FOODS, DRUGS, AND COSMETICS

Senator COPELAND. Proprietary foods.

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Senator HEBERT. Yes; proprietary foods. Could not that cbjection be overcome by filing the formula with the Department instead of putting it on the package? The representation was made to the committee the other day, perhaps you heard it

Mr. CAMPBELL. Yes.

Senator HEBERT. That it would destroy some lines of activity if that were done, if manufacturers were required to put their formula on the package.

Mr. CAMPBELL. Yes; I have heard that asserted, Senator. We have approached the consideration of this quite naturally from a standpoint which it is not acceptable to the manufacturer himself. Our thought has been that the purchaser of food products, the one who is going to take those food products into his system, is entitled, as a matter of simple right, to know what he is eating.

There are two reasons to justify that position. The first is an economic reason. It will prevent, in such circumstances, the substitution of products which may be of lesser food value or may be less expensive. The second, and the compelling reason, to my mind, is the element of health. I do not think you heard, and I am sorry that you and the entire committee did not hear Dr. Brown, of Washington, an expert on hypersensitivity, testify yesterday afternoon. He pointed out this, that he had a child in his office who was suffering from allergy. I don't know whether the cause was eggs or milk.

Senator HEBERT. What was that word, allergy?
Mr. CAMPBELL. Yes; allergy.

Senator HEBERT. How do you spell it!

Mr. CAMPBELL. A-1-1-e-r-g-y.

Senator HEBERT. What is the definition of it? a number of times and I admit my ignorance. to explain it to me.

I heard the term
Now, I ask you

Mr. CAMPBELL. You need not feel humiliated, because it is not in the dictionary, or at least it is not in those that I have consulted. It is a medical term. It means the hypersensitivity of certain individuals to certain protein products. It may manifest itself in the form of asthma or hives or other forms of physical distress. Senator COPELAND. What is food for one is poison for another. Mr. CAMPBELL. That is right.

Senator HEBERT. I would like to look up the derivation of that word.

Senator COPELAND. Here is a book on the subject.

Senator HEBERT. All right. I suppose it is one of those $14 words that physicians coin.

Senator COPELAND. There is a description. right there, in that book. Senator HEBERT. All right, go ahead.

Mr. CAMPBELL. Dr. Brown explained that the distressing physiological reactions that could be produced in those people who were hypersensitive to certain products could be caused by infinitesimally small quantities of the food product. I know that one of the members of a clinic in this country which is known from coast to coast is allergic to cottonseed oil. On a trip down the Mississippi River he made provision for his own food supply of some chickens. His own servants in his household knew he was allergic to cottonseed

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cil and never used it under any circumstances. However, he had a meal of chicken and was violently ill, reacting in every way characteristic of those reactions which he suffered from a consumption of cottonseed oil. When they really found out the cause they learned that the cook, in putting away the chickens the night before, had adopted a local custom of rubbing them over slightly with cottonseed oil.

I am bringing that out merely to show you the extremes to which the people who do have this hypersensitiveness suffer from the consumption of those foods which are wholesome in themselves to most people but are deadly poison in a way to them. I think on that basis that it is fair to let the individual know what is contained in the food product.

Now, bear this in mind, Senator, about the disclosure of ingredients. There is slight difficulty, by competent chemical analysis, in the determination of the ingredients of food products. We have very little difficulty ourselves in finding out what the ingredients are in proprietary foods.

Senator HEBERT. In quantities!

Mr. CAMPBELL. Yes. Of course, quantitative analysis is more difficult than qualitative analysis. Competitors can do the same thing through commercial laboratories or through their own chemists employed for the control of their own operations.

I am not in favor at all of a requirement that one inanufacturer who has spent years and money in experiments, who has been progressive in his work, and who has acquired something that in the public estimate is valuable, being required to make known the results of his researches to his competitors. I don't think that is fair, and I am not blind to that argument. But against that, it seems to me, is the fact that his secret is not so profound as he himself frequently imagines it is, that the character of the ingredients used can be and usually are determined. He is not required to state the proportions in which the ingredients are used. It is only the qualitative, the declaration on the label that is expected.

Senator HEBERT. Yes; it says, "in order of predominance by weight."

Mr. CAMPBELL. That is right.

Senator HEBERT. In other words, the greatest quantity of a given ingredient is first, and the next one follows!

Mr. CAMPBELL That is right. Otherwise you can see that without that particular requirement in the section a manufacturer could use an infinitesimally small quantity of a desired expensive ingredient and place its name at the top of the list. That provision was to avoid the deception which would otherwise result,

Senator CLARK. Mr. Campbell, in proprietary foods, is it not true ordinarily that a man may be able to take a combination, and sometimes not even a combination, of ordinary staple foods which are relatively cheap and by putting a brand on it and a label build up a business where he may be able to sell that simple food for very much higher prices than is ordinarily charged in the market?

Mr. CAMPBELL. He could give it a euphonious name and advertise it extensively and there is no question but what he could create demand.

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Let me point out furthermore that this particular paragraph does not require a disclosure of the flavoring and color that is employed. The flavor, the taste of ingredients may be the result of the technique of the individual who is preparing them. Some chefs can cater to patrons much more favorably than others and can prepare food products that appeal much more to appetite than can others.

There are secrets in the preparation of food products. We certainly do not want him to disclose that particular secret. That is the manufacturer's asset. Let him retain it. He is imposing on nobody in doing that sort of thing. This paragraph points out that he can indicate there just colors and flavors. That is sufficient. It does not require him to disclose the particular spice or the particular flavoring ingredient that is the secret of his success.

Senator HEBERT. Now, I have in mind the labeling of soups, for

instance.

Mr. CAMPBELL. Yes.

Senator HEBERT. How are you going to label a vegetable soup! Are you going to say there are three beans and four peas and half tomato!

Mr. CAMPBELL. Don't you think a vegetable soup made of no more than that ought to disclose what it is made of, even quantitatively and not qualitatively! That is anticipating, Senator, a succeeding section, and I know that the question which you brought up is one that has been discussed in the industry, one about which there is some particular concern.

Now notice that this section (f) applies only to food products if standards of identity have not been promulgated. Standards will be formulated only after public hearings. They undertake to reflect the best trade custom that prevails in the production of food products of common names and the conception of that product as it is in the minds of housekeepers. In such circumstances we assume that there will be little contributed either economically, or from the standpoint of health of the consumer, in declaring on such products the list of ingredients. And this section applies only to those for which no standards have been promulgated.

Now in the ordinary course of the work of the Department undoubtedly there will be standards for different types of foods now known commonly under a certain name, not the product of only one concern, not a novelty, not something that is sold under a fancy name and therefore called a proprietary product. I know that there is apprehension among some manufacturers over the fact that prior to the date of the promulgation of such standards or definitions there will be a requirement to declare ingredients on the labels.

Suppose, for instance, the the Department could not promulgate standards of identity for preserves or jam within the 6 months prior to the date the law goes into effect; that is, within the 6 months after its passage. That would require manufacturers now marketing jams and preserves to declare, in the order of their predominance, the ingredients of the product, for instance, sugar, fruits, spices, and so forth. They would have to declare the ingredients in the order of predominance. That would involve printing of a new supply of labels with the certainty that there would be a standard promulgated for that product within the course of a year or a year and a half, and that all such labels would be thrown away.

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Candidly, I think there should be some provision for that hiatus between the effective date of this law and the time when the Department, under stress of force, issues standards which would exempt such products from section 7, paragraph (f).

Senator HEBERT. Getting back to soup again, the first ingredient there would be water, wouldn't it!

Mr. CAMPBELL. Yes; quite right.

Senator COPELAND. You have explained, I assume, that you could readily establish a standard of identity for vegetable soup, we will say, where you would not have to reveal the contents.

Mr. CAMPBELL. Right. Let me point out this in explanation of that proviso on page 10 which was a matter of some concern to Dr. Woodward, I believe. He said that it was not quite apparent to him what the purpose of it was.

Senator COFELAND. Where was that?

Mr. CAMPBELL. That is lines 3 to 10 on page 10. I can tell you quite briefly what that is. We know that in the production or manufacture of livestock foods all of the States require a declaration of the ingredients on the label. In addition to that they require manufacturers to declare the chemical analysis, that is, the protein, fat, fiber, and carbohydrates. If a manufacturer were to prepare a product calling for a certain percentage of protein and certain percentage of fat, he might find it necessary to vary the proportion of cottonseed meal, for instance, which he would use in the preparation of that feed. So that today the one which would predominate would be cottonseed meal. Ordinarily the one which would predominate would be oats. This particular proviso is to take care of conditions of that character. That concludes misbranding of foods.

Mr. Chairman, I know that Senator Hebert particularly, from the questions he has asked, is concerned about the application of section 22, and especially the importance of paragraph (h) on page 37. The question of its significance has been raised by a number of those who have testified. It is a legal question entirely. For the record, and for the information of those on the committee who are interested, I would appreciate if at this point you let Professor Cavers, of Duke University, whom we called in to assist us in the drafting of this bill, make a brief statement. I ask this now because Professor Cavers must return home tonight.

The CHAIRMAN. You may go on, Professor.

STATEMENT OF DAVID F. CAVERS, PROFESSOR OF LAW, BUTTE UNIVERSITY

Mr. CAVERS. Mr. Chairman, as Mr. Campbell explained, I shared last spring in the drafting of Senate bill 1944 and have since continued to act as adviser to the Food and Drug Administration with respect to legal questions arising out of this proposed legislation.

I may add. in addition to myself in the work of drafting we had the valuable assistance of Professor Handler, of Columbia Law School, who is now general counsel of the National Labor Board and Mr. Frederick Lee, formerly, for many years, legislative counsel to the House of Representatives and later to the United States Senate.

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Senator COPELAND. I do not want to let the occasion pass, however, to say that the work Professor Cavers has done has been extremely valuable. I have been in contact with him ever since Christmas, most of the time.

Mr. CAVERS. I wish to speak, as Mr. Campbell explained, with respect primarily to paragraph (h) of S. 2800, and more particularly with respect to the last sentence of that paragraph.

The CHAIRMAN. What page!

Mr. CAVERS. Page 37, which provides, in formulating regulations under paragraphs (b) and (c)-I believe Senator Copeland wishes 'to add (d) to this section

The findings of fact by the Secretary shall be conclusive if in accordance with law.

The first part of that sentence, up to the word "section" in line 7, was not in S. 1944. We had assumed that that would be its interpretation and it was inserted to clear a misunderstanding which arose with respect to its application.

Even as so qualified, however, the provision has been the subject of much controversy, and criticism, and suspicion. Consequently I felt justified in seeking to explain the reasons for its insertion, as I understand them, the scope of its operation, and why I believe it is desirable that it should be continued in the bill.

I shall not seek to discuss the provisions giving to the Secretary the power to establish such regulations. Those are enumerated in paragraphs (b) and (c), and undoubtedly Mr. Campbell has adverted to them from time to time. Among them are the powers to establish regulations with respect to tolerances for poisons, standards of food, and the like.

I do wish, however, to stress two points, that such rule-making power is not an exclusive, un-American policy as to law.

Secondly, few subjects present greater justification for its exercise than that with which we are now concerned. To attempt regulation in a single statute of a product so diverse as foods, drugs, and cosmetics, without resorting to the rule-making power, particularly in view of the diversity of problems which are encountered under that, is to deny the administrative body the most effective and in some instances the only effective means of discharging its duty to the public.

It is urged that the power to make rules having the force and effect of law casts the burden of proof of misconduct not on the Government but on the defendant. A rule by an administrative body having the rule-making power operates to define the elements of the defendant's obligation. Proof of the violation of that obligation remains on the Government.

The situation seems to me, in large measure, analogous to that which might arise if after a statute which prohibited reckless driving were supplemented by a statute prohibiting the passing of stop signs at intersections to be placed by an administrative officer at points where it seemed necessary. In the former case under the broader statute the Government would have to prove reckless driving. After the enactment of that statute the Government would prosecute for failure to stop at the intersection.