as it is, and we find no evidence that the drinks are unsafe or present any risk at this point in time. It is something we will be continually evaluating as new data develops.

Mr. ADAMS. My final question is, and maybe Mr. Goodrich would like to comment on this, if it comes in the legislative area: Do you feel that you need any additional legislative authority or do you believe that your regulatory authority is sufficient to handle the problem of efficacy or effectiveness of nutrients as opposed to the actual dangers that are caused by them?

Mr. GOODRICH. We think on the basis of a Supreme Court case decided in 1941, we have the authority to fix these levels on the ground that the public is not able to make a choice now but simply because of the lack of knowledge about the roles these nutrients play and that because they are confronted with such a great variety of products both in terms of the nutrients present and in terms of the level, it is essential that if they are going to understand these problems and get out of them what they are hoping to get by spending a tremendous amount of money, they have to be standardized on the basis of scientific knowledge and at levels that bear some relationship.

Mr. ADAMS. Your program then is standardization of levels and labeling basically?

Mr. GOODRICH. Yes, sir.

Mr. ADAMS. I have no further questions.

The CHAIRMAN. Mr. Brown.

Mr. BROWN. Dr. Goddard, I would like to push a little further on the hallucinogenics. It seems to me when you suggest that the increase in the amphetamine price might be the result of a reduced supply, it might also be a result of an increased demand?

Dr. GODDARD. This is possible, too. I am relying on the advice of my experts in the drug abuse control area. The implementation of the drug abuse control amendments made it immediately more difficult for diversion of a product that was manufactured for legal purposes. This does not mean to say that some of it is not still occurring, but it made it more difficult for illicit production, and the increased controls would reasonably be expected to raise the price. Now, 3 weeks ago I think we seized 17 million of these tablets in 1 week which would indicate there is a market for them, of course, but I was trying to indicate our appraisal of the situation.

Mr. BROWN. Is it within the purview of the FDA or your other offices of the Health, Education, and Welfare Department to conduct. any study to determine the amount of addiction now present in the country? Has it reached the degree about which we should add some concern and if So, how much concern?

Dr. GODDARD. Such a study, as you suggest, is underway. It is being carried out through the joint sponsorship of the National Institutes of Health and the Food and Drug Administration-at least one phase of it is. I'd better limit that to indicate that we are trying to answer this question of drug abuse on college campuses as a beginning point. We also plan studies on drug abuse throughout society to identify levels of use and degree of use. There is information in terms of the general abuse. I am now talking about testimony given before this committee by my predecessor to indicate that we do have a serious national prob

lem. We don't have the statistically significant data that one would like to have to use as a yardstick to measure the progress again, but there is general agreement.

Mr. BROWN. Wait a minute. You mean that data does not exist? Dr. GODDARD. Yes.

Mr. BROWN. But are you preparing that data?

Dr. GODDARD. We are trying to in some of the studies we now have underway.

Mr. BROWN. Did I understand you to say that all the sources of the manufacture of LSD, meaning the basic drugs, are now under control? Dr. GODDARD. It is illegal for them to manufacture it. It is illegal to manufacture it, sell it, distribute it.

Mr. BROWN. What about the campus laboratory where it can be manufactured from raw materials, so to speak?

Dr. GODDARD. Well, they are engaged in an illegal manufacturing operation when they do so.

Mr. BROWN. The raw materials are not illegal?

Dr. GODDARD. Some of them are. Lysergic acid is the precursor. Mr. BROWN. "Precursor" is the word I was looking for.

Dr. GODDARD. Yes.

Mr. BROWN. Not all of the precursors are illegal?

Dr. GODDARD. Not all of them. Some of them are sold as prescription drugs.

Mr. BROWN. Are some of the precursors available without prescription limitation?

Dr. GODDARD. Well, sir, I would have to say that we then get down to a definition of what you mean by "precursors." I am not trying to split hairs, it is my word, I know. But a chemist may be able to start with hydrogen, carbon, and nitrogen and some other molecules and build it up if he is that sophisticated. I would say that of all of the precursors, the ones commonly available and used for LSD synthesis are under control of the law.

Mr. Goodrich points out the ones that make it most frequently possible for the amateur chemist to proceed are controlled.

Mr. BROWN. You are suggesting, then, that these are all under adequate control at present?

Dr. GODDARD. No, sir; I am simply saying that the sale and distribution and recordkeeping that is involved exists as a matter of law, and as a matter of practice.

Mr. BROWN. Are there any further steps which FDA ought to take to bring it under tighter control?

Dr. GODDARD. No; I think we have gone as far as we can on the precursors today.

Mr. BROWN. You have suggested that possession is not now against Federal law.

Dr. GODDARD. It is not.

Mr. BROWN. And that it should not be?

Dr. GODDARD. That is correct, in my opinion.

Mr. BROWN. But that it should be under State law?

Dr. GODDARD. Yes, sir. If possession is to be a crime, we think it should be a crime or held to be a crime by that legislative body that has the resources to enforce the law.

Mr. BROWN. What steps have you taken to encourage the creation of such a body of law in the country?

Dr. GODDARD. We prepared the model drug abuse law which has been made available to the States, and we have worked with and testified in support of this kind of law.

Mr. BROWN. How many States now have this kind of law?

Dr. GODDARD. May I supply that for the record? I believe a relative handful. Three or four is Mr. Pumpian's advice on this. (The information requested follows:)

STATEMENT OF THE FOOD AND DRUG ADMINISTRATION ON STATE DRUG ABUSE

LEGISLATION

In October, 1966 the Council of State Governments informally received the Model Drug Abuse Control Act prepared by the Food and Drug Administration. Although this was too late for submission to the 1966 meeting of the Council's Committee of State Officials on Suggested State Legislation, we understand that this model bill is to be submitted to the Council's Committee at its 1967 meeting. The Food and Drug Administration has sent copies of the Act to States requesting it. Wyoming is the only State to pass a Drug Abuse Control law per se; but the following States have laws which cover hallucinogenics:

Fifteen additional States are presently considering legislation controlling drug abuse:

Mr. BROWN. I would conclude from that that you feel inadequate promotion of this effort has been made.

Dr. GODDARD. It has only begun, sir. We have steps underway at the present time to reach the Governors with this recommendation to enact the model law.

Mr. BROWN. Are there any limitations on the promotion of drugs such as LSD?

Dr. GODDARD. Oh, yes. LSD cannot be promoted. Well, it is not available for legal sale. I am beginning to talk like my lawyer here. It is not available for legal sale, so, therefore, it cannot be promoted for sale. Now, Mr. Leary is able to promote the use of hallucinogenics through his campus activities and the statements to the press, but just the idea and not a specific drug.

Mr. BROWN. In other words, he is free to promote the use of the drug but not the drug. Is there any area of limitation here that might permit legislative treatment?

Dr. GODDARD. I have not seen any. It begins to impinge upon the freedom of the press and self-expression.

Mr. BROWN. Do you have any comment or consideration that you would like to make concerning what might be considered promotion by some of the public information media of the hallucinogenic drugs?

Dr. GODDARD. Could you give me an example and I can react? Mr. BROWN. Frequent articles we see on it-perhaps it is not fair to say the beneficial effects of these drugs, but some of the interesting side effects, their use in art, for instance, as an art form, or as a promotion of an art form. Is this desirable?

Dr. GODDARD. Well, I think it is hogwash. Now, whether it is desirable-I think it is probably desirable to allow people to express these beliefs. There is not any scientific evidence to support them, but I think you have to permit the expression of these beliefs, yes. Mr. BROWN. I am sure you have to permit it. My question was, is it desirable?

Dr. GODDARD. No, I don't think it is desirable.

Mr. BROWN. Whether or not it is responsible on the part of the
Dr. GODDARD. I don't believe it is.

Mr. BROWN. Let me push to one other area, if I may, Mr. Chairman, and ask for some kind of a definition from you and this may not be possible off the cuff. Where is the line in the fringe areas of use that relates to medical progress of nutrition in terminal cases? Now, when is this decision made to use a drug on a human being for the first time?

Dr. GODDARD. Well, this decision is made as a result of the submission by the proponent of a drug of an IND (Investigational New Drug) exemption request. In order for this to be a valid request, it must embody scientific data involving animal experimentation showing the physiologic effects of the drug which includes the lethal dose, what the toxic effects are, what side effects exist and to the extent these can be demonstrated the effects of the drug on diseases in animals and such kinds of information. Now, if that work has been properly done, then the exemption request is noted and they are permitted then to investigate this drug in humans for the first time. So in cases of drugs involving the treatment of cancer, it may first be tried in volunteers who do not have cancer to establish mechanisms of action. Small numbers of persons are used, and the drug is traced, perhaps taking it with a radioactive molecule to see how it is excreted. This may give some valuable clues as to how the drug works. If this continues to show promise and then they begin to use it in patients who have cancers of the type in which they think this drug will be useful, again under very rigid controls, careful supervision and careful collection of data. When this is done, I see no problem whatsoever.

Mr. BROWN. When we are talking about getting down to 180-day approval.

Dr. GODDARD. That is on the new drug applications.

Mr. BROWN. Are we talking in this area?

Dr. GODDARD. No. At the time the IND exemption request is mailed in they can start their studies in humans, so there is no delay on the part of the Food and Drug Administration. We are not in any way retarding the treatment of patients in a suitable investigative phase. Now, once the investigations have been completed, and the manufacturer or the proponent of that drug feels that this drug deserves to be marketed without the restriction of having to report the result of the study to the Federal Government, he then submits an NDA. It is at that time that the delays have occurred in the past. Although, I must

say in fairness to the staff at FDA, they have worked on this for a number of years, and I think they have handled cancer drugs expeditiously, as expeditiously as possible.

The CHAIRMAN. The questioning has been very searching there, and very good, Mr. Brown. I think the time has come when we will have to go on the floor, there being important business to take care of over there.

I want to thank you, Dr. Goddard, and you, Dr. Lee, for coming up. Certainly, it has been enlightening to the committee.

Dr. LEE. Thank you.

Dr. GODDARD. Thank you.

The CHAIRMAN. We have enjoyed having you.

The committee is adjourned until tomorrow morning at 10 o'clock. (Whereupon, at 12:24 p.m., the committee was adjourned until 10 a.m., Thursday, March 2, 1967.)