> DEPARTMENT OF HEALTH AND HUMAN SERVICES
>
> FOOD AND DRUG ADMINISTRATION
>
> PUBLIC MEETING ON
>
> REGULATIONS ON SUPPLEMENTS MADE
>
> FOR DIETARY SUPPLEMENTS
>
> Concerning the Effect of the Product
>
> on the Structure or Function of the Body
>
> Wednesday, August 4, 1999
>
> 10:00 a.m.
>
> Jefferson Auditorium
>
> U.S. Department of Agriculture
>
> Washington, D.C.
>
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> [FROM THE FOOD AND DRUG ADMINISTRATION:]{.underline}
>
> JANICE OLIVER, Deputy Director, Center for Food Safety and Applied
> Nutrition
>
> ANN WITT, Office of Policy
>
> ELIZABETH YETLEY, Director, Office of Special Nutritionals, Center for
> Food Safety
>
> LOUISA NICKERSON, Office of Chief Counsel
>
> DEBRA BOWEN, M.D., Deputy Director, Office of Drug Evaluation, CDER
>
> JANE AXELRAD, Associate Director for Policy, Center for Drugs
>
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> [AGENDA ITEM]{.underline} [PAGE]{.underline}
>
> **Welcome and Introduction**
>
> Janice Oliver, Deputy Director, Center
>
> for Food Safety and Applied
>
> Nutrition, U.S. Food and Drug
>
> Administration 6
>
> **Panel I: Definition of Disease** 12
>
> Ilene Heller, J.D., Center for Science
>
> in the Public Interest 16
>
> Regina Hildwine, National Food
>
> Processors Association 19
>
> Douglas Kamerow, M.D., M.P.H., Agency
>
> for Health Care Policy and Research 23
>
> John Neff, M.D., College of
>
> American Pathologists 26
>
> Bert Spilker, Ph.D., M.D., Pharmaceutical
>
> Research Manufacturers of America 29
>
> James Turner, J.D., Citizens for Health 33
>
> Discussion 36
>
> **Panel II: Common Conditions Associated**
>
> **With Natural States** 73
>
> Anthony Young, J.D., American Herbal
>
> Products Association 75
>
> Stacey Zawel, Ph.D., Grocery Manufacturers
>
> of America 79
>
> R. William Soller, Ph.D., Consumer
>
> Healthcare Products Association 82
>
> Richard Levinson, M.D., D.P.H.,
>
> American Public Health Association 86
>
> H. Logan Holtgrewe, M.D., American
>
> Urological Association 89
>
> Adriane Fugh-Berman, M.D., National
>
> Women\'s Health Network 92
>
> [CONTENTS]{.underline} (Continued)
>
> **Panel II: Common Conditions Associated**
>
> **With Natural States** (Continued)
>
> Grant Bagley, M.D., J.D., Health Care
>
> Financing Administration 96
>
> Discussion 100
>
> **Panel III: Implied Disease Claims** 132
>
> Jack Martin (on behalf of Loren Israelson,
>
> J.D.), Utah Natural Products
>
> Alliance 135
>
> Michael Falk, Ph.D., American Society
>
> of Nutritional Sciences 139
>
> Barbara Moore, Ph.D., Shape Up America 143
>
> Annette Dickinson, Ph.D., Council for
>
> Responsible Nutrition 147
>
> Brett Kay, M.A., National Consumers
>
> League 151
>
> Abbey Myers, National Organization for
>
> Rare Disorders 154
>
> Michael Ford, National Nutritional
>
> Foods Association 158
>
> John Lynch, M.D., American Cancer
>
> Society 161
>
> Robert Reyna, J.D., National Association
>
> of Attorneys General 165
>
> Discussion 169
>
> **Public Session** 191
>
> Betsy Woodward, Director, Public Policy,
>
> Association of Food and Drug
>
> Officials 191
>
> Jonathan W. Emord, Emord and Associates 195
>
> Robert Ullman, Ullman, Shapiro and Ullman 198
>
> Floyd E. Leaders, Jr., Ph.D., Chairman
>
> and CEO, Botanical Enterprises, Inc. 202
>
> [CONTENTS]{.underline} (Continued)
>
> **Public Session** (Continued)
>
> Stephen D. McCurry, Manager of
>
> Biochemistry, Cargill, Inc. 206
>
> Marc Ullman, Ullman, Shapiro and Ullman 208
>
> Kenneth Gorelick 212
>
> Scott Bass, Sidley and Austin 214
>
> **Closing Comments**
>
> Janice Oliver, Deputy Director, Center
>
> for Food Safety and Applied
>
> Nutrition, U.S. Food and Drug
>
> Administration 217
>
> **Adjournment** 218
>
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> **WELCOME AND INTRODUCTION**
>
> MS. OLIVER: My name is Janice Oliver and I\'m Deputy Director for the
> Center for Food Safety and Applied Nutrition. I\'d like to welcome all
> of you here to this public meeting, and it is a particularly focused
> meeting on three issues concerning our \"Regulations on Statements
> Made for Dietary Supplements Concerning the Effect of the Product on
> the Structure or Function of the Body, which we\'ll refer to later and
> I\'ll refer to as structure/function claims for all of you.
>
> But before we begin, I have two apologies to make. The first apology
> is for Joe Levitt. Joe Levitt is the Center Director for the Center
> for Food Safety and Applied Nutrition. He had intended to be here and,
> in fact, the schedule was worked around him. However, there is a
> hearing today on a single food safety agency and so he is on the Hill
> instead of being here and he does send his apologies.
>
> The other apology I\'d like to make is for all of those who arrived at
> eight o\'clock this morning. There were a number of you, I know, and I
> really do apologize. The announcement had originally gone out for
> eight o\'clock in the morning. We put out another announcement to
> correct it and we tried to get everyone who had pre-registered. From
> the arrivals this morning, we know we didn\'t get everyone who had
> pre-registered and we know also that a number of people who had not
> pre-registered showed up at eight o\'clock. So, once again, I give you
> my apologies and I hope that has made you more relaxed for the
> meeting.
>
> With that, let me start. We held a public meeting on dietary
> supplements on July 8, and at that meeting, we heard from our
> stakeholders and from many of you that are out there that you wanted
> involvement not only in the planning phase, but you wanted involvement
> in the issues related to dietary supplements and input at the various
> phases. So this morning, we are trying to give you that opportunity.
> We are here to listen.
>
> In April of 1998, we published the proposed rule on the types of
> claims that could be made for dietary supplements without prior
> authorization, and FDA received over 100,000 comments on the proposed
> rule. A large percentage of the comments objected to the new
> definition that we provided for disease, and some of them also
> objected to the criteria that we had put there.
>
> What I\'d like to say is that although the comments raised a number of
> issues besides this, as mentioned in the [Federal
> Register]{.underline}, we want to focus today on three issues, the
> first being the definition of disease; the second being the common
> conditions associated with the natural state, such as\--the natural
> states would include aging, pregnancy, menopause, those types of
> things; and we also want to concentrate on applied disease claims.
>
> It\'s an opportunity for us to receive your input, and the scope of
> today\'s meeting is limited and we\'d ask you to try to confine your
> comments and discussion to those topics. We\'ve heard your concerns,
> the concerns that have been expressed verbally and in the comments to
> the [Federal Register]{.underline}, and we\'re here to listen.
>
> I know and we all know that there\'s a whole diversity of opinion out
> there on the issue as well as the objections, and so what we\'d like
> is for you to listen to each other as well as to listen to the
> viewpoint that you have.
>
> We really need your help. We need your help in providing the
> assistance and input so that we can do rules that are appropriate and
> regulations that are consistent with the intent of DSHEA but that also
> protect the public health.
>
> So with that, let me just discuss a little bit about the format and
> the structure of today\'s meeting. First, there will be three
> stakeholder panels, and the stakeholder panels will be up on the
> stage. FDA will also have a panel and our panel is down below. The
> logistics didn\'t allow fitting the size of the panels so everybody
> could see them in the audience and so we did it that way.
>
> The FDA panel, I\'d like to introduce now. Ann Witt from the Office of
> Policy is here; Dr. Elizabeth Yetley, who is the Director of the
> Office of Special Nutritionals in FDA\'s Center for Food Safety;
> Louisa Nickerson from the Office of Chief Counsel; Dr. Debra Bowen,
> who is the Deputy Director for the Office of Drug Evaluation at CDER;
> and Jane Axelrad, who is the Associate Director for Policy at our
> Center for Drugs.
>
> I\'ve also had some questions and want to discuss the composition of
> the panels. You\'ll be hearing from panelists that were specifically
> invited by FDA and the panelists are representatives of such groups as
> industry, health professional groups, State associations, and consumer
> groups. They were invited so that we could present the range of
> opinions on the various issues.
>
> In addition, we have provided an opportunity for comment from those of
> you who are also here who might want to comment at the end of the
> meeting, as time permits, and I\'ll be announcing in the afternoon
> break how many have already signed up and how much time there is left,
> if we can have additional people sign up. We have limited time in the
> room and we have to keep pretty close to six o\'clock. We may be able
> to go a little beyond, but not that much.
>
> But getting back to the panels, when I call the panels, what I\'d like
> them to do is to come up on the stage. What we\'re doing is providing
> name cards for each of you and they\'re listed alphabetically by your
> name.
>
> I\'ve also been asked to do some housekeeping and talk to you about
> the microphones. I\'ve been asked to make sure the panelists know that
> they need to speak about six inches from the microphone because it
> won\'t carry if you don\'t speak that, so if you can try to do that.
> I\'d also like the panelists to speak individually from their seats.
> Because of the short amount of time we have and the concern by some
> that we might not have enough time for discussion and questions, we\'d
> like to move along in that fashion.
>
> Each person making a presentation on the panel has a five-minute
> limit. This will afford some time for discussion among the panelists
> and time for questions and comments from the FDA panel. We\'ll be
> asking questions and we\'ll also be asking for clarification.
>
> The meeting is being recorded and transcribed, so the transcripts will
> be available following the meeting.
>
> Following presentations by the panel, as I mentioned, FDA will be
> asking comments, requesting clarifications. We\'re here in a listening
> mode rather than a response mode, so I just want to remind you of
> that.
>
> We\'re going to begin each panel by a presentation that will summarize
> the issue and the questions we specifically would like input from, and
> that will refresh your mind as to the specific questions and the
> panelists can have that, too. As I mentioned, each speaker will have
> five minutes for the formal presentation. We\'ll have a timekeeper
> that will be right down here who will give you the one-minute signal
> and they\'ll give you the time to stop, and I\'m going to try to
> adhere to that as much as I can so that we can be fair to all of the
> panels, and I know some people have time limits for being here.
>
> The next thing I want to do is just do some housekeeping, and that is
> the ladies\' room, you make two rights, out the front to the right and
> a right and wing five and it\'s right there. The men\'s room is out to
> the left, another left to wing six, and there are public phones in
> each of those corridors.
>
> Another thing that I would like you to do, you see I have all of these
> IDs. Here\'s one, here\'s my name, here\'s this other. You\'ve got to
> have your visitor\'s ID on if you go out beyond the corridor. They
> will not let you back in without a visitor ID badge, so I want to make
> sure you do that.
>
> There is a cafeteria in this building down in wing two for those of
> you who might want to break or something or for lunch later, so I will
> do that.
>
> **PANEL I: DEFINITION OF DISEASE**
>
> MS. OLIVER: With that, I\'d like to ask the first panel to come up,
> and that panel is Panel I for the \"Definition of Disease.\" So if all
> those individuals could come up, please. I\'d also like to ask Ann
> Witt to come up. Ann is going to give the introduction to each panel
> on the issues we\'re going to be discussing. Thank you very much.
>
> MS. WITT: Good morning. This panel is devoted to the topic of the
> definition of disease. As I\'m sure most of you know, Section
> 403(r)(6) of the Food and Drug Act, which was added by DSHEA permits
> dietary supplements to make certain structure/function claims without
> review by FDA, but does not permit disease claims, that is, claims
> that the product diagnoses, treats, mitigates, cures, or prevents
> disease, unless those claims are subjected to a review process, either
> the drug approval process or the health claims process. The proposed
> rule that we issued over a year ago was FDA\'s attempt to distinguish
> between structure/function claims and disease claims.
>
> Before the agency could articulate what a disease claim was, we needed
> to know what we meant by disease. So the proposed rule included a
> definition of disease which was based on medical and legal textbook
> definitions.
>
> You should have received when you walked in a handout which includes
> two definitions of disease. The second one on that handout is the
> definition that we proposed. The definition reads, \"A disease means
> any deviation from, impairment of, or interruption of the normal
> structure or function of any part, organ, or system, or combination
> thereof, of the body that is manifested by a characteristic set of one
> or more signs or symptoms, including laboratory or clinical
> measurements that are characteristic of a disease.\"
>
> We recognized at the time we included this definition that we also had
> a preexisting definition of disease or health-related condition which
> we had promulgated to implement the health claims provisions of the
> Nutrition Labeling and Education Act. That rule was promulgated in
> 1993.
>
> The definition of disease or health-related condition is the first
> definition on the handout. That definition reads, \"Disease or
> health-related condition means damage to an organ, part, structure, or
> system of the body such that it does not function properly, e.g.,
> cardiovascular disease, or a state of health leading to such
> dysfunctioning, e.g., hypertension, except the diseases resulting from
> essential nutrient deficiencies, e.g., scurvy, pellagra, are not
> included in this definition.\"
>
> We did not use the health claims definition in the proposed
> structure/function rule because we believe that that definition might
> not cover some diseases or conditions medically understood to be
> diseases because of the reference to the word \"damage\".
>
> We received many, many, many comments on our proposed definition of
> disease. It generated probably the most comment of anything in the
> proposed rule. The great majority of the comments received opposed our
> new definition, arguing that it was too broad, that it would encompass
> many conditions that are not understood to be diseases, and the
> comments argued that the health claims definition had been the
> existing definition at the time DSHEA was passed, that Congress should
> be presumed to have understood that that was the definition of
> disease, and, therefore, that we should not change that definition,
> that we should adopt that definition in the proposed rule.
>
> Some comments supported the proposed definition. Most of those
> comments were from health professional groups.
>
> In the notice announcing this meeting, we listed four questions that
> we wanted the panelists to address on the issue of what the correct
> definition of disease should be for this rule. Those questions were,
> number one, what are the consequences with respect to the range of
> permissible structure/function claims of adopting, A) the health
> claims definition, or B) the new definition in the proposed rule?
>
> Specifically, what we would like to hear from the panelists, or at
> least we are interested in hearing, examples of claims that the
> panelists believe would be permitted by the old definition that would
> not be permitted by the new definition, more particularly, what kinds
> of claims could be structure/function claims under the old definition
> that would be considered disease claims under the new definition.
>
> The second question was, if FDA were to retain the health claims
> definition, that is the older definition, does its reference to damage
> exclude any conditions that are medically understood to be diseases?
> We asked that those addressing this question provide examples of such
> conditions.
>
> If the old health claims definition does not exclude any conditions
> understood to be diseases, is it otherwise consistent with current
> medical definitions of disease?
>
> And finally, if the health claims disease does exclude conditions that
> are medically understood to be diseases, could it be revised in a way
> that would include such conditions?
>
> These are the questions we hope that the panelists will address this
> morning. I\'d like to ask that they introduce themselves, beginning
> here.
>
> MS. HELLER: Good morning. I\'m Ilene Ringel Heller. I\'m a senior
> staff attorney for the Center for Science in the Public Interest. CSPI
> appreciates the opportunity to appear at this hearing. CSPI is a
> not-for-profit consumer health organization located in Washington,
> D.C. CSPI was formed in 1971 and it is supported primarily by more
> than one million subscribers to our \"Nutrition Action Health
> Letter,\" a monthly publication that reports on issues relating to
> diet and health.
>
> It is undisputed that the purpose of the Dietary Supplement Health and
> Education Act is to protect the right of access of consumers to safe
> dietary supplements. But permitting claims for products that address
> serious health conditions will undermine the intent of DSHEA by
> putting consumers at risk.
>
> As the Commission on Dietary Supplement Labels stated in its November
> 1977 report, dietary supplements should not suggest use for a serious
> health condition that is beyond the ability of the consumer to
> evaluate. Thus, label statements relating to serious conditions for
> which medical attention is appropriate should be prohibited. It is
> essential that this concept be included in the definition of disease.
>
> Unfortunately, the definition of disease proposed by the FDA fails to
> incorporate this principle. Instead, FDA\'s current approach has
> merely encouraged manufacturers to become wordsmiths, adept at
> crafting statements that legally fit under the rubric of a
> structure/function claim that does not require FDA premarket approval.
>
> But the distinction between claims relating to serious health
> conditions and claims relating to the structure or function of a
> bodily system or organ is undoubtedly lost on many consumers. For
> example, we doubt that many consumers would notice the difference
> between a label that states that the product will maintain cholesterol
> levels, which is a permissible structure/function claim, versus a
> product intended to improve cholesterol levels, a prohibited claim. To
> consumers, the message is the same. This product will help keep
> cholesterol levels down and reduce the risk of heart disease. Why else
> would consumers care about cholesterol?
>
> We believe that the FDA\'s definition of disease as applied in the
> proposed rule also fails to protect consumers because it permits
> product names that encourage self-medication for serious conditions.
> For example, under the proposed definition, Cardio Health and Heart
> Tabs are permissible product names merely because they refer to a
> bodily organ or system and do not mention the name of a specific
> disease. Similar names that incorporate a specific disease are
> prohibited, Carpelton or Hepaticure.
>
> But this hair-splitting distinction will be lost on most consumers and
> they may buy products called Cardio Health or Heart Tabs without first
> consulting a doctor about what could be a life-threatening condition.
> Consumers should not be relying on self-medication in such situations.
>
> In modifying its definition of disease, the FDA, therefore, must go
> beyond its proposed rule and address the conditions for which
> structure/function claims should be prohibited. CSPI believes that the
> guidance of the Commission on Dietary Supplement Labels should be
> followed.
>
> First, claims should be prohibited if they relate to a serious health
> condition beyond the ability of the consumer to evaluate.
>
> Second, statements of nutritional support relating to structure or
> function should not be used to imply effects that are currently
> considered prescription drug claims.
>
> We propose, therefore, that the FDA add the following language at the
> conclusion of the definition of disease. Disease claims include, but
> are not limited to, all claims relating to serious conditions that are
> beyond the ability of the consumer to evaluate and claims that imply
> effects that are considered drug claims.
>
> Under this approach, the FDA will be able to abandon the
> hyper-technical distinctions it has made between permissible and
> impermissible claims. The key distinction between acceptable and
> unacceptable claims will be the type of condition for which the
> product is promoted. Manufacturers of dietary supplements who desire
> to market their products with claims that are not permitted as
> structure/function claims would still have two options available to
> them. They could apply for the approval of a health claim or file a
> new drug application.
>
> There is no question that the FDA should ensure that safe dietary
> supplements are widely available to consumers, but the FDA must also
> ensure that supplement companies do not misleadingly encourage
> consumers to use supplements for inappropriate purposes that can lead
> to serious injury and death. The steps we urge here will help prevent
> that unfortunate situation from occurring. Thank you.
>
> MS. HILDWINE: Good morning. My name is Regina Hildwine. I\'m Director
> of Food Labeling and Standards for the National Food Processors
> Association. I\'m grateful for the opportunity to present NFPA\'s
> views on the definition of disease. In addition to my remarks this
> morning, we are filing comments to the docket today.
>
> The National Food Processors Association, or NFPA, is the principal
> scientific trade association representing the \$460 billion food
> processing industry. NFPA members are principally involved in the
> manufacture of conventional foods rather than dietary supplements, a
> factor that shapes our perspective. I would like to point out, as you
> already know, that FDA\'s April 1998 proposed rule applies not only to
> disease claims for dietary supplements but has broad implications for
> health-related claims generally, including those for conventional
> foods.
>
> The term \"disease\" is addressed in implementing regulations on
> health claims for the NLEA, which were finalized in 1993 and have been
> in effect for five years. In 1998, FDA not only proposed a new
> definition for disease for structure/function claims for dietary
> supplements but proposed a corresponding amendment to the health
> claims definition related to disease. I am not going into exactly what
> the rule at 21 CFR 101.14 says. You have that in your handout.
>
> Two important concepts from this definition have been lost in FDA\'s
> 1998 proposal to redefine disease. First, most importantly and
> explicitly, actual damage is a critical factor for a disease to be
> present.
>
> Second, implicitly, symptoms must exist that characterize the presence
> of damage to the body. Symptoms like pain or discomfort often are
> associated with normal conditions and do not in themselves
> characterize damage to the body. Disease should encompass actual
> damage or conditions that are direct indicators of damage such that
> the body does not function properly.
>
> NFPA believes that clinical measurements and risk factors that may
> indicate the future development of disease but do not indicate damage
> should not be included in the definition of disease. However, an
> actual disease marker, an indicator that the disease already is
> present at some defined stage, should be included in the definition of
> disease. The difference should depend on the relative certitude that a
> particular measurement is indicative of the actual presence of a
> disease.
>
> Under the 1998 proposal, every symptom, clinical measurement, and
> aberration, no matter how temporary or natural, potentially would be
> considered a disease. This makes no sense. Many of life\'s natural
> changes, the normal results of growth or aging, and plenty of normal
> unpleasantness, such as leg and joint pain from growth in teenagers or
> vigorous exercises, menstrual pain, discomfort of indigestion,
> occasional constipation, fatigue, even hunger pangs, these are not
> diseases. They do not indicate that the body is damaged and
> functioning improperly. To the contrary, these signs and symptoms
> indicate that the body is functioning exactly right.
>
> Where should FDA draw the line separating normal functions from
> disease? By requiring for disease the criterion of damage to physical
> systems so that they do not function properly, as is currently
> provided in the definition at 101.14. Consequently, we believe that
> FDA\'s 1998 proposal simply must be withdrawn. NFPA recommends that
> FDA consider a different approach to controlling irresponsible claims.
> This is a cause that NFPA strongly supports.
>
> FDA policy must require structure/function claims to be supported by
> solid scientific substantiation. Nowhere does the law exempt
> structure/function claims from the requirement that they be truthful
> and non-misleading. In fact, the DSHEA specifies that
> structure/function claims for dietary supplements must be
> substantiated.
>
> NFPA believes that issues related to unsubstantiated
> structure/function claims on dietary supplements may be addressed
> through enforcement and no new rulemaking is needed. You can apply the
> misbranding provisions of the FD&C Act to start with and then consider
> anti-deception concepts in the FTC Act.
>
> We have no doubt that there are problematic claims for which even the
> most basic substantiation files could not exist because the scientific
> literature is silent on the claim\'s structure or function effect. A
> few well-targeted warning letters in these instances would be very
> effective in sending the message that folklore is not substantiation
> and the statutory disclaimer does not provide a carte blanche.
>
> Finally, NFPA believes that the [Pearson]{.underline} decision, which,
> of course, I had to mention, which plainly discourages an
> all-or-nothing regulatory approach, suggests that the correct path to
> effective regulation is more aggressive enforcement of substantiation
> and not a broad redefinition of disease, which effectively bars many
> truthful claims.
>
> So, once again, NFPA urges FDA to withdraw the 1998 proposed rule.
> Thank you.
>
> MR. KAMEROW: Good morning. I\'m Douglas Kamerow. I work for the U.S.
> Public Health Service Agency for Health Care Policy and Research. A
> word about the agency. It\'s the smallest of the Public Health Service
> agencies and what we do there is health services research and
> evidence-based practice. I want to emphasize that we\'re a research
> agency, like NIH. We have no regulatory authority. One of the things
> that we do there, also, is assess clinical practices and technology. I
> direct the Center for Practice and Technology Assessment, AHCPR,
> speaking today as an individual about this issue.
>
> It seems to me that the goal here in the definition of disease is
> several-fold. We would like to have a definition that has clarity,
> consistency, accuracy, and common sense in the definition of disease,
> accuracy meaning that it\'s true, consistency meaning that when it\'s
> used by multiple people it\'s used in the same way, clarity meaning
> that most of us could understand it, and common sense, which
> unfortunately is often lacking in a lot of these regulations, would
> mean that it coheres with the thoughts that most people would
> understand when they bring to this issue.
>
> Given this goal, unfortunately, it seems to me unlikely that we\'ll be
> able to achieve all of these different qualities for several reasons.
> First of all, the history of supplement regulation, and this is just
> how things have evolved and the context in which we find ourselves now
> in having to kind of contort our positions to ally with past history.
> For instance, nutritional diseases obviously are diseases by any
> definition and yet they\'re specifically excluded because of
> historical matters and the way this came up.
>
> Secondly, the activities and the desires of the folks who manufacture
> these products to market them effectively, right up to and some would
> say beyond the limits of the law and common sense in making claims.
>
> Thirdly, the very great difficulty that we have and the confusion and
> sort of hair-splitting distinctions between diseases and symptoms and
> where does one begin and one end. As some of the materials that were
> distributed before point out, what conceivable difference could one
> make between seizures, which are a symptom, and epilepsy, which is a
> disease; between wheezing, which is a symptom, and asthma, which is a
> disease.
>
> So we find ourselves in a very difficult situation in trying to come
> up with this definition. For what it\'s worth, I certainly prefer the
> second definition that FDA put forward. It seems to me more inclusive
> and clear and so I would prefer that one.
>
> But it seems to me that more important than the question of disease
> definition, and I realize I\'m venturing from being responsive here
> and I apologize in advance, I don\'t think this is the key issue. The
> issue is claims and the evidence that backs them up. Supplement
> manufacturers should be responsible for documenting in advance any
> claims they make with scientific evidence. This includes treatment
> claims for symptoms as well as for any diseases, if there is a
> difference between the two. This also includes prevention claims. To
> do otherwise, that is, to not document this, robs the consumer or the
> people who are buying these products of the assurance that these
> products could actually do what they claim.
>
> So where should this evidence go? Should it go to the FDA? Should it
> go to the consumer? The good news here, I think, is that we have new
> methods of communication that would allow it to go to both. The magic
> of the World Wide Web, putting things on the internet, toll-free
> numbers, would allow manufacturers to make clear what the evidence is
> behind the claims, and FDA\'s role, it would seem to me, should be one
> that would serve as a traffic cop, to make sure that those claims hold
> some semblance of sense and that there is some evidence behind them if
> they work.
>
> This does venture away from the questions that we were asked to
> discuss here, but it seems to me that we need to move beyond that
> issue to look very carefully at what the key question is, and it seems
> to me, at least, the key question is where is the evidence behind
> these claims that are being made. Thank you.
>
> DR. NEFF: Good morning and thank you for the opportunity to be here.
> My name is John Neff. I am the Chair of the Department of Pathology in
> the University of Tennessee, a professor in the graduate school of
> medicine.
>
> Additionally, I chair the SNOMED authority of the College of American
> Pathologists. SNOMED stands for Systemized Nomenclature of Medicine
> and Veterinary Medicine. The authority which I chair consists of CAP
> leadership, a scientific director who chairs our editorial board, an
> internal staff of directors and key stakeholders from the United
> States and abroad.
>
> SNOMED is currently in the process of being merged with Clinical Terms
> Version Three, which formerly was owned by the National Health Service
> of Great Britain. When that is finished, and it will be finished by
> 2002, we will have a validated reference terminology that enables
> clinicians, researchers, patients, and the public to share concepts
> worldwide across clinical specialties and sites of care. Definition is
> our daily bread in SNOMED.
>
> There are two definitions, the 1993 NLEA definition, which focuses
> heavily on damage and dysfunction, and the newer definition, which, in
> addition to focusing on structure and function, focuses on symptoms
> and includes the laboratory and clinical measurements that are
> characteristic of disease. The question then is, compare and contrast
> 1993 and the proposed rule.
>
> The 1993 definition, the old one, is not consistent with commonly-held
> ideas throughout medicine regarding what constitutes a disease
> anywhere. For instance, a metabolic disease such as diabetes, which is
> characterized in its early stages by a mere elevation of blood
> glucose, a nutritional disease such as iron deficiency, which is
> characterized in its early stages by nothing more than a low serum of
> keratin, psychiatric diseases which are not associated with any known
> tissue damage, early neoplasms such as carcinoma of the cervix, which
> have not damaged the body as yet, genetic abnormalities which may only
> be manifested by DNA abnormalities observable by sophisticated genetic
> analyses, toxic conditions such as early iron and acetaminophen
> poisoning, which may at their early stages only be diagnosed by
> laboratory abnormalities, none would fit the 1993 definition.
>
> The proposed rule, having its problems\--all definitions have their
> problems\--is better since it includes signs, symptoms, laboratory
> measurements in that definition of disease.
>
> The 1993 definition excludes too many conditions to be consistent with
> current medical definition of disease. It would have to be revised
> and, in my opinion, it would have to be broadened. Damage is much too
> constrictive, such modern definitions of disease recognize disordered
> function as equally important as damage. Additionally, the 1993
> definition excludes disease resulting from essential nutrient
> deficiencies, and you all know those are most certainly diseases.
>
> Every physician spends the greater part of medical school, certainly
> the entire pathology course, learning what a disease is, how it\'s
> defined and what it is and what it is not. Of course, there are
> differing opinions concerning the definition of disease. However, the
> definition in the proposed rule is much more consistent with the
> generally accepted meaning of that term than is the 1993 NLEA
> definition.
>
> In the absence of a definition of disease which is tight and
> encompassing, consider the consequences. Consider the consequences in
> attempting to evaluate any kind of evidence. We would not be able to
> tell a benign from a malignant tumor. We would not be able to
> distinguish a drug fever from an infectious fever. We would not be
> able to distinguish a heart attack from heartburn. We might not be
> able to distinguish a good drug from a useless drug or, for that
> matter, from a toxic drug. In short, we couldn\'t get at the truth
> because truth requires benchmarks and requires definitions.
>
> Thank you for this opportunity to comment to the FDA I hope it\'s been
> useful to you and to all of you.
>
> DR. SPILKER: Good morning. My name is Bert Spilker and I am the Senior
> Vice President of Scientific and Regulatory Affairs for the
> Pharmaceutical Research and Manufacturers of America, otherwise known
> as PhRMA. PhRMA represents about 100 companies engaged in the
> discovery, development, and commercialization of medicines that
> improve American health and enhance our quality of life.
>
> You can understand why PhRMA is legitimately apprehensive about FDA\'s
> impending definition of disease. The linguistic distinctions to be
> drawn between a prohibited disease claim for a dietary supplement and
> a permissible statement of nutritional support, i.e.,
> structure/function claim, will have a profound effect on
> pharmaceutical research and development and, consequently, on the
> health and well-being of all Americans well into the next millennium.
>
> PhRMA is not prepared today to provide specific language on how FDA
> should define disease. However, we are prepared to articulate several
> principles that must be accommodated as the FDA considers this
> proposal further.
>
> First and foremost, FDA must define disease broadly enough to include
> those conditions or circumstances commonly and traditionally
> understood in the medical community as being a disease or as leading
> to one.
>
> Second, the distinction between a disease and a statement of
> nutritional support, i.e., structure/function claim, must reflect the
> prevailing consensus in the medical community. FDA should convene a
> small workshop of key physicians, patients, and other stakeholders,
> including PhRMA, to facilitate development of this consensus.
>
> Third, the definition needs to be clear and simple. A guidance cannot
> be allowed to substitute for definitional clarity. This clarity will
> foster informed consumer choice as patients decide whether and how to
> seek treatment for a disease.
>
> Fourth, FDA should closely link the substantiation requirement with
> the definition of disease. DSHEA requires substantiation for
> statements of nutritional support, i.e., structure/function claims.
> The more the statement resembles a disease claim, the higher the level
> of substantiation required. This approach is consistent with the
> Federal Trade Commission\'s substantiation policy. The FTC holds that
> the nature and extent of the required substantiation increases as the
> intensity of the claim increases.
>
> Fifth, no matter how disease is ultimately defined, FDA cannot permit
> to be accomplished indirectly what may not be accomplished directly.
> In other words, FDA must remain free to evaluate the overall context
> in determining whether or not there is an implied disease claim.
> Relatedly, FDA must not allow the statutory disclaimer to be used as a
> subterfuge that would permit disease claims to masquerade as
> statements of nutritional support, that is, structure/function claims.
> This is consistent with the recent decision in the [Pearson v.
> Shalala]{.underline} case. That case suggests that under the First
> Amendment, FDA should consider whether a disclaimer corrects an
> otherwise misleading message. Likewise, the statutory disclaimer for
> dietary supplements should be considered by FDA in determining if
> there is an express or implied disease claim. But in and of itself,
> the presence of the statutory disclaimer does not determine the
> question.
>
> Sixth, FDA should insist that any dietary supplement making even a
> statement of nutritional support, i.e., structure/function claim, let
> alone a disease claim, adhere to standards of quality, safety,
> efficacy, and purity commensurate with those required for
> pharmaceuticals.
>
> Seven, DSHEA was intended to create parity between dietary supplements
> and foods, not between supplements and drugs. A statement of
> nutritional support must be just that. It must be limited to the
> nutritional value of the supplement and not its pharmacological
> activity. This will allow for better and more informed consumer choice
> about the difference between drugs and dietary supplements.
>
> Finally, PhRMA is aware of the salutary purpose that Congress had in
> mind in enacting DSHEA in 1994. At the same time, however, Congress
> was mindful that DSHEA not erode the important statutory incentives
> that foster pharmaceutical research and development. If disease is
> defined narrowly, then dietary supplement manufacturers will
> consequently be permitted to make what are today generally understood
> to be drug claims. They will be free to do this without undertaking
> the extensive and costly research that is essential before the public
> and health professionals can rely on the safety and effectiveness of
> new drugs. Thank you.
>
> MR. TURNER: My name is James Turner and I\'m the Chairman of the Board
> of Citizens for Health. I\'m representing Citizens for Health today,
> but I did want to say to the FDA that our comments are meant to be
> discussive in nature. We are not stating any positions that we can\'t
> change or work with. We\'re interested in being involved in any
> dialogues that might take place.
>
> We were very much involved in helping to generate the 175,000 or more
> comments that opposed this definition and rule. We were also
> co-plaintiffs in the [Pearson]{.underline} case and we have been
> supportive of the other cases that have challenged FDA\'s approach to
> regulating information.
>
> We strongly support the first definition, the definition that was
> adopted in 1993, and we do that because we think definitions need,
> more than anything else, durability. The definition that is in the
> regulations from 1993, it\'s a legal statement. Our position is that
> when Congress passed DSHEA, it intended for that definition to cover
> the meaning of disease within DSHEA.
>
> We have had meetings with the FDA staff and we have told them
> directly, and to say it again, it would be our intention if FDA
> adopted any definition other than the disease definition in the 1993
> regulation to challenge that in court. Our belief is that any other
> definitional statement would violate First Amendment rights of people
> who wish to make structure/function claims.
>
> What we do suggest for FDA is that the problem facing it is not the
> proper definition of disease, but the problem facing the FDA is how to
> relate to the burgeoning information world that is taking place around
> us. What is FDA\'s regulatory posture going to be in moving into the
> kind of society with the kind of information flow that we have?
>
> Specifically, we argue that FDA should be more of a rheostat and less
> of an on/off switch. That was the purpose of bringing the
> [Pearson]{.underline} case. What the [Pearson]{.underline} case
> actually said was that the FDA should consider adopting various kinds
> of regulatory disclaimers to help understanding in the food supplement
> label area rather than looking at how to prohibit statements. Not only
> did they say they should do that, they said they are required by the
> Constitution to do that.
>
> Our suggestion is that a number of the concerns that have been raised
> by the panel members today about the definition, the one that we stand
> behind and intend to defend, is that those concerns be included in a
> process that creates a series of disclaimer statements in conjunction
> with the finding of [Pearson]{.underline}.
>
> The point here is that FDA needs to become the partner with the people
> who are seeking information in the marketplace, not their adversary.
> The important thing is to foster information exchanges between those
> people who are preparing and selling products and those people who are
> seeking and attempting to buy products. It would be very valuable, for
> example, if the distinction made between definition one and two here,
> for example, were included in a\--this is a potential idea, something
> to discuss\--basis for a disclaimer that could be added on the label,
> an indication that\--for example, if you can\'t tell the difference
> between heartburn and heart disease definitionally, it\'s going to be
> very difficult for the consumer to know that distinction just by
> having those experiences.
>
> We would suggest that it be considered that the distinctions between
> definition one and definition two might be looked at as a way of
> saying, here\'s an area where you could put a piece of information for
> the consumer on the label or in the electronic information mechanisms
> that currently exist.
>
> There are ranges of ways of approaching getting information to the
> consumer. The argument that Citizens for Health makes is that safety,
> information, choice, and access, the four basic consumer rights, are
> best advanced\--each of them are best advanced by a robust flow of
> information, that the FDA\'s role should be to use the prohibition of
> any piece of information as the last resort when all else fails.
>
> At this point, that is also the holding of the [Pearson]{.underline}
> case. We appreciate that the FDA chose not to appeal that case. We are
> urging the FDA to withdraw the current regulation and go back to the
> drawing board in the context that we have just described and we stand
> ready to work as strongly and as hard as possible with the FDA to
> bring into being a process that helps facilitate the robust flow of
> information, rather than attempting to prohibit or allow information.
>
> DISCUSSION
>
> MS. OLIVER: Thank you very much. I think we\'ve heard a range of
> opinions, and I\'m going to start with Regina Hildwine and Mr. Turner
> and ask you both a question. You both talked about going back to the
> NLEA definition in 1993. Can you give me some more examples of what
> would be included in the definition in 1993 that would be excluded in
> the definition that was in the structure/function rule?
>
> MS. HILDWINE: Very clearly, the concept of damage is dropped
> explicitly from the proposed 1998 definition. The proposed 1998
> definition also essentially says that any deviation from the norm
> would be viewed as a disease, and we don\'t believe that this passes
> the common sense test, that there are plenty of deviations from the
> norm that do not signify that a disease state exists, that they are
> simply circumstances that happen in the normal course of life. I did
> give you some examples in my prepared remarks and I think our comments
> that we are filing today have some additions.
>
> I would like to add that I think very key here is the whole history of
> the rulemaking of the definition of disease for the 1993 regulations.
> Just very briefly, FDA did not originally propose a definition of
> disease for the health claim regulations, and frankly, the entire
> history coming to the definitions that we have so far have been a
> matter of dueling dictionaries. One dictionary was put forward in
> comments; another dictionary was selected for the final rule. The
> proposed 1998 definition comes from a different dictionary, all of
> which have some relevance to the medical profession.
>
> For the purpose of defining disease for food labeling, there is
> nothing that says that the definition of disease has to be equal
> across the board agency-wide. As a matter of fact, try and find the
> definition of disease somewhere else in FDA\'s regulatory code. But
> for the purpose of food labeling, 21 CFR 101.14(a)(6) is adequate, in
> our view.
>
> MR. TURNER: The question that you asked, it contains within it the
> problem that I\'m trying to focus the FDA\'s attention on. If the FDA
> had adopted the second definition and had put it in place in 1993 and
> Congress had considered DSHEA with that definition in place, I would
> be making the same argument now about that definition.
>
> The point is that in order to structure a legal framework in which to
> move forward, we have to have a durable definition, one that was, in
> fact, on the table at the time that all the parties discussed
> legislative action. And, incidentally, the first definition is a
> regulatory, not an NLEA definition, but a regulatory definition, not a
> Congressional definition.
>
> In that construct, what I\'m suggesting is that if the second
> definition had been adopted in 1993, the very same problems that I\'m
> identifying would exist. Those problems are how to convey to the
> public a full range of concepts or ideas. What are the mechanisms
> available to do that? That\'s why we brought the [Pearson]{.underline}
> case.
>
> The concept of the FDA was first presented to Congress, the way it\'s
> regulating and so forth, in 1887. It was adopted in 1906. It was
> repealed and then reenacted in 1937, and it is a command and control,
> yes/no, light switch-type concept. This you can do; this you can\'t.
> That concept has moved its way into the kinds of claims that can be
> made for products. You can make this claim and you can\'t make that
> claim. That approach does not work. You cannot draw a bold line
> between a claim that you can make or you can\'t make.
>
> The point of the [Pearson]{.underline} case is that you can make clear
> the context of what it is that you\'re doing with your definition.
> Many of the points that were made by people who see the second
> definition being better than the first because it\'s more
> comprehensive and so forth could be utilized as a way of articulating
> statements that could be included in the information that\'s provided
> to the consumer, and we\'ve proposed some of those in our comments to
> the FDA.
>
> The concept that the [Pearson]{.underline} case is articulating and
> the concept that most of the 175,000 commenters were after is that the
> public has a right to have access to all the information that\'s
> available, that the FDA has a responsibility and a duty to make sure
> that that information is substantiated. But to carve out a situation
> where a substantiated claim that could be available to the public in
> some other forum cannot be available to the public through the
> commercial process is now held by the court to be unconstitutional.
>
> The only way that something can be prohibited is if it\'s an
> inherently misleading claim that has no substantiation. If it\'s not
> an inherently misleading claim, other avenues besides prohibition need
> to be looked at, and I\'m suggesting that the concepts that are in the
> second definition could be looked at as a way of helping to begin the
> disclaimer process that the [Pearson]{.underline} court has asked for.
>
> MS. OLIVER: Thank you. Dr. Kamerow?
>
> DR. KAMEROW: I would like to respectfully disagree with the comment on
> the definition. It seems to me that it\'s not just any deviation from.
> That would imply someone who is real tall or something like that. It
> continues, and that\'s the important part of it, because this
> deviation or impairment has to be manifested by a characteristic set
> of signs or symptoms, a recognizable condition of some sort, and
> that\'s what makes it a disease as opposed to just something that\'s a
> little different than normal and wouldn\'t be something that\'s
> treated. It seems to me that your very clear discussion by Dr. Neff as
> to why the second definition is preferable to the first.
>
> MS. OLIVER: Anyone on the panel?
>
> MS. WITT: Just to lighten the mood a little bit, we suggested a couple
> of examples of what we would call diseases that generated a great deal
> of controversy. We\'re rethinking some of those and I wanted to throw
> out a couple for the panel and see whether you thought that these
> should be considered diseases or not.
>
> The first is alcohol intoxication. Think about these in terms of the
> definitions that are in front of you and also in terms of any other
> principles that you think are appropriate. The other is constipation.
>
> DR. NEFF: I don\'t have a great deal of experience with the second,
> but let me comment on the first. Alcohol intoxication is, in fact, a
> disease. It has a very characteristic set of signs and symptoms and
> some laboratory values, and in its worst features even some structural
> abnormalities. Most assuredly, it\'s a disease.
>
> MS. WITT: Thank you. Anyone else?
>
> MR. TURNER: Can I restate my point once again? Real simply, alcoholism
> is a disease and courts found it to be a disease, interestingly
> enough, very early on in the 1960s, switched it from being a crime to
> being a disease in the law.
>
> The problem is that, let us suppose that we all agree that it\'s a
> disease. Is that sound grounds for banning all claims that might in
> any way be related to a dietary supplement in relation to alcoholism?
> My suggestion is, it\'s not. That\'s also true of the feelings that
> one gets that would be called heartburn.
>
> The problem is, what do you do with that piece of information once you
> have it, and I think it\'s interesting because the question that
> people start out on a road with often defines where they end up in the
> definition. So if the issue is, how do we define diseases in order to
> decide what we\'re going to prohibit, I think we\'ll come up with a
> much different kind of implication for the FDA than if we say we\'re
> going to define diseases in order to help us have the consumer have
> more access and more ability to deal with whatever their condition is.
>
> DR. NEFF: One brief comment. Definitions are\--the best definitions
> are those which are clean and tight definitions. It doesn\'t depend
> upon how people feel. It depends on what they think and what the
> evidence is.
>
> I chair an authority which has an editorial board that has folks from
> all the specialties, from nursing to OT, PT, government, and on this
> they all agree. I just point you to my summation statement. In the
> absence of good definitions, we cannot get at the truth. You cannot
> get at the truth. None of you can get at the truth. The public can\'t
> get at the truth.
>
> True, definitions change, but in this day and age, that 1993
> definition reads as though it was taken from the first paragraph, half
> of the first paragraph of the definition of disease and the person who
> was copying it got tired. It is not complete. It will not serve us
> well.
>
> DR. KAMEROW: It may be a little bit of a strain, but I thought I would
> try to talk about constipation for a second.
>
> \[Laughter.\]
>
> DR. KAMEROW: I think that, Ann, your question here is a very good one,
> because constipation is a perfect example of the problem that you find
> yourselves with in trying to make definitions, because constipation is
> normal. It can be something that\'s normal if one changes locations or
> changes diet. It\'s a normal thing to have some difference in one\'s
> pattern of elimination. It can be a symptom of something benign or
> very serious, indeed, as in an occult cancer or other kind of
> gastrointestinal problem. And, in itself, it can be a disease in rare
> cases and can be even life-threatening in some cases.
>
> So you really have hit it perfectly in trying to figure out and split
> the hairs that are almost impossible to split with terms such as
> constipation and trying to decide whether it, as a word, is a disease
> and, therefore, can\'t be addressed, or whether it is not a disease
> and, therefore, can be part of a claim for these.
>
> So my perception, which is not helpful, probably, is that this proves
> what a difficult position you\'re in and why you can\'t make
> distinctions between these things and have to figure out a way to
> allow these claims to be made if they\'re supported by some evidence.
>
> MS. HILDWINE: I think that the Federal Food, Drug and Cosmetic Act
> would support the finding that constipation is not a disease, and
> where this occurs is at the critical point of the food exclusion from
> the definition of drugs.
>
> Foods, as we know, have effects on the structure or function of the
> body. If it is not a food and has an effect on the structure or
> function of the body, by definition, under the statute, it is a drug.
> Now, I am not a lawyer and I don\'t pretend to be one, but I do
> understand that one point, and I can tell you that there is no
> question with respect to ameliorating constipation, some people are
> going to go to the medicine cabinet or the OTC section of the drug
> store and some, if it persists, may go to the physician for a
> prescription medication. But some people are going to ameliorate this
> condition, affect this structure or function of the body through their
> diet, and I can assure you, bran muffins and prunes are not drugs.
>
> So when you go back to the definition of a drug and the exclusion for
> food, you come to the conclusion when you look at the case of
> constipation that that is structure/function related. It is not a
> disease under the FFDCA.
>
> MS. YETLEY: Following up on the idea that you\'ve just been talking
> about and thinking also about the range of comments that we\'re
> received this morning, which I\'m very appreciative of, Ilene talked
> about disease should be conditions that require medical evaluation and
> treatment. Regina talked about needing actual damage. Others talked
> about needing to be able to look at the full characteristic set of
> signs and symptoms in order to interpret some type of a sign or
> symptom, I guess I should say.
>
> Given this range of perspectives, how would you deal with claims for
> something like pain or headache, which could sometimes require medical
> intervention, sometimes not, could be characteristic of a more
> underlying serious condition, may not be. How would you deal with that
> kind of subject of a claim?
>
> MS. HELLER: I think that the dietary supplement products could be
> limited to minor conditions, let\'s say minor headaches. They would
> not be able to be labeled for use for persistent headaches.
>
> I think what we need to do is to develop a list of conditions. One of
> my colleagues mentioned earlier this morning that a group of doctors
> should get together and define disease. I think what they really need
> to do is to come up with a list of categories of conditions that are
> amenable to self-treatment and conditions that require a doctor to
> evaluate or treat the condition, and I think that\'s where we\'re
> really heading.
>
> I also wanted to make one point about the [Pearson]{.underline} case.
> That\'s been waved around as limiting FDA\'s authority to restrict the
> flow of information. What needs to be kept in mind is that the
> decision did not turn on safety grounds. There was no safety issue
> before the court. So to the extent a dietary supplement is suggested
> for use for a serious condition and FDA has real safety concerns about
> that, then FDA can certainly limit the information or even ban the
> product.
>
> DR. NEFF: I can tell you that you can get a large group of doctors or
> a small group of doctors together and ask them to define those
> conditions for which treatment is needed and those conditions where
> you can self-medicate and you would never get an answer. I think you
> knew that when you asked the question. It\'s impossible.
>
> Let me make the point, though, in order to evaluate any claim for a
> substance to treat either one, you\'ve got to have a definition of
> what in the world it is or all the evidence in the world can\'t be
> evaluated. That\'s critically important, and that 1993 definition is
> simply defective, short-sided, and useless.
>
> DR. BOWEN: Along those lines, Dr. Neff, you said that you prefer the
> second definition. I think we heard that. You also said that no
> definition is completely fallacy-proof. Do you have any
> recommendations about that definition in terms of refining it further
> or any\--
>
> DR. NEFF: The first definition?
>
> DR. BOWEN: The second definition.
>
> DR. NEFF: The second definition?
>
> DR. BOWEN: And I would ask the same question to Dr. Spilker, because
> you felt that that second definition was not broad enough to cover
> what you consider related disease claims.
>
> DR. NEFF: Probably given some time and a small group of\--if I got
> together with my editorial board, they probably would wordsmith that
> thing. In fact, they might wordsmith it to death. That would be my
> great fear.
>
> It\'s pretty good. I can tell you, if you look at four or five
> textbooks of general pathology, you will find that the definition
> given there, in Robbins and some of the other major textbooks, pretty
> much conforms to that one. It\'s good.
>
> DR. SPILKER: I believe that, as I said before, that a small workshop
> of enough people to sit around the table and talk to each other who
> would be empowered to come up with a definition, starting with your
> second definition, could\--and, unfortunately, it is a question of
> wordsmithing and taking all of the different stakeholders\' views in
> mind. Everyone would have to be there.
>
> But I think that if you had the right people there, that you really
> could come out with a definition. It would be hard, but at least, even
> if you couldn\'t, I think it\'s worth a shot. I think that the fact
> that you had so many respondents to your definitions and other things
> that you\'re doing really illustrates that perhaps you\'re not quite
> there yet and at least we are trying to propose one workable solution
> that wouldn\'t cost a lot of money, it wouldn\'t take a lot of time,
> and we hope and we would try hard, as I think the others would, as
> well, to really come up with a solution that everyone was happy with.
>
> MS. NICKERSON: Mr. Turner, you had suggested that one approach FDA
> might consider would be to require a disclaimer addressing the
> differences between the first definition of disease and the second
> definition of disease. Could you elaborate a little bit on how that
> might work?
>
> MR. TURNER: Well, I think the answer would go to the charge that was
> given to the small group that met to decide what the definition is. If
> the charge was, this definition will draw the line between what is
> prohibited and what is not prohibited, I think you\'ll get a different
> answer from at least some of the stakeholders\--our groups, for
> example\--than if the charge was, we\'d like a definition that defines
> disease so that we can more fully inform consumers so that they can go
> into the market in a way that gathers useful information.
>
> So that, for example, if a definition were able to made that
> identified serious disease in the context of whatever that group would
> think it was and a disclaimer were then added to those kinds of
> symptoms\--let\'s say pain was an example, a statement that could
> say\--understand, I am doing this completely off the top of my head. I
> am not a focus group. I am only one person. I\'m not even sure I\'m
> speaking for Citizens for Health.
>
> But you could have a situation that said something like, \"It helps to
> reduce pain. If pain persists, it might be a sign of serious illness.
> Consider seeing a physician.\" That is a possible thing that you could
> say if you ended up with a definitional structure that made the
> distinction between those things which people think are not included
> in definition A but should be included in definition B, or are
> included in definition B.
>
> Our concern is not\--I agree totally with the arguments that say
> definitions are necessary for clarity of thought. What I am saying,
> however, is that when the implication of a definition is that a
> significant batch of information is going to be excluded from the
> marketplace just because of that definition, then you will have
> interest groups that will come and try to influence\--us, for
> example\--that definition to ensure that batches of information that
> we think are constitutionally protected, that the consumer has a right
> to, and so forth not be eliminated from the market purely because of
> the definition.
>
> On the other hand, if we\'re going to have a process that follows
> along what we believe the court is talking about in
> [Pearson]{.underline}, it is absolutely correct that we need
> definitions to make that work, and all the arguments about the need
> for clarity of definition apply in that context. If that\'s what
> we\'re talking about\--either way, we want to be in the discussion
> when the discussion comes, but we would really try to work hard to
> make clear, precise definitions of what we\'re doing, is helping get
> information to the consumer. I\'ve given you one example. I think that
> you could do that for a number of things that would be similar.
>
> Incidentally, I\'ll make another point. I don\'t believe that under
> [Pearson]{.underline} or the law that that\'s required. I believe that
> this would be a step forward in moving beyond the current framework.
> It would be something that would be permitted under the law that the
> FDA could do, but it\'s not required.
>
> MS. WITT: I have a follow-up question for Mr. Turner. Are you\--and
> I\'m just trying to get a sense of what you\'re saying\--are you
> suggesting that there really isn\'t any claim that couldn\'t be made
> on a dietary supplement label as long as it had appropriate context
> and disclaimers?
>
> MR. TURNER: No, I don\'t think that\'s true at all. I don\'t think,
> for example, a disease claim under the first definition, and there are
> some that exist under the first definition, couldn\'t be made without
> having the proper pre-clearance requirements that exist currently
> under the law. I\'m not, from my policy point of view, I\'m not sure
> that\'s a good policy, but that is the policy that exists and that\'s
> the way it works, and for the sake of the discussion that we\'re
> having here today, we\'re not questioning that. But there are a wide
> range of disease claims, the classical disease claims, that cannot be
> made without the basic substantiation pre-clearance and so forth that
> the FDA requires.
>
> MS. WITT: And, again, I\'m just trying to clarify in my own mind what
> your position is. I\'m confused myself about what we mean by the first
> and the second definition. The 1993 health claims definition\--
>
> MR. TURNER: Nineteen-ninety-three, correct.
>
> MS. WITT: \--that gives adequate guidance on what you would call the
> classical diseases? Is that a good definition, in your mind?
>
> MR. TURNER: Yes. The answer directly to your question is yes. What you
> need to understand, that what I\'m talking about is the role that a
> definition adopted by regulation creates or plays in the framework of
> our legal system. The problem is that you could get a whole bunch of
> experts together in 1492 and they could agree unanimously that the
> world is flat, or the earth is flat. That would not make it flat.
>
> Whatever the definition is that people get in the room and articulate
> is an effort to approximate as clearly as possible what\'s going on
> out in the real world. It in itself is not a statement of truth. Its
> usefulness is in making distinctions and classifications and its
> usefulness from a legal point of view is what is the implication
> legally for having adopted that definition.
>
> So that the concept I\'m talking about is that either of these
> definitions, in the construct I\'m talking about, would be adequate
> definitions. They would be adequate if they were accepted by the legal
> and legislative process. The way that the 1993 definition came into
> existence and exists and preceded the passage of DSHEA makes it the
> one that is legally the binding definition. I don\'t believe the FDA
> has the authority to change that.
>
> What I am saying is that the problems that FDA is worried about
> because of that definition, in my view and, I believe, in the court\'s
> view, can be addressed by addressing those problems inside that
> framework about how you allow information to flow in the culture that
> is broader than the information that\'s contained in the definition.
>
> What I believe the court said is, unless you\'re making the argument
> that it is an inherently misleading thing to include one of those
> things that would be in that category that would be added by the
> second definition, what you have to do is\--you can\'t ban it. You
> have to either allow it just as it is or you can create a framework of
> disclaimers. What I\'m suggesting is that that is sound public policy
> for moving into the area of how information is flowing, how people are
> gathering information themselves to make their decisions.
>
> MS. HILDWINE: I believe that this has implications beyond those just
> for a disclaimer, and I think that very key here, and it hasn\'t been
> brought up yet today, are the material fact provisions of the statute,
> and, okay, I know them, too.
>
> Does the label or labeling disclose enough material facts with respect
> to the consequences of use of the article? Second, does the label or
> labeling disclose sufficient material facts to support the
> representations made by the article?
>
> It\'s pretty simple. You don\'t need to change the definition of
> disease in order to get to the disclosure of necessary material facts.
>
> MS. HELLER: It doesn\'t end there. It\'s not that simple, Regina,
> because the definition of disease determines how something is going to
> be regulated. It\'s going to determine the class that a product falls
> into. It\'s going to determine whether something is regulated as a
> drug or whether it\'s a dietary supplement that\'s eligible for
> structure/function claims.
>
> So it\'s essential that we have a definition that\'s clear, because
> the regulatory consequences are very different depending on the
> category into which something is put into, and we just need to develop
> a continuum. I think Doug gave the example of constipation or some
> other thing where it starts out as being something very simple and
> something that consumers can treat, but after a while, if it
> continues, it may be symptomatic of something far more serious. If you
> have a cut, you can treat it with a band-aid, but if you tear open
> your arm, you need to see a doctor. There\'s a continuum of medical
> conditions and I think we need to keep that in mind.
>
> MS. HILDWINE: I would just like to add that, clearly, let\'s call it
> what it is. Dietary supplements are a subset of food. Dietary
> supplements are foods. Working through this definition, clearly,
> we\'re at a point where there is some suggestion that if they\'re not
> foods, they\'re drugs. But if you look at the way they would be, I
> believe, appropriately regulated, it\'s not that they would be drugs,
> it\'s that they would be making unapproved health claims if, in fact,
> the structure/function claim is not appropriate, simply because, I
> think unless they\'re using the statutory buzzwords for prevent,
> treat, cure, disease, that we\'re really talking about unapproved
> health claims for food. Dietary supplements are foods.
>
> MS. HELLER: Except for the definition of a drug. The definition of
> dietary supplements specifically says that dietary supplements are
> food for all purposes except for the definition of a drug. If you look
> in the drug definition, dietary supplements can make a limited number
> of claims without violating the drug provisions, and I think we need
> to keep that in mind. I think dietary supplements need to be treated
> differently.
>
> MS. HILDWINE: It\'s a little circular.
>
> MS. HELLER: That\'s Congress.
>
> MS. YETLEY: I guess while they\'re figuring it out, I\'ll ask another
> question. I\'d like Jim Turner to start, but maybe the others have
> comments. I\'m a little bit concerned about what appears to be a
> delinking between science and regulatory decisions. It seems to me
> that you\'re saying that regulatory definitions shouldn\'t change as
> we get better science to deal with them. We should simply use the old
> definitions and compensate with extra information. Can you clarify how
> science and changing science should interface with regulatory
> decisions?
>
> MR. TURNER: I think that the difficulty is how do you convey the
> changing scientific information to the public, and what I\'m
> suggesting is that constantly altering the definition creates a
> disjunct between the science and the law, the science and the way the
> information flows.
>
> The concept I\'m trying to talk about is how can\--and let me start
> with a different approach. If the gathering of more and more
> scientific information creates a situation where, by an artifact, you
> end up prohibiting information that was permitted before, and I\'m
> talking classes of information, because specific information is still
> subject to all of the substantiation and proof standards that exist,
> but general classes is what we\'re talking about.
>
> If changing scientific information\--if, for example, you change the
> definition from 1993 to 1998 and end up taking information that was
> there about pain and eliminate it, I think that\'s a serious problem.
> If, on the other hand, you take the definition of 1993 and you have
> knowledge that has developed that tells you more about pain than you
> knew in 1993, I would incorporate that by a regulatory process that
> causes that information to now be distributed along with everything
> else.
>
> In other words, don\'t take away the pain information that you already
> have, but add to it information that is useful for people about what
> we now know about pain that we didn\'t know in 1993.
>
> I believe that the process, the new knowledge that comes because we
> now can make a better definition, however that arrives, and says, we
> now have a whole bunch of new knowledge and on the basis of that new
> knowledge we will create a whole bunch of categories which eliminate
> information, I think is deconnecting the science and the regulatory
> process. What you need to do is to create a process that incorporates
> that information on a systematic basis.
>
> Let me say one other thing. One of the problems that we\'re having
> here is that the focus that you\'re talking about is what is disease,
> but the implication in the market is what\'s going to be banned. So
> the question you really want to know is, what should we permit and
> what should we ban as information, or I would put it more
> specifically, how do we handle information as it develops? To argue
> that we will handle the information on the basis of the way we define
> categories, I think separates the coworking of law and science.
>
> DR. NEFF: Just a brief comment. That 1993 definition was bad in 1993.
> Any second-year medical student could have told the FDA that it was
> bad in 1993. We knew enough to craft one then. It just is poor.
>
> Many of the comments\--I came here prepared to talk about the
> definition of disease, but as you can see, many of these comments have
> nothing to do with the definition of disease and I\'d suggest you get
> some of these folks back up here for Panels II and III, which is what
> their commenting about. What you asked for was a definition of
> disease. That 1993 thing is simply bad. Anybody can see that. The
> lawyers, the regulators, the people who invest large amounts of money
> in making it may like it because it allows them to keep doing what
> they want to do. I can\'t really comment about that. But it\'s a very
> poor definition of disease. That is, I understand, what we\'re talking
> about here.
>
> DR. SPILKER: People who are not familiar with definitions and
> dictionaries where you find these definitions tend to think of them as
> fixed objects in space, almost like butterflies on a board. But anyone
> who understands words, dictionaries, and language knows that it\'s
> evolving constantly. You go through the Oxford dictionary and you see
> enormous changes from edition to edition.
>
> Should definitions in this area be based on good science? Absolutely.
> If we\'re not going to be basing our definitions on the best available
> science, which does change\--there was a wonderful op-ed in the [New
> York Times]{.underline} a few days ago, how what we call truth in
> cancer keeps changing as you get more information. Certainly, we want
> definitions to change and evolve as science evolves or as cultural
> understanding evolves. It doesn\'t have to just be science. So I
> certainly support that and would say that that is the way definitions
> change. Almost no definitions are fixed, although they are
> historically important in many cases.
>
> MR. TURNER: I think that\'s an extremely important point, and that, I
> think, is what makes it tough for the FDA to make how it acts as a
> regulatory agency prohibiting things, to have that be contingent upon
> how the definition of a word like disease evolves over time. It makes
> it almost impossible to be a durable, consistent regulatory agency in
> this field, and I think that\'s the problem that really needs to be
> addressed.
>
> MS. WITT: I have a question for Ms. Heller. You had suggested that the
> demarcation between dietary supplement claims and drug claims or
> possibly health claims\--let\'s not argue about whether they\'re drug
> claims or they\'re health claims\--would have something to do with the
> seriousness of the condition that was being treated and the ability of
> the consumer to evaluate their condition, is that right?
>
> MS. HELLER: Yes.
>
> MS. WITT: Which, in my mind, translates roughly to the distinction
> between over-the-counter drugs and prescription drugs, something like
> that, which is an interesting distinction, but I wonder how it ties to
> the definition of disease.
>
> The distinction that the law draws for us is the distinction between
> disease claims and structure/function claims. The distinction you\'re
> drawing really doesn\'t relate to any definition of disease that\'s in
> front of us, and I wonder if you\'re suggesting that we just create a
> definition of disease that has as its outcome the distinction you\'re
> drawing, even though it\'s not perhaps a medical definition or even
> the 1993 definition.
>
> MS. HELLER: I think that\'s a fair assessment of what I was
> discussing. In trying to arrive at a definition, we were thinking,
> well, should we limit it to the conditions for which over-the-counter
> drugs are used, and we\'re tossing that back and forth in our office
> and we decided that, well, if it\'s over-the-counter drugs, dietary
> supplements aren\'t supposed to treat, cure, mitigate a disease. So
> you\'d have to distinguish, then, dietary supplements from the
> over-the-counter drugs, and maybe that can be done with yet another
> disclaimer.
>
> MS. WITT: Well, many over-the-counter drugs are intended to treat
> structure/function claims. They\'re not limited to disease claims.
>
> MS. HELLER: Right, but I think the most important thing is to ensure
> that however the definition is developed, that serious conditions
> cannot be the subject of a dietary supplement claim. If someone is
> talking saw palmetto for prostate cancer, that should not be allowed.
> That should be a drug claim.
>
> MR. TURNER: I think we\'re precisely at the problem. I think if you go
> out to the public and say, I\'m sorry, you\'re not allowed to take saw
> palmetto for prostate cancer, the 175,000 letters that you got are
> going to look real small compared to what will come in with something
> like that.
>
> MS. WITT: Let\'s clarify. We\'re not talking about what people are
> allowed to take for anything.
>
> MR. TURNER: All right. So then we\--
>
> MS. WITT: It\'s the way products can be promoted.
>
> MR. TURNER: But then you step back to what can be said about it, so we
> know that it\'s out there. What happens, what\'s happening now,
> without having a modulated information policy from FDA, is that all
> kinds of information that\'s politically protected by the First
> Amendment, not in the commercial window but in the political window,
> is out there making all kinds of claims about all kinds of stuff that
> is totally confusing and unclear, and at the same time, the commercial
> window has been made very, very, very narrow.
>
> But the commercial window is one where we have some control, and what
> we\'re suggesting is, open that window up by using additional
> information to allow things to be adopted by the public so that they
> can begin to actually have a dialogue about\--let\'s take saw palmetto
> and prostate cancer.
>
> Easily, a claim can be put there that is modified by something that
> the FDA adds along the lines of\--not that you can\'t take this
> because it\'s not right, but you can say, look, we don\'t know that
> this works or it hasn\'t met the requirements or a whole range of
> things that could be said that would alert the public to the fact that
> here is a place where they can learn something that has a debate going
> on, but here\'s where the FDA stands on that. That\'s the direction
> we\'re trying to go with the policy that we\'ve been pushing. We\'ve
> been doing this for 15 years. We\'ve been trying to move this policy
> forward.
>
> The FDA is going to be in the position of working with the public that
> is buying saw palmetto to use for prostate cancer or they\'re going to
> be working against them, and the strategy that we\'re trying to
> articulate is the one that allows the FDA and the public to work
> together. That\'s our purpose.
>
> MS. WITT: If I understood you correctly before, though, I thought you
> were saying that prostate cancer would not be a claim that could
> appear on\--
>
> MR. TURNER: It depends on\--as we know, as we all know, there is a
> whole coterie of lawyers in Washington that can get across on a label
> that saw palmetto is useful for cancer, and they can do it in ways
> that will not get regulated. It can be done.
>
> What I am suggesting is that rather than trying to block that\--and
> it\'s true in every one of these areas, you can snuggle right up to
> the edge and create a regulatory problem for the FDA, or for yourself,
> for that matter, but it\'s the problem. What I am suggesting is, the
> way to handle that is not to try to keep pushing it back but is to try
> to create a way that people can go into that world and can understand
> that this is up against a line and have the FDA say, hey, this is up
> against the line. Maybe you should go see your doctor.
>
> If you\'ve read in a book\--you know, the label is only so big, but
> you could say, if you have read in a book that saw palmetto might be
> good for cancer and that\'s why you\'re taking this, you might
> consider calling your doctor, or the FDA says you might consider
> calling your doctor. The concept is to try to get the information flow
> that\'s happening into a framework where there\'s some kind of
> reference, and I think a definitionally-based reference, so that the
> public can understand what all this stuff is that\'s going on about
> all of these products that are out there.
>
> DR. SPILKER: One caveat to that is that I think that of the FDA did
> what you suggest, it would be an implied endorsement and I think you
> would find the product you are talking about or any product that the
> FDA did that would then be much more widely used and lead to a lot
> more problems.
>
> MR. TURNER: I think that issue has been raised several times over the
> years, or over the struggle in dietary supplements. Understand, this
> struggle has been going on formally since 1962 and probably since 1947
> in the [Quaker Oats]{.underline} case. This battle has been going on.
> Where do you draw the line?
>
> Frankly, I mean, FDA has been pushed back and back and back and back
> on drawing that line. This issue, the issue about how a disclaimer
> looks, has been raised. I believe that that is a subject that can be
> looked at in a professional manner by FDA. They\'re thoroughly clear
> about how statements that have to do with a health claim affect the
> public. They go out and they do research. They can do the same, and
> they\'re going to have to do the same on disclaimer-type statements,
> because the court has said, you\'ve got to go out there and figure out
> if you can do disclaimers or not. So this issue is one that needs to
> be a part of the overall framework of how you communicate with the
> public.
>
> DR. BOWEN: I\'d like to get back to the question of OTC drug products
> and dietary supplements and the issue of parity for those two
> categories in marketing for structure/function claims. And
> particularly, I think I should address my question to you, Dr.
> Spilker. Could you give us your perception or comments on the question
> about the pain indication? As you know, there are OTC drug products,
> analgesics, which are marketed for minor aches and pains with a
> proviso that one follow up if there\'s a chronic pain condition. So I
> would be interested in your comments, given that you made statements
> about what you thought DSHEA was intended to do.
>
> DR. SPILKER: Pain, of course, is one of the most complex and difficult
> symptoms to deal with because there perhaps is a role, or there
> definitely is a role for drug therapy, that is, prescription drug
> therapy in many diseases where pain is a component. There is certainly
> for, I\'m sure, everyone in this room, OTC drug use for certain types
> of minor headaches, and it would not be unimaginable and quite
> reasonable for people to consider certain dietary supplements\' use.
>
> So I think you\'re getting back to the definition of the disease and
> the fact is that in some cases, as was said before, pain is a minor
> symptom, but whether or not you call it a disease could be treated
> with supplements or over-the-counter drugs. In other cases, it would
> be a harbinger.
>
> Obviously, it also touches on the enormous gray areas that the FDA and
> others are struggling with, trying to come up with clear lines in a
> very gray area. I certainly don\'t have the answer to the question,
> but I think that the way I would like to see it approached is by
> starting with perhaps the definition of disease.
>
> It\'s also possible that one can start the other side of this and look
> at the products, and in many ways, that is what has been done, as
> well. That is to say, RX drugs are those drugs that are doing X in
> terms of disease, et cetera, and OTC products and if they are safe for
> general use and the consumer is able to self-diagnose, then that can
> be used.
>
> I don\'t think that\'s a really great answer to your question, but I
> think we might have to talk about it more and we\'d be happy to do
> that.
>
> DR. BOWEN: Dr. Neff, could you give an answer?
>
> DR. NEFF: I can\'t add anything more.
>
> MS. OLIVER: Are there any more questions from the panel? If not, in
> our [Federal Register]{.underline} announcement, one of the things we
> said is there would be an opportunity if there was time, and there is,
> for individuals from the public to ask questions of the panel, too. So
> I would ask if anyone has any questions for the panel for the next ten
> minutes or so, and if so to go up to the podium with your questions.
> You could introduce yourself, too, for the record.
>
> MR. ROGOVIN: Thank you. My name is Jarrow Rogovin. I\'m President of
> Jarrow Formulas of Los Angeles, a dietary supplement company. A couple
> of questions.
>
> One is, concern was expressed that the consumer has to know the
> difference between heartburn and heart disease, but calcium carbonate
> is an OTC used to treat heartburn and I\'m not sure that\--it says a
> concern about dietary supplements\--this is answered by the present
> use of carbonate. So, in other words, I\'m not sure this is really a
> problem.
>
> MS. HILDWINE: I would point out to you that calcium carbonate is also
> an approved food additive.
>
> MR. ROGOVIN: I know that, right, and a dietary supplement.
>
> MS. HILDWINE: There are a lot\--
>
> MR. ROGOVIN: I\'m trying to understand, then, how a dietary supplement
> for heartburn is a problem if we have an OTC that\'s used. There is
> still the issue of whether it\'s heartburn or heart disease. That
> question is out there whether it\'s a supplement or an OTC.
>
> The other thing is, if I may with CSPI, the representative from CSPI
> was talking about cholesterol. One of the main drugs for cholesterol,
> statin drugs, inhibit HNG coenzyme A, which will inhibit cholesterol
> synthesis, but it also inhibits synthesis of coenzyme Q10. So not only
> is it desirable to label coenzyme Q10 to be given at the same time as
> statin drug therapy, but there\'s a number of dietary supplements that
> do lower cholesterol and it seems to me that the CSPI is simply
> hostile to supplements. I take your newsletter. We were
> attacked\--Jarrow Formulas was literally, I use the word
> attacked\--for labeling carnatine for energy production and I\'d like
> to ask CSPI how you would label a structure and function claim for
> carnatine.
>
> MS. OLIVER: I\'m not sure that\'s within the purview of the questions
> we\'re asking. The others were\--
>
> MR. ROGOVIN: I think it is, because CSPI seems to object to anything
> with supplements. I\'d like to know how they would label a supplement.
> Co-Q10 for adjunctive nutritional support to counteract statin drugs,
> very, very few cardiologists recommend coenzyme Q10. Many of them do
> statin drugs, and there\'s a serious question of whether people are
> developing cancer and their heart disease progresses to a certain
> extent anyway because of the inhibition of coenzyme Q10, because Q
> plays an important role in the LDL particle protecting the cholesterol
> from becoming a cholesterol oxide, and then from there, the whole foam
> cell cascades.
>
> MS. OLIVER: What I might ask is if Ilene wants to answer in the terms
> of the definition and how that applies, if you have any comments.
>
> MS. HELLER: I don\'t think it applies to definition, but I just wanted
> to say, for the record, that CSPI is not opposed to dietary
> supplements at all. We just want to make sure they\'re safe and
> effective.
>
> MR. ROGOVIN: What does effective mean?
>
> I think that I\'d like each person just to come up to ask one or two
> questions, but I appreciate your coming in.
>
> MR. ROGOVIN: This is sort of a reverse approach. Other than defining
> the disease, how are we going to define an application for carnatine
> or co-Q10 and see how close that comes to a disease or not a disease?
>
> MS. OLIVER: I hear you.
>
> MR. ROGOVIN: I see a few people nodding. They understand what I\'m
> trying to do here. I guess the other thing is, and I agree very, very
> much, profoundly, with the attorney from Citizens for Public Health.
> This is the modern American folk medicine.
>
> I have severe cervical arthritis. Now, I can take ibuprofen. This is
> going to accelerate the disease process and destroy my kidneys. So
> does anybody on the panel suggest how I\'m going to know what
> supplements to use to reduce the pain and the disease process of the
> cervical arthritis I have from a 35-year-old injury, because there are
> millions of people out there with arthritis. We know it\'s a disease
> and we know what the drugs do.
>
> Now, how are we going to define this and implement the labeling
> regulations of supplements in such a way that the public has access to
> information to substances that don\'t degrade the kidneys and
> accelerate the degeneration of cartilage because these NSAIDs
> interfere with acetylation, and we need acetylated glycoamenal glycans
> in order to maintain our proteo glycans \[ph.\].
>
> MS. OLIVER: What you\'re going into now is also making a comment and
> we\'re going to have opportunity for comments at the end of the day. I
> just wanted questions relating to definition for the panel, and you
> had some, but I might ask\--
>
> MR. ROGOVIN: I guess I\'m process oriented and pragmatic, but\--
>
> MS. OLIVER: Right, but you can\'t\--
>
> MR. ROGOVIN: The question then is, how are we going to use a
> definition of disease here to regulate supplements? What I\'m really
> concerned about is that this definition of redefining of disease is
> being used to suppress claims that there\'s an agenda here and it\'s
> not scientific.
>
> MS. OLIVER: Okay. We have one more person standing for a question. Did
> you have a question? Is the question related to the definition of
> disease on the panel? Okay. Thank you.
>
> MR. GORELICK: My name is Kenneth Gorelick. As I\'ve listened to the
> session this morning, I actually have to agree with Dr. Neff in that I
> came prepared for this session to discuss definitions of disease, but
> actually what I seem to be hearing is what is the regulatory
> application of the definition of a disease. I\'ve heard Mr. Turner
> suggest that the role of the FDA in this context should be an advisory
> one in terms of creating various advisories as to the application of
> the definitions and how strict those definitions should be. I think
> that\'s a more complex issue than the FDA\'s current regulatory role.
>
> But I would like to ask the question of the panel, perhaps, if the
> issue of the definition should include somehow a definition of disease
> that requires a level of medical diagnosis. In other words, does it
> pass the grandmother test? Would your grandmother send you to the
> doctor or would she treat it herself? Thank you.
>
> MS. OLIVER: Did anyone care to respond on whether you should consider
> whether someone should go to the doctor in the definition?
>
> MS. HELLER: To the extent that I indicated before, if something is a
> very serious condition, it should be considered a disease
> automatically.
>
> MS. HILDWINE: Well, what I talked about in my remarks, in fact, is
> that we think that the definition should include a concept of damage.
> I think the concept of damage speaks to seriousness of condition. I
> think this is going to be a very important thing, because we really
> here are not just talking about making structure/function claims for
> dietary supplements. We are also very much speaking about the whole
> context of making health claims for food, and I think we have to be
> very careful about how things are defined so as not to produce any
> unintended consequences for the regulation of foods.
>
> DR. NEFF: In an attempt to lighten things in this room, my Irish
> grandmother sent me to the physician for everything, including
> constipation.
>
> \[Laughter.\]
>
> DR. NEFF: My German grandmother would have kept me home while my
> appendix burst. Neither of them were physicians. Both were immigrants.
> I don\'t think they knew much about the definition of disease,
> frankly.
>
> MS. OLIVER: Thank you very much. We appreciate that.
>
> I think since we\'re running ahead of time, what we might do is break
> for lunch and come back at one o\'clock. That will give extra
> opportunity if people want to do public comment at the end of the day.
> So thank you very much.
>
> \[Luncheon recess.\]
>
> A F T E R N O O N S E S S I O N
>
> MS. OLIVER: If we could get back together and if I could have panel
> number two come forward, please. Once again, I\'d ask the panelists to
> speak into the microphone and to try to limit their presentations to
> approximately five minutes and we\'ll have an individual that will be
> doing the timing down below. I\'ll ask Ann Witt once again to come up
> and introduce the issues.
>
> **PANEL II: COMMON CONDITIONS**
>
> **ASSOCIATED WITH NATURAL STATES**
>
> MS. WITT: We seem to be missing one panelist, Stacey Zawel. Did she
> think it was at 1:30? The agenda did start at 1:30. Why don\'t we
> allow her to go last.
>
> The topic for the second panel is \"Conditions Associated with Natural
> States.\" In the proposed rule that we issued last April, FDA said
> that natural states, by which we meant such things as aging,
> menopause, pregnancy, the menstrual cycle, were not themselves
> diseases but could be associated with certain abnormalities that were
> diseases.
>
> We listed some examples of conditions associated with natural states
> that we would consider diseases. The conditions we listed were
> Alzheimer\'s disease, toxemia of pregnancy, hot flashes, PMS, and
> presbyopia and decreased sexual function associated with aging.
>
> This topic, like the one that was the subject of the morning\'s panel,
> received many, many, many comments, most of them objecting to our
> characterization of some of these conditions as diseases. Most of the
> comments focused on hot flashes, PMS, and decreased sexual function
> associated with aging and said that these conditions were so common
> that they should be considered neither abnormal nor diseases. I should
> say that none of the comments argued that Alzheimer\'s disease or
> toxemia of pregnancy were not diseases, but they argued vehemently
> that some of the other conditions we listed were not appropriately
> treated as diseases.
>
> We listed three questions in the [Federal Register]{.underline} notice
> announcing this meeting that we would like the panelists to address on
> this issue. The first question is, if FDA were to treat some
> conditions associated with natural states as diseases, such as toxemia
> of pregnancy and Alzheimer\'s disease but not others, such as hot
> flashes and common symptoms associated with the menstrual cycle and
> decreased sexual function associated with aging, what would be an
> appropriate principle for distinguishing the two groups?
>
> The second question was, for example, would it be appropriate to
> consider the severity of the health consequences if the condition were
> to go without effective treatment, and if that principle, namely the
> severity of the condition, were used, how should we define severity?
>
> Those are the questions that we hope this first panel of the afternoon
> will address. Perhaps we could start with Anthony Young, as Stacey
> Zawel isn\'t here yet.
>
> MR. YOUNG: Thank you, Ms. Witt. My name is Anthony Young and I\'m the
> General Counsel of the American Herbal Products Association. I\'m
> presenting their position on the subject of common conditions
> associated with natural states. AHPA is the trade association
> representing over 300 manufacturers, marketers, and raw material
> suppliers in the herbal dietary supplement industry.
>
> The Federal Food, Drug and Cosmetic Act, as amended by DSHEA, states
> that dietary supplements may make structure/function claims and
> statements, but that such statements may not claim to diagnose,
> mitigate, treat, or prevent a specific disease or class of diseases.
> These same amendments allow structure/function statements to be made
> for health-related conditions that are not diseases.
>
> AHPA believes that DSHEA clearly allows structure/function statements
> that address non-disease conditions such as fatigue, sleeplessness,
> constipation, PMS, prostate enlargement, menopause, excess weight,
> depressed mood, and stress and tension, to name a few.
>
> In this notice, FDA has asked whether some conditions should be
> treated as diseases, what principles should be used to identify those
> conditions, and finally, whether the severity of the health
> consequences of non-treatment should be one of those criteria.
>
> AHPA recommends the agency consider an alternative approach to these
> issues. Instead of devoting resources to redefining disease and
> resisting condition-related statements for dietary supplements, AHPA
> urges the agency to accept what is evident, that supplements can and
> will be sold for non-disease conditions and to devote the agency\'s
> resources to developing strategies fully to inform consumers about any
> potential and material health consequences of the conditions
> themselves.
>
> In this context, AHPA urges the agency to give recognition and meaning
> to the word \"education\" in DSHEA. Use saw palmetto as a case study
> of how the agency could address the concerns raised in the questions
> posed to this forum. Saw palmetto is used by many men who experience
> enlarged prostate, a condition as common to male aging as gray hair.
> It is no more a disease than menopause. The National Institute of
> Aging and the National Institute of Diabetes and Digestive and Kidney
> Disease have excellent information pieces on benign prostatic
> hyperplasia, BPH, including clear and concise descriptions of the
> signs and symptoms of BPH and the universally accepted message that
> those with BPH should see a physician.
>
> Here is what the NIA advises. The best protection against prostate
> problems is to have regular medical checkups that include a careful
> prostate exam. See a doctor promptly if symptoms occur such as
> frequent urge to urinate, difficulty in urinating, or dribbling of
> urine. That\'s a relatively short message. The herbal products
> industry and the agency should be able to agree that those using saw
> palmetto should have that message.
>
> NIH also teaches that two in every ten cases, BPH symptoms in those
> cases signal a serious medical condition requiring treatment. Is there
> any good and sufficient public health reason, policy reason, why the
> essence of the NIH teachings should not be included within saw
> palmetto packages so that men who have this condition can have the
> opportunity to read them? Wouldn\'t consumers benefit more from this
> condition-related information than from a protracted debate over
> whether the law permits the definition of disease to be interpreted to
> include enlarged prostate?
>
> To accomplish the goal of delivering important condition information
> to consumers, the agency might issue policy guidance interpreting the
> misbranding provisions of the Act with respect to saw palmetto and
> prostate. In that guidance, the agency could advise that any reference
> to the prostate in labeling is misleading if it fails to inform
> consumers of the National Institute of Aging recommendation because
> that advise is, in the words of the law, material in light of such
> representations or material with respect to the conditions or the
> consequences which may result from the use of the article to which the
> labeling refers. Such guidance could note that supplements without
> such a statement would be considered misbranded because the labels are
> misleading for failure to disclose material facts about prostate
> problems.
>
> This section of the Act which defines the word \"misleading\" has long
> been used by the agency to define the conditions under which labeling
> is deemed to be misleading or not, most notably with respect to
> patient labeling for estrogen drug products or the agency\'s authority
> under this section of the law was affirmed.
>
> AHPA believes that this approach deserves the consideration of the
> agency and of the agency\'s constituent stakeholders. AHPA believes
> this is an approach based on established and affirmed legal precedence
> and believes this approach deals with the reality that saw palmetto is
> and will be used for prostate by men who need to know more about the
> condition their prostate presents. Thank you.
>
> MS. OLIVER: Dr. Zawel has arrived, and, of course, she thought it
> started at 1:30. We got done earlier in the morning and started
> earlier. You can go now, Dr. Zawel, or you can wait and go at the end.
> We have just started.
>
> MS. ZAWEL: Thank you, Janice, and I apologize for being late. I
> actually had the wonderful opportunity of testifying on the Hill and
> just ran down from the Hill, but I\'ll go ahead and go now, if you
> don\'t mind.
>
> As Janice said and most of you probably know, I\'m Stacey Zawel with
> the Grocery Manufacturers of America. GMA is one of the world\'s
> largest associations of food, beverage, and consumer product companies
> and we have a deep interest in the use of structure/function claims
> for all food products, including dietary supplements, particularly
> because any structure/function claim that may be used for dietary
> supplements may also be used for conventional food.
>
> First and foremost, GMA applauds FDA for scheduling this public
> meeting on these very important issues that surround
> structure/function claims and also for reopening the comment period to
> allow for additional public participation in the development of an
> agency regulatory strategy for dietary supplements.
>
> GMA is committed to working cooperatively with FDA to reach a
> regulatory approach for dietary supplements and conventional foods
> that will accommodate the objectives of all interested parties, and we
> have submitted written comments in response to the July [Federal
> Register]{.underline} notice from which my oral statements are drawn.
>
> Our focus this afternoon, as requested, will be related to common
> conditions associated with natural states which we actually see simply
> as one part of the issue of what is a disease. Therefore, I first want
> to establish that we believe FDA should retain the 1993 definition of
> disease, which focuses on damage. The definition of disease should not
> be expanded to cover physiological conditions that occur in natural
> states of life, such as pregnancy, menopause, and aging, or that
> otherwise occur without underlying pathology, such as pain or
> constipation. Only pathological conditions that are not an inherent
> part of the natural status of life are properly classified as disease.
>
> To provide clarity, let me give you the following example in order to
> make a distinction between natural states and disease states. As
> people age, most experience deterioration in eyesight, women
> experience menopause, and men experience a decrease in sexual
> function. None of these examples constitutes a disease.
>
> In contrast, however, there are some conditions that occur in a
> minority of people with special physiological conditions, such as
> pregnancy, or with great frequency in all people as they grow older
> but are not inherent in the natural state itself. Toxemia of pregnancy
> does not occur in the majority of pregnancies. Cancer and Alzheimer\'s
> disease are not inherent in the aging process. These are pathological
> conditions that are properly classified as diseases.
>
> I\'ll elaborate by answering the three questions posed by FDA relating
> to this issue. The first is the principle for distinguishing disease
> from the natural aging process. To reiterate what has already been
> stated, the gradual deterioration of the human body is a natural state
> and does not constitute disease. In contrast, specific types of
> pathological conditions that become more prevalent as we age because
> the body deteriorates but that are not universal are not properly
> classified as natural conditions and are instead regarded as disease.
> Therefore, we suggest that making a claim about a disease or a direct
> manifestation of a disease, in itself, is inappropriate.
>
> Let me talk about the severity of condition. GMA does not believe that
> the severity of the condition or the health consequences that could
> result from the condition are appropriate criteria for determining
> whether a natural state is a disease. The natural changes that occur
> in all of our bodies unquestionably need to be managed. That is the
> responsibility of each individual. If we do not take care of
> ourselves, it is obvious that health consequences may result. If the
> severity of potential adverse consequences from lack of attention to
> personal health were to determine what is a natural state, however,
> there would be virtually nothing left for the natural state category.
>
> GMA opposes consideration of severity as a determining criterion.
> Thus, the claim \"reduces joint pain\" is a proper structure/function
> claim even though the natural pain and stiffness resulting from age or
> a brisk workout may be quite severe. A claim to treat the disease
> arthritis, on the other hand, would not be appropriate for a dietary
> supplement or a conventional food. It then follows that GMA believes
> the definition of severity would be unhelpful. Thank you very much.
>
> MR. SOLLER: Good afternoon. I\'m Dr. Bill Soller, Senior Vice
> President and Director of Science and Technology for the Consumer
> Healthcare Products Association. CHPA\'s membership includes over 200
> companies involved in the manufacture and distribution of self-care
> products, OTC medicines, and dietary supplements and their affiliated
> services. I have a one-page handout that I\'m going to be referring to
> that I\'ve given to the panel.
>
> Since FDA\'s proposed areas of discussion overlap considerably, I\'m
> going to provide CHPA\'s consolidated approach to these issues, and
> you\'ll see that the issue of natural state flows through these.
>
> First, the definition of disease under NLEA 101.14(a)(6), shown on the
> left side of the handout, is overly broad. The phrase, \"a state of
> health leading to such dysfunctioning,\" is overly broad and might
> include, for example, a healthy state despite high fat intake.
>
> Second, FDA\'s proposed definition of disease for structure/function
> claims for dietary supplements is also overly broad. Unlike the
> definition in 101.14(a)(6), FDA\'s proposed definition for
> structure/function claims inappropriately omits the concept of damage.
> As a result, under FDA\'s proposed definition, any deviation from
> normal could include aging well as a disease.
>
> Therefore, on the right-hand side of the handout, we recommend
> amending FDA\'s proposed definition to more clearly distinguish
> structure/function claims for dietary supplements from drug claims on
> the basis of the adverse nature of diseases for which drugs are used,
> on the one hand, and the non-adverse nature of natural states for
> which dietary supplements are used. Specifically, a disease is any
> adverse deviation from or impairment of or interruption of the normal
> structure or function of any part, organ, or system of the body that
> is manifested by a characteristic set of one or more signs or symptoms
> that are not characteristic of a natural state or process, and a
> natural state or process should be defined as a life change or
> physiological manifestation expected in the normal course of life
> progression.
>
> In sum, the concept of natural states or processes in the CHPA
> definition of disease is balanced by the concept of adverse to create
> the appropriate basis for regulating structure/function claims.
>
> With respect to common conditions associated with natural states, FDA
> suggests that non-diseases might be explicitly considered diseases for
> the purpose of structure/function claims, drawing the line based on
> severity of disease. We believe the concept of natural state should be
> distinguished from the concept of disease within the definition
> itself, as is done in our proposed redefinition. The demarcation line
> is defined by the adverse nature of the deviation from normal. As a
> result, the phrase \"any adverse deviation from or impairment of or
> interruption of\" would include such things as cancer,
> hyperthyroidism, toxemia of pregnancy, and hypertension.
>
> Further, the exclusionary phrase \"that are not characteristic of
> natural states\" would include a number of conditions that are
> identified on page five of our handout, but would include things like
> stress, frustration, pregnancy, PMS, menopause, weight management,
> benign prostatic hypertrophy.
>
> Now, on implied disease claims, the line should be drawn based on the
> law. Under DSHEA, claims may not be made about the use of a dietary
> supplement to diagnose, treat, mitigate, cure, or prevent a specific
> disease. To use these claims, manufacturers must have substantiation
> and the product label must bear the disclaimer, \"This statement has
> not been evaluated by the Food and Drug Administration. The product is
> not intended to diagnose, treat, cure, or prevent any disease.\"
>
> The statutorily-required disclaimer is intended to explicitly and
> effectively eliminate the potential for structure/function claims to
> be interpreted as implied disease claims. Therefore, FDA should not
> sanction disease claims by regulation which are outlawed by statute.
> Hence, there is no need for FDA to seek additional regulatory
> constructs to address the subject of implied disease claims.
>
> In conclusion, CHPA\'s definition of disease amends FDA\'s proposed
> definition by incorporating the distinction between natural states and
> processes, that is, the claims domain of dietary supplements, and
> adverse consequences to the body, the claims domains for drugs and
> other medical treatments. Thus, CHPA\'s proposed redefinition of
> disease would represent the fundamental regulatory standard against
> which structure/function claims for dietary supplements would be
> judged in conjunction with the required disclaimer.
>
> Finally, FDA should recognize that if it allows implied disease claims
> for a product category which by statute may not claim an effect on a
> specific disease, the agency leaves itself open for challenge.
> Therefore, rely on the construct of the disclaimer as Congress has
> authorized to avoid the implied disease claim conundrum. Thank you.
>
> DR. LEVINSON: Good afternoon. My name is Richard Levinson. I\'m the
> Associate Executive Director of the American Public Health
> Association. APHA is the world\'s largest and oldest association of
> public health professionals, with members throughout the world. We are
> currently celebrating our 126th anniversary and our mission is very
> clearly to improve the health status of all people wherever they may
> live.
>
> We are very much concerned about the issues raised before this panel
> and I\'d like to begin, as we did in our consideration of it, by
> talking about definitions. The first one is the definition of a
> natural state. The term is thrown around glibly. It\'s often quoted as
> something that is solid, etched in granite, if not more, and that it
> is something that is ageless and matchless. We, of course, all know
> that that is not true. The concept changes radically over time and
> there are many examples which I could give to prove this point. Let me
> just give a few.
>
> First of all, for centuries, if not for millennia, the process of
> pregnancy and childbirth was regarded as a condition, not necessarily
> a natural state, but a condition that required the utmost with regard
> to medical technology and often operative technology. We would hardly
> regard it that way at the present time.
>
> During my lifespan, the infectious diseases of children were regarded
> as part of the normal process of growing up. We now regard them as
> totally avoidable and eminently preventable, and we consider, those of
> us who have been in public health, we consider it a stain on our
> escutcheon if a single child shows up in our jurisdiction with one of
> these illnesses. That was not true for centuries and eons.
>
> So this definition is highly fluid and we must be aware of it, and
> what is a natural state today may not be regarded as a natural state
> in the near future and that is very pertinent to this discussion.
>
> The second issue that is very pertinent to this discussion is the
> definition of severity. Presumably, we\'re talking about the severity
> of unnatural conditions associated with natural conditions. Severity
> is a highly personal type of measure. What is severe to me may not be
> severe to you.
>
> Every stand-up comedian in America regards the loss of sexual potency
> with age as grist for their mill. The person who experiences it might
> not agree. Television soaps deal with the symptoms and signs of
> premenstrual syndrome in a somewhat illuminating, or not illuminating,
> but somewhat amusing manner to those who are amused by it. The person
> who suffers from it would hardly regard it as trivial.
>
> So our point is that we\'re dealing with incommensurables. We don\'t
> exactly know what a natural state is. That varies with time and place.
> And we\'re not at all clear about severity from anybody\'s point of
> view, including and most especially the public. But what we are
> concerned with is the fact that people will turn to the use of
> products that presumably will relieve their symptoms and signs or
> their syndromes, if these symptoms and signs are organized, and that
> whether we regard it as severe or not or natural or not, they will be
> turning to these products for relief.
>
> It is our belief that the public health is best protected if these
> products, whatever they are called, which make claims to relief
> symptoms, signs, or diseases must be closely regulated. Their claims
> cannot be based on testimonials and other questionable approaches and
> they cannot be couched in legalisms that prevent them from being
> examined. They need to be based on the best possible evidence and the
> people who take these products must understand the risks, the
> limitations, as well as the potential benefits from the product and
> the potential danger that they may be facing if they take them without
> regard to further consultation with medical or other health personnel.
>
> So what we are urging very strongly is that we not tie this up in
> definitions and conventions and so on, but that the issue be faced of
> whether or not products that claim to have some kind of a health
> benefit can document this benefit and do warn those who consume them
> that the product may not work, that they may have something more
> serious, and that they may need further consultation to define what
> that serious nature is.
>
> The definition of natural or unnatural state and the definition of
> severity are, to us, beside the point. It is the protection of the
> consumer to the utmost extent that we are most concerned with. Thank
> you.
>
> DR. HOLTGREWE: I\'m Dr. Logan Holtgrewe. I\'m Chairman of the Health
> Policy Council for the American Urological Association and a former
> President of the American Urological Association. We appreciate the
> opportunity of expressing our association\'s view, reflecting about
> 9,500 American urologists.
>
> We in urology are very concerned about the use of food supplements and
> plant extracts in the treatment of two conditions for which we are, as
> a profession, responsible, male erectile dysfunction, and more
> importantly, lower urinary tract symptoms.
>
> It\'s been long thought that as a man aged, he would develop a
> weakening urinary stream, frequency of urination, arising at night,
> and the feeling of incomplete bladder emptying, and this was, in fact,
> just part of getting old. That is absolutely incorrect. These symptoms
> always reflect a disease state. That disease state could be benign
> enlargement of the prostate, which, I might point out, is not a normal
> process of aging but a disease. It can be due to cancer of the
> prostate, the leading serious malignancy in African-American men and
> the second in Caucasian men. It can also reflect bladder cancer.
>
> The patient, of course, has no way of knowing which of these
> conditions he might have. If he is to take an over-the-counter product
> and obtain some relief, it is our fear that he will be deluded into a
> false sense of security and will avoid going to see a physician and a
> golden window of opportunity during which diagnosis and proper therapy
> could become curative would be lost. Yes, it is true that patients
> should read what\'s on the label of the material or medicine they\'re
> taking, but how many do? That is our concern.
>
> We feel that there have been very few and very inadequate studies done
> to prove the safety of these products. I have practiced urology for
> about 40 years, and I\'m frequently asked, are these products safe,
> and my answer is, I don\'t know because we have inadequate evidence to
> prove that they are safe either as a single ingredient or as a
> combination of ingredients, and as I suspect you know, many of these
> products are combinations. You really don\'t know what percentage of
> what compound is relative to another.
>
> It is our feeling that we must maintain an open mind regarding
> medications, but at the same time, we agree with my colleague to the
> right that these products should be considered just as are other
> products. They should be subjected to prospective randomized clinical
> trials, both for their efficacy and for their safety. We feel that
> these trials are currently not available with these products.
>
> Finally, in the area of erectile dysfunction, I would point out that a
> very recent study at the Bowman-Gray School of Medicine in
> Winston-Salem, North Carolina, one of our country\'s very
> distinguished centers, show that of those men arriving in the
> urological clinic for erectile dysfunction as a chief complaint, 15
> percent had some significant major urological condition, primarily
> prostate cancer.
>
> So, in summation, it is our view that these products may be
> efficacious, and if they are, so be it. We would like to use them. But
> we feel that they should be subjected to the same type of randomized
> clinical trial and study that other products are subjected to and we
> feel, therefore, that they should be brought under the control of the
> Food and Drug Administration, as are the other products.
>
> I would also conclude by saying that conditions of the prostate, which
> is the main disease we\'re discussing, can occur concurrently. You can
> have a man with benign enlargement and he can also have cancer. Only
> with proper evaluation can this be determined. We are concerned,
> first, that there isn\'t proper control of these products, and we\'re
> also concerned that men are taking these products and are being denied
> the opportunity of a proper evaluation because they simply don\'t read
> the label. We feel very strongly that these things should be
> considered as medicines and they are being taken for a disease, not a
> natural state, and, therefore, they should come under Food and Drug
> control. Thank you.
>
> DR. FUGH-BERMAN: Good afternoon. My name is Adriane Fugh-Berman. I\'m
> a physician and also on the Executive Committee of the National
> Women\'s Health Network, which is an independent consumer advocacy
> group that takes no money from drug companies, medical device
> manufacturers, or dietary supplement manufacturers.
>
> Much as I would like additional regulation of these products, I can\'t
> bring myself to call pregnancy, menopause, and normal menstrual cycle
> changes diseases. The Network has fought for decades against the
> medicalization of all of these conditions. Pregnancy is not a disease.
> Menopause is not a disease.
>
> But what we are most concerned about is consumer safety, and standards
> of safety are most stringent for any sort of drug that is aimed at a
> healthy population, and this is a healthy population. You can be
> healthy and have fibroids. You can be healthy and have contraceptive
> needs. You can be healthy and menopausal. And you can be healthy and
> have menstrual cramps. It bears noting that the drug treatments for
> these conditions have gone through extensive testing and the adverse
> events are very well delineated.
>
> We need to redefine dietary supplements, not disease. I use and
> prescribe botanical and other nutritional supplements and I don\'t
> want their availability to be limited by subjecting them to the same
> standards of testing as drugs, but there\'s a big difference between
> using an herb with a traditional history of use for a condition for
> which it\'s traditionally prescribed or for which there is adequate
> clinical trial data and using an herb, a drug, or a vitamin that\'s
> promoted for a new use that\'s dreamed up by a manufacturer\'s
> marketing department.
>
> Rational regulation would make clear distinctions among food, dietary
> supplements, and drugs. It makes no sense to regulate by intended use.
> It lumps benign, dangerous, and unknown supplements together. There is
> no population that is immune to adverse effects. There is a great
> leeway between demonstration of safety and assumption of safety, and
> dietary supplements lie at every point along that continuum.
>
> We want access to high-quality, properly labeled products, but let\'s
> not give dietary supplement manufacturers carte blanche. At the last
> meeting that CFSAN held in June, you heard lawyers representing the
> dietary supplement industry state, for example, that adverse effects
> due to ephedra were \"anecdotal\" and should not be relied upon
> because they were not from clinical trials, leaving aside the numerous
> deaths from herbal ecstasy, the clinical reports, the cardiovascular
> effects, and numerous pharmacokinetic studies on ephedra.
>
> The fact remains that clinical trials are done on as robust a
> population as exists and they\'re not designed to document the
> prevalence of adverse effects. In fact, if a substance is known to
> have adverse effects, it\'s unethical to enroll healthy people into
> the trial, and it\'s always unethical to randomize people to a trial
> looking for unintended effects. It would be impossible, anyway.
>
> Consumers assume that OTC products are safe and they assume that
> quality is ensured, and neither of these parameters is required with
> dietary supplements currently. We understand the limitations that the
> FDA is currently laboring under, and since you\'ve been excluded from
> defining a dietary supplement, you\'re sort of being forced to
> redefine disease.
>
> So until we can get rational legislation on dietary supplements, the
> FDA has to aggressively regulate what it can regulate. Among other
> things, you can require labeling, and you can require extensive
> labeling. I think that what we want, you couldn\'t fit on a label. So
> what we\'d like to ask for is something that the National Women\'s
> Health Network asked for more than 20 years ago with
> estrogen-containing drugs, which is patient package inserts.
>
> We recommend that patient package inserts be required for all dietary
> supplements and that they detail what is known about short-term and
> long-term toxicity, what is known about efficacy, evidence of
> manufacturing quality and adverse effects, contraindications, and we
> would be happy to work with you on establishing guidelines for these.
>
> Herbs and other dietary supplements have pharmacological effects. Red
> clover extract, for instance, has been heavily promoted for menopausal
> women as the safe alternative to hormone replacement therapy. Now,
> this is a traditionally-used herb, but it\'s not traditionally used
> for hot flashes. It\'s not a traditionally-used food supplement. It\'s
> sometimes used in flavoring. Cheese is flavored with clover. But it\'s
> not used as a main food source. And red clover contains cumerins. In
> fact, cumerins were originally derived from another species of clover,
> and it can cause bleeding, and I have seen this in my practice, people
> bleeding after an acupuncture treatment who had been taking red
> clover.
>
> Known adverse effects, contraindications, and interactions should be
> required on all labels, and I think what\'s most disturbing to us is
> the idea of more drugs being palmed off as dietary supplements. This
> has already happened with DHEA and melatonin. It\'s really alarming to
> us that these powerful hormones are available over the counter. It
> seems that any new orally-administered product can be considered a
> dietary supplement if it wasn\'t classified as a drug prior to DSHEA.
> This isn\'t access, this is anarchy. Health care professionals should
> be up in arms about this. If the dietary supplement industry is
> allowed to set the terms, we can expect major threats to public
> health. Thank you.
>
> DR. BAGLEY: Good afternoon. I\'m Grant Bagley. I\'m with the Health
> Care Financing Administration, where I\'m the Director of Coverage and
> Analysis, that part of HCFA which really deals with those things which
> we determine are scientifically proven and reasonable and necessary
> and, therefore, cover under Medicare.
>
> You might ask why I would be speaking here, since, clearly, dietary
> supplements are not a covered Medicare benefit. Even under the
> proposed Part D Medicare benefit which the administration has
> proposed, over-the-counter drugs and dietary supplements would not be
> a covered benefit.
>
> There is, however, I think, an important reason why I should be here
> to at least express some opinions from the Health Care Financing
> Administration, because we do pay attention to what the FDA does,
> contrary to what a lot of people may accuse us at times, we pay
> attention to what the rest of government does. In those periods of
> time between a proposed regulation and a final regulation, I\'m sure
> it may surprise some to know that a lot of work goes on through that
> protracted period of time, and within the government, there are
> opinions solicited from other parts of the Department.
>
> So HCFA would like to express at least their opinions on this
> regulation as it was in the developmental phase. I think FDA wisely
> asked for comment from other agencies in this open, interactive
> process to really give you a full flavor of what the dimensions of
> thought about this were.
>
> Again, I said I\'d say why we were interested. We\'re interested not
> because these are covered services, but more from the fact that we are
> very much constrained by the same kind of language that FDA has. We
> get statutory mandates that tell us how to administer the Medicare
> program. The Medicare program is very specific. That piece of Medicare
> that I\'m responsible for is the one where we determine what is
> necessary or what\'s reasonably necessary or medically necessary.
>
> The statute reads, as it applies to Medicare, \"Notwithstanding any
> other provision of this Act,\" so it means that this takes precedence
> over everything, \"that Medicare only pays for services,\" and again,
> it has to be a defined benefit, but then the magic words, \"for the
> diagnosis or treatment of an illness or injury.\" So it\'s very
> important for us how those terms are defined and what they are.
>
> Now, you might ask, well, what\'s the relationship between an illness
> and a disease, and one likely we will ask ourselves too and we will be
> asked by the public. Should the FDA in regulation define disease in a
> particular fashion, I can guarantee we will be invited to follow the
> same definition by public groups, showing that this is an expression
> of what public consensus is in regard to a disease.
>
> So I think it\'s very important how a disease is defined. It\'s very
> important how that then gives us guidance in trying to interpret what
> is an illness or an injury, so that categorization such as the
> consequences of non-treatment or the severity, and I would agree very
> much with Dr. Levinson that severity is a poor indicator in that
> severity is often a very personalized measurement, that such
> characterizations don\'t work well for us.
>
> We also have issues in the Medicare statute where we deal with what
> Congress apparently believed was a distinction between an illness and
> the consequences of a normal aging process. We do pay for, as I said,
> illness and injury and treatment thereof, but some things, such as
> presbyopia, aging and the need for eyeglasses, presbycusis, aging and
> the need for hearing aids, are specifically excluded from Medicare
> coverage.
>
> Congress was clearly looking at treatment of medical conditions and I
> don\'t think they felt this was necessarily characterized as a disease
> or not, but at least the belief apparently in Congress\--we don\'t
> know what the complete intent of that was in the 1960s\--but that
> these were common conditions, that they were at least common enough
> and they were pervasive enough, and apparently, using the same kind of
> rationale that the severity did not warrant coverage under at least a
> medical insurance program.
>
> But I think we have to be cognizant of characterizing things as an
> illness or a disease or an injury and the impact that\'s going to have
> on payment under health insurance, whether it be Medicare or whether
> it be other health insurance.
>
> Interestingly, the characterization that menopause and the
> consequences thereof aren\'t disease. It becomes an argument about
> whether or not it should be characterized that way, and I can tell
> you, in clinical practice, I routinely counseled patients with
> fibrocystic breast disease that fibrocystic breast disease was, in
> fact, not a disease. Let\'s call it fibrocystic breast change because
> it\'s a very common condition but one that we follow. I think that was
> useful for patient information. But I can tell you, I called it
> fibrocystic breast disease when I submitted a health care claim to the
> insurance company.
>
> So I think we need to be cognizant of those changes and how the
> definitions in one part of the Federal regulations can influence those
> in the other and be mindful of that, and I would caution FDA to do
> that as they go ahead.
>
> DISCUSSION
>
> MS. OLIVER: Thank you. I\'ve heard varied opinions amongst the panel
> and I\'ve heard one thing, take a different approach. This isn\'t the
> approach you want to take. I\'ve heard, change the definition of
> disease and you can deal with the natural state if you change the
> definition of disease. I\'ve heard severity isn\'t really what you
> want to look at. And I\'ve heard we need to focus on safety and we
> need to make sure that whatever claims there are, that they\'re
> substantiated in some way and proven and that the consumer gets the
> information that they need.
>
> I\'ll ask a question. In going back to the topic of the panel in
> discussing natural state, and I know you have the varying opinions
> from the point of use a different approach, but what\'s the principle
> that you actually would use in distinguishing the natural state and
> those illnesses or those conditions associated with the natural state
> from the others? I hear not severity. I\'ve heard discussion on
> pathology, and I\'d like something from a number of the panelists on
> it. Stacey, could I start with you?
>
> MS. ZAWEL: Sure. I mean, I think that in our comments, we stated that
> the way to make a distinction, and I\'m not sure if it\'s a hard and
> fast principle that\'s going to make you happy, but the way that we
> looked at it was either something is a natural state or it\'s a
> disease state, and that diseases aren\'t necessarily inherent with
> natural states. So just because you\'re pregnant, for instance, which
> is a natural state, doesn\'t necessarily mean you have toxemia, which
> is a disease. Just because you\'re aging and you go through menopause,
> which is a universal experience of women who are aging, doesn\'t mean
> you have it, that menopause is a disease.
>
> So that\'s the distinction. Either, one, the effect or the change
> that\'s occurring with a natural state is a universal change, or it\'s
> a disease state, where some people that are going through this natural
> state have a specific disease, but that to me is completely separate
> from the issue of a natural state.
>
> MS. WITT: Can I follow up on that? It seems to me\--I think I
> understand what you\'re saying, but I think there\'s something
> missing. I think you\'re assuming that we all know what is a disease
> state, when you say it\'s either a natural state or it\'s a disease
> state, but I think the real question on the table is, when is it a
> disease state?
>
> MS. ZAWEL: Well, and that\'s what I mean by something that\'s, I
> think, outside of common conditions associated with natural states. I
> don\'t think\--that, to me, is not the issue. It\'s whether or not you
> want to talk about a disease or not, regardless of whether it\'s
> related to a natural state.
>
> So, to me, you\'re talking about can you associate\--we\'re suggesting
> that you cannot necessarily say that a common condition associated
> with aging is Alzheimer\'s. Alzheimer\'s is a disease and we
> shouldn\'t be able to make structure/function claims about
> Alzheimer\'s disease. It is a disease. But aging in and of itself is a
> natural state. Menopause is not a disease. PMS is not a disease.
>
> MS. WITT: I think people would differ on the last one, so maybe you
> could elaborate on why PMS is not a disease.
>
> MS. ZAWEL: Because it\'s something that, universally, let\'s say, to
> certain extents, women all experience in a sense, some much less than
> others.
>
> MS. WITT: So does that mean if a woman experienced a very severe form
> of it that that might be a disease?
>
> MS. ZAWEL: No, I don\'t think so. I don\'t think PMS classifies as a
> disease at all. What I\'m suggesting is it\'s a natural state that we
> all universally experience, but at the same time, we universally
> experience it in a different way.
>
> MS. YETLEY: I wanted to follow up on that, too. PMS can have a wide
> range of signs and symptoms, from very mild and fairly common to very
> severe, which frequently require medical intervention. Where do you
> draw the line on that continuum so that you know which and when it\'s
> a disease, or are you saying it\'s never a disease even if it requires
> medical intervention?
>
> MS. ZAWEL: Well, the way that I would suggest is that, one, I
> wouldn\'t say that it\'s a disease, okay. First and foremost, in and
> of itself, it is not a disease. And so, secondly, whether or not you
> can treat these conditions with a drug or not is, to me, irrelevant.
>
> MR. SOLLER: Could I step in just on the PMS, and then I\'d like to
> come back and answer Janice\'s prior question after Tony, perhaps. But
> the way our group has looked at that is that hormonal fluctuations
> associated with the menstrual cycle are normal and, therefore, the
> effects that are attentive to that and experienced by 75 percent more
> of women should not be considered a disease, but more properly
> premenstrual disorder per the classification DSM IV would then
> constitute the disease. So we would separate PMS from premenstrual
> disorder.
>
> MS. ZAWEL: Actually\--
>
> MS. WITT: You\'d separate them because the disorder is listed in the
> DSM IV? Where\'s the line? How do you draw that line?
>
> MR. SOLLER: Well, the line is drawn in terms of here in the context of
> the population and looking at the number of individuals that are
> experiencing it in the context of our definition of natural state or
> process as a life change or physiological manifestation expected in
> the normal course of life. And if you\'re seeing a very large
> percentage of women in America that are experiencing that, I don\'t
> think we would necessarily constitute that as a disease.
>
> Now, we have disease risk reduction for osteoporosis, for example,
> which a large number of women experience, but that\'s handled for
> dietary supplements through the health claim, the disease risk
> reduction avenue.
>
> DR. HOLTGREWE: It strikes me that in this discussion centering around
> semantics, we\'re confusing what\'s common with what\'s natural. Men
> frequently development enlargement of their prostate as they age. But
> as I said in my testimony, that is not a natural state. It\'s a
> disease process. Not all men have it. Not all men get prostate cancer.
> Not all men have cancer of the bladder. Yet all of these diseases
> present the same symptoms, which can be treated in an effective manner
> and proper medical conditions under proper circumstances. But when the
> man has these symptoms and takes a food supplement and maybe gets
> relief or maybe doesn\'t, my concern and our association\'s concern is
> that we\'re losing valuable time and he\'s self-treating.
>
> So just because something is common doesn\'t mean that it\'s a natural
> state. No one would say that although coronary artery disease is
> common, it\'s a natural state. It\'s a disease state. When medications
> of any kind are given to treat symptoms which, in turn, are due to a
> disease state, then I think and our association feels they should come
> under Food and Drug Administration control.
>
> MS. ZAWEL: There is a controversy\--
>
> MR. SOLLER: The main issue that we\'re looking at here is, at least as
> we are looking at it, is to ensure that the debate is engaged within
> the definition of disease. I would say that we could get into a long
> discussion on perhaps specific issues, and that\'s why we think that
> the debate should exist within the definition of disease and why there
> should be an accommodation to the concept of natural state within that
> definition.
>
> DR. HOLTGREWE: But just because something is common doesn\'t mean that
> it\'s a natural state.
>
> MR. SOLLER: So what we\'re doing is book-ending natural state against
> adverse, and it\'s not just that it\'s common, but it is in the
> context of an adverse deviation. While there was a lot of criticism
> for 101.14, and we\'re not suggesting a change here, we\'re talking
> about the definition for disease for structure/function, about the
> word \"damage,\" there\'s been no discussion about the other phrase
> within that definition, a state of health leading to such
> dysfunctioning, which is also very, very broad. And we think by
> bringing the concept of damage, harm, adverse into the definition of
> disease for structure/function and clearly distinguishing it from
> natural states, then we have the boundaries within which the debate
> can occur.
>
> I would say that if there is a significant issue\--you know, the OTC
> panel a long time ago addressed the issue of headache and whether a
> person had a brain tumor and there was a long discussion, almost a
> half-day meeting that that panel had during the OTC review. It wasn\'t
> in the context of necessarily severity or in the context of the number
> of people, et cetera, but it was in a recognition that the overall
> benefit that could be given to the population was there,
> notwithstanding these very rare side effects that might occur.
>
> So to our colleagues on the left, I would say that if you have the
> data that would enter into the discussion and say that a significant
> number of people are being harmed because of whatever is being
> constructed here, ultimately, then that\'s how the debate should
> occur. But we\'re here to say what are the boundaries for that, not
> necessarily to argue the condition one way or the other, and that\'s
> why we\'ve come up with this particular construct.
>
> DR. FUGH-BERMAN: Neither PMS nor menopause fits into your disease
> category because of the second one, in terms of including laboratory
> or clinical measurements that are characteristic of a disease. There
> are no laboratory measurements with which you can diagnose PMS,
> although there are laboratory measurements with which you can tell
> whether a woman is menopausal. You can\'t tell whether she\'s having
> symptoms, which is really the case. Many women go through menopause
> without having any symptoms whatsoever, and actually, a lot of women
> do not notice any sorts of premenstrual symptoms or any that are
> bothersome.
>
> There\'s quite a bit of controversy whether premenstrual dysphoric
> disorder actually exists and even whether PMS actually exists. In the
> words of Mary Guaidon, who used to be at CDC, she believes that women
> are really suffering the rest of the month from prefollicular
> euphoria.
>
> \[Laughter.\]
>
> DR. LEVINSON: I think that it is absolutely clear that there are not
> two categories in this world, disease and not disease, or disease and
> natural state. There is a continuity between the two, and I mentioned
> in my testimony that the boundaries are, at best, arbitrary. Now, you
> might want to set up these boundaries for convenience. You can\'t
> cover the whole world all at once, et cetera, et cetera, so you can
> set up arbitrary boundaries recognizing how arbitrary they are and not
> based on any deep understanding of the world and then proceed to
> operate with the understanding that you need to change them as
> circumstances change.
>
> I cannot help but feel that a debate that focuses on these definitions
> and their boundaries is not productive in this setting, that the
> debate should focus entirely on patient safety, whatever they have. If
> they\'re taking something to relieve a symptom, to relieve a disease,
> however that may be defined, and that is what\'s important, not
> whether it\'s natural or unnatural, common or uncommon, disease or not
> disease, because ten years from now, the boundaries\--five years from
> now\--two years from now, the boundaries will have changed and the
> discussion is simply not productive. I don\'t think you get anywhere
> by pushing that issue to its limits.
>
> DR. HOLTGREWE: I completely agree, and my colleague to the right said,
> do we have evidence that there\'s harm from these products, and the
> evidence is, I wish we did. I wish we had any kind of evidence that
> showed us that these products are safe either in single form or in
> combination, because many of them are combination products.
>
> It\'s exactly what we in urology would like to have, is prospective
> randomized trials looking at the efficacy of these products compared
> to existing pharmacological products which we know, based on clinical
> trials, are effective, and we would also like to know the toxicology
> of these products. There is little in the way of peer-reviewed
> information concerning this. If you go to the peer-reviewed literature
> and look around the world for studies, long-term studies using food
> supplements in the treatment of prostate disease or male erectile
> dysfunction, you will find very, very little evidence.
>
> That\'s exactly what we want, and I think the same rule should be
> applied to these products that are currently applied to the alpha
> blockers and to conastride \[ph.\] and some of the drugs that are used
> in the treatment of prostate disorders. That\'s what we want. We want
> to keep an open mind, and it may well be that food supplements are
> very effective. Let\'s find out through a carefully controlled study
> that is required of all the products that are otherwise marketed, and
> I think the FDA is the group to conduct that.
>
> MR. SOLLER: If we could return to the regulatory construct here, we
> put the definition for disease before you and I mentioned the adverse
> versus natural and incorporating this, so we have the boundary of that
> debate. But there is a point that I would like to add in and that is
> that it doesn\'t\--and that\'s in some ways, and I understand the
> difficulty in setting up this meeting today, how do you structure it,
> and I\'m not criticizing that, but in some respects it\'s artificial
> because it\'s difficult to talk about these separately.
>
> So it\'s important to think about this proposed definition or whatever
> proposed definition in the context of what ultimately becomes the
> label claim and the fact that in the label claim, the product may not
> claim to treat, cure, prevent, diagnose a specific disease, and,
> hence, within the law, this disease definition tracks back there and
> it\'s tied into the disclaimer where the word \"disease\" also occurs.
>
> And then finally and ultimately, entirely right, it depends upon the
> substantiation and companies must have substantiation, and, frankly,
> FDA has the enforcement powers to pursue that.
>
> So putting aside what the criticisms might be, I think what we\'re
> trying to do is to provide an overall regulatory construct which would
> allow the debate to be engaged and, therefore, the field to be built.
>
> MR. YOUNG: I\'d like to focus back on the severity issue because
> that\'s in your last questions, and if that is the concern, I do agree
> with others here that the definitional argument is difficult. If you
> go and you read about these various conditions, you will find that NIH
> describes them as conditions and not as diseases in many cases, and
> the languaging is as a condition.
>
> So if severity is your concern, consider using the labeling provisions
> of the law to get useful and important information to consumers
> instead of engaging in a debate that probably will not result in
> products, for example, not being sold for prostate. Saw palmetto is
> going to be sold. It\'s going to be sold for prostate even if the word
> doesn\'t appear.
>
> Don\'t we benefit the consuming public more by getting the message
> that the urologists and others want to get across that they should see
> a physician when they have this condition? If we can get that message
> across to, out of 100,000, if 20,000 out of 100,000 are at risk of a
> severe disease of everyone who presents with those symptoms, if we can
> get that message to 20,000 of them, 1,000 of them go to their
> physician and get some kind of life-saving or life-sustaining
> treatment, then the law will have been used and the education part of
> DSHEA will have been given some meaning to the benefit of consumers.
>
> MS. ZAWEL: Let me emphasize what Dr. Soller said earlier, which
> provided some clarity to what I was trying to say, and that is that
> this whole issue of natural state, we believe, has everything to do
> simply with the definition of disease and how you define it. Either
> something is a disease or something isn\'t a disease. That\'s the
> debate and the discussion that this issue itself ought to surround
> itself in.
>
> MS. WITT: Can I follow up on that? Many of the comments\--I can\'t
> speak to your organization\'s comments specifically, but I would say
> the majority of the comments that we saw on this said that the reason
> these things were not diseases was that they were so common. And as
> somebody pointed out, whether something is common in the grand scheme
> of things can\'t be the definition of disease because 30 years ago,
> all children got chicken pox. That didn\'t mean it wasn\'t a disease.
>
> So there is something different here, at least the way the commenters
> saw it, between conditions associated with natural states and other
> conditions. It is tempting to say that it should just be whether it\'s
> a disease, but that isn\'t the way the commenters seem to see it.
>
> MS. ZAWEL: That\'s the way we saw it as a commenter.
>
> MS. WITT: And yet you were talking about the universality of the
> condition. Does that mean that a cold can\'t be a disease because
> everyone gets one?
>
> MS. ZAWEL: I would not classify a cold as a disease, no.
>
> MS. WITT: Because of its universality?
>
> MS. ZAWEL: Because it\'s not a disease, and it is universal. But in
> terms of when you talk about natural states like aging, for instance,
> and you want to make a distinction, not necessarily a distinction that
> we would move forward in terms of saying, okay, this is a natural
> state, a common condition associated with a natural state or not, we
> don\'t necessarily make that distinction.
>
> In helping you make that distinction, we would suggest that you look
> at specific diseases, and as far as I\'m concerned or GMA is
> concerned, there are really no common conditions associated with
> natural states that are inherently a disease. If there is something
> that happens as you age that results in you going to the doctor,
> getting a diagnosis that, in fact, you have a disease, then that\'s
> the disease. But it\'s not necessarily the enlarged prostate that\'s
> the disease, it\'s the prostate cancer that\'s the disease.
>
> DR. HOLTGREWE: Let me address that, if I can. First of all, severity,
> a man can have very mild symptoms and have cancer. He can have very
> severe symptoms and have a benign condition of the prostate. Both are
> diseases. So severity means nothing in the diagnosis of lower urinary
> tract symptoms and it means nothing in the diagnosis of male erectile
> dysfunction, which we now know is due to a vascular disease\--a
> vascular disease, not a natural state of aging.
>
> Again, I would applaud the fact that if the labeling on the food
> supplements is going to drive men to their physician for the proper
> diagnosis of their lower urinary tract symptoms, that would be
> wonderful. The trouble is, I\'m not convinced that that\'s going to
> happen very often because I don\'t think many are going to read the
> package insert, and even if they do, if they\'re better, they\'re
> going to say, well, I\'m better. I\'m going to stay home. And as I
> said earlier, that golden moment of diagnosis and curative therapy is
> going to be denied that individual, and this is one of our major
> concerns in urology. We feel very strongly about this, that these
> things should be controlled.
>
> DR. FUGH-BERMAN: One way to make the distinction is that if there\'s a
> collection of symptoms that has no underlying pathology, that it\'s
> not a disease. I would agree with the comments about impotence, which,
> although not a women\'s health issue, is of concern to many of us of a
> certain age, in that impotence can be caused by vascular disease, it
> can be caused by diabetes, it can be caused by depression, that
> impotence secondary to aging is not a diagnosis that a consumer can
> make in a drug store. So that would be different.
>
> But with menopause and PMS, for example, there are collections of
> symptoms that some people have. There\'s no identifiable underlying
> pathology in those conditions. And in answer to your first question,
> one way to make this distinction would be to talk about relief of
> symptoms from benign causes.
>
> DR. LEVINSON: I think there\'s some danger in underlying pathology. I
> don\'t know what the underlying pathology is for schizophrenia, but I
> don\'t know anyone that doesn\'t consider it a disease. We have some
> PET scans that suggest one part of the brain is more active than
> another, but I\'m not sure in pathological terms what that means. And
> there are many other examples, so I think if pathology means we can
> find damage, that\'s very dangerous. If it means that we can somehow
> or other formulate an explanation, whether biochemical, physiological,
> or what not, that it has more meaning, but that\'s a matter of time
> and place.
>
> So, again, for the tenth time, I think that some of these distinctions
> are not helpful. They will allow you to limit your work, but are not
> going to help very much in solving the issue.
>
> MS. YETLEY: Back to the issue of adding more information to the
> consumer to counteract\--I\'m talking to this side of the table
> now\--counteract some of the concerns raised by the other side of the
> table, do the people that are advocating, groups that are advocating
> more consumer information, do you have consumer research data to show
> how consumers are interpreting these types of medical state claims,
> and if, in fact, they would correctly and appropriately use the
> additional information?
>
> DR. FUGH-BERMAN: You can\'t make people read patient package inserts,
> but a number of people will read them, and there are some things you
> can do to increase the likelihood that people will read them. For
> instance, write them at an eighth grade reading level, include
> illustrations if appropriate, that sort of thing. But there is quite a
> bit of data in\--or we do have experience at this point in this area
> with PPIs for drug products, so we can learn for that. But more
> information is better than less.
>
> DR. HOLTGREWE: This is a very good point. If we had good information
> in that package insert for food supplements in the treatment of male
> lower urinary tract symptoms and \"prostatism,\" a term which means
> nothing, and male erectile dysfunction, that would be wonderful. The
> trouble is, we don\'t have the data. If you go to the peer-reviewed
> medical literature of the world and look, there\'s some, but it\'s
> minimal and very few long-term studies, very few prospective
> randomized clinical trials comparing the results from the food
> supplements against established pharmacological products that are out
> there that we know are efficacious, that have gone through prospective
> randomized trials.
>
> The simple point is, we don\'t have the information and we don\'t have
> information on toxicology. We have personal testimonials and
> brochures. We have that type of material. But we don\'t have what we
> in urology feel is very important, and that is good scientific data
> upon which to make decisions.
>
> DR. FUGH-BERMAN: Well, it is very important for the FDA to be aware of
> what data is out there, and I would actually really disagree with you,
> at least in the case of saw palmetto and BPH, that there are, I
> believe, 19 randomized controlled trials that have been met and
> analyzed by the Cochran Collaboration, published in JAMA, including
> comparisons with phenastride \[ph.\], which was the treatment being
> used at that time, although it\'s true that there have not been trials
> comparing it with terazasin \[ph.\]. At the time that these trials
> were done, there were trials that compared this to existing
> pharmaceutical drugs\--
>
> DR. HOLTGREWE: And what was the duration of those trials?
>
> DR. FUGH-BERMAN: Four weeks to 48 weeks, and there have been drugs
> approved for BPH on less than that, less than 48 weeks, and also, saw
> palmetto is a traditionally-used food by Native Americans, so it has
> been consumed in quantity traditionally.
>
> DR. HOLTGREWE: But what about the use of that drug with others that
> are in the same product? Is there a cross-toxication problem? Is there
> a mix? We don\'t know. There\'s no data on that.
>
> DR. FUGH-BERMAN: Well, there are\--saw palmetto\--
>
> DR. HOLTGREWE: We shouldn\'t probably get into a scientific discussion
> here, and I disagree with you that we have adequate information on saw
> palmetto or any of these. Most of the literature we have comes from
> Europe, not from the United States, and most are of very short
> duration and the number of patients in that 48-month study was tiny.
>
> DR. FUGH-BERMAN: European data is acceptable to the FDA.
>
> DR. BAGLEY: But, you know, that issue aside, and there may be more
> data on that issue than others, but I think it\'s important as we try
> to move forward and the entire profession is moving forward in the era
> of evidence-based medicine that it\'s no longer experiential or
> anecdotal but it\'s evidence-based. And as we move into an era of
> evidence-based medicine, the population needs to be educated to the
> fact that evidence should form the basis of medical decisions and
> treatment decisions and prevention decisions and lifestyle decisions.
> So I think we need to be cognizant of the fact that if we\'re going to
> ask for evidence in one area, we ought to sort of uphold the same
> standard in other areas, too.
>
> MS. WITT: Mr. Young?
>
> MR. YOUNG: Yes. I just wanted to make the point that what we are
> suggesting with respect to information on saw palmetto products is not
> information about efficacy but information solely on the need of men
> who present with those symptoms to seek medical attention because
> those are the signs and symptoms that at least the National Institute
> of Aging has said suggest you should see a doctor, and getting that
> message and that message alone across, no other message, simply that
> people who buy and use these products ought to consider seeing a
> physician, and there\'s a lot of other good and useful information on
> the various NIH websites that could be added to it about the effect or
> the possible progression of BPH into other entities.
>
> That\'s the only kind of information we\'re talking about, and I think
> on patient package inserts for estrogen, that\'s all that\'s in there.
> It doesn\'t talk about the efficacy of estrogens. It talks about risk
> factors.
>
> MR. SOLLER: Following up on what Dr. Yetley was asking, we do know
> that on the OTC side, that 98 percent of consumers say they read the
> label before using the product the first time and we\'re dealing in a
> self-care category. I\'m unaware of a similar sort of study that\'s
> been done on dietary supplements per se and am unaware of actual use
> studies that are done on the OTC side, where you look at the
> compliance picture in terms of a simulated OTC setting with the actual
> label.
>
> So the construct of the label even before the current reformatting of
> it was able to communicate to consumers, and if you look at much of
> the labeling on the dietary supplement side, it is in sort of
> character somewhat similar to the OTC labeling. I think that\'s
> probably the best that could be said. I would imagine our members
> would have a lot of market research, but I don\'t know that it\'s
> specifically been targeted to that, nor have we asked them.
>
> The second point I wanted to make was, you know, I agree. I don\'t
> think this is the spot for the scientific discussion, and we
> understood that coming in, because our perspective is that we\'re
> dealing five years post-DSHEA and we\'re sitting here wondering, how
> are we building the field. What we\'re trying to offer here is a
> regulatory construct that allows the debate to occur, and for the
> science and the data to be brought in and for the sides to, on a
> specific issue, to debate that issue and determine what is the best
> outcome. And the best outcome is not always taking the product off the
> market. We know that very well from the OTC side. The best outcome is
> often adding specific additional labeling, as Mr. Young has suggested,
> and we would advocate that.
>
> So I think it\'s worth looking at the definition of disease as
> book-marking against adverse deviation and the discussion can occur
> around what constitutes an adverse deviation and a natural state, and
> some of it is going to be very clear. Cancer, I think hypertension,
> adverse deviation, as well as diabetes, migraine headache,
> Alzheimer\'s disease, depression. Some are going to be gray and some
> are not going to be quite so clear, and those will be the difficult
> regulatory issues. But I think you are simply faced with that, and
> you\'re faced with that because you\'re simply not going to come up
> with a definition of disease that meets everything for all people. But
> you can try to create a definition of disease that contains the
> argument and allows people to understand where the polarities might be
> so the data can be brought to bear.
>
> That\'s why we\'ve come up with this and that\'s why we\'re
> suggesting, don\'t look at it in isolation but from a regulatory
> construct and a statutory construct, know that there are provisions
> about what can be said on the label and how you can disclaim that, and
> I fear, ultimately, [Pearson v. Shalala]{.underline} plays into all of
> this in the context of how the disclaimer is used and how it is used
> appropriately.
>
> MS. NICKERSON: We\'ve heard a number of panelists say emphatically
> that severity is no good as a criterion for distinguishing between
> diseases and non-disease conditions, so I\'d like to pick up on things
> that Dr. Fugh-Berman and Mr. Young said to see what you think about
> another possible criterion, and that is whether the condition is one
> that the consumer can evaluate. What do people think about that as a
> way of distinguishing?
>
> DR. LEVINSON: Would you define evaluation?
>
> MS. NICKERSON: Well, I\'d be interested in your views on how it should
> be defined. I was thinking\--I\'m certainly not a doctor, but I was
> thinking along the lines, is it something where the consumer can
> evaluate what\'s ailing him or her and what might treat it.
>
> DR. LEVINSON: Well, one way to do it is just to take the product and
> see if they get better, and intincture of time helps a lot of things,
> but it also disguises a lot of things. I mean, you seem to get better
> and you\'re not getting better. I mean, I think self-diagnosis like
> self-brain surgery is the desired outcome in the future, but I\'m
> really concerned about it.
>
> I think that most of us judge it on the basis of, well, I\'ve had it
> before so I\'ve got it again, and I\'ve taken this product and I feel
> better, or I\'m just better because I\'m better, and you just keep on
> going, but you know that there are many walking wounded that keep on
> going. So I don\'t know how you could evaluate whether the consumer
> really understands their condition to the point\--and not all the
> details, I understand that, but understands it to the point that
> they\'re able to understand whether a product is working or not.
>
> The placebo effect in these double-blind trials is a very critical
> issue because the placebo effect does disguise an awful lot of
> pathology. Now, if you\'re enthusiastically interested in a particular
> form of therapy because it helped Aunt Millie and it helped the dog
> and so on, you\'re probably going to believe, at least for a time,
> that you\'re better. We have seen the lame walk until they fall on
> their face because they\'re so enthusiastic about a particular
> treatment.
>
> So there\'s a gem of truth in\--I mean, a strong gem, but I just
> don\'t know how you operationalize it and how you spread it across 260
> million people.
>
> DR. HOLTGREWE: In the area of prostate disease, every randomized
> prospective clinical trial that has ever been conducted on the
> treatment of prostatic disorders, benign prostatic disorders, with
> medication, there is between a 30 and 40 percent placebo effect.
> Thirty to 40 percent of men get better if you give them an aspirin or
> you give them a sugar pill. Every trial that has ever been conducted
> shows that. There is an enormous placebo effect here.
>
> And one could say, is there a placebo effect with your food
> supplements? Of course. There will be. The difference, of course, is
> how much better is the food supplement than the placebo, and that is
> only done in a prospective randomized trial, and with all due respect
> to my colleague, there haven\'t been a lot of those that I feel and
> our profession feels is very satisfactory. That\'s the question.
>
> DR. BAGLEY: In many ways, this is not atypical from the whole debate
> about health care. We talk about what\'s medically necessary for
> health care and we spend a great deal of time educating the public
> around exactly this, around areas, specific areas in which it is
> necessary to have an intervention, symptoms of bleeding, of
> self-breast examination detect a mass. So we educate people about it.
> But for most things, we rely on people to use their own judgment about
> when an intervention is needed. Yes, I have aches and pains, but this
> one is severe enough that I need attention for it.
>
> So I guess severity, although it can vary along a scale, is very much
> something that people deal with and I think it\'s a mistake to try to
> flip this coin over and say, we want to define what is okay for people
> to ignore when most of our education has been trying to get people to
> look at the proper threshold when they should have intervention.
>
> So if you use a definition and say that a disease is inherently
> something that requires intervention, it is such a deviation from the
> norm that it requires medical intervention, it very much relies on
> people to make their own decisions, and I think they ought to do it
> within the construct of the health education we\'re giving them.
>
> DR. FUGH-BERMAN: I totally agree.
>
> MR. YOUNG: I think where self-evaluation is an issue, then that\'s
> just another opportunity to provide information and to require
> information about that condition. We\'ve talked about prostate, if you
> will, but there may be other conditions where information for the
> consumer would be appropriate because we recognize that they are
> self-evaluating for a condition. So it\'s just another opportunity to
> provide useful and material information in light of the consequences
> of the use of the product, which fits right into the law.
>
> DR. FUGH-BERMAN: We don\'t, however, need to reinvent the wheel. We
> have quite a lot of this information already from regulation of
> over-the-counter drugs. Having been in on many discussions when yeast
> medications became over-the-counter\--this was a big win for the
> women\'s health movement. We were allowed to be responsible for
> diagnosing our own recurrent yeast infections. But there have also
> been discussions at the FDA about whether cyclovir should be
> over-the-counter, whether oral contraceptives should be
> over-the-counter, whether emergency contraceptives should be
> over-the-counter.
>
> These issues have already been debated and, in many cases, are
> reflected by what is already on the shelves in terms of OTC drugs.
> That may be able to be used as a rough guide, at least in terms of
> what symptoms are we already allowing to be treated by OTC drugs.
>
> DR. HOLTGREWE: I have a little problem with\--first of all, I applaud
> the food supplement industry for their desire to put out good
> information and, hopefully, to get men who have lower urinary tract
> symptoms to go see their physician. I think that\'s very laudable.
>
> I have a couple of problems with that. First of all, if you really
> want to get the word out, I guess you could take out time on TV and
> advertise. You have symptoms, go see your physician.
>
> The other thing is that when we know there\'s this huge placebo effect
> and a man takes a pill, my concern and our association\'s concern is
> that this is going to delay the diagnosis of a very important disease,
> and there are an array of them out there. Even benign disease is
> lethal. We still have deaths in this country from benign prostatic
> enlargement.
>
> So I think that my concern is that we\'re wasting valuable time, in
> that a man takes the pill, he\'s better either because it works or
> because he gets placebo effect. He doesn\'t go to the doctor, and
> then, therefore, that golden moment and that window of opportunity is
> denied and he will die of a malignancy or some other problem.
>
> MR. SOLLER: Further to your issue on self-recognition, I\'m not quite
> sure exactly how you are defining it, but here are some thoughts. For
> a long time in the OTC field, we used to talk about self-recognition,
> and then notwithstanding the fact that asthma remedies out there
> required a physician diagnosis first and then the next notable
> example, of course, were the products for vaginal yeast infection. So
> as we thought about the field, it moved from self-recognition to
> self-recognition and self-diagnosis.
>
> The question, though, I think, or the problem is that you still are
> going to end up into an overlap area. I think that working this issue
> out ultimately means that you have to have that self-recognition
> yourself, that you will always end up with some overlap area. And
> here, if you\'re trying to use a self-recognition standard, an
> individual that decides to use a fluoride toothpaste, what are they
> self-recognizing? They\'re self-recognizing that it would be a good
> idea to prevent? What about a person who\'s going to use a
> vitamin-mineral product and give a child a One-a-Day vitamin-mineral?
> They\'re self-recognizing that maybe the child isn\'t getting all the
> vitamins and minerals in a particular diet.
>
> So you have that kind of overlap, just as an example, to try to use a
> self-recognition example between a drug and a dietary supplement. So I
> don\'t think it\'s a clear line that you\'d be able to draw. That\'s
> why we\'re back to the definition of disease.
>
> MS. ZAWEL: And I think that that\'s the issue with respect to
> self-evaluation, is that while GMA certainly appreciates your desire
> to draw a line between what is permitted and what\'s not permitted,
> this would produce a very fuzzy criterion, I think, in order to enable
> one to do so because you\'d have to rely on the broad population and
> who is the true consumer that you\'re talking about. Is it the least
> informed? Is it the most informed? Because of that, it\'s not
> necessarily the best way to make those distinctions between what\'s
> permitted and prohibited claims.
>
> MS. OLIVER: We probably have time for one more question.
>
> MS. YETLEY: I just had a question for Grant Bagley. You mentioned that
> in the Health Care Financing Administration, you had to make decisions
> about what is reimbursed and what is not reimbursed for conditions
> that are associated with natural changes. I think you mentioned the
> hearing and the vision changes in elderly. Do you have criteria, and
> what kinds of criteria would you use in making those cuts?
>
> DR. BAGLEY: It would be an easy answer if we had rational criteria. I
> think we struggle with the same issues, and we struggle with the same
> issues in not only that, but we have a certain amount of, over time,
> statutory overlay which makes it complicated.
>
> Eyeglasses for presbyopia, hearing aids for presbycusis are simply
> excluded by the law, so we don\'t have to make a decision based on
> that. On the other hand, we very liberally cover bone mass measurement
> and things associated with treatment of osteoporosis, and we
> specifically by Congress\' direction have a benefit for bone mass
> measurement for women who are estrogen-deficient, most of whom, I
> presume, are menopausal.
>
> Is that a disease? I don\'t know. We don\'t have to do a lot of
> guessing there. In the issue of an undefined condition where we have
> to actually make that decision, we\'ve done it again. People have
> accused us of being somewhat arbitrary.
>
> Obesity and surgery for the treatment of obesity or even other
> therapies, we don\'t cover because Medicare at some point in the past
> defined obesity as not a disease. So I presume the alternative would
> be we said it was a natural state.
>
> \[Laughter.\]
>
> DR. BAGLEY: So, I mean, we\'ve had to make those decisions and we\'ve
> struggled with the same kinds of things and we struggled with the
> issue of, I suspect, without articulating it, is there an effective
> treatment? Is this treatment reasonable? What are the effects of
> non-treatment, and some of those.
>
> But, specifically, as I start hearing the arguments that aging is a
> normal process, which I\'m having a little trouble accepting myself,
> and the consequences of aging, and I look at what we cover in the
> Medicare population, I find it hard to reconcile those two because I
> think many of the consequences and the ravages of aging are not only
> preventable but treatable and they\'re treatable sometimes with some
> expensive and extraordinary medical treatment. But I would hate to see
> them not treated because we considered them inevitable and, therefore,
> something that everyone should tolerate.
>
> That\'s a long answer to your question, but, yes, we struggle with the
> same issues because we have to make that determination, is it a
> disease, or is it an illness, as it says in our statute, and,
> therefore, is it qualified for treatment.
>
> MS. OLIVER: Thank you very much. Right now, we\'re going to take a
> break until three o\'clock. We\'re running a little ahead of schedule,
> and what I\'d say is that if people are interested still in making
> public comments, we had several people drop out that were going to
> make them, so if you go to the registration desk, you can sign up to
> make comments at the end of the day.
>
> \[Break.\]
>
> MS. OLIVER: If we could get back together again, please, and if I
> could have Panel III to come up on the stage. Ann?
>
> **PANEL III: IMPLIED DISEASE CLAIMS**
>
> MS. WITT: The subject of our third panel is \"Implied Disease
> Claims.\" In the proposed rule, FDA said that a disease claim could be
> either express or implied, although I think there may be some
> disagreement about where the line should be drawn between an express
> and an implied disease claim.
>
> The way FDA has traditionally understood that line, an express claim
> is one that specifically mentions the name of a disease. For example,
> \"cures cancer\" would be an express claim. An implied disease claim
> is one that does not mention the name of the disease but conveys that
> the product is intended to treat or prevent the disease through other
> means, such as by listing the characteristic signs and symptoms of the
> disease or by pictures that show sufferers of the disease, by
> comparing the product to another well-known product. Any number of
> things can be used to imply that a product is intended to treat or
> prevent a disease.
>
> In the notice and in our proposed rule, we mentioned a specific type
> of implied disease claim that was generating an unusual amount of
> controversy and that is a claim that a product corrects or improves an
> abnormal condition or laboratory finding that is not itself a disease
> but implies a disease or may imply a disease. The most prominent
> example of such a claim would be \"lowers cholesterol.\"
>
> In the proposed rule, FDA said that \"lowers cholesterol\" was an
> implied disease claim, but that \"maintains healthy cholesterol\"
> would be a permitted structure/function claim, and throughout the
> proposal, we maintain that distinction between correcting an abnormal
> condition and maintaining a healthy condition.
>
> In the proposed rule, we specifically asked for comment on that issue.
> We received comment on not only that issue but the general issue of
> whether implied disease claims are, in fact, covered by DSHEA and
> whether they are permitted structure/function claims. Most of the
> comments we received, particularly from the dietary supplement
> industry, the food industry, and individuals, argue that implied
> claims were, in fact, permitted as structure/function claims. These
> comments generally argued that the only types of claims that DSHEA
> prohibits in a structure/function statement are claims that mention
> the specific name of the disease.
>
> In the notice announcing this meeting, we listed some possible implied
> disease claims with the hope of generating some comment from our
> panelists on these claims. In contrast to the claim \"cures cancer,\"
> which would be an express claim, we listed \"shrinks tumors of the
> lung\" or \"prevents development of malignant tumors\" as a possible
> implied claim, since it doesn\'t mention the word \"cancer;\"
> contrasting \"treatment of epilepsy,\" which would be an express
> claim, with \"prevention of seizures,\" which would be an implied
> claim; and we contrasted \"treatment of hayfever,\" which would be an
> express claim, with \"relief of sneezing, runny nose, and itchy,
> watery eyes caused by exposure to pollen or other allergens\" as an
> implied claim.
>
> In the notice\--oh, let me back up for a moment. We also received a
> great deal of comment on the distinction between correcting an
> abnormal function and maintaining healthy function and on the specific
> example of \"lowers cholesterol\" versus \"maintains healthy
> cholesterol.\" The majority of the comments we received argue that
> there was no good distinction between those two types of claims.
>
> Most people agreed from both sides that both types of claims may be
> implied disease prevention claims. The comments from industry and
> individuals tended to argue that both types of claims should be
> permitted and that both \"lowers cholesterol\" and \"maintains healthy
> cholesterol\" should be permitted structure/function claims. Comments
> from health professionals and some organizations devoted to specific
> diseases tended to argue that neither type of claim should be
> permitted as a structure/function claim.
>
> In the notice announcing this meeting, we listed four questions about
> these issues. The first question was, if implied disease claims should
> be permitted, how should FDA draw the line between what constitutes a
> prohibited express claim and a permitted implied claim? If such
> claims, meaning implied claims, should be permitted, what are
> representative examples of the types of implied disease claims that
> should be permitted as structure/function claims? Are the examples
> mentioned in the notice, the ones I just read to you, appropriate
> structure/function claims? And finally, is a claim that a product
> maintains healthy function an implied disease claim in all cases? If
> not, under what circumstances is such a claim not an implied disease
> claim?
>
> I hope the panel can give us some interesting answers to these
> questions. Jack, do you want to start?
>
> MR. MARTIN: I am Jack Martin and I\'m going to read a statement from
> Loren Israelson, who\'s the Executive Director of the Utah Natural
> Products Alliance. Unfortunately, Loren is out of the country this
> week and was not able to attend.
>
> The Utah Natural Products Alliance was formed in 1992 to address
> various issues confronting the dietary supplement industry. At that
> time, the specific issue of claims allowable for dietary supplements
> was the foremost concern, occasioned by several key factors which were
> as follows.
>
> First, FDA\'s proposed health claim regulations created four
> pre-requirements to the filing of a petition for a health claim for a
> food or dietary supplement. Botanicals could not meet three of these
> four pre-conditions and, therefore, could not qualify to petition for
> a health claim. UNPA strenuously objected to these barriers, which
> remain yet today and which were one of the principal reasons for the
> introduction of the Health Freedom Act of 1992.
>
> Second, a group of European phytomedicine companies filed citizens\'
> petitions in 1992 and 1993 requesting a change in FDA\'s OTC drug
> review policy to allow consideration of well-known and long-used
> herbal extracts as OTC drug ingredients. These petitions remain
> without final agency action nearly eight years later. The lack of
> resolution to this issue contributes to the problem about which FDA
> has requested comments today.
>
> As mentioned, our trade association was deeply involved in the
> development of DSHEA to find solutions to these and other issues. The
> Congress was unambiguous in stating that dietary supplements can help
> promote health and prevent disease and even identified a number of
> diseases or health-related conditions for which dietary supplements
> have shown usefulness and which are widely used today by consumers.
>
> The Congress also took careful care to modify the definition of
> \"drug\" to assure that structure/function claims made under Section 6
> of DSHEA are not regarded as drug claims. The Congress further created
> the well-known requirement of Section 6 which includes the use of a
> disclaimer clearly stating that structure/function claims are not
> intended to diagnose, treat, cure, or prevent any disease. The
> definition of disease referred to in Section 6 came from FDA\'s NLEA
> regulations, after lengthy and broad-based input from all
> stakeholders.
>
> To now propose only a few years later a fundamental change to this
> definition in order to gain additional regulatory authority over
> structure/function claims is alarming to us and goes to the heart of
> the implied disease claim issue at hand. It is UNPA\'s belief that the
> sponsors and principal negotiators of DSHEA clearly understood that
> structure/function claims would encompass health conditions and health
> concerns that have potential disease implications. Cardiovascular
> health, bone and joint conditions, menopause, and various problems of
> aging are obvious examples of the type of claims we believe Congress
> intended DSHEA to cover.
>
> In essence, structure/function claims were envisioned as a type of
> pre-disease claim. This is the principal message of Section 6. Prior
> to DSHEA, existing law allowed a range of health-related claims, but
> it was not until DSHEA that the Congress explicitly intended to
> broaden the type and nature of claims that could be made to consumers.
> As a consequence, structure/function claims may imply disease or
> health condition benefits. If such claims are truthful,
> non-misleading, and substantiated, they are within the intent of
> Congress and should not be challenged by the agency.
>
> We urge the agency to be less concerned about whether a
> structure/function claim implies a disease or health claim endpoint,
> but to focus on two other issues. First, that this class of claims are
> truthful, non-misleading, and substantiated, and second, does a
> structure/function claim seek to diagnose, mitigate, treat, or cure an
> illness?
>
> We share FDA\'s concern that consumers receive the right treatment,
> use the right medicines, and have access to the best advice when they
> are sick. It is not in anyone\'s interest to do otherwise.
>
> We would note that a review of the structure/function claim submitted
> to FDA and the courtesy letters sent by FDA show a clear pattern where
> some in our industry apparently do not understand the difference
> between a structure/function claim and a disease claim. Many of the
> claims which draw a courtesy letter are clearly intended to treat
> symptoms. These are inappropriate. The broader and more difficult
> issue is what to do with claims that discuss cholesterol lowering,
> menopause, or wellness during the cold and flu season. This is where
> we believe the agency intended that such claims be allowed.
>
> We restate our willingness to work closely with the agency, create a
> robust process to discuss the vanishing point between legitimate
> structure/function claims and frank disease claims, and urge FDA to
> use the flexibility provided by the guidance policy making process as
> the means to achieving this, and we look forward to working with the
> agency on this.
>
> MR. FALK: Good afternoon. I\'m Michael Falk, the Director of the Life
> Sciences Research Office, an office of the American Society of
> Nutritional Sciences. The ASNS is the principal professional nutrition
> research society in the United States. The purposes of the Society and
> its divisions include extension of nutrition knowledge and proper
> application of nutrition research findings in the practice of medicine
> and related health professions.
>
> Through the actions of the LSRO, the ASNS avails the public of the
> expertise of the scientific community in deliberative panels and
> workshops and conferences and preparing special reports on science
> issues. Through the participation of the ASNS in public forum, through
> its many educational outreach projects, and through its journals, the
> Society helps educate both health professionals, scientists,
> regulators, and consumers alike.
>
> Today, we have three main points to make. First, maintaining the FDA
> credibility in this process, we believe, is paramount. The FDA holds a
> high degree of credibility because it balances research data along
> with economic, political, and other diverse interests in arriving at
> regulatory approaches. Consumers, legislators, and scientific
> organizations see this high degree of credibility as enhancing the
> FDA\'s ability to protect the public health. Were it to lose its
> credibility, none of the distinctions being debated today will have
> any value. Thus, the underlying concept constant in these discussions
> must be that no action should be contemplated that may undermine this
> credibility.
>
> The scientific issues underlying the understanding of
> structure/function relationships and the distinction from disease
> states are exceedingly complex, we believe too complex for simple
> definitive solutions. Yet, that is just what we are striving for in
> today\'s meeting.
>
> We urge the FDA to take a greater reliance on objective third-party
> advisory committees, such as the National Academy of Sciences and the
> LSRO. The FDA and Congress should use these vehicles to examine the
> underlying principles in order to craft better laws and regulations to
> obviate exercises in sophistry. This will only serve to enhance the
> credibility of the FDA\'s decisions.
>
> Secondly, we believe that these decisions should be based on
> scientific fact. The FDA\'s credibility is, in part, because it has
> based its decision on the best available scientific evidence and
> utilized scientific principles in its judgment. Decisions should not
> be made based on unproven assertions or the intuitions of individuals
> or interest groups.
>
> The FDA must use scientifically valid behavioral research criteria to
> understand consumers\' true interpretation of implied disease claims.
> This will provide the answer to questions such as can consumers
> distinguish between structure/function and disease claims, can they
> distinguish between FDA approved disease claims, implied or express,
> and can they choose between provable assertions and advertising
> puffery? The FDA should avail itself of the many extant resources to
> sample and test consumer understanding.
>
> However, we also recognize that consumer understanding is just a
> snapshot in time. Carefully crafted standards and rules based on
> today\'s best-available evidence won\'t be valid in just a few years.
> Consumer understanding of these issues, what consumers infer from
> label claims will certainly continue to evolve. Too narrow a
> definition, one that cannot stand the test of time, may eventually
> come to threaten FDA\'s credibility.
>
> Finally, we believe that the answer to all these questions will come
> from improving consumer understanding. The ASNS continues to have
> concerns that any mention of a disease on a label may reassure a
> consumer that the item, if consumed, will itself prevent a disease or
> substitute for choosing a well-balanced diet. Scientific knowledge has
> yet to come to a full and complete understanding of all the components
> that comprise foods, the interplay between these components, how the
> foods and food components are digested, absorbed, and metabolized,
> what roles they may play in maintaining health and preventing disease.
> Consumers must be educated to recognize supplements are just that,
> supplements, not replacements to adequate intakes from dietary
> sources.
>
> In DSHEA, Congress has stated its intent to enhance consumers\'
> choices and improve their understanding so that they can make informed
> judgments on matters of health maintenance and promotion. Congress is
> asserting that consumers\' interests are best served when consumers
> themselves make these choices based on truthful and not misleading
> information. However, we are concerned that the quality of this
> information is not properly differentiated. We continue to have a
> concern that consumers are not being presented with the appropriate
> perspectives of the scientific community.
>
> As members of the community, ASNS and its member scientists are
> willing to assist the FDA in bringing the best scientific judgments to
> bear on the questions of science. The FDA and the scientific community
> both have an important role to play in educating the consumer so that
> they can properly evaluate the labeling claim.
>
> Perhaps FDA\'s most important educational mission is to educate the
> consumer in understanding the FDA\'s role. The FDA must make the
> public understand the importance of the DSHEA label disclaimer, \"This
> statement has not been evaluated by the FDA.\" If the importance of
> this disclaimer is clear, then the significance of decisions about
> implied disease claims will be made moot. The fact that a claim has
> been evaluated by the FDA can be a validation by itself, and
> conversely, withholding FDA recognition of a claim can be as powerful
> a tool as prohibiting a misleading claim.
>
> The ASNS expresses its continued support for the FDA and will be
> pleased to assist in areas of science and analysis in any manner that
> is appropriate to the process, and thank you for the opportunity to
> present these comments.
>
> MS. MOORE: My name is Barbara Moore and I want to thank the FDA for
> the opportunity to express my views regarding an issue that is of
> great concern to Shape Up America. Former Surgeon General Dr. C.
> Everett Koop founded Shape Up America as a nonprofit 501(c)(3)
> organization in 1994 and I\'ve been the organization\'s President
> since 1995. The mission of Shape Up America is twofold, to increase
> the awareness of the growing epidemic of obesity in the United States
> and to provide responsible, science-based information on healthy
> weight management.
>
> Today, there is widespread agreement that obesity is defined as an
> excess of body fat and that the body mass index, or BMI, is a useful
> indicator of obesity. The BMI is simply a number that is calculated by
> dividing your body weight, expressed in kilograms, by the square of
> your height, expressed in meters. A BMI of 30 or higher is widely
> accepted as an indicator of obesity in adults. Persons with a BMI of
> 30 or higher face a significantly increased risk for a wide spectrum
> of diseases, including heart disease, diabetes, hypertension and
> stroke, and certain cancers.
>
> There is a clear association between obesity and these leading causes
> of death and disability. It is a serious threat to health. It can
> shorten the length of life. It erodes the quality of life, and it
> disproportionately afflicts minority populations, the poor, and the
> less-educated in the United States.
>
> I would argue, and I think many experts would agree that for adults
> maintaining a BMI of 30 or higher, obesity is a disease. The
> implication of this is that products that promise weight loss are, in
> effect, making an implied claim about disease treatment.
>
> Today, there are more than 30 million obese Americans and many of
> these people are desperately searching for medications that will help
> them lose weight. Shape Up America maintains an award-winning website,
> shapeup.org, and last month, for example, 150,000 people visited our
> site seeking information on physical activity, diet, and nutrition as
> it relates to healthy weight management.
>
> Through our website, we receive many inquiries about dietary
> supplements, as well as prescription medications. For prescription
> medications, there are published, reliable, scientific, peer-reviewed
> data, as well as the FDA drug approval process to rely upon in
> responding to these inquiries in a responsible manner.
>
> In the area of dietary supplements that are purported to support
> weight loss or fat reduction or the enhancement of muscle at the
> expense of fat, my response is, show me the data. In other words, show
> me the published clinical trial data demonstrating that your
> supplement works at the dosage you are marketing and that you are
> consistently delivering that dosage in your product. And, above all,
> show me that that dosage is safe when used for extended periods of
> time, since that is how obese people use them.
>
> Some of the dietary supplements marketed as weight loss or fat loss
> agents have been found to be quite dangerous. Others, and possibly all
> of the others, simply do not work.
>
> No information is available on possible interactions with prescribed
> medications the person may be taking and interactions with other
> herbals or supplements. The perception that natural is safe causes
> patients to not discuss this with their health care providers. Yet,
> for obese people with an increased burden of disease, these
> interactions are very important because they\'re likely to be taking
> other medications.
>
> Because of the danger and the fraud that permeates this particular
> category of dietary supplements, I would encourage the FDA to focus
> carefully and with a high priority on dietary supplements that
> purportedly promote weight loss or fat loss or the enhancement of
> muscle at the expense of fat. The manufacturers of such supplements
> should be required to supply appropriate clinical trial data and the
> FDA should rank the data and make those rankings available to the
> public on their website, organized by category of active agent. One
> such ranking system is described on page four of Shape Up America\'s
> \"Guidance for Treatment of Adult Obesity,\" and I have submitted
> several copies of this document, along with a copy of my remarks to
> the FDA.
>
> In conclusion, I believe that the seriousness of obesity, the huge
> numbers and desperation of obese people, and the great need for safe
> and efficacious adjunctive weight loss therapeutic agents demands that
> the FDA focus on this category of dietary supplements as a priority
> and that the burden of supplying appropriate and adequate proof of
> safety and efficacy falls on manufacturers and marketers of these
> products, and I thank you for your attention.
>
> MS. DICKINSON: I\'m Annette Dickinson, Vice President of Scientific
> and Regulatory Affairs for the Council for Responsible Nutrition. CRN
> is a trade association representing some 100 companies in the dietary
> supplement industry, ranging from suppliers of bulk ingredients to
> manufacturers of finished products, including manufacturers of
> national brands as well as manufacturers of store brands familiar to
> you in all of your drug stores, supermarkets, and super stores.
>
> As FDA noted in the preamble to the April 1998 proposal, almost any
> structure/function statement could possibly be considered an implied
> disease claim at some extension. If this is the case and if,
> therefore, almost all structure/function statements could in some
> sense be considered to be implied disease claims, then the options
> available to FDA would appear to be to either accept them all or
> reject them all.
>
> DSHEA does not permit FDA the option of rejecting them all, since
> structure/function statements are specifically permitted under the
> law. The logical conclusion, then, is that FDA is obligated to accept
> them all under a broad concept of structure/function statements.
>
> The entire concept of implied claims may require reconsideration, at
> least for dietary supplements. One of the questions that has been
> posed earlier today is, is it possible to have an implied disease
> claim in the face of a disclaimer that specifically states that the
> product is not intended to diagnose, treat, or prevent any disease.
>
> FDA appears to view some, but not all, effects of products on risk
> factors or markers to be implied disease claims. CRN believes that
> virtually all statements about risk factors or markers are permissible
> structure/function statements. Examples of these include statements
> such as \"maintains a healthy heart,\" \"maintains cholesterol,\"
> \"lowers cholesterol,\" \"lowers homocystine,\" \"lowers
> triglycerides,\" and \"lowers platelet aggregation.\"
>
> Regarding the question of whether consumers may view some of these
> statements as disease claims, I think that is largely irrelevant to
> the question of what claims FDA should permit. We already know from
> consumer surveys that were done in connection with the Keystone Report
> and also more recent surveys done by IFEC that many consumers
> interpret even straightforward nutrient content claims to be disease
> claims. Therefore, the extensions that a consumer may make from an
> innocuous statement cannot be used as the basis for a conclusion that
> the statement itself is an implied disease claim.
>
> As a test to us, I think, FDA\'s notice of this meeting mentioned some
> fairly extreme examples of worst-case extrapolations of purported
> structure/function statements. In CRN\'s view, the more dramatic
> examples mentioned by FDA clearly are not appropriate
> structure/function claims. These include \"shrinks tumors of the
> lung,\" \"prevents development of malignant tumors,\" and \"prevents
> seizures.\" All three of these claims use synonyms of disease, even if
> they do not use the precise or preferred disease term. Tumors are
> widely believed to be synonymous with cancer, and seizures are
> generally believed to be synonymous with epilepsy.
>
> Thus, the statements cited by FDA in the notice of this meeting do not
> describe effects on the normal structure and function of the body but
> instead are effects of overt and serious manifestations of disease and
> clearly are not permissible as structure/function statements.
>
> Statements about minor symptoms of relatively benign conditions may be
> more problematic. For example, statements about relieving sneezing,
> runny nose, and itchy, watery eyes may be permissible as
> structure/function statements and may require further discussion, even
> though the symptoms may, to some, be characteristic of an allergy.
>
> In a similar vein, CRN believes statements about enhancing mental
> focus or improving concentration are permissible structure/function
> statements, even though at some extension, those kinds of conditions
> may be symptoms characteristic of some diseases. In cases where there
> is some potential for minor symptoms to be indicative of more serious
> disease, we believe it may be desirable to include a statement in the
> labeling cautioning consumers of this fact and urging them to consult
> with a health professional if symptoms persist.
>
> CRN is not aware of any instance in which a statement about
> maintaining healthy function would be an implied disease claim. In
> FDA\'s April 1998 proposal, there are numerous examples of appropriate
> structure/function statements about maintaining healthy functions and
> no examples suggesting that such statements would ever be considered
> implied disease claims. For example, we agree with FDA\'s examples of
> helping promote urinary tract health, maintaining cardiovascular
> function, maintaining regularity, maintaining a healthy cholesterol
> level.
>
> In conclusion, the language of DSHEA allows and intends to allow for a
> wide variety of structure/function statements. Only specific disease
> claims are prohibited by DSHEA, and this should be FDA\'s guidance in
> implementing the law. The focus, as has been mentioned earlier, should
> be on assuring that those statements are truthful and not misleading
> and that manufacturers have appropriate substantiation for them. Thank
> you.
>
> MR. KAY: Good afternoon. My name is Brett Kay. I\'m a Program
> Associate for Health Policy at the National Consumers League. I just
> want to thank the FDA for holding this important meeting.
>
> The National Consumers League, which is America\'s oldest nonprofit
> consumer advocacy organization, has a long history of working to
> ensure proper labeling of products in the marketplace, from meats to
> orange juice to OTC medications.
>
> With an increasing number of consumers turning to dietary supplements
> and herbal remedies to treat a host of health conditions and prevent
> others, it is vital that consumers know what they are taking, and more
> importantly, how these products affect the intended conditions for
> which they are being taken. Because some consumers mistakenly believe
> that dietary supplements are approved or regulated like prescription
> and OTC medications, they may not evaluate dietary supplements
> adequately. As a result, they may fail to realize the supplements\'
> benefits or may place themselves or their families at risk from using
> them.
>
> On the issue of implied disease claims, consumers have no way of
> evaluating the validity of claims about dietary supplements,
> particularly for products marketed for serious conditions such as
> cancer or heart disease. Without FDA approval based on scientific
> research and clinical trials for safety and efficacy, as are those of
> prescription drugs and OTC medications, implied disease claims may
> mislead consumers and possibly prevent or prolong necessary medical
> attention. As a result of self-medication for conditions that do need
> professional medical attention, consumers should have adequate
> information about this.
>
> NCL feels that implied disease claims should not be permitted where
> the implied claim clearly refers to treatment or prevention of a
> serious disease or medical condition. Some examples, as were given in
> the FDA\'s proposed regulation, of shrinks tumors of the lung or
> reduces blood clots.
>
> The line between permitted structure/function claims and prohibited
> claims is currently too narrow and legalistic. Consumers cannot make
> the necessary distinctions between these statements in many instances,
> especially when the claims are for conditions where the symptoms or
> risk factors are as well known as the condition, for example, high
> cholesterol and its relation to cardiovascular disease, or seizures
> and epilepsy.
>
> Label claims for such products should not suggest use for a serious
> health condition that is beyond the ability of the consumer to
> evaluate, as the Commission on Dietary Supplements stated in its
> November 1997 report.
>
> On the issue of the claims about maintains a healthy function or
> promotes a healthy function, these should be considered an implied
> disease claim in all cases where having an unhealthy function leads to
> disease or other serious medical condition where professional medical
> attention is necessary.
>
> The question to ask is this. If by not maintaining a healthy function,
> will one become ill? When a consumer sees a statement such as,
> \"maintains healthy function,\" they imply it to mean that it will
> prevent, cure, or treat some problem that may develop or they may
> already have. Why else would anyone take dietary supplements or other
> health-related products if not to prevent or treat a current problem?
>
> In sum, it is the condition that determines whether the claim is an
> implied disease claim and should be prohibited. Serious medical
> conditions are exactly that, serious. Consumers cannot and should not
> forego the attention of trained health care professionals in these
> instances. If implied disease claims are permitted for products that
> are not approved or proven to treat these serious conditions,
> consumers may be at risk for their health and safety. Thank you.
>
> MS. MYERS: Yes, I\'m Abbey Myers of the National Organization for Rare
> Disorders, which is known as NORD. We are a consumer federation of
> approximately 140 voluntary health agencies and individuals who are
> dedicated to treatment and identification of orphan diseases. These
> are people with rare disorders, and some people with rare disorders
> have valid medical need for products that are not available as
> pharmaceuticals but are only available as nutritional supplements.
> Unfortunately, they will never be developed as drugs because no
> company would invest the amount of money needed for FDA approval when
> they have to compete with unregulated supplements that are
> manufactured for very little money.
>
> Because the supplements are unregulated, we are very concerned about
> the lack of quality of these products and the absence of uniform
> standards promising that every pill or tablet must contain the exact
> amount of active ingredient specified on the label and that every pill
> or tablet will dissolve appropriately in the human body and that
> consumers will be provided with accurate information about dosage and
> side effects.
>
> A hundred years ago, patent medicines sold in the United States
> claimed to cure every malady known to man, from arthritis to cancer,
> and it was only after several major public health crises and needless
> deaths from unregulated medicines that the government required proof
> of safety before medicines could be marketed. During the 1960s,
> requirements for efficacy were added.
>
> Today, as the century comes to a close, the nation has reverted 100
> years to an era of unregulated nutritional medicines that are
> advertised as effective against health problems without adequate
> scientific proof and without any assurance of safety. When you have a
> valid medical need for these products, you really have a problem.
>
> Even after the agency calls for withdrawal of unsafe supplements,
> retail stores can continue to sell them. We urge you to increase
> enforcement actions to prevent further public health tragedies.
>
> The subject of today\'s meeting is the discussion about the structure
> and function claims. According to agency rules, supplement
> manufacturers are not permitted to make disease claims but they can
> make structure and function claims. We understand that you\'re
> required to do this under the law, but, frankly, the public couldn\'t
> care less.
>
> The public will interpret structure and function claims in exactly the
> same way that they interpret disease claims. There is no difference
> between curing cancer and shrinking tumors. Both imply that the
> supplements will prevent or cure disease or enhance health. Even if
> the public doesn\'t see a claim on a label, they\'ll surely see it in
> the pamphlets and the literature that is distributed close by the
> retail shelves where the supplements are sold.
>
> The public doesn\'t read the [Federal Register]{.underline}. It may
> come as a shock to you, but when you got 100,000 comments on your
> proposed rule, do you really think that 100,000 people were sitting
> around one day thumbing through the [Federal Register]{.underline} and
> happened to see FDA\'s rule and decided to respond to it?
>
> I think that ordinary consumers, consumers who want truthful labeling
> and safe products, have not been part of this whole public discussion
> and the industry has been very well organized in creating lobbying
> campaigns that are not in the public interest.
>
> I collect very old antique medicine bottles, but I only collect them
> when they still have a label on them. Most of them are around 100
> years old. I want to read some to you. \"Pain\'s celery tonic,
> restores strength and vitality to the blood, kidneys, and bowels.\"
> Under your current proposed structure/function rules, Pain\'s celery
> tonic could be sold today as a modern nutritional supplement.
>
> But then there\'s Kunkel\'s bitter wine of iron, and this remedy
> enhances digestion, helps constipation, it works on all diseases of
> the skin as well as general prostration, and it purifies the blood and
> give tone to the system. Under today\'s proposed rule, all Mr. Kunkel
> would have to do is delete reference to diseases of the skin.
>
> We have Dr. Dennis\'s system renovator and blood purifying syrup. I
> wish I could have brought these, but they\'re so delicate, I don\'t
> want the labels to fall off. This medicine improves the liver, the
> kidneys, and the spine. It also cures rheumatism, syphilis, fever
> sores, ulcers, glandular diseases, and diseases peculiar to females.
> Under today\'s rules, the first sentence could stay, but the second
> would have to go.
>
> And finally, there\'s William Radom\'s microbe killer. This one
> doesn\'t have a label because the claims are etched directly into the
> glass bottle. It simply says, cures all diseases.
>
> \[Laughter.\]
>
> MS. MYERS: I assume under your proposed rule, William Radom would not
> be able to sell this product in any health food store today because
> cures are not allowed. Excuse me?
>
> MS. OLIVER: If you could wrap up fairly soon.
>
> MS. MYERS: Okay. Instead, he would have to rebottle his compound in
> new containers that say, \"enhances good health,\" but the fact is,
> he\'d still be able to sell it.
>
> I think you need to think very clearly about the proposed regulation
> and how it reverts to 100 years ago, when people could sell products
> like this without any enforcement from the government and without any
> consumer protections, and the role of the FDA is to protect consumers,
> even if an industry doesn\'t like it. Thank you.
>
> MR. FORD: The industry does like it. I\'m Michael Ford, Chief
> Executive Officer of the National Nutritional Foods Association. We
> represent health food stores and manufacturers and distributors of
> dietary supplements and other natural products.
>
> As far as the specific questions raised in the [Federal
> Register]{.underline}, I would like to submit for the record the
> comments that we submitted last year on the proposed regulation
> because we addressed those questions in detail, actually, and go
> pretty deeply into the area of Congressional intent.
>
> What I\'d like to do today is to comment on the process that we\'re
> going through here. I think the FDA is attempting to draw a line based
> on a 1938 statute that never contemplated these complex issues, and
> the overwhelming response to the FDA\'s structure/function proposal, I
> think, compels the FDA to move toward drawing clear lines.
>
> But I think that the FDA is seeking answers as complex as the
> questions and I don\'t think that\'s good regulation. If you want
> clean lines, why don\'t you think about taking some simple steps to
> begin with. Right now, the agency seems to be concentrating on what\'s
> come to be called a gray zone, where it\'s endeavoring to determine
> what\'s a disease, what\'s a condition, what\'s chronic, what\'s
> acute, what does the label imply, what does the consumer infer. Again,
> I suggest some more simple steps.
>
> For example, look at the Federal Trade Commission. They have no
> trouble at all identifying what we call the outliers, the egregious
> claims-making products out there. It should not be difficult for the
> FDA to determine what disease means in this context in defining a more
> limited gray zone.
>
> Unfortunately, right now, I really don\'t disagree with some of the
> things that have been said. The market does abound with AIDS cures and
> impotence cures and cancer cures and instantaneous obesity cures and
> products whose very name or claim incorporates the name of a
> prescription drug. I don\'t see how those\--why there would be any
> delay in determining what\'s a structure/function claim, what\'s a
> disease claim. This is fraud.
>
> You have the authority to remove these products from the market and
> you should do so very quickly using your current authority. As I said
> last time addressing a panel, I wish I had a Nike t-shirt on so I
> could pull it off and it said, \"just do it.\" You need to enforce.
>
> Unfortunately, too, we\'ve not really reached the point where the FDA,
> Congress, the industry, consumers, the scientific community know with
> laser-like precision exactly where the line might be permanently
> etched to maintain the integrity and intent of DSHEA while protecting
> pharmaceutical investment and research, and I think a lot of this,
> this is what this is about.
>
> Therefore, I today repeat my call for the creation of an advisory
> body, not one found in the Advisory Committee Act, but an ad hoc group
> comprising representatives of FDA, industry, academia, consumers, and
> State and Federal legislatures. This group can help you define the
> gray zone as we learn more about consumer reactions and the future
> direction of health care. I think this would be a lot preferable to
> getting 100,000 comments on each proposal that you make, having
> televised oversight hearings. Instead of this nearly daily reinvention
> of the health claims wheel, take the incremental steps. You\'ll better
> meet your obligation to ensure consumer access to information on using
> dietary supplements to maintain health.
>
> So just to conclude, my three messages here, enforce the law. Go after
> the obvious fraud. Secondly, impanel an ad hoc advisory panel to
> assist you in determining enforcement directions and looking at
> tighter definition of your gray zone. And give us a structure/function
> regulation that looks toward a new health millennium instead of one
> that works so hard to define its limits that it can\'t take a first
> step.
>
> DR. LYNCH: I\'m Dr. John J. Lynch, a medical oncologist and Associate
> Medical Director of the Washington Cancer Institute at the Washington
> Hospital Center. I do not have the sophistication of the law to be
> able to understand all of the questions that are being asked in terms
> of structure/function, et cetera, but I do have the feeling as a
> physician who sees patients and who deals with the issue of
> medications, dietary supplements and herbs, and patients taking them,
> in some cases not informing their physicians that they are taking
> them.
>
> I would just like to make a few comments. I would say that it appears
> to me, as somebody unsophisticated, that we have a double standard.
> The pharmaceutical industry is required to do all sorts of things, and
> I forget what the latest figure is to get a product approved by FDA
> and get to the market. It involves, I think, something like 10 or 11
> years and millions of millions of dollars, and yet we can have bottles
> of materials on shelves that talk about various symptoms and they can
> be sold without any regulation.
>
> Incidentally, most of the public that I run into thinks that all this
> stuff that\'s sold has some oversight and approval by the Food and
> Drug Administration, despite the fact that they may make disclaimers
> to that point.
>
> The various dietary supplements, vitamins and minerals and herbs, make
> various promises concerning depression, sleep disorders, diminishing
> memory, cancer, indigestion, arthritis, anti-aging effects,
> rejuvenation, elimination of toxins, and I probably have just named a
> few. The public frequently thinks that there is a major benefit to
> these as either a supplement or as primary treatment. However, the
> scientific evidence and the data that\'s required of other products
> that the FDA approves is certainly lacking.
>
> The anti-oxidant supplements are no substitute for a food that we can
> take and have been urged to take. For instance, the five fruits or
> vegetables a day would go much further than all the medicines you
> could buy off the shelf, yet only one-third of the Americans take that
> sort of diet. They seem to prefer to spend money in a health food
> store, since 80 percent of Americans are alleged to take vitamins and
> minerals and buy the medication.
>
> There actually have been three studies of beta-carotene supplements in
> lowering the risk of cancer and heart disease and these have all been
> failures. As a matter of fact, there was one study done in Scandinavia
> that showed in patients who smoked or people who smoked, the use of
> beta-carotene actually showed up to cause a greater incidence of
> cancer in those individuals.
>
> Supplements do not produce the same beneficial effects that vegetables
> and fruits will. I grant that in certain situations, such as pregnancy
> and frail elderly and certain children, there may certainly be
> benefits to the intake of vitamins. However, this is a very limited
> situation and the indications of vitamins are a vitamin deficiency.
> This is seen primarily in people who have absorption problems or
> people who are alcoholics and have an insufficient diet.
>
> The mega-doses that have been recommended by some organizations
> certainly have great potential for toxicity, since the oil-soluble
> vitamins and the fat-soluble vitamins are stored in the fat and you
> can have toxicity related to that. I would remind us that the
> water-soluble vitamins are excreted in the urine, and I frequently ask
> people that are taking these massive doses, or regular does, do you
> notice that your urine is fluorescent yellow? Of course. I said, we
> will have very healthy fish in the Potomac.
>
> The herbs are of particular concern, also, because the source of where
> they are from may vary batch by batch. They are not standardized as to
> the amount of the medication or herb that\'s supposed to be there.
> Appropriate dosing is sometimes unknown and cross-reaction with other
> medications that patients may be taking, either cancer patients or
> heart patients, certainly cause problems. Sensitivity to either the
> herbs themselves or the contaminants that are frequently found may
> cause problems, and some of these problems have been recorded by CDC
> as being fatal.
>
> I suggest that we are dealing with, certainly in cancer, with
> desperate, vulnerable people and they have a fear of the disease. They
> have fear of the treatment, surgery, radiation, or chemotherapy. The
> pressure of implied benefits can steer consumers, or what we call
> patients, away from the state-of-the-art treatment.
>
> I think the label and its truthfulness, when that exists, is extremely
> important. Patients believe what they read on labels, and it\'s not a
> giant leap for them to look at symptoms that they have and figure that
> this is going to be helpful without any investigation as to whether
> these symptoms may be serious or early indicators of disease that is
> curable.
>
> The customers understand what\'s on the label and how can we think
> otherwise? I think to make the statement that what the customer
> deduces from what\'s on the label is their problem and not ours, I
> think that\'s a disservice to the American public, which in many cases
> is not as sophisticated as we might like to believe.
>
> Clearly, when you cite the signs and symptoms, even without the name
> of the disease, it just makes it very attractive for people who would
> like to avoid physicians to take this, and I think it\'s misleading.
>
> We need stricter regulation of dietary supplements, especially the lay
> one, and as I mentioned as I started, it is my concern. I mean,
> Senator Kevaufer, I believe, a number of years ago said that we had to
> show not only efficacy but safety, and clearly, that doesn\'t seem to
> apply to dietary supplements.
>
> I guess, as a physician, I am somewhat dumbfounded and also very
> concerned about the public. I think that we are allowing industry
> entrepreneurs to overtake common sense.
>
> MS. OLIVER: Dr. Lynch, if we could wrap up fairly soon\--
>
> DR. LYNCH: I\'m all finished. Thanks very much.
>
> MR. REYNA: My name is Robert Reyna. I\'m the Director of Consumer
> Protection in the New Mexico Attorney General\'s Office. I very much
> appreciate the invitation that came to the National Association of
> Attorneys General to provide someone to comment on the questions that
> have been raised today, especially on the question of implied disease
> claims.
>
> While I don\'t speak for the National Association of Attorneys General
> because they have not passed a resolution or taken any particular
> position on this, I can tell you that the Health Fraud Working Group,
> which is a group of over 20 States that regularly prosecute these
> cases either individually or as a group strongly feel that we need to
> have the tools to prevent consumer fraud in the area of dietary
> supplements.
>
> We receive requests not only from the government side and from
> consumers but also from industry to take action in this area, and the
> points that Michael Ford just raised are ones that we have discussed,
> that we need to be able to pursue enforcement in this area, and I\'m
> afraid that in the area of implied claims, that the possibility exists
> that you might end up with a regulatory scheme that doesn\'t permit us
> to go after even the obvious fraudulent products.
>
> Let me try and run through it. Contrary to the question of what is a
> disease, what is an implied claim is a totally legal question, and I
> hate to disagree 100 percent with another member of this panel, but
> what the consumer perceives is the question when they see an implied
> claim, and that\'s a well-settled principle in the law.
>
> I\'m sorry the Federal Trade Commission wasn\'t on one of the panels
> today because the State law parallels the position that the Commission
> has taken on this issue, but it\'s easier to state in terms of what
> the Commission has held, and the Federal Trade Commission has held
> that you can only judge an implied claim if you test it on consumers
> and try to find out how they are perceiving it.
>
> So what I would propose is, and I\'m not proposing any committee that
> would attempt to rewrite DSHEA because I think a lot of the comments
> that have been made today are actually proposing ways to rewrite the
> statute because it\'s unworkable or people don\'t like the way it
> turned out, but what really needs to be done as far as implied claims
> is to sit down and figure out an orderly system for determining what
> the implications of any of these sample statements that have been made
> here are on the public and how they take them.
>
> It\'s really a more serious question than that because the public
> assumes that what\'s on these labels is true. We already have the
> ridiculous situation that they\'re required to have substantiation and
> that the claim be true, but there\'s a statement on the label that the
> Food and Drug Administration has not evaluated the claim that is on
> there. I don\'t see how that disclaimer survives the recent court
> case, the [Pearson]{.underline} case, because there\'s a great
> inconsistency there.
>
> Not only are these implied claims, these are also what the Commission
> has called establishment claims, because if it\'s required to be true,
> a representation that it\'s true is a representation that there\'s
> scientific proof to support that claim, and if that\'s not true, those
> are really some of the most significant and serious types of
> advertising claims that are made to the public.
>
> We can\'t permit a situation where it would be litigated and held to
> be against the law to advertise a dietary supplement for a certain
> condition but you could put it on the label, and that\'s the
> upside-down situation that you\'re headed toward if you don\'t try to
> get conformity in the law between the types of implied claims that
> would be permitted in advertising and the types of implied claims that
> would be permitted on the labeling of the products.
>
> It\'s really a question of science versus anti-science, I believe,
> because if you\'re really going to take responsibility to make sure
> that these claims are true, it may not be the popular thing or the
> easiest thing to do, but you really can\'t ignore the way\--if a
> consumer believes that they\'re taking this and it\'s going to keep
> them from seeing the physician, that really is a serious claim and one
> that needs to be evaluated in the appropriate legal manner. Thank you.
>
> MS. OLIVER: Thank you very much.
>
> DR. LYNCH: I represent myself. I do not represent the American Cancer
> Society. They will be submitting a separate document in terms of their
> findings and feelings.
>
> DISCUSSION
>
> MS. OLIVER: Thank you. Once again, we\'ve heard a variety of opinions
> on the panel on the implied claim, but I asked the question, and I
> know some of you are saying it\'s not the question to ask and some of
> you are saying just do the outliers and the egregious, but some of you
> are also saying that there is a line between what would be permitted
> as an implied claim and other implied claims. I think some have also
> said that the examples in the [Federal Register]{.underline} notice
> for this meeting were egregious and we\'re looking at it as a test for
> what you\'re doing.
>
> I think what we were looking at is an idea on what you thought implied
> claims\--what implied claims you were looking to\--if we were to allow
> implied claims, the question would be, what kind of line would we draw
> or where would we draw the line? I know I\'ve heard some of the
> outliers on either side. I\'d ask Annette Dickinson for your thoughts
> on that.
>
> MS. DICKINSON: In terms of the actual using, whether something is a
> disease claim for purposes of permitting it or not permitting it, we
> are arguing that under DSHEA, you\'re really only talking about
> specific disease claims that cannot be permitted, and the examples
> that I raised from your [Federal Register]{.underline} announcement
> are cases where I think the terms that you used in terms of seizures
> and tumors are essentially synonyms for the disease, not that they\'re
> implied disease claims, they are the disease claim.
>
> So I certainly would not think that under this provision we would
> anticipate that people could use synonyms for disease claims and get
> away with purporting that those are structure/function claims.
> However, short of that, I think the fact actually is that we all need
> to face the reality that up to that, almost anything is permissible,
> and I know that\'s an outrageous sounding statement and there are lots
> of bad examples we might could talk about that would be permitted if
> that were the rule\--I think it is currently the rule\--but I think
> those can be dealt with in terms of what\'s truthful, what\'s not
> misleading, what\'s substantiatable, and also possibly some cautions
> having to do with the area where some of those statements may lead up
> into suggesting to consumers that these may treat serious diseases or
> encouraging consumers not to seek appropriate medical treatment. We
> certainly don\'t want those things to happen.
>
> When I say that whether the consumer perceives something as a disease
> claim may not be very relevant to this issue, I don\'t think I really
> would take issue with Mr. Reyna, what he thought was an opposite view
> on that. I don\'t think we\'re necessarily on opposite sides of that
> question. I do think that what the consumer perceives as an important
> feature in the way that FTC treats it as an important feature and may
> determine how much evidence a company needs in order to support
> something.
>
> But I don\'t think it draws the line. I don\'t think that is what can
> draw the line between what\'s a disease statement and what\'s not a
> disease statement. I think that really goes beyond the ability of the
> ordinary consumer to evaluate, in a sense, because many consumers, the
> surveys show us, treat almost anything as an implied disease claim or
> as a real disease claim, and that goes all the way\--I mentioned
> nutrient content claims, but it even goes further back than that, even
> to some statements in ordinary nutrition labeling, even the
> quantification of cholesterol, for example, in nutrition labeling some
> of the consumers in those surveys have interpreted to be disease
> claims. So I think if that\'s the situation we\'re looking at with
> consumers, that cannot be the determining factor of what is a disease
> claim.
>
> MS. WITT: Let me follow up on that a little bit. You suggest that if
> it\'s a synonym for a disease, then it\'s the same as making an
> express disease claim. What\'s a synonym here? I mean, you would say
> seizure is a synonym for epilepsy. I don\'t know if physicians would
> agree with you, but how will we know a synonym when we see one?
>
> MS. DICKINSON: The only examples that I\--I looked back at the
> original FDA proposal and at many of the examples that you cited there
> of implied or not implied disease claims. Other than the ones that you
> mentioned in this notice, that is, the seizures and the tumors, I
> didn\'t really see any others that I would have considered to be
> synonyms.
>
> For example, I certainly would not consider elevated cholesterol to be
> a synonym for heart disease. It is a risk factor, but not a synonym,
> whereas stroke or myocardial infarction would be synonyms for
> cardiovascular diseases of various kinds. I don\'t know if that helps,
> but I think that\'s as far as I can go based on the examples that
> we\'ve looked at already in what\'s before us.
>
> DR. LYNCH: Seizures can come in a lot of varieties, and frequently use
> the term seizure disorder. If it happens to be a young child, it\'s
> probably due to a fever. If it\'s an elderly person, it\'s probably
> due to hypoxia in the brain, or the lack of oxygen. So it\'s all sorts
> of range, but to me, it\'s always a disease.
>
> MS. MYERS: It\'s a symptom. You\'re talking about a tumor is always a
> symptom of cancer, isn\'t it, and a seizure would always be a symptom
> of some type of malfunction of the brain.
>
> MS. WITT: I think that\'s how we were intending it. Ms. Dickinson is
> saying that it\'s not so much a symptom as a synonym, and I was trying
> to probe what a synonym is in this context.
>
> MS. MYERS: But the average consumer is still going to think about that
> as a health claim. They\'re going to interpret it in the same way. If
> I take this supplement, I will either prevent or cure cancer because
> it shrinks tumors.
>
> MS. DICKINSON: And we\'re not arguing that that should be allowed.
>
> MS. MYERS: It should not be allowed.
>
> MS. WITT: But I think, if I understood your comments correctly, you
> are arguing that other ways of conveying a disease that don\'t mention
> the disease or a synonym, that would clearly convey the disease to
> anybody who read it, would be permitted. For example, prevents bone
> fractures in post-menopausal women, there\'s no synonym for
> osteoporosis, but I think most people would understand that\'s what
> the claim was.
>
> MS. DICKINSON: I guess in that case, I would say that that\'s a pretty
> direct health claim. That is a restatement of the already-approved
> health claim and, therefore, should be treated as a health claim, not
> as a structure/function statement.
>
> MS. WITT: Because it happens to have been approved as a health claim.
> What if we were talking before the health claim were permitted? It\'s
> an implied disease claim, also, and I thought you were saying any
> implied disease claim really is permitted under DSHEA as a
> structure/function statement, with the possible exception of use of a
> synonym.
>
> MS. DICKINSON: Right, and I would view fractures in post-menopausal
> women as being essentially a synonym unless they\'re due to falling
> down stairs or some other condition that is not related to the loss of
> bone associated with aging that is osteoporosis.
>
> MS. WITT: You are saying that would be a synonym, also?
>
> MS. DICKINSON: Yes.
>
> MS. WITT: I guess it\'s not my understanding of the word \"synonym.\"
>
> MS. DICKINSON: I would not argue with you that the difference between
> synonyms and symptoms may in some instances be in the eye of the
> beholder.
>
> DR. LYNCH: If I saw something on a label that talked about improving
> the symptomsÊof bone loss, I would be thinking osteoporosis.
>
> MS. YETLEY: So how do you put criteria on to make these distinctions?
> How do you differentiate between that being a disease claim versus
> others that would not be?
>
> MS. DICKINSON: I guess I decided before I came to this meeting to be
> blunt about it and not to dance around it. What we\'re saying is that
> you don\'t need to worry about that, that what you need to worry about
> is that the statement is truthful, not misleading, and substantiated,
> and that it contains whatever other material facts may need to be
> conveyed in order to help consumers understand it, to alert them that
> under some conditions, they may need to seek medical attention, to
> alert them that in some situations, it may be a symptom of a more
> serious disease, but that, basically, the requirement that is put to
> you under DSHEA is that statements that are, literally speaking,
> structure/function statements should be permitted unless they are
> disease claims.
>
> And we\'re back to the circular\--I can see you\'re smiling at that,
> but we\'re back to the circular definition. There are going to be some
> close calls that it isn\'t going to be easy to make, and maybe some of
> the suggestions that have been made here, that on those cases you
> might call in advisory groups, might be a good idea. I don\'t think,
> though, that you should get hung up on the entire scope of things by
> the few examples we may all be able to dredge up of cases where we
> really can\'t draw that line.
>
> I think part of the problem with this effort is that we are trying to
> draw lines that really are not drawable in a way that a large number
> of people are going to agree to. And so I think what you need to do is
> to kind of move past that, in a way, and figure out what we can do to
> assure that everything that\'s said on the label is truthful, not
> misleading, and substantiated and not get quite so hung up about the
> definition of disease aspect of it.
>
> MS. OLIVER: Going back to the circular definition, when you\'re
> talking about disease, the implied claims that are disease claims and
> are really a synonym for disease, I really hear you drawing a line,
> albeit you can\'t draw a fine line for it. You see some things and you
> can\'t get the definition and get them there.
>
> If there are prescription drugs that are out that are known treatments
> for particular diseases and the product name is extremely similar, I
> mean, to that, would you include that to be an implied disease claim?
> I\'m trying to get out what your definition of an implied disease
> claim is and what you mean a little more in synonym to understand it.
>
> MS. DICKINSON: As in the case of herbal phen-fen, right?
>
> MS. OLIVER: Okay, those kinds of\--or if you have something that\'s
> some type of an herbal prozac, I\'ve heard of that, some other types
> of things. There are other things that are names that might be to
> treat a disease, such as reinouds \[ph.\] or something. It might be
> something that would have that in their name. Do you consider that to
> be a synonym for disease, too, and getting at what you\'re talking
> about?
>
> MS. DICKINSON: If you\'re mentioning reinouds, yes, I would consider
> that to be a synonym for disease.
>
> MS. OLIVER: Okay.
>
> MS. DICKINSON: In the other cases, for herbal prozac and herbal
> phen-fen, I would consider that that\'s covered by other aspects of
> your ability to prevent misleading statements or prevent the
> representation of this as a prescription drug, not necessarily that
> it\'s a disease claim, not necessarily that saying it\'s herbal prozac
> constitutes a disease claim, but you\'re saying that this is a
> substitute for a prescription drug, which surely is not something that
> you should permit.
>
> MR. FORD: Well, herbal prozac, that would be a drug claim, herbal
> viagra or herbal phen-fen, herbal anything that mentions a
> prescription drug. You wouldn\'t have any hesitation to take after
> that, would you?
>
> MS. WITT: On what basis?
>
> MR. FORD: Fraud.
>
> MS. MYERS: That\'s a trademark infringement. It\'s not even your
> department.
>
> MR. FORD: It\'s a drug claim. If you say that you do what prozac does,
> then you\'re making a drug claim, aren\'t you?
>
> MS. WITT: What do you mean by a drug claim? A lot of what we\'re
> talking about today are drug claims. Structure/function claims can be
> drug claims.
>
> MS. DICKINSON: Only if they\'re not for foods, which includes dietary
> supplements.
>
> MS. WITT: I just don\'t know what we mean by drug claim there.
>
> MR. FORD: Relieves depression. Isn\'t that what prozac supposedly
> does? I mean, there are ads in consumer magazines now for prescription
> drugs.
>
> MS. WITT: Right, but what we would probably say is that there\'s an
> implied claim, an implied claim that it treats depression because of
> the use of the word \"prozac,\" and what I heard Annette Dickinson say
> is that we would not go after it because it was an implied disease
> claim, we\'d go after it on some other basis, but I don\'t know what
> the other basis would be.
>
> MS. MYERS: I think you don\'t have to worry. The manufacturer of
> prozac would start the lawsuit before you\'d even think about it.
>
> MS. DICKINSON: Well, they wouldn\'t necessarily win it, though.
>
> MS. MYERS: I think one of the issues is here, what is a nutritional
> supplement and what isn\'t, and there\'s a lot of things out there
> that are not made out of foods. GHB, which turns into a huge problem,
> gamma hydroxybuterate and all of the derivatives, for example, are
> industrial solvents, and yet they\'ve been selling it in nutritional
> supplements. Why doesn\'t FDA step in there and say, this is not a
> botanical. This is not a food. Get it off the market.
>
> MS. DICKINSON: Well, they have.
>
> MR. FORD: They did.
>
> MS. MYERS: Well, they just did, but it should have been done a couple
> of years ago before a couple of people died.
>
> MS. OLIVER: Do you have any questions?
>
> MS. YETLEY: Several of you had mentioned that allowable
> structure/function claims should be pre-disease claims or claims for
> healthy maintenance. I wonder if that is again always true or if there
> are shades along a continuum. I\'m thinking about two claims,
> \"maintains normal healthy blood sugar,\" \"maintains normal healthy
> blood pressure.\" Would you see those, given the different definitions
> that have been proposed this afternoon or different criteria, would
> you see those as disease claims or structure/function claims?
>
> DR. LYNCH: Absent evidence, I\'d consider it baloney.
>
> MS. MYERS: I would wonder if a person who has a chronic problem with
> low blood pressure would walk into a health food store and say, well,
> if I take this, it\'ll raise my blood pressure. The question is, what
> does the product actually do? Does it really lower blood pressure?
> Well, then it\'s not maintaining healthy blood pressure, is it,
> because if your blood pressure is very high, it may lower it, but not
> to something your doctor would think would be normal.
>
> So you have to understand that the people who shop for these things
> are not lawyers and they don\'t understand legal definitions and
> they\'re going to make their own assumptions. So how can you force
> these companies to be truthful?
>
> MS. DICKINSON: But thinking about this in terms of food claims, there
> are certainly foods, individual foods and food categories, that are
> believed to be helpful in maintaining normal healthy blood sugar, not
> assuming that your blood sugar is high, but foods that are less likely
> to result in a rise in the glycemic level, things like high fiber
> foods, complex carbohydrates as opposed to simple carbohydrates. And
> so if you can draw that kind of connection for foods, then I don\'t
> know why you shouldn\'t be able to draw it for supplements at some
> level, although the truthfulness and not misleading might be the
> critical factor.
>
> Likewise, in terms of healthy blood pressure, it\'s general belief
> that bananas and other things with good potassium levels do, in fact,
> contribute to maintaining a healthy blood pressure, not assuming that
> you have high blood pressure, but just assuming that, for permanent
> maintenance of healthy blood pressure, you would like to have lots of
> fruits and vegetables and things that are good sources of potassium.
> Potassium supplements are not really an issue here because there\'s a
> prohibition on supplements having more than 100 milligrams of
> potassium, but it\'s not inconceivable that that kind of statement
> could be made for foods, and, therefore, by extension, for
> supplements.
>
> MR. FALK: I think there are very few bright lines here that are
> scientifically supportable. I think this is a broad spectrum that\'s
> out of focus. You can\'t make a bright line right in the middle of it
> that\'s going to be true for everything. Even a simple claim that
> soluble fiber and high fiber may lower your glycemic intake, there\'s
> vast literature out there that weighs on both sides of that issue.
> It\'s not straightforward, even that.
>
> So I think that it\'s a very, very difficult exercise that you\'ve set
> out for yourselves by dealing with it in this way. It has been set out
> for you, perhaps, by having to deal with it in this way. This
> distinction that supplements are largely closer to foods and foods are
> generally safe and that drugs are inherently not safe but perhaps
> prevent disease is just a spectrum. It doesn\'t have even a clean
> distinction, and what is a supplement isn\'t a clean distinction, even
> though it\'s well-defined by DSHEA, I mean, fairly well defined. GBH
> is a good example of how it\'s a fine distinction without a
> difference.
>
> So I think that you risk long-term credibility by trying to make
> arbitrary decisions that are recognized by everyone as arbitrary, but
> also recognized by everyone from their own viewpoint as being wrong
> from their viewpoint. The consumer thinks it means something, the
> health professional thinks it means something else, and they both
> think you\'re wrong.
>
> MS. YETLEY: Jack, how would you see that fitting into your pre-disease
> concept?
>
> MR. MARTIN: I think the basic issue that leads to that is that
> Congress\--it\'s pretty specific. They wanted to broaden the basis of
> what you could say as a claim. We still look at whether it is to
> treat, cure, mitigate disease. If it doesn\'t say that and it does, in
> some way, imply disease or health condition benefits, we think that
> that would fall under what Congress is intending as they expanded what
> you could say as part of the labeling of a dietary supplement.
>
> Obviously, they have left, as was just stated, a very difficult
> decision for the agency as to how clear do you want to define the
> line. If you define the line too clearly, then, once again, will
> Congress come back and say, well, we don\'t like that. Let\'s try it
> again. Or will Congress say, let\'s relegislate. You know, you\'re in
> a very tough position on this.
>
> UNPA, though, believes that you should be able to get into the area of
> health and disease condition benefits without specifically going into
> the area of treating, curing, mitigating disease, but we also, as
> we\'ve said, the claim should be truthful, non-misleading, and there
> should be substantiation to what you say.
>
> I don\'t know if that really specifically answered it. It\'s very
> difficult to carve that line, I think is one of the key issues, and
> Congress, I think, specifically made it that way so that there is
> leeway to go back and forth.
>
> DR. LYNCH: If the label says something about not diagnosing, not
> treating, whatever, why take the stuff to start with? I mean, what\'s
> it for? That\'s a cover-up, but people are still going to buy it
> because it says if you\'re short of breath and you take this, it\'ll
> help you. This whole stuff defies common sense. It just blows my mind.
>
> MS. YETLEY: And I guess, Robert Reyna, from the perspective of the FTC
> model, how would you see those types of claims being dealt with?
>
> MR. REYNA: Well, I mean, I think unless you can judge whether or not
> there\'s evidence as to what the claim means to people, then you
> wouldn\'t be able to really support any decision you made on these. I
> think you have to enforce it in this area. I don\'t see why anybody
> would try and put through an approved health claim after the
> [Pearson]{.underline} case if you\'re not going to regulate implied
> drug claims. They\'d just state everything is an implied drug claim.
> If they put in a proposal to make a health claim, you might require
> them not to put some sort of disclaimer with it. They\'re better off
> just claiming it\'s not a disease claim and litigating that question.
> You really have to answer the question, is this implied claim a
> disease claim or is it not a disease claim?
>
> MR. FORD: Looking at the blood pressure example, I don\'t know if
> there\'s a real claim out there. What it should, if you\'re going to
> describe the dietary supplement\'s effect on blood pressure, you might
> talk about the mechanism by which it accomplishes that, so to say that
> fish oil gives elasticity to the arteries, thus contributing to normal
> circulatory health, something like that. I think that would be
> allowed, or should be allowed.
>
> In the current proposal, though, you would not be able to mention a
> body system or body part or organ, so it makes it difficult to
> describe the mechanism by which the dietary supplement accomplishes
> its goal. But I would say that if you just say, lowers blood pressure
> on a dietary supplement, that, to me, would be a disease claim.
>
> MS. DICKINSON: May I add just a comment on the FTC model, because the
> FTC model is excellent because it doesn\'t require you to make this
> decision about disease and non-disease. I mean, it basically says, if
> you have a health-related claim. They don\'t have the categories that
> you have. That is, they don\'t have to deal with whether something is
> a supplement or a food or a drug and treat it differently according to
> what it is.
>
> What they say is that the amount of substantiation you needed is
> related to the seriousness of the health claim, and the health claim
> or the health benefit or the health statement, they don\'t really care
> whether you\'re making it for a drug or you\'re making it for a
> supplement or you\'re making it for a food. You need the same amount
> of substantiation regardless of the product category.
>
> I think in this case, what I\'m trying to say, what we\'re trying to
> say, CRN, is you\'ve got a definition of a dietary supplement. It is
> not the intention under DSHEA that in addition to that you use
> gradations within this gray area of label statements to decide that
> something isn\'t, in fact, a dietary supplement. It\'s intended that,
> while there can\'t be direct disease claims, that these
> structure/function claims that we\'re prepared to admit are implied
> disease claims in the way that you have previously thought of implied
> disease claims, are supposed to be permitted.
>
> Therefore, it\'s right for you to look for more substantiation. The
> more significant the health statement is, the more significant the
> health benefit is, but it\'s not a factor that should throw something
> out of the dietary supplement category except in these clear disease
> claim situations. And some enforcement that went directly after those
> disease claims, there are products out there making direct claims
> about arthritis, about cancer, about heart disease, and we could start
> by getting rid of that stuff, and then continuing to discuss this gray
> area, perhaps, and basically take action under the Act, because the
> Act gives you clear authority to act against things that make specific
> disease claims or that are not substantiated or that are false or
> misleading.
>
> Is there a reason why we couldn\'t all agree together that we\'re
> going to go move against all of that stuff and get it off the market,
> get it out of the way as a complicating factor in considering this
> whole category, rather than spending all of our time, five years since
> DSHEA, trying to define what it is we\'re going to go after, which I
> think we\'re seeing here is a very difficult task because that throws
> us into a gray area where we\'re really not comfortable being and
> where we don\'t have the answers that would be needed if you were
> going to try to turn that gray area into a bright line.
>
> MS. AXELRAD: But isn\'t the issue here\--if you go after the people
> that are making a claim they\'re curing arthritis, but because of the
> way we define disease claims and implied disease claims, all they have
> to do is change their labeling to say, \"prevent joint pain\" or
> \"relieves aching joints\" or something like that and they can stay on
> the market, how much will we really have accomplished by that
> enforcement action?
>
> MS. DICKINSON: Don\'t you think you will have accomplished something?
> You will have gotten rid of things that are in overt, deliberate,
> flagrant violation of the law. You will still have this gray area to
> deal with. But what\'s the problem with somebody saying that something
> helps increase joint mobility or helps decrease joint pain if they\'ve
> got substantiation for it? Is that where you really ought to be
> spending your energy, is to try to go after that as opposed to getting
> rid of the worst stuff?
>
> MR. FORD: Do all joint pain and mobility issues result from arthritis?
> See, to me, going back to the synonym issue, tumor, there is no
> question in mind, tumor means cancer. But joint pain and mobility
> issues are not necessarily arthritis. And, by the way, there is a
> product out there on the shelves and on TV called the arthritis cure.
> It blows my mind.
>
> DR. LYNCH: Correction. All the word tumor means is a mass, and it\'s a
> euphemism that physicians used to use and some still do when they
> don\'t want to use the word cancer. But tumors come in two varieties,
> malignant and non-malignant or benign.
>
> MS. OLIVER: We have time for one more comment or one more question.
>
> MR. REYNA: Let me, if I might, tell you that the Federal Trade
> Commission has written a guidance to industry regarding advertising
> claims for dietary supplements and they have an example that goes
> exactly to the question of implied claims and it might be helpful to
> read their example and explain what position they would take on it.
>
> They\'ve given a rather, I think, an obvious example because I think
> they feel that they would be able to support through perception
> studies that the consumer would take from this example the idea to be
> that this was a disease claim and that it would have to be
> substantiated. So it might be on the market for some significant
> length of time if the company just put it on the market and waited for
> the FDA to challenge the labeling before the FTC could attack it on
> the basis of advertising.
>
> This is example number four under identifying express and implied
> claims. An ad for a dietary supplement called Arthro-Cure claims the
> product maintains joint health and mobility in old age. A \"before\"
> picture shows an elderly woman using a walker; the \"after\" picture
> shows her dancing with her husband. The images and product name likely
> convey implied claims the product is effective in the treatment of the
> symptoms of arthritis and may also imply that the product can cure or
> mitigate the disease. The advertiser must be able to substantiate
> these implied claims.
>
> So if this is the type of claim that the Federal Trade Commission is
> going to be acting on or challenging or the standard that they\'re
> going to use, the proof is going to be whether or not the ad actually
> implies that. So when you\'re taking a label, and I\'m saying this
> because the States enforce both the advertising and the labeling end
> and we would approach it from an evidentiary point of view exactly the
> same way. We would say, do these claims imply that this product is
> being sold for the purpose of treating arthritis or is it being sold
> only for the purpose of\--for a limited claim that it has some effect
> on mobility and movement?
>
> MS. OLIVER: Thank you very much.
>
> **PUBLIC SESSION**
>
> MS. OLIVER: The next session that we\'re going to have now is the
> comment from the people that are here. We have nine people that are
> signed up. What I\'d like to do is to have the commenters come up to
> the podium to present your comments. You will each have five minutes,
> and once again, we have the timer down there. She will be holding up
> for you the one-minute sign and the time is up and I\'ll try to hold
> you to that.
>
> I\'m going to read the order of the individuals so that you can come
> up front and be near and save time in getting up to the mike, but then
> I\'ll say your name before each one is to present first.
>
> So the presenters are in this order: Betsy Woodward, Jonathan Emord,
> Robert Ullman, Tracy Fox, Floyd Leaders, Stephen McCurry, Marc Ullman,
> Ken Gorelick, and Scott Bass. Betsy?
>
> MS. WOODWARD: Thank you for the opportunity to be here. I\'m Betsy
> Woodward, Director of Public Policy for the Association of Food and
> Drug Officials, which is a nonprofit professional association
> consisting of State, Federal, and local officials as members, industry
> representatives. From its very inception 103 years ago, AFDO has
> recognized the need for uniform laws and regulation, has actively
> promoted uniformity and cooperation within the regulatory arena, and
> that is among local, States, and the Federal Government.
>
> AFDO strongly supports FDA\'s desire to develop effective strategies
> for achieving proper regulation of the safety in labeling of dietary
> supplements while providing product access. We have testified
> frequently with respect to the issues and the implementation of the
> Dietary Supplement and Health Education Act.
>
> With respect to the enhancement of consumer safety, which we consider
> to be a primary issue, FDA needs to follow the recommendations of the
> President\'s Commission on Dietary Supplement Labeling and address
> areas where labeling is currently inadequate and guidance is needed.
> This includes the seven guidance statements contained on page 38 of
> the report, which identifies some of the boundaries for the things we
> have been discussing today, drugs, health claims, and
> structure/function claims. These are referenced in the proposed rule.
>
> Clearly, structure/function claims must be distinct from drug claims,
> which require adherence to drug regulations, and from health claims,
> which under the Nutrition and Labeling Education Act, characterize a
> relationship between a food or a food component and a specific disease
> or health-related condition. DSHEA identified and stated definitively
> that dietary supplements were foods.
>
> The definition of disease must be examined in the light of both the
> definition of drug contained in the Act and the defined provisions for
> health claims under NLEA, which reference a relationship between a
> food or a food component and a specific disease or health condition,
> which we\'ve been talking about a lot.
>
> The term \"damage\" can be broadly interpreted to handle most of the
> issues, and abnormal bodily function can be seen in our eyes as a
> damaged bodily organ or system. AFDO believes that the interpretations
> of Section C(1) and (2) of the April 29, 1998, proposal can be
> supported using the current definitions.
>
> AFDO considers structure/function claims under DSHEA as wellness or
> healthy body claims that do not reference directly or by implication
> specific disease states. Any structure/function claim that references
> a disease state must either be considered a drug claim or a health
> claim and be regulated appropriately for those types of claims, both
> of which require an examination of substantiation and an approval by
> FDA.
>
> There will always be some tension between structure/function claims
> and the other two because good health in and of itself is a disease
> prevention strategy. However, when claims relate to specific disease
> states, they are not structure/function claims. AFDO believes that a
> disease claim, explicit or implied, is unacceptable unless approved as
> a health claim.
>
> The FDA has asked for comments regarding conditions associated with
> natural states. Generally, natural states should not be considered
> diseases. Only an abnormal health condition or complication can
> constitute a disease state. AFDO does not consider Alzheimer\'s and
> toxemia as natural states. Certainly, a brain affected by Alzheimer\'s
> is definitely damaged, and toxemia\'s manifestations, such as
> hypertension, is definitely a disease-related state.
>
> A structure/function claim has to approach any natural state or
> condition from the general wellness point and cannot reference what is
> commonly recognized as abnormal health-related or disease states. When
> a structure/function claim mentions specific disease management or
> abnormal health-related states directly or indirectly, again, as we
> have said, it must either be approved as a health claim, as under
> NLEA, or be considered a drug claim, rendering the product a drug.
>
> FDA asked for specific comments on their intention to treat explicit
> and implied claims the same. AFDO strongly agrees with this approach.
> Uncontrolled implied claims on food became the \"Tower of Babel,\"
> which resulted in the specific corrective requirement that Congress
> embodied in the NLEA. To not regulate both implied and explicit claims
> equally would result in an even worse market nightmare of misleading
> consumer health and safety information. Further AFDO believes that the
> FDA should write specific requirements for implied claims, much as
> they did for the implied claims under NLEA.
>
> Again, AFDO appreciates the opportunity to present these comments on
> these issues referenced in this docket. Thank you.
>
> MS. OLIVER: Thank you. Jonathan Emord?
>
> MR. EMORD: My name is Jonathan Emord. I\'m the attorney who
> represented the plaintiffs in the [Pearson v. Shalala]{.underline}
> decision. I appear here today on behalf of the JAG Group, Wieder
> Nutrition, International, Pure Encapsulations, Inc., Meditrend, Excel
> Health Care, Dr. Julian M. Whitaker, and others \[ph.\].
>
> FDA in the proposed rule seeks to redefine the term disease, expanding
> its definitional scope, extending it beyond damage to an organ, part,
> structure, or system of the body, the current definition to reach any
> deviation from, impairment of, or interruption of the normal structure
> or function of any part, organ, or system.
>
> The health claim rule prohibits any nutrient-disease relationship
> claim, as you well know, unless the FDA approves it following the
> filing of a health claims petition. Thus, the effect of the proposed
> rule is to prohibit a vast quantity of health information that
> heretofore has been allowed on the labels and in the labeling of
> dietary supplements. There is inherent ambiguity in the proposed rule
> terms deviation, impairment, and interruption that invites endless
> agency expansion of the scope of prohibited claims, thereby flouting
> the will of Congress, which was to foster rather than hinder the
> dissemination of health information, and the command of the First
> Amendment, which is to favor disclosure over suppression.
>
> Indeed, unlike the term \"damage,\" which yields an objective meaning
> and can yield an objective meaning, the terms \"deviation,\"
> \"impairments,\" and \"interruption\" are abstract and capable of
> great definitional latitude, inviting the agency to divine virtually
> any change in human physiology resulting from normal structures and
> functions to be diseases.
>
> In particular, the proposed rule would give the FDA greater power to
> suppress claims it regards as implied. The agency views implied claims
> as ones that do not include an express reference to a disease but have
> among their many possible connotations at least one that may suggest a
> nutrient-disease association. Viewing implied claims in this broad
> fashion causes all of the non-disease connotations arising from these
> implied claims to be suppressed along with the single disease
> connotation.
>
> I believe there is a better way, and I don\'t come here strictly for
> the purpose of criticizing the proposed rule. The joint commenters we
> represent have today proposed in comments filed that an alternative be
> employed by the agency. The alternative involves use of disclaimers of
> implied claims, disclaimers designed to disclaim the particular
> disease connotation. The new disclaimer would be added to the general
> disclaimer prescribed for all statements of nutritional support in
> DSHEA, and this approach would ensure that valuable health information
> is disclosed rather than suppressed, and that the agency\'s objective
> in preventing the disease implication is preserved.
>
> Consider the following example. Under the proposed rule, a saw
> palmetto supplement bearing the claim, \"may improve urine flow in men
> over age 50,\" is viewed as an impermissible implied health claim,
> said to imply a treatment for benign prostatic hypertrophy. Of course,
> the presumption that the claim implies a treatment for BPH is but one
> of many possible connotations reasonably derived from that claim.
>
> To permit the claim\'s health information to reach consumers but avoid
> misleading the public into believing that the FDA recognizes saw
> palmetto as a treatment for BPH, FDA may simply mandate the use of the
> following disclaimer, in addition to the general disclaimer specified
> in DSHEA. Here is the disclaimer, the additional one. \"FDA has not
> approved saw palmetto for use in the treatment of benign prostatic
> hypertrophy.\"
>
> In this way, FDA may satisfy its First Amendment obligations of
> avoiding suppressing the dissemination of health information. It may
> satisfy the Congress of the United States by allowing, rather than
> hindering, the dissemination of health information. And it will not
> deny the American people the health information they have a right to
> receive. FDA can avoid speech suppression, yet guard against a
> potentially misleading connotation.
>
> In conclusion, the joint commenters whom I represent respectfully
> request that FDA withdraw the proposed rule, retain the current rule,
> and propose a new rule to implement the disclaimer approach that we
> have mentioned here for implied claims. Thank you.
>
> MS. OLIVER: Thank you. Robert Ullman?
>
> MR. ROBERT ULLMAN: Thank you. Good afternoon. It\'s been a long day. I
> appreciate your patience.
>
> My name is Robert Ullman. I appear here today as an attorney who, for
> more than 35 years, has been privileged to practice law with the
> dietary supplement industry, as regulated by FDA and other agencies,
> being a significant part of that practice. Over this period of time, I
> have seen the industry mature greatly in the development of its
> products and its responsible presentation of those products to a
> public that craves open, truthful, and non-misleading information
> about nutrition and the maintenance of good health. Unfortunately, I
> think there are times that the agency has not matured quite as rapidly
> in its regulatory attitude towards the dietary supplement industry.
>
> Many in the agency, going as high as at least its immediate past
> Commissioner, have pointed to DSHEA as handcuffing FDA\'s ability to
> regulate the industry. It is true that DSHEA was a message from
> Congress about the importance of dietary supplements as well as the
> importance of a fully well-informed health-conscious public. But DSHEA
> did not diminish the agency\'s ability to regulate the industry. To
> the contrary, FDA\'s regulatory authority was enhanced. In saying that
> dietary supplements are not food additives, Congress endorsed existing
> law, as already expressed by two Federal district courts and two
> courts of appeals in the black currant oil cases in which I was lead
> counsel, and the right to make structure/function claims for foods,
> including dietary supplements, without such products becoming drugs,
> existed as an exception to the drug definition in the Food and Drug
> Act long before DSHEA.
>
> The proposed new definition of the word \"disease\" is not necessary.
> Its only potential would be to serve as yet another tool for those who
> want to handcuff the industry and the public with arbitrary restraints
> on the ability to give and receive truthful, non-misleading
> information.
>
> The introduction of such vague concepts as \"deviation from\" and any
> \"interruption of\" the \"normal\" function of any body part or system
> as the criteria for disease will not provide direction to the dietary
> supplement industry, nor will it help the consumer. In announcing
> today\'s meeting, FDA said its proposed definition is based on medical
> and legal dictionaries. Is that what the consumer understands? Or is
> it more likely that the consumer understands Webster\'s Ninth
> Collegiate Dictionary definition, \"a condition that impairs the
> performance of a vital function\"?
>
> The only value of words like \"deviation,\" \"interruption,\"
> \"normal,\" is to provide the basis for further restricting the
> dietary supplement industry\'s right to inform consumers about the
> health benefits of dietary supplements and the opportunity for
> consumers to receive important health information. FDA\'s proposal
> flies in the face of Congressional intent and defies constitutional
> restraints against governmental interference with free speech,
> including commercial free speech, which today, as recognized in an
> ever-growing number of Supreme Court cases, is entitled to the same
> privileges and protection.
>
> To suggest that the term \"disease\" has to be fixed because the word
> \"damage\" in the present definition could be narrowly interpreted to
> apply to only serious or long-term diseases, excluding, for example,
> depression or migraine headaches, is really pushing the envelope. Who
> would argue that depression and migraines are not serious? Who would
> deny that some body part or system is not functioning properly in the
> presence of these conditions? The admonition, \"if it\'s not broke,
> don\'t fix it,\" applies well to the existing definition of disease.
> Indeed, one might say, \"if it\'s not broke, don\'t break it.\"
>
> Having said that, I would commend to your consideration the definition
> that was put forth today by Dr. Soller on behalf of CHPA in its
> proposed definition of disease. I think it is a product of very hard
> work. I think it represents perhaps what the present definition
> already is, and yet says it a little more clearly.
>
> Finally, I would like to suggest that questions pertaining to
> individual human needs and conditions do not always lend themselves to
> so-called bright-line distinctions for categorizing nutrition, health,
> and health information. Surely FDA recognizes the difference between
> \"lowers cholesterol,\" on the one hand, and \"shrinks tumors of the
> lung\" or \"prevents development of malignant tumors\" on the other.
> To suggest that anyone would seriously argue or prevail that the
> latter should be treated as permissible structure/function claims
> provides an unrealistic and untenable basis for the current proposal.
>
> Bright lines do not always present reasonable borders. Any rule that
> attempts to predetermine the by whom, the what, the where, and the
> when of implied claims or establishes FDA as the pre-screener and sole
> arbiter of such questions is likely, either in its general
> promulgation or its specific application, to run into constitutional
> challenges that are best avoided in the first instance by a common
> sense ad hoc approach, subject as it is now to judicial review, when
> necessitated by irrational positions whether by FDA or the industry.
> Thank you.
>
> MS. OLIVER: Thank you. Tracy Fox?
>
> \[No response.\]
>
> MS. OLIVER: Is Tracy Fox not here? If not, let\'s go next to Floyd
> Leaders.
>
> MR. LEADERS: Good afternoon and thank you for allowing me to speak.
> I\'m Dr. Floyd Leaders. I am Chairman and CEO of a company called
> Botanical Enterprises, which focuses on science-based medicinal
> botanicals. I\'ve also co-chaired a series of FDA co-sponsored
> meetings through the Drug Information Association on science-based
> botanicals.
>
> Today, however, I am speaking as a consumer, the first one on the
> program that is representing himself and not a group of consumers.
> I\'ve asked to speak because of a real concern that the comments
> solicited by the FDA for this particular discussion have overlooked a
> very important consumer-oriented focus. No one has mentioned that
> structure/function claims are not designed for the physician. They are
> designed to inform the consumer. This is a big difference between
> structure/function claims and prescription drug labeling.
>
> With that in mind, I believe without a consumer focus, it is unclear
> how a definition of disease or the other issues can really help the
> public safety. I believe that, as everybody has said, that they need
> to provide truthful, non-misleading, but one additional, meaningful
> information to the consumer, and that that\'s the basis upon which we
> need to proceed.
>
> How can a structure/function claim and/or other labeling on a product
> most effectively provide information needed by consumers to make
> informed decisions at the point of purpose? The proposal which I will
> outline would remove the structure/function claim discussion from the
> current medical-legal framework and shift it to a science-based,
> consumer-focused paradigm in which the product label for each product
> reflects the data available to support that product. Simply put, let
> the data determine how the structure/function claims are presented to
> the consumer.
>
> In the proposal that I am offering, each dietary supplement product
> would contain a uniform statement of medical scientific support based
> on the data available for that product. It would include, one, a
> statement of historic, traditional use; two, a statement of support
> for effectiveness; three, a statement of support for safety; four, a
> benefit assessment based on the effectiveness data, and a risk
> assessment based on the safety data.
>
> Detailed proposed statements of medical scientific support and the
> supporting criteria are included in written comments submitted to the
> docket. Due to time limitations here, I can only emphasize probably
> one of these to give you an idea about how they would connect.
>
> On the history of use, if a product has a basis of historic or
> traditional use, the label statement could claim,
> \"Historically/traditionally used for,\" and then a meaningful
> structure/function claim. If the effectiveness of the specific product
> has been confirmed by clinical trials or other scientific-based
> information, then the statement could be, \"The effectiveness of the
> specific product has been confirmed by clinical studies and the
> effectiveness has been tested in X clinical trials,\" or how much
> detail we can put on the label. The same thing would apply to safety.
> If there is none on the specific product, the label should reflect
> that.
>
> On the benefit and risk potential, a very simplistic scheme of rating
> each of these as low, medium, or high could be based on the data. For
> example, if the effectiveness of a specific product has been
> confirmed, the benefit potential would be rated high. If the product
> class is supported only by historical, traditional use, but the
> specific product has not been evaluated for safety, the risk potential
> would be graded moderate.
>
> Manufacturers would continue to submit structure/function claims to
> the FDA, but the FDA review process would be augmented by a consumer
> panel to verify that the claim that is desired is meaningful to the
> consumer. This is something the technology exists to support and the
> industry uses it. Why not ask the consumer?
>
> MS. OLIVER: If you could wrap up, please. Your time is up.
>
> MR. LEADERS: I\'m sorry?
>
> MS. OLIVER: If you could wrap up soon, because your time is expired.
>
> MR. LEADERS: Oh, my time is up? Okay. My take-away message is, only
> when consumers have meaningful labeling information and they make
> informed product choices based on safety, efficacy, as well as on
> price. Thank you for listening, and I\'m sorry. I didn\'t see your
> signs go up.
>
> MS. OLIVER: Thank you. Stephen McCurry?
>
> MR. McCURRY: I\'m Steve McCurry. I work for Cargill. I\'m here
> representing the research-based Dietary Ingredient Association, which
> is a small, recently-formed trade association of companies that hold a
> lot of values in common about the degree of scientific testing and the
> degree of safety testing that should be necessary and should be done
> for products in this category.
>
> We filed some detailed comments, and it\'s five o\'clock, so I\'m not
> going to spend a lot of time up here trying to enlighten you with
> profound thinking that might have been a lot more profound, say, at
> ten o\'clock in the morning than at five.
>
> First of all, I do want to thank FDA for having this session. I think
> this was a very good idea, to get all of these topics on the table.
> There has been lots of interesting discussion today. However, I would
> hesitate to say the discussion lends itself to coming to a coherent
> conclusion. I do not envy you your job in pulling this together and
> figuring out the next steps.
>
> The issue of which definition of disease, whether either of the two
> proposed or any of the other possible ways of looking at disease that
> were proposed this morning, I think I\'ll leave unaddressed.
>
> The issue of conditions associated with natural states, this question,
> like the other questions asked, certainly begs the definition of
> disease as part of it and really can\'t be addressed in a vacuum. On a
> comment that I heard moments ago, though, about disclaimers, it would
> seem that a comment could be put on products if there is a concern, as
> I heard voiced a lot today, about people taking a dietary supplement
> that might alleviate a system, that might delay them going to a
> physician.
>
> There certainly could be requirements to warn people that this symptom
> can be a sign of something serious. If it persists for more than
> such-and-such a time, go see your doctor. Don\'t use this product as a
> treatment. That, to me, I think would be heard by consumers as a
> stronger statement than these comments have not been evaluated by the
> FDA and so on, which I do think confuses some people.
>
> The only other comment that I will make is one that I didn\'t hear
> made exactly this way today, and this comes from me being a scientist
> rather than a lawyer or something else, and it falls under the implied
> disease claim section. The advantage of making a claim like, \"this
> product lowers cholesterol,\" or serum cholesterol, or \"this product
> did lower serum cholesterol when the experiment was done this way,\"
> or however it was done, is something that is real. You can lay your
> hands on it. It\'s a piece of data. You can say, this was done, this
> is exactly the result, this is what happened.
>
> If we move that to \"maintains healthy cholesterol,\" does this
> product lowering somebody\'s cholesterol mean that their cholesterol
> is now healthy? I don\'t know. I don\'t have any data to support that.
> I don\'t even have any data that says it was healthy in the rats or
> the rabbits or the people that this was done in before.
>
> I think the issue under implied disease claims, there has to be some
> way of factoring in the fact that what was actually tested and what is
> scientifically supportable, there has to be a way to communicate that
> and it has to be done in a way that doesn\'t confuse the public, but
> it also has to be done in a way that the company or the person doing
> the research can feel like they can support. I certainly wouldn\'t
> feel like I could support a claim, \"maintain a healthy cardiovascular
> system,\" or something like that, based on data about cholesterol or
> triglycerides or one other biomarker, even a biomarker as strong as
> cholesterol.
>
> Thank you very much. I hope everybody has a good day, or evening.
>
> MS. OLIVER: Thank you. Marc Ullman?
>
> MR. MARC ULLMAN: Good afternoon. I am a partner in the New York City
> law firm Ullman, Shapiro and Ullman. I am here today on behalf of
> Traco Labs, Incorporated, a manufacturer and supplier of dietary
> supplements.
>
> On June 10, 1998, Traco submitted comments to FDA\'s publication of
> the proposed rules at issue here today. Among other things, Traco\'s
> comments argued that the proposal failed to provide any meaningful
> guidance as to the agency\'s views of acceptable structure/function
> claims, confused the nature of what FDA views as an acceptable claim
> by inconsistent references to over-the-counter drug monographs, and
> was an ill-considered effort to ban what the agency believes to be
> implied drug claims based upon its naked assertions of consumer
> perceptions.
>
> We respectfully refer to and incorporate those comments within our
> comments here today, as we continue to believe that FDA\'s proposed
> regulations are designed to thwart the Congressional intent behind
> DSHEA to guarantee the dietary supplement industry\'s ability to
> convey truthful and non-misleading health information to the American
> public. Traco\'s comments to FDA have consistently urged the agency to
> adopt a regulatory structure that permits transmittal of just such
> information because it is mandated not only by DSHEA but by the First
> Amendment to the United States Constitution.
>
> The [Federal Register]{.underline} notice calling this meeting
> specifically requested comments on two subjects that Traco believes
> are of the utmost importance. The first is the agency\'s attempt to
> change the definition of disease following DSHEA\'s express
> authorization of structure/function claims on behalf of dietary
> supplements. If adopted, the proposal would operate to vastly expand
> the scope of claims that fall within the Food, Drug, and Cosmetic
> Act\'s definition of drugs as articles intended for use in the
> diagnosis, cure, mitigation, treatment, or prevention of disease in
> man or other animals.
>
> Following the passage of the NLEA in 1990, FDA defined the term
> \"disease or health-related condition\" as meaning, in relevant part,
> damage to an organ, part, structure, or system of the body such that
> it does not function properly, or a state of health leading to such
> dysfunctioning. The proposal, however, would vastly expand this
> definition to include any deviation from, impairment of, or
> interruption of the normal structure or function of any part, organ,
> or system of the body or a state of health leading to such definition.
>
> FDA has acknowledged that this change represents a vast expansion of
> the definition of disease. For the agency to take such action after
> Congress enacted DSHEA based upon the then-operative definition is
> tantamount to a spoiled child changing the rules of the game after it
> realizes that things are not going exactly the way it planned.
>
> Traco believes that the use of the term \"deviation from normal\" in
> the proposal is so vague that it provides no meaningful guidance
> whatsoever and can be interpreted in a manner that would bar almost
> any claim beyond \"helps maintain normal,\" and then you can fill in
> the blank. So we ask, normal for who, you, me, a 21-year-old
> decathlete in peak physical condition, or a 65-year-old female
> retiree? If normal is the decathlete, then we submit that we are all
> in a lot of trouble.
>
> FDA has also asked whether retention of the term \"damage\" in the
> present definition would exclude any conditions that are medically
> considered disease. Traco believes that the agency\'s narrow focus on
> this question is disingenuous. The current definition not only
> encompasses actual damage, but also a state of health leading to such
> dysfunctioning. This is sufficiently broad to cover any state of
> health that could be rationally considered a disease.
>
> The second issue we wish to address is FDA\'s effort to ban what it
> considers implied disease claims. Any analysis of this portion of the
> proposal must start with an understanding of the basic proposition
> that the First Amendment to the United States Constitution protects
> all truthful and non-misleading speech. Even where the speech in
> question could be considered commercial speech, the Supreme Court has
> clearly stated that so long as it is truthful and non-misleading, the
> government must demonstrate a substantial interest that is directly
> advanced by its regulation without burdening substantially more speech
> than is necessary.
>
> This principle was reaffirmed again last week in the District Court
> for the District of Columbia in [Washington Legal Foundation v. Henny
> and Shalala]{.underline}. There, FDA took the position that the court
> should not apply the First Amendment commercial speech scrutiny to the
> law and FDA regulations restricting the dissemination of information
> concerning the off-label use of prescription drugs because the law
> permits speech so long as it complies with the requirements of the
> statute. Judge Royce Lamberth rejected this notion as preposterous.
>
> Perhaps the most glaring defect in the proposal on implied claims is
> FDA\'s effort to define a drug or disease claim by fiat. This action
> clearly defies the requirements of the First Amendment. Thank you.
>
> MS. OLIVER: Is Tracy Fox here yet?
>
> \[No response.\]
>
> MS. OLIVER: Okay. Ken Gorelick?
>
> MR. GORELICK: Thank you. My comments are not prepared. They\'re in
> response to some of the statements that were made during the session
> today and I really only have two points.
>
> The first is that many of the comments concerning claims and disease
> claims were based on a need for clinical trials or based on the
> presence of clinical trials that supported the purported claim. In
> order for a clinical trial to be meaningful and to be relevant to a
> particular product, it needs to be performed with something that
> resembles that product, and, in fact, DSHEA specifically states that
> herbs and herbal products covered under DSHEA have to be within the
> historical context.
>
> Today, I think data that have been widely disseminated in newspapers
> like the [Los Angeles Times]{.underline} and consumer magazines like
> [Consumer Reports]{.underline} have indicated that despite claims of
> standardization, standardization is not the norm in available
> botanical products. So in order to have a common ability to discuss
> what a dietary supplement does, we have to be speaking from a common
> standard, a common platform of what exactly a product is and how best
> we can approach the controlled manufacture of such products.
>
> Just as an aside, there was a discussion of saw palmetto products.
> Many of the clinical trials on saw palmetto have been conducted with a
> product that is not available in the United States, using an
> extraction method that is not used for products sold in the United
> States. The relevance of those studies to the actual efficacy of that
> product is not entirely clear.
>
> My second point is directed to the panel that discussed conditions
> associated with natural states. Many of the natural states that we
> talked about were associated with the aging process, things like
> menopause, presbyopia, et cetera, but one particular natural state is
> of great concern, I think, to the public health, and that is
> pregnancy. While pregnancy would by no means be considered a disease
> by any reasonable person, pregnancy is not the same as a normal
> healthy state. The regulations that govern drug manufacture stipulate
> that drugs must be tested in a variety of systems that will inform us
> about how they might affect pregnancy and fetal development.
>
> Herbal products, botanical products, dietary supplements work
> presumably because they contain active pharmacologic agents, and in
> the interest of public health, I would ask that while pregnancy,
> again, is a natural state, we consider the possibility of evaluating
> the effect of dietary supplements that may be used by women who are
> pregnant or at risk for becoming pregnant, should be evaluated for the
> possible impacts on the fetus. Thank you.
>
> MS. OLIVER: Thank you. Scott Bass?
>
> MR. BASS: Good afternoon. I\'m Scott Bass. I\'m an adjunct professor
> at the Georgetown University Graduate School of Public Policy, a
> partner at Sidley and Austin in Washington, and counsel to companies
> and associations with interests in these proceedings.
>
> My purpose is to add a short point here about the statute. I think it
> might be helpful as an overlay to what I think has been a very good
> faith effort by FDA to deal with a very difficult issue.
>
> If we step back for a minute and ask, why is Section 6 of DSHEA in the
> statute, there are two reasons. The first was, there was a strong
> feeling in Congress and by the groups involved in negotiating the bill
> that the interpretations by the government and the courts of Section
> 201(G)(1)(c) about permissible structure/function claims were too
> narrow, too restrictive. As a consequence, there was a need to expand
> that group of permissible claims to give more information to
> consumers. It was, therefore, written separately from Section
> 201(G)(1)(c) for a couple of reasons, one of which was to separate it
> from standard food claims.
>
> The second reason for Section 6 is it\'s not Section 5 of DSHEA. Put
> another way, Congress wanted a line between drugs and supplements to
> remain. Section 5 was injected into the Act because the herb industry
> felt that it must talk about therapeutic claims, and the compromise
> reached within Congress was, we\'ll allow drug claims for herbs
> through the third party literature provision. I won\'t go into those
> requirements, which are well known, but nonetheless, there was an
> attempt to distinguish structure/function claims from drug claims
> there. In Section 201(F)(f)(3), the rush to market provision, there
> was another explicit attempt by Congress to distinguish between drugs
> and dietary supplements. So, at bottom, Section 6 is there to expand
> prior narrow interpretations of structure/function claims but to keep
> the intended use continuum in play in the Food and Drug Act.
>
> So that leaves us, really, after listening to the testimony today,
> with about 90 percent of the issues agreed upon by all the speakers
> and ten percent in a gray zone. The questions that have been raised in
> the [Federal Register]{.underline} notice are very important
> questions, and I would suggest these are questions that require
> ongoing review and the input of the medical community, the medical
> containment community, industry, and government agencies.
>
> But I don\'t believe that it\'s possible for FDA today to effectively
> define the entire playing field. We do not need a regulation today
> that defines implied claims. What I suggest is that FDA start with a
> simple first step, which is to define some types of claims that would
> cross the line that Congress sought to retain between drugs and the
> innovation that must be protected in the drug field, as well as the
> consumer safety requirement, the policy requirement that consumers be
> protected from unsafe products. We need to have supplements to this
> guidance, this initial guidance, as we learn more from industry and
> the medical community about what exists in this ten percent gray zone.
>
> It\'s important to clear the playing field right now of players making
> inappropriate claims, but at the same time to leave the process
> dynamic through the use of advisory groups and constant input in
> hearings like these to establish a meaningful line between drugs and
> supplements. Thank you.
>
> MS. OLIVER: Thank you. One more time, Tracy Fox?
>
> \[No response.\]
>
> **CLOSING COMMENTS**
>
> MS. OLIVER: Okay. The audience is a little smaller than it was earlier
> today. Having my back to the audience, I couldn\'t tell that as well,
> but there have been a lot that have left.
>
> I\'d like to thank everyone for their input, and obviously a lot of
> people who have provided their input are not here to be thanked. As
> you who are left can see, there\'s a broad range of comments that we
> had. We\'ve had a lot of input and a lot of good things to think about
> and to consider, and so I want to thank you and assure you that we
> will.
>
> Have a good night. It\'s really a nice day out today.
>
> \[Whereupon, at 5:20 p.m., the meeting was adjourned.\]