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FOOD, DRUGS, AND COSMETICS

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I do not think it will be denied by cosmetic manufacturers that there is a need for regulation of this industry. Some very definitely tragic occurrences have been recorded.

Here is a product that is off the market now. It is a depilatory and contains thallium acetate. It has been responsible for injuries of an irreparable sort. Notwithstanding that fact, it was advertised as safe for use.

Here is another article by the name of "Lash-Lure." It is to be used in the treatment of eyelashes. This is a photograph of an individual before using it. This is a photograph of the same individual a few days--only a few days--after using it, showing the effect of this cosmetic.

Here is a placard advertising the product that I have just pointed out to you, which we obtained from a local store in Washington. It is actually on the market at the present time.

I have nothing more to say about section 5.

The CHAIRMAN. Let me ask one question.

Line 14 says, "if it is or may be injurious to the user."

How would you determine that; by a scientific and clinical test? Mr. CAMPBELL. It would be determined in the same way, Sonator, that the identical question is now determined with respect to poisons in foods.

The toxicity of the product would be appraised by taking into account the work done by anyone in the field, not necessarily in our organization, but a general survey of the entire situation.

In other words, it would contemplate the utilization of all availablo scientific information which we could secure upon the subject.

The CHAIRMAN. Would there be any objection to changing that to read, "If it is or has been found by scientific or clinical tests to be injurious to users"?

Mr. CAMPBELL. I am not sure that I am aware of your point.

I do not know in what respect your definition differs from the one here.

The CHAIRMAN. To be certain that it is not an arbitrary decision on the part of the department. I do not press the matter at all. Mr. CAMPBELL. Do you wish to discuss that now?

The CHAIRMAN. No. Go ahead.

Mr. CAMPBELL. The following section defines misbranding.

The first portion relates to general misbranding.

Paragraph A reads, "if its labeling is in any particular false, or by ambiquity or inference creates a misleading impression regarding any food, drug, or cosmetic."

Senator McNARY. Is that new?

Mr. CAMPBELL. Yes.

That is new language. It is the requirement in the act now, but now language to inlude cosmeties.

Seuntor MCNARY. Then it really would be new language.

Mr. CAMPBELL. To that extent; yes, it would be new language.

In view of the fact that there has been so much comment about that paragraph, the alleged harshness of its terms, I wish to make further reference to it.

Section 8, on page 17, of the Food and Drugs Act reads-
The CHAIRMAN. What section do you have reference to?

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FOOD, DRUGS, AND COSMETICS

Mr. CAMPBELL. Section 8, on page 17, if you have the same copy that I have.

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 confianed therein which shall be false or misleading in any particular, and to any food or drug product which is falsely branded as to the State, Territory, or country in which it is manufactured of produced.

The language that we have employed in paragraph A of section 6 of the present bill requires nothing more than the existing language does.

In the Supreme Court's interpretation of the existing language occurs this statement:

The statute is plain and direct. Its comprehensive terms condemn every statement, design, and device which may mislead or deceive. Deception may result from the use of statements not technically false or which may be literally true. The aim of the statute is to prevent that resulting from indirection and ambiguity as well as from statements which are false.

We have frequently encountered what we considered to be unquestionably misleading statements appearing on labels. This even though the individual sentences comprising that statement might be true and could not be refuted. The inference was undoubtedly of a character to deceive and mislead the purchaser.

Our thought was that misunderstanding on the part of manufacturers would be overcome by giving them adequate notice of their obligation and of their responsibility by saying quite definitely. "If this labeling is in any particular false, or by ambiguity or inference creates a misleading impression regarding any food, drug, or cosmetic." The CHAIRMAN. Would the thought you have in mind be made if it were to read, "If this labeling is in any particular false or if unsupported and unscientific claims are advanced"?

Mr. CAMPBELL. I am sorry I do not understand your point.

The CHAIRMAN. Or if unsupported or unscientific claims are advanced.

Mr. CAMPBELL. Yes; if we were making a prohibition against a certain type of misleading statements. But that would not be sufficiently inclusive, do you think, Senator, to cover the category of misleading statements which are made.

The Chairman. The objection I have to this subsection is its very ambiguity.

Mr. CAMPBELL. That it is ambiguous?

"If this labeling is in any particular false? That is clear to mo, and I am afraid I do not understand your point. The CHAIRMAN. That is what I had reference to. Mr. CAMPBELL. Why not write it in the form we If it creates a misleading impression, it is immaterial whether it is by way of ambiguity or inference. The object of this language is to prevent that.

propose?

The Supreme Court has taken into consideration that this is a statute for the consumer, and that the labels on the product must be free from any false, ambiguous, and misleading statement, even where that misleading statement is created by truthful declarations. Let me point out this to you; let me call your attention to this sheet here.

FOOD, DRUGS, AND COSMETICS

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There is a full page advertising statement-a full page advertisement stating the fact that colds are injurious; in other words, stating that you should avoid colds if you would guard against tuberculosis. The word "tuberculosis" is in big letters at the top.

If you will read all of that statement, I doubt whether you will find any single sentence to which you can take exception, but unquestionably the general inference on the part of the individual who reads it, and I submit to you that that would be a normal and justified conclusion, is that the article advertised is of some value in the treatmont of tuberculosis.

The CHAIRMAN. Let me ask if there is any particular change between the present language and the language you have here, in any great particularity?

In other words, if it is at the present time a violation, if this label has anything of if that creates a misleading impression.

Mr. CAMPBELL. That is the requirement of the present law.

The CHAIRMAN. Do you have a court decision sustaining you on that?

Mr. CAMPBELL. Yes.

I will read it.

"Which shall be false or misleading in any particular."

That is the language of the present act.

There can be no objection to the use of that language in this bill if you prefer it.

I have told you what the Supreme Court said in the interpretation of that language. It condemned labels creating misleading impressions, even those impressions that might result from inferences or ambiguity.

Our purpose in stating that fact specifically in the language was to make the manufacturer of foods, drugs, and cosmetic products aware of his own responsibility.

Our thought was that, with the knowledge of the requirements of this act, he would violate the law less frequently than otherwise. The CHAIRMAN. I presume the Department is not proud of the authorship here, particularly?

Mr. CAMPBELL. Oh, no.

The CHAIRMAN. Then let the record show the reference to the Supreme Court decision.

Mr. CAMPBELL. I read from United States Reports, volume 265, at page 438.

Paragraph B. "If in package form it fails to bear a label containing: (1) the name and place of business of the manufacturer, packer, seller, or distributor."

That is new. That paragraph was put in at the request of State officials. When they have occasion to investigate products sold by peddlers in their jurisdiction, this information is valuable.

(2) An accurate statement of the contents in such terms of weight, measure, or numerical count as may be prescribed by regulations of the secretary.

The CHAIRMAN. That is new?

Mr. CAMPBELL. That is, at the present time, the law as it applies to food. One (1) is new; (2) is the law, substantially as it is now.

The CHAIRMAN. How does it differ from the present law? You say it is substantially the same?

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Mr. CAMPBELL. This is the Gould amendment of the act. There is a proviso-from line 10 and including line 19-which is new language. The CHAIRMAN. From line 10 to line 19 is new language? Mr. CAMPBELL. Yes.

That gives the Secretary of Agriculture power to make exemptions where canned food products are put up at one of several factories, and brought to some central point where they are labeled before being placed upon the market.

As a matter of fact, that has been done. That is what has been done administratively, by the secretaries in the past, and this is asked, simply, as legislative confirmation of such action.

The CHAIRMAN. Has that anything to do with apples?

Mr. CAMPBELL. No.

The CHAIRMAN. I was not purely facetious in what I have said. It has been the fear of some apple growers that this food and drug bill would take over the regulation of the contents of baskets or packages of fruit.

Mr. CAMPBELL. I think that question will present itself in a following section.

I do not think there is any objection by any of the industries to this portion that we are discussing now. This is the entire paragraph B. Shall we pass on?

The CHAIRMAN. Yes.

Mr. CAMPBELL. Paragraph C.

The purpose of that is obvious. That is new. Under the net-weight requirements at the present time, it is provided that the quantity of contents must be plainly and con-picuously marked on declared.

That has been omitted from the above portion and the general requirement included in paragraph C, for prominent and legible statements of all label declarations required by the bill.

The next is "misbranding of food." A food shall be deemed to be misbranded if its container is so made, formed, or filled as to mislead the purchaser, or its contents fall below the standard of fill prescribed by regulations as hereinafter provided.

This item is nothing more or less, in different language, than the old slack-pack measure that passed the House on 3 or 4 different occasions but never has become law.

Here are a number of samples that illustrate the necessity for that particular paragraph.

The CHAIRMAN. I did not get much encouragement from the Senate when I had that bill in.

Mr. CAMPBELL. I hope you will when it appears in this bill. Cortainly it is needed. This package of spice, black pepper, is a little more than one half full. The content of it can be seen as indicated by the line on the package.

The consumer would assume that it is entirely full and has a right to that assumption.

This package of cheese has a false bo tom. The way to detect the extent of deception created by this extract bottle is to turn it up and look through the bottom.

Shall I pass on to the next section?

The CHAIRMAN. Yes.

Mr. CAMPBELL. Here is an interesting form of deception, Mr. Chairman, that should be seen in connection with this provision.

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These are specimens of plain noodles, both without eggs. But one is packed in yellow cellophane to create the impression that it is an egg noodle.

Before I leave the paragraph, let me present an advertisement, Mr. Chairman, which is illustrative of the extent to which manufacturers are selling containers on the ground that they will create a false impression among consumers.

Paragraph B

The CHAIRMAN. I read here, "You need not be a magician to make your eggs be the same size. Only an expert buyer, after careful study, could detect any difference in size.

This is advertising to a firm selling eggs?

"

Mr. CAMPBELL. The firm is putting out a box to make one egg look like the others in size. It will make them all look the same size. Paragraph B and paragraph C are practically those that are now

in the act.

The CHAIRMAN. B und C?

Mr. CAMPBELL. Yes. B and C.

The CHAIRMAN, Proceed.

Mr. CAMPBELL. We come now, Mr. Chairman, to paragraphs D and E.

The CHAIRMAN. They are new?

Mr. CAMPBELL. Yes. They are now.

Section 7, paragraph D-

The CHAIRMAN. That is on page 8?

Mr. CAMPBELL. Yes.

Paragraphs D und E, line 14:

If it purports to be or is represented as a food for which a definition of identity has been prescribed by regulations as hereinafter provided.

Turning to section 11, because I think that would be the orderly way to consider this--that is on page 15--you will see that the Secretary is authorized to formulate and promulgate definitions of identity and standards of quality and fill of container for any food. This is, to my mind, one of the most important provisions of the act. The CHAIRMAN. That is here?

Mr. CAMPBELL. Yes.

Certainly, from an economic standpoint, it is the most important. There are no legal standards now, by which there could be a regulation of food products. There are legal standards for drug products; the Pharmacopoeia, and the National Formulary are the legal standards for the regulation of the traffic in drugs.

This particular provision is one that has been recommended by the Departinent of Agriculture for the last 20 years, to my personal knowledge.

It is a provision that was recommended by Dr. Wiley in the original bill. It has been considered by Congress from time to time.

You introduced, yourself, Mr. Chairman, in the last Congress a bill to make provision for the administrative determination of legal food standards.

The procedure which we must follow now, is that of showing that trade custom, or household understanding has fixed the composition of food products and determined what they must be.

Paragraphs 1, 2, and 3, of section 7 of the existing law connote standards.

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