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

 

Welcoming Remarks:

  Dr. Robert E. Brackett    4

 

Call to Order and Opening Remarks:

  Norman I. Krinsky, Ph.D.    7

 

Subcommittee Discussion    11

P R O C E E D I N G S

    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.