VOL. 1 LEGISLATIVE HISTORY OF THE FOOD, DRUG,

COSMETIC ACT

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FOOD, DRUGS, AND COSMETICS

The language employed in the original law is:

In the case of food, first, if any substance has been mixed or packed with it so as to reduce or lower or injuriously affect its quality or strength; second, if

any substance has been substituted wholly or in part for the article; third, if any valuable constituent of the article has been wholly or in part abstracted.

How are you to determine when the standard of a product has been lowered? When some valuable constituent has been removed; or when some ingredient has been substituted, unless you proceed from a definite conception of a standard?

In the enforcement of this law now we are required to go into court and show by testimony of manufacturers, and the testimony of housewives, what that standard is.

You can easily appreciate the fact that the standard set up in such circumstances is not an exact standard. Manufacturing praoticos and consumer conception of standards of identity vary. This variation will involve a spread of from 5 percent to 10 percent or more. We are now formulating and publishing administrative standards; as a matter of fact, that was done long before the passage of the present law. They have no legal status under the Federal laws.

The appropriation bill of 1902, up to and including 1906, carried items covering the expenses of the operations of a standards committee.

The issuance of administrative standards by a committee was renewed by us after a lapse of several years, for the very definite purpose of influencing manufacturing practices. Wo understand that such advisory expressions can do much to establish a uniform standard in the preparation of food products. Further we prepare these standards to meet the needs of some 20 States that have passed laws making these advisory standards of the Department of Agriculture legal in those States.

The CHAIRMAN. In this section 11, did my bill have practically this same requirement?

Mr. CAMPBELL. I think your bill indicated in more particularity what the committee should be and how it should function.

The CHAIRMAN. That is to say, my bill was a little more specific as to how these standards should be fixed?

Mr. CAMPBELL. Yes.

The CHAIRMAN. As a matter of fact, under this provision, as it is included here, how would the department fix the standards?

Mr. CAMPBELL. The Department would proceed in substantially the same way that it does now in the determination of these administrative standards.

There is a committee that is composed of departmental and State officials, and representatives from scientific associations.

There is an appearance before this committee, at periodic hearings, at which time we take up certain food products, the nature of which has been announced specifically, in advance, to permit manufacturers and others to discuss them.

Unfortunately, there has been no general participation on the part of the public, in spite of the fact that we have made these hearings known to the public, and have invited the public to attend.

At that time, there is an attempt by the committee to canvass the expectation of the buyer of the product and the difficulties involved in the preparation of it so as to meet that conception.

The standard

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authorized by this bill would not be set up on an arbitrary basis by someone in the Department, but on facts developed through the employment of groups of competent people, in the same way that the present standards have been arrived at. The standards committee would operate in the same way that the present administrative standards committee functions. As a matter of fact if this bill becomes law, it is my conception that the existing food standards established for administrative purposes would be adopted substantially as they are now.

The CHAIRMAN. I assume there would be first a notice of a public meeting, and there would be submitted to this group of experts, to this scientific body, provided for in some way, and after 30 days or some other time, a promulgation by the secretary of the standard so set up; that would become the arrangement. Would that be subject to appeal to the courts?

Mr. CAMPBELL. Yes. Any action we would take would be subject to court review.

Senator MCNARY. Does this general statute provide for any right of appeal from the Food and Drugs Act?

Mr. CAMPBELL. No; possibly the Code provides that.

Senator MCNARY. The right of appeal is not a common law right but must be specifically set forth.

Mr. CAMPBELL. There could be no objection to that being put in. It would, however, be necessary to establish a special court for the purpose since the establishment of a standard is a quasi-legislative and not a quasi-judicial act.

The CHAIRMAN. If the committee decidos that there should be a right of appeal provided, the Department would not object?

Mr. CAMPBELL. Not at all. The Department is anxious to have provided some legislation which would permit administrative functioning for the protection of the public. This is now impossible because of the lack of legal standards, definite tolerances, and other features covered in this bill.

Turning back to page 8, may I say that this is an extremely important provision, not only from the standpoint of the establishment of identity standards as prescribed in D, but also the standards of quality provided for in (6). There has been more public interest in that paragraph and in its companion section in the misbranding portion of the act than in any other provision of this bill. The housewife is giving more consideration to questions of dietetics and home economics than ever before. Under the present law it is impossible to require labeling of an affirmative character regarding the composition or quality of food products. There is more and more a demand for that type of information. I was agreeable surprised when my attention was called a fow days ago to the fact that this same provision was recommended also by Dr. Wiley in the measures that were considered prior to 1906.

Senator MCNARY. Was not that same recommendation made later on?

Mr. CAMPBELL. Yes. For standards and definitions, yes. This bill provides for definitions of identity, and standards of quality or grades. This section divides itself into grades and into standards of identity.

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So far as E is concerned, this is actualy being put into effect now, Mr. Chairman, by the Department of Agriculture, under an item in the appropriation bill, with reference to perishable farm products. What we are asking is legislation to extend the standard making authority to take care of the consumer interest in fabricated products as well as perishable farm products which are now being taken care of, as I said, through the grading operations of such products. We desire to extend this, from the standpoint of consumer interest, to fabricated products to which the items in the appropriation bill do not apply.

The CHAIRMAN. Is subsection F practically the same as the present law?

Mr. CAMPBELL. No; it is now, entirely.

The CHAIRMAN. Have you renched it now?

Mr. CAMPBELL. Yes. That is the section that requires a declaration of ingredients in food products in the order of their predominance by weight. It is to give to the consumer information that he cannot get at the present time. Let me tell you that more than a year ago, in order to counteract some of the vicious advertising prac tices that prevailed, the Department, at the invitation of the broadcasting companies went on the air with a series of broadcasts on the subject of "Read the Label." The reaction was instantaneous and extensive. But, in reading the labels, under the requirements of the present law, it was impossible for consumers to acquire much, if any, information. The only thing sought here is to require the manufac turer to give consumers the information necessary to make in intelligent purchase. This idea is not something new. Most of the States require such information to be placed on packages of feed for livestock. It seems to me with that interest which is being manifosted in nutritional questions, the housewife is entitled to comparable information when it comes to the selection of food for her family. The CHAIRMAN. Would it be required in a case of self-rising flour that there should be a declaration on the label of the flour as to the soda and the other contents of the flour, whatever those articles might be? Is that correct?

Mr. CAMPBELL. Yes; if it is an article or a product for which no definition or standard has been declared. What this paragraph doos is to subject food products to the same supervision that drug products havo.

The CHAIRMAN. That is to say, to use my same example, if you had established a standard of self-rising flour, there would be no occasion to put it on the label?

Mr. CAMPBELL. Yes. We have a number of exhibits here. I regret to take up so much time because I know how anxious you are to expedite this hearing, but I think I have here something that should be brought to your attention, Mr. Chairman. Those aro samples of a mixture of chicken and noodles. Notice the variation in the amount of the moat, the exponsive part of it. You see it ranges from 9 percent to 15% percent.

The CHAIRMAN. That is the percentage of meat? Mr. CAMPBELL. Yes. You c what this means to the consumer from the economic standpoint and also to the manufacturer who wants to maintain a definite standard. This shows exactly what competitive pressure will cause manufacturers to do.

There

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There

is no way by which we can require a definite standard now. is no way by which the buyer can purchase understandingly or intelligently in the absence of informative labels. In the event that standards were promulgated for articles of this sort, they would be required to comply with such standards. Otherwise they would fall squarely within the provisions of paragraph (f). Notice the continuing portion of paragraph (f) which says that the Secretary is authorized to prescribe by regulations, requirements for such further information on the label thereof as he may deem necessary to protect the public from deception. The Secretary would be authorized to require manufacturers to disclose the percentage of meat or to give to the buyer that information in some other form.

That particular authorization to the Secretary is extremely important in more than just matters of economy. For instance, we know that tomato juice has been popularized because of its vitamin content. It so happens that it contains one of the very important vitamins, but one that is easily destroyed. Suppose a manufacturer were to prepare a product in which tomato juice is an ingredient, and in my selective purchasing I buy it because of that fact. If it had been found that the vitamin content of that tomato juice had been destroyed by processing operations it would be extremely important for my protection that some further information be given than that tomato juice is one of the ingredients.

The CHAIRMAN. Is there anything unusual in the language contained here that the Secretary is authorized to prescribe by regulation? Is this quite a common thing in the practice of the Department? Mr. CAMPBELL. Under certain statutes it is not only a common practice in this Department but in other departments.

The CHAIRMAN. Proceed.

Mr. CAMPBELL. We now come to the misbranding of drugs. Paragraph 8 (a) (1) states that a drug is misbranded if its labeling bears the name of any disease for which the drug is not a specific cure but is a palliative, and fails to bear in juxtaposition with such name and in letters of the same size and prominence a statement that the drug is not a cure for such disease; or if its labeling bears any representation, directly or by ambiguity or inference, concerning the effect of such drug which is contrary to the general agreement of medical opinion.

I have read items (1) and (2). The particular significance here is in the word "cure." "" The form of statement is not prescribed. It may be expressed properly in any language which conveys the idea. Senator McNARY. That is not in the present law?

Mr. CAMPBELL. That is entirely new.

The CHAIRMAN. The whole section is new?

Mr. CAMPBELL. Not the entire section, but this paragraph of it. This is new. That entire paragraph (a) is new.

Senator McNARY. Who would decide whether the particular drug is a specific or cure or palliative?

Mr. CAMPBELL. The court.

Senator McNARY. This goes to court?

Mr. CAMPBELL. Yes; everything we do will go to court.

Senator MCNARY. This is very satisfying. Is it a very difficult matter for the medical experts to determine whether a drug is a cure

or not?

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Mr. CAMPBELL. No.

The CHAIRMAN. It is the requirement for an agreement of medical opinion. Do you regard that as possible?

Mr. CAMPBELL. Generally, yes. I am dealing with the first paragraph, I have not reached that portion of it to which you refer, Mr. Chairman. There are only a few specifics, but the public does not know that. The medical fraternity knows it and most manufacturers of medicines know it. The public, by the character of labels which prevailed prior to 1906, and the nature of advertising that has been extensively used since that time, has been led to believe that almost any concoction which manufacturers produce may be utilized to cure some disease. Where diseases are mentioned on labels the public thinks of the medicine usually in terms of a cure. Contrary to what has been asserted, in this paragraph we are not advancing the cause of the medical practitioners.

Senator MCNARY. I am not quarreling with you on that. This may have an angelical form and be a very angelical statement, but if you go into the drug store and buy a bottle of medicine that represents itself to be effective for a certain disease, who is to determine as to whether it would be a cure or a palliative? There is the difficulty I would experience in getting this medicine, in going into a drug store and purchasing a bottle of medicine.

Mr. CAMPBELL. I do not think that would be a difficulty.

Senator MCNARY. I might find it as a curo, and a member of my family might find it as a palliative, and someone else it would not do any good at all. I confess I am perplexed about that. Who would

decide whether it was a curo?

Mr. CAMPBELL. If the manufacturers stated on the label that it was a cure for malaria and it did contain the amount of quinino and directions for the proper use of that specific, there could be no quarrel with it. On the other hand, if the package contained only those ingredients which would merely give relief from pain, and contained nothing really curative; if it contained substances used by the physicians for this purpose, or products employed in the home as pain relievers, and the label gave information as to its very definite painrelieving value, there would be no objection. If it is not a cure of any disease but does contain the drugs which are recognized as being palliatives, it should be labeled as a palliative. The specifics are few and well known.

Senator MCNARY. Who is going to make for me decision as to the effectiveness of various drugs that I might tako?

The CHAIRMAN. I think you have got to take that section along with the second subsection. It seems to me that you have to consider this under subsection (a) to answer what the Senator says.

Mr. CAMPBELL. This paragraph does not require, in this language, that the product be labeled a "palliative"; it does not require that it be labeled "Not a cure." The paragraph says in effect this: In those diseases such as influenza--and I think that medical science will admit that there is no specific cure for it; I think the chairman will bear me out that--the most the medical fraternity can do in influenza is to give you medicines which will relieve the distress until the disease has run its course. They give you palliatives, anodynes to case tho pain or discomfort while the disease runs its course. Senator MCNARY. What was that?