When I worked with Ralph Nader and wrote the book, The Chemical Feast: The Nader Report on the Food and Drug Administration we analyzed the national television information on food and found that the top ten foods advertised on television, all fell outside the basic four food groups, that was the main way we talked about nutrition in the late 1960’s. 

Number one was beer and wine, number two was candy, number three was chewing gum and so
forth. All of the top ten fell outside of the basic four foods. The result of that from my point of view
in 1968 when I began working with Nader, was that the American public was being given one set of
information through the mainstream of information that we used, and it was opposite of the
information that was useful to them personally. 

Now, the purpose of my being here today is to speak about a set of subjects and the over arching idea is FDA and the Nutrition Community - past, present and future. FDA, friend or foe. 

I’m going to divide that into two sets of discussions : One today at lunch and one this evening at
dinner. The one at lunch is Dietary Supplements and the one at dinner is Health Care Reform and the Congressional Nutritional Agenda. All around, the nation of how we look at the FDA. 

My way that I got into this issue - personally I was very interested in food as a result of the story I
just told you, and then I got very interested in Ralph Nader, because as a law student in 1966 I was
assigned a class in which my assignment was to read everything written by and about Ralph Nader .

And what intrigued me was that in all that I had to do a brief and an oral argument on his position on
our safety. What intrigued me was that Ralph Nader was known as an auto safety advocate in 1966, but when you read his technical writing, he was actually arguing that the major corporations in
America should have social responsibility. 

Its important because they make the major decisions about the kind of society that we live in. And
then he said for example, lets take the auto industry. And then he wrote all about the automobile
industry. When I read this, I said to myself that no one understands that he is talking about a broad
social issue and not a narrow one. He is talking about the whole notion of the corporate structure of
the American society, not just out of safety. 

And so I worked real hard, it took me a year to find him and get hold of him and sit down with him
and talk to him, and I suggested that in order for people to understand his larger issue, we needed to
look at some other area in American life that had the same problem that autos had. And we kicked it around for a while, and then finally, I said, "look, I’m really interested in food why don’t we do it in
food, because food corporations are the ones that define our food supply, They’re the ones who
define what people eat. And my experience personally is that what they’re defining isn’t what people
who know about food would say that you should eat." 

So then we started on our activities on working on nutrition and the food industry, and right at the
core of that issue lies the FDA. The FDA is the strongest, single law enforcement agency in the
United States. It has more power, more reach, and covers more area than any other law enforcement agency that exists. And remember, always remember it is a law enforcement agency. It is a police force. That’s its job. And it had enormous power. FDA regulates 25% of the gross national product. That’s 25% of every dollar spent in the United States on a product regulated by the FDA. No other institution in the United States government has that kind of reach. In addition, regulating foods and drugs has traditionally been one of the prime rate purposes of state power for 5,000 years. 

When you find the existence of a government, you will find one of the things that the government
does is regulate the food supply, and regulate health. You can find it in all tests, and so, you take an
agency that had tremendous reach and real depth and give them enormous power and now the way
we eat and the way me maintain our health is shaped by this institution. Its a powerful institution. 

When we began our study of the FDA, what intrigued me was the full range of things that they were
doing in my opinion "wrong". Not only the dietary activities, but many others. And my conclusion as
I looked at it, and looked at the whole history of regulatory agencies, and its all spelled out in the
chemical piece if you ever want to find it at the library, was a very successful book, in print for 11
years and sold well over a million copies. 

But the point that we came to is that a regulatory agency has its own agenda, which is secondary to
whatever the purpose it was created for. So that the FDA, in addition to having 25% of the market
place under its control, in addition to having the long tradition of regulating food and health behind it,
it also has its own internal agenda, 30,000 or so employees, several hundred million dollar budget, and it continuously argues for things that it wants to do.

In this situation, the first question I raised with the FDA that intrigued me was the fact that they had
50,000 cards and letters in their files in 1968 opposing the regulation of dietary supplements. 50,000
cards and letters. Went on my first trips over to meet with an FDA official and I said, "Gee this is
very interesting. You have 50,000 people opposing you on this. What do you think about that?" And this official said, "Well, that’s 50,000 quacks". 

Well, I was due in Washington, so I didn’t know exactly how to respond to that. I went back to
Nader and I said, "Gee, the FDA says that these 50,000 people (by the way, the most that they have
ever received on a proposed rule before was about 70 letters - cards and letters - on caffeine and
Coca-Cola. And that was a tremendous outpouring.) Here, they have 50,000. So I went back to
Nader and I said, "Gee, you know Ralph, the FDA says these are 50,000 quacks. What do we say
about that?" He said, "50,000 quacks? That’s 50,000 consumers." 

So then from then on I was free. I could go out and fight about this issue. But try and get that
mentality. I’ve worked now for a long time in Washington to try and break that mentality. 

In 1975 the FDA proposed a rule to ban the words "natural, organic and health food" from the
marketplace. Fight. I was the appointed Consumer Representative to oppose that, and I did, and we were successful, we won. The Judge said, "You can’t do that". But in the break during one of the
meetings - by the way, this whole session was 12 weeks long, and that was one of the issues - I said
to the lawyer from the FTC, just exactly how are you going to enforce this law? I mean there are
health food store windows all over America that say Health Food Store on them. What are you going to do? I said, "Well, maybe we’ll just get tanks and go up and down the street and shoot the windows out." I mean he was joking. It was a joke, but that’s what he said. I mean, he intended it to be a joke.

I had actually persuaded a whole lot of the people at the FDA that they should not talk like this
anymore - not only myself, but many other people. And they actually had taken public positions and
the Commissioner and others had said we don’t think these people are quacks, and we don’t think
they are bad people and we are going to work with them, its going to be better and so forth, and then I just happened to get a copy of their enforcement manual, it was about two years ago, and there it is, an entire page on quackery in the dietary supplement industry.

Its not an issue of - there are quacks in the dietary supplement industry the argument is that the
dietary supplement industry is quacks. That was the argument they were making. Now, again my
problem is the enormous power that this institution has, By making statements, it creates realities.

In 1976 a couple of years before that, a number of us, some of the people here, got involved in
challenging FDA with Congress about the way it has handling the nutritional questions that it was
dealing with, and we were very successful in getting the Proxmeyer bill passed through Congress.
This is a bill that gave a kind of limited faith haven to nutritional products. It said that the FDA could
not treat them differently from the way that it treated other food products essentially. It could not put
a higher burden on them, it could not treat as a primafacialy bad and forcing them to prove that they
were good and so on. And that was the high water mark of resistance to the FDA power that had
taken shape over the 50 years or so that they had been enforcing the drug law. 

That particular piece of legislation passed the Senate 90 to 10 and passed the house overwhelmingly. And it was like the shot across the bowel of the FDA, saying look, you’ve got to use your power in a restrained and responsible manner. FDA officials who got that message began to talk to themselves in their own culture inside that world where they set their own priorities about the Proxmeyer Bill, the ticking time bomb in the American health care system. The argument was that because the FDA had its wings clipped in this area, some horrible thing was going to happen to create a terrible crisis and it would be the direct result of this bill having taken away some of their authority. And they shopped and they looked and they worked and they really tried hard to find something and then ultimately were able to make an issue out of tryptophane. There they had it. The thing that they had been predicting all along. As I say, institutions with this kind of power create their own reality and they then use that as a wedge to create more and more difficulty around the dietary supplement and nutritional marketplace. 

Incidentally, I will have five or six minutes for questions, and if there are questions about any of these
points - I’m sort of skinning across them - but we can try to straighten them out a little bit or when
I’m walking around, if you want to ask me something, we can do that. In this atmosphere, the FDA
then began - there was one other line of argument going on at the same time, and that was the FDA’s insistence that anything that made a health plan was a drug. If you said eat prunes for regularity, that was a drug. And you had to prove it. And you couldn’t make that claim. In fact, they didn’t. Banned prune extract. Certain point.

This line of reasoning with the FDA was using granted serious problems in 1985 when Kellogg decided to go to the National Cancer Institute and gather evidence that certain brands helped prevent certain cancers and then get permission from the National Cancer Institute to use their name on brand cereal products. And so Kellogg hit the market with the statement, "The National Cancer Institute has concluded that certain brands help prevent certain cancers - for further information, call the National Cancer Institute …" and they put the number down. 

This was a direct violation of the law and challenge to the FDA. And in my own guise of doing things
end up in strange places , so I was invited to participate with a panel of people to talk about the
Kellogg issue at the Kraft companies, one of their meetings, who invited me to come and talk about
this along with six people altogether. And the three of us were supporting the Kellogg effort and three of us were opposed, and I made my argument about the effort which said - my argument was that there’s no way that a court is going to throw out the Kellogg ad because the court would have to pick between the FDA and the NCI and no Federal Court is going to do that. They are going to say, "Go back and talk to the secretary of HHS or HEW as it was at the time - go back and talk to them or him and get him to sort this out, because its not my problem. 

So, the next guy got up, a very, very well know national nutritionist who got up and said - I said, "as
long as long as NCI is going to take that position we can’t change the labeling, no matter what the law says." This guy got up and said, "Well, I formulated my positioning, and we believe from the nutrition community (all of you is part of that) believes that its wrong to say that and we never knew we re going to have the problem with having a quack running the National Cancer Institute. You know, I - part of the reason why I say Washington is, you know, one hundred square miles surrounded by reality. You have to just kind of shake your head and wonder what these people are talking about.

However, the fact is that that set off - that Kellogg effort set off an enormous policy battle in
Washington, which culminated ultimately in the NLEA - The Nutrition Labeling and Education Act of 1990. The NLEA’s empatice for existence is a reform movement to clip the wings of the FDA on health claims. That’s its empatice for existence. That’s where its energy politically came from. However, and this is the most important point I want to make to this group: However, because the people who were the constituency of that impulse, the people who believe that there is a direct relationship between food and health and that the American public ought to be let in on that fact, that group was not politically sophisticated enough to turn its victory into a new positive policy. 

So what happened, all this energy, focused on Congress - they got together and they wrote a law,
using the energy of a public that was outraged, the drugs, (the narcotics were called drugs if they were food that made a health plan) they took that energy of those people and turned it into the Nutritional Labeling and Education Act, giving the FDA massive new powers to control health claims and the relationship between food and health in the marketplace.

And the way they did that was to do something very, very much out of the FDA’s desire to create its own agenda. They said - the Congress said no health plan can be put on food unless the FDA
approves it first. Now this, remember was the reform. The argument was that the FDA doesn’t let
any health claims on. So they said, "Okay, we’ll reform that, we’ll say you can put health claims on if
the FDA lets you." That was the reform. Tremendous energy. And that was the reform, because the
constituency behind the reform was not able to translate the public energy into sound public policy -
was not able to win that fight in the detail. On it in the overall, but not in the detail. 

So the result is, that in Congress and - for first things we want you to look at - these ten things -
we’ve listed ten areas. We want you to look at those first to see whether any of them are things that
you’re going to allow a claim to be made in. Those ten areas where the dietary supplement industry
thought were the most - by the way the food industry is also upset about this. This is not only dietary
supplement, its also foods. But they happen to be the ten things the dietary supplements people were
most concerned about. 

There were some food people that were concerned as well. In the FDA (they set about looking at these) basically rejected 6 or 7 of them completely. Just rejected them. And only an enormous public battle got them to accept the notion that folic acid might help prevent tubule pregnancies. Even though the Federal Government was totally on record in every health agency recommending that all women of child bearing age increase the amount of folic acid they take on a daily basis, above what you can get from food - the FDA still would not allow that claim to be on its food products that it regulated. It took five months after the Commissioner said, I adopt the policy for the FDA to finally come up with wording, that is really unacceptable wording but its there - to let that claim on.

All right - this is the situation that everyone faced at the beginning of Congress a year ago, essentially.
And that’s when Senator Hatch and Congressman Richardson began to develop the legislation that
known as the Hatch/Richardson legislation, and its design to correct basically, two or three problems, mostly the problems I just outlined to you. 

Currently, right at this very time between last Monday and next Friday, there is negotiation under way between five principal members of Congress who will control the outcome of that legislation. Senator Hatch, Senator Kennedy, Congressman Dingle, Congressman Waxman and Congressman Richardson. The five of them and their staff are working on legislation. Senator Kennedy, who is the person who will make the decision, because he’s the committee chair of the health committee and Senate, had said that there will be a bail out of some kind by the end of April - out of the committee - and will have a bill passed through the Senate by May. It will either be the Hatch bill or a compromise.

We would be - anybody interested in this issue would be more interested in a compromise than the
Hatch Bill because it would mean that Senator Hatch and Senator Kennedy and Dingle and
Richardson will come to an agreement in that whatever bill passes is likely to go all the way through.
If it comes out a Hatch bill, that mean that there was not an agreement, and there will be an
enormous fight with both the Senates and the House, probably it will pass the Senate - the house will
be very much more difficult.

There are currently - The Hatch bill had 68 co-sponsors and the Richardson bill has 240 co-sponsors, well over half of the house. The problem is that many co-sponsors, when put to the test, will have to start trading off their own power inside the house in order to decide whether or not they are going to go with the bill. That’s the situation that we face today. Legislatively. And its very important for anybody whose interested in these issues to let their Congress people know that this is an important piece of information - an important piece of legislation - an important piece of information to the American public, and that the American public deserves that, and they should be participants in this dialog that’s leading toward this resolution. 

Every single one of the five people that I have named has said that FDA to some degree has gone
outside of what was intended by NLEA. Waxman said that, Dingle has said that, Richardson, Hatch, Kennedy, all of them say the FDA has gone off the reservation. The debate is about what are we going to do it get it back on the reservation. And the Hatch/Richardson people have a set if ideas that they are using and Waxman and Dingle and Kennedy are trying to hold the line and make it less of a restriction on FDA, whatever the reform is.

Now that the situation with dietary supplements, and I believe that the only way that FDA can be made a friend of Nutrition and Health is by being harnessed so that the massive energy can be used to do positive things. And there are positive things that it can do. They raided a group - a store not long ago - 2 and a half years ago and took away a bunch of bran products and they said, "we’re seizing these products because they say that bran will help reduce cancer." That was big headline - That was what the stories reported, but the last paragraph of their press release said, " These products contained no bran."

I personally want guys that put out products that they read "cures cancer" and call them bran rolls and they don’t contain bran to be put in jail. I mean yeah, great. I’m for that. That’s what they should be doing. They don’t have to sit around and argue whether bran does nor doesn’t prevent cancer, but they sure as heck have a job to - role to play when they say bran is here and it isn’t there. And so there are good things that the FDA can do and they should limit themselves to that.