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Mr. FLOOD. With the advent of frozen food as a common household item, and the unfreezing and refreezing, is this a problem? Does this bother you much?

Dr. GODDARD. This is an area we are paying increased attention to. Mr. FLOOD. It is disappointing to realize even in the plush restaurant so much, much, much of the food is little more than TV dinners. I understand this is one reason this last chef left the White Housetoo much frozen food for his liking.

What sort of a problem is this, if it is a problem?

Dr. GODDARD. În our present budget request we do ask for funds to carry out additional research because there is concern about the so-called convenience foods and frozen foods would be one example.

The assumption is often made that directions will be followed precisely. However, we are well aware that not everyone at all times follows the precise directions as far as handling is concerned. We wish to find out what impact this has and study these "convenience" foods in greater detail.

Mr. FLOOD. Have we run onto any bad problems that have disturbed your shop any place in this country?


Dr. GODDARD. In a somewhat analogous area, the smoked fish episode of 1964, I believe would be an example of this type of occurrence that was really one of great concern.

Mr. FLOOD. Are those people back on the track yet like the cranberry people? How are the cranberry people? Are they all right now? Has it blown over?

Mr. DUNCAN. Yes.

Mr. FLOOD. We have always had cranberry juice around.

Mr. DUNCAN. Their market has been recovered. They were hurt very badly.

Mr. FLOOD. Do you not have them in New England?


Mr. FLOOD. In our house, we went right through it as though nothing happened. I would pick up the paper and read, and drink the juice.

Dr. GODDARD. To get back to the fish problem, we are continuing studies on the matter of botulism in fish. We have research contracts

with universities.

Mr. FLOOD. Did those people recover from their shock?

Dr. GODDARD. I do not know what the economic situation is with respect to the smoked fish industry.

Mr. FLOOD. What area was involved?

Dr. GODDARD. The Great Lakes area involving smoked whitefish.


Mr. FLOOD. Speaking about having a tiger in your tank in the gasoline field, what about you fellows and additives?

Dr. GODDARD. Any particular part of the additive problem?

Mr. FLOOD. No; just the whole field of additives. Is this something to worry about?

Dr. GODDARD. It does come into our area of jurisdiction.

Mr. FLOOD. What do you examine, the additive, or final package? Dr. GODDARD. Both. The manufacturer must submit evidence the additive he proposes to use is safe, and he must carry out certain. types of studies.

Mr. FLOOD. What is an additive-"Exhibit A"?

Dr. GODDARD. I would like to submit the technical definition of an additive.

Mr. FLOOD. You can to that.

Dr. GODDARD. It is something used by the manufacturer to enhance the color, stabilize the product, make it more usable in terms of having a longer storage life. It is often a chemical compound. An additive would be a dye. It is intentionally put into the food product for a specific technological purpose by the manufacturer.

(The technical definition was submitted as follows:)


The term "food additive" is defined on page 201 (u) of the Federal Food, Drug, and Cosmetic Act, as amended, 1960, as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use of food) to be safe under the conditions of its intended use." The law goes on to exclude certain items that are treated elsewhere, such as a pesticide chemical in or on a raw agricultural commodity or used in the production, storage, or transportation of any raw agricultural commodity, a color additive, or any substance approved for use by the Poultry Products Inspection Act, the Meat Inspection Act, or the Food, Drug, and Cosmetics Act.

This definition encompasses literally hundreds of food additives from such obvious things as flavors, preservatives, and such supplements as vitamins and minerals, to subtler things like the chemicals found in various packaging materials or in the machinery used to manufacture and store food products.


Mr. FLOOD. That invites an inquiry about the whole broad realm of pesticides?


Mr. FLOOD. This is apparently your current No. 1 headache.
Dr. GODDARD. One of them.

Mr. FLOOD. With movies, books, stage plays, lectures and ladies' clubs, you have had a bear by the tail.


Dr. GODDARD. It is a significant problem for all of us as consumers to bear in mind and particularly the Food and Drug Administration must monitor this field along with other responsible agencies. last report which I saw last week indicated that the impact of pesticides on humans was not increasing, and that the amount of pesticides stored in human tissues was either holding constant, or decreasing, which is a favorable sign.

In general, great efforts are being made to learn to use these in a way which will result in smaller residues on the crop being marketed, and a variety of techniques are used.

Mr. Flood. It is a vicious circle.

If we are going to feed the world, we have to do this, and if we do this, we get that, and if we get that, here we go again.

Dr. GODDARD. Sir, I would not characterize it as a vicious circle. Mr. Flood. Ştrike out the word "vicious”. Dr. GODDARD. Certainly, each new introduction poses new kinds of problems, and it is our job to make certain these do not have a deleterious effect on health.



Mr. Flood. To what extent, if any, do you get into the field of international commerce? What about foreign drugs, imports, and so forth? Dr. GODDARD. We are involved in international commerce in that

We are responsible for determining that both food and drugs imported into this country meet the standards our manufacturers must comply with.

We do carry out in the field of drug imports, inspection of plants in which these drugs are manufactured, and sample, if it involves insulin or antibiotics, the batch-by-batch process that they carry out.

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Mr. Flood. With the advent of medicare, and its impact on our medical facilities and services, are you getting ready for the blow that will follow from this?

Dr. GODDARD. We are planning, sir, to have a vigorous program : in attempting to educate the persons in the older age groups so they in will have a more intelligent knowledge of what medicines can do for them. Many of these people purchase over-the-counter remedies. We would like to help educate them on the worth of medicines in general and do a better job of consumer education for them.


Mr. Flood. It strikes me you are on the threshold of an extremely difficult few years.

Mr. Flood. With the advent of medicare.

Dr. GODDARD. I would not limit it to the advent of medicare. I think the nature of the industries we regulate is that they are becoming increasingly complex. There are many interrelationships.

Whether we are talking about effects of multiple pesticides on different foods, or the new drugs being developed, they often are designed for use over long periods of time. This means that we must have more sophisticated techniques to assess the impact of these on our citizens.


Mr. Flood. How closely do you work with the enforcement people of the narcotic squads on the abuse of the use of narcotics-drugs generally?

I had in mind narcotics in particular, but drugs.

Dr. GODDARD. There is close cooperation between our investigative agents and the agents of the Bureau of Narcotics and responsible State agencies where this is indicated.

I personally met with the Director of the Bureau of Narcotics within the past week, and there are many instances in the past where there have been collaborative efforts aimed at stopping the illicit traffic of drugs that come primarily under our jurisdiction, so we exchange information frequently.

Mr. FLOOD. Do you work with State people who enforce State laws in these general areas?

Dr. GODDARD. Yes, we do, sir.


Mr. FLOOD. Do you work with the Federal Communication people, if anyone can work with them, on these weird TV advertisements"This is not a sleeping pill, this does not put you to sleep, this simply lets you sleep"?

Dr. GODDARD. We provide information to the Federal Trade Commission and the code authority.

Mr. FLOOD. I am not naming any particular product.

This is not a sleeping pill. This is not a narcotic. This is not a drug. This does not put you to sleep. This merely helps you sleep, like a punch in the mouth.

What about that sort of thing?

Dr. GODDARD. We are jointly considering these kinds of problems with the Federal Trade Commission.

Mr. FLOOD. This is semantics. Is this not a narcotic? Is this not a drug? What is a drug?

Dr. GODDARD. It is not a narcotic, sir.

Mr. FLOOD. What is a narcotic as distinguished from a drug? Dr. GODDARD. A narcotic has the quality of being habituated with its continued use. One becomes dependent on it.

Mr. FLOOD. It has to produce that condition. If it does not do that, it is merely some kind of a drug?


What is a counterfeit drug?

Who are you?

Mr. RANKIN. I am Acting Deputy Commissioner.

Mr. FLOOD. How long have you been around?

Mr. RANKIN. I have been with the Food and Drug Administration for 26 years.

Mr. FLOOD. Go ahead and talk.

Mr. RANKIN. A counterfeit drug is a drug that is manufactured to imitate an established drug product.

Mr. FLOOD. A clandestine manufacturer?

Mr. RANKIN. Generally, it is a clandestine manufacturer. The drug generally also is manufactured under poor control conditions. We have even found counterfeit drugs being manufactured in the basement of a private residence, in garages, or in attics under deplorable conditions. The problem with counterfeit drugs is that because of the poor manufacturing conditions we must expect periodically

bad batches will be put out which will cause harm. This is in addition. to the economic problem.

Mr. FLOOD. Do they counterfeit the whole package or just the drug?

Dr. GODDARD. We have found the whole package being counterfeited.

Mr. FLOOD. They would have to counterfeit the whole package, or there would not be any point to it.

Dr. GODDARD. That is right.

Mr. FLOOD. They are produced under conditions that invite filth. Dr. GODDARD. Low potency, or even the incorporation of the wrong drug in the tablet, or other medication.

Mr. FLOOD. How do they market a thing like that? Here is a drugstore, or a physician. Is it just corruption and bribery? Why would a druggist who knows and buys from BC & D company, and knows the drug, buy from Joe Zilch?

Mr. RANKIN. We broke up a counterfeit ring a few years ago operated by a man and his son, the Palmers, in the Midwest.

Mr. FLOOD. I remember reading about that.

Mr. RANKIN. They secured counterfeit drugs. They put them up in packages that looked like the genuine articles and then traveled from one drugstore to the other and they represented to the purchaser that through special buying arrangements they had been able to get a special price so they offered the drugs at a special price.

Mr. FLOOD. They were con men besides?

Mr. RANKIN. They were con men. I am not trying to excuse the druggists who bought. They ought to have sense enough to know you do not get good drugs at a very low price.

Mr. FLOOD. Is this much of a problem?

Mr. RANKIN. It is a periodic problem.

Counterfeiting will spring up. We will take care of it and then for a few years we do not hear of it and it springs up again.

Mr. FLOOD. When some sharp character gets an idea, you have a problem?

Mr. RANKIN. That is correct.


Mr. DUNCAN. Along that same line, it has always seemed to me as far as the major pharmaceutical houses are concerned this business ought to be largely self-policing.

Dr. GODDARD. It is my impression that the major pharmaceutical manufacturers are concerned that their image remain good and they do attempt to protect their buyers in terms of producing a good product.


Mr. DUNCAN. If Squibb or any of the rest of them should submit a new drug and in your justification you say it is quite common now to have 10 or 20 volumes of supporting evidence-do you have to go through all those experiments again, or do you just check their technology?

Dr. GODDARD. We do not go through the experiments again.

May I also add that the same attitude I have found exists in small manufacturers, some of whom I have met. They are anxious that

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