U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

Wednesday, June 24, 1998 10:00 a.m. & Thursday, June 25, 1998 10:00 a.m. Auditorium, Cohen Building 333 Independence Avenue, Washington, D.C.
CONTENTS:
June 24 Opening Remarks: Joseph Levitt, Michael Friedman, M.D.
Overview of Resource Allocation/Resource Needs :Joseph Levitt
Panel 1: Joseph Levitt, Robert Lake, Janice Oliver Phillip Spiller, Terry Troxell, Ph.D.
Panel 2 ;Joseph Levitt, John Bailey, Ph.D. Catherine Carnevale, V.M.D., Laura Tarantino, Ph.D.
June 25 Opening Remarks :Joseph Levitt
Panel 3 :Joseph Levitt, Arnie Borsetti, Ph.D., Ken Falci, Ph.D. Elizabeth Yetley, Ph.D.
Nutrition/Dietary Supplements
Council for Responsible Nutrition -- Annette Dickinson, Ph.D.
Nutrition Network, Inc. -- Charlene Rainey
National Nutritional Foods Association -- Michael Ford
Trade Associations
National Food Processors Association -- John Cady
The Society of Plastics Industries, Inc. -- Jerry Heckman & Tom Brown
Apple Processors Association -- Paul Weller
Health Professional Organizations
American Heart Association -- Carole McGeehan Johnson
American Dietetic Association -- Tracey Fox
Companies
Viskase Corporation -- Tom Higgins
PROCEEDINGS
Opening Remarks
MR. LEVITT: Why don't we go ahead and get started. I am Joe Levitt. I am the Director of the Center for Food Safety and Applied Nutrition here at the FDA. I want to welcome you to day two of our priority-setting meeting, an opportunity for public input.
Since we have a few new people who were not here yesterday, I am going to take probably five minutes in trying to summarize what we heard yesterday, so we have the right context.
First, Dr. Friedman came and gave a broad FDA overview of the different areas of focus and the different areas we have given priority to, to get feedback on that, as part of our general obligations this year under Section 406 of the FDA Modernization Act to develop a plan by November for Congress on how we are going to meet all of our statutory responsibilities, and as part of that, to meet with all our different constituencies in this meeting as part of that overall process.
Second, I took a few minutes and outlined the purposes of the meeting which is to really especially being a new center director to really take a good look at, you know, where are the priorities recognizing we can't do everything. One of the speakers even said we need to accept what our limitations are and recognize that, too, and I used one of my favorite analogies that FDA too often has 100 pebbles moving up a mountain at one mile an hour, and at the end of 50 years, what do we have, 50 pebbles halfway up the mountain, and nothing to show for it, and I prefer the fewer boulder up and over the hill and something to show for yourself theory.
I also showed a couple of slides on resource history. I don't have the projector here today, but basically, what it showed for CFSAN, for the Center, and this was a surprise even to me, even though I have been here all this time, is that 20 years ago, in 1978, which was about the peak, the Center had roughly a thousand people, it was 995.
Within 10 years, during the eighties, a constant decline every year, and then about '88, '89, there started to be some increases that were dedicated to four specific purposes: imports, food safety, NLEA, and finally, the food safety initiative, and even with those increases, nevertheless, we began this fiscal year at a little under 800, or a 20 percent cut.
So, the first message is, whether anybody has noticed or not, we have a 20 percent cut from 20 years ago, and what I didn't say yesterday, but I usually do, and those cuts were all taken through attrition, so they were not planned cuts. Whenever people leave, that is who your reductions are.
The second slide I then showed is, of course, if you are somebody working in the Center in one of those programs that is not covered by those four areas--I am sorry, seafood is the second one--so if you are not in imports, you are not in seafood, if you weren't part of NLEA, or you are not part of the food safety initiative, and you take out and subtract those additive resources, then, the rest of the program is really down to about 660 or a full one-third reduction.
So, if you are in food and color additives, if you are in pesticides, if you are in dietary supplements, if you are in cosmetics, if you are in the milk programs or the other cooperative programs, this is what your world is at the FDA.Then, the third slide I put up was during that same period of time, the additional laws that Congress has passed--and there re about six or eight of those including most recently the dietary supplement laws and the Modernization Act, and so we have a clear pattern.

We have sharply declining resources, sharply increasing responsibilities for the food safety initiative on top of that, and in my mind, it just means it is even more critical that we carefully look at where are our priorities, are we getting a return on our investment, which for me is the bottom-line question, where do we do the most good for consumers.
In the Federal Register notice we outline six questions which I won't repeat because you all have them, and a number of speakers have started speaking to them.
Yesterday's discussion was excellent, I look forward to continuing today. The format will continue to be the same as it was, which we will invite people up in a series of panels of people that have something in common in terms of background and interests.
We will let each speaker speak for seven or eight minutes. We have a timekeeper sitting right here in front, and she will flash you a sign when you have two minutes left, and a red sign that says you are out, and if you don't notice the red sign, I will remind you of it.
Then, at the completion of the speakers, we will have questions, and we have up here a panel in addition to myself, several senior members from the Center, and when the Q's and A's are done, we will proceed to the next. There also will be a written summary of this meeting, and we are holding the record open for 30 days for people to submit written comments, either supplementing what you have done or people who weren't able to speak, some written comments. We certainly encourage everybody to do that.
With that, we anticipate that we will be done certainly by 1 o'clock. If we need to take a short break later in the morning, we will. We kind of play that by ear.
With that, let me invite up first the FDA panel. We have Beth Yetley, our Director of our Office of Special Nutritionals; Ken Falci, our Director of the Office of Scientific Analysis and Support, Arnie Borsetti, who is the Director of Executive Operations Staff, and we have Juanita Wills' name up here, but I don't believe she is here because she usually needs to be in Parklawn on Thursday mornings.
I invite you to come up and join me, please, and we will also invite up the first set of speakers from the dietary supplement industry. We have representatives from the Council for Responsible Nutrition, the Nutrition Network, and the National Nutritional Foods Association. I have listed Annette Dickinson, Charlene Rainey, and Michael Ford.
I am having additional copies of the slides from yesterday made up, so for people who were not able to get a copy, they should be available before you leave today.
Finally, I would encourage, especially since it looks like we are only having a half-day today, to the extent it is possible for people to stay not only for their presentations, but for others, as well, because I think it is important, as far as the overall priority setting, for people to see what everybody else's priorities are, not just their own.
With that, let us begin with Council for Responsible Nutrition, Dr. Annette Dickinson.
Panel 3
Nutrition/Dietary Supplements
Council for Responsible Nutrition
DR. DICKINSON: Thank you, Mr. Levitt. We are very pleased to be here to participate in this priority-setting meeting.
The Council for Responsible Nutrition is a trade association representing the dietary supplement industry. We have about 100 member companies including suppliers of vitamin, mineral, and botanical ingredients, as well as finished product manufacturers whose products are sold in the mass market, health food stores, direct sales, as well as mail order.
We have a little trouble, Mr. Levitt, with your pebble and boulder comparison because, in one sense, the entire dietary supplement industry is only a pebble as compared to the food industry. We had sales estimated in 1997 of about $12 billion compared to over $450 billion for the entire food industry.
However, the interaction of FDA with dietary supplement issues has presented some boulders of issues over the years, and we serve a number of consumers, as well as members of the industry, who have a certain tendency to storm the barricades when they perceive that FDA is acting in what they do not believe is their interest.
CRN's proposition to FDA is that the industry is committed to be more proactive in the coming years in terms of self-regulation in order to relieve some of the burden that FDA currently suffers in terms of manpower and resources in dealing with dietary supplement issues. However, there are some basic FDA actions that need to be put into place in order for an industry self-regulatory system to thrive.
One of these is nutrition labeling, and that I am happy to say is something that has already been done. Your final rules were published in September of '97, we submitted some petitions for reconsideration which FDA granted earlier this month, and we appreciate FDA's receptiveness to those petitions. So, we are ready to move forward with nutrition labeling. You are already seeing those new labels on the shelf.

A second issue has to do with Good Manufacturing Practices. DSHEA authorizes FDA to establish GMPs for dietary supplements. The industry is committed to helping you do that, and has submitted a draft document which you published as an ANPR in 1997, and a group of the Food Advisory Committee is currently looking at this, CRN has members represented on that, and we are prepared to do anything else that you would suggest to us we can do to move that process along because we think it is one of the building blocks we need for action in the future.
Statements of nutritional support is another area of controversy. DSHEA's provisions on statements of nutritional support were self-implementing. Companies began using these statements immediately after the law passed. FDA has three and some-odd years now of experience with this, and, in general, our perception is that the fact that FDA has only needed to respond to about 7 percent of the notices indicates a fairly substantial degree of agreement between industry and FDA about what the permissible scope of these statements is.
In our view, this is not an area that required rulemaking. In other words, it is not an area that we believe has presented a problem of misunderstanding or of lack of compliance that really required rulemaking. Nevertheless, FDA has issued a proposed rule and we are deeply studying that rule and will be submitting extensive comments in October.
We do think that FDA made a couple of missteps in that rule. The first we believe was to enter the discussion by broadening the definition of disease, which we see as highly problematic and which we see as necessarily limiting the scope of statements of nutritional support.
We think the second problem area was to adopt what, in our view, is very much a medical model of disease as the basis of this presentation rather than the fully emergent model of health promotion and disease prevention. We think that it is true, as FDA observes in the notice, that almost any structure/function statement at some extension of its logical extension will have disease prevention implications.
We believe that DSHEA clearly anticipated that product labeling have this kind of information available to consumers specifically so that they could use these products for disease prevention and to help reduce health care costs, so we think that this needs some major reconsideration on the part of the agency and we will be submitting extensive comments to assist in that reconsideration.
As much as any industry may object to the existence of regulation, the fact is that an industry needs a strong regulatory agency and consumers need FDA in place and they need to be confident that if there are unexpected problems that come up, FDA can respond to those.
That means that there needs to be swift enforcement when unanticipated questions arise. For example, last year we had an issue involving plantain products which were contaminated with digitalis.
FDA notified the industry almost as soon as it learned about this case and also issued a public health alert. The industry and the agency were very productive in working together to rapidly locate the source of the problem, remove the contaminated material from the market, and correct the situation. We believe this is a good model for future cooperation between the industry and the agency in resolving these kinds of problems, which ideally should not occur, but which do