Mr. CAMPBELL. Perhaps by careful investigation you could find an individual who would be unable to understand a statement written in the plainest and most specific terms. I cannot conceive that any misleading impression which would be reached by a person so incapable of interpreting the English language would constitute a basis upon which court action could be inaugurated. This section, like the present misbranding section of the food and drugs act, would be enforced by undertaking to determine what would be the inference or conclusion to be reached by a reasonably intelligent person or people from that language. I think that was the attitude the Supreme Court had in mind in rendering the opinion to which I referred. Administrative officers must first reach a conclusion on the question. We would consider totally unreliable the testimony of an individual who definitely misinterpreted a specific and accurate statement.

Senator MCNARY. Would your department attempt to decide whether the ad appeared to be misunderstood?

Mr. CAMPBELL. It would be required to do so in the first instance. Quite naturally it must reach a conclusion that the ad is false and misleading before it could take the steps indicated in this bill to refer the matter to the courts on a charge that it is false and misleading.

Senator MCNARY. Does the Department decide whether there is any misleading language or not?

Mr. CAMPBELL. The Department decides it, but the Department must assume in every case to sustain by adequate evidence that its findings in that respect are correct.

Senator MCNARY. By evidence tending to prove that that had been misleading and false?

Mr. CAMPBELL. Yes, a number of witnesses. It would not be possible to try it on one isolated instance.

Senator MCNARY. The point is if it is inferred. This is a thing that is not easy to understand. Why do you say "by ambiguity or inference create a misleading impression"? What is the reason you go beyond untruth? You must first establish the untruth of the article.

Mr. CAMPBELL. Yes.

Senator MCNARY. Why do you use the words "ambiguity" or "inference creating a misleading impression"?

Mr. CAMPBELL. That is indeed a pertinent question, Senator, and I hope to explain it by referring to the advertisement I showed you a moment ago, with the word "tuberculosis" across the top of the page. I said when presenting it that I did not think there was perhaps a single sentence in it that could be considered positively untrue -speaking of the individual sentences.

However, I think that the inference to be drawn from the entire advertisement is so obvious that few would hesitate to consider it false. That is the sort of misleading advertisement covered by this language.

The CHAIRMAN. I think you can use language which would be better if you had it read "or is capable of creating a misleading impression.'

Mr. CAMPBELL. If I may explain briefly, Senator, our purpose in using that language was to employ the most explicit terms possible in writing the definition. That is made possible by using the language of the Supreme Court in interpreting the existing terms of the

act defining misbranding. As I pointed out to you, in the present law it says that the product is misbranded

The CHAIRMAN. You are referring to page 18?
Mr. CAMPBELL. Page 17, section 8:

That the term "misbranded" as used herein shall apply to all drugs or articles of food or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein, which shall be false or misleading in any particular.

Now, in interpreting the last four words the Supreme Court has said in the decision to which I referred that deception may result from inference and ambiguity. It is possible to state the truth and still create a false impression by an advertisement of the kind to which I have referred, such an advertisement may be read by taking every sentence in and of itself, independently, severally, and divorced from the rest of the article, and found to be entirely true; but there can be no question in anyone's mind about the final conclusion which will be reached. As I have said, in using this language, we have merely paraphrased the requirements which now exist in the present definition of misbranding.

You may ask, most properly, why we did not use the language in the present law; as a matter of fact, we would be satisfied to have misbranding and false advertising in the bill defined in that language.

Our thought was that if the bill carries in specific words the interpretation of that language, as expressed by the Supreme Court, it will apprise manufacturers more completely of their responsibility.

The CHAIRMAN. You are seeking merely to relieve any misunderstanding of the law, as those provisions of the law have already been interpreted?

Mr. CAMPBELL. Yes.

This particularly refers to ambiguity and to inference and is, as we interpret it, through the medium of the Supreme Court decision, nothing more than is required right now of statements on labels.

The CHAIRMAN. Would there be any objection to inserting the word "material" on line 22?

Mr. CAMPBELL. What page?

The CHAIRMAN. Page 12, line 22:

"Shall be deemed to be false if in any material particular it is". Mr. CAMPBELL. If you add any other words like "material" then you have introduced

The CHAIRMAN. Another lawsuit?

Mr. CAMPBELL. Another lawsuit.

With greater vagueness of meaning, it will cause more difficulty. If you make it less exacting than the labeling provision of the present law, the value of the prohibition would be greatly diminished. I do not think we would be getting the result we are after here.

If the requirements of the present law can be met insofar as statements on labels are concerned, why can we not apply it with the same force and effect to advertisements?

The CHAIRMAN. Let me ask you a further question: If section 8, line 17, of the existing law, if that were interpreted in the light of the decision which you quoted, you would be entirely satisfied?

Mr. CAMPBELL. Yes; that is quite right. That is all we are asking for.

As a matter of fact, we could have perhaps allayed some of the apprehension that has been developed in the public consideration of this bill if the language now existing in the present act had been employed in the bill, and there had been no effort on our part to do what seemed of advantage to the manufacturers by giving them a clear view of their obligations under the law.

The CHAIRMAN. If you had left the old language in, you would have saved me a lot of headaches.

Mr. CAMPBELL. If I were inclined to take headaches from this criticism, I would have been suffering most of the time.

The CHAIRMAN. You have no objection to Dr. Emerson's suggestion that "contemporary" be put before "medical opinion"? Mr. CAMPBELL. Not at all. I think that is an improvement. The CHAIRMAN. Go ahead.

Mr. CAMPBELL. In (c), the first few lines introduce the purpose of this paragraph more effectively than anything that I might say to explain it. It says that to discourage the public advertisement for sale in interstate commerce of drugs for diseases wherein self-medication may be especially dangerous, or patently contrary to the interests of public health, any advertisement of a drug representing it indirectly, or by ambiguity, or inference, to have any effect in the treatment of any of the following diseases shall be deemed to be false. Then follows a list of such diseases.

The CHAIRMAN. Suppose on line 13 you inserted the word "curative." Would you be willing to say that there is no medicine that would affect something in the way of adding comfort or palliation to diseases listed there?

Mr. CAMPBELL. This applies to advertising only.

There are certain diseases where it may be contrary to the interests of society to have a self-diagnosis and self-treatment undertaken.

To discourage the tendency on the part of victims of those diseases, to further impair their health, reaching the point where, perhaps, even through the administration of the conventional treatment, recovery would be made impossible, our thought was to proscribe absolutely any rerefence in advertisements to such diseases, whether the statement made describes it as a cure, a palliative, or anything else.

The CHAIRMAN. On line 17, that is manifestly an error; a typographical error.

Mr. CAMPBELL. Yes.

The CHAIRMAN. That was written perhaps by an Englishman; was it not?

Mr. CAMPBELL. Perhaps so.

Let me draw your attention now particularly to the statement beginning on line 22:

Except that no advertisements shall be deemed to be false under this paragraph if it is disseminated to members of the medical and pharmacological profession only, or appears in scientific periodicals.

There is no disposition to write anything into the bill to interfere with progress. If, in the course of time there should be developed therapeutic agencies, or adjuncts which are effective in the treatment of these various diseases, of course, it would be in the interests of society to have them placed on the market.

The advertisement statement which may mention these diseases and may be made in scientific publications to be read, not by laymen but by those who have definite knowledge of the causes of diseases and the limitations of medical treatment, must in every instance be as definitely true as the advertisements that appear in lay publications.

The proviso on page 14 is one which authorizes the subtraction from this list, and the following proviso is one that authorizes additions to the list.

Exemption in scientific periodicals does not, as has been asserted, lift the ban on truthfulness.

That concludes this section.

We have already discussed section 10, I think.

We have also discussed section 11.

The CHAIRMAN. Mr. Campbell, I would like to have you return to the second proviso on page 14.

Mr. CAMPBELL. Line 14.

The CHAIRMAN. "That this paragraph shall not be construed as indicating that self-medication for diseases other than those named herein or designated by regulations of the Secretary under the authority hereof is safe or efficacious."

Is that a little bit gratuitous?

Mr. CAMPBELL. Yes. That is wholly gratuitous. The only purpose was to prevent the conclusion being reached inadvertently that the foregoing portions of this section did subscribe to the principle that self-medication for diseases other than those listed herein was advantageous.

The CHAIRMAN. That is the usual province of the physicians?
But, it seems to me, just a bit strange to put it into the law.
However, it is not worth arguing over now.

Mr. CAMPBELL. Section 12 is the one that authorizes the Secretary to require manufacturers of certain classes of foods and drugs, or cosmetics, to obtain licenses. It has been asserted that this would be a requirement generally imposed.

There is no such purpose involved in suggesting that section, and the very terms of this section would prevent such use being made of it. It speaks clearly, and says that only in those instances where products are injurious to health, and furthermore where such injurious nature cannot be adequately determined after they have entered interstate commerce, is the Secretary authorized after notice and hearing, to make such regulations governing the condition of manufacture, processing, or packing, as he deems necessary to protect the public health.

Our prime motive was to protect the public against occurrences like the botulinus out breaks some years ago from the consumption of ripe olives. There were many fatalities.

Botulinus infection comes from the soil, and it is necessary to insure proper handling of food products in order to avoid it.

Perhaps the olive industry at that time could not have been blamed altogether for what occurred.

And, I wish to state that the condition has been quite definitely corrected.

The packing of olives is now so directed and supervised to eliminate very largely the conditions which would cause a recurrence of botulinus infection.

That was done by California agencies working out a very definite method of processing, which renders the product safe.

The organism is one which they realized that they had to contend with at all times. The germ which causes botulism comes from the soil, and it is very extensively distributed. It is the toxin produced by this organism which causes illness and death.

The packing operations, for these and for other food productsI refer now to olives are at present carried on under all conceivable precautions and conform to methods which it has finally been determined, will make the food product safe for consumption.

The precautionary steps taken in the interest of the consumer have proved effective.

It is our expectation that this section will be employed with infrequency and only when as experience has shown the protection of the public health cannot be otherwise assured.

It is not contemplated that the license system shall be imposed upon the general line of manufacturers of foods, drugs, and cosmetics. It will be employed only where dangerous outbreaks occur, or dangerous products are produced, and where there can be no correction otherwise.

The CHAIRMAN. It has been suggested to me that there will be a very general imposition of this system, because it might be such as to demand or sufficient to cover an inspector hired constantly in the factory; was there any such thing in the thought of the Department? Mr. CAMPBELL. Not at all.

Senator COPELAND. You are simply aiming here to take care of special problems, like that of the olive?

Mr. CAMPBELL. That is right. These permits are temporary; they will be issued only temporarily. Where a condition is found that involves a menace to health, and it can be corrected, it is the purpose to prevent shipping of the product from that plant until corrections have been made. The following paragraph (b), merely refers to the revocation and the renewal of these permits, dependent upon developments, as they manifest themselves from time to time. Paragraph (c) merely authorizes access to the premises at appropriate times by the inspector. This quite naturally is necessary in dealing with the serious condition which is to be expected where this authority is invoked, and is requisite for satisfactory handling. Are there any more questions on that, Mr. Chairman?

Senator COPELAND. I am glad that you have made the statement with respect to your idea of a permit, namely, that the permit is to be used only in the case of emergency involving the public health. Mr. CAMPBELL. That is right.

Senator COPELAND. And it has nothing to do at any time with those products which could in no sense undermine health.

Mr. CAMPBELL. Not at all. I think the terms of the section itself are very definite, and that they impose their own limitations. Senator COPELAND. All right. Go ahead.

Mr. CAMPBELL. Next is section 13.

Senator MCNARY. Is that wholly new?

Mr. CAMPBELL. Section 13 is entirely new. This authorizes an inspection of manufacturing plants, warehouses, or establishments in which foods, drugs, and cosmetics are manufactured and which are held for shipment in interstate commerce. This is merely an