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SUPPLEMENTARY MEMORANDUM FILED ON BEHALF OF ASSO

CIATED MANUFACTURERS OF TOILET ARTICLES WITH REFERENCE TO SENATE BILL 2800

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This supplementary memorandum is filed only with reference to the following paragraph, section 5 (a): “A cosmetic shall be deemed to be adulterated : (a) if it bears or contains any poisonous or deleterious substance in such quantity as may render it injurious to the user prescribed in the labeling thereof, or under such conditions of use as are customary or usual."

The difficulty with this paragraph is that there is no definition of deleterious" or "poisonous ", and it is therefore thought that the word average or " ordinary” should be inserted before the word “user in this paragraph.

Section 10, with reference to “added poisonous or added deleterious substances” and prescribing tolerances for such deleterious or poisonous substances, is of no help in this connection because the ambiguity is altogether with reference to the definition of the word “deleterious " or "poisonous.”

To take a concrete example, a number of manufacturers represented by this association manufacture sulphide depilatories. The book, One Hundred Million Guinea Pigs, makes the following statement about these particular depilatories : “ The chemical depilatories that dissolve excessive hair are not quite so innocent. These, whether in liquid, powder, or paste form, 'may be dangerous, because they depend for their action on the power of the drug to dissolve the 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 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, with the result that the chemical-usually barium or calcium sulphide is in many cases used too often or left on the skin too long, and 'sulphide burns' ensue. • Neet' is one of the widely used depilatories of this type. There is considerable risk in the daily use of a sulphide depilatory such as “snow', which is now being advertised and sold to men as a substitute for shaving."

Depilatories of this class have been used in the United States for more than 50 years. They are not innocuous in all cases. They sometimes harm hypersensitive skins. The public wants them because there is no better way of doing the work for which they are designed. If there was a better way, the manufacturers would be glad to have it. They do not cause serious injuries, and in the ordinary sense, they are not “poisons." Such a provision as section 5 (a) in its present form might well be used to overnight abolish a considerable industry.

The public is entitled of course to warning of the nature of these items, some of which, frankly, are on the borderline of being deleterious. The public is entitled to have full knowledge of what it is using, but so far, the public has much preferred, even at the risk of occasional discomfort, to have these articles than not to have them, and it is thought it is entitled to continue to have same if they are honestly sold.

It must be remembered that manufacturers nowadays are in a double peril on account of the existence of the laws of negligence.

A syndicate has lately been operating in New York whose objectives were the restaurants, and the members of this syndicate systematically went into a number of restaurants to be “poisoned.” One, more daring than the rest, usually carried a dead mouse into the restaurant, which of course he acci. dentally discovered in the food, and a number of restaurants settled on account of the same dead mouse before he was finally put in jail.

It is well known that makers of articles which are entirely harmless are being constantly sued under the negligence laws. We refer to suits of which we have actual knowledge, based upon the sale of ordinary soap, of cold cream, and similar articles.

Hundreds of individuals have the misfortune to have disagreeable symptoms appear on the application of a particular article. This is very often pure coincidence, as medical tests have shown, but nevertheless forms frequently the basis of damage suits.

If all articles which contained ingredients which were likely to be injurious to hypersensitives were banned under section 5, paragraph (a) of this bill, it would cause needless hardships to many manufacturers and needless inconvenience to thousands of their customers.

The public is entitled to full knowledge as to what it is buying, especially where there is any possibility of injury, however the slightest.

On the other hand, the language of the bill should not be so general as to proscribe articles which have found an honorable place in the cosmetic or drug field and which are a source of great convenience to their users.

It took many years for the Department of Agriculture to pass upon the question of the use of saccharine and benzoate of soda in foods, and a tolerance limit was appointed for the use of benzoate of soda.

Cosmetics are used externally and such as have found universal acceptance in the United States should not be banned merely on account of any ingredient which may be deleterious to only abnormal members of the population. Respectfully submitted.

ASSOCIATED MANUFACTURERS OF TOILET ARTICLES. The CHAIRMAN. Is Mrs. Franklin W. Frietche of Baltimore in the room? If not, I will call Mr. Bingham. I understand he wants only one minute.

STATEMENT OF HERBERT M. BINGHAM ON BEHALF OF THE

DRUG INSTITUTE OF AMERICA

Mr. BINGHAM. My name is Herbert M. Bingham, of the law office of Mr. J. Bruce Kremer, who represents the Drug Institute of America. This morning a question was propounded to Mr. Robb as to what the Drug Institute was. For the information of members of the committee the Drug Institute is an association composed of more than 40,000 individual members, approximately 37,000 being retail druggists; the balance being manufacturers and wholesale druggists..

The views of the Drug Institute have heretofore been presented to the committee by Mr. Kremer at the previous hearing, and also by Mr. Robb this morning, and later I understand by Mr. Hoge.

Thank you.

The CHAIRMAN. I understand Mr. John S. Hall wants to catch a train. He asks for 5 minutes. We will hear him.

STATEMENT OF JOHN S. HALL, CHICAGO, ILL.

Mr. Hall. I am general counsel for the flavoring extract manufacturers of the United States, general counsel for the National Association of Bakers and Confectioners supply houses, general counsel for the National Association of Manufacturers of Fruit and Flavoring Syrups. Also secretary and counsel for the National Manufacturers of Soda Water Flavors.

In behalf of the members of the various associations that I represent I wish to advise that careful consideration has been given to all pending legislation regarding revision of the Federal Food and Drug Act of 1906. It is the consensus of opinion of the majority of our members that they are opposed to Senate bill 1944, Senate bill 2000, and Senate bill 2800 in their present form.

Regarding Senate bill 2858 they have expressed themselves as not being opposed to this bill. However, they heartily endorse the intent and purpose of the Stephens bill, Senate 2355 with the amendments to the present Federal Food and Drug Act of 1906 to provide for necessary protection to consumers, inclusion of cosmetics, appliances, and devices, also false advertising.

I wish to call this committee's attention to just one or two specific objections that have not as yet been covered.

Regarding section 7, “Misbranded foods":

A food shall be deemed to be misbranded if its container is so made, formed, or filled as to mislead the purchaser.

I believe that that is a provision that should be further modified so as to provide that the container must evidence an intent to deceive or mislead the purchaser. Therefore I recommend that section (a) (1) be amended to read as follows:

If its container is so made, formed, or filled so as to evidence an intent to deceive or mislead the purchaser.

One of the other important questions revolves around the sale of compounds, mixtures, and fillers that are sold to food manufacturers for further manufacturing purposes, and therefore we recommend that section 7-A, paragraphs E and F be stricken from the bill.

We recommend that a provision be inserted in the bill setting forth that the provisions of this section shall not apply in cases of mixtures or compounds which may now or from time to time hereafter known as articles of food under their own distinctive names, and which mixture or compound is not offered for sale under the distinctive name of another article, if the name be accompanied on the same label or brand with the name and address of the packer or dealer, the net weight of the contents, and in cases of imitation the word " imitation"

appears. I further request that I be granted the privilege of filing a petition regarding other provisions of the bill. May I file these petitions ?

The CHAIRMAN. Permission to do so is granted. (The petitions referred to are as follows:)

Your petitioner, the Flavoring Extract Manufacturers' Association of the United States, respectfully presents to this honorable committee for its consideration the following objections to the passage of s. 1944, S. 2000, and S. 2800 (proposed revision of the Federal Food and Drugs Act of 1906).

The Flavoring Extract Manufacturers' Association of the United States was organized in 1907 and its members consist of manufacturers engaged in the manufacture, production, preparation, packing, distribution, and sale of flavoring extracts, common household remedies, packaged foods, and allied food and drug products.

It is the opinion of our members that the food, drug, and cosmetic industry is threatened with the most revolutionary and gnfiscatory legislation ever imposed upon such an important and essential industry. The proposed revision of the Federal Food and Drugs Act of 1900 now before this honorable committee suggests that the American people abandon the reasonable regulatory policies under which this industry has cooperated with Government for the past 27 years. The efficiency of the present act and its demonstrated soundness has been well proven by the numerous legal interpretations over this period. It is now proposed that this successful policy be discarded and a drastic and revolutionary act be substituted. The proposed act would create new and fundamental revisions of law as well as setting up a bureaucratic dynasty in the hands of the Secretary of Agriculture.

It is well to direct the attention of this honorable committee to the profound wisdom exemplified by Senator Heyburn, author of the present Federal Food and Drugs Act of 1906, which was then known as the Heyburn bill. I quote Senator Heyburn (Cong. Rec., vol. 40, pt. 3, p. 2721): "If there is anything that this bill, and especially that this section of it (sec. 4), does not provide, it is for the fixing of standards by anybody. If there is anything that is not provided for or permitted under this bill, it is that the Chief Chemist, or the Chief of the Bureau of Chemistry, shall have power to denounce anything under any circumstances or to place a ban of disapproval upon anything.

do so.

He is given no such power. He is simply the agent of the courts to gather testimony upon these questions for the purpose of being used at the trial in the court room and nowhere else. This bill fixes no standard upon any. thing; it authorizes no officer to fix any standard. It provides that the courts, and the courts alone, may determine whether or not an article is contraband under the provisions of this act. The object in avoiding any possible construction that might be held to be fixing a standard was that the bill might never come to conflict with the pure-food legislation of the various States. The States have established different standards, and they have a right to

Inasmuch as those standards vary, it would be impossible for an act of Congress, a general law, to avoid some conflict with some of those State laws if you should undertake to fix standards.

I again quote from page 2723 the following statement made by Senator Heyburn:

I wish to have it understood that this bill does not permit the Chief Chemist of the Bureau of Chemistry to fix standards or to punish anybody, or to brand his goods as fraudulent, under any circumstances. It does not permit the Secretary of Agriculture to do so. It does not permit anyone except the court, after a trial by a jury, if the party shall appeal to that right, to brand the goods as being fraudulent or obnoxious to the provisions of this bill.

A vivid contrast will be apparent from a study of the foregoing principles and the tenor of the drastic amendments now contained in the proposed revi. sions, S. 1944, S. 2000, and S. 2800. A condition no less than confiscatory is threatened in the food, drug, and cosmetic industry if the tenets of the above bills are carried into effect. I desire to direct your attention to definite interpretations of the various sections of these bills, and the manner in which they will affect our industry.

SEC. 2. Definitions.-S. 1944, S. 2000, and S. 2800 (J) provides that the term “ advertising” shall include all representation of fact or opinion disseminated in any manner or by any means other than by the labeling.

Objection to language that includes oral representation and not confined to labeling on articles of food, drugs, and cosmetics.

SEC. 3. Adulteration of food.-S. 1944 provides (a) (1): That a food shall be adulterated if it is or may be dangerous to health.

Objection is made to the use of the words “if it is may be dangerous to health.” No reasonable interpretation is provided and the Secretary is sole arbiter of fact.

S. 1933, S. 2000, and S. 2800 provide (6) (4): That a food shall be adulterated if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight in a deceptive manner, or reduce its quality or strength, or create a deceptive appearance.

Objection to the language so broad and loose that may be subject to harmful interpretation, especially regarding compounds and mixtures, also deceptive appearances.

SEC. 4. Adulteration of drugs.-S. 1944 (a): If it is or may be dangerous to health under the conditions of use prescribed in the labeling thereof.

Objection to the terms “if it is ” may be dangerous to health.” No reasonable interpretation provided, and the Secretary is sole arbiter of fact.

S. 2000 and S. 2800 provide that a drug shall be adulterated (a) if it is dangerous to health under conditions of use prescribed in the labeling thereof.

Objection: This entire section should be eliminated as no drugs sold to the consuming public bear a label wherein its common use is dangerous to health. The only purpose of this section is to grant power to the Secretary to direct condition of use of all drugs.

SEC. 6. Misbranded food, drugs, and cosmetics.-General: S. 1944 provides (a) that food, drugs, and cosmetics shall be misbranded if their labeling is in any particular false, or by ambiguity or inference creates a misleading impression.

Objection: The Secretary is sole arbiter of inferences, ambiguous, or misleading impressions.

S. 2000 and S. 2800 provide (a) that food, drugs, and cosmetics shall be misbranded if their labeling is false or misleading in any particular. Any representation concerning any effect of a drug shall be deemed to be false under this paragraph if that representation is not supported by substantial medical opinion, or by demonstrable scientific facts.

There are two serious objections to this section. First the Secretary is sole arbiter of as to whether or not the labeling on any food, drug, or cosmetic may be classified as being misbranded without regard to trade customs. Second the

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requirement that manufacturers offer proof and defend the wording on the labels of all drugs by substantial medical opinion or demonstrable scientific facts shifts the burden of proof from the Government to the manufacturer. What shall be considered substantial medical opinion or demonstrable scientific facts rests entirely in the hands of the Secretary, who is sole arbiter.

S. 1944, S. 2000, and S. 2800 (6) provide that food, drugs, or cosmetics shall be deemed misbranded if they fail to bear the name and place of business of the manufacturer, packer, seller, or distributor.

Objection to the place of manufacture requirement. A strict enforcement of this provision would result in sectional distinction, and un-American disparities.

S. 1944 (c), S. 2000, and S. 2800 (d) provide that if any word, statement or other information required on the label to avoid adulteration or misbranding under any provisions of this act is not prominently placed thereon in such a manner as to be easily seen, and in such terms as to be readily intelligible to the purchasers and users of such articles under customary conditions of purchase and use, shall be classified as being misbranded.

Objection: The Secretary is granted sole authority without qualification or specific limitations to determine if any word, statement or other information is prominently placed upon labels in such a manner as to be readily seen, and in such terms as to be readily intelligible.

SEC. Misbranded food.-S. 1944, S. 2000, and S. 2800 (a) (1) provide that a food shall be deemed to be misbranded of its container is so made, formed or filled as to mislead the purchaser.

Objection: The Secretary allocates to himself the exclusive right to delegate the manner in which all food products shall be packed for sale, and the kind, size, shape, etc., of container.

S. 1944, S. 2000, and S. 2800 (d) provide for minimum definition and standards of identity of food.

S. 1944, S. 2000, and S. 2800 (e) provide for minimum standards of quality of food.

S. 1944, S. 2000, and S. 2800 (f) provide that in the event no minimum definitions and standards of identity, nor minimum standards of quality are provided ior facil then the libel shall bear (1) the common or usual name of each ingredient such food contains in the order of predominance by weight.

Objection to power granted to the Secretary to establish legal minimum definition of identity and minimum standard of quality of food products. The requirement that all mixtures and compounds bear a label setting forth the common or usual name of each ingredient such food bears in order of predominance by weight is nothing more than a demand that all food manufacturers disclose private formulas. This provision is intended to grant power to the Secretary to destroy all distinctive name products. No harm has come to the consuming public in the purchase of distinctive name products.

SEC. 8. Misbranded drugs.-S. 1944 provides (a) (1) that i drug shall be 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 just a position with such name and in letters of the same size and prominance a statement that the drug is not a cure for such disease; or (2) 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.

Objection to the language contained in this provision as being so broad and loose that it would be subject to any kind of an interpretation at the direction of the Secretary. It is common knowledge that no general agreement of medical opinion exists.

S. 200 and S. 2800 (a) provide a drug shall be deemed to be 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 a plain and conspicuous statement, so placed as to be readily observable where such name occurs, indicating that the drug is a palliative and how the palliation is effected.

Objection to the language contained in this provision as being so broad and loose that it would be subject to any kind of an interpretation at the direction of the Secretary. It is common knowledge that it is impossible to describe or ascertain the manner palliation is effected. Neither would it be possible to set forth the same on a label or carton.

S. 1914, S. 2000, and S. 2800 provide (b) and (c) that all drugs containing so-called “narcotic” or “hypnotic” substances bear a label with a declaration of the name and quantity or proportion of such substance, and the further state

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