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Now to say on his labels that this article is a palliative for sweating, or to try to explain the mechanism by which that palliation is produced is almost impossible.

May I say in this section, and in section 9, that this attempt to put a burden upon a manufacturer which is not put upon the doctor and has never been put upon the chemist.

If I may digress a moment, Mr. Charles Goodyear invented the vulcanization of rubber about 100 years ago. The vulcanization of rubber was effected, as you know, by the adding of sulphur in the rubber. Patents were freely granted on that meritorious invention. As far as I know to this date there has been no satisfactory explanation of the theoretical mechanism by which rubber may be vulcanized by the addition of sulphur, and that is a comparatively simple process. If you go to the Patent Office with a new process you do not have to explain why it works, you have to tell them what you would do, and if it works, and they will give you a patent on it.

In many cases the theory, as Mr. Thompson has well explained by which these cures are effected are unknown. I think this section, worthy as it is, has no place in the bill.

Dr. Beal in his statement, yesterday, called attention to a matter which I wish to also emphasize and that is this: The term “ drug on page 2 was defined for the purposes of this act to include all substances and preparations recognized in the United States Pharmacopoeia and so forth.

Now, there are some cosmetics which appear in the United States Pharmacopoeia. I do not think it is the intention of the framers of this bill to have two kinds of definitions for the same article. So we wish to heartily endorse the amendments suggested by Dr. Beal, that this be limited to all medicinal substances so it will not include cosmetics.

On page 34 there is a suggestion of an appointment of a public committee, of a committee on public health to assist the Secretary of Agriculture in the framing of regulations and in the operation of this act. Dr. Beal suggested the inclusion of two persons from the drug trade. Two persons from the food trade is mentioned in the subsequent paragraph.

There are many paragraphs in this bill which relate to the misbranding of cosmetics; some of which relate to the labeling of cosmetics and others which relate to the packaging of cosmetics.

I think the members of this committee have been impressed, during these hearings, with the necessity, both in the drafting of this bill and in carrying out its operations, with the necessity of the technical knowledge concerning the particular trade of profession represented.

Now we say that it would be in the public interest to have some cosmetic manufacturer or somebody connected with the cosmetic industry upon this committee of public health. It may be necessary to enlarge the committee, but we think it would be both beneficial to the public and to the industry if someone was on the committee, who knew this particular specialty thoroughly.

Now, I have just one or two points more. On page 31 there is a provision, section 20, line 18, which reads as follows:

It it appears from the examination of such samples or otherwise that other false advertisement of such food, drug, or cosmetic has been disseminated in the because they depend for their action on the power of the drug to dissolve hair”, says the American Medical Association. "As the structure of the hair is practically identical with the structure of the outer skin, anything that is powerful enough to destroy one may injure the other. Used properly and only occasionally on not too sensitive a skin, they are fairly safe, but it is considered psychologically bad and not good business practice for the manufacturers to put warnings on labels or wrappers that chemical acids, berium, or calcium sulphide is in many cases used too often if left on the skin too long."

Now, this is not a dangerous product in the sense that it doesn't cause cancer, it doesn't cause death, it doesn't cause serious injuries. It sometimes causes inconvenience, depending upon the skin of the user. It may be called one of the products referred to by Mr. Thompson where there is a hypersensitivity in certain

cases. These products have been on the market for many years. The manufacturers in this industry would like to continue to sell them. They think they should be permitted to do so, and for that reason we submit that the word "average" should be inserted before the word “ user."

I may say there is another reason why we want that word in. There is a new industry, very popular, throughout the United States, and that is to sue manufacturers of nationally advertised articles. I refer not only to cosmetics but to drugs and to food products. They will sue on the slightest pretext. There isn't a manufacturer in this room that has not every year some suits of that kind. If these particular products are pronounced in any way dangerous, it is an encouragement for multiplying litigation of that kind.

There has been numerous mention by people here made to palliation. Section 8, paragraph a, on page 10, and substantially the same article, section 9, paragraph‘a, of page 15, refer to that. I do not intend' to take up the time of the committee in bringing in the numerous changes on that, but as manufacturers of cosmetics we are also interested in this because some of the products we manufacture have a drug in them.

Now, I think I can very simply explain the origin of this particular paragraph, section a, which provides in substance that if an article is not a cure it is a palliative and must be so stated.

Now the benevolent persons that drew this bill—and I use the word“ benevolent” seriously and earnestly—had in the drafting of that particular article such articles in mind as cough remedies and liniments which are clearly palliatives. I presume that in at least 99 percent of the cases where a cough remedy is used, where it helps, it helps the symptoms but it does not remove the cause of the disease. Now that paragraph would fit cough remedies beautifully but there are hundreds of other cases where it does not fit.

Now the manufacturers represented by this association make deodorants. Deodorants are used principally by ladies to prevent the evidence of excessive sweating. The liquids used for that purpose are mild, they are beneficial. They, as a product, have found a wide acceptance.

Now the last thing in the world a manufacturer of a deodorant would want to do would be to cure the sweating, because he doesn't want to. He does not want to stop the operation of the sweat glands of the skin, he only wants to remove the unpleasant evidences.

Now to say on his labels that this article is a palliative for sweating, or to try to explain the mechanism by which that palliation is produced is almost impossible.

May I say in this section, and in section 9, that this attempt to put a burden upon a manufacturer which is not put upon the doctor and has never been put upon the chemist.

If I may digress a moment, Mr. Charles Goodyear invented the vulcanization of rubber about 100 years ago. The vulcanization of rubber was effected, as you know, by the adding of sulphur in the rubber. Patents were freely granted on that meritorious invention. As far as I know to this date there has been no satisfactory explanation of the theoretical mechanism by which rubber may be vulcanized by the addition of sulphur, and that is a comparatively simple process. If you go to the Patent Office with a new process you do not have to explain why it works, you have to tell them what you would do, and if it works, and they will give you a patent on it.

In many cases the theory, as Mr. Thompson has well explained by which these cures are effected are unknown. I think this section, worthy as it is, has no place in the bill.

Dr. Beal in his statement, yesterday, called attention to a matter which I wish to also emphasize and that is this: The term “ drug on page 2 was defined for the purposes of this act to include all substances and preparations recognized in the United States Pharmacopæia and so forth.

Now, there are some cosmetics which appear in the United States Pharmacopoeia. I do not think it is the intention of the framers of this bill to have two kinds of definitions for the same article. So we wish to heartily endorse the amendments suggested by Dr. Beal, that this be limited to all medicinal substances so it will not include cosmetics.

On page 34 there is a suggestion of an appointment of a public committee, of a committee on public health to assist the Secretary of Agriculture in the framing of regulations and in the operation of this act. Dr. Beal suggested the inclusion of two persons from the drug trade. Two persons from the food trade is mentioned in the subsequent paragraph.

There are many paragraphs in this bill which relate to the misbranding of cosmetics; some of which relate to the labeling of cosmetics and others which relate to the packaging of cosmetics.

I think the members of this committee have been impressed, during these hearings, with the necessity, both in the drafting of this bill and in carrying out its operations, with the necessity of the technical knowledge concerning the particular trade of profession represented.

Now we say that it would be in the public interest to have some cosmetic manufacturer or somebody connected with the cosmetic industry upon this committee of public health. It may be necessary to enlarge the committee, but we think it would be both beneficial to the public and to the industry if someone was on the committee, who knew this particular specialty thoroughly.

Now, I have just one or two points more. On page 31 there is a provision, section 20, line 18, which reads as follows:

It it appears from the examination of such samples or otherwise that other false advertisement of such food, drug, or cosmetic has been disseminated in the

United States by the importer or exporter thereof, or any person in privity with him within 3 months prior to the date said article is offered for import, then the article shall be banned.

It is unnecessary for me to discuss the possible unconstitutionality of that, taking property away without due process of law, but it seems to me that where an article is honestly labeled and honestly manufactured, the mere misconduct of the importer of the article, who does not stand in any relation of agent to the manufacturer abroad, should not permit the article to be seized or otherwise given a black eye. If the false advertisement is by the agent of the manufacturer abroad or by someone in privity with the manufacturer, I can see that that section is altogether fair, otherwise I think it should be amended.

In closing may I say this: If these few amendments are incorporated into the bill the Association of Manufacturers of Toilet Articles is in favor of the bill as relating to cosmetics. The association feels that it is better to have a bill which has been carefully considered and worked over for months by a committee of the Senate than to have legislation sponsored by the several States of the United States. Said legislation is often inconsistent with each other, and we never know what it will be.

The history of the Pure Food and Drug Act of 1906 shows that the several States in nearly all cases followed the lead of the national act. It is very probable that if a satisfactory act is produced here the same result will follow.

Now if the members of the committee inquire why the approval of the association is limited to cosmetic articles, may I

say

that it is quite evident that a bill involving so many details of such complexity cannot be endorsed by an association as a whole until the association as a whole has had a chance to consider the entire bill and has had the benefit of professional counsel relating thereto, and that is the reason we can give only this limited endorsement to the bill.

I thank you.

Mr. Hugo Mock. I wish the privilege of filing these additional memoranda to be inserted in the record.

The CHAIRMAN. Permission is granted.
(The additional memoranda referred to are as follows:)

MEMORANDUM FILED ON BEHALF OF ASSOCIATED MANUFAC

TURERS OF TOILET ARTICLES WITH REFERENCE TO SENATE BILL 2800

The revised Copeland bill, S. 2800, is, in the poinion of the Associated Manufacturers of Toilet Articles and its members, a great improvement over the original Copeland bill, S. 1944, and it is the sense of the Associated Manufacturers of Toilet Articles that no further revision of S. 2800 is necessary, except in one particular which will be hereafter mentioned.

You will recall that the Associated Manufacturers of Toilet Articles were represented at the public hearing in Washington on Senate bill s. 1944 on November 17, 1933 and succeeding days, and at that time a brief was submitted outlining the views of the Associated Manufacturers of Toilet Articles and giving, on page 9 thereof, a summary of the changes requested in Senate Bill S. 1944. For your convenience, a copy of this brief is herewith enclosed.

It appears to us that revisions 2 to 7, inclusive, have been included in the bill as requested in this brief. The only revision not made in the bill is the

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recommendation 1: "that in section 5, paragraph (a), the word ordinary." be inserted before the word 'user'".

Although the wording of section 5, paragraph (a), defining what is an adulterated cosmetic is different from the original wording, we fear that witb reference to the particular objection of the Associated Manufacturers of Toilet Articles, the change in the wording has not obviated this objection.

The original wording was: “A cosmetic shall be deemed to be adulterated : (a) if it is or may be injurious to the user under the conditions of use pre scribed in the labeling thereof, or under such conditions of use as are customary or usual."

The wording in the S. 2800 now reads: "A cosmetic shall be deemed to be adulterated : (a) if it bears or contains any poisonous or deleterious substance which may render it injurious to the user under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual”, and attention is again called to the comment following the reprint of this section on page 5 of the enclosed brief.

If every cosmetic shall be deemed to be adulterated, if it bears any poisonous or deleterious substance which may render it injurious to the user, then there is always the grave possibility if a single or several cases of injury are show to the use of a particular product, although these injuries may consist only of a temporary dermatitis and may be entirely due to hypersensitivity, such injuries may give an opportunity for an otherwise harmless product to be banned.

The word deleterious is capable of many different meanings, and so much depends upon the quantity of concentration of a substance that many articles considered harmless and in common use might be said to contain a deleterious substance.

Every soap which contains any free alkali whatever contains a deleterious substance, but it is obvious that if the alkali is not in such quantity as to be harmful to the average skin, such soap should not be banned although con

ng a deleterious substance such as free alkali. Acids, represented by acetic acid and vinegar, and other acids, such as citric acid, for foods are common and harmless ingredients of food products, but in any other concentrations might be deleterious.

The difficulty of possible unfairness to legitimate manufacturers in the present paragraph (a) of section 5 in banning" “any poisonous or deleterious substance which may render it injurious to the user" is the fact that there is at the present time no recognized or adequate definition, at least qualitative definition, of what a poison is. No less an authority than Dr. John J. Abel, emeritus professor of pharmacology of the Johns Hopkins University, in an article in Science, issue of January 26, 1934, says: “ What is poison? Let me say to begin with that no one has ever been able to give a concise and accurate definition of a poison that would apply to every one of the many thousands of known poisons. All attempts to do this have simply ended in offering definitions that do not define. The medical jurisprudence of this country and of England has never attempted to define the word poison.”

It is clear that no scientific definition of poison can be given unless such a definition is quantitative as well as qualitative.

Naturally, where a poisonous ingredient is cumulative in its action such as arsenic or mercury, it would be entirely fair to ban such an ingredient alto gether in a preparation, but where an ingredient in mild dilution, such as quinine or strychnine is altogether beneficial and not cumulative in its action, no reason is seen why it should be banned except that if necessary a warning should be given as to overdosage.

The Associated Manufacturers of Toilet Articles still believe that it would improve paragraph (a) of section 5 if the word “ordinary” were inserted before the word “ user", or in lieu thereof would recommend a paragraph such as, “if it bears or contains any poisonous or deleterious substance in such quantity as likely to render it injurious to the ordinary user under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual."

We think that such a revision would be fairer than paragraph (a), section 5, in its present form.

If the foregoing changes are made, the Associated Manufacturers of Toilet Articles is ready to give its unqualified endorsement to Copeland bill 2800 as affecting cosmetics. Respectfully submitted.

ASSOCIATED MANUFACTURERS OF TOILET ARTICLES NEW YORK, N.Y.

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