.

DR. BOWEN: Sort of the format, the forum of these\--

MR. PROCHNOW: Yes. I think basically what it would be is this\--is that
you would send out a notice\--let\'s just pick Colorado Springs\--that
there will be a meeting in Colorado Springs, and the people that will be
there will be the District Director of Colorado and somebody\--let\'s
say Bob Moore\--from the Washington, D.C. office. There will be a topic
presented\--let\'s say it\'s quality control and good manufacturing
practices in the dietary supplement industry. I think there should be a
short, like, overview, and maybe that topic divided into five segments.
And then the meeting should be split up with, let\'s say, 10
people\--let\'s say you have 40 people there\--10 people in a session
that considers one of the issues, reports back and makes recommendations
to the group as a whole.

I think that process, you know, can take a half day or take a day, but
it worked really effectively in the meetings I went with the medical
device community, and it\'s been just\--the people I\'ve talked to have
come away feeling that they finally had the FDA listening to things. And
it\'s just so often that there\'s so little chance for a mass of people
to be participating in meetings like this that you\'ll really find out
what the multi-level marketing distributor sees as the problems it
confronts, or the contract manufacturer says \"Here\'s where I really
need some help,\" or where we could use some more working with or
regulation with the FDA.

It\'s that kind of format that I think would be very effective.

MR. LEVITT: Thank you.

I\'ll give the phone back to Margaret.

MS. PORTER: This is\--actually, Dr. Bowen actually asked one of my next
questions. So let me just do a little bit of follow up, because I think
that your comments, when you focused on sort of taking the Agency to
the\--going to the people and really engaging in a grass-roots way, I
think the Agency also found the Denver meetings with the medical device
industry quite productive, in terms of really having a way of listening
to concerns and responding to them.

There are several different kinds of people that I think the Agency\'s
interested in trying to reach out to at a grass-roots level. Certainly
one kind of stakeholder is the industry itself, and you suggested, I
think, the forum under which the Agency might do that.

Do you have some suggestions for reaching consumers directly? We\'ve
obviously heard from a number of national or regional consumer
organizations today, but I\'d be interested if you\'ve got some
suggestions for grass-roots consumer outreach as well.

MR. PROCHNOW: I\'ll let others speak to it. But one thing I do want to
say is I think the gentleman who represented AARP had a really good
suggestion. I\'m now an AARP member, for all of you that were wondering.

\[Laughter.\]

But their magazines\--I mean, I read [Modern Maturity]{.underline}. I\'m
55 years old now and all of that, and it\'s the people who are in that
age category\--this is important things, and they respond to it. And
you\'re talking about a huge segment of the American population. So I
think the use of some mass media opportunities like that is the best way
that I can think of. But others probably have other ideas about that.

MR. McNAMARA: It strikes me there are lots of interesting and important
segments of consumers. A significant segment of dietary supplement
users, it appears to me, based on things that have just happened to come
up in our practice of the law, include younger people in college and
high school. There\'s a group of people who are highly interested in
issues relating to diet and health and in supplements, and in
alternatives, and I assume there are ways to reach college-age people as
well. And one\--again, we\'re lawyers, not marketing folks, but one
certainly can get advice about reaching the various segments.

But it seems to me the important issue is to try and reach a lot of
them. Sitting here as another\--I hate to say how many years\'\--member
of the AARP, but those\--my children never read those magazines. Let\'s
put it that way.

MR. LEVITT: Okay. Thank you very much.

Before we let you walk back down, we get the one final question: looking
ahead a year from now, if FDA could do one thing it would be?

MR. ALLIS: Umm\--

MR. LEVITT: One thing.

MR. ALLIS: One thing.

\[Laughter.\]

MR. ALLIS: Better access through guidance and interaction with your
review staff so we can hit these targets that seem to be moving targets
some times; the definitions and such.

MR. LEVITT: Okay.

Steve McNamara.

MR. McNAMARA: Well, I\'m here for a particular client, so focusing on
that particular\'s interest I\'d like to see FDA withdraw the pending
proposal on ephedra; have informal meetings that could then be held with
the ephedra dietary supplement industry, focusing upon things that FDA
may want, including long-term follow-up and issues that like, and have a
guideline, or at least an indefinite interim guideline issued about the
Agency\'s views about labeling composition and what a responsible
company should be doing, including\--insofar as you feel that\'s
important\--follow-up monitoring and reporting to the agency about
events.

MR. LEVITT: Okay. Thank you.

Jim.

MR. PROCHNOW: I think I\'m going to be able to do one\--and-a-half here,
because I agree with everything that Steve had to say about the ephedra
rule: guidance document only.

Beyond that, I think that, seriously, all of the people here have raised
this issue about maybe not more regulation but the need for the FDA to
be actively involved in the process with the industry. And so therefore,
at the end of this year I would hope that we have completed a round of
intimate industry meetings in a lot of different districts throughout
the United States, so we\'re in a better position to move forward with a
master strategy plan after next year.

MR. LEVITT: Okay. Thank you.

Claudia.

MS. LEWIS-ENG: And to be totally predictable\--

\[Laughter.\]

\--I would like to say I would like to see a faithful implementation by
the Agency of [Pearson v. Shalala]{.underline}. And I also would like to
say that I want to rally behind Jim and Steve\'s request that the FDA
withdraw the proposal on ephedra.

MR. LEVITT: Okay. I thank this panel very much. As you\'re getting ready
to get up and walk back down, there are two additional people that have
asked to speak. I\'d ask them to come up together, and we\'ll have a
mini-panel here.

One is Anne Fonfa, and one is Mary Silverman. And then that will
conclude our day.

Thank you very much, the four of you. And thank you for traveling\--and
the many other people that traveled, too.

\[Pause.\]

**ADDITIONAL COMMENTERS**

MS. FONFA: I\'m just going to start.

MR. LEVITT: Thank you. If you\'ll just let the gentleman behind you sit
down. And again, while you\'re up here, we\'ll give you the same five
minutes everybody else had\--

MS. FONFA: Thank you.

MR. LEVITT: \--and we\'ve got the timer right down here in the front
way. If you can identify who you are, and where you\'re from, and who
you\'re representing. Thank you.

MS. FONFA: My name is Anne Fonfa, and I\'m a cancer patient. I represent
a group called the Annie Appleseed Project, and what we do is speak and
for cancer patients who are using alternative and complementary
therapies which, as you probably know, is a majority of cancer patients.
I also speak to health professionals and other people about this issue.

So\--patients are using complementary therapies and alternatives, which
include dietary supplements and every single thing we heard mentioned
here today. I echo the safety concerns of everyone else, but I have to
say, for cancer patients, proof of efficacy has become the critical
thing. People are doing things right now. They\'re not waiting for
safety, and they\'re certainly apparently not waiting for efficacy. So,
from my perspective we can solve two birds with one stone if we focus on
efficacy, I think we\'ll find that that will resolve the safety
questions pretty clearly.

Standards for drug development that we\'re currently using for cancer
have been toxicity, terrible effects that are called \"side effects\"
but aren\'t. So we\'re not as concerned as others might be about the
safety in the same way. We don\'t mean it in the same way that everyone
else does.

I also agree with many of the speakers that research exists and can be
looked at, and I think it needs to be brought together in a way that
will make it clear to cancer patients, and others, what it is that we
can use appropriately.

I don\'t think we should limit anything to a single element. That\'s
been a problem in both drug development and with supplements. We know
that people use things in combination, and that needs to be studied
directly.

We need to send a message to pharmaceutical companies that supplements
can be used with their products, and that they need to be concerned
about their\--the dangers of their products. I don\'t think it\'s
specifically the herbs and other things that are so dangerous, but the
way they interact with pharmaceuticals. And I think if garlic is a blood
thinner, that\'s not necessarily bad. It may indicate that we could
consider use of garlic as a way to reduce our use of pharmaceuticals,
because every pharmaceutical product as unwanted effects.

We want health care professionals to be involved. No one was here today.
That\'s a concern of mine. I think they should be part of this process.

The final thing is I think\--I wrote something here that I can\'t even
interpret. Oh, yes\--patients start a regiment of supplements, and then
they become scared because they are looking at the statement that says
it hasn\'t been evaluated by FDA. And that\'s a concern, because they
start something and they stop it. They may desperately need something.
They may have been already finished with conventional treatment, which
is the way most people use alternative or complementary therapies; or
they\'re looking for them to reduce side effects. And since they\'re not
sure how it works, its efficacy, they lose faith in it, and they stop at
a point at which they might be gaining something from it. Because we\'re
used to pharmaceuticals, we want an instant reaction, and we know that
herbals and dietary supplement may take time\--at least I know that, and
you all know that. But many of the cancer patients are without direct
information.

So I truly think that going toward efficacy immediately, and having
statements of efficacy would be extremely useful to our population.
We\'re doing it now. Our lives are at stake. Our time is limited and our
money\'s limited.

Thank you.

MR. LEVITT: Thank you.

Please\--you may sit right there if you like.

MR. SILVERMAN: Okay. Thank you.

My name is Maury Silverman, from Silver Spring, Maryland, and I wanted
to share some personal impressions.

Several people here asked your panel about completing the ephedra
regulation question. And I have some impressions and thoughts I\'d like
to share with you, and ask your comments.

I\'ve watched that issue through the years. I was personally somebody
who worked for passage of the DSHEA law. I think it\'s a good law, and a
good structure; and that industry and consumers and the FDA need to join
ranks and work effectively and objectively to implement it and get it
down to the details beyond what might be in the actual language that
went through late that night at the end of that session.

I wonder if the ephedra issue is kind of a bad red herring for all of us
; all people concerned. I remember attending the two-day Food Advisory
Subcommittee meeting on ephedra\--it\'s, oh, many years ago now. And I
remember well one of your best experts at the table was Varro Tyler. And
he flat-out stated on the second day, \"Regulate the chemical ephedrine
as a drug, as it is. Regulate the botanical ephedra alkaloids under
DSHEA.\" And he gave labeling recommendations; label contraindications,
label a maximum daily dose and per serving dose, that\'s objective for
the benefits of ephedra.

I want to ask you two questions. I remember seeing the effects
literature that was brought to that meeting, and it was clearly all
effects of chemical ephedrine. And I want to ask a basic question before
you decide on a final rule, or whether to accept it, toss it out, revise
it, just go back to a guidance procedure\--whatever.

Has FDA distinguished where the serious side effects came from? Chemical
ephedrine, or botanical ephedra\--also known as mah-wong; it\'s also
known as Mormon\'s tea, for a good reason.

I think that\'s an important question to be answered, and it might clear
up what some of the confusion has been, because Varro Tyler\'s remarks
that day several years ago echo in my mind with this.

I\'d also like to ask if FDA has ever determined if dietary supplements
have been spiked with chemical ephedrine, and is that a possibility
where some of what are called the \"serious side effects\" are coming
from?

I also attended the Government Reform and Oversight Committee Hearing a
few Thursdays ago, and a lot of that testimony was illuminating. There
was a gentleman who gave a very good historical and scientific narrative
about the thermogenesis properties of ephedra. And I think that\'s why
one of the common names for ephedra, or the botanical source is Mormon
tea. It\'s what helped those people go west in the middle of a winter
and predominantly make it there.

And I think these are important questions to be asked and answered. And
like one of the previous people that were up here at this table said,
please don\'t let the bad actors throw the good people and well-meaning
people out. Please don\'t throw the baby out with the bath water.

One example was the testimony the other Thursday that the proposed
dosages of ephedra are lower than the effective doses for thermogenesis
in weight loss. And, as you know, there have been a lot of problems with
some of the pharmaceutical drugs that are put in the marketplace for
weight loss problems. And I think this should be done objectively and in
a reasoned manner.

Some of it kind of reminds me of all the brouhaha over tryptophan which,
my understanding was a problem with a Japanese manufacturer, Shawa
Denka, that they took some of the activated charcoal steps out of their
process and their might have been a bioengineered organism involved
there was a problem with. And there was a later Mayo clinic study that
identified a contaminant. And that the lots of the those contaminated
batches correlated with where the incidence of the eosinea myalgia
syndrome came up\--explained a lot. I heard testimony that there was
virtually none of these cases in Canada, because none of those lots
reached Canadian markets. And I feel sad that if issues like that are
used by the people who would like to gut the DSHEA law, when we really
need to implement it right.

An example, I think, would be the good manufacturing processes
provisions in DSHEA could have solved the tryptophan problem before it
really became a problem with eosinea myalgia syndrome. And I think these
are some things that need to be thought about, taken to heart, and part
of the learning process in developing this law, and implementing it
properly for the public safety and in all people\'s interest. I think
that\'s in all our interests, and that we should do this in a calm,
reasoned manner, and look at the history of this, and do it right.

Thank you.

MR. LEVITT: Thank you very much for that presentation.

I\'m not sure if you were here in the morning when we began, but one of
the things I tried to explain is, today is really for us to kind of take
in information and to listen, and to elicit more, and not get into a
back and forth. You know, I presume, from everything you\'ve said that
we did issue a proposed rule on ephedra a couple of years ago that did
have a lot of information in there: what the agency based in on. We\'re
now looking at all of that in trying to make the determination where to
go. But, beyond that, we really\--this is not the forum\--

MR. SILVERMAN: No. All we realize\--is we ask you to take all these
comments home with you\--

MR. LEVITT: Right.

MR. SILVERMAN: \--and take them to heart. Thank you.

MR. LEVITT: Okay. Thank you very much. Let me thank both of you.

\[Pause.\]

That concludes our meeting today. We started a few minutes late, but
we\'ve finished a few minutes early. That\'s because, I think, number
one, people came very prepared; people were very gracious and adhered to
the rules of procedure that were laid out.

Let me again thank everybody who came today; people who presented. We
will be taking all this information in, together with written comments
at a meeting we\'re having on the West Coast in July, and really trying
to develop\--as I said at the beginning\--an overall framework. Clearly
our goal is to implement DSHEA in a responsible way and to get
consumers, as one of the speakers reinforced, access to products that
are safe and properly labeled.

Let me thank everybody for their attention. Thank the panelists. And
that will bring this meeting to a close.

\[Whereupon, at 4:42 p.m., the meeting was adjourned.\]

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