ATFOOD AND DRUG ADMINISTRATION

> DEPARTMENT OF HEALTH AND HUMAN SERVICES
>
> CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
>
> **IMPLEMENTATION OF THE FOOD AND DRUG ADMINISTRATION**
>
> **MODERNIZATION ACT: PROVISIONS FOR USE IN**
>
> **FOOD LABELING OF HEALTH CLAIMS AND NUTRIENT CLAIMS**
>
> **BASED ON AUTHORITATIVE STATEMENTS**
>
> **PUBLIC MEETING**
>
> Tuesday, May 11, 1999
>
> 8:35 a.m.
>
> Jefferson Auditorium
>
> US. Department of Agriculture
>
> South Building
>
> 1400 Independence Avenue, S.W.
>
> Washington, D.C.
>
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> Welcome and Introduction
>
> Mr. Robert Lake 3
>
> Framework for Discussion 8
>
> Dr. Christine J. Lewis, Ph.D.,
>
> Questions from the Audience 24
>
> Opening Remarks
>
> Mr. Joseph Levitt 51
>
> Commenter Panel Presentation
>
> Dr. Annette Dickinson, Ph.D. 45
>
> Mr. Michael Ford 56
>
> Ms. Tracy Fox 61
>
> Ms. Ilene Heller 70
>
> Ms. Regina Hildwine 77
>
> Dr. Bernadette Marriott, Ph.D. 89
>
> Commenter Panel Discussion 85
>
> Questions for the Panel 102
>
> Scientific Body Panel Presentation
>
> Mr. Phillip Schwab 128
>
> Dr. William Harlan, M.D. 132
>
> Dr. Linda Meyers, Ph.D. 139
>
> Dr. Dixie Snider, M.D. 144
>
> Dr. Allison Yates, Ph.D. 150
>
> Discussion/Questions from Audience 159
>
> Registered Speakers
>
> Donna Porter 176
>
> Dr. Colin Broughton 185
>
> Jonathan W. Emord 194
>
> Richard L. Hanneman 201
>
> Lisa Katic 206
>
> Ronald M. Lawrence, M.D. 211
>
> Stephen D. McCurry 214
>
> Michael McGuffin 219
>
> R. William Soller, Ph.D. 222
>
> Adjournmet 228
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> **WELCOME AND INTRODUCTION**
>
> MR. LAKE: Good morning. We might as well go ahead and get started.
>
> My name is Bob Lake. I\'m with the Food and Drug Administration Center
> for Food Safety and Applied Nutrition. My new title, since we went
> through a slight realignment, is regulations and policy.
>
> Let me first welcome each and every one of you. We have a long day and
> I would like to stick as closely to the schedule as possible,
> particularly the panelists that we have coming at 1:00, right after
> lunch. Their time‑‑several of those people have time that is very
> tightly constrained, so in particular we want to be on time for that
> part of the program.
>
> As you came in, there were cards on which you could write questions
> and I would encourage you to, if you have questions, to write them
> down on one of those cards and at three different times during the
> course of the meeting, we will take questions. The first time will be
> after‑‑I\'m going to give a little bit of an introduction here and
> then Dr. Christine Lewis will be giving a little bit of the framework
> for the rest of the day and we will take some questions at that time
> and before we have our morning break.
>
> Again this meeting today is about the provisions on authoritative
> statements relative to claims that is found in the FDA Modernization
> Act, and I\'ll say more about that. Indeed, the whole topic for the
> day will be about that.
>
> Let me give you a few housekeeping things before we get into the meat
> of the program. I\'m told that the ladies room, for those of you who
> wish to visit it during the day, that if you turn left after going out
> the back of the auditorium‑‑no, I\'m sorry; ladies room is to the
> right, down to wing 5 and then you go up wing 5, past the elevators
> and there will be the ladies room, water fountains and also
> telephones.
>
> For the men, if you go out and turn left down to wing 6 and up wing 6
> till you see water fountains, restroom and also some telephones there.
>
> At the lunch break if you want to eat in the cafeteria, that will be
> available to you. You go to the right down to wing 3 and then down the
> steps.
>
> Incidentally, as you\'re wandering in the building, if you wear the
> name tags that you picked up when you came in, that will allow you to
> come back into the complex. That\'s the security mechanism that they
> are using here.
>
> This meeting is being hosted by the Food and Drug Administration but
> the folks at the Department of Agriculture have been kind enough to
> make this auditorium to us and to provide the service here and we very
> much appreciate that.
>
> The Food and Drug Administration Modernization Act, otherwise known as
> FDAMA, was signed into law in November of 1997. It provided for health
> claims and nutrient content claims based on authoritative statements
> from federal scientific bodies that had responsibility for nutrition
> research and also the National Academy of Sciences.
>
> FDAMA became effective 90 days after passage. And, of course, it\'s a
> very large piece of legislation and has a lot of provisions in it.
> FDA, all parts of FDA, have been very busy since its enactment,
> figuring out how to implement the various provisions in it.
>
> In many instances we\'ve had to begin some implementation prior to
> actually having the opportunity to develop regulations and the
> authoritative statements are one of those situations. We first issued
> guidance relative to authoritative statements in May of 1998, about a
> year ago.
>
> The first notification that the agency received for health claims
> based on authoritative statements was received in February 23 of 1998.
> It was a single notification but it contained nine different health
> claims based on various statements that were identified as being
> authoritative by the notifier.
>
> FDA issued interim final rules to prohibit the claims, which is one of
> the options. We actually have to respond in 120 days to prohibit or
> modify. If we take no action, the claim is allowed by operation of the
> statute.
>
> In the case of these original nine health claims, we did publish
> interim final rules to prohibit them and these were published in June
> of 1998.
>
> In the preamble to the first of these nine rules, the one concerning
> vitamins C and E, FDA spelled out a tentative approach on how we were
> going to deal with these notifications for‑‑or claims based on
> authoritative statements. Since that time, we, of course, have gotten
> a lot of comment and it is because of the number and nature of the
> comments that we\'ve gotten that we felt that we needed to have this
> meeting today to provide a public opportunity for considering some of
> the issues around how we should be dealing with authoritative
> statements in the future.
>
> The agency at this point is very open on where we go in the future and
> we\'re looking forward to hearing the comments from the two panels
> that will be coming up here momentarily, as well as the other people
> from the audience. A number of people have asked to speak this
> afternoon and so we will be hearing those comments, as well.
>
> I think at this point what I will do‑‑well, let me briefly review the
> agenda and I\'ll tell Chris Lewis to start getting ready because
> she\'ll be up here momentarily. And then, following her presentation,
> we will have an opportunity for questions, which can be about the
> further proceedings if you wish. I mean any questions about the
> arrangements or anything like that we will certainly take at that
> time.
>
> Following that, we will have a break and then, at 10:00, we have
> scheduled some remarks from Joe Levitt, the director of the Center for
> Food Safety and Applied Nutrition. He is, as many of you know, not new
> to the agency but new to CFSAN and coming into the whole area of
> health claims and authoritative statements with an open mind. So he
> will have some remarks.
>
> Then, following that, we have a panel and we won\'t ask them to come
> up until after the break but this will‑‑and the panelists know who
> they are, but it\'ll be the representatives from several segments of
> the industry.
>
> Following that, there will be an additional opportunity for questions.
> Then we will break for lunch, and again you\'re on your own for lunch.
> The cafeteria is the closest thing, the one in the building, but there
> are other places outside if you wish. But again we will be promptly
> reconvening at 1:00 to listen to the scientific panel, which we\'re
> all anxious to hear from.
>
> Once that is over, we will have a further opportunity for questions
> and then, following that, the speakers how have registered to speak
> will be given their opportunity to address us and you.
>
> With that, let me turn now to and introduce Dr. Chris Lewis. She has
> been with the agency and the center for a long time, is very heavily
> involved in these issues, is very competent, from a technical
> standpoint, is also a delightful person and without taking any more of
> her time, Chris, it\'s all yours.
>
> **FRAMEWORK FOR DISCUSSION**
>
> DR. LEWIS: Thank you very much, Mr. Lake and good morning.
>
> My purpose today is to set the framework for discussion. And, as Mr.
> Lake indicated, this is a description basically of our tentative
> approach and today we\'re in more or less a listening mode for your
> remarks and comments on this approach.
>
> If I could have the first slide, please. The framework for discussion
> that I will try to move through in the next few moments offers an
> outline of the tentative approach that FDA took in working with the
> first notification we received now more than a year ago. And also my
> intent is to highlight the areas that have raised questions vis‑a‑vis
> this tentative approach.
>
> Just to give some very quick context, I think we need to remember that
> FDAMA has been considered to have given us an alternative process or a
> fast track for nutrient content and health claims.
>
> In short, the situation is more or less that under the NLEA petition
> process, a petition is submitted by an interested party. FDA conducts
> a review of the scientific basis, usually in conjunction with a PHS
> agency. This then goes through notice and comment rulemaking and, in
> the end, there\'s an authorized claim.
>
> Under the FDAMA notification process, the scientific basis is
> established by the scientific body, not FDA, by the scientific body in
> an authoritative statement. A notification is submitted by an
> interested party and without prohibition on the part of FDA, the claim
> is authorized by the statute.
>
> As Mr. Lake mentioned, last year we went through the process of
> reviewing our first notification under the FDAMA provisions. The kinds
> of issues that have been raised fall into four broad groupings.
>
> First, can authoritative statements be generally characterized? What
> are the characteristics of authoritative statements? Second, what\'s
> FDA\'s role here? How should FDA interact with the scientific bodies?
> Third, what should be included in notifications? What are
> notifications to contain? And then last, how should we think about
> implementing regulations? At this point in time we do not have
> implementing regulations, so this is an issue on the table.
>
> For the moment, let\'s start our framework directly with some context
> on authoritative statements, and we have to keep in mind that
> authoritative statements are more or less the star of today\'s
> program.
>
> We know from the legislation that authoritative statements are
> statements from federal scientific bodies or the National Academy of
> Sciences that, as described in the legislation, are currently in
> effect about a relationship between a diet or disease or, in the case
> of a nutrient claim, about a nutrient level. They\'re published and
> they\'re not made by employees in their individual capacity.
>
> But the first question that\'s been raised by some is the question of
> whether all statements published by scientific bodies are
> authoritative. The legislation refers to authoritative statements, not
> just to statements, and FDA has tentatively proceeded with the
> assumption that not all published statements from these bodies are, in
> fact, authoritative statements.
>
> Not all agree with this interpretation, so we ask the first question:
> Are all statements from federal scientific bodies and the Academy
> authoritative?
>
> If, for the purposes of continuing and fleshing out the approach taken
> by FDA, we proceed in the direction that not all statements are
> authoritative, the next question we have is what distinguishes an
> authoritative statement from another statement? As I mentioned before,
> we have these four characteristics from the legislation itself. And
> while they\'re helpful, they don\'t appear to sufficiently distinguish
> among the various statements to allow a conclusion as to what is an
> authoritative statement.
>
> So in many ways, the pivotal question for us today is what are
> authoritative statements? Or perhaps more directly, how is it we know
> when we have an authoritative statement?
>
> Before we actually tackle questions on authoritative statements
> themselves, I want to backtrack just a little and talk about the
> process relative to these FDAMA provisions. As you\'ve heard from Mr.
> Lake, a notification concerning the use of an authoritative statement
> for a claim on a food is to be submitted to FDA 120 days before the
> intent to use the claim. The notification is to include or to identify
> the authoritative statement and to provide the exact wording of the
> claim.
>
> FDA can act to prohibit or modify the claim but in the absence of FDA
> action, the claim is authorized by statute.
>
> It would seem, then, that the first step in this whole process is more
> or less a kind of routine check‑in. FDA would look to see if all the
> pieces are there. Is there an authoritative statement? Is the source
> identified? Is there wording for the claim? And does the notification
> contain a balanced presentation of the scientific literature? This was
> required by statute.
>
> But the question is what happens next? From FDA\'s perspective, the
> scientific body is the best arbiter of whether its statement is
> authoritative. They are in the best position to determine when they
> have issued an authoritative statement.
>
> But the reality of the situation is that FDA has the notification in
> hand and it needs to know whether the statement is an authoritative
> statement. Our questions to you are how should we handle this? How
> should we get this needed input?
>
> After the passage of FDAMA, Secretary Shalala facilitated a channel of
> communication for FDA. Each federal scientific body was contacted and
> asked to provide a person with sufficient authority to speak for the
> agency; that is, to assist FDA in this effort. These persons formed
> the so‑called Liaison Group on Authoritative Statements. And in this
> afternoon\'s panel, which consists of these members of the Liaison
> Group, you\'ll hear from them directly.
>
> I just need to note as an aside that the legislation refers to
> scientific bodies and identifies these as federal agencies and as the
> National Academy of Sciences. It does not further clarify who these
> federal agencies might be, although it gives as specific examples CDC
> and NIH.
>
> The four federal agencies listed here are, at this time, the agency\'s
> best thinking as to the federal agencies that would constitute the
> scientific bodies under the FDAMA provisions. But, of course, this
> tentative conclusion is open for comment.
>
> The channel of communication, this Liaison Group of Scientific Bodies,
> is a first step when we begin to think about what is the next step?
> And during this initial first step, FDA also considered the benefits
> or the utility in identifying general characteristics of authoritative
> statements. It was considered that such a listing could be helpful to
> notifiers in identifying or distinguishing authoritative statements
> from other statements, but it was also well recognized that a listing,
> if it were to be done, a listing of general characteristics, had to be
> developed with the Liaison Group members; that is, with the scientific
> bodies.
>
> In the spring of 1998, the Liaison Group began to meet. The National
> Academy of Sciences, while a scientific body by legislation, is not a
> federal agency and therefore have not taken part in these Liaison
> Group meetings. However, we at FDA did meet with them separately and
> kept them informed about the Liaison Group activities.
>
> As I mentioned, you will hear from the Liaison Group members today,
> but I think it\'s fair to characterize these early discussions as
> open, with a great deal of give and take. The discussions were
> informal and the topics ranged from how to make this communication
> channel work to identifying general characteristics of authoritative
> statements.
>
> Some have characterized this effort, these discussions within the
> Liaison Group, as helpful. Others have considered them to be
> inappropriate, misguided and even heavy‑handed.
>
> The approach used in these discussions was to turn to the legislative
> history for the FDAMA provisions to better understand and perhaps to
> clarify the nature of authoritative statements. Through this process
> three characteristics were added to the general list already provided
> specifically within the statute.
>
> It was considered that a statement would have undergone a deliberative
> review. It was considered that a statement would not be about a
> relationship that was preliminary or inconclusive, and that the
> statement would reflect official policy.
>
> Concerning deliberative review, both the Senate and the House report
> highlighted a characteristic that they described as deliberative
> review. This characteristic was added to the list but it was not
> defined. Its definition, it was felt, was better left to each
> scientific body.
>
> Secondly, the House report indicated that authoritative statements
> would have presumption of validity and that more scientifically sound
> nutrition information would be provided to consumers. On this basis,
> not preliminary or inclusive was added as the general characteristic
> of an authoritative statement. But again no definition was attempted.
>
> Third, the legislative history indicates that authoritative statements
> should reflect consensus within federal scientific bodies and the
> statute identifies these statements as not coming from subdivisions of
> the federal scientific bodies, nor from individual employees. So the
> concept of official policy was added to the list but again without
> specific definition.
>
> As I believe you will hear from some of the scientific bodies this
> afternoon, experience that they have had in considering this during
> the last year has given them some pause about this concept of official
> policy and it may need to be reconsidered as a characteristic of an
> authoritative statement.
>
> These three added characteristics have been the subject of a great
> deal of discussion. Our questions today: Are these characteristics
> helpful to notifiers and to others? Are they appropriate?
>
> Some disagree they\'re appropriate. Some disagree that it\'s
> appropriate to link validity and scientifically sound to a
> characteristic of not preliminary or inconclusive. Others are
> concerned that reference to deliberative review and not preliminary
> forces into play the standard of significant scientific agreement.
>
> FDAMA makes reference to SSA or significant scientific agreement but
> not in the context of authoritative statements. FDAMA brings in SSA
> further along in the process and for the first notification, the
> issues we dealt with never got to the SSA point and the standard of
> SSA was not used.
>
> Nonetheless, SSA is a very controversial issue. But if you\'ll bear
> with me, we\'ll leave significant scientific agreement or SSA just for
> the moment and return to the question of the characteristics of
> authoritative statements.
>
> Having general characteristics of authoritative statements generally
> fleshed out, generally agreed upon, FDA considered whether there was
> utility and whether it was appropriate for FDA to conduct a kind of
> screen or sorting procedure relative to authoritative statements.
>
> Certainly the clear and desirable goal is to have the scientific
> bodies consider the statement, but question we had was was it possible
> for FDA to play some role and should we play some role?
>
> It\'s difficult to understand exactly what this type of screening
> might be without some examples, and so I have pulled from the first
> notification four examples.
>
> Submitted in the first notification was the statement identified as an
> authoritative statement for a health claim about chromium.
> \"Scientists must often draw inferences about relationships between
> dietary factors and disease from animal studies or human metabolic
> studies and population studies that approach issues indirectly.\" This
> was from the Surgeon General\'s Report.
>
> In looking at the statement, we could find no substance mentioned and
> no disease mentioned, so under the statute, the statement couldn\'t be
> considered an authoritative statement from our perspective.
>
> Our question is perhaps such a statement could be screened by FDA and
> there would not be a need to consult with a scientific body, but
> that\'s a question and it\'s a question at one end of the continuum.
>
> Another example from the first notification probably raises the
> question of preliminary or inconclusive. The statement, identified as
> an authoritative statement, began with the phrase, \"If the findings
> hold up in further research, eating more,\" and then goes on to
> discuss beta carotene from fruits and vegetables and cancer. Our
> question is could this be clearly in the domain of preliminary or
> inconclusive? Could it be screened?
>
> It gets somewhat more complicated with our third example from the
> first notification. A rather definitive sentence about anti‑oxidants
> and cancer, here bolded in white and submitted as the authoritative
> statement is followed immediately in the text, the publication, by a
> second sentence that says, \"Nevertheless, many important questions
> need to be answered before either micronutrient supplements or food
> fortification can be recommended as a cancer prevention strategy. The
> second sentence was not included in the submission.
>
> Our question is is this something that can be screened or does it need
> to go immediately to the scientific body which authored the statement?
>
> And then finally, at the far end of our continuum, is our fourth
> example. This is probably not a good possibility for a screen. It
> reads, \"High dietary carotene and possibly vitamins C and E and
> folate are associated with reduced risk of cervical cancer.\" It\'s
> about a diet‑disease relationship, it doesn\'t appear to be qualified
> and we\'re not sure that FDA could easily screen such a statement.
>
> Because it\'s acknowledged that the determination of whether a
> statement is authoritative rests with the scientific body, our
> question then is: Is a preliminary screen appropriate? It is useful?
> Is it possible? If so, could guidelines be developed for FDA? Could
> they address issues such as context? What is the situation? Those are
> our questions.
>
> As I\'ve mentioned, the scientific bodies later today will highlight
> how they see moving through these steps and how they see the approach
> to interacting within the Liaison Group. But perhaps at this point we
> need to emphasize that one of the most important questions we\'re
> raising today is how should or how can FDA best establish the working
> relationship with the scientific bodies, given that the regulatory
> responsibility is FDA\'s and the determination of whether the
> statement is authoritative rests with the scientific bodies?
>
> What are the options? Tentatively we have followed the route of direct
> communication. We\'re asking questions about the possibility of a
> screen.
>
> At the other end of the options continuum, there\'s a question of what
> if a scientific body is not interested or does not prefer to review
> each and every statement? What if they provide guidelines or general
> policy statements and it\'s the expectation that FDA will conduct the
> review? What should we do? How should we handle this? Is it
> appropriate?
>
> I want to move to the next phase of questions and please don\'t let
> this slide overwhelm you. It\'s only attempting to show that once we
> leave the box of determining authoritativeness, if that\'s a word we
> can use, other factors come into play. Once the decision is out of the
> box of the scientific body, the process returns to FDA and we have a
> number of questions all along the way.
>
> Obviously if the statement isn\'t authoritative, it\'s intended that
> FDA would prohibit the use of the claim, and the process ends. And,
> for the most part, that\'s what happened with the first notification.
> The process ended there.
>
> But if the statement is authoritative, the process continues down
> along the right and along the bottom of the continuum and it\'s
> possible that the issue of significant scientific agreement or SSA
> could arise.
>
> The FDAMA legislation provides that FDA may prohibit a claim if SSA is
> lacking. We note that it doesn\'t require that FDA determine SSA, only
> that it may prohibit on the grounds of lack of SSA. So at some time
> after a statement is determined authoritative, SSA could become an
> issue.
>
> We haven\'t had the opportunity to face this yet, so we have a lot of
> questions. What is the practical application of this provision? What
> is FDA to do? Is it desirable to request input from the scientific
> bodies on significant scientific agreement? I hope it\'s very clear
> that we\'re very interested in input on the procedures relative to
> this aspect of the provisions.
>
> At this point, though, we\'re finally entering the home stretch and
> it\'s this home stretch I\'d like you to consider now, down along the
> bottom of the schematic. These bring up procedural issues and they
> bring up comparisons to existing NLEA provisions for health claims and
> nutrient content claims. Most of these questions, these issues, go to
> the heart of what is needed for a notification, what should be
> included in a notification.
>
> As already provided for by FDAMA, the notification must identify the
> authoritative statement, it must provide the wording of the claim, and
> it must offer a balanced presentation of the scientific literature.
> One quick question we have is what is a balanced presentation? How
> should FDA use it? How should it be evaluated?
>
> But then moving along into existing provisions, how do we or should we
> incorporate existing provisions? Section 101.13 lays out principles
> for nutrient content claims. It talks about things such as claim
> location on the label and referral statements. How do these apply to
> FDAMA provisions?
>
> Section 101.14 for health claims gives certain definitions, plus it
> invokes disqualifying levels for the claim and the so‑called jelly
> bean rule. What\'s to happen with these provisions?
>
> Secondly, what is the best approach if the authoritative statement
> does not provide information on an effective level? What do we do in
> the absence of an effective level for the notified claim? Are such
> claims misleading to consumers if an effective level is not
> established?
>
> Third, what about the analytical method for compliance purposes?
> Certainly this is an important part of the regulatory framework. Is it
> likely that an authoritative statement would contain discussions of
> analytical procedures? What are we to do without this information?
> Who\'s responsible for it?
>
> And finally, last but certainly not least is the issue of the wording
> of the claim. The notifier is required to submit the wording of the
> claim, but what about the provisions of 101.14? Clearly under 101.14
> claim wording is an important concern. There\'s a desire not to
> mislead the consumer. Claims need to accurately reflect the science
> and allow consumers to understand the claim within the context of the
> total daily diet. How should this be done? How should the decisions be
> made? And how should the evaluation be carried out?
>
> In short, for this home stretch along the bottom, what are the
> approaches to be used? What about existing provisions? What\'s to be
> in a notification? In short, what\'s needed and who does it?
>
> My last set of questions for setting the framework are important
> questions with very broad impact. The first is, as I\'m sure many of
> you know, FDAMA provides, in the case of health claims, only for
> conventional foods. FDAMA does not extend health claims for
> authoritative statements to dietary supplements.
>
> FDA has proposed to extend the idea of a level playing field and has
> proposed to expand the FDAMA provisions to dietary supplements. The
> comment period for this proposal closed April 6 but still today these
> issues are ones that we\'re putting on the table for discussion.
>
> Second, given the statutory language and some legislative history, FDA
> has taken the tentative approach that the FDAMA notification process
> cannot be used to modify existing claims. We\'d like your input on
> this issue.
>
> And then thirdly, the legislation is silent on whether the
> notification should be made public when received or whether it should
> be considered confidential. FDA has not made a decision on this but
> clearly we will have to soon, and again we encourage your input.
>
> If I could have the lights up, that, more or less, bring to close this
> framework. We are certainly interested in hearing today\'s discussion.
> Admittedly, we\'ve put out a large set of complicated questions, but
> we think these are very important questions, so we look forward to
> today\'s input. And thank you.
>
> \[Applause.\]
>
> MR. LAKE: Thank you, Chris. I think that does a nice job of laying out
> the issues or the framework for the further discussion.
>
> Let me remind you that we have had available when you came in cards on
> which you can ask questions. We\'ve come to a point where you have the
> opportunity to ask questions you may have at this time. I guess we
> have people who collect the cards. Yes, here they are.
>
> As they are doing that, I failed to mention at the beginning that FDA
> is making a transcript of the entire meeting. Also one of you has
> asked to videotape the meeting and so we have someone doing that, as
> well. The transcript is ours. I\'m not sure who owns the videotape but
> one of you out there does.
>
> **QUESTIONS FROM THE AUDIENCE**
>
> MR. LAKE: We actually did bring our lawyer and I think this first
> question may be for him or some combination. She wants to be sure, I
> think, that I don\'t refer all the questions to she and David, so I
> will move over to the other microphone as they consult on the answer
> to the first question.
>
> Do we have other questions that people want to bring forward at this
> time? Well, we\'ll respond to this one and then take others as they
> come.
>
> DR. LEWIS: The question is we\'re not quite sure but about the federal
> agencies not represented on the initial list of Liaison Group, such as
> NASA, the Veterans Administration and the Department of Agriculture.
>
> I guess just to clarify, we\'ve certainly included in the four federal
> agencies tentatively the U.S. Department of Agriculture. The statute
> provides for federal scientific bodies that have responsibility for
> human nutrition or human nutrition policies, I believe. In fact, we
> can read it.
>
> \"Scientific body of the U.S. government with official responsibility
> for public health protection or research directly relating to human
> nutrition, such as NIH or CDC.\"
>
> The question here is why‑‑I think the question is why have we not
> included NASA, the National Aeronautics and Space Administration, or
> the Veterans Administration.
>
> Again as we\'ve mentioned, all of this is open for comment, but our
> initial read was that these agencies likely were not ones directly
> responsible for human nutrition research or nutrition policy. But
> again we\'re open for comment.
>
> MR. LAKE: We do have another question.
>
> DR. LEWIS: The question we have here is how is \"employee\" defined?
> Is an expert who\'s been hired to conduct scientific research an
> employee?
>
> I think this is an interesting question but it\'s also a question that
> is largely in the domain of the scientific bodies and I would probably
> defer that to them.
>
> I think the statute is indicating within the context of the statute
> that there\'s a great deal of interest in it being from the scientific
> body and not therefore some employee of the body speaking. Whether
> this is someone hired by the agency I think is also open for further
> discussion.
>
> I don\'t think I see or we see FDA making this call. This would be
> something that the scientific body would have to indicate. It\'s
> difficult for us to tell, for instance, when something published under
> someone\'s name is, in fact, representing some policy decisions by the
> agency or whether it\'s the individual\'s own statement.
>
> This, by the way, is David Dorsey from our Office of Chief Counsel.
> And, of course, interpreting the statute always requires at least one
> lawyer, and he\'s been very active in this process.
>
> MR. DORSEY: This poses three questions. The first is were the meetings
> of the Liaison Group FACA meetings or meetings subject to the Federal
> Advisory Committee Act and were they open to the public?
>
> The answer to that was we would say no. The only attendees at that
> meeting were representatives of federal agencies and therefore they
> wouldn\'t have been subject to FACA, I believe. We didn\'t make
> transcripts, so those can\'t be made available. There was no person
> there transcribing them.
>
> And will such meetings be subject to FACA in the future? Again I think
> the answer is no, they wouldn\'t be subject to FACA. Whether they
> would be open is certainly, I guess, a question and we\'d like to hear
> input about that from people.
>
> DR. LEWIS: One of the questions I have is could you comment on the
> kinds of publications that could carry authoritative statements?
>
> It\'s one of the reasons we have the panel, the scientific body panel
> with us today, is that we feel that it\'s the individual agency\'s
> decision both as to what they\'ve done in the past that could be
> authoritative statements and how they wish to handle the future of
> authoritative statements. So I would defer this question to them later
> on.
>
> And likely another question that says shouldn\'t the scientific body
> set aside a specific publication that could be used as the basis for
> claims? I think this is an interesting question. It\'s really a
> two‑pronged issue in that how scientific bodies might deal with
> authoritative statements in the future is one set of questions, but
> how we deal with existing publications now‑‑that is, statements made
> in the past‑‑is another.
>
> Again I would take this question, shouldn\'t the bodies set aside
> publications for authoritative statements, and defer that for their
> discussion later on.
>
> MR. DORSEY: This question says, \"Ms. Lewis stated that the
> legislation does not require FDA to determine SSA affirmatively but
> does provide that FDA may prohibit a claim if there is not SSA. Where
> does the legislation provide that?\"
>
> Okay, this has specifically just to do with health claims and Section
> 303 of FDAMA included‑‑added two provisions to Section 403(r)(3).
> Those were provisions (C) and (D). And (r)(3)(D) states the
> following‑‑well, (C) was the provision that provided for the
> notification process based on authoritative statements from scientific
> bodies.
>
> And Section 403(r)(3)(D) or 21 U.S.C. 343(r)(3)(D) states, \"A claim
> submitted under the requirements of clause (C) may be made until such
> time as the Secretary issues a regulation under the standard in clause
> (B)(i).\"
>
> And clause (B)(i) reads as follows: \"The Secretary shall promulgate
> regulations authorizing claims of the types described in subparagraph
> (1)(B)\"‑‑those are health claims‑‑\"only if the Secretary determines,
> based on the totality of publicly available scientific evidence,
> including evidence from well designed studies conducted in a manner
> which is consistent with generally recognized scientific procedures
> and principles, that there is significant scientific agreement among
> experts qualified by scientific training and experience to evaluate
> such claims, that the claim is supported by such evidence.\"
>
> So the FDAMA provision itself referenced the significant scientific
> agreement standard articulated in 403(r)(3)(B)(i) and stated that the
> Secretary or FDA may issue a regulation prohibiting or modifying a
> claim based on using that standard.
>
> DR. LEWIS: I didn\'t say all of that but, in fact, that\'s the
> derivative of how we\'re able to say that significant scientific
> agreement is an issue in FDAMA.
>
> I have a question about how have the four federal agencies reacted to
> the idea of being asked the direct questions. I\'m assuming that\'s
> the question that they also would want to answer, but I would just
> indicate that vis‑a‑vis the Secretary\'s letter to the agencies, we
> received very prompt input from the four federal agencies and were
> immediately given the contact person to form the Liaison Group.
>
> They all attended the meetings and when they could not personally
> attend, did send substitutes and took active part in the discussions.
>
> So I guess if I were to characterize the reaction to this, I would say
> they were cooperative and interested. For further individual comments
> I would suggest again we hold this to this afternoon when the
> scientific bodies are present.
>
> MR. DORSEY: This is a question that reads, \"Can
> qualified\"‑‑underlined‑‑\"health claims be made that accurately
> reflect an authoritative statement which describes a relationship that
> is not conclusive?\"
>
> Of course, as Dr. Lewis described, FDA\'s tentative approach was that
> a statement that describes the scientific evidence about a
> relationship as preliminary or inconclusive wouldn\'t be an
> authoritative one. But assuming that\'s not the case, which I suppose
> is the premise of the question, it\'s really asking, I think, a
> question about Pearson, Pearson versus Shalala, a case that many of
> you I\'m sure are aware of. And that certainly wasn\'t our initial
> approach and we\'re interested in hearing people\'s reactions to this
> further.
>
> I guess all I can say for now is that the agency is discussing how to
> react to Pearson with the Department of Justice, and those discussions
> are on‑going. And currently, at least, Pearson didn\'t apply to
> conventional foods and authoritative statements or health claims based
> on authoritative statements are currently authorized‑‑I\'m
> sorry‑‑health claim based on authoritative statements are currently
> authorized only for conventional foods. Therefore, we don\'t believe
> the Pearson decision applies in that context directly. But I\'m sure
> we\'ll hear more comment about it later as the day proceeds.
>
> DR. LEWIS: I have two questions that while they aren\'t exactly
> related, I think I can more or less answer at the same time.
>
> \"Could you please describe who or what people and offices within
> CFSAN review the notification, conduct the check‑in and make the final
> decision after consulting with the liaison groups? And does FDA
> possess adequate resources to implement FDAMA with respect to existing
> claims\"
>
> In the case of the offices involved within CFSAN, it\'s, of course,
> the Office of Special Nutritionals in conjunction with the Office of
> Food Labeling that conducts the review and a check‑in. The staff will
> vary depending on the nature of the issue and staff resources.
>
> I suppose does FDA possess adequate resources to implement FDAMA is
> one of those questions I think we get 40 times a day, 100 times a
> year, and the answer is always the same. We are doing the best that we
> can.
>
> Certainly there is a statutory hammer on this and when that happens,
> we work very hard to complete this process in a timely manner.
>
> I also have a question that says, \"Dr. Lewis said that the
> determination of what is authoritative rests with the scientific body.
> For the sake of consistent policy and since FDA has been authorized to
> administer FDAMA, shouldn\'t FDA be the ultimate arbiter?\"
>
> These discussions are interesting, specifically I think when the
> scientific bodies begin to talk about this process. I think the clear
> intent of FDAMA was to provide an alternative approach for the
> scientific review component of health claims and, to a certain extent,
> nutrient content claims that was conducted by FDA.
>
> The statute indicates that the scientific basis could be established
> by others, specifically relevant federal agencies and the National
> Academy of Sciences, and that this scientific basis should be the
> basis for a claim if appropriate. That\'s not to say FDA doesn\'t have
> responsibilities around this in a regulatory mode, but it is evident
> that FDAMA intended that scientific review could be conducted
> elsewhere.
>
> So the issues for us today are not what FDA should do relative to the
> scientific basis but how FDA should interact so that the outcome, an
> appropriate claim, is conducted in a way that\'s consistent with the
> statute.
>
> MR. DORSEY: This question reads, \"What language in Section
> 403(r)(3)(C) does FDA rely upon to support the agency\'s assertion
> that an authoritative statement must contain a balanced presentation
> of scientific literature?\"
>
> Let me just clarify. I don\'t believe FDA\'s ever asserted that the
> authoritative statement must contain a balanced presentation of
> scientific literature. Rather, what we believe is that the statute
> requires that the notification of a claim based on the authoritative
> statement must include such balanced presentation of scientific
> literature.
>
> And that can be found in 403(r)(C)(ii)(III), where it says, reading it
> slightly‑‑I\'ll try to pull it out‑‑a person has to submit to the
> Secretary at least 120 days before the first introduction in
> interstate commerce of the food with the label containing the claim a
> notice, a copy of the statement referred to in subclause I, a copy of
> the authoritative statement and 3, a balanced representation‑‑it\'s
> not presentation but representation‑‑of the scientific literature
> relating to the relationship between a nutrient and a disease or
> health‑related condition to which the claim refers.
>
> And there\'s a parallel provision in 403(r)(2)(G) with respect to
> nutrient content claims based on authoritative statements.
>
> MR. LAKE: I\'m going to give Chris and David a break because I
> actually got one question that I think I can answer, so you can be
> looking at the others.
>
> This is an interesting question, actually. I will read it. \"Has a
> user fee arrangement been considered whereby applicants would pay a
> fee for the notification review process?\" And, of course, the statute
> certainly does not provide for anything like that at the present time.
>
> If you have been following, though, budget discussions and what‑not,
> you know that the administration is pursuing user fees in areas where
> user fees have not been pursued before, particularly with regard to
> things where the industry actually can get some benefit; i.e., you\'re
> asking the agency to do something, are wiling to pay for the resources
> to have that consideration.
>
> The idea of user fee in FDAMA actually came up in two places. One, the
> Prescription Drug User Fee Act was reapproved. That\'s the major user
> fee provision relating to drugs. Also there was consideration of user
> fee in the context of a premarket notification system for food
> packaging materials. That was agreed to by the Senate. It was not
> agreed to by the House, so it did not become a part of FDAMA, but
> there is an on‑going reconsideration for whether that should be
> included in the future.
>
> Also there have been broader considerations of perhaps premarket
> approval for food additives.
>
> I have not heretofore heard the issue of user fees raised in the
> context of health claims, but if there is any interest in exploring
> that, I think we would be open to that discussion.
>
> DR. LEWIS: I have a question that I really like. I think it goes to
> the heart of the kinds of mechanistic issues we\'ve been wrestling
> with. I think there are, in the last year on this FDAMA notification
> process, there have been very deep philosophical discussions and very
> mechanistic discussions, all of which have very broad ramifications.
>
> This question is, \"Does FDA intend to notify the submitter if it does
> not intend to modify or prohibit the submitted claim?\"
>
> I can\'t tell you the hours of discussion we\'ve had trying to decide
> procedurally what to do. Certainly I mentioned earlier the idea of are
> in‑coming notifications confidential? Should they be put in a public
> docket? If they\'re in a public docket, 120 days ticks by and the
> question is at the end of 120 days if there\'s no action, what does
> this mean?
>
> So I think this question, \"Does FDA intend to notify the submitter if
> it does not intend to modify or prohibit the submitted claim?\" is the
> tip of the iceberg of a lot of questions about how we deal with this.
>
> If a claim is authorized by statute in the sense that we do nothing,
> both how does the notifier know that 120 days has passed and nothing
> terrible is happening? On the other hand, how does the world at large
> know?
>
> We haven\'t resolved these questions. We haven\'t gotten to that
> process and it\'s certainly something we need to know for implementing
> regulations. So we\'re interested in these discussions today.
>
> MR. DORSEY: This poses three questions. \"Does FDAMA apply to medical
> foods? If not, why not? And if not, do you see that changing any time
> in the near future?\"
>
> I guess I can answer the first two questions as a lawyer. The third
> one is in some sense more question for policy people or maybe even
> Congress.
>
> But \"Does FDAMA apply to medical foods?\" I think the answer is no
> and the reason would be that FDAMA‑‑both Sections 303 and 304 of FDAMA
> amended 403(r), added provisions to paragraph 403(r) of the Act and
> 403(r)(5)(A) states that this paragraph does not apply to infant
> formulas subject to Section 412(h) and to medical foods, as defined in
> Section 5(b) of the Orphaned Drug Act.
>
> So the statute, by its terms, doesn\'t make the health claim
> provisions apply to medical foods, and so the FDAMA amendments
> themselves wouldn\'t, either.
>
> And then as to whether that could change, I think because it\'s in the
> statute, it appears that it would be up to Congress to make that
> change.
>
> DR. LEWIS: I have a question that reads, \"Given the dynamic realities
> of the information age for both the government and the public‑private
> sector, i.e., the Internet and e‑commerce, how do you see the process
> of cybersourced statements based upon either early published studies,
> peer‑reviewed, or federal agency authoritative source statements based
> upon SSA?\"
>
> I\'m not quite sure I understand the question but perhaps it\'s going
> to a couple of points. One is I think could an authoritative statement
> be published in the sense of being on the Internet? What does to be
> published mean? And certainly in our first attempts to consider
> implementing regulations, the question of what is published came up.
>
> Pulling something from the Internet, does that fall into the category
> of published? There are a number of groups, I think, that are taking a
> look at what the Internet means and how this might impact on us is
> something that we\'ve not yet resolved.
>
> The second part of the question‑‑
>
> MR. LAKE: Chris, could I maybe just make a comment there, too? I think
> there\'s also an issue about to what extent it is possible to construe
> certain information that manufacturers might put up, say on a web
> page, might be considered as labeling, as opposed to advertising.
>
> That is an issue that the agency is considering very broadly in the
> context of all FDA‑regulated products and are also discussing with the
> Federal Trade Commission and it would be my expectation that some
> policy will be proposed on that in the not too distant future. It is a
> very interesting question, however.
>
> Go ahead, Chris.
>
> DR. LEWIS: The second part of the question concerning early published
> studies, as opposed to statements based on SSA, I think for us, the
> issue is has a federal scientific body or the Academy issued an
> authoritative statement. Whether the statement is based on significant
> scientific agreement or early or published studies goes to the heart
> of what is an authoritative statement, and those are the questions
> we\'re asking today.
>
> So I think the latter half of this question is certainly one that
> we\'re not equipped to answer yet.
>
> A question that I have here is, \"Will there be or does a mechanism
> exist whereby data may be submitted to a scientific body in order to
> generate a claim that is submission of a study or studies conducted in
> Europe or elsewhere?\"
>
> Again you\'re in a domain that we\'re out of. How a federal scientific
> body or the Academy would want to go about its scientific reviews, how
> it would want to issue statements is something we can\'t address and
> one of the reasons we have the scientific body panel this afternoon.
>
> I would also indicate that the purpose, I suppose, for submitting data
> to this group would not be to generate a claim but to generate an
> authoritative statement that then could be put in a notification for a
> claim.
>
> One question is, \"Has there been any thought or concern on how the
> use of health claims would be regulated by the FDA? The concern
> relates to the vast amount of claims that are being made by companies
> for their products that are clearly making drug claims\" and
> something‑‑the comment goes on.
>
> MR. DORSEY: \"The concern relates to the vast amount of claims that
> are being made by companies for their product that are clearly drug
> claims and little to nothing is being done at this point to stop these
> claims from being made.\"
>
> DR. LEWIS: I think we need to be careful that we don\'t mix authorized
> health claims with structure‑function claims, and I\'m not suggesting
> that this person was doing this. Claims on food labels that are health
> claims are authorized by the agency and they are only specific claims.
> They\'re preauthorized by the agency.
>
> So how the use of health claims could be regulated by FDA, that\'s how
> we regulate them. They are authorized.
>
> To the extent that we\'re able to locate and identify unauthorized
> claims, we do take action. Admittedly our resources aren\'t as cushy
> as we\'d like them to be and I\'m sure some things fall through the
> cracks, but we do have authorized claims and we do recognize that
> there are unauthorized claims and we do try to take actions against
> them.
>
> MR. DORSEY: This question says, \"How does FDA plan to deal with
> changing authoritative statements, given that the direct link to
> scientific bodies but also the likelihood that scientific thinking on
> a particular matter will evolve?\"
>
> I think it may be that one reason Congress added 403(r)(3)(D) and
> 403(r)(2)(H), which allows the Secretary or FDA to issue a regulation
> prohibiting use of a claim, is if the scientific evidence has changed
> to such a degree that it warrants prohibiting the claim, then the
> agency would be authorized to do so.
>
> So that may be at least a partial response to that question.
>
> DR. LEWIS: I have a question that reads, \"Does the all‑or‑nothing
> status of the significant scientific agreement criterion serve the
> public well? It fails to communicate the uncertainties that always
> exist and makes it difficult for the government to change its mind in
> light of evolving science. Would a numerical rating system serve us
> all better?\"
>
> I think in order to answer this question I have to go back to the
> original provisions for health claims. And FDAMA, if you\'ll recall,
> does not really, in effect, change the end point of a health claim‑‑a
> health claim is a health claim is a health claim‑‑but instead changes
> the process by which a health claim is authorized.
>
> The question that it fails to communicate the uncertainties that
> always exist and makes it difficult for the government to change its
> mind‑‑during the original discussions on health claims, there was a
> great deal of interest in making sure that these claims were stable
> over time. In fact, the purpose of the significant scientific
> agreement standard is to ensure that these claims would remain stable
> over time because there was a great deal of concern that changing
> claims on labels only undermines the consumer\'s belief that certain
> things could be done for their health and also belief in the
> credibility of the label.
>
> I think that\'s why significant scientific agreement is a fairly
> difficult, albeit not impossible, end point to reach, that the purpose
> is that the government would not have to change its mind periodically,
> that it should not reflect evolving science but should, in effect,
> reflect solid science.
>
> Now the question also goes to the heart of well, nothing is ever known
> for sure, and that\'s why the wording is \"may reduce the risk.\"
> There was clear effort to make sure that the public did not believe
> this was a magic bullet. That\'s why the claim needs to be set in the
> context of the total daily diet and qualified in any way that\'s
> appropriate, so the consumer understands that they\'re reducing their
> risk but not an absolute.
>
> I\'m not sure that\'s exactly the answer to the question that the
> questioner was looking for but the purpose of health claims was
> ultimately certainly not that they would change and have to be
> responsive to emerging science. They aren\'t intended to reflect
> emerging science under the current provisions.
>
> Is this my question? I guess it is. \"Will FDA accept authoritative
> statements published prior to the effective date of FDAMA?\"
>
> Absolutely. There\'s nothing in the provisions that talks about dates
> of this, other than currently in effect. And again the issue is those
> four points for authoritative statements: currently in effect,
> published about a disease relationship and not an individual.
>
> We have had discussions in the Liaison Group and you\'ll be able to
> talk with them later this afternoon about what \"currently in effect\"
> means and we did feel, through those discussions, that that\'s
> something that\'s up to the individual agency. FDA probably cannot
> determine when something is currently in effect.
>
> FDAMA doesn\'t grandfather anything forward or backward. It simply
> makes the provision \"currently in effect.\" So if it was issued 10
> years ago and the agency still considered it‑‑the scientific body
> still considers it currently in effect, then it\'s currently in
> effect.
>
> MR. LAKE: Is that all the questions?
>
> DR. LEWIS: I believe that\'s all we have, yes.
>
> MR. LAKE: Okay. Well, let me first thank the audience for asking a
> number of very good questions. I assume as the program goes on some of
> these questions or the panelists will shed light on some of these
> questions and there will be a further for you, two other further
> opportunities, actually, to ask further questions.
>
> Let me also thank my fellow panelists for doing the heavy duty
> answering. They certainly sounded like thoughtful answers to me, so I
> appreciate that.
>
> At this time we will take a break and we will reconvene at 10:00.
> Thank you.
>
> \[Recess.\]
>
> MR. LAKE: Mr. Levitt has not yet arrived, so I think what we will do
> is go ahead and begin with the panel and when Mr. Levitt does appear,
> we will bring him to the podium.
>
> **COMMENTER PANEL PRESENTATION**
>
> MR. LAKE: Thank you for returning promptly. We will go ahead and go
> with hearing from our very distinguished panel. In fact, they\'re so
> distinguished that the only way we could figure out how to
> appropriately order them is to simply do it by alphabetical order, so
> we are doing that.
>
> We are asking each of the panelists to talk for 10 minutes. I will
> send a signal at about eight minutes, if I may, to let you know that
> your time is nearing the end. And at the end of that we will have a
> further opportunity for one, a panel discussion and also for questions
> from the audience.
>
> And again when Mr. Levitt arrives we will, after the completion of
> whoever is talking, go ahead and bring him to the podium.
>
> Why don\'t we go ahead and begin? The first speaker is Dr. Annette
> Dickinson from the Council for Responsible Nutrition.
>
> DR. DICKINSON: Thank you, Mr. Lake, very much. We appreciate being
> here.
>
> The Council for Responsible Nutrition is a trade association
> representing the dietary supplement industry. We have about 100 member
> companies ranging from bulk ingredient suppliers to finished product
> manufacturers and ranging from manufacturers of national brand
> products to manufacturers of those hundreds of different brands of
> store brands of products that you see in your supermarkets, drug
> stores and health food stores.
>
> Our member companies distribute their products through the mass
> market, health food stores, direct sales and mail order.
>
> We are committed to working cooperatively with FDA to resolve
> regulatory issues and we are pleased to have been invited to
> participate in this public meeting to discuss FDAMA health claims.
>
> CRN submitted extensive comments to FDA generally supporting the
> FDA\'s denial of the nine health claims submitted by petition in 1998
> while, at the same time, expressing strong concerns about some of
> FDA\'s approaches to evaluating those claims.
>
> FDAMA authorizes health claims, as we know, based on authoritative
> statements of scientific bodies. In its 1998 guidance document and
> also in the decision on denying health claim petitions, FDA appears to
> be unduly limiting its definition of scientific bodies and appears to
> greatly expand the congressional requirements for authoritative
> statements.
>
> FDA indicates that NIH and CDC would qualify as scientific bodies, as
> specified by FDAMA, but implies that the individual institutes at NIH
> may not. If I misunderstand this provision, I apologize, but this is
> my reading of the guidance.
>
> This is contrary, I believe, to the mission statements and to the
> expectations of the individual institutes, which are, in fact, the
> bodies recognized as authorities in their respective fields of
> research and policy at NIH.
>
> Further, it is the mandate of those institutes to produce educational
> information for consumers and health professionals and for use in
> policy situations.
>
> FDA should therefore recognize the individual institutes at NIH as
> scientific bodies for purposes of FDAMA.
>
> CRN believes that an authoritative statement is one that is made
> publicly by a scientific body with the intent that consumers and
> health professionals will rely on it. As emphasized by FDAMA, it is
> obviously not the statement of an individual, but a statement to which
> the scientific body has lent its authoritative support and the support
> of its expertise and reputation.
>
> There was clearly no intent in FDAMA that anyone be allowed to put
> words into the mouth of a scientific body with which it might not
> agree or to take any statement made by that body out of context.
> Therefore, the statement must be one that the scientific body made
> intentionally for public advice and it must be considered thoroughly
> in context.
>
> However, a scientific body, we believe, should not be invited by FDA
> to decide whether a statement is authoritative because under those
> circumstances, the body might be tempted to decide that a statement is
> authoritative under most circumstances and in the context of their
> educational information, but for one reason or another not
> authoritative in its opinion for purposes of FDAMA health claims.
>
> We are concerned that FDA\'s proposal to ask scientific bodies to
> affirm that certain statements are authoritative invites them to do
> exactly that.
>
> In its guidance document and in its response to the 1998 petitions,
> FDA adds three new requirements, as Dr. Lewis mentioned, to those of
> FDAMA in determining which statements are authoritative. FDA say the
> statements must have undergone deliberative review, must reflect the
> official policy of the body and must not relate to preliminary or
> inconclusive evidence.
>
> CRN believes these requirements all go too far. Instead, it should be
> sufficient that the scientific body has relied upon its own internal
> processes to arrive at an authoritative statement consistent with the
> manner in which it normally produces information intended for
> education and the guidance of consumers, health professionals and
> policy‑makers.
>
> It is inappropriate for FDA to establish any separate requirement
> regarding the manner in which each scientific body reaches its own
> conclusions.
>
> If a scientific body views the evidence on a diet‑disease relationship
> to be persuasive, even though inconclusive, then FDA should accept the
> possibility that an authoritative statement could be made about that
> fact. In such a case, the petitioner who wishes to use the claim
> should, of course, include the full statement, complete with
> qualifiers.
>
> The recent Pearson versus Shalala decision by the Court of Appeals
> requires FDA to give consideration to qualified health claims for
> dietary supplements under NLEA and it should also apply to
> consideration of FDAMA claims, we believe
>
> This would not, of course, allow a statement to be taken out of
> context or used without the appropriate qualifying language expressed
> in the original statement. For example, it is conceivable that an
> appropriate scientific body might conclude in the near future that
> although more research is needed, there is sufficient evidence to
> justify a recommendation that consumers use supplements and fortified
> foods containing RDI amounts of folic acid and vitamin B‑12 to lower
> homocysteine levels and potentially, potentially underlined, reduce
> the risk of heart disease.
>
> If this statement were published as a conclusion or recommendation by
> a scientific body, then it should be eligible as the basis for a FDAMA
> health claim, with the qualifications included.
>
> In making its final determinations on NLEA health claims for dietary
> supplements in 1994, FDA made the decision that there should be a
> level playing field for dietary supplements and for conventional foods
> and that the same rules and procedures should apply to both.
>
> The Commission on Dietary Supplement Labels agreed with that
> determination and CRN fully supports it.
>
> Therefore, it is appropriate, as FDA has already proposed in proposed
> regulations, that the same procedures for FDAMA health claims should
> apply to dietary supplements, as well as to conventional foods.
>
> I\'d like to address one more issue just briefly and that is the issue
> of a dietary supplement advisory committee in the priority‑setting
> meetings last summer. CRN has testified there and in other locations
> about the importance of a dietary supplement advisory committee that
> FDA could use in making decisions about health claims or any other
> issue relating to dietary supplements, and I\'d like to reiterate the
> importance that we put on the existence of a dietary supplement
> advisory committee with appropriate expertise to help FDA deal with
> these issues.
>
> Thank you very much.
>
> MR. LAKE: Thank you, Annette, both for the content and the fact that
> you actually saved Joe a little bit of time here.
>
> Let me next introduce the director of the Center for Food Safety and
> Applied Nutrition. He has long experience with FDA, beginning in the
> General Counsel\'s Office, working later in the Commissioner\'s
> Office, came to CFSAN from the Center for Medical Devices. He\'s
> getting close to a year and a half now at CFSAN.
>
> He is very engaged, a quick study. He\'s become very interested in the
> whole area of health claims and gotten obviously involved in
> authoritative statements.
>
> So without taking any further time of his, let me introduce Joseph
> Levitt.
>
> **OPENING REMARKS**
>
> MR. LEVITT: Thank you very much. I apologize for the tardiness of my
> arrival and I thank you for going on with the program and fitting me
> in.
>
> However, I would like to just take a step back and just anticipate, as
> if I were the first speaker and somehow had the physical capability to
> get downtown at a decent hour, and just try to generally set the stage
> for this meeting‑‑why we\'re having it, what we\'re hoping to get out
> of it, what we encourage all the speakers to be doing today.
>
> Number one, I think it\'s important just to note that I was not
> personally involved in any of the FDAMA negotiations, the discussions
> on the Hill with respect to the food provisions. I was actually quite
> involved with the medical device provisions but they\'re really
> largely separate and divorced from this.
>
> But I think as we approach any law, implementation of any law, we
> really have to start with what does the law say on its face and what
> additional guidance does Congress give us in the legislative history?
>
> There is always a temptation for those who were involved to say, \"I
> was there and I know what this really meant. And we were all there‑‑I
> wasn\'t personally but many of us were there and many of us were there
> and we all know what it really meant.\" But the way the system really
> works is Congress tells us what they really meant and they guide us in
> the legislative history for what else they really meant, and a lot of
> the other stuff around that is really kind of distant. We need to kind
> of exert, I think, some discipline and tie ourselves to what does the
> law say, what does the legislative history say, and how do we go from
> there? I think that\'s point number one.
>
> Point number two is that the Center has tried to implement this
> provision of the law. We came out within the first spring, as
> everybody knows, with a guidance document on this particular
> provision. We also came out with‑‑I don\'t know if we called it
> actually an interim rule, an interim final rule on the first set of
> notifications.
>
> Frankly, our preference would have been to have had more time back
> then for stakeholder input, but the timing and everything was such
> that we just didn\'t have it, so we did the best thinking that we
> could on our own.
>
> We\'ve gotten a lot of comments on both the guidance and the first set
> of Federal Register notices. And I guess I would call the reaction
> kind of quite mixed. There are some groups that strongly favor the
> approach we took. There\'s also a considerable number of people and
> comments that think we have pointed too far in one particular
> direction.
>
> And when we saw that, I said we did the best we could without public
> input; let\'s pause and let\'s open up the process. I\'m very much in
> favor of what I think of as participatory policy development. I think
> the developing regulatory policy that really works includes a
> meaningful involvement from stakeholders, and that\'s why we\'re
> having this today.
>
> So the first thing I would ask today, as I\'m sure people will, is to
> really come in with your best ideas and views of how we ought to be
> implementing that provision. And I have every confidence that
> everybody will do that.
>
> The second one is a little harder. The second request I have is not
> just to focus on your own comments but listen to those that differ
> from yours. You\'ll actually find yourself feeling a little more like
> we feel because you will hear comments from this side and comments
> from that side and it will not be so easy to say, \"All right, we had
> this meeting; now it\'s clear.\"
>
> What we want is for today\'s comments to really help inform us on the
> best way to go forward. We don\'t have to come out with consensus.
> That\'s not by any means a needed objective. If it happens, that\'s
> great, but sometimes by getting everybody together and listening to
> each other we can see a little more of how these differing points of
> view maybe can mesh in some ways. And I think we should be looking for
> those opportunities but recognize that we\'re going to have to think
> for those opportunities because coming in and looking at the comments,
> I can\'t say it\'s entirely obvious, to me, anyway.
>
> So I think we have to all come with an open mind. I can assure you
> that FDA will come with an open mind and will hope very much that this
> day provides us with a foundation with which we can move forward and
> have, as Dr. Henney\'s top priority for the agency has said over and
> over, full implementation of FDAMA both to the letter of the law and
> to the spirit of the law.
>
> I think the last thing I would ask, and it\'s kind of hard in a big,
> public room like this‑‑you know, we\'re up and everybody\'s got
> microphones and there\'s a video camera out there and somebody\'s
> transcribing the meeting. It feels very formal. And that\'s okay; it
> is a formal setting in a way that it helps define the rules of
> engagement, just in terms of how we proceed.
>
> But I really would urge people to be open, even within this setting,
> to be open, to be candid. It\'s okay for this to be a working session
> and for us to move the agenda forward to the extent that we can in
> this kind of session.
>
> But overall, I think that we can only benefit by all coming together
> and hearing the different points of view, coming back to what the
> statute says, what the legislative history says, what fundamentally is
> in the best interest of American consumers.
>
> I think that we all recognize that the authoritative statement
> provision of FDAMA is one piece of a broader framework of how we\'re
> going to get good health information to consumers. We want it to be
> reliable. We want it to be information that consumers can reasonably
> act on. And there\'s a long history of trying to provide this,
> starting with NLEA, and FDAMA is very much, I think, a progression
> along that direction.
>
> So I think final thing is in addition to what the statute says, what
> the legislative history says, what the different points of view say,
> is how we\'re going to take this and really make into what is in the
> best interest, what is going to provide the most benefit to the
> American consumers.
>
> With that, I thank you very much and I will gladly turn the program
> back to Mr. Lake. I will be able to stay for much of the remainder of
> the morning but will need to sneak out at some point for the rest of
> the other activities that I need to be involved in today.
>
> Thank you very much for coming. I think this is an excellent turn‑out
> and I\'m pleased to see the panelists we have.
>
> \[Applause.\]
>
> MR. LAKE: Thank you, Joe.
>
> **COMMENTER PANEL PRESENTATIONS ‑ CONTINUED**
>
> MR. LAKE: Now we will pick up with our panelists and the next speaker
> is Mr. Michael Ford from the National Nutritional Foods Association.
>
> MR. FORD: Thank you. The National Nutritional Foods Association, NNFA,
> wishes to thank you for inviting me here to speak this morning as a
> member of this panel. As the token male on the panel I especially
> appreciate it. I\'m used to that sort of thing.
>
> NNFA represents close to 3,000 health food stores and about 1,000
> suppliers and distributors of natural products, including health foods
> and dietary supplements and natural ingredient cosmetics and, as such,
> our members have a vital interest in communicating scientifically
> established relationships between their products and health‑related
> conditions.
>
> I want to focus on five issues this morning in my comments. Basically,
> to tell you what I\'m going to tell you, we support the idea of the
> FDA clarifying just exactly what these authoritative statements are
> meant to be. Secondly, we urge you to look at the plain language of
> the Act as your best guide. Third, we\'d like you to consider a little
> broader definition perhaps of allowable sources. We want you to be
> innovative in looking at this.
>
> Fourthly, as has been stated, there\'s an inexorable link to the issue
> of significant scientific agreement that obviously you\'ve addressed
> this morning and I\'m sure you will continue to address. And finally,
> in league with my colleague Dr. Dickinson, we also believe that FDA
> should be the ultimate arbiter in the issue of what is an allowable
> statement and perhaps you need to establish a dietary supplement
> advisory committee to help you in that regard.
>
> Let me go into a little depth on my five points. We support your
> proposal to clarify by rulemaking that dietary supplements, as well as
> conventional foods, are covered by the authoritative statement
> provisions of FDAMA. Dietary supplements, as you know, are also foods
> and FDA has applied the health claim standards of NLEA to dietary
> supplements and conventional foods on an equal basis. So it follows
> that Section 303 of FDAMA, which amends those health claim standards,
> should extend to supplements.
>
> Secondly, Congress has explicitly defined an authoritative statement
> that can be used to support a health claim. An authoritative statement
> has four elements that you\'ve mentioned. It must be issued as an
> authoritative statement by a scientific body, which has been well
> defined as a government research agency. It must be published. It must
> be currently in effect and it must be a statement about the
> relationship the nutrient and a disease or health‑related condition to
> which the claim refers.
>
> These criteria could not be any clearer. Congress has drafted a
> precise definition which requires no augmentation or amplification by
> regulation, guidance or otherwise. It\'s very much in that respect
> like the Dietary Supplement Health and Education Act.
>
> We believe that additional criteria, which have been mentioned, such
> as deliberative review by the scientific body and identification of
> nutrient levels are already covered by the statutory criteria.
>
> We urge you not to approach this as; What are we going to do about
> this runaway train? We think that the approach should be: What is the
> best way to get information to people, not how many filters can we put
> up?
>
> Third, while FDAMA provides that authoritative statements be published
> by governmental agencies, the private nutrition‑related research
> sector should be considered part of the authoritative statement
> process. Many of the clinical studies and other data cited in an
> authoritative statement as grounds for its conclusions will likely
> have been generated by private research entities, such as medical
> schools and teaching hospitals, clinics or medical societies, and many
> of these entities may have received governmental funding from the very
> research agencies identified by you and by the Act.
>
> We encourage the government scientific bodies who issue authoritative
> statements, we encourage them to foster nutrition‑related research by
> resource‑intensive private research institutions. This is bound to
> further the interest of the public health and give you a little more
> novel approach to seeking out sources.
>
> Fourth, as I said NNFA maintains the significant scientific agreement
> standard for health claims is absolutely linked to FDAMA\'s
> authoritative statement standard. This is so because by FDAMA\'s very
> terms, an authoritative statement can serve as a substitute for a
> determination that there is significant scientific agreement
> supporting a health claim.
>
> Secondly, in the alternative, FDA can prohibit or modify a health
> claim based on an authoritative statement if, notwithstanding the
> conclusion of the statement, the agency decides by regulation that
> significant scientific agreement for the claim is lacking.
>
> The interplay between the significant scientific agreement and
> authoritative statement standards will require FDA to take the recent
> Pearson court decision into account in implementing FDAMA\'s
> authoritative statement provisions. Pearson directs FDA to promulgate
> a concrete definition of the term significant scientific agreement for
> evaluating the validity of health claims. If FDA were to consider
> prohibiting or modifying a health claim based on the authoritative
> statement because the agency believes the claim is not based on
> significant scientific agreement, it cannot do so until it defines the
> term itself.
>
> Finally, we urge you not to give away the authority to make your
> decisions on what qualifies as a claim based on an authoritative
> statement. Where health claims for dietary supplements are involved,
> we look to the FDA to really make those regulatory decisions. It is a
> regulatory decision, not so much a scientific decision, as to what is
> going to be used.
>
> If you need assistance in determining some problems that may come
> up‑‑it\'s certainly conceivable‑‑if there are problems that need to be
> fleshed out, we urge you to create a dietary supplement advisory
> committee to help you with that. I think that that group would be much
> better positioned to help you on this and many other scientific issues
> that come before you.
>
> And we would like some consistency in the policy that you develop on
> these statements and I think in order to do that, it really needs to
> come from your agency, not from research institutions. Thank you.
>
> MR. LAKE: Thank you.
>
> Next we have Tracy Fox from the American Dietetic Association. Tracy?
>
> MS. FOX: Thank you and good morning.
>
> My name is Tracy Fox and I\'m the senior federal regulatory manager
> with the Government Affairs Office of the American Dietetic
> Association. My written comments also express the views of the
> American Heart Association and the American Cancer Society.
>
> With over 70,000 members, ADA\'s mission is to serve the public
> through the promotion of optimal nutrition, health and well‑being. We
> believe that health and nutrient content claims authorized for foods
> and dietary supplements should be based on the totality of the
> publicly available scientific evidence, including results from well
> designed studies conducted in a manner that is consistent with
> generally recognized scientific procedures and principles.
>
> The Food and Drug Administration Modernization Act did not change this
> overarching public health need.
>
> We are deeply committed to assuring that information communicated to
> consumers on food and dietary supplement labels is truthful and not
> misleading. ADA\'s been active in labeling issues for many years, both
> on its own and in coalitions comprised of numerous organizations. We
> took an active role during the debates surrounding passage of FDAMA
> and worked closely with members of Congress and their staffs to strike
> a healthy balance between expediting the claim authorization process
> and ensuring that claims were scientifically sound.
>
> We congratulate FDA for holding this open meeting and soliciting input
> from various organizations on the complex issues surrounding health
> and nutrient content claims and thank FDA for inviting ADA to
> participate in this panel.
>
> Since it would be impossible to address the many questions that have
> arisen from FDAMA, my comments are limited to those areas of
> particular concern to ADA, specifically the scientific underpinning of
> health and nutrient content claims. And, as mentioned earlier, my
> comments also reflect the views and concerns of the American Heart
> Association and American Cancer Society.
>
> I\'ll talk first about authoritative statements. What is an
> authoritative statement? Is it any statement made by an appropriate
> scientific body about the relationship between food substance or
> nutrient and a disease or health‑related condition? ADA believes that
> all statements published by scientific bodies are not necessarily
> authoritative. Indeed, it is scientifically naive to assume otherwise.
>
> FDAMA uses the term \"authoritative\" and presumably the Congress
> intended FDA to give that term some meaning. We believe FDA would
> shirking its responsibilities and failing to comply with the intent of
> the law if it did not decide when a statement is or is not
> authoritative.
>
> To this end, a preliminary screen is essential. We support FDA\'s
> approach of using a process that includes communication between FDA
> and the scientific body to determine whether or not a statement is
> authoritative.
>
> We also agree with the concept put forth by Secretary Shalala on an
> authoritative statements liaison group. FDA can\'t determine whether a
> statement is authoritative in a vacuum. The scientific body to which a
> statement is attributed must be consulted early on regarding the
> authoritative nature of a statement.
>
> Regarding the National Academy of Sciences, we recognize the
> challenges that are presented in terms of FDA utilizing NAS as a
> scientific body. We do recommend that FDA look to NAS as scientific
> advisers. Since NAS research is partially funded by government bodies,
> sometimes solely funded, the scientific liaisons from these bodies
> should serve as a primary contact with the appropriate NAS
> representatives serving as key scientific advisers.
>
> ADA agrees with the seven characteristics of an authoritative
> statement that FDA has identified in the framework for discussion that
> Dr. Lewis spoke about this morning. However, FDA should not be limited
> in its discussions to only those seven, just as it should not be
> limited in discussions with only the liaison of a particular
> scientific body.
>
> The agency should engage in whatever deliberations and clarifications
> it deems necessary and consult with a variety of experts to determine
> whether a statement is authoritative. FDA must also remain the final
> arbiter for these determinations.
>
> ADA firmly believes that for a statement to be valid or scientifically
> sound, it cannot be preliminary or speculative. Common sense should
> dictate this. If just any statement in a public from a scientific body
> is allowed to form the basis for a health claim, many misleading and
> potentially harmful statements would appear on food labels, resulting
> in millions of confused and distrustful consumers. And ultimately,
> this would defeat one of the primary purposes of FDAMA‑‑to provide
> scientifically sound choices to consumers that may enhance their
> health.
>
> There\'s another risk if FDAMA is interpreted to allow preliminary or
> speculative statements to form the basis for a claim. If authoritative
> statement is too broadly characterized or defined, this could have a
> very serious and chilling effect on statements by scientific bodies,
> research in this country and the publication of new, emerging and
> potentially promising theories.
>
> Researchers and scientific bodies they work for could be reluctant to
> share new ideas and outcomes for fear that they would be taken out of
> context or exploited commercially without an adequate scientific
> basis. No one benefits from this scenario‑‑not consumers,
> manufacturers, researchers, not the scientific bodies issuing the
> statements. This again would undermine the very purpose of the law.
>
> I\'ll talk a little bit about significant scientific agreement. ADA
> asks whether it\'s logical and efficient to apply the SSA criteria
> only after a statement has been found to be authoritative. We realize
> that FDA has determined that the application of SSA comes later in the
> notification review process, as described in the framework for
> discussion, but in practical terms, we suggest that consideration be
> given to incorporating the concept earlier.
>
> For example, a scientific body should be allowed and indeed encouraged
> to assess the degree of SSA during the generation of or deliberation
> about an authoritative statement. It seems reasonable and more
> efficient that an assessment of SSA be considered as one outcome of
> the deliberative review, a characteristic for determining if a
> statement is authoritative.
>
> In this light we urge FDA to consider renaming the characteristic or
> describing it as deliberative review and assessment of SSA.
>
> For the intent of FDAMA to be realized, ADA urges FDA to expeditiously
> outline criteria for characteristics of SSA, just as it has done for
> authoritative statements. The need for these characteristics cannot be
> overstated. The timing of when SSA is applied, for example, whether
> it\'s in the initial review, during the assessment of whether a
> statement is or is not authoritative, or in the final steps toward a
> claim is less important than providing guidance about SSA itself.
>
> Defining a set of characteristics of SSA that can be widely understood
> and applied will only be beneficial to the scientific bodies, the
> private sector, health professionals, and the public. Even if the
> characteristics are, by necessity, imprecise, such information, which
> could be refined over time, is a necessary step that would assist both
> the private sector and government agencies in implementing FDAMA.
>
> To initiate the process and outlining the characteristics of SSA, we
> urge FDA to convene a multidisciplinary group representing the
> designated scientific bodies, as well as external experts, to examine
> the issue and outline characteristics, with the expectation of
> providing guidance to industry and consumers. Areas of expertise
> represented should include but not be limited to nutrition
> epidemiology, clinical nutrition research, basic research, public
> health and ethics.An example of a committee structure to provide such
> guidance would be FDA\'s Food Advisory Committee.
>
> I\'d like to now address the issue of context. ADA sees two distinct
> but related context issues within FDAMA. The first context issue
> addresses whether or not an authoritative statement is taken out of
> context from the source document.
>
> Let\'s take, for example, the following hypothetical statement from a
> publication from a scientific body. The statement would read:
> \"There\'s a growing body of research demonstrating the relationship
> between increased consumption of Substance Z and decreased incidence
> of stubbed toes. This increased consumption of Substance Z is also
> associated with a high incidence of toe loss, thereby resulting in
> fewer stubbed toes.\"
>
> Taken out of context, the health claim based on this statement could
> read, \"Substance Z helps prevent stubbed toes.\" While we realize
> that no responsible manufacturer would make such a claim, FDA should
> not be powerless to prohibit something like this from occurring.
>
> The second context issue relates to whether or not a claim is stated
> in the context of the total diet and the claim is not misleading. In
> other words, using the scenario above, does the claim, Substance Z,
> help prevent stubbed toes, assist consumers in understanding the
> relative importance of Substance Z in the overall diet?
>
> ADA recommends that FDA consider looking at a system established under
> Title III of the National Nutrition Monitoring and Related Research
> Act to assist in the review of potential claims which are clearly
> dietary guidance, to assure that they are based on valid, scientific
> or medical knowledge and, very importantly, that they are not
> misleading to consumers.
>
> If health claims are to help consumers make informed choices, then
> consumers must be informed. In this light, ADA recommends that FDA
> require notification packages from manufacturers to include
> information on the effective level of the substance that is the
> subject of a claim, as well as information on levels of the substance
> that are potentially harmful.
>
> Consumers need to know how much of a substance they need to consume
> for it to be effective. They also need to know how much is too much in
> terms of no added benefit or potential harm. It\'s unrealistic to
> assume that FDA can examine these issues and make these decisions,
> along the all the other FDAMA requirements, in a 120‑day period. This
> information must be provided by the manufacturer as part of the
> notification package.
>
> Information on effective levels and potentially harmful levels must
> also be included either as part of a health and nutrient content claim
> or somehow be displayed on the label so that consumers can see and
> understand it. This information is also essential for nutrition
> professionals, such as registered dietitians, so we can educate
> consumers about the potential benefit of certain nutrients and
> substances.
>
> We also recommend that the manufacturer submit a copy of the
> notification package or, at a minimum, the sections related
> specifically to the claim and the source document to the scientific
> body at the same time the official package is submitted to FDA. This
> will facilitate more timely discussions between FDA and the scientific
> body.
>
> Until FDA determines how best to implement FDAMA, a final decision
> about applying FDAMA provisions to dietary supplements should be
> deferred. ADA agrees that the playing field for health and nutrient
> content claims on foods and dietary supplements should be level.
> However, there are far too many unanswered questions, as we have seen
> and heard today, and we\'ll hear a lot more today, I\'m sure, for ADA
> to recommend at this time that FDAMA provisions right now apply to
> dietary supplements.
>
> We recognize the important positive health benefits that certain
> nutrients and food components can have but no claims will be useful
> unless they are supported by sound science and information is provided
> to consumers in the context of an overall healthy diet in a way that
> they can understand and apply.
>
> Again we thank you for inviting us here today and we welcome the
> opportunity to discuss our thoughts further.
>
> MR. LAKE: Thank you for those comments.
>
> Next we have Ilene Heller from the Center for Science in the Public
> Interest.
>
> MS. HELLER: CSPI thanks FDA for the opportunity to appear on this
> panel. CSPI is a nonprofit consumer organization supported by more
> than 1 million members that has worked since 1971 to improve national
> health policies.
>
> In enacting the Food and Drug Administration Modernization Act,
> Congress made a procedural change to the means by which manufacturers
> could legally market products containing health claims. In lieu of
> petitioning the FDA for a regulation to permit the use of a new health
> claim or nutrient content claim, manufacturers may now make such
> claims without going through the rulemaking process.
>
> Such claims are permitted so long as the claims are based on an
> authoritative statement from a scientific agency of the U.S.
> government or the National Academy of Sciences and FDA does not
> object.
>
> Although Congress created a streamlined alternative to the rulemaking
> route, the Senate committee report makes it clear that this
> legislation \"maintains the rigorous scientific standard health claims
> must meet under existing law.\"
>
> The House report appears to permit the FDA to apply an even higher
> standard than the existing scientific agreement. The report states
> that the FDA must determine \"whether the authoritative statement upon
> which the notification is based is supported by scientific consensus
> to the extent the Secretary considers appropriate to allow the
> claim.\"
>
> Congress provided limited guidance as to what constitutes an
> authoritative statement. It must be a published statement by a
> scientific body of the U.S. with health and nutrition responsibilities
> or the NAS, must be currently in effect, cannot be the work of an
> individual in his own capacity and must concern the relationship
> between a nutrient and a disease or health‑related condition.
>
> Congress further concluded that the statement must be based on a
> deliberative review by the scientific body of the scientific evidence.
> Statements meeting these criteria are subject to a presumption of
> validity.
>
> Congress did not, however, specify the point at which a statement from
> a qualifying agency becomes authoritative. Nor did it specify whether
> the FDA or the agency responsible for the statement should determine
> whether the statement is authoritative. And it also did not address
> coordination issues that are raised when more than one agency is
> involved in making a determination as to the permissibility of a
> particular claim. In the time allotted to me I will address these
> issues.
>
> First, when does a statement become authoritative? Because Congress
> did not define the point at which a statement by a qualifying
> scientific agency becomes authoritative, it is the role of the FDA to
> make this determination. As the Supreme Court has stated in the
> Chevron case, the power of an administrative agency to administer a
> congressionally created program necessarily requires the formulation
> of policy and the making of rules to fill any gap left, implicitly or
> explicitly, by Congress.
>
> In determining the point at which a published statement by a
> qualifying federal agency constitutes an authoritative statement, the
> FDA must consider the definitiveness of the statement. The dictionary
> definition of authoritative is official, entitled to credit or
> acceptance, conclusive. Finality appears to be the key.
>
> For example, if an agency issues a final executive regulation
> interpreting an ambiguous statement, courts have held that this is
> considered to be an authoritative statement from the executive.
>
> Similarly, a decision by the Supreme Court, the court of last resort,
> is considered authoritative because it is the final step in the
> appeals process. As the Supreme Court has stated, \"It is this
> court\'s responsibility to say what a statute means, and once the
> court has spoken, it is the duty of other courts to respect that
> understanding of the governing rule of law.\" A judicial construction
> of a statute is an authoritative statement on the meaning of the
> statute.
>
> In analogous regulatory proceedings, other agencies have provided
> concrete examples of what makes a statement authoritative. For
> example, in a discussion of a proposed rule governing refrigerants,
> the Environmental Protection Agency cited a report by the
> Intergovernmental Panel on Climate Change as being authoritative.
>
> Quoting from the EPA, \"The first IPCC report was developed by 170
> scientists from 25 countries and was peer‑reviewed by an additional
> 200 scientists. Since that time, the number of scientists developing
> and reviewing the report has grown. This group comprises most of the
> active scientists working in the field today and therefore the report
> is an authoritative statement of the views of the international
> scientific community at this time.\"
>
> The FDA has appropriately drawn the line between authoritative and
> preliminary statements in its actions surrounding the rejection of
> nine petitions for health claims filed by Weider Nutrition
> International. Press releases, progress reports on specific projects
> and analyses conducted on behalf of a particular agency by an outside
> contractor did not reflect the kind of deliberative study that
> Congress envisioned when it adopted the authoritative statement
> requirement.
>
> Congress intended the authoritative statement process to provide an
> alternative to an FDA rulemaking proceeding only if another agency
> with scientific expertise had thoroughly addressed the issues that
> would otherwise need to be raised in a petition.
>
> Congress wanted FDA to be able to rely on data from other agencies
> that was comparable to the data the FDA would rely on in its own
> regulatory proceeding to justify the issuance of rules permitting
> health claims or nutrient content claims.
>
> The fact that Congress determined that authoritative statements must
> be based on thorough scientific analyses is demonstrated by the fact
> that the statute gives the FDA final approval authority over health
> claims based on the findings in another agency\'s authoritative
> statement. In modifying or prohibiting a health claim based on
> authoritative statements, the FDA is required to evaluate the claim to
> determine whether there is significant scientific agreement among
> experts qualified by scientific training and experience to evaluate
> such claims and that the claim is supported by such evidence.
>
> Second question is who should determine whether a statement is
> authoritative? The FDA has established liaisons with the various
> scientific agencies with authority over health and nutrition. We
> believe that these designees should be responsible for determining
> whether a statement is authoritative.
>
> To facilitate the determination of whether a statement is
> authoritative, we would recommend as follows. Manufacturers who wish
> to make a claim based upon an authoritative statement should submit a
> notification letter to the FDA. FDA, after verifying that the
> notification is complete, should submit it to the agency whose
> authoritative statement is the basis for the claim.
>
> The notification should be promptly placed on the public docket and
> indicate the date of referral to the relevant government agency.
>
> To facilitate review by the public, notification should be placed in a
> single public docket entitled health and nutrient claims based upon
> authoritative statements.
>
> The agency to whom the notification is sent should determine whether
> it can certify that A, the statement is the result of a thorough and
> extensive investigation by the agency of the scientific issues at
> issue and represents the authoritative opinion of the agency; B, that
> if a report was conducted by an outside contractor, the agency has
> adopted the contractor\'s findings as its own; C, the manufacturer\'s
> claim can reasonably be based on the authoritative statement of the
> agency; and D, with respect to health claims, the statement represents
> significant scientific agreement.
>
> Following the receipt of a written notification from the agency that
> reviewed the authoritative statement, FDA will determine one, whether
> it agrees with the determination of the other agency and two, whether
> the label claim needs to be modified to comply with the terms of
> Sections 101.13 or 14 of the FDA\'s regulations.
>
> In conclusion, there\'s no doubt that Congress intended to provide an
> alternative procedural route for manufacturers to obtain approval to
> make legitimate health and nutrient content claims. But providing and
> alternative route is not synonymous with providing a less stringent
> standard for claims.
>
> If another agency has thoroughly addressed an issue, manufacturers
> should be permitted to rely on another agency\'s findings, but if
> another agency has not thoroughly addressed an issue, the FDA cannot
> view its statements as authoritative. To do so would make a mockery of
> a statute that\'s designed to protect the consumers from false and
> misleading statements.
>
> MR. LAKE: Thank you. Next we will hear from Regina Hildwine of the
> National Food Processors Association.
>
> MS. HILDWINE: Thank you very much. I\'m grateful very much for the
> opportunity to present NFPA\'s views on the claims provisions of the
> FDA Modernization Act of 1997.
>
> The National Food Processors Association is the principal scientific
> trade association that represents the \$430 billion food processing
> industry. This morning I\'m going to discuss authoritative statements
> and make some remarks on significant scientific agreement. Of
> necessity, my points are top line. NFPA addressed these topics and
> other topics in greater depth in written comments we filed in October
> of \'98, as well as those we are filing in association with this
> meeting.
>
> Before I discuss our main points, NFPA believes that it is important
> to begin with some remarks both retrospective and prospective.
>
> NFPA has been thinking about FDAMA‑type health claims for five years.
> The germ of the FDAMA claims provisions emerged from a petition which
> NFPA filed with FDA on October 25, 1994. In that petition, NFPA
> requested several actions which would increase flexibility for making
> nutrient content claims and health claims.
>
> One key NFPA request was that FDA should permit truthful,
> non‑misleading health claims based on the findings of a governmental
> body responsible for public health protection or research directly
> relating to human nutrition.
>
> On First Amendment grounds, NFPA had argued that this action would
> relax what we viewed as overly restrictive criteria for making health
> claims only through FDA prior authorization. NFPA also wanted to
> ensure that there would never be another folic acid health claim
> disaster in which FDA had rejected a health claim on folic acid and
> neural tube defects despite a clear CDC recommendation about this
> diet‑disease relationship.
>
> In May 1995, NFPA received an extensive preliminary response from FDA
> and in this letter FDA indicated it would propose rules on most of the
> actions that we had requested. FDA proposed those rules in December of
> \'95 and the final rules are currently pending.
>
> From FDA\'s letter and the December 1995 preamble, it is well known
> that FDA denied NFPA\'s request to establish an alternate framework
> for health claims. FDA stated that by law, it could not authorize
> health claims without FDA prior approval. This, of course, was the
> signal to pursue the remedy through legislation.
>
> NFPA drafted legislation to establish an alternative to FDA prior
> approval of health claims and this formed the model of the FDA
> Modernization Act provisions on health and nutrient content claims.
> The final statutory language now bears a striking resemblance to the
> language in the NFPA petition, sort of like the way a child resembles
> its parent.
>
> That\'s the backward look. For the forward view, NFPA believes that
> FDAMA claims implementation will be influenced by other factors. First
> there\'s FDA\'s 1998 proposed rules governing structure‑function
> claims for dietary supplements in which FDA proposed to revise the
> definition of disease for the health claims general principles.
> Amending the definition of disease clearly would impact all types of
> health claims, both those established through petition and those
> established under FDAMA.
>
> Also prospective is what I like to call the Pearson effect‑‑the impact
> of the court\'s decision in Pearson, et al v. Shalala on FDAMA health
> claims. The government says Pearson\'s about dietary supplements but
> it is also about health claims, and the rules and policy governing
> health claims are identical for foods and dietary supplements.
>
> Under Pearson, FDA apparently would have to permit qualified health
> claims which were stated in a non‑misleading way, that accurately
> reflect preliminary or possibly emerging science. This is only one
> aspect of the Pearson effect, which undoubtedly will have profound
> impact on health claims policy.
>
> Questions for today. What is an authoritative statement and who can
> make it? FDAMA authorizes two essential groups; that is, the
> scientific bodies of the United States government with official
> responsibility. I won\'t read exactly from the statute. You have
> plenty of written material on that. Or the National Academy of
> Sciences or any of its subdivisions.
>
> We believe that every institute of NIH is a scientific body of the
> United States government that meets the FDAMA criteria, but under
> FDA\'s interpretation, subdivisions of federal agencies apparently
> could not issue authoritative statements. We believe this is
> misguided. The word \"subdivisions\" in FDAMA applies only to the
> National Academy of Sciences for the simple fact that the NAS is not a
> government body and the scope of its authority must be specified.
>
> NFPA believes that the appropriate scientific bodies of the U.S.
> government should include the following, and this is not an exhaustive
> list from HHS, USDA and other federal departments, and I\'m just going
> to flip through these rapidly. They\'re articulated in copies of my
> slides and presentations that are out on the desk.
>
> In our view, other bodies, such as the National Science Foundation and
> the Life Sciences Research Office, could also qualify when carrying
> out federal responsibilities under contract to a federal scientific
> body that\'s charged with public health responsibility. We believe it
> would be the burden of the claim notifier to determine that the U.S.
> government scientific body has the level of responsibility that FDAMA
> directs.
>
> What kinds of statements are authoritative statements? Authoritative
> statements do not mean ex cathedra. It doesn\'t mean that you need a
> big, giant neon arrow saying this is authoritative.
>
> NFPA believes, first of all, an authoritative statement should be
> consistent with the agency mission and the program responsibility of
> that agency or its subdivision. An authoritative statement should
> include any published statement of a federal scientific body
> concerning a diet‑disease relationship that is prepared within the
> scope of the body\'s delegated legal authority and consistent with the
> scope of responsibilities of the subdivision, as reflected in the
> publicly available materials describing the mission and the scope.
>
> For example, the National Cancer Institute would be authoritative on
> statements about cancer. The National Heart, Lung and Blood Institute
> would be authoritative on cardiovascular diseases.
>
> The determination of an authoritative statement should rest on the
> agency\'s or subdivision\'s authority to issue statements on
> diet‑disease relationships and not on whether the specific review, in
> fact, constitutes a surrogate for FDA petition approval, and that
> would be in the judgment of FDA.
>
> NFPA believes it should be the burden of the notifier or the user of
> the claim to determine that the statement is authoritative or within
> the mission and scope of the agency or subdivision.
>
> It would be arbitrary to decide whether a statement is authoritative
> through informal consultation between FDA and the scientific body.
> Determination of an authoritative statement should not be open to
> interpretation of either FDA or the scientific body.
>
> NFPA believes that an authoritative statement does not need to be
> official policy of the scientific body as a whole; nor does it need to
> reflect only diet‑disease relationships that are firmly established.
> We believe that authoritative statements only need to be within the
> scope of delegated responsibility of the scientific body.
>
> There should be no obstacles erected for FDAMA health claims that
> would make it appear that FDA is creating an architecture of premarket
> approval to overlay premarket notification. FDAMA health claims are,
> in fact, a different type of health claim than the type established
> under NLEA, just the way that GRAS is a different type of status of a
> substance compared to food additives.
>
> In closing, I want to say a few words about significant scientific
> agreement and how it should apply to FDAMA health claims.
>
> First of all, FDA, we believe, has misinterpreted significant
> scientific agreement in the years since NLEA and now would be a good
> opportunity to reexamine it, especially since the Pearson decision
> directs FDA to do just that.
>
> The NLEA amendments place the term in this context, that there is
> significant scientific agreement among experts qualified by scientific
> training and expertise to evaluate such claims, that the claim is
> supported by such evidence.
>
> NFPA believes this standard means that scientists in this area
> generally would agree that the health claims statement, as expressed,
> with any qualifying information, is supported by the currently
> available published scientific evidence. The necessary degree of
> agreement would be less than unanimity, even less than consensus. It
> simply means general agreement.
>
> But more importantly, agreement about what? The law makes it clear
> that it is the claim about the diet‑disease relationship that must be
> supported by the evidence and not the relationship between the dietary
> component and the disease which must be fully established.
>
> Under the NLEA, significant scientific agreement should be determined
> by posing a simple question. If the scientists in an area reviewed the
> science on this issue, would they generally agree that the specific
> health claim made, considering the exact words used, is supported by
> the body of this evidence? This standard does not require that
> scientists would draft the health claim by using precisely the same
> language but only that they would concede, from the standpoint of a
> reasonable consumer, that the claim fairly represents the body of
> scientific evidence and is not misleading.
>
> There are many more ideas along these lines and must be explored and
> really this is just a beginning. NFPA is grateful for the opportunity
> to share these views. Thank you very much.
>
> MR. LAKE: Thank you. Our final panelist is Dr. Bernadette Marriott
> from the Northern Arizona University and you\'re going to do this from
> the floor, I gather.
>
> DR. MARRIOTT: We\'re having technical difficulties.
>
> \[Pause.\]
>
> MR. LAKE: Okay, that is going to take a minute, so maybe we can ask a
> question or two of the other panelists.
>
> Maybe now\'s an opportunity to give a minute or two to the panelists
> to comment on anything they\'ve heard from the other panelists. So
> we\'ll be thinking about that as we\'re waiting for this technical
> difficulty to get resolved.
>
> The other thing is that those of you in the audience, again if you
> have cards, you can begin to write your questions. We\'ll be getting
> to those in a little bit, as well.
>
> **COMMENTER PANEL DISCUSSION**
>
> MR. LAKE: Annette, why don\'t we start with you? You were the first
> speaker. If you have any comment that you wish to make relative to any
> of the other panelists, you might want to do that now. Or I guess the
> other alternative is if you have a question of the other panelists,
> now would be a time for that, as well.
>
> DR. DICKINSON: I guess I can start by saying that I certainly
> sympathize with the point that Mr. Levitt made earlier, which is that
> discussing all of these issues is going to be ultimately useful but it
> may not immediately result in any clear consensus among the people who
> are commenting on it, as we have seen in our first panel here.
>
> I think, though, there\'s one thing that we would all agree on, which
> is that the purpose of FDAMA is to allow us to make more use, more use
> for consumers in labeling, to make use of labeling as a way of getting
> information to consumers about what scientific bodies think is
> important for them to know.
>
> I think if we focus on that as the underlying driving factor here, it
> can help maybe cut through some of the apparent disagreement that we
> have on definitions of other terms that might come into play as we
> make that decision.
>
> I think that all of us would like to see FDA implement this in a way
> that, in fact, facilitates the spread of the information that is
> agreed upon by scientific bodies to consumers, using labeling as the
> mechanism for that distribution. And however much we may disagree on
> defining authoritative or defining other terms that may come into play
> here, I think if we focus on that as the driving factor, that maybe it
> helps to resolve some of those disagreements.
>
> MR. LAKE: Thank you for those additional comments.
>
> Michael, do you have something?
>
> MR. FORD: Well, I think there was agreement among us that we really
> want FDA to take the ball and run with it here. I think there\'s
> agreement among us that the language of FDAMA is pretty
> straightforward and does not require voluminous regulation to be
> published. My organization would say the same thing about the Dietary
> Supplement Health and Education Act.
>
> And I didn\'t mean to make anyone wince when I mentioned the runaway
> train in connection with looking at this provision as a runaway train.
> When there is a runaway train, there\'s the brakeman and the engineer
> and the brakeman has one simple task‑‑make the doggone thing stop. But
> engineer has to look at innovative approaches to make sure that nobody
> gets hurt. Maybe he\'ll decrease the steam pressure. Maybe he\'ll even
> consider putting the wheels in reverse. And we hope that you\'ll take
> the engineer\'s course, not the brakeman\'s course.
>
> MR. LAKE: Thank you for that.
>
> Tracy, do you have some comment?
>
> MS. FOX: I think I\'d just like to reiterate what Dr. Dickinson said
> about looking at the consumer and what does the consumer need. That\'s
> something ADA thinks a lot about in terms of what information is
> useful to consumers that they can apply in the context of a diet.
>
> And I think that\'s an important key that regardless of how we define
> authoritative statement, when and if significant scientific agreement
> comes into play, the ultimate goal is to basically inform consumers
> with sound science. And I think that\'s a goal that hopefully we can
> reach at some point, but that should be the goal of FDAMA and
> hopefully one of the outcomes of our discussions today.
>
> MR. LAKE: Thank you. Ilene?
>
> MS. HELLER: I agree with what Joe Levitt said earlier, that we have to
> do what\'s fundamentally best for the consumer. And I think for
> authoritative statements to be meaningful, they really have to be
> authoritative. It\'s like the Surgeon General\'s statement on
> cigarettes: cigarettes are hazardous to your health. That\'s the kind
> of meaning that we have to have behind these statements.
>
> The public has to know that when the government speaks out on a
> statement, the government is in agreement among the different
> agencies. Otherwise it becomes meaningless.
>
> MR. LAKE: Thank you. Regina?
>
> MS. HILDWINE: I think that we really need to focus on the whole
> general concept of scientific substantiation and what FDAMA means
> particularly in the light of NLEA health claims.
>
> In NLEA health claims, it\'s the petitioner that has to prove
> something. With FDAMA‑type health claims, it\'s the government that
> concludes something and states something. And because the government
> states it, then it becomes something that you could translate into
> labeling.
>
> I\'ve always liked to use the example of the Dietary Guidelines for
> Americans in which the government makes recommendations to consumers
> on what they should eat, on how they should eat and talks about
> reduced risk of certain diseases. And in the Dietary Guidelines for
> Americans bulletin there often are tentative or preliminary statements
> made. Nevertheless, the government feels comfortable enough to
> recommend these actions to consumers.
>
> And we\'ve always made the point that if it\'s okay for the government
> to say in a publication, then it should be okay to take those very
> words and put them on a label.
>
> MR. LAKE: Thank you.
>
> It looks like we have our technical difficulty resolved, so we will
> hear from our final panelist. In the meantime we\'re accumulating some
> questions, as well, but why don\'t you go ahead and proceed?
>
> DR. MARRIOTT: I\'m sorry for the delay. It appears that there was a
> power surge or failure or something like that.
>
> My name is Bernadette Marriott. I\'m a vice provost and dean of
> graduate studies at Northern Arizona University. As such, here I am
> representing myself as an individual scientist. Unlike the other
> panelists, I am not representing a specific organization, so my
> comments today do not represent Northern Arizona University or the
> Arizona Board of Regents, which is the governing body that regulates
> the Arizona State Universities.
>
> I\'m very grateful to the FDA for inviting me here today and I\'ll
> take Mr. Levitt\'s comments to heart because as an individual, I will
> be using a few lighter remarks today.
>
> FDAMA raised many issues that deal with how science progresses and how
> policy is made. These issues are not only pertinent to food and
> dietary supplement health claims but also have far‑ranging
> ramifications in terms of the rapidity with which science progresses
> and how it is transmitted to the public and also interpreted for the
> public and the consumer.
>
> My purpose here today is to address several selected issues that are
> raised by FDAMA and presented as questions in today\'s framework for
> discussion. I\'m going to comment on the existing situation in
> science, with several suggestions for ways the FDA and the designated
> scientific bodies could help.
>
> I\'d like to remind the audience that while all of us in this room may
> read the Federal Register on a regular basis, the people out in the
> hinterland, whom I represent, don\'t necessarily read it on a regular
> basis.
>
> Today I\'m going to address several different issues: definitions of
> authoritative statements, significant scientific agreement, and also
> the FDA process, specifically the time frame, the steps that they\'ve
> proposed and who is involved and how.
>
> We read the Federal Register. However, most of the public and
> consumers see information about what\'s going on here today from a
> slightly different perspective.
>
> Here we have a recent cartoon from Arlo and Janis where Arlo, the
> scientist with the white rat, goes home to talk to Janis. \"Studies
> show how moderate activity is as good for you as strenuous activity
> but they don\'t recommend that people stop going to the gym. Studies
> show high fiber food doesn\'t reduce colon cancer but they don\'t
> recommend we cut back on eating it. Red wine can be good for you, but
> they won\'t say we should drink it. Something\'s fishy.\"
>
> I think as we move forward we need to make sure that nothing is fishy
> about how we interpret authoritative statement and how the FDA moves
> forward with its process in a very direct and singular fashion.
>
> So the current situation is that the public and consumers are very
> confused about the mixed messages regarding health claims. The
> confusion stems from multiple messages from multiple sources.
> Confusion also stems from what we are grappling with here today‑‑no
> clear source and definition of an authoritative statement.
>
> The public, the consumer, assumes that any information that originates
> with a federal scientific body is authoritative. Now we know, as
> statements are put together from various scientific bodies, that they
> have different levels of presentation, different levels of authority
> behind them. But when this is presented outside of the government
> framework, all of these statements are regarded by the consumer as
> authoritative.
>
> So FDAMA and authoritative statements have led us to weigh several
> different arguments. The Congress, in proposing FDAMA, said that the
> current process is cumbersome and may result in critical health
> benefit time loss, such as what was exemplified by the folic acid
> issue. And therefore health claims can cite authoritative
> statements‑‑and we\'ve talked many times today about how this was
> originally defined by FDAMA‑‑of key federal scientific bodies, and
> these were named and several were given as examples.
>
> The FDA has taken what was presented in the law and further
> characterized authoritative statements by adding three additional
> points. I beg to point out that these could be the beginning of a more
> definitive conclusion about what an authoritative statement is.
>
> Now here we\'re all talking about health claims and health claim
> issues, but if you step back, we\'re also talking about authoritative
> statements in general, as was exemplified by one of the other
> panelists.
>
> The FDA also further elaborated on key federal scientific bodies and,
> as several of the panelists have indicated here today, this can also
> bear additional discussion.
>
> In terms of the scientific bodies and how they\'re weighing these
> issues, public education information is not authoritative. That\'s one
> of the statements that has come out of some of the scientific bodies.
> Others disagree. There needs to be internal consensus within each
> scientific body as to how they\'re going to present the information
> that is based on science.
>
> Again we come back to the public, consumer and industry. When is a
> statement authoritative? We need some help. Scientists, as well, need
> help because they are tasked with interpreting their data for the
> public.
>
> We need to keep in mind, in terms of scientific statements, that one
> person\'s deliberative review can be very biased, depending upon the
> materials chosen to review. Therefore, an authoritative statement must
> include some type of group review or consensus or multiple reviews to
> really become authoritative.
>
> Science has been progressing very, very rapidly and will continue to
> progress. With this, there are evolving roles for scientists and for
> federal scientific bodies. Scientists are researchers. They\'re
> authors. They\'re now tasked at most universities and research
> institutions as being scientists/entrepreneurs.
>
> So with raising money for one\'s own research and supporting one\'s
> own research, can we bring forward issues of conflict of interest and
> intellectual property, which I also want to raise in relation to
> authoritative statement.
>
> Scientists are also politicians and in some instances expected to be
> public relations specialists.
>
> Federal scientific bodies‑‑they conduct research, they support
> research, and they do this very well. They do it carefully and with
> separation of the groups that do both of these possibly conflicting
> types of activities.
>
> They interpret research results, they educate the public and they also
> have to present a public image. These different roles for federal
> scientific bodies can also often cause internal conflict as they are
> weighed with the success of the organization.
>
> Authoritative statements. We\'ve heard a number of different
> characteristics. Some of them are easier to discern. Whether the
> relationship exists or not is fairly straightforward. Whether it has
> been published is fairly straightforward. Where it has been published
> and whether that constitutes an authoritative statement based on the
> source of the publication needs more discussion.
>
> It\'s fairly straightforward, the characteristic that it\'s not a
> statement of an employee, and we can fairly quickly understand whether
> something is couched in the language of being preliminary or
> inconclusive.
>
> However, I feel that the more controversial issues that we need
> forward on as quickly as possible are what constitutes the
> deliberative review, whether official policy should be a part of this,
> and the term that people seem to be skirting around the edges of a
> little bit is whether an authoritative statement is currently in
> effect. In other words, what is the acceptable time line? Is something
> from 1989 acceptable as currently in effect? And whether or not it can
> contain qualifiers. I tend to support the comments of several people
> on the panel that it can contain qualifiers.
>
> I\'m going to go out on a limb a little bit here. Authoritative
> statements have raised the issue of how agencies provide educational
> material, whether they\'re written by public relations‑trained
> individuals based on their reading or consulting with scientists, and
> whether or not the review of these materials that are put forward as
> educational and therefore very carefully worded yet simply worded have
> a review level that is such that they can be authoritative statements.
>
> We need recommendations, summary or review pieces that are
> scientifically peer‑reviewed within the scientific bodies. Congress
> states that these are routinely compiled. That is true; they are
> routinely compiled. These need to see the light of day and they need
> to be presented for what they are, which is authoritative statements.
>
> Agencies need to step forward. Educational materials, if not reviewed,
> need to be reined in because the public, the consumer views these as
> authoritative statements. The agencies need to decide whether they are
> or they aren\'t. Agencies also need to respect the scientific
> expertise of one another.
>
> Some suggestions regarding authoritative statements. FDA and the named
> federal scientific bodies need to speak as one voice. I suggest that
> they identify a list of no less than five model authoritative
> statements examples and they publish a white paper that includes these
> models and explains the approach, essentially, a set of standards
> about the relationship or nutrient level, where these authoritative
> statements can be published, acceptable locations on an agency by
> agency basis that are defined.
>
> Defining \"currently in effect,\" what is the acceptable time frame?
> How far back in scientific history, with the dynamism of science, can
> we go and still have an authoritative statement? They need to explain
> the type of deliberative review among recognized scientific experts in
> the field and explain the criteria that are necessary to have an
> authoritative statement.
>
> Is a consensus statement that is prepared by non‑experts in the field,
> whether they are experts in other fields, considered an authoritative
> statement when we\'re talking about a diet and health issue?
>
> We need guidance on whether or not they may contain qualifiers but are
> not preliminary. In other words, the scope needs to be carefully
> examined. What literature is needed for a claim?
>
> Authoritative statements and scientific bodies. Federal bodies must in
> general take the lead based on their mission and define the issues
> jointly, recognize the authority of subunits to make authoritative
> statements representing their scientific expertise. NCI, NHLBI, et
> cetera represent the expertise, as has been said on this panel, with
> their respective disciplines.
>
> Each federal body needs to determine who represents that body,
> designate a process for what represents authoritative statements and
> again designate publications that will contain these statements from
> their agencies or subunits.
>
> As NIH is an example, each institute has its own public information
> office or an office that manages review of information for accuracy
> and currency. There\'s also an organization called the Nutrition
> Coordinating Committee. They have a subcommittee that reviews
> nutrition education materials across NIH. Does the NCC‑reviewed
> material represent an authoritative statement of NIH on nutrition?
> This needs to be addressed.
>
> Each scientific body or subunit needs to designate again who and the
> process for which it will be represented in terms of authoritative
> statements.
>
> The FDA process should proceed as it has been outlined by Chris in her
> initial discussion piece. However, I think initially, within the
> scientific bodies, they need to designate one scientific liaison per
> body, and this would mean for the subunits, as well, if so designated
> by the overarching agencies.
>
> The bodies need to decide on an internal process for their own review
> and the bodies need to establish guidelines. The FDA then can use
> their 120‑day notification process. They can check that the pieces are
> in place, using the issued guidelines. The FDA can distribute the
> claims to the federal bodies with the confidence that these bodies
> have an established review process in place and are not retesting
> their statements time and time again.
>
> Then the authoritative statements that come back to the FDA can go to
> the Liaison Group for reviews for SSA. This is a secondary process.
> And it appears that this Liaison Group may be a good group to look at
> the SSA overall for these claims.
>
> The FDA process must include context review initially. The
> notification needs to include balanced presentation and literature
> review, but the FDA and the liaison panel need to give some guidance
> on this.
>
> The bottom line is that the bodies cannot disallow all statements.
> This is a great concern, that the statements that the public and the
> consumer is turning to from these agencies and believing in cannot
> suddenly be disallowed as they\'re put under the light of
> authoritative statement. The liaison panel needs to have clear
> membership with a rotation policy and the ability to determine SSA by
> a designated process.
>
> Just quickly, the other questions that were asked for this meeting:
> Should expansion of federal bodies be as listed in the guidance for
> industry? Yes, plus the DOD and the VA and their subunits when they
> focus on these issues. Both of these organizations do set nutrition
> policy for special populations and for special environments.
>
> Should health claims based on authoritative statements be used for
> supplements? Yes. Should the notifications be put in a public docket?
> Yes, but again in concurrence with other members on the panel, one
> docket, not by company.
>
> I\'d like to remind you that the food supply and related issues are
> becoming more complex daily. On our horizon, not too far off, we may
> see color‑coded vegetables‑‑asparagus purple, which contains high
> potency zinc and is labeled as such; green asparagus with regular
> potency but well characterized; yellow asparagus, high potency vitamin
> E; orange asparagus, high potency beta carotene. We will be able,
> within the next 10 years, to choose diet based on genetic risk factors
> and individual preferences.
>
> The FDA and the scientific bodies need to act now to be prepared to
> handle these issues, as well as authoritative statements.
>
> Again the public and the consumer is reading much more of this type of
> information than they are the Federal Register. Here we see a cartoon
> by Cathy. We see a Power Bar in the middle with all of the different
> nutrients carefully labeled. We see a man over on the right. He\'s
> called a power smoothie. He\'s sensitive. He has wit and charm.
>
> He asks Cathy, \"Would you like to go out sometime?\" She says, \"What
> bonus nutrient do you provide?\" \"Excuse me?\" he says.
>
> \"This is the age of nutritional enhancement. What do you offer?\"
> \"What?\" he says.
>
> \"Calcium, soy protein, vitamin C, vitamin E, folic acid, bran, zinc,
> ginkgo biloba, echinacea, fiber, electrolytes. Read the labels.
> Everything\'s beefed up, boosted, fortified, enhanced, energized. Even
> a bowl of Fruit Loops has 11 essential vitamins and minerals. What\'s
> your added health benefit? What minimum FDA requirement do you
> satisfy? Why, with the universe of 6 billion single men, should I hand
> over three prime time hours of my life to you?\"
>
> He says, \"I haven\'t run from the room screaming yet and no one else
> has in this room.\" She says, \"Ah, an excellent source of stamina.
> How\'s Tuesday?\"
>
> Again this is where our consumers are getting their information.
>
> In conclusion, scientific bodies need to act quickly to establish
> internal processes and designated publications. The bodies and FDA
> need to continue to work together and I recommend that they publish a
> white paper that contains models of authoritative statements and clear
> guidelines and definitions. If the FDA moves forward to designate its
> process quickly and that is clear and widely available to the consumer
> as well as to those individuals who are directly concerned, the end
> result will be less confusing for the public, a more direct path for
> industry and we will be prepared for new food questions and new foods
> that are just down the pike. Thank you.
>
> \[Applause.\]
>
> MR. LAKE: Thank you. And as you\'re moving back up to rejoin the
> panel, I think I will turn now to Mr. Levitt to ask the first
> question.
>
> **QUESTIONS FOR THE PANEL**
>
> MR. LEVITT: Thank you. I have to begin with a confession. I\'m only a
> moderate source of stamina myself. I\'m going to have to be leaving
> shortly. I get to argue for our budget this afternoon and I certainly
> don\'t want to miss that opportunity, but I\'m glad I got to hear all
> the presentations. Annette, I\'m sorry I came in midway through yours
> but I\'ll be sure to go back and read it.
>
> I would like to just first reflect on something I said before and ask
> people to think about, not to answer now. But as you go back and hear
> the discussion, it\'s okay to come back to us afterwards and say,
> \"You know, I\'ve rethought this and it would make sense to move a
> little in this direction.\" I don\'t want people to feel like‑‑I know
> we all represent organizations; people have to go back and check back
> home with the people they represent. But it is okay to have evolving
> thinking if part of the public discussion helps persuade.
>
> And I\'ll give you just two particular points to kind of start
> thinking on. One has to do with a lot of the discussion I heard this
> morning on just what is an authoritative statement. I think it was
> Michael Ford that said the statute is pretty clear on its face, and
> Regina expanded on that by saying it\'s pretty clear it\'s any
> published statement.
>
> And I guess the honest question I have is I have a feeling if Congress
> meant that authoritative statement meant any published statement, they
> probably could have figured out how to write any published statement,
> that that\'s more of a common word. But authoritative, it seems to me,
> must mean something more than any published statement.
>
> And while I know you\'ve come in with a position that represents your
> organization and you probably need to stick to that now, I guess I\'d
> ask people or others to think, is there something that people can
> offer more than any published statement that seems to reflect
> authoritative?
>
> MS. HILDWINE: If I could just respond to that?
>
> MR. LEVITT: Please.
>
> MS. HILDWINE: I believe what I said was that any published statement
> that was in the scope and responsibility of the authority of the
> government agency, and I think that\'s very important because there
> are very few government agencies that have authority for every segment
> of public health protection or research directly related to human
> nutrition. And as a consequence, there are going to be some areas that
> are the appropriate turf for one agency or another.
>
> The examples that I gave were that the National Cancer Institute would
> be authoritative on statements about cancer, but the National Heart,
> Lung and Blood Institute would be authoritative on statements related
> to cardiovascular disease.
>
> If you reverse those areas, you can envision a situation in which the
> National Cancer Institute might make statements related to
> cardiovascular disease but it raises some questions as to whether or
> not that\'s in the scope of their authority and their responsibility.
>
> So I think the agency that makes the statement has to match well with
> the statement that\'s being made.
>
> MR. LEVITT: That\'s a fair comment. I would still ask you to go back
> and think. I think still any published statement within the scope of
> authority still strikes me as a good bit away from authoritative.
>
> MS. HILDWINE: I will certainly think about it but this, of course,
> raises other questions. You know, what\'s the government putting out
> these days? And should consumers view them as authoritative
> recommendations in any sense?
>
> This is a really important thing for us to explore, but this is a
> situation where the first statement is being made by the government
> and I think that we need to look at what\'s behind that environment.
>
> MR. LEVITT: Thank you. My second question comes from the other
> direction a little bit. A number of commenters today have said that
> FDA was too limited in the either number or designation of scientific
> bodies that have been officially designated by us or identified by us
> is maybe a better phrase, as recognized scientific bodies here.
>
> I don\'t know if any of the other panel members‑‑Tracy or Ilene or any
> of the others would also encourage, as some of the other speakers
> have, that we expand that list and in what way?
>
> MS. FOX: I think in looking at the law, clearly there are examples
> that are given and I also recall from the debates with the staff of
> members of Congress during the FDAMA debates that it was always my
> understanding and I also thought the staff\'s understanding that the
> entities that were identified, certainly the ones that were provided
> as an example and I think also others that were envisioned, would be
> entities responsible for conducting research that would apply
> generally to the public, not to small subsets of populations, not to
> pockets of the population for which we could then identify an
> authoritative statement to apply broadly.
>
> And I think that\'s the concern that the entity should be one that
> really does publish for the most part or at least conduct research for
> the most part that can be applied fairly broadly to the population
> because that\'s who is reading health claims, not particular entities
> of an organization.
>
> MR. LAKE: All right. Now we will proceed with some other questions.
>
> DR. LEWIS: We have two and then I think both David Dorsey and I have
> some questions, as well, but to try to be responsive to the audience,
> the first question I have from the audience says, \"Did I understand
> correctly that CRN and others believe that FDA should be the final
> decision‑maker on whether statements are authoritative and NFPA
> disagrees? That is, the scientific body to which the statement is
> attributed should decide?\" That\'s the question.
>
> So did they understand correctly that CRN and others believe FDA
> should be the final decision‑maker on whether the statement is
> authoritative but NFPA believes the scientific body should decide when
> it has an authoritative statement?
>
> DR. DICKINSON: They are correct at least in the first part of that,
> that CRN believes FDA needs to make the final decision about whether a
> statement is authoritative and should not basically buck that decision
> to the scientific body.
>
> MS. HILDWINE: But they\'re not correct in what NFPA stated and I hope
> that I was able to communicate this clearly.
>
> We believe that a lot of the authoritative statement issue is going to
> be on the face of it, that first of all, it\'s the burden on the claim
> notifier to assure that the statement is authoritative and secondly,
> that the authoritative statement, while you don\'t have to ask the
> scientific body if it\'s authoritative, that it comes out of the
> context that that is where the scientific body has its authority.
>
> But in fact, we see that the final judgment is FDA\'s but that the
> burden of demonstrating it to FDA belongs to the claim notifier. It
> gets a little complicated but I think that\'s exactly how I would
> characterize it.
>
> MR. LAKE: Thank you both.
>
> DR. LEWIS: I have a second card from the audience and it\'s directed
> to Dr. Dickinson and Miss Heller. It\'s a fairly long question. I\'ll
> go ahead and read it all the way through and then we can go through it
> again if clarification is needed.
>
> Again to Annette Dickinson and Ilene Heller, \"FDAMA provides
> responsibilities to FDA on appropriateness for health claims or
> nutrient content claims based on authoritative statements of
> scientific bodies.
>
> \"One, if NIH or CDC or the National Academy says the statement is
> authoritative, FDA can accept this determination or can reject it with
> explanation. Two, if NIH or CDC or the Academy says the statement is
> not authoritative, FDA can say it is authoritative.
>
> \"Three, if NIH does issue an authoritative statement and CDC does
> likewise but the conclusions or recommendations on the same scientific
> data differ, A, what should FDA do? B, regardless of what FDA does,
> what recourse do the two conflicting agencies have? And C, who is
> responsible for informing the public of the basis for the
> disagreement?\"
>
> I think it\'s an interesting question. It\'s a long one. Again it\'s
> directed to Dr. Dickinson and Miss Heller but I don\'t see any reason
> why others can\'t comment on this, as well.
>
> MR. FORD: I\'m certainly willing to defer to Dr. Dickinson.
>
> DR. DICKINSON: You\'re so kind.
>
> I certainly take the point that even if a scientific body makes its
> own determination of whether something is authoritative, that doesn\'t
> necessarily mean that FDA has to accept that determination. They could
> agree or they could disagree. I think that was the only point being
> made in the first part of that question.
>
> The second part of it, what if two agencies differ and come to
> different conclusions? I think that\'s a situation where frankly from
> my point of view as to what I see as reasonable and what I think CRN
> sees as reasonable, it is very significant information for consumers
> that that has occurred. It may not be the basis for a FDAMA health
> claim, but it certainly should be the basis for information that those
> agencies and possibly FDA in some fashion would want to convey to
> consumers as to why they arrived at different conclusions based on the
> same scientific evidence.
>
> I\'m sure that if this were to occur, and it probably has occurred‑‑I
> know it has occurred on some instances‑‑I\'m sure that the respective
> agencies would be publishing statements regarding their conclusions,
> publishing papers which would then get in the media. The media would
> be discussing how come it is that CDC thinks this way and FDA thinks
> that way? And it would actually, in the long run, I think, contribute
> to a very useful discussion that would help resolve that issue.
>
> I think that if you have that kind of issue, it clearly is not yet
> ripe for a FDAMA health claim, that you should not have a FDAMA health
> claim in two different directions on the same subject from two
> different agencies.
>
> So I think that in that case, FDA\'s logical decision would be that
> there is not agreement, significant scientific agreement or any other
> term that they might ultimately choose to define that. There is not
> agreement among the authoritative bodies on this issue.
>
> I don\'t think that necessarily means that on every case they have to
> poll the scientific bodies to determine the level of agreement, but I
> think that in those cases that may come up where there is, for one
> reason or another, dramatic disagreement, that certainly would not
> lead to a FDAMA health claim, at least in my view.
>
> MS. HELLER: I would echo Annette\'s statements on this. I think FDA
> has to be the final arbiter on decisions by other agencies because if
> FDA finds that there\'s other information by other agencies,
> particularly within the government, that\'s contradictory, it is just
> going to confuse consumers. FDA has to make the ultimate decision as
> to whether there\'s significant scientific agreement.
>
> And I think Annette had a really good point about the situation where
> if two agencies disagree with each other, there shouldn\'t be a health
> claim on that but there should be some airing of this to the public.
> Let the public know that two agencies are conflicting about this and
> get some more input on it.
>
> MS. FOX: There\'s just one point I want to make in terms of ADA also
> supports FDA being the final arbiter once there\'s been a vetting and
> a good open discussion with the scientific body. And I think it\'s
> important because scientific bodies for the most part, up to this
> point, haven\'t been in the business of regulating health claims on
> foods, and FDA has for many, many years.
>
> I think that\'s an important point, that regardless of‑‑I don\'t want
> to say regardless of what the science says but there might be a number
> of other factors that have to be considered because we\'re talking
> about health claims on food labels, not just straight science at this
> point.
>
> MR. FORD: I would agree with that, as well. We look to the research
> agencies to do the research and the regulatory agencies to regulate
> and that is your charge, to regulate under this provision of FDAMA.
> And it\'s up to the company to do its best to convince you that it has
> used an appropriate source and the way they\'ve perhaps qualified it
> makes it a reasonable claim, but it\'s up to you to make that final
> decision.
>
> And I want to put another plug in here for the idea of perhaps getting
> assistance from a discrete dietary supplement advisory committee in
> these areas.
>
> DR. LEWIS: Does anyone else on the panel wish to make a comment on
> that before we move to another question?
>
> MS. HILDWINE: I did want to sort of throw another perspective into the
> mix. What happens in the valid situation in which the science is
> absolutely equivocal; that is, it\'s right down the middle. This has
> happened. Your conclusion depends on how you view this and all of the
> factors that you bring into your interpretation of the science.
>
> One government scientific body interprets the science tending toward a
> particular way; another equally qualified authoritative government
> scientific body interprets the same science tending the opposite
> direction.
>
> Is it appropriate to make such a statement as the basis for a FDAMA
> health claim? Possibly, and for this we have to look, I think, to the
> Pearson decision. The Pearson decision says that if
> language‑‑essentially it says if language is appropriately qualified
> and you give consumers more information rather than less, how can they
> be misled? If a health claim were to state on a label \"While all
> government agencies do not agree on this perspective, this government
> agency has said that this particular thing\" and perhaps expand upon
> that.
>
> So, in fact, in this situation, and it\'s a fairly common situation,
> where the science is very much equivocal, even though it is well
> developed and robust and has been studied for many years, it may be
> possible to make well qualified health claim statements that give
> consumers more information rather than less information and therefore
> do not mislead.
>
> MR. FORD: You may wish to consider perhaps a standardized or standard
> disclaimer‑type language to accompany perhaps a qualified claim. That
> might be an approach. I think the disclaimer has worked well with
> DSHEA. It might work well in this instance.
>
> DR. LEWIS: Bernadette, did you have anything you wanted to add?
>
> DR. MARRIOTT: I\'ll say that the discussion between or among
> scientific bodies, which clearly gives their rationale for their
> approach or their conclusions, can do nothing but help the public and
> the consumer, providing them with more information on which to make
> their decisions.
>
> DR. LEWIS: I believe FDA in the voice of David Dorsey has a question
> and so we\'ll turn to him now.
>
> MR. DORSEY: My question is directed at least initially to Annette
> Dickinson and CRN\'s proposal. I guess I want to try to characterize
> what your proposal is and I hope you\'ll correct me if it\'s a
> mischaracterization, and then I\'ll ask you to flesh out some details
> more. There\'s one particular issue that I\'d like you and others to
> address.
>
> It seems to me that you\'re basically saying or CRN is basically
> saying that an authoritative statement is a recommendation to
> consumers to consume a certain nutrient because of its relationship
> with a disease. And it\'s only when it\'s a recommendation to
> consumers that it should be considered authoritative.
>
> In the particular example you gave, and I\'m wondering, is that an
> accurate characterization of your approach? And also if you could fill
> in some of the details about how we would identify, how FDA, for
> example, or anyone would identify when a statement is, in fact, a
> recommendation.
>
> One example you gave was the example you gave with folic acid and
> homocysteine included the level of folic acid required, and certainly
> the authoritative statement, the folic acid neural tube defect
> statement from CDC, also identified the level.
>
> Is that something that you think any authoritative statement must
> include, a level? And if not, why not? If it doesn\'t, who has to
> provide it? Is it something FDA is required to come up with? Should
> the notifier give it to us? And I\'d like others to respond, as well,
> if possible.
>
> DR. DICKINSON: First of all, I would be a little bit broader than
> using just the term recommendations. I did say that in our view, an
> authoritative statement is a statement that an agency means to be
> acted on by consumers and by others. In other words, it\'s not just a
> statement they make in passing in kind of thinking about the state of
> the evidence. It\'s a conscious statement that they make intending
> that consumers, health professionals and others will pick it up and do
> something with it.
>
> So whether that necessarily characterizes it as a recommendation or
> whether they might call it something else, but basically it\'s that.
> It\'s an intentional statement. It\'s something that they mean to be
> acted on.
>
> I do think that the level that is recommended is an important feature,
> as is required among the general requirements for health claims. I
> think that if the authoritative statement itself does not embody that
> information, then certainly it is an appropriate piece of information
> for FDA to add to it as part of a definition of what kinds of products
> are eligible for that FDAMA health claim. Presumably there will be a
> statement of eligibility that goes along with that claim and it would
> not simply be allowed for anything that has either a trace or a huge
> amount of something in it.
>
> MR. DORSEY: So if I may follow up, you\'re saying you think FDA should
> identify the level but the notifier would not be responsible to
> identify the level?
>
> DR. DICKINSON: Ideally, the notifier would incorporate that as part of
> their petition to you. But if they do not, I think that ultimately
> somebody has to make a decision on what the threshold level is for a
> product to bear that claim.
>
> MR. LAKE: Do others wish to comment on that question or answer?
>
> DR. LEWIS: I have more or less a related question. Maybe we could
> incorporate that into the comments. It\'s both a question I had and
> one that has come from the audience.
>
> The question from the audience is how can all of the factors that need
> to be looked at adequately by FDA in terms of making decisions,
> whether they\'re decisions on effective levels or methods of
> compliance, how can that all be accomplished in 120 days?
>
> As I was listening, I also had the same set of questions in my mind. I
> know what we\'ve gone through in the first experience of 120 days and
> it seems like a short amount of time to accomplish all of the tasks.
>
> I do know from reading the statute and I\'m sure David would agree
> that FDA can still act after 120 days, but at that point the claim is
> already on the market and that seems to be a somewhat disingenuous
> approach to regulating these.
>
> So I think the notion of timing on all of this, especially given what
> is being suggested as being on FDA\'s plate, is one I\'d like to hear
> a few comments on.
>
> MS. HELLER: I think you\'ve just made the argument for public notice
> as soon as a notification is filed with the FDA, so this way you can
> get the input on the levels from people who would know about this from
> various agencies, various groups that have an interest in these
> products, and that will provide you with the information.
>
> MS. FOX: I think also in terms of the notification package, I think
> that does need to be about as complete as possible in terms of
> identifying effective levels of nutrients or substances. I think a lot
> of the homework has got to be done before it hits the FDA door because
> if it\'s not, then there\'s going to be more need for FDA to send out
> for more information, which does stop the clock and restarts the
> 120‑day period.
>
> So I think it\'s to the benefit certainly of FDA, to the manufacturer,
> to consumers who can get the information sooner for that package to be
> about as complete as possible.
>
> MR. DORSEY: If I can ask a follow‑up, there\'s language in the
> legislative history that says a problem with the petition process was
> the burden it caused on manufacturers. It takes a lot of money and a
> lot of time to assemble a typical health claim notification.
>
> And part, it seems, of the notification process was to relieve the
> burden, especially for smaller manufacturers, I think as identified in
> the legislative history.
>
> And one thing we\'ve been discussing at FDA and we\'d like to hear
> your thoughts about it is it\'s a nice idea to front‑load as much of
> the stuff into the notification, but that ups the burden on the
> notifier and it doesn\'t seem that that\'s something we should do,
> given the intent to minimize the burden on notifiers. And yet we have
> to balance these two concerns.
>
> Anyone have suggestions?
>
> MS. HELLER: I think the balance is struck by the fact that when
> someone files a petition for a claim, they have to provide all the
> information. In the case of a notification, they\'re relying on a
> government agency that has already done the work, and they may have to
> attach a bibliography of other relevant studies, but it\'s still
> nowhere near the amount of data that needs to go into a petition. So I
> think the burden is still much less for an authoritative statement
> than it would be for a petition.
>
> MS. HILDWINE: I would agree with that. The burden is less but the
> burden is still squarely on the notifier.
>
> To develop a health claim petition, the petitioner not only puts
> together a literature review of the science but often sponsors the
> scientific research themselves. We are usually talking several
> millions of dollars. This precedent has been established in the case
> of health claim petitions that have come in to FDA already.
>
> For a FDAMA health claim, the process of drawing the conclusion about
> the diet‑disease relationship and making a statement about the
> diet‑disease relationship is with the government scientific body or
> the parts of the National Academy of Sciences. The notifier then has
> to do the homework. They have to identify the statement. They have to
> make sure that the science to support the statement, at least in terms
> of outlining the published science that\'s well documented.
>
> Somewhere throughout that science to support the government statement,
> there\'s going to be information about the levels, the effective
> levels of the substance that\'s in the claim.
>
> The burden is squarely on the notifier. I think it has always been
> envisioned as that process. But it is a different type of burden than
> the burden of scientific proof that you have to assemble and in some
> cases sponsor research, submit that to FDA and essentially prove your
> case with that particular burden. It\'s different.
>
> DR. DICKINSON: I think in addition to that, in the case of the small
> manufacturer, they will have associates that they can cooperate with
> in terms of gathering that information‑‑either their trade
> associations or other groups, ad hoc groups that they may put together
> of interested manufacturers.
>
> I think that the benefit of having a claim like that approved or being
> able to use a claim like that under FDAMA is sufficient to justify
> that investment.
>
> MR. FORD: I think that you\'d find there\'s some precedent under the
> Dietary Supplement Act with structure‑function statements. While
> companies need only notify the FDA, they must have the substantiation
> to support the statement on the label. I know when the FDA gets around
> to rigorous enforcement of that particular section of DSHEA, you\'ll
> find that the substantiation is out there, in varying degrees
> certainly, but it\'s out there. The companies have to accept that
> burden within the guidelines that you create for specifically what
> must be submitted.
>
> DR. LEWIS: We\'ve got three more questions from the audience, one for
> Dr. Marriott, one for Regina Hildwine and then a general one
> concerning NIH consensus conferences.
>
> For Bernadette, could you elaborate more on why FDA and the scientific
> bodies need to define an acceptable‑‑they\'ve used the term time frame
> but I think they\'re referring to currently in effect? Do you need a
> guideline or a rule? Should one be developed in which a decision
> becomes antiquated; for example, all decisions made prior to 1989.
> Could you elaborate on that?
>
> DR. MARRIOTT: I was asking for either the liaison panel working in
> conjunction with the FDA to put some guidelines around the time frame.
> I picked 1989 only because that was when the last RDAs were delivered
> and also when the Diet and Health Report was published, two pivotal
> publications. Parts from the Diet and Health Report may be currently
> viable, but other parts clearly are not.
>
> So does that constitute an authoritative statement? What parts of that
> do? That\'s something that the National Academy of Sciences will have
> to address in their talk this afternoon. However, I\'m just requesting
> that there be some guidance in terms of time frame in general and then
> some specific suggestions related to some pivotal documents.
>
> DR. LEWIS: And then we have a question for Regina Hildwine. You say
> that even if two government scientific bodies disagree on
> interpretation of data, the health claim can still be used, as long as
> there is a qualifier statement. Doesn\'t this directly contradict the
> intent of significant scientific agreement?
>
> The idea of SSA means that scientific bodies agree on data, not
> disagree. Is it possible for three out of four bodies to agree and
> consider this SSA? To have it split down the middle, this is not
> significant scientific agreement. It isn\'t consensus or general
> agreement.
>
> MS. HILDWINE: I did raise the question of whether it would be
> appropriate for a FDAMA health claim but I maintain that communicating
> more information to a consumer relative to these findings certainly
> would ensure that the claim is not misleading. And I think that\'s
> where we are really going, that significant scientific agreement
> frankly is a guard, a guarantee to ensure that the claim is not
> misleading.
>
> Now perhaps a 50/50 split‑‑okay, that\'s going to be a real conundrum.
> I think everybody\'s going to have a real probably with 50/50. A 75/25
> split is significant scientific agreement. Two out of three is
> significant scientific agreement. Significant scientific agreement
> does not have to be unanimity, does not have to be consensus, has to
> be general agreement.
>
> I think we need to keep in mind that scientific bodies may not always
> be basing their recommendations entirely on science, that, in fact,
> there can be some basis of history and tradition as to why they might
> base certain recommendations.
>
> Well, I\'m frankly looking forward to the continued debate on just
> what is significant scientific agreement but from our point of view,
> it does not mean consensus and it does not mean unanimity.
>
> DR. LEWIS: We also have a general question, so I\'ll throw it out for
> any interested panel member. It reads, \"Often NIH holds a consensus
> conference with a report derived from a group of scientists not expert
> in the field being evaluated. Their findings may be in opposition to
> other NIH subunits or office statements. Should such consensus
> statements be given the same weight as to deliberative review from NIH
> as a whole?\"
>
> MS. FOX: Sounds like a question for NIH.
>
> DR. LEWIS: We can hold it for the scientific panel discussion and we
> are having quite a few‑‑
>
> DR. DICKINSON: It\'s also part of the problem with defining NIH as a
> whole as the only part of NIH that can take a position. I think it
> would be relevant information that a consensus conference concluded A
> and that some subdivision of NIH, some center or institute at NIH has
> a different conclusion and again to air the reasons why those two
> different conclusions occurred, not necessarily as part of a FDAMA
> health claim if there\'s not enough agreement for that, but certainly
> as information that consumers should be aware of.
>
> And while I\'m talking, I\'d like to also just enthusiastically
> endorse what Bernadette suggested in terms of a white paper that would
> actually give us a few examples of statements that we would all agree
> hopefully are authoritative statements of scientific bodies, with
> appropriate designation of levels of intake and all of that kind of
> thing, because I think part of what makes it difficult to discuss this
> now is that the only comprehensive document anybody has put in front
> of us to look at is the petition that FDA received last year, which
> has some problems in terms of being the sole driving force of the
> discussion.
>
> I think it would be enormously helpful if FDA or anyone else in the
> audience were to prepare a white paper putting forth some examples,
> some good, solid examples of claims that actually should be made or if
> someone submitted a new petition to FDA on that, I think it would help
> clarify a lot of these questions, because I think right now people are
> fearing things that probably are not very likely to happen, and if we
> had some positive examples in front of us, I think we could see that
> more clearly.
>
> DR. MARRIOTT: Thank you, Annette.
>
> I think that the scientific bodies that have been designated by
> legislation and those indicated also by FDA can identify what they
> consider authoritative statements from within their own bodies, and
> that would be a start because otherwise, I feel we will continue the
> discussion somewhat in circles and with fear on all sides as to what
> might be misconstrued in one area or another.
>
> MR. LAKE: I think we have one final question from the audience.
>
> DR. LEWIS: We do have one final question and it indicates that it has
> to do with the analytical methods. It says, \"Is it appropriate to
> request analytical methods vis‑a‑vis the notifier? How do you handle
> the wide variety of variability among ingredients and the lack of
> batch to batch consistency of the ingredients? The quality of these
> ingredients vary greatly.\"
>
> The question is analytical methods for compliance purposes.
>
> DR. DICKINSON: I think it is reasonable to expect the notifier to
> submit an analytical method for something if they\'re proposing a
> claim for which there is not currently an accepted analytical method
> for the ingredient.
>
> MS. HILDWINE: We would agree with that. The issue relative to
> variability of ingredients, in part, goes to the good manufacturing
> practices of the manufacturer, but there\'s also going to be an issue
> relative to the reliability of the method.
>
> If there is no established official method for a particular substance,
> then, in fact, the notifier should provide that information, complete
> information on the analytical method, including limits of detection
> and any analytical variability.
>
> MR. LAKE: Thank you.
>
> Before we adjourn for lunch I have a couple of announcements, but
> before I get to those, let me thank each and every member of the panel
> this morning. I think your opening comments were very useful and I
> think the continuing discussion has also been very helpful to us and I
> think to the audience. So I think we should give them a round of
> applause.
>
> \[Applause.\]
>
> MR. LAKE: A couple of announcements. One, let me announce that the
> Food and Drug Administration will be holding a public meeting on the
> overall strategy for regulating dietary supplements under the Dietary
> Supplement Health and Education Act. The meeting will be held on June
> 8 of 1999 in the auditorium of the Cohen Building at 330 Independence
> Avenue, Washington, D.C.
>
> Now we had some Federal Register announcements of this in the back. I
> am told that we have run out of those, but let me give you a couple of
> alternative ways of getting the information.
>
> One, the information is on the Internet at www.cfsan.fda.gov. Or if
> you want to leave your name and fax number at the sign‑up desk in the
> back, we can provide you with that additional information.
>
> Also, I\'ve had inquiries about how to get the transcript. We are
> hopeful that it will be available in about 15 days and it will be
> available from our Dockets Management Branch. The charge will be about
> 10 cents per page.
>
> The other inquiry I had was relative to the videotaping that is going
> on. Again the thing that FDA is doing is having the meeting
> transcribed. The videotaping is being done by a private party. If you
> have questions about how you might obtain that or whether it will be
> made available in some fashion to others of you, I will refer you to
> the gentleman who\'s doing the taping. I hope that\'s not too much of
> a burden on him, but if you have questions, you should address those
> to him.
>
> With that, let me remind you that we want to start promptly at 1:00.
> We will have the scientific panelists at that time and their schedule
> is very tight, so we want to begin promptly at 1.
>
> I thank you for being very attentive this morning and look forward to
> seeing you again at 1:00.
>
> Lunch again, if you go down to the right to corridor 3, you can go
> downstairs and get something there or you can go elsewhere. Thank you.
>
> \[Whereupon, at 12:07 p.m., the meeting recessed for lunch.\]
>
> [A F T E R N O O N S E S S I O N]{.underline}
>
> \[1:04 p.m.\]
>
> MR. LAKE: Good afternoon, ladies and gentlemen. Thank you for
> returning promptly. We\'re going to go ahead and begin this
> afternoon\'s session because some of our panelists are going to have
> to leave.
>
> We do have one substitution. Dr. Phillip Schwab is here for Dr. Eileen
> Kennedy and he is going to have to make his presentation and run, so
> we\'re going to give him the floor first.
>
> **SCIENTIFIC BODY PANEL PRESENTATION**
>
> DR. SCHWAB: Thank you very much. Thank you for the opportunity to
> address this public meeting on behalf of USDA. I\'d like to apologize
> for Dr. Kennedy, the Deputy Undersecretary for Research, Education and
> Economics. She\'s actually out of the country this week and was unable
> to give the comments today.
>
> But USDA is pleased to participate in this process and we\'re also
> very happy to supply the facility for this meeting.
>
> The agency definitely has an open mind on this issue and certainly
> appreciates the valuable comments and the input that we\'re hearing
> from the public today. Clearly this is a complex issue which has
> emerged from a complex piece of legislation and will require a great
> deal of consultation and careful thinking to work through.
>
> My comments this afternoon will be brief and generally reflect the
> current state of thought about this issue at USDA as we are currently
> developing more thoughts on this process, in consultation with the
> Liaison Group.
>
> The issue of defining what is or is not an authoritative statement is
> particularly difficult for science‑generating agencies like USDA and
> I\'m sure for my colleagues here on the panel, as well.
>
> What would constitute an authoritative statement from USDA? Who should
> decide if the statement is authoritative? Who should decide when a
> statement is no longer current? These are all critical questions which
> must be answered to properly administer this provision of the FDA
> Modernization Act.
>
> USDA has heard and does appreciate the various perspectives on this
> issue that have been expressed here today.
>
> Now I\'d like to provide just a little bit of perspective on how USDA
> views this issue. USDA directly employs thousands of scientists
> through the Agricultural Research Service, Economics Research Service
> and other agencies. USDA also indirectly supports thousands more
> through competitive grants and our land grant partners. These
> scientists are constantly generating new information, developing new
> technology and publishing their research results. This includes
> science and technology directly and indirectly related to diet, health
> and nutrition.
>
> Communicating with our customers about research results is a vital and
> integral part of our research mission and we use a variety of media to
> do that. The sheer volume of scientific information generated by USDA
> scientists and disseminated by our extension partners has the
> potential to lead to a great deal of confusion over what constitutes
> an authoritative statement from USDA.
>
> Two examples which may help define the question we are examining
> today. First, USDA, after a great deal of deliberation and
> consensus‑seeking, issues broad dietary guidelines. These guidelines
> are general in nature but result from years of nutrition and health
> research and can be applied generally across the population. They are
> updated when the need arises or science changes, again through a
> deliberative process. This is one example of something that could be
> interpreted as an authoritative statement from USDA.
>
> On the other hand, USDA scientists make thousands of recommendations
> every day for thousands of applications, based on the best science
> available at the time. Fertilizer recommendations, animal nutrition
> and health, water quality protection are just some of the examples of
> areas where our science and extension partners give advice and
> transfer scientific results from the laboratory to the field.
>
> Likewise, our extension home economist partners and expanded food and
> nutrition education program case workers are just two examples of how
> USDA‑affiliated groups sometimes give advice to people on proper
> nutrition and diet.
>
> These recommendations that cover a broad range of issues are not, from
> USDA\'s perspective, what we would consider to be authoritative
> statements based on consensus or broad deliberation.
>
> From the discussion this morning and from legislative intent, it seems
> clear that individual investigator publications or employee statements
> do not constitute authoritative statements. We learned time and time
> again that preliminary research results are constantly revised and
> refined with the discovery of new information.
>
> From the perspective of USDA, an authoritative statement is the
> product of deliberation and broad consensus which forms long‑term and
> replicated scientific conclusions. But there is a huge continuum.
> There\'s the dietary guidelines that are the result of broad
> consensus‑seeking and those every‑day recommendations that an
> extension agent or home economist gives on diet and nutrition. And
> where should the line be drawn between a recommendation and an
> authoritative statement?
>
> And I appreciate the good input that all of you are providing to that
> question today and we\'ll continue to work on implementing those
> recommendations.
>
> USDA is clearly going to continue to work with FDA when claims are
> submitted on the basis of USDA statements. USDA has been and will
> continue to be an active partner in the Liaison Group process. The
> agency has every incentive to carefully consider and review whether a
> particular claim represents an authoritative statement on behalf of
> the agency. And we welcome further discussion on this complex issue as
> we work to continue to define our policy and our relationship with
> FDA.
>
> I apologize for having to run out. I\'m due at another speaking
> commitment in about 15 minutes. So thank you very much for this
> opportunity and I look forward to seeing the comments from the
> process.
>
> MR. LAKE: Thank you.
>
> The remaining panelists will be introduced according to alphabetical
> order. The next speaker will be Dr. William Harlan from NIH.
>
> DR. HARLAN: Good afternoon. It\'s a pleasure to join you. I\'m the
> associate director for disease prevention of the National Institutes
> of Health, within the Office of the Director.
>
> What I\'d like to present today is the way in which we\'ve approached
> the issue of what is an authoritative statement and then the process
> for determining whether it\'s an authoritative statement in response
> to the FDA queries.
>
> You saw this morning these blocks where the Food and Drug
> Administration supplies to an agency a statement and asks whether
> it\'s an authoritative statement. The agency then makes a
> determination and responds back to the FDA.
>
> I\'m going to open this middle box, at least as far as the NIH is
> concerned. Let me point out first that the National Institutes of
> Health actually is 25 institutes and centers and, in addition, the
> Office of the Director. And from the very first authorization of NIH
> it was to conduct health research, but another important part of that
> was to interpret and report the findings to the public, to health
> providers and to researchers of that research.
>
> So it\'s in the authorization of NIH and has been there from the
> beginning, for now over 50 years.
>
> The product of the research that\'s supported are a very large number
> of reports, and I\'ve tried to break them down here so that we could
> talk about them in an informed way.
>
> First of all, we support research throughout the entire country and
> throughout the world through grants and contracts. These scientists
> who are supported may report their results without our review. And, as
> a matter of fact, we don\'t try to abridge their First Amendment
> rights by even attempting to review what they say.
>
> So they may say, as a result of the research that they have conducted,
> a number of different things for which we have no review and no
> responsibility with respect to how they\'ve interpreted the science.
>
> We also have about 15 percent of our budget is engaged in intermural
> research and these researchers also may report their results. Their
> research is reviewed generally before it\'s sent out but more from the
> perspective of the quality and the validity of the research, rather
> than the interpretation of the research.
>
> Those are, however, reports by individual scientists and often contain
> very speculative comments, speculation on the future direction of
> research, on the mechanisms that might be included.
>
> Periodically the reviews are initiated by an IC, an institute or
> center, or the Office of the Director and are reviewed by the
> sponsoring institute and center before release, and the membership on
> many of these is usually nonfederal or federal, usually both, and the
> review is designed to assess all the available information, the
> so‑called totality of evidence, and arrive at statements that
> represent a consensus or identify controversies that need further
> exploration.
>
> Let me give you an example of how one might move from the second of
> these to the third of these. Very frequently we conduct large clinical
> trials. The results of those large clinical trials are put forward in
> a public announcement of the result of the trial and yet that\'s not
> considered a statement that has reviewed all the evidence.
>
> Following the release of a large clinical trial, we quite frequently
> impanel a group of individuals to look at the results of that study,
> that trial, in association with all of the foregoing research and come
> to a conclusion about the interpretation and the utilization of the
> information that\'s being provided.
>
> Now there are also reviews that are initiated by an institute or
> center and by the Office of the Director that are not reviewed and
> approved by NIH and the question came up this morning about consensus
> conferences.
>
> Just a quick reminder. The consensus development conferences, the
> membership is all nonfederal. There is no review of the statement made
> by the consensus panel and, as a matter of fact, the institutes and
> centers may disagree with the statement made by the consensus panel.
>
> Those of you who are familiar with the consensus conference on
> mammography for women under 50 years of age two years ago will
> recognize that the consensus panel came to one conclusion and
> following that, the National Cancer Institute impaneled a group of
> federal and nonfederal individuals to look at the information and came
> up with a different conclusion. So consensus conferences are not, in
> our view, authoritative statements.
>
> We also develop a lot of public education materials and they\'re
> developed by individual institutes and centers, often in collaboration
> across the institutes and centers. They may be designed by
> individuals. They\'re reviewed by staff. And where they have to do
> with nutrition, they\'re reviewed by the Division of Nutrition
> Research Coordination, Education Subcommittee or by their ad hoc
> groups.
>
> Most of these contain statements that are based on recommendations
> that have come from prior institute and center assessments. That is,
> they seldom are groups impaneled to come up with an authoritative
> recommendation at that moment, looking at all of the science. Rather,
> they are to interpret and to carry forward the recommendations that
> may have been made by an earlier panel, this one down at the bottom,
> and put it into an educational framework.
>
> Incidentally, not all of those educational programs are currently
> reviewed necessarily by a panel of federal employees or by a group
> within NIH. So, in fact, some of them would not have had that agency
> review that would form the general agreement or consensus.
>
> The definition of authoritative statement that we\'ve used is included
> here. None of this is terribly new to you except I would emphasize a
> couple of things.
>
> As we looked to some of the earlier statements, it was apparent that
> it should be a statement that\'s in context, and some of the
> statements had been taken out of context so that it gave one set of
> meanings when, in fact, another was intended, even by the author. And
> some of the context that\'s removed contains this kind of speculative
> statement or discussion of possible further studies that might be done
> or further actions that might be taken by the public.
>
> Current statement I think is a bit difficult because, in fact, we\'ve
> never sat down and tried to determine when a statement was no longer
> current, except for consensus statements, which are reviewed
> periodically, now about every two or three years, to be sure that they
> are current. But we\'ve not done that and clearly it\'s done at the
> time that one is asked what is an authoritative statement.
>
> We have used the view that this is a consensus from the NIH
> perspective, that is, as a single agency, keeping in mind that with 25
> institutes and centers, with a good deal of joint funding, a good deal
> of joint interest, that no one institute owns the nutritional area or,
> in fact, many different areas, with respect to any particular disease.
> In fact, the trend is very strongly for the institutes to fund jointly
> projects that are involved with modalities such as diet and exercise
> that cut across many different disease entities.
>
> Moreover, many of the institutes have cross‑interests. The National
> Institute on Aging, for example, obviously has common interests with
> the Cancer Institute, with the Heart, Lung and Blood Institute. The
> National Center for Complementary and Alternative Medicine obviously
> has an interest that cuts across almost all of the other programmatic
> institutes.
>
> So we\'ve taken the position that we do need to have an understanding
> within the total agency about any particular statement.
>
> Now these things that they are not, I think we\'ve discussed already.
>
> Let me say something about the process that\'s used. What we have done
> is to identify representatives from the institutes and centers that
> have expertise in nutrition and nutritionals, and I have coordinated
> the reviews with the input from those individuals and we have simply
> taken the statement that was presented to us, followed up on the
> information, made an interpretation of that and supplied that
> interpretation back to the FDA. We\'ve not been involved in looking at
> whether the claim is a legitimate claim with respect to the statement,
> only whether the statement is, in fact, an authoritative statement
> that represents the view of the agency.
>
> We would intend to continue to do this with coordination across the
> institutes and centers and provide a single view that represented the
> view of the entire agency. And secondly, we hope, as we move along
> through this, that we\'ll begin to have some meetings that will allow
> us to come to a better common understanding, I think, of what would
> constitute an authoritative statement. We\'ve been operating very much
> on an ad hoc basis thus far.
>
> I\'ll stop at that point. I think I\'ve answered some of the questions
> that arose this morning but I\'m sure there will be others. Thank you.
>
> MR. LAKE: Thank you very much. That was very informative.
>
> Next we\'re going to hear from Dr. Linda Meyers, DHHS.
>
> DR. MEYERS: Thank you. I\'m pleased to be here today as the acting
> director of the Office of Disease Prevention and Health Promotion in
> the Office of Public Health and Science in the Office of the Secretary
> in the Department of Health and Human Services.
>
> The Office of Public Health and Science is headed by Assistant
> Secretary for Health and Surgeon General David Satcher.
>
> Given our smaller role and portfolio in relation to my colleagues from
> NIH, CDC and USDA, I\'m going to keep my remarks very brief.
>
> Surgeon General Satcher spends much of his time talking with and
> especially listening to the American people, including around
> priorities that encompass achieving healthy lifestyles through
> community and individual interventions. So I\'m sure he would want me
> to thank FDA for convening this meeting and you all for participating
> in this opportunity to talk and to listen.
>
> The timing of this meeting is particularly useful to us because we are
> still working on operationalizing our role related to authoritative
> statements.
>
> I have appreciated the opportunity to hear the perspectives this
> morning and I look forward to further discussion this afternoon.
>
> I wanted to mention three assumptions that underlie my comments. One,
> that it is important to educate consumers about healthful food
> choices; two, the use of authoritative statements, if used
> appropriately, can facilitate this; and three, we in public health
> have an obligation to work to achieve the expeditious translation of
> sound scientific evidence to consumers in ways that they can apply to
> improving their health.
>
> A number of questions are on the table for discussion today. I\'m
> going to comment on only several of them, recognizing that these are
> \"draft thoughts,\" if you will, and not \"authoritative statements.\"
>
> Before I do that, let me explain what falls in our portfolio. When I
> began, I mentioned that the Surgeon General was also the Assistant
> Secretary for Health. This dual role is rather unique and encompasses
> responsibilities as the senior adviser for public health and science
> to the Secretary, thereby providing senior professional leadership on
> population‑based public health and clinical preventive services,
> directing program offices housing a variety of essential public health
> activities, providing senior professional leadership across HHS on
> White House and secretarial initiatives involving public health and
> science, guiding and providing technical assistance to 10 regional
> health administrators, and directing the Public Health Service
> Commission Corps.
>
> The Surgeon General is generally viewed as the nation\'s doctor and is
> charged also with enhancing the public\'s understanding of public
> health issues and focussing attention on critical health issues.
>
> You are familiar with Surgeon General\'s Reports. The Surgeon General
> also issues proceedings of workshops and has issued letters. Of the 30
> or so Surgeon General\'s Reports, many on tobacco, there has been one
> on nutrition in 1988 and one on physical activity in 1996. These are
> listed on the Surgeon General\'s website if you\'re
> interested‑‑surgeongeneral.gov, which, by the way, is being updated
> and enhanced for release later this month.
>
> Reports on oral health, mental health and dietary fats and health are
> expected at different points within the next year.
>
> These reports are characterized by review and discussion of key and
> often contentious scientific issues of public health importance and by
> specific recommendations. They are also characterized by a
> deliberative review process.
>
> The overall recommendations are generally regarded to be as firm as
> the collective scientific wisdom of the Public Health Service and the
> broader scientific community allows. They are not the work of an
> individual employee and they go through a formal clearance process
> within HHS, so one might characterize the recommendations as official
> positions.
>
> Thus, a Surgeon General\'s Report is an authoritative document and one
> would think its recommendations are authoritative statements. However,
> it is difficult for me to argue that each sentence in the document
> should carry the same weight as a recommendation because many are
> providing background or commenting on differing perspectives.
>
> The same might be said for the Dietary Guidelines for Americans, which
> is also coordinated for HHS by the Office of Public Health and
> Science.
>
> To the extent that a recommendation is cited as an authoritative
> statement, that would seem clear‑cut and require little additional
> consideration by a scientific body. We have not seen that, however.
> What we have seen is individual sentences used that are just
> background or that are taken out of context, and I think that has made
> our task more challenging.
>
> Dr. Satcher often quotes John Gardner\'s statement to the effect that
> life is full of golden opportunities masquerading as irresolvable
> problems. I am hopeful that today\'s discussion will move us in the
> opportunities direction. And as we move in that direction, I think we
> need to make sure that our actions derive from and are driven by a
> science base, address important public health priorities, and resonate
> and are useful to the American people in their health decisions.
>
> MR. LAKE: Thank you for those comments.
>
> Before going to our two final panelists, let me remind you that at the
> end of the presentations by the panelists, there will be further
> opportunity for questions and again we will use the same procedure we
> used this morning of you filling out cards and our people bringing the
> up to us.
>
> The next speaker is Dr. Dixie Snider from the CDC.
>
> DR. SNIDER: Thank you very much. I, too, appreciate the opportunity to
> be here and engaged in this dialogue about authoritative statements.
>
> I\'m the associate director for science at the Centers for Disease
> Control and Prevention. And in order to help you understand CDC\'s
> role in assisting FDA in implementing FDAMA, I wanted to provide you
> with some explanation of the role of CDC in the public health
> community and say a few words about how we develop and disseminate
> health messages.
>
> Of course, CDC is a part of the Department of Health and Human
> Services and our mission is to promote health and quality of life by
> preventing and controlling disease, injury and disability. And we
> would consider appropriate health claims as being a part of that
> mission.
>
> As part of our mission, we work very closely with other agencies
> within the Public Health Service, in particular FDA and NIH. We
> routinely share new findings and pertinent information and even do
> joint investigations and research projects with them. We\'re all
> working toward the common goal of improving the nation\'s health.
>
> We also work with the department and all the recommendations regarding
> human nutrition are reviewed by an interagency Nutrition Policy Board
> prior to release.
>
> CDC began in 1946 as a malaria control program and many people
> consider us still an infectious disease agency, but we\'re really much
> more than that now. We work closely with state health departments,
> with local health departments and many other partners throughout the
> nation to accomplish our mission and we monitor health, detect and
> investigate disease outbreaks, perhaps one of the things we\'re most
> noted for, conduct research, develop and advocate sound health
> policies, implement prevention strategies, promote healthy behaviors,
> again usually with partners in the community, such as health
> departments and other community‑based organizations.
>
> We\'re not a regulatory agency but rather, we\'re focussed on carrying
> out all these activities. And since our inception, we\'ve played an
> essential part in the prevention and control of a number of diseases,
> such as smallpox, polio, Legionnaires disease, AIDS, hanta virus,
> eboli and, more recently, hendra virus and influenza H9 and whatever
> comes along.
>
> The scope of our activities has broadened and while we still maintain
> our historic commitment to the prevention and control of infectious
> diseases, today we address virtually all of the major health threats,
> from environmental hazards such as lead poisoning to chronic diseases,
> such as heart disease and cancer, to occupational illnesses, injuries.
> And one of the characteristics is that our research programs tend to
> be closely linked to operational control and intervention programs.
>
> As you may be aware, CDC has become very active in recent years in
> providing leadership in promoting healthy eating patterns and we\'re
> committed to improving the overall nutrition of the public. And many
> of our centers, institutes and offices are engaged in activities to
> further this goal, very similar to what Bill described.
>
> Most activities in the area of human nutrition, however, do involve in
> some way the Division of Nutrition and Physical Activity in our
> National Center for Chronic Disease Prevention and Health Promotion.
> This is where many of the reports and guidelines related to nutrition
> and physical activity, including Surgeon General\'s Reports that have
> been mentioned, were born.
>
> We disseminate information regarding nutrition and other
> health‑related conditions in a variety of ways. My role as associate
> director for science is to promote and support an environment of
> scientific excellence and integrity, as well as the rapid
> dissemination of scientific information.
>
> And to achieve these goals, my staff and I are responsible for
> resolving controversial scientific issues, for developing sound
> scientific policies and procedures for the agency, for promoting the
> highest standards and criteria for scientific reports, for assuring
> the protection of human subjects and for facilitating the timely
> transfer of knowledge and information that improve public health. So
> that means my office gets involved with a lot of these documents
> we\'re talking about today.
>
> Health information from CDC is relayed in a variety of ways‑‑through
> scientific reports, articles, perhaps most notably in the Morbidity
> and Mortality Weekly Reports. The primary audience for most of the
> publications is the scientific community, although other groups may be
> targeted, as well.
>
> And scientific reports and articles that are authored by individual
> employees or groups of employees in a specific center, institute or
> office of CDC are peer‑reviewed but they do reflect, and this is again
> very similar to NIH, they reflect the findings, the individual
> opinions of the scientists within the centers, and not those of CDC.
>
> On the other hand, there are other publications, such as the MMWR
> Recommendations and Reports series, which contain in‑depth articles
> that relay policy statements for prevention and treatment of many
> areas in CDC\'s scope of responsibilities. And it\'s these kinds of
> statements in the MMWR Recommendations and Reports series which have
> undergone clearance by the Office of the Director, by my office.
> They\'ve been reviewed usually extensively by the other Public Health
> Service agencies so that we not only have consensus within our own
> agency but hopefully a consensus within the Public Health Service
> about what\'s being published.
>
> An example of that would be the publications of the committee that
> I\'m the executive secretary for, the Advisory Committee on
> Immunization Practices, where we have an FDA representative, an NIH
> representative participating in the deliberations of representatives
> from many professional societies, as well as individual external
> members. They come up with recommendations for the CDC director and
> then the director decides whether or not he accepts those
> recommendations and, if so, they\'re published in the Morbidity and
> Mortality Weekly Report and I would regard most of those as
> authoritative statements, although even then I think there would have
> to be some caveats because you may remember the hanta virus outbreak,
> I think we issued an MMWR about how to keep rats out of your home,
> which basically represented the opinions of several experts and not
> too much science behind them.
>
> So I think making some blanket statement about the MMWR
> Recommendations and Reports series would be inappropriate. However,
> you would commonly find authoritative statements from CDC in that
> particular location.
>
> We do have guidelines that are on the Internet. There\'s a CDC
> Prevention Guidelines Database, which is a repository of 400 CDC
> guidelines for the prevention and control of public health threats.
> They were originally published in the MMWR\'s monographs or perhaps
> they were published as chapters in books or articles in peer‑reviewed
> journals. And we have a steering committee which includes
> representatives from various components of CDC that selects entries
> for this database through the recommendations of the various associate
> directors for science and other individuals in CDC management.
>
> These guidelines have undergone review and approval by my office and
> would be considered official CDC policy.
>
> So I think we have a lot of commonalities with NIH, but a few specific
> examples of where authoritative statements from CDC are likely to be
> found. I hope this gives you a little bit of understanding of how
> we\'re thinking about this.
>
> And I don\'t have to repeat what Bill has already shown you because we
> operate very much the same way in terms of the process, with me
> serving as the central liaison, then using our various centers and
> institute divisions and offices, as appropriate, to look at those
> documents and then provide the information back to FDA. Thanks.
>
> MR. LAKE: Thank you.
>
> Our final speaker for this panel will be Dr. Allison Yates from the
> National Academy of Sciences.
>
> DR. YATES: Thank you very much. I\'m Allison Yates, as I was
> introduced. I\'m the director of the Food and Nutrition Board. You\'ve
> heard many times but I guess I have to spend a little bit of time
> reinforcing what is the National Academy of Sciences and how it does
> its work, to try to differentiate how the approach to authoritative
> statements is being interpreted within the Academy.
>
> The first overhead is essentially a description of the National
> Academy of Sciences. It is not part of the government. It\'s a private
> corporation that was established by federal charter when Lincoln was
> president to essentially address issues of scientific interest that
> are of national interest, in response to requests from various federal
> agencies, from Congress at times, and then from the private sector on
> occasion.
>
> The one basic component is all of the studies that we do, at least
> half of the funds that come forth to support the study are from
> nonprofit federal or private foundations that are not going to
> directly have any benefit perhaps to the outcome of the study.
>
> I think it\'s important to talk about how the Academy operates because
> when you get into the language that was put into the FDAMA
> legislation, it makes it a little problematic for us to function as
> some of the other scientific bodies that were identified do.
>
> The next slide just gives you an idea, when we talk about the National
> Academy of Sciences and its subdivisions, that there are essentially
> three honorific membership organizations: the Academy of Sciences,
> which, as I said, started in 1863, but also the Academy of Engineering
> and the Institute of Medicine, which all have members involved.
>
> Well, there were so many questions that were coming to the Academy
> before World War I that the National Research Council was set up as an
> administrative arm. So many times you see reports of the National
> Research Council, which are actually reports of the National Academy
> of Sciences.
>
> The next overhead provides a little bit of description of the Academy
> and what it does a little differently than some other units. One is,
> as I said, it responds to requests from the government and the private
> sector, but it can make some of its own determinations.
>
> Is it an appropriate request? Just because it\'s written into
> legislation that we will look at something or the Academy is to
> conduct a study, it doesn\'t mean that we have to accept that charge,
> and at times we don\'t.
>
> It\'s allowed to specify the approach and the scope for the study.
> There is a contract but it\'s usually fairly brief for the type of
> work that\'s outlined. The Academy determines who\'s going to be on
> committees that look at these issues, what experts are going to be
> pulled together, and usually there\'s a definition of the type of
> expertise that will be required.
>
> It has an internally built‑in peer‑review process for all the reports
> that would, in essence, be consensus reports, and as such, is a little
> different than other groups that may be contracted with to provide
> scientific assessments.
>
> And typically it can also identify topics that the staff or members of
> the Academies or the organizations think are important and then
> seeking funding and, if necessary, fund from internal endowment funds,
> so that not all the reports from the Academy have federal sponsorship.
>
> So it\'s somewhat independent and I imagine that was the rationale for
> why it was included as one of the scientific bodies in the actual
> language of the legislation.
>
> The next overhead has a few points about the Food and Nutrition Board.
> Here, as you see, what we\'re dealing with in looking at diet and
> health promotion, one of the major focus areas of the Food and
> Nutrition Board has, over time, been evaluating nutrient requirements
> and relationships between diet and reduction of risk of chronic
> disease.
>
> Now, this happens to be an old slide of mine, so I didn\'t do it just
> for this meeting, but you can tell why perhaps this language went in.
>
> But I want to point out that there are a number of groups within the
> Academy that do studies that relate to diet and health relationships.
> If it deals with pesticides or potential carcinogens, it may come out
> of another board on environmental studies and toxicology. There\'s a
> board on agriculture and natural resources. So not all the reports
> that might be actually under FDAMA are actually under the group that
> I\'m involved with. So that means that we have to have more of an
> Academy‑wide approach to how do we deal with authoritative statements.
>
> The next overhead has actually the three components that we\'ve
> already talked about from the FDAMA legislation, talking about, and I
> guess this is more from my perspective, the three issues that, as one
> of the scientific bodies, we have to deal with would be: Is it an
> accurate reflection of what appears in a report? Has the group
> determined that it\'s authoritative in some sense? And then is it
> current?
>
> Well, I brought along some of the reports actually that Dr. Marriott
> mentioned. This is the Diet and Health Report from 1989. It obviously
> has a number of statements in here relating diet and health to
> disease. And then there\'s the \'89 RDA, Recommended Dietary
> Allowances book, which goes over the specific nutrients and their
> involvement in various types of diseases.
>
> The real concern, though obviously, is how do you look at this and
> really say well, which of the statements included in here would we
> recognize as authoritative? And because also it\'s important to
> realize that a fair amount of what‑‑in fact, almost all that the Food
> and Nutrition Board certainly does comes from specific funded projects
> that the project funding for diet and health went out certainly in the
> 1980s and we no longer funded to review these issues. We have to have
> a project in process where there\'s a current review in order to
> really answer a question in terms of currency. Is this still current?
> Well, some of the topics in here may be and others may not be.
>
> Many of you know we\'re currently going through an expanded format for
> developing RDAs. It\'s called dietary reference intakes. Well, part of
> this process is to look at not just things that have been previously
> determined nutrients but other things that are found in foods that may
> play a role in health. So, in a way, many of the components that are
> in the Diet and Health Report are being reviewed in the new process
> for dietary reference intakes.
>
> So the real question of what\'s current can be problematic. And just
> as someone else earlier said, we don\'t normally say, \"Aha, we
> declare this book null and void; it\'s no longer current.\" We
> typically don\'t reprint it and then the print runs out and so it\'s
> no longer available. If it\'s in a series, then we have a new edition,
> and that would be more obvious.
>
> The next overhead goes over, though, what the Academy\'s response has
> been to providing some guidance about what would be an authoritative
> statement from the Academy. In fact, almost a year ago the governing
> board of the Academy, based on discussion of what are authoritative
> statements for the purpose of FDAMA, developed a policy statement
> which I\'m going to read to you, but the major points are outlined in
> the overhead. And it\'s only two paragraphs.
>
> \"In the conduct of studies with regard to relationships between diet
> and health and in the course of review of research relating to
> questions under study, it is possible that reports of the NRC or
> IOM\"‑‑Institute of Medicine‑‑\"may describe associations between
> foods, nutrients or food components and aspects of health. These
> statements would not necessarily represent authoritative statements of
> the NRC or IOM because they might not summarize the totality of the
> evidence that would be required by the Academy when formulating an
> authoritative statement.
>
> \"For example, a report may contain descriptions of the work of others
> or, on occasion, minority reports expressing the views of individuals.
> Descriptive materials and minority reports, as examples, are not
> considered authoritative statements of the National Academy of
> Sciences or any of its subdivisions.
>
> \"For the purposes of FDAMA, authoritative statements of the National
> Academy of Sciences or any of its subdivisions, including the NRC and
> the IOM, are limited to those that represent the consensus of a duly
> appointed committee or views of a duly appointed principal
> investigator so that they appear explicitly as findings, conclusions
> or recommendations in a report that has completed the institutional
> report review process.\"
>
> So we are delimiting what might be considered an authoritative
> statement, and I think you can see that those are the major points.
>
> Let\'s go to the next overhead, which in essence is some guidance that
> we\'ve provided to date.
>
> As I said, we don\'t have a continued stream of funding to deal with
> authoritative statements. Actually we have no funding to deal with
> authoritative statements. And in truth, if one really wanted to
> determine if a statement that appeared in one of our books or reports
> was authoritative and accurate, we might have to bring the whole
> committee back together again and have them look and say well, is this
> what you meant?
>
> And we did discuss that, but it was determined that really that is
> meeting a regulatory need, as opposed to the scientific need. If
> someone doesn\'t understand what\'s written in here, then we should
> redo the report.
>
> So the determination has really been that the executive summary, by
> and large, and most of our reports have executive summaries, is the
> place that one is going to find the integration of all of the material
> that the committee looked at and the major findings related to some
> aspect of diet and health.
>
> And in the case of this book, it\'s roughly about 16 pages, so it\'s
> not a huge component but it does contain the major findings.
>
> And, as an example, there may be a chapter on cardiovascular disease,
> talking about a particular food component and it may be positive,
> where in another chapter dealing with cancer, it may have a negative
> effect, so one has to review all of that in the totality of the whole
> report.
>
> I think that\'s the last overhead, I hope.
>
> So I think the important thing to note is that we have chosen, because
> we are not part of the government, to not necessarily, in fact, to not
> respond to individual requests about is this authoritative or not, to
> provide this guidance to the regulatory bodies that are charged with
> enforcing the regulations and the legislation that\'s been passed and,
> as best we can, provide guidance in a more general way because within
> our processes, in order to make a decision‑‑is this authoritative or
> not?‑‑we would have to convene a whole committee and that\'s not
> possible within the time frame of FDAMA, within four months, or within
> the cost constraints of our operation. Thank you.
>
> MR. LAKE: Thank you.
>
> We have a few questions left over from this morning that actually
> relate more to this panel that we\'ll come to in a moment. Again we
> have people who will be taking any cards with questions from people in
> the audience.
>
> But before we get to that, let me just give the panel members
> themselves, if you have any comments that you wish to make that were
> triggered by comments by other members of the panel or if you have any
> questions of each other, now would be an opportunity to do that. I\'ll
> give you that opportunity first.
>
> \[No response.\]
>
> MR. LAKE: All right, none of those.
>
> Chris, we have some questions from this morning and maybe you could
> start with some of those.
>
> **DISCUSSION/QUESTIONS FROM AUDIENCE**
>
> DR. LEWIS: One of the questions that did come up this morning that
> we\'ve reserved slightly, at least, for this panel is the question:
> Will there be or does a mechanism exist whereby data may be submitted
> to a scientific body in order to generate a claim? So there\'s some
> interest in how the world at large can interact with scientific bodies
> relative to authoritative statements. Perhaps each of you could
> comment on that.
>
> DR. HARLAN: I\'ll give it a try, if I understand the question. The
> question would be would someone come forward with a body of data and
> then ask the federal agency to evaluate that and make an authoritative
> statement based on that?
>
> DR. LEWIS: I\'m assuming that\'s the question, yes.
>
> DR. HARLAN: I guess the only mechanism that quickly comes to mind is
> for someone to go to a part of NIH and suggest that they have a review
> meeting to look, let\'s say, at the differences that have now arisen
> in opinion regarding the amount of fat in the diet or the type of fat
> in the diet. Then the agency would have to, I think, convene a review
> group to address that.
>
> But I don\'t know that there\'s any kind of petitioning mechanism that
> I know of to do what I think the question implies.
>
> DR. LEWIS: Thank you.
>
> DR. YATES: Maybe I could comment. Of course as part of our DRI
> process, we are looking at many nutrients and food components and
> their role in health. So in that process, we are essentially, I think,
> providing at least the scientific review. But then, as I said, it\'s
> really up to, at least from our perspective, the FDA to determine is
> this new information authoritative. From our perspective, if it\'s in
> the summary and so on, it probably would be, based on our policy. And
> then determine if it\'s significant scientifically.
>
> DR. SNIDER: From CDC\'s perspective, it would be very similar to the
> NIH response in that except for established external advisory
> committees where a proposal could be put forward on issues, I would
> anticipate, first of all, that most of our scientists who are working
> in a particular area under their charge are pretty well aware of the
> scientific data, but we\'re certainly open to having additional data
> and suggestions presented to our programs.
>
> Then I think what process we might choose to try to ascertain whether
> the strength of the evidence and how much consensus there is around
> the interpretation of the evidence and so forth might vary, depending
> upon the particular type of issue that\'s being addressed.
>
> We have formal advisory committees around certain issues that inform
> certain parts of CDC. These are chartered under the Federal Advisory
> Committee Act. Then at other times we get ad hoc groups together or
> may call public meetings like this to try to ascertain the level of
> consensus.
>
> But I guess the bottom line would be that we\'re always open to
> talking to people about the data and what that might mean in terms of
> how consumption of any particular food item or supplement might
> improve people\'s health and work with them to determine what the
> policy implications of the data might be.
>
> DR. MEYERS: I think Dixie actually reflected the interest that I would
> have in his last few statements when he talked about the public health
> implications.
>
> I think the broader question is is this really a relationship that is
> of public health significance that we in the Surgeon General\'s Office
> or in the federal government should be paying more attention to and
> informing the consumers about, not necessarily limited to a health
> claim, but is it a broader issue that we need to be doing something
> about?
>
> DR. LEWIS: And then one other question left from this morning is the
> question: Shouldn\'t the scientific bodies set aside a specific
> publication that could be used as the basis for claims? I\'ll let
> anyone who\'d like to answer that do so.
>
> DR. HARLAN: Would you repeat the question?
>
> DR. LEWIS: I know it\'s difficult to hear up here. I\'m sure for the
> audience it\'s hard to know why we keep frowning at each other but
> there\'s an incredible echo.
>
> Shouldn\'t the scientific bodies set aside a specific publication that
> could be used as the basis for claims?
>
> DR. HARLAN: Oh, you mean should there be a separate and identifiable
> publication in which all claims were to be published, and that would
> be the standard for‑‑
>
> DR. LEWIS: Presumably all authoritative statements, yes.
>
> DR. HARLAN: Where all authoritative statements should be published. I
> guess none of us has really thought about doing that. At NIH, as you
> probably know, our inclination now is to try to put as much up in
> public as possible by using electronic means, rather than print means.
>
> So dedicating a journal or a particular site for this goes in the
> opposite direction from what we\'re trying to do now, which is to
> provide as much information as widely available as possible.
>
> DR. SNIDER: I guess my response would be that at least
> retrospectively, that would seem to me to potentially work against the
> interests of the public health, as well as the interests of industry
> and others. I mean if there is a bona fide authoritative statement out
> there that we all could support and it doesn\'t happen to be in this
> particular designated journal or whatever we want to call it, then we
> should use it anyway.
>
> I think in thinking prospectively about how to disseminate information
> and what we\'re disseminating, it\'s a useful comment or question in
> that not that we necessarily want to put documents that contain
> authoritative statements all in one place, because there are different
> audiences and different ways to reach those audiences. But we also
> might think of them as whether they are authoritative statements or
> not and use electronic technology that Bill was just talking about to
> create some file that might be considered a file in which there are
> authoritative statements.
>
> But I think if we were to pursue that, it would require a lot more
> discussion and thought than we\'ve been able to give it here.
>
> DR. LEWIS: We actually have now a series of questions all directed to
> NIH and one of them leads off with a question for us, which would be
> to give the name of the USDA representative.
>
> Mr. Phillip Schwab, S‑c‑h‑w‑a‑b, was substituting for Eileen Kennedy
> today for USDA.
>
> Then in terms of a question for Dr. Harlan, when would NIH‑‑when would
> he accept an NIH subunit statement as authoritative statement; that
> is, without a whole or entire NIH review?
>
> DR. HARLAN: You\'ll have to repeat it. I still didn\'t hear it
> clearly.
>
> DR. LEWIS: When would you accept an NIH subunit statement as an
> authoritative statement; that is, without an entire NIH review?
>
> DR. HARLAN: Well actually, most of the statements that come through
> are seen clearly by the subunits as a part of this liaison activity
> and they simply are moved from the coordination office, mine, down to
> the subunits and then some discussion against those subunits that have
> a particular interest in it.
>
> Osteoporosis, for example, is of interest to the Arthritis,
> Musculoskeletal and Skin Diseases, to the National Institute on Aging
> and to the National Institute of Diabetes, Digestive and Kidney
> Diseases. So if something came through related to osteoporosis, we\'d
> obviously want to have, at minimum, the view of those three groups.
>
> Now if it\'s something related exclusively to cancer and there\'s no
> other source of information or no other interest, we probably would
> take that and simply ask them to review it, look at it and then pass
> it along.
>
> I guess that answers the question.
>
> DR. LEWIS: I think the interest is in the subunits versus the whole
> and you did answer that.
>
> There\'s also another question for NIH that we discussed a little
> earlier this morning. Often NIH holds a consensus conference with a
> report derived from a group of scientists not expert in the field
> that\'s being evaluated. Their findings may be in opposition to other
> NIH subunit office statements. Should such consensus statements be
> given the same weight as to the deliberative review from the NIH as a
> whole?
>
> DR. HARLAN: Actually we have a number of indications that this isn\'t
> the way that NIH works, even before the issue of authoritative
> statements came up. And the best example is the mammography
> conference. The consensus panel concluded that mammography was not in
> the interest of all women under age 50 and a panel was put together by
> the National Cancer Institute that came to a different conclusion
> about a year or 14 months later. And that is the policy of NIH; that
> is, the National Cancer Institute policy.
>
> DR. LEWIS: Now there is a question for CDC and the Academy. Have you
> provided authoritative statements to federal agencies other than FDA?
>
> DR. SNIDER: Yes, I\'m sure we have. I\'m not sure of the purpose of
> the question or exactly how it fits in, but certainly in the
> development of many of the statements that we would view as
> authoritative statements, in addition to FDA, NIH or HRSA or AHCPR or
> USDA, many other people may be involved and often are involved in the
> development.
>
> Also let me just comment also about CDC as it relates to the
> statements of our centers. I want to emphasize again that just because
> a division has a certain name doesn\'t mean that that is the only
> division or branch within CDC that has an interest and knowledge about
> a particular topic.
>
> So one of the reasons, one of the rational aspects of this, having it
> as a CDC statement, something that\'s been approved by the Office of
> the Director, means that all of our scientists who have the knowledge
> and interest in a particular topic, even though they may not work in
> the place where the authoritative statement arose, the first draft
> appeared, there are other parts of our agency that need to take a look
> at it.
>
> And we would not feel a level of comfort of consensus within the
> agency until we had that opportunity to cross clearances, as well a
> look from the Office of the Director.
>
> DR. YATES: What was the question?
>
> DR. LEWIS: Have you ever provided authoritative statements to federal
> agencies other than FDA?
>
> DR. YATES: I have to say that I don\'t know that we have \"provided
> authoritative statements.\" What we have done is produce reports that
> are the result of consensus committees that are available to anyone,
> not just to FDA. And imbedded in these reports would be statements
> that one could really say meet at least the definition that the
> Academy has developed for what is an authoritative statement for the
> purposes of FDAMA.
>
> DR. LEWIS: We now have a question for the entire panel and it\'s a
> follow‑up, I believe, on the suggestion that Dr. Marriott put forth
> earlier this morning.
>
> What is your opinion of preparing a white paper on specific examples
> of authoritative statements? Do you feel it\'s a practical starting
> point for the types of discussions we\'re having today?
>
> DR. HARLAN: I\'ll start off, since I\'m down at this end of the table.
> I think it\'s a reasonable thing to do. I would keep in mind that
> there are lots of examples out there of what, in retrospect, would be
> called authoritative statements. If you look at the cholesterol
> education program, for example, regarding dietary intake, serum
> cholesterol and coronary heart disease, there are several iterations
> of that and if you wanted examples of that, you can both follow the
> process that was used in coming to those statements and also the exact
> statement itself.
>
> I think writing a white paper that provides examples of both the
> process and the thinking that went into it, as well as examples of the
> actual statements that came out, might be helpful. I wouldn\'t think
> that it would be terribly difficult, at least for us, because I think
> we have a fair number of statements out there.
>
> And I might say incidentally that most of these also were done
> collaboratively with the other agencies. We share with CDC, for
> example, membership on a lot of committees that they have and the
> committees that we have. So it doesn\'t reflect just our one federal
> agency, if you will.
>
> One could do that, I think, without a great deal of difficulty. I
> don\'t know how helpful it would be but it\'s doable.
>
> DR. LEWIS: I suspect the question was going to the issue of perhaps
> what might be the function of the Liaison Group in the future and
> perhaps we could talk a little bit about how you see the activities of
> the Liaison Group.
>
> I\'m not looking at you specifically, Dr. Harlan. I\'m looking at the
> entire panel.
>
> DR. HARLAN: I\'ll sit in the middle of the table next time.
>
> DR. LEWIS: Certainly the Liaison Group will undoubtedly continue to
> meet and I know they\'re having some internal discussions about how
> they\'d like to proceed.
>
> One of the questions that we have in front of us and I guess I could
> read the next question, is can any of the federal agencies represented
> envision FDA characterizing as authoritative or not authoritative a
> statement of that agency without consulting that agency?
>
> DR. HARLAN: I couldn\'t visualize that but it\'s perhaps my view of
> the world.
>
> DR. LEWIS: It\'s a question on the card, anyway. It\'s not FDA\'s
> question. It\'s a question on the card.
>
> DR. YATES: Well, the Academy is not part of the Liaison Committee, so
> we\'re exempt from that question.
>
> DR. LEWIS: No, actually the question says any of the federal agencies
> represented or scientific body, sorry.
>
> DR. SNIDER: I don\'t think it would be the usual practice. I guess I
> could envision it. If there was an FDA person who had been part of the
> whole process throughout, knew how it was developed and knew the whole
> story behind it, then they wouldn\'t have to consult us at all. But in
> most cases I would think that there would be information that FDA
> would want from the originating agency about what process was used
> because most of the statements don\'t describe process often in great
> detail. They don\'t necessarily describe how much data was looked at
> or how it was analyzed and some of these things would be important to
> know in the decision‑making process.
>
> So I think if nothing else, seeking information and possibly opinions,
> as well, but certainly information.
>
> MR. LAKE: Let me ask the other panelists. What I think maybe is behind
> that question or at least one that it triggers in my mind is would it
> be the opinion of the agencies and the other scientific body
> represented here that as a matter of course, that FDA ought to be
> talking with them before making a determination about whether a
> particular statement is authoritative?
>
> DR. MEYERS: I think there are some cases where they wouldn\'t need to.
> I think if the criteria are quite clear and if it\'s generally agreed
> a recommendation in a Surgeon General\'s Report is authoritative, then
> there would be no need to consult.
>
> The area where I think it\'s going to be the fuzziest is the issue of
> currency and what\'s current.
>
> DR. HARLAN: I agree with that. I think one of the problems we tend to
> forget is that science is a continuing and iterative process and that
> even now, as we think about the amount of fat in the diet and as a
> Surgeon General\'s Report is being written, new information is coming
> along that may change all of that.
>
> So what is current today may not be current next year, and that\'s
> what concerns me.
>
> DR. YATES: I think in terms of the Academy, that\'s probably the only
> question we would probably answer, is is there anything else that you
> have done that would indicate that this is not current?
>
> So if we\'re in the middle, say, like we are right now of reviewing
> vitamin C and vitamin E, what we might have in the statement we would
> say well yes, that may be the most recent thing we did but what we\'re
> going to finalize by the end of the year is going to be more current
> than that. And then it\'s up to you to decide do you want to go ahead
> with whatever it is as an authoritative statement or not.
>
> DR. LEWIS: I also have a question that I think is a direct outgrowth
> from some of my comments earlier this morning.
>
> Do authoritative statements have to reflect official policy of the
> scientific body?
>
> DR. HARLAN: Official policy?
>
> DR. LEWIS: Certainly I admit that in my opening remarks we indicated
> that we had included that as one of the three characteristics we\'ve
> added. I think in experiencing this in the last year, the notion of
> official policy was one that I think as various scientific bodies
> talked about it, it was one that they didn\'t feel was well fleshed
> out or one that they could readily point to.
>
> So there was concern perhaps about characterizing this using the exact
> term \"official policy,\" but perhaps there were other concepts and
> other frameworks you put around authoritativeness that maybe were not
> exactly characterized by the words \"official policy.\"
>
> It has been invoked as a characteristic and perhaps that\'s something
> we need to discuss.
>
> DR. SNIDER: I would think the term is probably too restrictive. In our
> case I think documents that would have printed on them
> recommendations‑‑at least I can think of a number that would be what I
> would consider authoritative statements, I think the term \"official
> policy\" probably restricts the universe of documents that we would
> want to consider as authoritative statements.
>
> DR. HARLAN: I think you might call it official position. At least
> that\'s the way I think of it, rather than policy, not some
> overarching set of principles that do not change over time but rather
> the official position and, incidentally, current official position.
>
> DR. SNIDER: Whatever we call it, it has to be generally understood or
> well defined.
>
> DR. MEYERS: I agree. I like using the term \"position.\" This may just
> be the bureaucracy, but the term \"policy\" tends to have a narrow use
> and triggers an unbelievable review process, in addition. So I think
> that\'s part of the reaction.
>
> DR. LEWIS: We have a number of questions here but I think we have time
> for just one more before the break and I\'ll read this one.
>
> \"Since absolute statements are rare in science, is there such a thing
> as a qualified authoritative statement?\"
>
> DR. SNIDER: I\'ll comment on that. I think the panel this morning also
> grappled with that. To me, I think the answer is yes. I think that, as
> was pointed out, we\'re all trying to educate the public about what
> the science, to the best of our understanding, says about a particular
> nutrient.
>
> And at times, the science base, as was pointed out, is equivocal. At
> times there is a lot that supports a particular conclusion but there
> are still some gaps. And in trying to be honest about what the data
> say, one has to be less than definitive at times.
>
> DR. HARLAN: I think we always have qualifications. We most frequently
> say on balance or looking at all of the evidence, this is the main
> force of the statement that\'s made, but there are situations in which
> it may not apply or we may see different information that will change
> the statement that we make. And sometimes we do quality it by talking
> about special populations or something of that sort.
>
> I think to qualify it by saying that there\'s a minority report, for
> example, on the same issue begins to take away from the educational
> aspect and the informational aspect for the public. I think we all
> have had the problem that when you say \"on the one hand, on the other
> hand,\" you know, you always want that one‑armed economist so that you
> don\'t get caught up in that. You\'d like to come out with a statement
> that gives the preponderance of evidence and say \"This is the message
> that you should carry home.\" Frequently within the document there
> will be qualifications, however, that there is other information or
> there\'s a group of people who do not respond in the same way.
>
> DR. LEWIS: I know in reading some of the comments that were submitted
> relative to the interim final rule qualification was also discussed in
> terms of putting it in context. For instance, some of the soluble
> fiber claims are always made within the context of it being a part of
> a diet low in saturated fat and cholesterol. So in that way
> qualification comes in.
>
> I think there\'s another end of this, which is qualification of the
> strength of the science, as opposed to qualification of the context in
> which this is a recommendation. And perhaps that\'s something that
> needs to be tackled.
>
> Is there someone else who wanted to tackle it?
>
> DR. MEYERS: You said the same thing I was going to, that science
> qualification and the contextual, the context in which something is
> said are different and sometimes overlap, and I think we have to be
> very careful about that.
>
> MR. LAKE: Let me thank each of you on the panel for coming and being
> with us this afternoon. I think we\'ve all heard some things that have
> been at least enlightening to me and I think the audience and the rest
> of us, as well. So again thank you very much.
>
> We will at this time take a break and if you would be back in about 15
> minutes, we will have presentations from several speakers who asked to
> make presentations for this afternoon. Thank you.
>
> \[Recess.\]
>
> MR. LAKE: If people would come on in and get settled again, we will
> begin the final session for the day.
>
> **REGISTERED SPEAKERS**
>
> MR. LAKE: We have a number of speakers who registered the make
> presentations this afternoon. Again, as with the panelists, we\'re
> asking that they limit themselves to 10 minutes.
>
> The first speaker is sort of by special invitation. Donna Porter from
> the Library of Congress was asked by us to summarize the issues, so
> the first presentation will be from her. Then we will go to the others
> who have asked to speak.
>
> Donna?
>
> MS. PORTER: Thank you, Bob.
>
> I\'m Donna Porter. I\'m a specialist in life sciences in the
> Congressional Research Service, which is part of the Library of
> Congress. I\'d like to thank the FDA for the invitation to share my
> views on these issues surrounding the implementation of the
> authoritative statement provisions of FDAMA.
>
> My statement today is based solely on my own perspective and views
> after 25 years of research in the area of nutrition policy in this
> government. My statement does not reflect the views of the
> Congressional Research Service, the Congress, the Institute of
> Medicine, the Keystone Center or any other organization that I\'ve
> been affiliated with in the last quarter century. It is rather a
> synthesis of my experiences with the issue of claims messages
> associated with the foods in these many venues.
>
> From my perspective, this issue originates with the dietary goals for
> the United States that was issued as a staff report of the Senate
> Select Committee on Nutrition and Human Needs in 1977, just prior to
> that committee\'s demise. While the document\'s seven goals caused
> considerable controversy among the interested parties that were part
> of the food and nutrition establishment at that time, it also
> represented the first time that any entity of the federal government
> provided direction for the public on the relationship between diet,
> chronic disease and achieving better health.
>
> Following its release and the subsequent congressional hearings,
> numerous government and health organizations began examining the
> scientific literature for the evidence that diet and disease were
> related and what dietary directives might be broadcast to the general
> public.
>
> Most dietary guidance documents were relatively similar in the
> messages that they addressed in consumer brochures issued by the
> respective organizations both in and out of government.
>
> The issuance of the 1988 Surgeon General\'s Report on Nutrition and
> Health and the 1989 NAS diet and health study, both comprehensive
> reviews of diet and health literature at that time, propelled this
> government forward into comprehensive changes in food labeling and
> related health messages.
>
> Now starting with authoritative statements, it seems to me that an
> authoritative statement for a claim is provided for under FDAMA is a
> statement of the consensus of the totality of the scientifically
> available literature on a diet and disease relationship. This
> consensus would have been reached by a scientific body or agency with
> expertise in nutrition research of either the federal government or
> the National Academy of Sciences.
>
> When claims were first allowed, many health experts believed that
> limiting claims to those that paralleled dietary guidance statements
> issued by scientific entities, such as the ones that I\'ve already
> mentioned, was a good way to match the dietary messages between
> nutrition education and labeling and prevent the type of Tower of
> Babel described by DHHS Secretary Louis Sullivan in 1989.
>
> The FDAMA provisions seem to have returned us to the option of basing
> claims on dietary recommendations in the form of authoritative
> statements from scientific bodies.
>
> If the petition process first is the notification alternative. It\'s
> the FDAMA provisions are an alternative to the time‑consuming and
> authoritatively demanding NLEA process procedures and standards for
> health claims, then NLEA seems to me to be the good standard and that
> the FDAMA provisions provide a fast track mechanism to facilitate the
> implementation of the NLEA processes, procedures and standards. Let me
> explain what I mean.
>
> The existing petition process established by NLEA requires the
> manufacturer in the petition to provide the totality of the publicly
> available scientific evidence that\'s believed to establish the basis
> for the diet and health relationship. The petitioner must also provide
> information about the claim that will be made and its wording.
>
> NLEA requires FDA to conduct a review both internally and with its
> other PHS agencies to determine if the science supports the existence
> of the relationship. Based on this review, FDA was directed to
> authorize a health claim based on this scientific review when it
> established that there was significant scientific agreement among
> qualified scientific experts that the claim is supported by that
> evidence. This review was subject to notice and comment rulemaking.
>
> In short, health claim statements on labels and in labeling are to be
> specific affirmative statements that are accurate, based on the
> totality of the scientific evidence and able to convince qualified
> individuals that the food substance, when used in a dietary context,
> will have the stated impact on a disease or other health‑related
> condition. This standard has been in place since 1990.
>
> FDAMA provided an alternative mechanism for the authorization of
> health claims in part because the interested parties recognized the
> time‑consuming, resource‑intensive nature of the NLEA‑ mandated
> process. It directed that health and nutrient content claims could be
> authorized under circumstances where an authoritative statement had
> been made by a scientific body of the federal government or NAS with
> expertise in the area of nutrition research.
>
> The Act provided four criteria that we\'ve heard repeatedly today and
> I will not repeat them. These criteria seem to assume several
> advantages that might be provided from the work of nutrition research
> and dietary guidance conducted by other health agencies and the
> Academy.
>
> The work, if currently in effect, concerning a food substance and its
> relationship to a health condition and published as a position or a
> policy of that agency or the Academy, would undoubtedly represent the
> current state of the science and be based on a deliberative review of
> all the evidence available at the time at which the position was
> authored by that agency.
>
> Authoritative statements would have both internal and external review
> by the issuing entity and, in the case of information for the general
> public published by the federal government, be required to be reviewed
> by the secretaries of both Agriculture and Health and Human Services
> under the provisions of the Nutrition Monitoring and Related Research
> Act of 1990.
>
> Such documents are generally quoted widely in the public health and
> dietary guidance literature, the media and textbooks. As such, these
> authoritative statements would represent the consensus of the
> scientific community at the time of their publication.
>
> Authoritative limits. However, not all statements, including every
> line of every Academy report, would be authoritative. Committees,
> agencies, surgeon generals, consensus development conferences and
> advisory councils frequently address issues of diet and disease that
> are exciting preliminary findings from emerging science that need
> considerably more research work before they can become the basis for
> dietary guidance, substantiation for advertising messages or reach
> significant scientific agreement for health claims.
>
> Many preliminary and inconclusive findings do not bear up under
> subsequent intense research scrutiny. Therefore it seems that the
> Academy or any of the agencies issuing a document that contains a
> statement that has been signaled as authoritative must be responsible
> at the outside to comment on whether it considers that statement to,
> in fact, be an authoritative statement of that organization.
>
> This determination could be achieved in several ways. The notifier
> could be required to provide as part of the justification the explicit
> opinion of the issuing agency that the statement is authoritative, or
> as the first step in FDA\'s process, it could contact the issuing
> agency for such a determination. And I would suggest that the 120‑day
> response period by the agency not start until a written response is
> received from the agency or the Academy concerning the authoritative
> statement.
>
> Beyond authoritative determination. Assuming that the issuing agency
> indicates the criteria for FDAMA are met by the statement, then FDA
> needs to determine whether the claim, as worded, is truthful and not
> misleading, juxtaposed to the context in which the authoritative
> statement is published.
>
> The presumption of validity and availability of scientifically sound
> information to promote consumer knowledge and choice, as outlined in
> the House report on FDAMA, suggested that authoritative statements as
> the basis for claims must be grounded on some level of evidence that
> would assure consumers that the effect described could be reasonably
> expected to occur.
>
> The official position of a scientific body could be expected to be
> based on consensus of those knowledgeable about the relationship on
> which an official statement would be made. Consensus in this context
> would be a higher standard than that of significant scientific
> agreement, as outlined in NLEA.
>
> A comprehensive review of FDA\'s initial experience of SSA as the
> standard for claim authorization, as outlined in the Keystone
> dialogue, indicates that surely there was not a consensus on any of
> the 10 relationships that Congress directed be reviewed for
> consideration for authorization as health claims. In fact, former FDA
> Commissioner David Kessler testified at a congressional hearing once
> that SSA was 51 percent of the scientific evidence.
>
> Each body‑‑that is, the scientific bodies‑‑would need to have its own
> policy on what constitutes deliberative research. In fact, some of
> that probably already exists. Whether individual bodies would have a
> policy on the use of its official public statements as authoritative
> for the purposes of authorizing claims would need to be an internal
> determination.
>
> FDA screening. If FDA wished to conduct an initial screen of submitted
> notification information, it could do so by determining whether all
> the required information was provided and met its criteria, along with
> the response of the issuing agency as to whether a statement is
> authoritative. Then FDA could be prepared to contact the notifier if
> the scientific body responds that the statement is not authoritative
> or the agency determines that the notification information is
> incomplete.
>
> Again it is my feeling the 120‑day period should not commence until
> the FDA has the complete set of information before it needed to make a
> determination concerning the claim.
>
> Clarification should be made available as to what is needed to be
> followed in a notification process and the information to be
> submitted. Likewise, the notifier should have every opportunity to
> provide that necessary information so that a favorable response on a
> claim can be made.
>
> Claim meaning and application. From the Keystone Dialogue on Food,
> Nutrition and Health, it\'s clear that industry favored shorter
> messages for health claims. The subsequent FDA consumer research
> suggested that shorter messages were meaningful to consumers in cases
> where the claim was for a relationship on which the public had prior
> knowledge of a diet and disease relationship. This was not true for
> relationships on which they did not have prior knowledge, where only
> longer statements were meaningful for them in terms of understanding
> the message.
>
> MR. LAKE: Donna, could you kind of wrap it up?
>
> MS. PORTER: Okay. Concerning the general principles for nutrient
> content in health claims, these should be applicable to the process in
> terms of notification. Only if the message‑making and the information
> required of manufacturers and in labels is consistent will it be
> possible for manufacturers to have a level playing field and if it\'s
> not consistent, consumers will not understand the difference.
>
> Finally, I just wanted to comment. I believe that dietary supplements
> should be allowed to make claims under the authoritative statements
> provisions. It seems to me consistent with the work of the commission,
> that that was what they had in mind. And I do believe that as soon as
> possible in the process, information should be made publicly available
> so that the rest of the universe can provide input into the process
> and understand what\'s coming forward from the agency. Thank you.
>
> MR. LAKE: Thank you.
>
> Let me just indicate that I would like other speakers to follow
> Donna\'s example of getting up to the podium over there.
>
> The next speaker is Dr. Colon Broughton, transition director, Office
> of Natural Health Products, Health Protection Branch, Health Canada. I
> guess he\'ll give us a little bit of an international flavor to this
> meeting.
>
> DR. BROUGHTON: Good afternoon, ladies and gentlemen. I thank the U.S.
> Food and Drug Administration for the opportunity to be here to tell
> you about the Canadian way.
>
> In the summer of 1977 the Canadian government dissolved Parliament. It
> was a Liberal government at the time. They dissolved Parliament,
> believing that they could get reelected, and indeed they did. However,
> the minister of health of the day did not get reelected.
>
> And for those of you who know about the Canadian parliamentary system,
> which has some very fundamental differences between what you
> experience down here and the way you\'re governed down here, I was
> talking yesterday at a meeting and I said it used to tick Pierre
> Elliot Trudeau off no end, who was the Liberal leader in the 1970s
> through the middle of the 1980s, to get off an airplane following the
> president of the United States, who got a 21‑gun salute and Trudeau
> only got 19 because our head of state is the Queen of England in
> Canada. She lives in another country, but that doesn\'t bother us
> because it gives live to the parliamentary system.
>
> And in Canada, if you are a minister of the crown, equivalent to your
> secretaries, you must have been an elected person; i.e., a
> congressman, occasionally a senator. Senators are not elected in
> Canada so it\'s very similar to yours. They are chosen. But the MPs
> who come back to Parliament, having knocked on the door, and that\'s
> the phrase they use, meaning that they got the most votes and
> therefore they are back on and they come in.
>
> It gave the prime minister the opportunity then to assign a new
> minister of health because Mr. Dingwald, who had been our minister up
> until the proroguing of Parliament, lost his seat and Mr. Alan Rock,
> who was formerly minister of justice in the previous Parliament,
> became minister of national health.
>
> The biggest single issue facing the members of Parliament, prospective
> members of Parliament as they went to the door was what are you going
> to do about herbs and botanicals, dietary supplements and the like? We
> want to have the freedom of choice in Canada so that we can manage our
> own self‑care.
>
> Mr. Rock, being the astute politician that he is, asked the questions
> within the department and we said, Minister, it\'s a minefield because
> we do not have the political will to make any changes. And right now,
> Minister, and as it happens right as we speak, if you wish to make a
> claim for a product that is going into the human body, except for
> medical devices and we won\'t worry about those because they tend to
> be not through the GI tract, but if you\'re going to put something
> into the body, into the GI tract, you only have two options and that
> is it\'s either a food or it\'s a drug, and there is that interface
> that is managed.
>
> If you make a health claim for a food, it immediately becomes a drug.
> It becomes a therapeutic product and it is subject to the same
> regulatory requirements as any pharmaceutical product that is going to
> end up as an over‑the‑counter drug or as a Schedule F; in other words,
> prescription drug in terms of our parlance in Canada.
>
> Clearly a very unsatisfactory state of affairs. Colleagues and myself
> have dealt with this for 30 years. No political will to change it.
>
> Mr. Rock placed the issue before a standing committee on Parliament
> and I have chosen to pass around, because I\'m not really going to be
> speaking very much to the subject at hand except for a little bit at
> the end, but the government of Canada would not presume to tell the
> government of the United States what to do.
>
> I have before you a boilerplate speech which spells out what has gone
> on in Canada and the penultimate slide shows the website where you can
> go and get information. There is a 1/888 number. Unfortunately we did
> not pay to make it North America‑wide, so unless you\'re in Montreal
> or Toronto, it won\'t work.
>
> So what happened? In November 1977 the Standing Committee on Health,
> which is a standing committee of our Parliament comprising all parties
> in power‑‑of course the Liberal government, which is the party in
> power, does have the most members on the committee. They are not so
> foolish as to think it\'s so open that you\'re going to have a free
> vote under those circumstances.
>
> They began deliberations. They began meetings. They began video
> conferences. There was a write‑in campaign for them and we also, at
> Health Canada, had a standing or an expert panel advising us. They
> kind of got took over and in May of 1998, which is exactly one year
> away, they tabled their report to the department. We gave it to the
> standing committee and said, \"Here is more grist for your mill,
> sir.\"
>
> And they took it and in November of that year about 170 days ago the
> committee came up with a report. And I thought I was going to bring a
> copy up to the podium with me but I didn\'t.
>
> Annette, could you grab it? It\'s in the top of my bag. Just wave it
> around. It\'s the yellow‑covered 100‑page document. There you go.
> That\'s it.
>
> It\'s the Standing Committee on Health\'s Report from Parliament. In
> there you will find, if you can get your hands on them‑‑they\'re not
> available really anymore but on the website that I have given to you
> there, if you click on that in English, because we do work in both
> official languages in Canada, click on the English side, go down to
> the bottom left and find a shady brook, which says natural health
> products.
>
> Click on that and you\'ll go immediately into the minister\'s speech
> when, on May 26 of this year, he accepted on behalf of the government
> of Canada all 26 recommendations contained in the document, the
> Standing Committee on Health\'s Report. It\'s on the fifth line in
> that document and if you click on that you are immediately hot‑linked
> to our parliamentary website and up comes that document that Dr.
> Annette just lifted up.
>
> On about page 102 there are the 53 recommendations. They cover some 16
> areas and I will just very quickly go through them and tell you what
> those are.
>
> Definitions. Mr. Rock said in his charge to the committee, would you
> please be good enough to tell me, give me a good definition of what
> natural health products are. For natural health products, folks,
> include your dietary supplements and others. We are saying, and it may
> be argued circular, it\'s a circular argument, as Peter Bartonhutt
> argued with me just the other day in a very friendly way; he said that
> well, what you\'re saying is kind of circular but anyway, I like it. I
> like circular ones. He said they mean nothing; you can get away with
> murder. And I said that\'s the idea.
>
> The point being that natural health products in my parlance are
> products that are natural and for which health claims are made. Now
> that includes milk if you\'re talking about the calcium content in
> milk. It includes ginkgo biloba if you think it\'s going to hold up
> Alzheimer\'s. It talks to all of those things.
>
> So we do not use or we have not formally embraced the subject of
> neutraceuticals, functional foods, medical foods, as you have here.
> The belief is, and I think you may have shared this in terms of being
> aware of where we\'re going, it would look as though the word
> neutraceuticals will become the umbrella word at some point in the
> future.
>
> We don\'t have a problem with someone pulling out naturally and
> putting into a dosage form; therefore it becomes something different.
>
> We are saying that there is a risk‑benefit continuum and along that
> risk‑benefit continuum sit all things. And if you\'re saying that you
> now only have this food‑making claims, it becomes a therapeutic
> product, which it is. What the report says and the government has
> accepted as government policy as of March 26, that we\'re going to
> open this up.
>
> The report does say to me, since I am the transition director and my
> minister told me that the prime minister told him, \"Alan, we are not
> going to see this back at the door, are we?\" Excuse me. He said,
> \"You can assure me that we will never see this back at the door\" and
> he said, sounding like that well known British television series,
> \"Yes, Prime Minister.\"
>
> He said to me, \"We\'re not going to see it at the door. You\'re going
> to do things that will not see it at the door\" and I said, \"Yes,
> Minister.\" Same part of the same show.
>
> To give you an indication that that is the political will in Canada to
> do it, all 53 recommendations, never heard of in 10 years of existence
> of the committee. They normally say well, we\'ll take 10 or 15 and
> this one and that one.
>
> Mr. Volpe, who was chair of that committee, was really very surprised
> I withstood with him because there had been absolute cabinet
> confidence in that regard. He did not until Mr. Rock spoke on the 26th
> at a health food store on Young Street in downtown Toronto which was
> just opening and he was pleased to say that the government was
> accepting all 53.
>
> Definitions. They didn\'t come with a definition. They put it back to
> myself and an expert advisory committee that\'s going to do this and
> advise my office of what expertise we need, what regulatory structure
> we need.
>
> Mr. Rock said to me, \"Colin, give me a statement that the people of
> Canada will understand. We want it to be safe and efficacious.\" I
> said, \"Make is safe, cleanly made, correctly labeled and
> advertised,\" and that covers it all and we believe it does.
>
> And I know I\'m running out of time and I will simply draw your
> attention to the fact that we are going to be studying all of these
> recommendations because all are going to be implemented.
>
> We go on there and I understand there may be time for questions
> afterwards. You can see the organizational structure on the back
> sheet, that the Office of Natural Health Products stands with
> Therapeutic Products Program and Food Directorate and the penultimate
> one is our coordinates, where you can reach us.
>
> And I have just one thing to say, that when I read your FDAMA Act and
> saw that indeed your Congress had seen fit to say that there are four
> areas in which you will be working, but yet there is some abrogation
> in the terms that it says in reference to 201FF, that these are exempt
> from putting in place, one of the things that you are exempting is
> harmonization with Canada and Mexico, and it is the Canadian
> government\'s position that we would like to see that revised and
> instead of saying \"competent agencies of the government of the United
> States,\" it says \"competent agencies and departments of the
> governments who are signatories to NAFTA.\" Thank you.
>
> MR. LAKE: Thank you.
>
> Our next speaker is Jonathan W. Emord, counsel to Weider Nutrition
> International, Incorporated, American Prevention Medical Association,
> Pure Encapsulations, Incorporated and Dr. Julian Whitaker. He\'s with
> Emord & Associates, P.C.
>
> MR. EMORD: Thank you for the opportunity to speak today. I appreciate
> it.
>
> I\'m an attorney who practices constitutional and administrative law
> before the federal courts and agencies. I\'m also the attorney who
> successfully argued the Pearson versus Shalala case, so it\'s a
> distinct privilege for me to have an opportunity to speak in advance
> of any final rules on this question because I believe it touches so
> dearly upon our constitutional rights under the First Amendment and
> upon the question of ultimately who has the power to say what is and
> what is not permissible in the realm of health claims for dietary
> supplement products and for foods.
>
> FDA has two legal masters. It has the statute and it has the
> Constitution. Today I will describe in brief the plain meaning and
> purpose of FDAMA Section 303, the constitutional limits on agency
> authority under Pearson versus Shalala and an alternative to the nine
> interim final rules that I think better comports with both the statute
> and with the constitutional requirements of the First Amendment.
>
> First, Pearson versus Shalala, because this decision is truly a
> landmark case that affects FDAMA, as well as any instance in which the
> Food and Drug Administration will regulate health claims for foods or
> dietary supplements.
>
> Pearson\'s constitutional analysis governs every instance where FDA
> would presume to limit access to information of any kind pertaining to
> foods and dietary supplements and particularly health claims, which
> were an issue in Pearson.
>
> In the context of claims based on authoritative statements of
> government health agencies, Pearson requires FDA to permit every such
> claim and to rely upon reasonable disclaimers to cure any potential to
> mislead.
>
> You see, Pearson is predicated upon a long constitutional heritage,
> from In re RMJ in 1979 up to 44 Liquor Mart, in which the Supreme
> Court has said consistently that if commercial information is not
> inherently misleading but is only potentially misleading, it is
> incumbent upon government to allow the information to reach consumers
> with disclaimers as its remedy, as opposed to outright suppression.
>
> The court, in Pearson versus Shalala, utterly rejected the Food and
> Drug Administration\'s justification for suppression in lieu of
> disclaimers and imposed upon the agency this constitutional
> requirement, bringing it in line with every other agency of
> government, both federal and state, under our Constitution.
>
> Thus, Pearson remains a constitutional guidance for this agency to
> deal with the issues of health claims, whether they arise under FDAMA
> or whether they arise under FDCA Section 305(b), 304(b) or any other
> aspect of agency regulatory authority and discretion.
>
> So the agency is beholden to the Constitution and the First Amendment
> and must not suppress outright claims of nutrient‑disease
> relationships when it may use disclaimers to allow the information to
> reach consumers and correct the misleadingness‑‑the court\'s term‑‑in
> the claim.
>
> Thus, the message of Pearson versus Shalala is that disclosure over
> suppression is a constitutional imperative that FDA may not ignore. It
> should be the centerpiece of discussions on these issues and it should
> be both a starting point and an ending point because it really does
> subsume in a massive way, under the Constitution, anything that the
> agency attempts to do with respect to claims on nutrient‑disease
> relationships.
>
> The statutory meaning. FDAMA Section 303 is, despite probably today\'s
> discussions, not a complex matter, actually. In its own terms, FDAMA
> Section 303 is different from the FDCA Section 304(b) in that it does
> not, by its own terms, delegate to the agency discretion as to how to
> define things, such as authoritative statements, and such as the
> procedure to be used in implementing the Act.
>
> Instead, in an extraordinary departure from prior statutory law, it
> defines those things in the statute itself, thereby not delegating to
> the agency any discretion as to what the specific definitional
> provisions mean but providing it instead within the context of the
> statute.
>
> Congress, it must be remembered, reacted, as the Senate and House
> reports on this issue make clear, reacted adversely to FDA\'s refusal
> to authorize under, the significant scientific agreement standard, a
> folic acid neural tube defect claim for three and one half years and
> attributed to FDA\'s failure to approve the claim approximately 2,500
> preventable neural tube defect births each such year.
>
> It was that that was the impetus, as you clearly see in the Senate and
> House reports, for the enactment of FDAMA Section 303, the purpose of
> which was to provide an expeditious alternative to significant
> scientific agreement review, one that would not depend upon
> significant scientific agreement but would be, by the terms of the
> Senate and House reports, an alternative to it that would be a
> meaningful alternative.
>
> FDA will err by trying to impose regulatory requirements on health
> claimants that exceed those expressly defined in the statute. Congress
> aimed to provide a less costly, streamlined alternative to significant
> scientific agreement. FDA\'s interim final rules in this case, I\'m
> afraid, do the opposite.
>
> The solution lies in faithful adherence to the statute, in defining
> the term authoritative statement only as the statute does, in favoring
> disclosure over suppression.
>
> FDAMA Section 303 is thus not a redundancy. It is meant to be an
> alternative to significant scientific agreement review. It is meant to
> be an expeditious alternative to that review. Congress did not defer
> to FDA in FDAMA Section 303 as it did in FDCA Section 403(b), under
> significant scientific agreement rule.
>
> Instead, Congress defines all of the essential terms and procedures to
> be followed in the statute itself. Those definitions and procedures
> are both necessary and sufficient, consistent with the congressional
> goal of creating a less costly and more efficient alternative to
> significant scientific agreement. FDA should withdraw its nine interim
> final rules and rely upon the statute and the Constitution, as defined
> by Pearson, as its guide.
>
> Congress has defined the term authoritative statement simply in the
> statute. FDA should not alter that definition. Congress deemed an
> authoritative statement to be any statement of a federal scientific
> body if the statement is published by that body and is not a statement
> of an employee of the body made in the individual capacity of that
> employee.
>
> That is your starting point, that is your ending point if you mean to
> follow the intent of Congress.
>
> Congress also defined the procedure to be followed. The statute
> contemplates the submission of only three items. FDA should not add to
> the list. FDA should not subtract from the list. FDA should follow the
> intent of Congress and follow the statutory directive.
>
> Congress expects that claimants will file a notice of the claim, which
> shall include the exact words used in the claim in a concise
> description of the basis upon which the claimant has determined that
> the statement is published. In the case of a nutrient content claim,
> it must identify the nutrient level to which the claim refers. In the
> case of a health claim, it must identify the relationship between the
> nutrient and a disease to which the claim refers. And the claimant
> must provide a copy of the statement upon which the claim is based and
> provide a balanced representation of the scientific literature
> relating to the claim.
>
> Congress thus expects FDA to approve claims under FDAMA Section 303,
> to do so more prolifically than has been the history under the
> significant scientific agreement standard so long as they meet the
> statutory definition of authoritative statement and include all of the
> elements specified in the statute for filing with the notice.
>
> And under Pearson, the discretion the agency has is in identifying
> reasonable disclaimers to avoid any potential to mislead. If our aim
> is to inform the public, this is the constitutional manner in which we
> can do so.
>
> We supply the information, preliminary or not. We use disclaimers to
> characterize the level, quality and nature of the evidence. We do so
> succinctly and we do so in a manner that enables the average consumer
> to comprehend it, but we get the information out because under our
> First Amendment, regardless of the complexity of issues, our First
> Amendment commands us to have faith in the American people and in the
> individual judgment of citizens to make determinations as to what is
> best for them and as to what they believe and do not believe.
> Government is not to make that decision for us.
>
> The constitutional command of Pearson is disclosure over suppression.
> The test for the agency is whether it will, in spirit and in
> substance, humbly and faithfully follow the statute and the
> Constitution, or will it endeavor to erect barriers to the
> dissemination of health information based on authoritative statements
> that mimic those barriers deemed unconstitutional in Pearson versus
> Shalala.
>
> We will hope for the former and, as lawyers are fond of saying, we
> will see you in court if the latter. Thank you very much.
>
> MR. LAKE: Thank you.
>
> Our next speaker is Richard L. Hanneman, president of the Salt
> Institute.
>
> MR. HANNEMAN: Good afternoon. I\'m going to change directions from
> what you\'ve had the last couple of times.
>
> I am Dick Hanneman. I\'m the president of to Salt Institute and we are
> the trade association of manufacturers of sodium chloride, salt, which
> is the largest source of dietary sodium, and we\'re here to talk about
> some lessons we think from what we\'ve done so far that may be useful
> for FDAMA\'s implementation. Particularly my message is one of
> consistency, the importance of consistency.
>
> FDA faces difficult challenges in implementing FDAMA, particularly in
> extending the basis for health claims on food labels, and the
> challenge grows from the inconsistency with which FDA has implemented
> NLEA from the beginning, especially in its treatment of issues
> surrounding the presence or absence of significant scientific
> agreement, as well as the difficulty in adjusting health claims to be
> current, to reflect advancing science.
>
> Therefore, even before considering the question of what outside
> bodies, what authoritative sources might be, we think that we ought to
> consider the sources of internal consistency and see whether we can
> improve that.
>
> I was struck by Dr. Lewis\'s framework discussion this morning where
> she said that there would be some point after the statement is
> determined to be authoritative where the SSA would come into play.
>
> Let me just share our example with you. There are a couple in my
> written statement and there are citations for what I\'ve stated. The
> example I would raise with you today is the science used to support
> the sodium and hypertension health claim, which has been approved, and
> the fact that it does not seem to be nearly as compelling to support
> that as that which was offered to support a health claim for calcium
> hypertension, which health claim was denied.
>
> For example, FDA has maintained the health claim for sodium, despite
> the fact that serious scholars are in widespread disagreement about
> the meaning of the science, that expert societies continue to debate
> it. FASA just a couple of weeks ago, the American Society of
> Hypertension next week, that NHLBI has just in January of this year
> conducted a workshop at which the experts were convened and reached
> absolutely no consensus. And the world\'s premier general science
> journal Science has documented efforts by NHLBI to make sure that the
> end result of our reading of the science is consistent with their
> policy, quite a tortured effort.
>
> FDA maintains a sodium and hypertension health claim, although the
> scientific rationale is limited and questionable. The meta‑analyses of
> the clinical trials find a small overall population blood pressure
> reduction on low sodium diets, but the benefit being confined to a
> subset of older primarily and salt‑sensitive individuals with
> hypertension.
>
> There have been six studies that have examined the fundamental
> question of whether low sodium diets reduce the risk of cardiovascular
> events and all of them were either totally inconclusive or
> disturbingly adverse to FDA\'s interpretation of the science and its
> health claim.
>
> And the NHLBI‑funded trials of hypertensin prevention phase 2
> documented no significant diastolic blood pressure reduction, which
> was the primary hypothesis, and a reduction from 127.7 millimeters
> mercury to 127.1 millimeters of mercury the secondary hypothesis.
>
> Against that backdrop then, let\'s consider what evidence FDA
> determined to be unpersuasive when it denied the petition for a health
> claim for calcium and hypertension. Our reading of the calcium
> evidence is more sanguine than FDA\'s with regard to the benefits of
> calcium with regard to blood pressure.
>
> Unlike the evidence regarding sodium and hypertension, the literature
> on calcium has been consistent and positive associations in the
> epidemiological literature. Unlike the sodium and hypertension
> literature, while some subjects derived great benefit than others,
> there does not seem to be evidence of blood pressure increases with
> increases in calcium, as there is in sodium.
>
> And unlike sodium and hypertension, where there\'s evidence of
> publication bias, the estimates from the observational studies predict
> remarkably well the outcomes of the randomized controlled trials.
>
> So FDS was presented with evidence of improved blood pressure response
> in both interventions‑‑in low sodium and in high calcium. But FDA
> sustained the health claim for sodium and hypertension when the best
> meta‑analyses found falls of 1 millimeter or 1.2 millimeters mercury
> and the long‑term trials of hypertension prevention was 0.6
> millimeters, whereas they rejected the calcium and hypertension health
> claim when the best meta‑analyses found falls of 1.27 and 1.44.
>
> So what\'s wrong with this picture? We\'ve got quite a bit of
> inconsistency and it illustrates our concerns about our inability to
> evaluate health claims when we have evolutionary scientific
> understanding.
>
> Further, FDA is required to base a health claim on that evidence which
> is currently in effect. And because science itself evolves, government
> policies can become outdated and a policy which no longer enjoys
> significant scientific agreement should not be considered in effect
> and therefore serve as a basis for a health claim.
>
> We consider sodium to be a perfect example and hope that the National
> Academy of Sciences can find the resources to get back to what is now
> well over a decade old finding which we don\'t consider any longer
> sustained in the science.
>
> We believe that Congress expects FDA to impose the same high standard
> under FDAMA to allowable authoritative statement health claims, but
> unless FDA can bring some clarity and consistency to the way it
> administers the program internally, claims based on authoritative
> statements by outside bodies will create a quagmire for FDA and
> confusion or chaos for the public.
>
> It\'s crucial that FDA apply the same high standard for health claims
> the agency has adopted by regulation so that health claims that are
> not representative of significant scientific agreement at the current
> time can be revisited and, if appropriate, withdrawn.
>
> In conclusion, FDA faces a great challenge implementing FDAMA while
> enforcing high standards to protect consumers against misleading
> nutrient health claims, nutrient content claims or health claims.
>
> The first priority should be to revisit and resolve the current
> inconsistent standards which FDA has used to approve health claims
> under NLEA. Then, with those standards consistently enforced, FDA
> should expect identified authoritative statements to meet these same
> high standards. Lowering the standards or applying them inconsistently
> ill serves the consumer and undermines the validity, legitimacy and
> ultimately the credibility of approved claims. Thank you very much.
>
> MR. LAKE: Thank you.
>
> The next speaker is Lisa Katic, director, scientific and nutrition
> policy, Grocery Manufacturers of America.
>
> MS. KATIC: Thank you, Bob, and thank you to FDA for the opportunity
> for the Grocery Manufacturers to present our views to you today.
>
> And out of sympathy for the panelists and all of you attendees in the
> audience, I will be brief today. I know it\'s been a long day but a
> very excellent, I think, panel and discussion this morning.
>
> For those of you that may not know, GMA is the world\'s largest
> association of food, beverage and consumer product companies. We have
> sales of more than \$450 billion. GMA members employ more than 2.5
> million workers in all 50 states. We are led by a board of 44 chief
> executive officers and we speak‑‑GMA speaks for food and consumer
> product manufacturers at the state, federal and international levels
> on legislative and regulatory issues.
>
> Related to the forum today, certainly GMA and its member companies
> have a deep interest in the use of truthful and nonmisleading disease
> prevention claims and nutrient descripters based upon authoritative
> statements by federal health agencies and the National Academy of
> Sciences.
>
> GMA and its member companies urge FDA to use this occasion to
> reconsider and revise its approach to the use of truthful and
> nonmisleading health claims in food labeling.
>
> As we\'ve reiterated many times, and they say repetition is certainly
> how you learn and if you don\'t know by now, what we\'re talking about
> in authoritative statements certainly expresses the clear intent of
> Congress to extend available health claims for foods beyond those
> formerly adopted by FDA.
>
> Congress intended that FDA\'s role in the use of health claims, based
> on the statements of authoritative bodies, to be largely ministerial.
> As such, Congress did not anticipate or encourage FDA to provide
> advice and consent to its sister agencies, such as NIH and the Surgeon
> General\'s Office, in the deliberations of those bodies relating to
> diet and disease.
>
> Instead, FDA\'s role is to establish processes and procedures to
> facilitate the adoption of health‑related statements on food labels
> which accurately reflect such authoritative statements without
> substantial health risk to the American consumer.
>
> GMA encourages FDA to recognize and implement the intent of Congress
> to establish workable mechanisms for prompt evaluation of claims
> submitted to the agency and to promote the responsible, and I
> emphasize responsible, development and use of authoritative
> statements.
>
> I\'m just going to summarize three areas that have been pretty well
> discussed already today, and that\'s authoritative statements, the
> context issue, as well as significant scientific agreement.
>
> As far as authoritative statements, Congress did not unduly limit the
> source of an authoritative statement other than, and I repeat again,
> that it must represent the position of an agency and not an
> individual. I won\'t say any more about that.
>
> And I think this is stated in the Senate committee report, and in
> quotes. \"Important federal public health organizations as part of
> their official responsibilities routinely review the scientific
> evidence pertinent to diet and disease relationships and publish
> statements developed through such reviews.\"
>
> I think some examples were discussed earlier or given. I would also
> like to emphasize one that was mentioned. The Heart, Lung and Blood
> Institute would certainly be an appropriate body making
> recommendations on cardiovascular disease or high blood pressure.
> Also, the National Cancer Institute, which was already mentioned,
> would certainly be appropriate to be making recommendations on certain
> types of cancer.
>
> As far as context, a statement labeled as a draft or a preliminary
> review would not qualify as an authoritative statement because of the
> context of that clear classification. Now having said that, the
> context of a statement in an agency publication will, of course, be
> determinative of the type of claim that can be based upon that
> authoritative statement.
>
> For example, a carefully worded and qualified authoritative statement
> may be accurately and truthfully conveyed in any claim based upon it.
> On the other hand, a broad and sweeping authoritative statement will
> justify only a broad and sweeping claim.
>
> Thus, the context of an authoritative statement is of far greater
> importance in determining the type of claim that can be made than it
> is in determining whether the statement is authoritative.
>
> Related to significant scientific agreement on authoritative claims,
> we say that even preliminary findings that reflect a general consensus
> of an authoritative body are an acceptable basis for a properly
> qualified health claim.
>
> For example, an initial finding by an authoritative body which
> indicates that people who consume diets high in a particular food or
> nutrient show lower instances of a certain disease or condition is
> sufficient justification for an appropriately qualified claim, even
> though such a finding may be characterized as preliminary and in need
> of additional supporting information.
>
> FDA\'s role under such circumstances should not be to assert that no
> statement can be made. Instead, the agency should encourage such
> statements while assisting the regulated industry in assuring such
> claims are appropriately qualified.
>
> This is the role contemplated by FDAMA and the role mandated by recent
> judicial decisions, of course Pearson, applying well settled legal
> commercial speech protections under the First Amendment.
>
> This is the conclusion of my statement. We\'ve certainly provided
> further comments in written form to the docket. Thank you again.
>
> MR. LAKE: Thank you.
>
> The next speaker is Ronald M. Lawrence, executive director of the
> Council on Natural Nutrition.
>
> DR. LAWRENCE: Thanks to the FDA for allowing me to make this short
> comment today.
>
> The Council on Natural Nutrition is a nonprofit council which has
> three major goals. I, as the executive director, my name is Ronald
> Lawrence, M.D., Ph.D., formerly having served on the National Advisory
> Council on Aging and also on the advisory board of ADAMHA, well
> familiar with the intricacies and difficulties of government in
> arriving at decisions, appreciate this opportunity to address you.
>
> The three aims of the Council on Natural Nutrition is to one, educate
> physicians about supplements, vitamins, herbals. It\'s a big area.
> Number two, to educate the public in a likewise fashion.
>
> And number three, to encourage the type of actions that are being
> taken in regard to this particular subject that we\'re talking about
> here today, which is to guarantee content and to in some way relate
> these natural products, which are now becoming close to a \$20 billion
> industry and growing all the time, so that we, as consumers, and
> particularly those of us who are in the age category that I\'m in,
> with many of these people not having much money but going out, as many
> as two out of three of those people, which has been proven and which I
> think the FDA should consider, two out of three Americans,
> particularly in the 55 and above age group, are going out and spending
> their hard‑earned money and are looking for guidance.
>
> But also under the situations developed at the NCI, the National
> Cancer Institute, where after years of research to \"cure cancer,\"
> now comes out with statements that prevention is where it\'s at, and
> we believe prevention is where it\'s at, and that the FDA, being an
> arm of government, has a responsibility to reduce disease in any way,
> shape or form, particularly if there are no great dangers associated
> with that. And in that way we are particularly concerned about the
> authoritative statements and how they will be arrived at.
>
> And, as I told you, I have served in government so I am particularly
> concerned about that. These decisions may take years and years. For
> example, with vitamin E, 50 years ago we knew what it would do. It is
> only less than a decade that we now, with the approval of government,
> accept the concept that vitamin E is important in regard to prevention
> of heart disease and circulatory disorders, et cetera. Do we have 50
> years to wait?
>
> As a concerned citizen, not only for our government and the money that
> is going‑‑heck knows, I take care of most of my practice in Medicare
> patients and the money being poured into that and going nowhere in
> many instances, we have to reduce that great burden. It is in
> prevention that we\'ll reduce that burden.
>
> So authoritative statements, and I\'ll wrap it up here, we must take
> into consideration the industry, as well as governmental situations.
> And I would recommend to this committee that in some way scientists
> who are accredited scientists, and that we can determine pretty
> easily‑‑among many who sit here are scientists. It isn\'t difficult to
> determine whether someone is a creditable scientist. And in science,
> we argue both sides of the issue. Science, even though the public
> doesn\'t realize it, is not clear‑cut. The winner is the 51 percent.
> When you down 51 percent of your opponents, then your scientific
> theory will prevail.
>
> So we must have outside input in regard to authoritative statements.
> In that way, and there is a way to develop this within the confines of
> the bill, and that is something that has to be addressed. In other
> words, scientists who are not only serving presently on these bodies,
> these governmental bodies, but scientists outside these bodies who are
> creditable scientists should have input into this very important
> situation.
>
> I thank you for allowing me to address you.
>
> MR. LAKE: Thank you.
>
> The next speaker is Stephen D. McCurry, manager of biochemistry for
> Research‑Based Dietary Ingredient Association.
>
> MR. McCURRY: Thank you very much. I want to make a small correction to
> that introduction. The Research‑Based Dietary Ingredient Association
> is a small group. We have no professional staff. That\'s actually my
> Cargill title rather than any title‑‑in the trade association, I\'m
> coincidentally treasurer, but that\'s kind of irrelevant to these
> comments.
>
> The Research‑Based Dietary Ingredient Association formed about a year
> ago. It\'s a small group of companies committed to championing the
> role of science in the development of functional food ingredients and
> related products. We believe it\'s essential for science‑based
> companies to take the lead in establishing and abiding by standards
> for scientific research, to assure product safety, substantiate claims
> and assure consumer trust.
>
> I really appreciate this opportunity to come here today and make these
> remarks and I will keep them short, in tune with the end of the day,
> and a lot of this has already been said.
>
> We have submitted comments to this that address some of the FDA\'s
> questions in some more detail. I\'d like to take this opportunity to
> offer some perspectives on closely related issues that are really part
> of this whole topic that we\'ve talked about today but haven\'t
> directly talked about.
>
> Several speakers today have talked about the fact that this is complex
> and important legislation. We certainly agree that it\'s very
> important. The complexity has been talked about a lot today and there
> certainly seems to be, from the regulatory side, a great deal of
> complexity to the issue.
>
> If I were speaking just as a consumer, I might think it was a little
> simpler topic. I would say something like I really want to know if the
> product is safe and if it does what it says it does and if that\'s
> good for me.
>
> There are a lot of ways to address this topic. One of them is by the
> means of FDAMA. There are several others that are not the topic of
> today\'s meeting and I\'m not going to talk about those.
>
> RDIA believes that the scientific issues are common across these
> different ways of addressing the question that the consumer is
> interested in. We believe that consumers have the right to know that
> the foods and dietary supplements they consume are safe and that the
> claims made about them are truthful and not misleading. This would be
> a hard statement to argue with, I think.
>
> We believe that there are two fundamental principles that should guide
> all aspects of research and development of ingredients in the food and
> supplements industries and the products in which they appear.
>
> First of all, whether they\'re conventional foods, dietary supplements
> or new dietary ingredients, the products should meet a common safety
> standard and that their consumption will not pose a significant or
> unreasonable risk to health when used as intended in the population
> for which the product is intended.
>
> And I want to distinguish the use of standard here from process
> because I think some of the confusion sometimes gets them mixed up
> together. Meeting the standard may require a scientific process
> similar to that used to demonstrate that a product is safe, that a
> product is GRAS.
>
> For example, if the safety assessment of a new dietary ingredient in a
> dietary supplement indicates the safety standard listed above, that
> there\'s not enough information for it already in the literature or in
> prior public use, then some form of safety research is going to be
> needed to demonstrate the safety.
>
> We believe there\'s a need for uniformity of understanding in the
> industry as to what this safety standard means and what information is
> required to be assured the standard is met. While DHEA does not
> require the GRAS process, neither does it excuse any company from
> providing products that are safe for the target population at the
> specified level of ingestion.
>
> RDIA\'s goal is to help establish within the industry uniformity in
> understanding what information are science are required to meet the
> safety standard, as indicated by law.
>
> The second fundamental principle is to the other side of this. Any
> type of labeling claim made about food ingredients or dietary
> supplements should be based on competent and reliable scientific
> evidence that establishes its truthfulness to a reasonable certainty.
> In addition, RDIA believes that products whose benefits to health have
> been demonstrated by sound scientific research to a reasonable
> certainty should be able to describe these benefits in labeling and
> via other means of communication.
>
> We see no rationale for differing standards‑‑there are different
> processes but not different standards‑‑of substantiation for labeling
> claims for either foods or dietary supplements. The nature of the
> science needed to support a claim likely will vary, depending on the
> type of claim being made, but the same standard of reasonable
> certainty that the claim is truthful and not misleading should be
> required.
>
> We further believe that claims about the physiological effects of
> foods and supplements should be allowed, providing they do not state
> an ability to prevent, cure or treat a disease regardless of the
> biomarker status of the particular health condition.
>
> Currently the food and dietary supplement industries are developing
> products with claims based on new data at a pace that exceeds the
> abilities of the FDA, with its limited resources, to review them
> expeditiously. We believe there are other approaches to this and I\'ll
> offer one example, just as an example.
>
> A process similar to that used for private GRAS assessments could be
> applied for claims evaluation. A company could seek evaluation of an
> independent body of experts to provide an unbiased opinion of the
> adequacy of the data. A body such as the Life Science Research Office,
> for example, or other organization of similar stature could do this.
> It could be considered as an independent expert. Claims determined to
> be adequately supported could be distinguished on labeling.
>
> This option would take much of the burden of data evaluation off of
> FDA. And if such a process were done voluntarily by the manufacturers,
> we would even say that FDA could exercise its own authority under
> FDAMA as the authoritative body to authorize a health claim on such
> research.
>
> Those are the only comments I have. If you want to see a slightly
> longer document, you can get the comments we turned in. Thank you.
>
> MR. LAKE: Thank you.
>
> The next speaker is Michael McGuffin, chair of the Government
> Relations Committee, American Herbal Products Association.
>
> MR. McGUFFIN: Thank you very much. And again thank you to FDA for
> sponsoring this. It\'s really a good forum for this kind of
> discussion.
>
> My name is Michael McGuffin. I am here today on behalf of the American
> Herbal Products Association or AHPA. AHPA is the trade association of
> manufacturers of herbs and herbal products, including dietary
> supplements.
>
> I would like to offer comments on three particular points related to
> today\'s discussion from the perspective of herbal dietary
> supplements.
>
> First, AHPA is aware that FDA has proposed to permit the use on
> dietary supplements of health claims based on authoritative statements
> under the notification procedures in FDAMA. AHPA agrees that health
> claims based on authoritative statements should be allowed for dietary
> supplements and therefore agrees with FDA\'s conclusion in this
> regard.
>
> However, AHPA notes that all of FDA\'s NLEA and FDAMA health claims
> implementing regulations must be reevaluated to consider the recent
> mandate and decision of the U.S. Court of Appeals in Pearson versus
> Shalala.
>
> Secondly, AHPA wishes to express its concern regarding one particular
> definitional limitation of FDAMA. By defining authoritative bodies to
> include only a scientific body of the U.S. government that has
> official responsibility for public health protection or research
> directly relating to nutrition or the National Academy of Sciences and
> its subdivisions, any information that comes from scientific bodies
> that may have such responsibilities in other countries is irrelevant
> to the establishment of a scientific basis for a legitimate health
> claim.
>
> In an era when communication is nearly instantaneous and when
> international harmonization has been accepted as a valuable concept,
> this is an unfortunate limitation. Because almost all of the
> contemporary research on herbs has been conducted outside of the
> United States, this is particularly unfortunate for consumers of
> herbal products.
>
> AHPA is aware that in identifying this last statutory limitation
> inherent in the language of FDAMA, it has identified a concern that is
> outside of the scope of the authority of the U.S. FDA. Nevertheless,
> it is important that we\'re all aware of the fact that the current
> laws and regulations of the United States do not allow consumers of
> herbal dietary supplements to have straightforward access to all of
> the scientific information that might assist them in making choices
> about their health. Until such time as this limitation is addressed,
> AHPA intends to continue to work closely with FDA and the legislative
> process to attempt to correct this defect.
>
> Finally, there is one additional related issue that demands comment.
> In the dietary supplement proposal published in the Federal Register
> on December 28, 1995, FDA sought to clarify the agency\'s thinking
> with regard to the relevance of health claims for nonnutritive
> substances. It concluded at that time that \"nutrients that are the
> subject of Section 403(r)(1)(B),\" that is, nutrients subject to
> health claims, do include vitamins, minerals, herbs and other
> nutritional substances.
>
> This position was reiterated in the coverage accompanying the final
> rule for requirements for nutrient content claims, health claims and
> statements of nutritional support for dietary supplements published in
> the Federal Register on September 23, 1997.
>
> AHPA supports the agency in maintaining this position and, in fact,
> would consider the opposite position to be a serious flaw in providing
> meaningful, health‑promoting information to consumers of the broad
> range of dietary supplements and particularly herbal dietary
> supplements.
>
> Thank you very much for your attention and thank you again to FDA.
>
> MR. LAKE: Thank you.
>
> The next speaker is Dr. R. William Soller, senior vice president and
> director of science and technology for Consumer Healthcare Products
> Association.
>
> DR. SOLLER: Good afternoon. I\'m Dr. Bill Soller, senior vice
> president and director of science and technology for the Consumer
> Healthcare Products Association and with me here today is Miss Eve
> Bachrach, general counsel for the association.
>
> CHPA, formerly the Nonprescription Drug Manufacturers Association,
> represents producers of quality dietary supplements and
> nonprescription medicines, including over 200 member companies across
> the manufacturing, supply and service sectors of the self‑care
> industry.
>
> Our comments have been submitted to the docket and I\'ve just handed
> you copies and I will make three basic points from them, and I\'d like
> to add one postscript, if I could, based on the discussions.
>
> First, we support application of the authoritative statement
> provisions of FDAMA to dietary supplements. Second, FDAMA Section 303
> explicitly stipulates criteria defining an authoritative statement,
> and FDA should not expand these criteria so as to supersede a
> qualified scientific body making an authoritative statement.
>
> And third, FDA review of health claims and nutrient content claims
> based on authoritative statements should be a three‑step process that
> emphasizes confirmation that an authoritative statement has been
> issued by a scientific body, not scientific rereview and approval of
> that authoritative statement. And I\'d like to amplify on this last
> point.
>
> Now it all starts with an authoritative statement from a scientific
> body of the U.S. government with official responsibility for public
> health protection or research directly relating to human nutrition or
> the NAS, and we would say possibly other appropriate organizations,
> and it would make sense to us, based on discussions we heard today, to
> expand this to appropriate centers within these organizations, such as
> NIH.
>
> But in any case, the authoritative statement is the presumptive
> surrogate of an FDA deliberative process, leaving FDA with an
> authorization role in a three‑step process.
>
> Step one would be the notification of FDA by submission about a health
> claim based on an authoritative statement under the statutory 120‑day
> procedure. FDAMA elaborates the components of this notification, which
> should not include detailed scientific data and information as might
> be submitted for de novo development of an authoritative statement by
> FDA itself.
>
> Step two is the confirmatory step where FDA would first determine if
> all the components, per 403(r)(2)(G) and (3)(C) are present, where FDA
> would then determine what nutrient is at issue and confirm the
> authoritative statement is attributable to a scientific body and is
> published per 403(r)(2)(g) and (3)(C), and where FDA could then, as
> needed, contact the scientific body and confirm the authoritative
> statement is currently in effect and determine that the statement is
> not by an employee in his or her individual capacity, again per FDAMA.
>
> Now step three would be the authorization step, where FDA would review
> the claim so that it is an accurate representation of the
> authoritative statement, including its context, and so that it is able
> to be comprehended by the public, including its relative significance
> in the context of the total daily diet, again from FDAMA. And part of
> this authorization step would obviously be notification of the
> petitioner and public.
>
> Importantly, this three‑step process is basically outlined in the
> statute and does not have FDA invoking a significant scientific
> agreement standard per se to evaluate a scientific body\'s
> authoritative statement. To do so would overengineer FDAMA, certainly
> the regulatory implementation of it by FDA, and it would run counter
> to congressional intent to have an alternative mechanism to streamline
> and expedite health claims authorization.
>
> Clearly the confirmation step where FDA could, as needed, contact the
> scientific body and determine that the authoritative statement is
> current and not the statement of an employee in his or her individual
> capacity is the appropriate level of regulatory oversight, consistent
> with the statute, to ensure the claim is appropriately supported and
> attributable to the scientific body and/or its centers or institutes.
>
> In sum, there is no basis for an independent FDA review of the science
> that has already been reviewed by another federal government
> scientific body. FDA reexamination of the claim under an NLEA
> significant scientific agreement standard would basically bootstrap
> the NLEA standard and procedure into the FDAMA procedure. It would
> mean that FDA could substitute its own judgment for the authoritative
> statement of another federal government body, effectively gutting the
> FDAMA provision. And this would produce a repetition of the problem
> represented by the folic acid situation, which the FDAMA provision was
> intended to correct.
>
> Now I\'d like to add my postscript, if I may, based on the
> discussions. I think that there is no such thing as a qualified
> authoritative statement. An authoritative statement is a statement
> from an authoritative scientific body. The authoritative statement is
> based on data and information where in probably almost every case the
> science is not absolute.
>
> The authoritative statement, however, as it is written, can be
> definitive in nature and potentially, as we think we\'ve outlined in
> the three‑step process, the situation for FDA authorization could be
> relatively straightforward.
>
> Or we think it could also be a judgment about persuasive data in terms
> of a diet‑disease relationship and as such, some health claims may
> appropriately bear a disclaimer as part of the statutory requirements
> of truthfulness and accuracy.
>
> The basis for such a disclaimer is obviously tied to the First
> Amendment commercial speech doctrine reflected in Pearson v. Shalala,
> as well as the Washington Legal Foundation on drug claims about
> unapproved uses.
>
> So the challenge to FDA is to embrace procedures that facilitate
> satisfying this tremendous demand that consumers have for
> health‑related information for personal decisions about self‑care and
> product choices. The food and dietary supplement product label is
> where this should happen, with or without appropriate disclaimers, per
> the statute and per the Constitution. Thank you.
>
> MR. LAKE: Thank you.
>
> Our final registered speaker for this afternoon is James S. Turner,
> Esquire, chairman of the board of Citizens for Health. He\'s with
> Swankin & Turner. Is Jim here?
>
> VOICE: He\'s in court and he wasn\'t sure he could be here.
>
> MR. LAKE: Oh, I see. Is there perchance anyone in the room on his
> behalf?
>
> \[No response.\]
>
> Okay, well I guess that is the end of that.
>
> Let me say that we did not build into the schedule an opportunity to
> question the presenters during this last session. I would, however,
> encourage the speakers to linger a bit after the meeting is over so
> that if people have questions of you, that they may get them answered.
>
> I guess with that, let me turn to my colleagues as to whether there\'s
> anything else that‑‑okay.
>
> Let me start by thanking them. They\'ve been terrific support for
> this. Let me also thank the other people who helped with the
> registration, the collection of the cards, et cetera.
>
> And again let me thank the USDA for providing the auditorium and their
> staff for helping us with the arrangements here this afternoon.
>
> Finally, let me thank each and every one of you for attending, for
> listening, for asking good questions and for contributing to this
> overall effort to get some more input on how we should handle these
> important issues.
>
> With that, I will close the meeting. Again thank you and have a good
> journey wherever you\'re going.
>
> \[Applause.\]
>
> \[Whereupon, at 3:54 p.m., the meeting was adjourned.\]
>
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