> DEPARTMENT OF HEALTH AND HUMAN SERVICES
>
> FOOD AND DRUG ADMINISTRATION
>
> CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
>
> NUTRITION SUBCOMMITTEE MEETING
>
> TOTAL FAT AND TRANS FAT
>
> Wednesday, April 28, 2004
>
> 8:10 a.m.
>
> Loews L\'Enfant Plaza Hotel
>
> 480 L\'Enfant Plaza
>
> Monet Room
>
> Washington, D.C.
>
> PARTICIPANTS
>
> Norman I. Krinsky, Ph.D., Chair
>
> Jeanne Latham, Executive Secretary
>
> MEMBERS
>
> Susan S. Baker, M.D., Ph.D.
>
> R. Jean Hine, Ph.D. (Consumer Rep)
>
> Guy Johnson, Ph.D. (Industry Rep)
>
> Michael J. McGinnis, M.D., MPP
>
> Susan T. Mayne, Ph.D.
>
> Suzanne Pelican, M.S., R.D.
>
> Barbara M. Shannon, Ph.D.
>
> TEMPORARY VOTING MEMBERS
>
> Alice Lichtenstein, Ph.D.
>
> Eric Rimm, Ph.D.
>
> C O N T E N T S
>
> [Page]{.underline}
>
> Welcoming Remarks:
>
> Dr. Robert E. Brackett 4
>
> Call to Order and Opening Remarks:
>
> Norman I. Krinsky, Ph.D. 7
>
> Subcommittee Discussion 11
>
> [P]{.underline} [R]{.underline} [O]{.underline} [C]{.underline}
> [E]{.underline} [E]{.underline} [D]{.underline} [I]{.underline}
> [N]{.underline} [G]{.underline} [S]{.underline}
>
> MS. WILKENING: I guess we will get things started this morning. I
> would like to introduce you to Dr. Bob Brackett who is the Director of
> our Center for Food Safety and Applied Nutrition who is here to say a
> few remarks to you.
>
> **Welcoming Remarks**
>
> DR. BRACKETT: Good morning to all of you.
>
> One of the things I wanted to do in coming here and giving these
> remarks is actually welcome you to the Advisory Committee.
>
> For those of you who have either followed the FDA Advisory Committees,
> and in particular with CFSAN\'s Advisory Committee, you don\'t realize
> how valuable you are to the Agency, as well as to public health and
> some of the scientific background that you bring to these.
>
> I participated on the Food Advisory Committee before I came to FDA,
> and have been involved with several others within FDA, as well as a
> joint committee that we have with USDA, and I think two things that I
> hope that you will find, one of which is that you will get a sense of
> accomplishment from what you are doing, because some of the issues
> that you have to deal with are very difficult, as I understand,
> yesterday, it sometimes stimulates some lively debate, and that is one
> of the two things that we do want, but in the bottom, when we are all
> done, I think what we really want is some of the best scientific
> advice that we can get on many difficult issues.
>
> Fats and trans fats is one of the things where I think there is the
> most debate. I came from a meeting yesterday where involving both
> there is academic people there, as well as food industry executives
> and some government people, and I think about 80 percent of the day or
> the discussions, and it was sort of free on a lot of different issues,
> centered on qualified health claims and trans fats.
>
> So, it is of interest and it is something that we very much want to
> have the best scientific knowledge on, so that we can make decisions
> that can benefit the public, as well as give the regulated industry
> guidance on how they can label foods, how they can structure the
> claims that they wish to make, so it is quite important.
>
> One of the things that I think that you will also find is that you
> will end up making some\--if you haven\'t already\--different types of
> associations and connections with others on the committee and also
> people that make public remarks during the committee that I think will
> be of benefit to you in your professional life. At least that was what
> I had found.
>
> I think it a very enriching experience to do this, and if you haven\'t
> served on these advisory committees before, I think that you find it
> valuable to yourself.
>
> So, I welcome you again and I really would offer that anytime that you
> have questions or concerns, please feel free to contact any of the
> people at the Center that are dealing with the committees, and me
> personally.
>
> We do want this to be the very best that it can be.
>
> With that, I will let you get on with your deliberations, because I
> know you have some interesting things to cover.
>
> Thanks.
>
> **Call to Order**
>
> DR. KRINSKY: Thank you very much, Bob.
>
> We will now call the meeting to order.
>
> I would like to take this opportunity to introduce Dr. Michael
> McGinnis who unfortunately was not able to be with us yesterday, but
> who will be with us today. So, welcome. You missed out on some
> interesting discussions, and actually, of the three questions, we
> actually voted on one.
>
> That reminds me, I was actually reminded by the Executive Secretary
> that this is transcribed, and not videotaped, so that, for the record,
> the vote on Question 3 was 8 yes, no no\'s, and no abstentions. That
> is being double-checked by Dr. Rimm. So, we have confirmation that
> that was the actual vote.
>
> For future votes, I am sure the Executive Secretary will again remind
> me to put it in the oral recording.
>
> I think that we can return to Question 1. The question has been
> rephrase.
>
> DR. JOHNSON: Mr. Chairman.
>
> DR. KRINSKY: Yes.
>
> DR. JOHNSON: Could I say something before we get started officially? I
> spent a long time sort of thinking about what a headline for this
> meeting and the Washington Post might say, and the headline would be
> something like FDA Nutrition Committee concludes that trans fats are
> worse than saturated fats, and I guess I felt like that headline,
> taken out of context, would not really be reflective of our
> discussion, so what I wanted to do was just read a statement from
> myself into the record to make sure that it reflected that. I wrote it
> down, so I would get it right.
>
> The statement is I believe that although the answer to Question 3 is
> technically yes, this black and white answer does not reflect the
> considerable uncertainty discussed by the Committee as to whether this
> difference is significant from a public health perspective at the
> level of trans fatty acid intake typical in the United States.
>
> I just wanted to be on record to make that point.
>
> Thank you.
>
> DR. KRINSKY: That is fine, Guy, and I appreciate that comment, and I
> think one of the problems with questions that end up with yes or no
> answers is that they lose all of the shading that comes in the
> discussion, and we end up with a black and white question when, in
> fact, we are dealing with all of the shades between black and white,
> and even a vote of 5 to 3 would not necessarily get into the shading,
> so that, you know, we have the questions.
>
> The Committee will vote on them, and that is what is recorded without
> the benefit of the discussion. But the FDA is here and is listening to
> our discussion, and I hope that they are appreciating the shades that
> we are presenting on these questions, the shading that we are
> presenting.
>
> DR. JOHNSON: I guess my concern was that they had said that if they
> don\'t adhere to an advisory committee ruling, then, it is very
> uncomfortable for them, and I wasn\'t sure if by having a black and
> white vote, we put them in a position of kind of all or none, so I
> just wanted to officially acknowledge that we are in a gray area here.
>
> DR. KRINSKY: Well, let me just point out that the decisions, the vote
> that we take does not go directly to the FDA, it goes to the parent
> Food Advisory Committee, and I only have limited experience, but the
> recommendations of subcommittees have not engendered long discussions
> by the Food Advisory Committee.
>
> There may be a few questions that come up for clarification on the
> issues, but they don\'t then initiate a rehashing of what we have
> done, and then after that, then, the FDA takes that information and
> they do with it as they please. Is that\--yes, so hopefully, they will
> pay attention to what we are saying. I am looking around the trying to
> make the FDA feel guilty.
>
> \[Laughter.\]
>
> DR. KRINSKY: All right.
>
> **Subcommittee Discussion**
>
> DR. KRINSKY: Let\'s then return, unless there are any other comments,
> to Question 1.
>
> We have rephrased Question 1 so that we can answer it as opposed to
> the initial phrasing. So, the question, it has been suggested that the
> question now read as follows:
>
> Does the current scientific evidence suggest a relationship between
> total fat intake and risk of coronary heart disease?
>
> Does the current scientific evidence suggest a relationship between
> total fat intake and risk of coronary heart disease?
>
> Now, I might point out that this question has been modified by the FDA
> for our benefit, and I would be certainly willing to entertain any
> suggestions on the part of the committee if they wanted to suggest a
> further revision of that question.
>
> DR. RIMM: I presume that this question follows the first statement in
> Question 1. So, the first statement still stands.
>
> DR. KRINSKY: That is correct. I didn\'t read that first question
> because I am under the assumption, and it\'s a correct one, that we
> can all read that first\--
>
> DR. MAYNE: I am sorry, Norman, I didn\'t have the full question. It is
> coronary heart disease risk, is risk what should be added?
>
> DR. KRINSKY: The relation between total fat intake and risk of
> coronary heart disease.
>
> DR. MAYNE: Risk of coronary heart disease, okay.
>
> MS. PELICAN: I am going to ask guidance from other people who are on
> the committee, who are, you know, much more familiar with the
> literature than I, but I guess I am thinking that is\--I mean it is
> good that the question has been rephrased, but I find that it is a
> little harder to answer in my mind with some of the statements that I
> think were in Chapter 11 from the IOM report.
>
> With regard to I think, I just had made a note, page 22 of Chapter 11
> talking about practically, it is very hard to avoid high saturated fat
> intake when fat is greater than 35 percent of total energy.
>
> They way it is phrased now, it sounds like there is no level, I mean
> that there is no relationship, and I would say could we talk about
> that as a group and get some input from people who know the literature
> better than I.
>
> DR. KRINSKY: Let me just point out that we are not even addressing the
> saturated fat issue in this question.
>
> MS. PELICAN: Right, but if we think about the relationship between
> total fat and coronary heart disease, that statement that once you
> reach\--there is, in my mind, a relationship between total fat at
> those high levels, that statement that came from the IOM report, I am
> just asking for clarification and thoughts from other people on the
> committee.
>
> DR. LICHTENSTEIN: It is certainly possible to have a diet that is low
> in saturated fat and is high in total fat, and I think we have to view
> the question within the context of what the current dietary patterns
> are in the United States.
>
> So, from that perspective, it appears that the question is clear and
> covers all the issues.
>
> DR. RIMM: I mean I think if you look at the epidemiological evidence,
> there is the two, large-scale clinical trials that I mentioned
> yesterday, that randomized people to high fat diets\--or that
> randomized people to low fat diets, and did not find any difference
> between the high fat and low fat, and that is only within a certain
> range. They obviously can\'t randomize people to diets that are 80
> percent of calories from fat, so if you look at 40 percent of calories
> versus 30 percent, you can construct a diet that is 40 percent of
> calories from fat that is not high in saturated fat.
>
> Then, there is the three or four prospective studies that just took
> free-living individuals, had them report what they eat, and within the
> range of those diets, which is usually somewhere in the range of 25 to
> 40 percent, you don\'t see any association between fat and coronary
> heart disease.
>
> So, what we have to do, I think, if we send the message that the
> evidence doesn\'t suggest that there is any relationship between fat
> and coronary heart disease, then, I am sure that Guy will be talking
> to people already who are making, you know, canola oil and other oils,
> making food with other oils that are high in polyunsaturated fats or
> monounsaturated fats, so very easily, industry can change to fit the
> science, which is what has been done in the past, sometimes maybe we
> were wrong.
>
> I think there is a lot better evidence now to suggest that it is not
> the fat, it\'s the composition of the diet.
>
> DR. SHANNON: I can\'t help but be worried about how this will play, as
> Guy has brought up, because here, education is going to become very
> important. I think in the public mind, the difference between total
> fat and saturated fat may not be that clear, and I can just see some
> people thinking oh, now, fat is not related to heart disease.
>
> I am not arguing against the statement, but I am concerned about how
> it will play in the public.
>
> DR. JOHNSON: Could I just emphasize the context of the question is
> within health claims, and it is not the intent of anybody, I don\'t
> think, to broadcast this message. It is just whether health claims
> that have to do with cardiovascular disease would require foods to be
> low in fat. That is the issue here, and there are lots of controls on
> those health claims with respect to saturated fat and other things in
> the regs.
>
> I don\'t think the idea here is to wave a red flag and say, hey, you
> don\'t have to worry about total fat anymore. It\'s within the context
> of a health claim.
>
> DR. LICHTENSTEIN: I think in a sense what it does is it remediates a
> situation that does not allow the best communication of health
> information, and that is, if the total fat criteria precludes you from
> labeling something like canola oil or an unsaturated oil, or again, a
> fish that is high in omega-3 fatty acids, with the health claim,
> because of the total fat, and we know that the total fat is not
> related to the risk of developing cardiovascular disease, so it is not
> for the whole diet, although it for the most part is fairly consistent
> with the whole diet, but this is sort of individual foods, and I think
> we are in not in an unusual situation where some of the criteria for
> whole diets have actually been transposed to criteria for individual
> foods, and that has I think further complicated the situation.
>
> DR. SHANNON: I think that this conversation is very good because I
> think what I am trying to say is I would like to hear this
> conversation here in this group, making it clear what we are talking
> about specifically, so the record will show that we are not
> misconstruing it.
>
> MS. MAYNE: I mean one possibility might be to modify the question to
> include something about independent of saturated fat intake, because
> then I think it would be much clearer what we are discussing.
>
> So, it would be something like does the current scientific evidence
> suggest a relationship between total fat intake and risk of CHD,
> independent of saturated fat intake.
>
> MS. PELICAN: That would certainly help address some of my concerns. I
> don\'t know, thinking about what Barbara is suggesting, too, I realize
> that on our written page here, you know, we have got the opening
> phrase, but could it say, \"In relation to the health claims\" in
> terms of, you know, FDA and health claims on labels, actually, to add
> that preface, because I think, maybe back to what Guy is saying,
> thinking about how a single question is interpreted or pulled out. I
> wouldn\'t mind having that qualification, too.
>
> I was actually also going to suggest a small modification of including
> the caveat of saturated fat, and that probably take care of the
> concerns and also the potential interpretation of the recommendation.
>
> Procedurally, can we do that, FDA?
>
> MS. LATHAM: The committee can come up with a recommendation, yes,
> based on this modified question, that\'s fine.
>
> DR. LICHTENSTEIN: And then we can vote on the modified question?
>
> MS. LATHAM: Yes.
>
> DR. RIMM: I don\'t know if we have enough evidence to say it\'s
> independent of saturated fat. That suggests that total fat is not
> associated with coronary heart disease when saturated fat is 30
> percent of calories or when saturated fat is 10 percent of calories if
> we are saying it\'s independent of saturated fat.
>
> I don\'t know if we can say the trials and the observational data test
> all levels of saturated fat. I mean we already have the health claim
> set in place for saturated fat, that you can\'t have a food that is
> high in saturated fat and say this is a whatever low fat food.
>
> I think it is conservatively written right now, and I think it is
> appropriate because this matches the epidemiological evidence as we
> have it. I don\'t know, maybe I am not articulating the issue
> carefully enough, but I mean would we say it\'s independent of monos,
> independent of polys? I don\'t think so, I don\'t think we have enough
> evidence.
>
> The evidence is three or four observational studies, two clinical
> trials, and that is not enough to say that at all levels of saturated
> fat, total fat is not going to be associated with heart disease.
>
> DR. LICHTENSTEIN: My interpretation is that it would be just to tie
> together the two criteria formally, because as you said, that there is
> a separate one for saturated fat, so in this case it would just be to
> make sure that they would be linked.
>
> DR. KRINSKY: As I understand it, the guiding rule now is that there
> can be claims for low fat, is that correct? And that there are
> exemptions, and those exemptions are based on the type of fat that is
> in the product, so that if you have a good fat, then, you have an
> exemption and you can get away from the low fat position.
>
> Alice.
>
> DR. LICHTENSTEIN: Well, that concerns me because the bar is then
> higher for those foods and frequently those are the foods that we
> would want to encourage people to consume, so that the playing field
> is not really level.
>
> I think that is probably why this question has come up, because to go
> through the whole exemption process is quite cumbersome and it may
> actually deter certain foods or certain companies or purveyors from
> actually asking for the health claim, petitioning for the health
> claim.
>
> DR. RIMM: The exemption I think we heard was for walnuts, was the most
> obvious case where the saturated fat was low and the other fats were
> good. You mentioned whole grains, which I think doesn\'t apply to
> this.
>
> DR. LICHTENSTEIN: And soy beans and margarine and then the whole
> grains, so currently, there are four.
>
> DR. RIMM: So, it is almost like this Question 1 refers to foods that
> are low in saturated fat, so it is not independent of saturated fat,
> it is only just as long as saturated fat is low.
>
> DR. KRINSKY: But it doesn\'t state low in saturated fat.
>
> DR. RIMM: No, it doesn\'t that, but that is sort of implied, because
> there is already an existing health\--an existing food claim for foods
> that are low in saturated fat, so walnuts, if we said that here is
> Question 1, this is the eligibility criteria, fat is not associated
> with heart disease just as long as saturated fat is low, then, it
> would automatically sort of bring in walnuts, bring in fish, bring in
> everything for which we think there is no problem consuming high fat
> foods.
>
> DR. JOHNSON: Assuming they are low in saturated fat. I mean the key is
> that all of the cardiovascular health claims that have been authorized
> so far require that the foods be low in saturated fat, and nobody is
> arguing with that.
>
> It is just that they have gone through the process of having to exempt
> foods from being low in total fat so many times, it seems unnecessary
> to do that if the food is already low in saturated fat, and then there
> is all kinds of studies to show that it does good things to
> biomarkers, and so forth. I think that is what the point of this is.
>
> DR. KOCH: Also, from an educational perspective, to tie the total fat
> and saturated fat together would probably be beneficial.
>
> DR. KRINSKY: Well, Susan tried to do that in her amendment to the
> question. Does that actually accomplish what we want to accomplish
> that we just had in this discussion?
>
> DR. MAYNE: One of my comments now, again one of the disconnects I am
> sensing is we are talking about a dietary pattern, but here we are
> considering the use for labeling in foods, and I am wondering if it
> might be useful to think about saying something that foods low in
> saturated fat, that contain high fat, are associated with coronary
> heart disease risk or something like that, because this is going to be
> applied to individual food items, and not a dietary pattern.
>
> DR. KRINSKY: If that is the case, I wonder if it might not be useful
> to, in fact, insert the health claim preface in the first sentence at
> the beginning of this particular question, that is, for purposes of
> the health claim, does the current scientific evidence suggest total
> fat intake suggest a relationship between total fat intake and risk of
> coronary heart disease independent of saturated fat intake.
>
> DR. LICHTENSTEIN: I think it would be helpful if the term \"in an
> individual food\" was inserted because that is really what this
> pertains to.
>
> DR. KRINSKY: If we each insert two or three words into this question,
> it will become the mother of all questions, but this is what is known
> as a committee creating\--crafting is not the word\--creating a
> question that it wants to answer.
>
> But give me your version again, Alice.
>
> DR. LICHTENSTEIN: I have lost track of the whole sentence, but I was
> suggesting that the term \"individual food\" be in there, because
> there has been a lot of I think misunderstandings as far as whether
> some of these health claims are referring to individual foods or
> dietary patterns, and they can\'t refer to dietary patterns because
> you don\'t know what else is being consumed with these individual
> foods, so that we should just be real clear as to what it is actually
> referring to.
>
> DR. JOHNSON: Actually, many of these health claims do say that the
> food must be consumed in the context of a diet low in saturated fat
> and sometimes cholesterol.
>
> DR. KRINSKY: Michael.
>
> DR. McGINNIS: I am reluctant to say anything since I missed some of
> the discussion and I am not voting today, but just two quick comments.
> I am presuming that since the reference is to the evidence base, our
> evidence is primarily on dietary patterns, and not on individual
> foods, so I am not sure that we don\'t get into some trouble if we try
> to introduce the notion of individual foods.
>
> Secondly, I do think the educational value, if not the scientific
> accuracy of the qualifier for saturated fats, is an important one to
> include.
>
> DR. KRINSKY: But the exemptions are for specific foods, not for diet,
> so though that should be put in the context of a diet, that is to say
> you don\'t want an exemption for walnuts while you are eating a diet
> that is supplementing the walnuts with a high fat, high saturated fat
> diet.
>
> DR. LICHTENSTEIN: Not necessarily high fat, but not high saturated
> fat. Maybe what we should do is step back and decide which critical
> points we want to include in the question, and then it might be easier
> to craft a sort of trim question.
>
> I mean the issues we want to get across the concept that the total fat
> content of the food is not related to cardiovascular disease risk,
> that the saturated fat content of the food is related to
> cardiovascular disease risk, and that this is for an individual food.
>
> DR. KRINSKY: So, I will give you another version.
>
> For the purposes of establishing a health claim of individual foods,
> does the current scientific evidence suggest a relationship between
> total fat intake and risk of coronary heart disease independent of
> saturated fat intake?
>
> I will repeat that. The only problem I have with that, and it\'s a
> combination of everything that we have brought up so far, is that that
> last clause \"independent of saturated fat intake,\" I think should
> sort of be earlier.
>
> DR. McGINNIS: Grammatically, I would agree if you have total fat
> intake, independent of saturated fat comma.
>
> DR. KRINSKY: I will reread this. Thank you, Michael. It is getting to
> be like a Rube Goldberg diagram on my sheet here.
>
> For the purposes of establishing a health claim of individual foods,
> does the current scientific evidence suggest a relationship between
> total fat intake, independent of saturated fat intake, and risk of
> coronary heart disease?
>
> Is something still missing? I wish we had a screen where we could put
> it up.
>
> DR. LICHTENSTEIN: Can we say within the context of a diet that is low
> in saturated fat?
>
> DR. RIMM: I think we want to educate people, and you want the message
> you get across, I think saying \"independent\" means very little to
> people who are trying to understand it. I think you have to say in the
> context of a low saturated fat diet, because that is where it has been
> tested.
>
> DR. KRINSKY: Is there a computer up there? Can the computer be hooked
> up? Okay.
>
> \[Break.\\
>
> DR. KRINSKY: The Committee is back in order.
>
> Now, we will proceed to some disorder. Alice left. Alice will be back.
>
> Now, we have the following points, whether it is in appropriate
> grammatical form or not, we have the following points. We are talking
> about establishing a health claim. We are talking about individual
> foods. We are talking about the relationship between total fat intake
> in the context of a low saturated fat content, and risk of coronary
> heart disease.
>
> Now, I understand that there is a suggestion for modification on my
> right.
>
> DR. MAYNE: I am still vacillating between two different options, but,
> first, the health claim should be four individual foods instead of
> \"of individual foods,\" is that right? Yes, okay.
>
> Where I got stuck was the phrase there, \"in the context of a low
> saturated fat content,\" I am not sure what that means. Does that mean
> foods, does that mean patterns, does that mean the overall diet?
>
> One option is to simply clarify that. The other thing Eric and I were
> discussing was would it make sense to modify it something like, \"For
> the purposes of establishing health claim for individual foods low in
> saturated fat,\" does it make sense, and then that would kind of get
> rid of the ambiguous clarification there.
>
> But then it leaves then we are still dealing with total fat intake and
> CHD risk, so I am not sure which is the preferred option, but that is
> the alternative is to put the low in saturated fat intake with the
> individual foods at the beginning of the sentence. So, those would be
> the two choices.
>
> DR. KRINSKY: So far the claims have been for foods that are low in
> saturated fat, so this, in fact, would be supporting the prior claims
> that have been accepted.
>
> Guy.
>
> DR. JOHNSON: I don\'t want to complicate things, but I have just
> talked to the FDA folks, and what they are interested in, I just think
> we are making this a little more complicated than it needs to be, what
> they are interested in is should there be an across-the-board
> requirement that foods that make cardiovascular health claims be low
> in fat.
>
> They have already got saturated fat covered, they have got cholesterol
> covered. They are not looking for is there any condition where total
> fat could be associated with heart disease, they just want to know can
> they get out of having to exempt foods that are not low in fat from
> making a health claim if they are low in saturated fat and low in
> cholesterol.
>
> I mean that is the question that they want, and, you know, as we
> talked about yesterday, the Heart Association is there, ATP3 is there,
> I think we are there. It is just we have kind of got ourselves into an
> exercise here of trying to worksmith something.
>
> So, I just raise that for what it\'s worth.
>
> DR. KRINSKY: Then, let me hear your suggestion for a simpler
> statement.
>
> DR. JOHNSON: I should have figured that out before I opened my mouth,
> shouldn\'t I?
>
> DR. KRINSKY: Yes.
>
> DR. JOHNSON: Okay. One eligibility criteria that FDA has applied to
> most health claim regulations pertaining to heart disease risk is that
> foods bearing these claims be low in total fat.
>
> Should this criterion be continued for future health claims?
>
> DR. KRINSKY: Independent of the type of fat?
>
> DR. JOHNSON: Those are already covered. There is already criteria for
> saturated fat and cholesterol. So, the question is should that
> criterion be an automatic part of health claims, yes or no.
>
> DR. RIMM: I wholeheartedly agree with Guy on this one. I mean I think
> yesterday when we discussed it, we discussed it for 10 minutes and
> said this is a no-brainer and we moved on to Question 2, because the
> way it was stated was obvious, that there is no relationship between
> total fat and coronary heart disease, and as Guy said, all the other
> claims are covered by other things.
>
> So, I think\--now, I am going back on what we were saying\--I don\'t
> think we need to educate people within this statement. I think the FDA
> is already educating people with the saturated fat and cholesterol,
> and we should just go back to the simple way that you reworded it,
> maybe even take out \"For the purposes of a health claim,\" and just
> go back to the fact does the current evidence suggest that there is a
> relationship between total fat and risk of coronary heart disease.
>
> We will answer is and let the FDA interpret it from there, because I
> think they just want the answer does fat cause heart disease.
>
> DR. LICHTENSTEIN: I would just like some clarification from the FDA as
> to whether, by doing that, which I think is perfectly appropriate,
> whether that is going to complicate the educational message, and then
> that\'s it, whether that opens them up to some misinterpretation,
> potentially misinterpretation or exploitation of the specific
> statement, because otherwise, scientifically, I think we all agreed
> yesterday it was accurate.
>
> DR. KRINSKY: Can we get some clarification, please, from somebody at
> the FDA whether the simpler question, and I can assure we can make
> this question more complicated, we are not through yet, whether the
> simpler question would be adequate for the FDA for their purposes of
> educating the public.
>
> MS. WILKENING: FDA will have the benefit of the entire transcript, so
> we will put this in context when we use it in rulemaking.
>
> DR. KRINSKY: Thank you.
>
> DR. SHANNON: Could you read the question as you posed it, because I
> found that very helpful.
>
> DR. JOHNSON: I didn\'t write it down, but I will make it up again. One
> eligibility criterion that FDA has applied to most health claim
> regulations pertaining to heart disease risk is that foods bearing
> these claims must be low in total fat. Should this criterion be
> continued for future health claims?
>
> DR. LICHTENSTEIN: I withdraw my concern about the educational
> implications or interpretation, because I was just reminded that we
> are just advising, we are just answering a scientific question, we are
> not crafting any kind of health claim or statement or anything like
> that.
>
> DR. SHANNON: But I still like Guy\'s, the way he stated that question.
> To me, it is a much clearer thing.
>
> DR. KRINSKY: Let me go back to the beginning of the morning, which
> seems like hours ago, and that is the modification that the FDA
> originally suggested for this question.
>
> Does the current scientific evidence suggest a relationship between
> total fat intake and risk of coronary heart disease?
>
> That was the modification that we started out with.
>
> DR. RIMM: May I suggest, Mr. Chairman, that we take a vote?
>
> DR. LICHTENSTEIN: I will second that.
>
> DR. KRINSKY: I question has been called which eliminates all further
> discussion according to page 82 or Roberts Rules.
>
> So, I would like to ask the voting members to raise their hands if
> they agree with the question: Does the current scientific evidence
> suggest a relationship between total fat intake and risk of coronary
> heart disease?
>
> All in favor?
>
> DR. SHANNON: What are we voting on? Are we voting on that\'s the
> question, or are we voting on the answer to the question?
>
> DR. KRINSKY: We are voting on the answer to the question, and the
> question calls for a yes or no answer.
>
> Let\'s have a show of hands of those that agree that the current
> scientific evidence suggests a relationship between total fat intake
> and risk of coronary heart disease.
>
> All in favor?
>
> All opposed?
>
> All abstaining?
>
> DR. KRINSKY: There were six people that voted no, two people
> abstained.
>
> Now that we have finished that simple question, we have done two out
> of three.
>
> Amy, thank you very much. You can turn that off because we don\'t want
> to look at that anymore, although I hope that the FDA has appreciated
> what we have tried to do in that rather complicated question. We are
> just trying to repeat what the FDA already has in place.
>
> MS. PELICAN: I just wanted to add. Maybe it is in the same spirit of
> Guy, who I think has really helped us make sure that we are looking
> beyond just an immediate question even though our obvious focus is
> what FDA wants us to address.
>
> But I wonder if I might just add just a comment because I am thinking
> about sort of with all the consumer and industry and media focus on
> fat these days, if not FDA, but in terms of proceedings and what might
> get out about what this committee has agreed to, a statement such as,
> in the light of widespread consumer, industry and media interest in
> fat in relation to weight management, I would like to make a
> clarification that dropping the requirement for health claims for
> foods to be low in total fat is based on evidence for coronary heart
> disease only, and should not be inferred to mean that total fat is not
> an important consideration in other areas of intake, for example,
> energy density and energy balance.
>
> DR. KRINSKY: Any discussion?
>
> DR. McGINNIS: I would encourage a comment of that sort. I think it
> would be very helpful to clarify the record.
>
> DR. KRINSKY: Susan.
>
> DR. BAKER: Yes, I actually wanted to make a comment for a couple of
> moments here. I hope the committee will acknowledge that we are making
> recommendations based on data that has been obtained in adults. There
> is precious little, if any, data available in children.
>
> I would also like the committee to acknowledge that what children eat
> is very important, not only to their health at that moment, but also
> to their long-term health. We have very little data on that.
>
> We have some information that suggests that depending on how much of a
> particular fatty acid a child has early in life, maybe their blood
> pressure is a little different at other ages. We know for specific
> minerals the cognitive function, anxiety, and mental disease
> correlates with minerals in the first year of life.
>
> I also hope that we will acknowledge that, at least for children under
> two years of age, that food labeling has no acknowledgment of the
> amount of fat that is contained in that food for specific reasons.
>
> So, I hope that we can recognize that much of what we are doing here
> pertains to adults, and while at some time we may find that it is very
> important for children, right now we simply don\'t have that
> information available.
>
> DR. KRINSKY: I am glad you said that, Susan, and that will be
> obviously in the minutes of this meeting for the benefit of the FDA. I
> am not sure what type of action we as a committee can take on this,
> but it is in the record, and I think that is the important thing.
>
> DR. BAKER: Yes, I didn\'t expect us to take any action, I just wanted
> us to acknowledge that our work is very important for adults. We
> don\'t have any idea how relevant or important it is for children,
> maybe more so, maybe not relevant. But thank you.
>
> DR. KRINSKY: So, let me go back to Susie\'s comment. Could you do me a
> favor and reread that?
>
> MS. PELICAN: In light of the widespread consumer, industry, and media
> interest in fat in relation to weight management, I would like to make
> a clarification. Dropping the requirement for health claims for foods
> to be low in total fat is based on evidence for coronary heart disease
> only, and should not be inferred to mean that total fat is not an
> important consideration in other areas of intake, for example, energy
> density and energy balance.
>
> DR. KRINSKY: That is absolutely true, and the question is I am not
> quite sure how we do this apart from you are also putting that in the
> record of the minutes of this particular committee.
>
> I am not sure that we are in a position to make any further
> recommendation than the coronary heart disease issue, which we have
> been asked to vote on. We obviously were not asked to vote on total
> fat in obesity, which would also be a no-brainer, and we could do in a
> day or two with the group\'s ability to discuss these issues.
>
> MS. PELICAN: No, it\'s just a clarification, thanks.
>
> DR. LICHTENSTEIN: I think that is a totally different discussion, and
> I think we haven\'t reviewed the literature and we shouldn\'t even get
> into it at this point.
>
> DR. KRINSKY: I don\'t want to get into it at this point, and I
> withdraw the comment from the record, and I will personally see to it
> that it is blotted out of the final record. When it is transcribed,
> there will be a transcription error.
>
> DR. McGINNIS: I think what she was asking for was a statement similar
> to Guy\'s, a personal comment to enter into the record.
>
> DR. KRINSKY: Let\'s return to where we were yesterday, and that deals
> with Question 2. I will read it.
>
> The Dietary Guidelines Committee may suggest that less than 1 percent
> of energy should be obtained from trans fatty acids (2 grams per day
> for a 2,000 kcal diet).
>
> Does the scientific evidence support this level?
>
> We spent a good deal of time yesterday in trying to answer this
> question and trying to see whether, in fact, there was scientific
> evidence for supporting any level, let alone this level.
>
> As I recall the discussion, there did not seem to be very strong
> scientific evidence for supporting a level of this nature, and I would
> be interested in comment from the committee.
>
> DR. RIMM: I think, I don\'t know if it was Guy yesterday or Robert
> Earl when he spoke, someone had mentioned that, if used, this will
> likely be used as a target if we look at the label, that the 1 percent
> trans would be put on there as a target, much the way we have a target
> for saturated fat of 20 grams, a total fat of 65 grams, sodium of
> 2,400 milligrams, total carbohydrates 30 grams, and fiber 25 grams for
> someone who has 2,000 calories, if you want to refer to your label
> that we got yesterday.
>
> So, again, as I said yesterday, I don\'t think that levels of that
> amount for any of those macronutrients or for sodium have a necessary
> threshold where there is benefit or risk. I think it is really put
> there as a target, and, you know, Dr. Enig would like to have a target
> of zero percent, based on her talk yesterday, and I think we have the
> realization that there are trans in dairy and beef and therefore a
> target of zero percent would not really be rational, but I think a
> target of 1 percent would not be that far off if we think of removing
> all trans fats from hydrogenated foods if we remove those from the
> diet.
>
> DR. LICHTENSTEIN: I think we could perhaps deal with this in two
> separate ways, and, first, answer the question regarding the
> scientific evidence and then perhaps propose guidance to the FDA that
> in the absence of hard scientific evidence for a specific number, that
> a target be established consistent with the targets for saturated fat
> and cholesterol.
>
> DR. MAYNE: My only comment is that my understanding is that those
> targets were set at a time when intake was higher than that, so, for
> example, the 30 percent fat was when U.S. intake was 37 percent of
> calories from fat, so setting a lower target was desirable, but from
> our discussions yesterday, it sounds like the intake of trans fatty
> acids in the U.S. is really very close to what this is right now.
>
> So, if we are trying to set a target, I mean we heard different, that
> it is not clear yet where the target level is or what the U.S. intake
> is. We heard some discussion yesterday that it is not entirely clear
> what the intake levels are, but if we are at 2 percent of energy or
> 1.5 percent of energy, I think we should definitely make the target
> lower because consistent with the IOM report, as low as possible.
>
> So, how certain are we of what the current intake levels are? I mean
> we heard different figures yesterday and that there is a lot of
> ambiguity in the data.
>
> DR. LICHTENSTEIN: Yes, I don\'t think we have any idea what the actual
> intake is, but it probably is above 1 percent, and, yes, any target
> that you would want to set, you would want something below what the
> current intake levels are.
>
> MS. PELICAN: If you would bear with me, I just took some time to write
> some things down last night, so I am going to be reading this.
>
> I want to say how much I valued everyone\'s input through all the
> discussion, but particularly this one, to thank Eric and Alice for
> being really truly our expert consultants.
>
> I am not comfortable voting to establish a D.V. for trans fat, and it
> is not that I don\'t want to have one. As an educator, I would welcome
> a D.V. that is both defensible and workable, but I don\'t see that
> those two bases are fully covered.
>
> First, in terms of being defensible, it doesn\'t seem like we have
> enough of a basis to distinguish the desirability of 1 percent from a
> half a percent to 1.5 percent.
>
> I know several comments have been drawn parallels with the saturated
> fat guideline of 10 percent or less, but this brings me to my second
> dimension or area of hesitation, and that is the workability.
>
> I was struck by a couple of points that Norman and Susan made. Norman
> noted that a product with a half a gram of trans fat would display, if
> we used that 1 percent, 25 percent in the D.V. column.
>
> Susan noted a problem with measurement, that being the difference in
> 0.1 grams from 0.4 to 0.5, would change a label value of from trans
> not being listed or from zero to listed as 25 percent.
>
> With saturated fat, we often deal with amounts that are ranging from
> like 1 to 20 or more grams, and those are amounts where the 0.5 gram
> increments at those levels are small relative to the total, whereas, a
> 0.5 gram increment with the trans represents a huge proportion of that
> total.
>
> So, just educationally, I think this could be really confusing. My
> hope would be that we could get more information on what an upper
> level might be, better trans fat composition data and more research,
> and on that note with more research, I would like to refer to the
> ruminations of two other important groups, the Institute of Medicine
> and the Dietary Guidelines Committee.
>
> It wasn\'t until last night when I was reading one of the Federal
> Registers that we just got yesterday from April 19th, I hadn\'t
> realized that in addition to the 2002 IOM report in which that report,
> the 2002 did not, you know, give any kind of a DRI value for trans.
>
> The 2003 report suggested an approach\--and I didn\'t realize that
> there had been a 2003 report\--suggested an approach to estimate
> minimum trans fat intakes with a nutritionally adequate North American
> diet, and use that value to establish a D.V. for trans fat. But again
> they, themselves, did not establish a D.V., they are looking to others
> to do that.
>
> With regard to the Dietary Guidelines Committee, I find it very
> helpful to know that they are considering a limit of 2 grams or 1
> percent of energy intake. I would encourage FDA to use whatever
> quantitative value that the Dietary Guidelines Committee sets as a
> basis for doing consumer research, both FDA-conducted research, as
> well as extramural research by others, to assess consumer
> understanding and use of trans fat labeling with a D.V. equal to the
> dietary guidelines value.
>
> In conclusion, I will quote a friend of mine who says one of the good
> things about being a nutritionist, that we will never starve because
> we get to eat crow every few years.
>
> I think it is better to promise less detail now and add more later
> when we have it than to specify it now and change the specifics later
> and have something be very confusing. I don\'t think it serves
> consumers or industry or FDA well.
>
> Thank you.
>
> DR. KRINSKY: Thank you very much, Susie, that was an excellent
> statement. Again, this is a statement that I am sure will be
> appreciated very\--it is appreciated by me\--and I think by the other
> members of the Committee, and I hope it will be appreciated by the
> FDA, as well.
>
> So, we are in a position where we are virtually asked to vote on
> whether we want to establish a D.V. or something comparable to a D.V.
> by establishing a value that we are asked is there scientific evidence
> to support a value, a level of trans fatty acids, and that is
> troubling to me.
>
> Susan.
>
> DR. MAYNE: Again, clarifying the question, I mean it doesn\'t
> explicitly say should we establish a D.V. It is kind of implicit in
> the question, but to me, they are quite different.
>
> Again, coming back to my comment I made yesterday, I just think that
> if you do have a D.V. there, there is no way, there is so much
> uncertainty in the amount of trans fatty acids in the individual food
> items, that the D.V. is going to have plus or minus 25 percent error
> for each individual food item.
>
> So, I think it makes no sense to have a D.V. of 2 grams per day when
> we have plus or minus 0.5 grams measurement problems with the content
> in an individual food item. You can\'t operationalize it.
>
> DR. KRINSKY: Eric.
>
> DR. RIMM: Again, I think that maybe we are thinking that the FDA is
> not going to think about this a little bit more. It is very possible
> they can change the definition of how to measure or how to list trans
> fat or how to do the D.V., and I am sure that industry can measure
> trans fat down to less than 500 milligrams, plus or minus 500
> milligrams, and we measure micrograms of folate, so I am sure it is
> very possible to measure grams of trans fat down to lower levels, so
> it is very possible that it won\'t have to be listed on a per
> half-gram or a per 25 percent D.V. increment.
>
> So, I think if we vote on the question and then put it to the FDA
> saying now you need to be more creative about how you are going to
> list on the label, because there is evidence to suggest that there may
> be risk at 2 grams, so maybe we should maybe we should make the
> increment smaller, between zero and 2.
>
> DR. LICHTENSTEIN: I would just like to say something about the
> measurement, that we have to keep in mind measuring trans fatty acids
> is not like measuring something like folate, that you have got many,
> many isomers in there. When you think about it, the difference in a
> cis versus a trans isomer, especially if you have something like 18
> carbons, and you have 3 double bonds, they have 1 in the trans
> position, it may be in different positions, and with each one of those
> measurements, you have error, and then you are accumulating and adding
> up the error, so that is just a technical point as far as measuring
> the accuracy of measuring.
>
> The other thing, I just want to say one thing about the Dietary
> Guidelines Committee and recommending a D.V. or any number. I am not
> sure, with all due respect to that committee, that they have any more
> resources or access to information than the IOM Committee or this
> committee with respect to actually coming up with a number.
>
> So, whether they come up with a number or not, I am not sure that that
> is particularly applicable to this situation.
>
> DR. RIMM: The only thing is I think it would be great if the USDA and
> the FDA worked together. I think it would be very nice if both groups
> came to one point, so there wouldn\'t be confusion by consumers and by
> industry, because in the past, there have been differences in how
> D.V.s and RDAs were set.
>
> So, it would be nice if they did come up with a similar number.
>
> DR. KRINSKY: This is an apolitical committee.
>
> DR. RIMM: I am a very apolitical person.
>
> DR. HINE: I would support what Eric just said and I would also like to
> add something about folic acid and measurement error that might
> indeed\--
>
> DR. LICHTENSTEIN: A bad example, I am sorry.
>
> DR. HINE: Okay\--be applicable here. I believe that two people from
> the FDA measured the actual content of folic acid in breakfast cereals
> versus what was on the label, and found in some breakfast cereals that
> there was up to 3-fold higher level that was actually present in the
> food.
>
> I think this may indeed be of concern in this area, too, and would ask
> the technical people to comment on this. I think of doughnuts, for
> example.
>
> DR. JOHNSON: Let me talk a couple of things. One, this measurement
> thing, I agree that in a purified system with sophisticated analytical
> techniques, you can get very precise in determining trans fatty acids,
> but we are dealing with a commercialized food product, and as you
> mentioned yesterday, it could be 10,000 gallon batches of something
> based on biological materials.
>
> Think about a meat-containing product, for example, that would have
> varying levels of naturally occurring trans fatty acids. To that you
> may add exogenous sources of trans fatty acids. There are formulation
> variability, there is homegenicity in food products, even formulated
> products, that is a real issue.
>
> Then, there is analytical variability, and all of this makes it very
> difficult to be precise down to 100 micrograms in a food product. It
> just doesn\'t work from a practical standpoint, that is just the way
> it is.
>
> Then, I can\'t help\--forgive me for replowing this ground\--but the
> studies that we have on the effect of trans fatty acids in the diet
> are conducted at levels beyond\--most of them are conducted at levels
> beyond typical intakes, and there is a paucity of data points in the
> area around 1 percent of the diet.
>
> Granted, there are epi studies, but I know there are potentially other
> factors involved there, so, you know, if I am FDA and I create a D.V.
> and put it on a label for trans fatty acids, and they say where are
> the studies that show that it makes a difference from 3 to 2 to 1
> percent, and they say, well, gee, we don\'t have much, I think that is
> not a very defensible position particularly when we are talking about
> a nutrition facts panel. It really should have sound science behind
> it.
>
> I will get off my soapbox again.
>
> DR. McGINNIS: Just a question, Mr. Chairman, about the discussion
> around the wording of the question. Did you discuss yesterday, as you
> apparently did in Questions 1 and 3, the rephrasing of this as a
> binary response yes/no, is that what you are intending to do?
>
> DR. KRINSKY: Yes. Just for the purposes of simplifying the responses,
> that if, in fact, we can get yes/no answers, it will make it much
> better than an answer of yes, but I don\'t think this and I do think
> that.
>
> Susie.
>
> MS. PELICAN: Just to respond back to Alice, which I think she was
> commenting just with this idea of the Dietary Guidelines Committee, I
> guess my thought was not that I wouldn\'t think that they have access
> to different scientific data than we do, but just to say in some ways
> their charge is different than ours.
>
> I had made a couple of notes during one of the presentations yesterday
> that I think this question FDA is asking with the idea that could a
> D.V. be set. So, I guess that was my thought and what I shared was
> just that I just am not comfortable answering yes to this with the
> idea that FDA is looking to then develop a D.V. with their best
> interpretation, but at something around this level.
>
> I guess my point was to encourage FDA to take whatever the Dietary
> Guidelines Committee sets, not to put that on the label, but to use
> that in research.
>
> So, I cleaned out one of my nut labels yesterday. I had chips
> yesterday, today I have my mixed nuts, and just looking and having it
> blank for trans or just as we do for polyunsaturates and
> monounsaturates, or as I shared yesterday, with that asterisk with the
> disclaimer, but to do that consumer research and see how do people use
> and understand that information if there were to be a D.V. at 2 grams
> or 1 percent energy level.
>
> DR. KRINSKY: But if, in fact, a D.V. is set at 2 grams per day as one
> possibility, and your label says zero, your label could contain 0.4
> grams, that is to say, 20 percent of the D.V., and that would just
> vanish because nobody would know about that.
>
> MS. PELICAN: That\'s right, and that is my concern, and that is why I
> am saying I would not do that.
>
> DR. RIMM: Well, based on what you heard yesterday, Suzanne, do you
> think that a target should be set? Do you think that we should have
> something on the label that gives a target for people to shoot for to
> stay below, so if they see the trans fat and the 1 gram, they have
> some context?
>
> MS. PELICAN: I guess that, you know, on the one label that I got where
> it said, \"Intake of trans fat is encouraged to be as low as possible,
> which I think is taken right from the IOM report, I mean that is one
> option, or just on this label, there is nothing next to
> polyunsaturates and monounsaturates.
>
> That is where my point was, that I would rather see less. To me, less
> is better right now than to try to put something out with these
> percentages that go from zero to 25 percent in a 0.1 gram increment.
> So, I would let FDA with their best judgment\--
>
> DR. RIMM: My concern would be that if a label like the one you had, or
> if you have ice cream and it says 9 grams of saturated fat and 2 grams
> of trans fat, has an asterisk at the bottom that says, \"Keep trans as
> low as possible,\" someone will look at it and go oh, I only have 2
> grams of trans, I have 9 grams of sat, I am keeping my trans as low as
> possible, but they are at what we would consider eating too much
> trans.
>
> So, I would be concerned about not having some target in some context
> rather than just sort of a vague statement saying keep it as low as
> possible.
>
> I mean I do agree there should be something on the label that is a
> little bit more than just grams, but I am not sure just having a vague
> statement is sufficient.
>
> MS. PELICAN: I have a response, but I think Barbara wanted to respond
> first.
>
> DR. SHANNON: All I wanted to say was if we had the same data, by all
> means, having a target there is most helpful to the public, but having
> targets change is extremely confusing to the public, and right now I
> am very uncomfortable with whether we have the data for a target.
>
> MS. PELICAN: I was just going to add that that is where the consumer
> research, if we could put something on now, and I realize I say that
> and for industry to do this, there is a lot of expense to end up
> changing labels down the road, but I think for the sake of minimizing
> confusion and promoting understanding, I think educators would have a
> better base for then, if the label said either there was nothing under
> trans or there were the two asterisks that said minimize intake as
> much as possible.
>
> Educators can take that dietary guidelines, if it turns out to be 2
> grams, we can develop materials around that, and we can do research to
> say do people understand that, but I think to go from nothing to that
> 2 grams is really risking a lot both in terms of scientific, that sort
> of defensibility, as well as workability.
>
> DR. JOHNSON: Let me talk about education again. We had talked about
> putting the E back in NLEA, and I think this is an area where we are
> really going to need to do that.
>
> I can tell you from experience that consumers do not understand the
> daily values thoroughly, and I don\'t think that there has been
> sufficient education for them to do that.
>
> I used to talk with the 800 number people at Pillsbury on a regular
> basis, and many consumers don\'t understand percents. They don\'t look
> at a label and go oh, let\'s see, that means I need to eat 10 servings
> of this in order to\--they just don\'t make that connection.
>
> In fact, when NLEA first came out, if you look at the label, under
> total fat, the D.V. is 65 grams. We had a lot of people that said how
> come you have got 65 grams of fat in all of your products.
>
> I mean we are sophisticated and we understand these things, but you
> are asking the label to do a lot, so I think that particularly if a
> D.V. for trans means that you are either free or an excellent source,
> with the difference of a half a gram, you are really going to fuel
> that confusion, and I am not sure you want to go there. So, let\'s
> educate consumers.
>
> Then, the other thing is, as was mentioned, the IOM Applications
> Report suggested that a D.V. for trans fatty acids be developed on the
> basis of current intakes, and so forth, and whatever data is around.
>
> We are chasing a moving target right now, and this is a very
> complicated sort of process that needs to be done thoughtfully, I
> believe, and to pull an arbitrary number out of the air without really
> getting into the intake data and really figuring out what the
> ramifications are, I think would be premature and counterproductive.
>
> So, I would like to reinforce the thought of let some people
> thoughtfully look at the best data available and figure out how to
> implement that recommendation, and I don\'t think it is going to
> happen in the next six weeks.
>
> DR. BAKER: I just want to echo what Suzanne said. I am a clinician for
> a good deal of my time, and my practice sees about 5,000 patients a
> year. My practice is very typical for pediatric practices across the
> country. About 30 percent of our patients are Medicaid.
>
> All of our educational materials are read by a reader, so that they
> are not above a sixth grade level, and even that sometimes stretches
> people\'s ability to understand what we are trying to communicate.
>
> When I or my dieticians try to work with label reading, it is very
> difficult for people. The daily value is absolutely a concept that
> doesn\'t make it, and particularly for children, it is irrelevant.
>
> I really want to support what Suzanne said in terms of giving less
> information rather than more. The numbers are very difficult. When
> people have to do a percent of a percent or something like that, they
> just don\'t have the math skills.
>
> I think we may do a disservice by trying to put in more numbers and
> more percents than we really have hard data for, and then if we change
> it, as we have done with total fats and bounced all over the place,
> people have no confidence in us.
>
> So, I really hope that maybe we can take what you have suggested under
> serious advisement, and that is not perhaps support a particular
> number at this time.
>
> DR. RIMM: Let me say also I agree with what has been said. I think
> there is no question that education has to be an important component
> of what comes out of this, because, you know, I think part of the
> issue is related to not just fat, but anything in the diet, there is
> not good enough education at all levels for adults and for children.
>
> It took I think 20 years to get sort of the basic food pyramids out,
> teaching to children, and now they are teaching them new food
> pyramids, so I think there has to be a lot of time and concerted
> effort spent on education.
>
> Along those lines, I think that for trans fat, you know, what we
> waiting for? Is there really going to be 10 or 15 more years, until
> Alice does three more trials, until there is one or two more? There is
> not going to be huge long-term clinical trials on trans fat, which is
> what we like to see, what we saw for total fat, but there is not going
> to be huge trials in that for trans fat.
>
> So, I agree that maybe we can\'t come up with a daily value for trans
> because of the complication of the small amount of grams it takes, but
> giving a message that there should be a target of 2 grams and putting
> trans fat as 2 grams in the bottom part, and just leaving the daily
> value blank, would be a message to individuals, it would be something
> educators could look it and say, look, you have 1 gram of trans fat,
> you shouldn\'t have more than 2 grams in your diet, and forget the
> percentages.
>
> I think that would give a strong message that there is concern that
> having foods that are too high in trans fat, above 2 grams per day is
> a bad idea.
>
> I think, you know, there is four observational studies. There is one
> study done where you measured trans in adipose, there is all the
> metabolic studies that we discussed yesterday, and they all sort of
> point to the same relationship, that there is a linear association
> between trans and risk of coronary heart disease.
>
> In addition to that, something we didn\'t even discuss yesterday is
> that when you take an oil like soybean oil or canola oil, which has
> alpha-linolenic acid in it, 18.3, which is important for a child\'s
> development, and important for reducing sudden death, that is the
> first oil to hydrogenate.
>
> So, in addition to looking at the impact of trans and lipids, what we
> haven\'t even talked about is other health effects from the oils that
> we are getting rid of because we are hydrogenating in oil.
>
> So, I do hope, it would be nice to send some message about trans, and
> that is something that we could start educating people now, instead of
> this committee meeting 10 or 15 years from now and saying, look, we
> have, you know, six pieces of evidence, but we still don\'t have
> enough evidence, let\'s wait for another 10 or 15 years.
>
> So, the IOM spent a year and a half reviewing all the available
> evidence, and there has been nothing really new in the last, you know,
> year since we have been\--maybe a little bit new\--since we met last.
>
> What we came up with is that really there is no reason to have trans
> in the diet, so going up to 1 percent, a lot of people have beef and
> dairy, you know, sufficient amounts, and you can still be below 1
> percent.
>
> So, I think we should send the strong message because I think the
> scientific evidence does support a level for trans for which there
> could be harm.
>
> DR. LICHTENSTEIN: I would like to bring up a somewhat different issue.
> First of all, I think we need to come to some resolution on Question
> 2, but then I was sort of thinking about the example that Eric used
> earlier as far as ice cream that may have 8 grams of saturated fat and
> 2 grams of trans, that there should be some way of communicating that
> information, and it goes back to something that I mentioned yesterday,
> and that is combining sats and trans.
>
> We have just voted that trans and sats are not the same, however, they
> both increase risk of cardiovascular disease. It would be unfortunate
> to lose the trans information if there are inadequate data to set a
> D.V., so another alternative would be to represent trans and saturated
> within the same target of less than 10 percent and express that on the
> label.
>
> DR. JOHNSON: I just wanted to go back to something that Eric said, and
> it is my contention that we are already educating people about trans
> fatty acids. It is going to be a mandatory part of the label starting
> in 2006. Those numbers are already starting to show up, and I can tell
> you that consumers are engaged about trans fatty acids, and they will
> be hearing more and more about it, and whether there is a little 2 in
> the footnote of the label, I don\'t think there is strong evidence
> that that is going to be a motivator to people at all.
>
> I think they have already gotten the message, the industry is
> responding, and there has been an awful lot of progress being made
> already, and I would hate to complicate the message for consumers by
> getting more detailed than we really need to be.
>
> DR. KRINSKY: I am looking at the label again, and the trans fat line
> is the line that is going to be implemented in 2006, but there is no
> percentage of daily value that is going to be there, so you are just
> going to have this line sitting, hanging sort of free.
>
> Now, are we expecting too much of the consumer to see this line and
> know what to do with it? That is an issue that I think we should be
> concerned with, because if a consumer sees that the trans fat line is
> going to have 1 gram, and the saturated 8 grams\--
>
> DR. RIMM: Great food.
>
> DR. KRINSKY: Well, great food or not great food, how are they going to
> interpret that unless additional information is given? For example, we
> do have that saturated fat should be less than 20, whatever the figure
> it, it is 20 grams on our sheet, so there is some indication there for
> the consumer of what the goal should be.
>
> I guess the basic issue is should there be a goal for the trans fat.
> Is there scientific evidence for a goal for the trans fat?
>
> Jean.
>
> DR. HINE: I would like to support what Eric originally said, and that
> you just commented on. I think people look at the labels and if there
> is no qualifier for trans fat, they think the number looks low, so
> this is a fine food.
>
> So, there should be some type of qualifier that indicates at least our
> concern we don\'t know anything about the duration of exposure,
> especially for children, nor do we know very much about the duration
> of exposure for adults, and in what matrix they get their exposure.
>
> DR. KRINSKY: Barbara.
>
> DR. SHANNON: I am just asking a question, and I think it has been
> answered. Do we have the option of leaving the line hanging there, but
> putting \"less than\" statement at the bottom, in other words, not
> putting a percentage, but still having the statement of less than
> whatever, is that option available?
>
> DR. KRINSKY: Not to this committee. We are not the ones that will be
> writing or have any real responsibility for writing the label,
> however, we can make suggestions, and then that can be acted on or
> ignored depending on whoever is listening to the suggestion.
>
> Alice.
>
> DR. LICHTENSTEIN: It would be helpful to me if perhaps we could
> address the question and then address the follow-up, because we keep
> going back and forth between the question and then what other options
> there are, so I am going to call the question.
>
> DR. KRINSKY: As a member, you are certainly free to call the question,
> but as the Chair, not hearing a second to the call, it would indicate
> that the Committee is still not prepared to vote on the question.
>
> If anybody were prepared to vote on the question, they would have
> seconded, but it is now no longer possible to second it, because the
> Chair has interrupted with his comments.
>
> However, I am not getting a sense of a lot of input from the
> Committee, and there does not seem to be a single point of view. I
> think one of the problems is the word \"scientific\" in the question.
>
> I think that some of the members of the Committee may feel that this
> is appropriate, but may be a little bit concerned about the strength
> of the scientific evidence, and as all of us know, everybody has their
> own definition of strength of scientific evidence.
>
> I don\'t want to review that, thank you, I don\'t want to put that on
> the table because we won\'t get out of here at 4 o\'clock this
> afternoon if we open up that can of worms.
>
> The other thing, Alice, is that once we vote on the question, we will
> have completed our responsibilities.
>
> DR. LICHTENSTEIN: Then, I withdraw it because I thought then we could
> go on and discuss some of the alternatives that have come up and make
> some specific recommendations to the FDA. I didn\'t realize that would
> terminate the meeting.
>
> DR. KRINSKY: Well, I would be perfectly happy to hear alternatives and
> suggestions and follow-ups once this question is answered regardless
> of how it is answered. We could answer it yes, but, and we can answer
> it no, but, and I think the buts may be as useful, if not more useful,
> to the FDA than, in fact, the simple answer to the question.
>
> Eric.
>
> DR. RIMM: So, let\'s go back and read the question. So, the first part
> of the question says the Dietary Guidelines Committee is already
> thinking about this.
>
> DR. KRINSKY: \"May suggest.\"
>
> DR. RIMM: May suggest this, so the Dietary Guidelines Committee
> presumably has read the IOM report very carefully.
>
> DR. KRINSKY: I would hope so.
>
> DR. RIMM: And may suggest that a trans fat target of 2 grams be set.
> Then, the next one says, \"Does the scientific evidence support this
> level?\"
>
> It doesn\'t say does the scientific evidence, you know, absolutely
> prove this level, it just says does the scientific evidence support
> this level.
>
> I think we are not making a definitive thing saying does it absolutely
> cause coronary heart disease, it says does it support this level.
>
> DR. BAKER: May I ask Guy or anyone else here who has more experience
> than I do, if the only trans fatty acids that were available in your
> diet were those that occur in naturally\--and I use the word
> advisedly\--occur in food products, such as those from ruminant
> animals or dairy products, how much trans fatty acid would a person
> actually take in?
>
> You are a hunter/gatherer, and you have your cow and you milk that
> cow, and you kill a wildebeest every now and then, how much?
>
> DR. KRINSKY: Are you representing that particular individual?
>
> DR. RIMM: I am from Wisconsin, and we do a lot of huntering and
> gathering there. Those are not normal diets, though.
>
> I think someone from the FDA pointed us to the page yesterday where we
> had the gram amounts of trans you get from a serving of beef and
> dairy, and they were quite low, below 1 gram per day.
>
> I will say that in the Nurses Health Study, when we look we look at
> grams of trans from ruminants versus grams of trans from hydrogenated
> oils, it was only the trans from hydrogenated oils which related to
> coronary heart disease, it wasn\'t the specific trans that you can
> identify from ruminant animals.
>
> So, I think there actually are probably biological differences because
> you get like 100 different trans from hydrogenating oils, and in the
> ruminant animals you get one or two different types of trans.
>
> DR. BAKER: Thank you very much. That is very helpful. The question was
> if we are going to try and set a lower limit or we are discussing some
> sort of number, it would be really important to know what kind of
> number would not be bad, what kind of number we might actually want to
> have in people\'s diets, particularly if those are the naturally
> occurring ones.
>
> MS. PELICAN: Just to follow up, the Federal Register, that part of our
> background papers, 41-470, also lists animal products that give a
> separate total, if that might be helpful here, and I think what Susan
> just suggested is, in fact, what the IOM, the 2003 report did
> encourage, what is a nutritionally adequate diet and how much trans
> would we get a from a nutritionally adequate diet.
>
> But I find this table on 41-470 of the Federal Register helpful.
>
> DR. RIMM: It is also on page 8-45 in Section 5 of our booklets where
> it has servings of meat, range from 0.01 to 0.21 grams per serving,
> butter is 0.4 grams per serving, milk is 0.22 grams per serving.
>
> DR. HINE: But what is notably missing from there, rather vaguely, the
> fourth line up from the bottom of the paragraph, \"Therefore, foods
> that are contributors of trans fatty acids, fried foods, doughnuts,
> and french fries,\" and a lot of people eat a lot of those things,
> there is no estimate or range for the content there.
>
> DR. RIMM: Usually, french fries are in the range of 4 to 6 grams per
> serving.
>
> DR. HINE: Four to 6 grams per serving?
>
> DR. RIMM: Grams, correct, and I believe doughnuts are in the range of
> 3. We have done some analysis, Frank Sachs has done some analysis in
> our lab of a few chain french fries, and the grams per day were in the
> range of 4 to 6 per serving.
>
> DR. LICHTENSTEIN: But those analyses were done at least five years
> ago.
>
> DR. RIMM: Correct.
>
> DR. LICHTENSTEIN: So, we really would need data to say if it is
> actually that high at this point, because\--
>
> DR. RIMM: We were told at McDonalds\--sorry\--that the large M company
> were not able to change their hydrogenation methods, which is why they
> are not taking trans out, so it is true, we have not done the analysis
> in the last five years, but it is well above what you get in meat and
> butter.
>
> DR. KRINSKY: But the point, Eric, is epidemiologically, the natural
> trans fatty acids are not associated with coronary heart disease risk.
>
> DR. RIMM: To the best of our ability. I mean from the trials that
> Alice has done, those were not necessarily done on meat products, they
> are done on hydrogenated oils, which is what we are talking about, the
> whole list of different trans, not the trans from ruminant animals.
>
> DR. BAKER: I can\'t help but make a comment, and please forgive me
> because I live with this day to day, what the heck am I going to tell
> my poor patients? I means we have trans fatty acids here, some are
> good, some are bad, the label says trans.
>
> I am very confused, and I can\'t imagine that I am going to serve
> people very well, and I just point this out as something, if we are
> looking to label, to help people make good decisions or to make
> recommendations, so somebody can write a label to help people make
> good decisions, how are we serving that goal?
>
> DR. LICHTENSTEIN: I think what we should do is tell people to minimize
> their intake of saturated and trans fatty acids. I think that is the
> best advice that you can give people, and they can do that by limiting
> their intake of animals fats from both meat and dairy, and limit their
> intakes of commercially fried and baked products, because that is a
> major source of hydrogenated fat in the diet.
>
> DR. RIMM: Yes, even the ones that we have here, which show up as zero
> as trans because they are all less than 0.5, so I think if you want to
> give a specific message about trans, it would be to lower trans as
> much as possible in addition to what Alice said.
>
> DR. BAKER: I just want to be a little careful about dairy particularly
> for children. It is the most bioavailable source of calcium that we
> have.
>
> We know that we have a tremendous long-term problem with bone health,
> and if we are going to comment on dairy, perhaps we want to say low
> fat or something like that. We really are a having a problem getting
> adequate calories in, particularly with the numbers that we are being
> given currently.
>
> DR. LICHTENSTEIN: Absolutely, if you were going to make specific
> recommendations. My comment was specifically for dairy fat, and also
> my understanding is these goals are for individuals above the age of
> two, and not below the age, but clearly, it would specifically be low
> fat and non-fat dairy products, which is part of the dietary
> guidelines in the IOM report.
>
> DR. McGINNIS: I may be totally out of order here.
>
> DR. KRINSKY: No one has been out of order in the past, and there is no
> reason why you should start being out of order.
>
> DR. McGINNIS: But it seems to me that there is a strong consensus that
> the specification of a certain number that would represent a maximal
> daily intake is not possible given the current scientific evidence
> unless I have misheard the discussion.
>
> Hence, the answer to the question, does the current scientific
> evidence suggest a specific level that would be an acceptable maximal
> daily intake of trans fatty acids in terms of risk of coronary heart
> disease is one that we ought to be able to answer.
>
> DR. LICHTENSTEIN: I call the question.
>
> DR. McGINNIS: Second.
>
> DR. RIMM: I think the word is target, though, it is still a target
> that we want people to shoot for.
>
> DR. KRINSKY: We have got the question called on this question.
>
> DR. McGINNIS: I can\'t second, I can\'t vote. Sorry.
>
> DR. KRINSKY: That\'s true. That is a good point, Michael, as to
> whether you can second, although you can\'t vote on the action, and I
> don\'t recall Roberts Rules of Order that much, but I don\'t believe
> that you can second.
>
> DR. LICHTENSTEIN: If nobody wants to second it, then, it shouldn\'t be
> seconded.
>
> DR. KRINSKY: To me, the problem is the question doesn\'t address what
> we have been discussing. That is the basic problem. We have been
> discussing a lot of issues with respect to trans fatty acids. We
> already have established that they are more adverse than saturated
> fatty acids as far as coronary heart disease is concerned.
>
> We have been talking about the fact that their intake should be
> minimized with the exception of children. We do not want to deny them
> milk, et cetera.
>
> But as I said, I believe yesterday, I have a lot of trouble talking
> about recommending a little amount or a large amount without any
> quantitation.
>
> So, really the question addresses are we at the stage where there is
> sufficient evidence for quantitation, not that we are setting\--well,
> yes, we would be setting this, unless I am wrong, as a daily value,
> less than 1 percent of energy, less than 2 grams per day.
>
> Wouldn\'t that be interpreted by the FDA as our recommending this as a
> daily value? It may or may not be interpreted. I am looking for head
> nods on the table.
>
> Do you want a five-minute break? Let\'s take a break for a few
> minutes, because this is how I am interpreting this. If we vote in the
> affirmative, we are essentially saying that there should be less than
> 1 percent of the energy value as trans fatty acids, and that to me is
> the same as recommending a daily value for trans fatty acids, which
> would, in fact, change this sheet completely because under those
> circumstances, one would now have room for percent, and one would
> have, at the bottom, less than 2 grams per day.
>
> DR. RIMM: You don\'t know if they actually would make the percent,
> they may just put the 2 grams at the bottom.
>
> DR. KRINSKY: That is true, but it seems to me the logical outcome
> would be that they might do something of that nature. Certainly,
> because of the inaccuracies of the measurement and the difficulty with
> the small amount where less than half a gram, which could be 25
> percent, would not be recorded, it may not make sense to put the
> percentage down, but that is their call, not our call.
>
> Let\'s just wait a wait a few minutes.
>
> It is now 9:45. Checkout time is noon, although they will make an
> exception for you at 11:30, and we can take our break now, our 10:15
> break now. We are going to break for 15 minutes.
>
> \[Break.\]
>
> DR. KRINSKY: I would like to reconvene the Committee and would ask for
> the members to resume their seats and pay attention to the Chair.
>
> I want to get this correct, that according to the FDA, if we were to
> vote in the affirmative on this issue, it would not necessarily be
> establishing a D.V., it would simply be saying that we agree that less
> than 2 grams per day of trans fatty acids would be useful, valuable,
> healthy.
>
> DR. LICHTENSTEIN: Then, it sounds to me like the question has to be
> rephrased because that is not how it is written.
>
> DR. KRINSKY: Well, let me just say that it is referring to the
> preceding sentence, and I would be certainly willing to have it
> rewritten, but it is referring to the preceding sentence, the Dietary
> Guidelines may suggest that less than 2 grams per day for a 2,000 kcal
> diet should be obtained from trans fatty acids.
>
> DR. LICHTENSTEIN: And then does the current scientific evidence
> suggest.
>
> DR. KRINSKY: Support this level. Okay.
>
> DR. LICHTENSTEIN: So, we have to vote on what is written, not what the
> interpretation is.
>
> DR. KRINSKY: That\'s right\--well, no. With respect to a D.V., we have
> no input on that. We are not establishing a D.V.
>
> DR. LICHTENSTEIN: I am not suggesting a D.V., I am just saying that we
> need to vote on what is actually written on this page or it needs to
> be officially changed.
>
> DR. KRINSKY: Did you have a comment, Michael?
>
> DR. McGINNIS: Well, I did. I guess that it sort of picks up on this to
> some extent. As it is written, I would have taken the essence of the
> discussion to lead us to a negative answer to this question in terms
> of the conclusion about the evidence suggesting a specific point, so I
> do think the question would have to be reworded if we are seeking
> otherwise.
>
> Let me just take 60 seconds to revisit what I had interpreted the
> essence of the discussion as indicating.
>
> What I heard us trying to do is to accomplish certain specific things.
> One is to be faithful to the evidence. Second, given the fact that
> there is reference to the Dietary Guidelines Committee here to not get
> crosswise with the Dietary Guidelines Committee and meddle
> unnecessarily in their deliberations, and thirdly, to leave the FDA
> with sufficient flexibility in label design, in order to do that, my
> interpretation, which is not a proposal because I don\'t want to muddy
> the waters with a proposal, but my interpretation of what Question 2
> in essence would say is that as a signal, that trans fatty acid intake
> should be reduced to the lowest practical level, the Dietary
> Guidelines Committee may suggest that intake be reduced to less than 1
> percent of energy, 2 grams per day from scientific perspective, then
> the question goes on, does the current evidence suggest an acceptable
> maximal daily intake of trans fatty acid for reducing the risk of
> coronary heath disease.
>
> That divorces the issue of the practical guidance of the Dietary
> Guidelines Committee from this committee\'s judgment on the adequacy
> of the scientific evidence.
>
> Now, that may lead us down the wrong path. If there is a simpler
> wording change that can be effected in the nature of the question,
> then, that seems a perfectly reasonable approach.
>
> DR. KRINSKY: Thank you.
>
> Guy.
>
> DR. JOHNSON: Well, I get the sense, I mean I agree that based on the
> question that is written, the sidebar conversations that have gone on
> here, and the general discussion leads to the irrefutable conclusion
> that there is no hard scientific evidence to support that, and at the
> risk of boring you again, the studies that were listed in Ascherio
> diagram show that based\--that is 861\--I am a person who has a fair
> amount of experience in petitioning FDA for health claims, and they
> have very little sense of humor in interpreting the strength of the
> data on this\--but when you petition for a health claim, you have to
> have strong evidence to support your position.
>
> Here are the data that are available to support a level of trans fatty
> acids. If you look at the trials in that study, there are three that
> were conducted at levels below 4 percent of the intake of trans fatty
> acids, arguably, two that are at the current estimated level of intake
> or less.
>
> Both of those studies failed to find a significant difference between
> the LDL level of the control diet and that containing trans fatty
> acids.
>
> We hop over to the HDL side, which is what led this committee to
> conclude that there is a difference between trans fatty acids and
> saturated fats at high levels, a caveat which did not make it into our
> answer.
>
> There are six studies below 6 percent of calories of trans fatty
> acids. Five of those studies found no statistically significant change
> in HDL, and one did.
>
> If I submitted those data to FDA, and said you need to come up with a
> D.V. for trans fatty acids, they would laugh. Those are the data that
> is there.
>
> Now, we are basing an assumption that 1 percent is supported by hard
> data. It is an assumption, and I suppose we are at liberty to do that,
> but let\'s not kid ourselves into thinking that the data that is in
> the published literature supports that. It does not, and if we come to
> that conclusion, shame on us.
>
> DR. KRINSKY: Well, that gets back to the issue that I raised earlier,
> Guy, and that is the definition of scientific evidence, and we all
> have our own definitions. It is quite clearly what yours is, and that
> is that there is not adequate scientific evidence to adopt this
> particular position.
>
> DR. JOHNSON: That is clearly my position, and my contention is that my
> position is based on the evidence. I don\'t see any other way to
> interpret it. This is what the data show. This is peer-reviewed data
> that has been published in the literature, and I have been hesitant to
> say this, but the Ascherio diagram was not in peer-reviewed
> literature, it was published as sort of an editorial on the New
> England Journal, and my contention is that by looking at the ratio and
> forcing it through the origin, it\'s misleading and has been
> misinterpreted.
>
> Now, I can\'t argue that at high levels of trans fatty acids, there is
> a statistically significant difference, I am there, but that is based
> on intakes that are beyond typical intakes in the U.S.
>
> If you look at these studies, I don\'t see how you can come to any
> other conclusion, and I don\'t see how FDA could come to any other
> conclusion, and that is assuming that HDL is given the same sort of
> weight as a biomarker that LDL is, and if you look again at the
> Federal Register documents we have, there is a lot of discussion about
> how HDL is not risen to the same level as LDL in terms of a
> cardiovascular biomarker.
>
> FDA used it in the cost analysis section, but they viewed the ratio of
> HDL to LDL with some skepticism, and again shows that the way FDA
> interprets data is very rigorous and rightly so, because no matter
> what they do, somebody beats on them, so they need to make sure that
> what they do is very evidence based.
>
> By forcing them to ignore the data that are there because we think
> that there is a dose-response relationship, when a reasonable
> scientist can conclude just the opposite by looking at the data, I
> think is a very dangerous road to go down.
>
> DR. KRINSKY: Just for my own personal clarification, does that mean
> that nobody beats on the Dietary Guidelines Committee when they come
> up with a recommendation? Does anybody know?
>
> DR. LICHTENSTEIN: I think since none of us have been to the Dietary
> Guidelines Committee and we are not privy to what the conversations
> were, I really don\'t think that we can make any determination about
> what is going on in that committee.
>
> Now, I certainly understand that there should be some consistency
> between the Dietary Guidelines Committee and the FDA, but at this
> point, I think it is totally premature to even address that issue.
>
> DR. KRINSKY: Well, I know that when I first saw this question, I was
> troubled by the \"may suggest\" in the sentence, and found a little
> bit of difficulty in trying to interpret how we were supposed to
> address a \"may suggest\" issue.
>
> DR. JOHNSON: The way I interpreted that was the Dietary Guidelines are
> thinking about it. If they do, what do you think?
>
> DR. KRINSKY: But we are not asked if they do, we are asked does the
> scientific evidence support this particular value.
>
> DR. JOHNSON: Based on the assumption that they took that position.
>
> DR. KRINSKY: Well, but we can then move independently of their
> assumption, of their position, and we can address our own position,
> and that is to say do we feel that the normal U.S. diet should contain
> less than 2 grams per day of trans fatty acids, or does the scientific
> evidence indicate that the American diet should contain less than 2
> grams of trans fatty acids per day.
>
> DR. JOHNSON: And as will be no surprise to this committee, my point of
> view is a resounding no, as I said yesterday, and other people sitting
> around this table have also said.
>
> DR. SHANNON: Would you repeat again how the FDA will interpret our
> answer if it is yes?
>
> DR. KRINSKY: Well, as I understand it, and I sit to be corrected, and
> their understanding would be that we concur that the diet should
> contain less than 2 grams of trans fatty acids per day, that may or
> not be included in the nutrition facts label, that is going to be up
> to the FDA and up to rulemaking, and all of that nature, but it may,
> in fact, given them a leg up in terms of doing something like that.
>
> In the absence of a yes vote on our part, they are not in a position
> to incorporate that particular number.
>
> So, that is my understanding of the FDA\'s position.
>
> DR. KRINSKY: I think that Eric was up first.
>
> DR. RIMM: I just wanted to respond to Guy\'s comment or one of his
> comments. I think that it is too bad that Guy and I used to be friends
> before this meeting. I do disagree with him a little bit on several
> points, and I know that there have not been tons of trials in the low
> level of trans fatty acids, which is where the rub sort of is, even
> though the four or five observational studies do assess trans fatty
> acid at the lower levels.
>
> Apparently, Guy does not think that is scientific evidence, but to the
> point that Ascherio\'s review was a review and published in 1999, and
> not a peer-reviewed, the paper that we did get sent to us via e-mail,
> that someone contributed, which was Mensink\'s review, Mensink, Zock,
> Kester, and Katan, who I think are some of the leading scientists in
> this area, did a meta-analysis of 60 control studies, and their
> conclusion, the first line of their conclusion is, \"The replacement
> of trans fatty acids with unsaturated fatty acids from unhydrogenated
> oils is the single most effective measure for improving blood lipid
> levels.\"
>
> So, that is the main point of this meta-analysis, and the
> meta-analysis reviews the eight metabolic studies, and they
> ranged\--unfortunately, it doesn\'t have as nice a picture, so we
> can\'t see all the studies or we can\'t see anything that was new
> since the Ascherio review in 1999, but I think it does point to the
> fact that there is a dose-response between trans fatty acids and the
> total cholesterol-HDL ratio, which is what they have used as the
> outcome measure.
>
> Unfortunately, there is not a PowerPoint presentation that I can make
> on this, but all of us have this paper from the AJCN 2003. I will get
> the exact reference. AJCN 2003, Volume 77, pages 1146 through 1155. I
> don\'t know if everybody has that or not, but it was something that I
> believe either Mary Heonig \[ph\] or someone else contributed to our
> meeting.
>
> DR. KRINSKY: I believe this was sent to us by the FDA.
>
> DR. RIMM: Oh, the FDA sent this to us as additional information, so
> this is peer-reviewed, and this is put together by some of the leading
> scientists in the world in this area. I don\'t think Guy, Alice, or I,
> you know, going through this, could come up with a better
> interpretation than they have done, because this is what they do.
>
> In the eight studies that specifically examined trans monounsaturated
> fatty acids, the intake of trans ranged from zero percent to 10.9
> percent of energy, and these values included the trans fatty acid-free
> control diets in these studies, and then it goes on to discuss them.
> Unfortunately, it doesn\'t have as pretty a picture, but I really
> think there are metabolic studies to support the fact that there is a
> dose-response between trans and lipids.
>
> It goes along with the observational studies, and I don\'t want to
> rehash the data, you know, just like for saturated fat, there was not
> obvious level where we picked, and just like for sodium, there was no
> obvious level.
>
> The USDA has picked a target of 2 grams, and I think the evidence
> supports that a low level of trans would be the healthiest.
>
> DR. LICHTENSTEIN: I want to go back to what you were saying, Norman. I
> think there are two issues here. I think one is does the scientific
> evidence support a specific number, and as I have said before, I
> don\'t think it supports a specific number.
>
> The other issue is should there be a target, and we have already voted
> that trans fatty acids have an adverse effect on cardiovascular
> outcome, and everyone has sort of re-reviewed that, therefore, should
> a target be established, and I think that that may be reasonable, but
> there are two different points.
>
> DR. KRINSKY: The target would be based on scientific evidence?
>
> DR. LICHTENSTEIN: I don\'t think that there are adequate scientific
> evidence to come up with a specific number. Could we try to come up
> with a target as was for saturate fat, which was really a target, as
> was pointed out earlier by Susan, the intake levels were higher than
> the target in the United States, it made sense to aim towards a lower
> number? We don\'t really know what the trans intake is in the United
> States, but I think we would all agree we would benefit if it was
> decreased.
>
> Therefore, again, it is reasonable to set a target. In that way, I
> think that what we do can be defended, because we can\'t go beyond
> what the scientific data tells us, and it is not a black and white. If
> you consume below this number, you are not going to change your risk
> of cardiovascular disease, and if you consume above this amount, you
> are going to increase your risk of cardiovascular disease, it is a
> continuum.
>
> DR. KRINSKY: Could you give me the target number you are thinking of?
>
> DR. LICHTENSTEIN: I am not thinking of a target number. I think of
> things in small doses, so what I would like to do is deal with one
> issue, and then discuss the other issue, because right now we keep
> going back and forth, and we are mixing up the discussion of whether
> there is adequate scientific data to come up with a specific number
> and whether it\'s advisable to set up a target, one of the
> implications would be to the FDA.
>
> DR. KRINSKY: I understand we are mixing things up, but I would not be
> adverse to, in fact, having a statement as you have made, and to hear
> what your target number would be independent of our voting on this
> particular question.
>
> Then, we could move forward with that particular proposal and then
> return to the question, to Question 2. That is why I was asking you
> what the target number should be, and the reason I am asking you is
> that 24 hours ago, not quite, I was disturbed by talk about low and
> high. To me, that is not very scientific.
>
> DR. LICHTENSTEIN: Well, I don\'t have a target number. I can certainly
> react to other people\'s target numbers, but I do have a position on
> the second question, and my position on the second question is totally
> independent on whether we can set a target number or what the target
> number would be.
>
> DR. KRINSKY: Again, I want to point out that when we complete our
> action on the second question, that is all that the FDA has asked us
> to do, so I would like to sort of get any of our other input in before
> we vote on Question 2.
>
> DR. LICHTENSTEIN: So, is what you are saying that once we vote on
> Question 2, we have to stop the deliberations?
>
> DR. KRINSKY: We have no other responsibilities.
>
> DR. LICHTENSTEIN: Is that true?
>
> DR. KRINSKY: Oh, I have been told that we can come up with
> recommendations, but when we vote on Question 2, will you then give me
> a target number?
>
> DR. LICHTENSTEIN: I don\'t have a target number. I can certainly
> support or not support, I didn\'t realize I was expected to come here
> with a target number.
>
> DR. KRINSKY: You weren\'t, but you are the one that raised the target
> number issue, and if you are willing to support or not support target
> numbers, you must have something in mind, you know, if somebody says 5
> grams a day, you might be willing or not willing to support that, if
> somebody says half a gram, et cetera.
>
> So, you want us to come up with some values. Okay, fine.
>
> DR. LICHTENSTEIN: I am just suggesting that that might be appropriate,
> but I am just trying to move the discussion forward, and I feel that
> sometimes we are spinning wheels, and I am sure that nobody wants to
> hear me repeat lots of stuff that I have already said, and it seems
> like we should be able to address at least the question that was given
> us, and then we can decide if we want to go further or not as a group.
>
> DR. JOHNSON: Well, I will just reiterate my point that I don\'t think
> there is enough scientific evidence to support that, but let me say
> that whatever we do, please, please, please let us not lose sight of
> the fact that we are dealing with both trans fat and saturated fat.
> The practical realities of the matter is if you beat the industry into
> acting prematurely on trans fat, there is a possibility that you are
> going to increase saturated fat just by the realities of food
> chemistry and technology that is available.
>
> So, we need to be cognizant of what we do here can have unanticipated
> consequences in terms of the total dietary content of fatty acids that
> could raise LDL.
>
> Also, I can\'t resist\--this is again based on my experience with
> health claims with FDA\--a meta-analysis of studies does not
> constitute a dose-response based on the way FDA interprets health
> claims.
>
> If there aren\'t studies double-blind, randomized, controlled studies
> in the dosage that you are interested in talking about, they don\'t
> anticipate a regression line through the studies based on a
> meta-analysis as dose-response.
>
> DR. KRINSKY: Your position, Guy, by the way, is reinforcing the
> Mensink position because what their quotation is, that was read to us
> a moment ago, risk is reduced most effectively when trans fatty acids
> and unsaturated fatty acids are replaced with cis-unsaturated fatty
> acids, so that it is not simply the reduction of trans and saturated,
> it is the replacement with the cholesterol lowering fatty acids, and
> this, of course, the question doesn\'t address that at all.
>
> You had a comment, Eric.
>
> DR. RIMM: I guess I wasn\'t sure on what Guy\'s point was. There are
> all randomized, double-blind trials. It is just a summary of those by
> giving you a better dose-response. I don\'t think you could have one
> study that would have 15 levels of trans. This is a way to look at it
> across the different dose-response in trans.
>
> DR. JOHNSON: Well, a true dose-response would be a single study that
> fed graded levels of trans, and the data in the meta-analysis, most of
> those studies again are conducted at levels higher than the current
> intake of trans.
>
> So, you are extrapolating the data from an area above typical intakes
> in the U.S., down into an area that is atypical, and assuming that
> that is a linear relationship. That is an assumption, I am sorry, but
> it is.
>
> DR. LICHTENSTEIN: That statement that was read for Mensink and
> somebody and Katan, sorry, that sort of got back to the total fat
> issue, which we have already addressed, that you substitute trans and
> sats for unsaturated, but we still have the option, if we could get
> beyond the question, to then perhaps propose a target for trans plus
> sats if that is what we want people to decrease, and we could discuss
> having separate ones, but there are multiple options.
>
> MS. PELICAN: I appreciate FDA\'s clarification that this is not
> necessarily to be used to set a D.V., because that certainly was one
> of my concerns, so I appreciate that, but I am going to go back to
> something that Susan Mayne said yesterday, and this is without putting
> you on the spot, Susan, if you could just see if you are still of the
> same mind.
>
> I think we were talking about linear and threshold effects, and you
> said we do lack data points, but you prefer seeing assuming a linear
> relationship, because we don\'t see a threshold, and I guess my
> question is if the idea in thinking back to the IOM, the 2002 report,
> if their recommendation was that we consume as little trans as
> possible, is there consistency with that question, does the scientific
> evidence support a level at 1 percent, 2 grams, 1 percent of energy,
> does that idea of linearity support that, that yes, this is low. If
> you could respond to that, that would be great.
>
> DR. MAYNE: Just two comments. One is on the Ascherio study which
> looked at the clinical intervention studies, and just looking at the
> data points, I see no evidence that there is a exponential
> relationship, so therefore, with the lack of evidence that it is
> nonlinear, the more conservative approach is to assume that that is a
> linear relationship. So, I assume that people in risk management
> toxicology, if they saw that relationship, and they were using this
> for public policy, they would take the more conservative approach in
> the absence of evidence contradicting that.
>
> The second one was the observational epi data, which was not included
> in the Ascherio study. That looked at the quintile distribution and
> did a statistical test to see whether there was evidence that the
> relationship was linear, so that is the kind of thing that we would
> look at, for example, in the Nurses Health Study and the Health
> Professionals Follow-up Study, to see if there is significance that
> there is a linear relationship, because sometimes we will see
> associations, let\'s say, at the highest quintile versus the lowest,
> and we run a statistical test. They will say, well, there is no
> evidence that that is a linear relationship.
>
> So, those were the two things we were looking at. When I just
> eyeballed the estimates, the relative risks from the Nurses Health
> Study and the Health Professionals Follow-up Study, it looked pretty
> linear.
>
> So, even though the second quintile was not significantly different
> than the first quintile, the relative risk estimates increased at each
> level of intake in several of those prospective epidemiological
> studies.
>
> DR. KRINSKY: But isn\'t that the same as saying that if you do an
> experiment, and you are looking at the difference between 1 percent
> and 2 percent, you may not find a statistical difference, but if you
> were to do 1 percent, 2 percent, 4 percent, 8 percent, then, you might
> interpret the data as linear.
>
> DR. MAYNE: That\'s correct.
>
> DR. McGINNIS: Picking up on this notion of consistency and boldly
> going into the notion of targets that has been requested, I will
> actually offer a proposal for people to shoot down as a trial balloon.
>
> Something on the order of although current scientific evidence does
> not indicate a specific acceptable intake for trans fatty acids, it is
> consistent with reducing trans fatty acid intake to a level of less
> than 1 percent of energy (2 grams per day for a 2,000 kilocalorie
> diet).
>
> DR. KRINSKY: That, to me, is a very reasonable statement that we can
> discuss, but I am getting the feeling that, in fact, that statement
> should be discussed after we carry out our vote.
>
> I know that the question has been called twice and has been rejected
> resoundingly by the Chair, and seeing no further comment, the Chair is
> prepared to call the question.
>
> DR. LICHTENSTEIN: Second.
>
> DR. KRINSKY: No, no, I think you are out of order, Dr. Lichtenstein,
> but I appreciate your support of the Chair\'s position.
>
> So, we have discussed this question enough. Any disagreement? No.
>
> So, the question is: The Dietary Guidelines Committee may suggest that
> less than 1 percent of energy should be obtained from trans fatty
> acids (2 grams per day for a 2,000 kcal diet).
>
> Does the scientific evidence support this level?
>
> All those who want to answer yes, please raise your hand.
>
> All those who want to answer no, please raise your hand.
>
> The Chair votes.
>
> The no\'s carry this question 5 to 3, so that we have responded to the
> question put to us by the FDA, but we are not through with our
> deliberations, and the FDA will allow us to continue? Okay.
>
> So, let\'s go to your statement, Michael, and if you could you re-read
> it for the benefit of the Committee.
>
> DR. McGINNIS: Although current scientific evidence does not indicate a
> specific acceptable intake for trans fatty acids, it is consistent\--
>
> DR. BAKER: Excuse me, I am a really fast typist, I don\'t claim to
> spell, but would you like to see this up there?
>
> DR. McGINNIS: Sure.
>
> DR. BAKER: Would that help you?
>
> DR. KRINSKY: We would be indebted to you for a long period of time.
>
> DR. BAKER: You could start reading it.
>
> DR. McGINNIS: Okay. Although current scientific evidence does not
> indicate a specific acceptable daily intake for trans fatty acids, it
> is consistent with reducing trans fatty acid intake to a level of less
> than 1 percent of energy (2 grams per day for a 2,000 kilocalorie
> diet).
>
> For the purpose of a vote, you would have to rephrase this as a
> question, but have at it.
>
> DR. KRINSKY: Thank you very much, Michael.
>
> Let\'s have some comments.
>
> DR. LICHTENSTEIN: I have more just an alternative concept to consider,
> that the IOM report also recommended, that saturated fat be as low as
> possible, and thinking from both an educational perspective and a
> conservative perspective, could we not consider recommending that
> trans plus saturated fatty acids be less than 10 percent of energy?
>
> DR. KRINSKY: Would you have any concern or are there circumstances
> where one can, in fact, have foods that would contain a relatively
> high trans to saturated fat content?
>
> DR. LICHTENSTEIN: That could potentially happen, but on the other
> hand, it would address the issue of manufacturers taking trans out and
> potentially putting in saturated fatty acids, and we know that
> although, gram for gram, trans increase risk of cardiovascular disease
> more than saturated fatty acids, we also know that the proportion of
> trans and saturated fatty acids in the diet is quite different.
>
> So, yes, I guess theoretically, that could happen, I think it is
> highly unlikely, and I think what we have heard is that using the
> Nutrients Facts Panel, as confusing as it is, I think the least
> information, the clearest information is probably the best from the
> perspective of public education and use.
>
> DR. RIMM: I don\'t disagree at all. I mean I think that we really need
> to educate as best as possible with saturated fat and trans fat,
> however, I think there is two or three pages in the Federal Register
> that were sent to us saying why they didn\'t put those together,
> because the would have meant that by taking trans out, that suddenly
> there was a new D.V. for saturated by adding trans as saturated that
> changed what the D.V. mean for saturated, so I think they separated
> the quantitative amounts purposely because trans is different from
> sats, even though the educational message should be have as little as
> possible, I think that combining them into one percentage then makes
> the interpretation of saturated fat is more difficult. That is my
> reading of the Federal Register report.
>
> DR. JOHNSON: Here we go again. Part of the issue there is stearic
> acid, and there seems to be pretty good agreement that stearic acid is
> neutral from a biomarker standpoint. If we are going to get into this,
> I think we need to recognize that fact.
>
> I do agree that the message really should be broad enough to be
> actionable for consumers who are interested in managing their risk of
> heart disease, and the simpler the message, the better.
>
> DR. RIMM: Which is why I think Michael\'s message is quite clear.
>
> DR. KRINSKY: Except it doesn\'t indicate any disease relationship
> here, and do you think that we should reducing risk of coronary heart
> disease in the statement?
>
> DR. RIMM: Well, I think that that statement may change, because I
> think there is a growing body of evidence that trans affects diabetes,
> that trans may impact obesity, that trans may have other effects where
> the evidence is not as strong, not as yet strongly documented by
> metabolic studies and by observational studies.
>
> So, I think this makes it very clear because a 12-year-old picking up
> a package of Doritos will say, ah, I am not worried about heart
> disease, so I think if you just say limit it as much as possible, I
> think that would give a pretty clear message.
>
> I don\'t know if we are in the business of making messages, but I
> think this is consistent with all of our discussions that we have had
> today and yesterday, saying that there is scientific evidence to
> support it, keeping it less than 1 percent would be best.
>
> DR. KRINSKY: We have made a lot of messages in the last day and a
> half, which are not up on the screen, but they are on the tape of this
> meeting.
>
> Alice.
>
> DR. LICHTENSTEIN: Maybe what we could do is just encourage the FDA, if
> there is a major reassessment of the Nutrient Facts Panel, to
> ultimately consider the possibility of creating a category of the
> fatty acids that increase risk of cardiovascular disease or other
> chronic diseases, accepting that my suggestion of trans plus sats
> might not be a good idea, or might not be scientifically defensible
> because of the issue of stearic acid.
>
> DR. KRINSKY: Maybe more importantly would be a comment about fatty
> acids that decrease the risk of coronary heart disease.
>
> DR. LICHTENSTEIN: Potentially, but I think the major problem in the
> United States right now is excess caloric intake, so I think we need
> to be very careful if we get into that arena of recommending increased
> intake of anything, but at this point, I think we can feel pretty
> confident that decreased risk of trans fatty acids and certain
> saturated fatty acids is advantageous.
>
> DR. KRINSKY: A point well taken.
>
> DR. McGINNIS: For the purpose of consistency with the other two, if
> you want to rephrase this as a question, just transpose the \"it\" and
> the \"is.\"
>
> DR. KRINSKY: Is it consistent, and then end with a question mark.
>
> DR. JOHNSON: I have got to make the observation that I think we are
> dealing largely with a matter of semantics here. Basically, we are
> saying that the data is consistent, but not supportive. It sounds kind
> of like a qualified health claim, I guess.
>
> But I really encourage the Committee to make sure that\--and to
> consider the possibility of unintended consequences here. What you are
> doing here is raising a big red flag about trans fatty acids in the
> current food supply, and this is going to have the effect of really
> drawing a lot of attention to trans fatty acids, and there is, I
> think, a reasonable likelihood, in fact, there is probably consumer
> data out there to verify that you are going to minimize the importance
> of saturated fats in the mind of the consumers.
>
> You know, we are making this up as we go along, and not basing this on
> scientific evidence, and I ask the Committee to consider the fact that
> there could be unintended consequences particularly in the reality of
> the food science that dictates the way foods are reformulated to
> remove trans fatty acids.
>
> DR. RIMM: I agree that if we take the trans out, something else will
> be there, because we are not going to reconstruct all foods, but I
> guess I am not quite sure what you are proposing then.
>
> Do you think that we should just leave it alone and not make a comment
> about trans? We have already said trans is worse than saturated fat.
> Should we not make a message at all about the health impacts of
> hydrogenated oils?
>
> I think that, you know, shame on industry if they want to take
> hydrogenation out and put something else in before testing it and
> doing studies themselves, and I think they should take responsibility.
> I mean I think there should be some onus on industry also, if you are
> going to create a food product, that you should also do some testing,
> and I don\'t think you should just put the onus on this committee.
> There has to be some responsibility on both sides.
>
> DR. JOHNSON: Well, I would contend that industry is already responding
> heavily in the trans fatty acid area. Let me point out that many of
> the studies that we are talking about were funded by industry.
>
> I was part of ILSI when they funded the Judd II study. That was like a
> million bucks. So, they have been very science driven in this whole
> thing, and I really believe that they are trying to respond to the
> demands in the marketplace, which is ultimately what industry does
> best, and they are doing a pretty good out of it.
>
> They can\'t be held accountable for the level of technology that is
> available to make these changes in the food supply. They are doing the
> best they can. I haven\'t made this point up until now, but I was at
> Pillsbury when the whole issue of animal fat really took off.
>
> When I started work at Pillsbury in 1989, all of our prepared dough
> products were made with beef tallow, and there was all kinds of
> criticism about that, oh, my God, animal fat, cholesterol.
>
> Now, there weren\'t any trans fatty acids, and we responded to the
> demands of the marketplace and the public health community to get rid
> of animal fat, and the technology, the best technology available at
> the time that everybody agreed to was hydrogenated soybean oil.
>
> It gave the functionality that consumers demand, it didn\'t have any
> cholesterol, and the industry was regarded as being really responsible
> for doing that.
>
> Now, we have got new data which nobody anticipated, and the industry
> is getting beat up, and we are being forced to take another leap. I
> just caution that we look before leap as much as possible, and the
> industry is trying to do that with the constraints that they have.
>
> I would like to see more of a partnership in addressing this issue and
> before we force the issue by saying 1 percent of energy from trans is
> the number. Consumers aren\'t going to make the distinction between
> whether the evidence is consistent or supporting it. That distinction
> is going to be lost.
>
> I just think there is a danger in showcasing trans fatty acids
> particularly when although we agreed that trans fatty acids have a
> different effect on heart disease than saturated fats, it was with the
> big caveat that didn\'t get included in our vote that it is at high
> levels, whatever that is. There is no evidence, at least in my
> opinion, they are worse at levels that are currently consumed.
>
> That is my last soapbox speech.
>
> DR. SHANNON: I really appreciate Guy\'s soapbox, but I would like to
> come back to a few other statements.
>
> First of all, in relation to what you read us would be FDA\'s
> interpretation, your last statement was in the absence of a yes, and
> we have just voted in the absence of a yes.
>
> Then, in the absence of a yes vote, we voted no, there is not the
> evidence to support, scientific evidence.
>
> So, if we stop now without any kind of follow-up statement, we have
> left it there, it\'s the absence of a yes, and that is where we have
> left it.
>
> Then, I want to come back to this label. Well, first of all, you have
> said be careful about showcasing trans fats. They are already
> showcased, they are going to be showcased on the label, so they are
> showcased, and they are showcased right here on this label.
>
> Let\'s say it\'s a label that says there is 6 grams of saturate
> fat\--well, let\'s say it says 10 grams of saturated fat and 2 grams
> of trans, a lot of people are going to say woo, this is great, there
> is just 2 to 8 unless there is some other indication.
>
> Now, what we are doing with this statement is just saying to FDA take
> that into consideration. Down the road, we are opening the door to
> continue this consideration of helping out with that 2 versus 10,
> which is going to be showcased on there.
>
> So, that is just I feel some follow-up statement to our no vote is
> needed.
>
> DR. KRINSKY: Thank you, Barbara.
>
> Again, not hearing any further discussion on this, Michael suggested
> that we move on this question, on this statement and this question.
> What it does is acknowledge that there is not adequate current
> scientific evidence, but that we do encourage reducing trans fatty
> acid intake, and we have set a goal or recommended goal in this
> statement.
>
> So, I would like to call this question, and it again calls for a yes
> or no answer.
>
> Those of you that are in favor of transmitting this statement to the
> FDA as an addendum to our votes on the three questions that they
> supplied us, please raise your hand and indicate yes.
>
> And those voting no?
>
> And abstaining?
>
> As I read this, we have 6 yes votes, no no votes, and 1 abstention.
> Therefore, this Committee is transmitting this statement to the FDA to
> use for whatever purposes they see fit, or if not used as they see
> fit.
>
> With that, if I see no other red lights on, I am going to adjourn the
> first meeting of the Nutrition Subcommittee of the Food Advisory
> Committee of the FDA and express my appreciation to all of you for
> your participation, to Jeanne Latham for the wonderful executive
> secretary function in whispering in my ear occasionally, and to the
> FDA staff sitting off to our side, and particularly to the audience
> behind us. I do want to apologize for facing my back to the audience
> for this day and a half routine, but apparently those are the rules
> and regulations of the FDA, Article 6, Section 4, or whatever it is.
>
> So, as far as the Committee is concerned, luncheon will be served, and
> the luncheon is available at 11:00 a.m. this morning for those of you
> that eat early, and you are free to lunch with us or not lunch with
> us.
>
> For those of you that would like your notebooks FedEx\'d back to your
> homes or offices, Amy will see to that.
>
> If there are no other comments, thank you all very much and we
> adjourned.
>
> \[Whereupon, at 11:00 a.m., the meeting was adjourned.\]