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I would like to submit that for your consideration, and I have just one other point in reference to what was discussed yesterday that I think is worthy of some further consideration. I refer to page 5 of S. 2800, line 17:
And it fails to meet the definition, formula, and description.
There seemed to be some discussion on the floor yesterday with reference to what was the meaning of the word "formula" and it was thought that it might be interpreted as meaning the chemical formula, the symbol for a compound or an element. It is my opinion that the writers of this bill, in placing this word "formula" in there, had in mind that when a person bought a U.S.P. or a N.F. preparation they were entitled to receive a produce that was made from the ingredients as specified in the United States Pharmacopoia or National Formulary.
I feel that it is very essential that the law retain this word "formula." If it is not clear what is meant by "formula", then it should be modified by " working formula" or "ingredient formula." I can illustrate what I have in mind by how possible it will be if you do not retain that word "formula" for unscrupulous manufacturers to adulterate the United States Pharmacopoeia and National Formulary products.
If we turn to the United States Pharmacopoeia under "fluid extract of cascara and we refer to the test defined in the law, it says it must correspond to the test given in the Pharmacopoeia, but the United States Pharmacopoeia does not give any test for bona fide fluid extract of cascara, it simply requires in the formula that it must be made from cascara bar.
Therefore, it is important to keep that formula. I have here a fluid extract of cascara, I can label it such, if you do not get that word "formula" in, and the product does not contain one bit of cascara. It is made out of buckthorn. The therapeutic activity of buckthorn may be similar to cascara, but I believe if a person specifies he wants fluid extract of cascara, he should get fluid extract of cascara made according to the United States Pharmacopoeia. The test in the Pharmacopoeia simply is an alcohol test; it must contain an average of 23 percent of alcohol. There is no other requirement. So we must retain this formula, or we will be subject to adulteration and sophistication of the official products.
Here is another one, a very important product of the United States Pharmacopoeia, powdered extract of nux vomica. The United States Pharmacopoeia does give some test, but it is a simple and easy process, just so it contains a certain amount of alkaloids. If we do not retain the word "formula ", I or nobody else can manufacture it.
These are big propositions, and the Department of Agriculture will have to pass these products because they comply with the law. You take the powdered extract of nux vomica; that product is made out of ginger mock. By "ginger mock" I mean ginger that is exhausted with some solvent and simply powdered, and I have added to it alkaloids of nuxin, brucin, and strychnin. In the preparation given in the Pharmacopoeia they answer all of the official tests, but surely a physician or anyone asking for powdered extract of nux
vomica is entitled to obtain a preparation made from the drug and not from some exhausted mock treated up with some alkaloids. In fact, I wouldn't even have to use the alkaloids specified in nux vomica; I might use the palliative alkaloids and use them in the correct molecular proportion, and it would answer the requirements of the Pharmacopoeia.
I would therefore stress that that law should retain this word "formula", and if you want my suggestions as to how it can be done, I would again refer to the McCarran-Jenckes bill, which so ably takes care of the situation, wherein it states, " and which differs from the standard of strength, quality, and purity." If we get the words "quality and purity" there won't be any question regarding the formula, because then it must comply with the official requirement. Senator OVERTON. It has been suggested that the word "formula be clarified by the adjective "chemical ", so it would read "chemical formula." Do you think that covers your objection?
Mr. SNYDER. No, sir; I don't think it wants to be "chemical formula." It wants to be so specified that it is the actual working formula of the National Formulary or the Pharmacopoeia. There are many products in the Pharmacopoeia and the National Formulary for which it would be impossible to give a chemical formula, because they are not pure substances.
The CHAIRMAN. Now, there are two gentlemen who want to leave the city, and I understand they have asked to be allowed to speak 10 minutes. We have just 20 minutes to adjournment, so I trust each gentleman will stay within the 10 minutes.
Mr. R. M. Allen.
STATEMENT BY R. M. ALLEN, NEW YORK CITY, REPRESENTING THE AMERICAN PURE FOOD LEAGUE
Mr. ALLEN. I appear to represent the American Pure Food League, with a telegram from Mrs. Harvey W. Wiley, the president, as follows:
ROBERT M. ALLEN,
New York City:
Please represent league hearing Tuesday. Have arranged Commerce Committee for you to speak.
Mrs. HARVEY W. WILEY.
I think, Senator, I said to you a little while ago I wished I had been heard over in the Commerce Committee room. In 1903, shortly after I was just out of college, we had a hearing then, I remember, before Senator McCumber on the then pending pure food bill. Yesterday afternoon I recalled the Members of the House and Senate committees, the food commissioners that were with me then, and I happen to be the only one living.
During those intervening years I have had charge of the food and drug control work in Kentucky. For some 16 years I was secretary of the National Association of Food Control Officials, from 1902 to 1906. I served as a special assistant, although from the staff, to Attorney General Bonaparte in the final enforcement of cases arising under the Food and Drug Act.
When I read the Senate bill, Senate bill 1944, I said to myself it is an honest bill; it has been written out of the best experience that we have had during the last 30 years. It should be taken as a model by the committee to construct this very difficult piece of legislation that you gentlemen have.
I heard a suggestion yesterday from Dr. Jordan. By the way, he made a splendid talk, an honest talk, a helpful talk. He represented the college, as I understand, of pharmacy. The suggestion was very much akin to the way I handled the thing in Kentucky. Our pharmacists did not want the State board of health to have it. The State board of health did not want the pharmacists to have it, so the State board of pharmacy appointed a member on the committee, the State board of health a member on the committee, and the director of the experiment station. We worked it out splendidly that way. The American Pure Food League, Mr. Chairman, was organized back in those days, out of the senate of conference which came together from the different groups, the General Federation of Women's Clubs, the National Consumers' League, the State food commissioners. They all organized themselves into the American Pure Food League, and it later served as a clearing house for information back of the bill and for the bill.
It has been reorganized here, and may I put into the record—I won't put any dynamite in, if you will trust me-may I put into the record the letter that was sent, the statement that has been sent to the members of the league?
Dr. Carl L. Alsberg, who is regarded a rather conservative professor, wrote that he held up accepting the invitation until he looked the bill over. Here is his letter that he is in support of its general provisions:
FOOD RESEARCH INSTITUTE, STANFORD UNIVERSITY,
Miss ALICE LAKEY,
DEAR MISS LAKEY: If I have not replied to your letter of October 31 at an earlier date, it is not because I do not believe the Federal Food and Drugs Act needs strengthening. I simply wanted to secure a copy of the bill and examine it. I have now done so, and find myself in sympathy with its aims. I am, therefore, glad to accept your invitation to serve on the advisory board of the American Pure Food League.
Very truly yours,
CARL L. ALSBERG.
Mr. Charles D. Howard, who was with us in those old days, the chief chemist and State food and drug control official of the State board of health of New Hampshire, and a member of the advisory board of the American Pure Food League, has written in the bulletin of the New Hampshire State Board for January 1934, a comprehensive and not too long review of that. I would like to have that included in the record.
(The review mentioned above follows:)
THE FEDERAL FOOD AND DRUG BILL
The anticipated bombardment on the part of the well-known" interests " against the pending much-needed Federal food and drug law revision has been in full force for some time. Those of us who have reason to be familiar
with the methods of these adversaries and who have a knowledge of the history back of the eventual passage of the original act of 1906-a history of 40 years of fighting for this pioneer accomplishment-may well feel apprehensive as to the outcome at this time.
THE EVOLUTION OF MANY MINDS
In the press one finds a favorite editorial belittlement of this bill in the reference to it as being the pet conception of a "Bolshevik theorist ", and one is led to infer that it is exclusively the brain child of that professional member of the President's "brain trust" whose name it happens to bear. That the present Assistant Secretary of Agriculture is its enthusiastic champion and that he had a prominent part in its final preparation is not to be disputed. For his active collaboration praise is due.
But it is as well the handiwork of others. Made a part of the Administration. program and known to have been introduced by express direction of the President, after having received the careful scrutiny and approval of the Department of Justice, it is nevertheless a fact that this measure has been in process of evolution for some years. It is the final product by no means of the ideas of one man but of a number who each have had some part in shaping it-men who have had long experience in food-law enforcement, who are all too well acquainted with the manifold deficiencies, defects, and weaknesses which characterize the existent act, and who have time and again found themselves hampered in attempting to accomplish even the things for which the present law is supposed to provide, to say nothing of those things for which it ought to provide but does not.
EXISTENT LACK OF COSMETIC CONTROL
To cite one outstanding instance of the considerable number of the latterwhich can also serve as an instance of the multiauthorship of the bill, in that this writer had some small part in shaping this feature-there is no provision whatever in the present law for that highly important class of preparations known as cosmetics-articles closely allied to drugs and of universal and everyday use on the person.
Although this is a gigantic industry, with sales running into the hundreds of millions of dollars annually, and although there are here involved great potentialities for both personal injury and fraud, second in this respect only to remedial preparations, the makers and distributors have always enjoyed complete immunity from regulation. Against all attempts at State legislation the industry has invariably advanced the long-familiar and plausible-sounding alibi that national legislation must come first. "Let a Federal bill be introduced and we'll support it "—a tongue-in-cheek promise that is now being given active repudiation.
A short-sighted attitude, because a great majority of cosmetic preparations are above criticism as to composition, and hence the reputable maker should welcome the proposed housecleaning. In this connection it has been well said that "laws are made and enforced for the control of the minority which, unless controlled, may damage in serious ways both consumers and honest competitors." A stumbling block here is in the fact that the industry, or no small part of it, craves continuance of the prerogative of advertising in a manner to delude the purchaser.
STANDARDS OF IDENTITY
It is being made to appear that the provision which would confer upon the Secretary of Agriculture authority to set up standards which would have the force of law is to give this official "czaristic powers." Arbitrary and by executive fiat, it would seem, he could dictate a given standard overnight. Yet the food industry well knows that no such autocratic action is contemplated or would be involved. This writer knows whereof he speaks, as it happens that for the past 15 years he has had the honor of being a member of a Federal board which is charged with the duty of formulating food standards.
The proceedings to this end are anything but hasty or ill-considered. The particular industry concerned is extended a hearing-not infrequently several of these may be held on a single topic-at which those interested are invited to appear and express their views, the facts and arguments presented being
thereafter profoundly considered by the board; whereupon a tentative standard is developed and sent out to the industry for its comments and a possible further hearing. The standard eventually evolved must next receive the careful scrutiny of the Department's law officer, and not until then is it finally promulgated by the Secretary. Nothing could be fairer. This method has the great advantage over the legislative one that in the event the need for some modification of a standard is made apparent, this can be effected without incurring the time and expense necessitated by a special act of Congress.
The objection to the present standards is that they do not have the force of law; they are advisory only and serve to the court merely as guides. Hence where a respondent chooses to ignore them in his defense, the Government is placed to great expense in each such case by reason of the necessity of presenting expert testimony in their support. This means a serious handicap to enforcement, and one which is quite unnecessary, because practically never is one of these standards upset in the court proceedings.
From the standpoint of public-health protection the bill includes a number of valuable provisions not contained in the present law, provisions of various and wide application. To cite one example, at the present time there is no authority for control of the sanitary conditions of food-producing establishments, other than meat. It makes no difference how extensive the abuses may be; the only recourse against these is to prove by objective examination of the food product itself that this is unclean or decomposed. There are various articles being sold as food which are, per se, hazardous to health and the production and distribution of which should be under careful control. Such foods at the present time are not in violation of the act, although obviously dangerous to health. As proposed, food will be deemed adulterated if it is of such character or origin that its consumption entails a health hazard.
SYNTHETIC LIQUOR UNDER REPEAL
With the advent of prohibition repeal we are already finding, as was to be expected, gross abuses in connection with the composition and labeling of liquors, abuses for the control of which the present law is ineffective. Space does not permit of the enumeration here of the various other muchneeded features embodied in this bill and which are not covered, or are not adequately covered, by the existent act.
FALSE AND DECEPTIVE ADVERTISING TABOOED
An outstanding feature of this bill, and the one that is now causing a prodigious hullabaloo in certain quarters, is the seemingly reasonable proposal that we shall have truthful advertising of foods, remedials, and cosmetics. Only Heaven and the enforcement officials have any adequate appreciation of the present pernicious and widespread abuses in this respect and of the crying need for reform. Yet, with peculiar appropriateness-with an opposition running true to form this proposal is being met by a highly organized campaign the weapons of which are derision, sneers, appeals to prejudice and ignorance, misrepresentation, and downright lying.
This is not to say that all of the opposition is of this character. Much of it, as is the case with all control legislation, arises from honest misapprehension. So far as the food industry is concerned, this is now for the most part on an honest basis, and the same is true of the manufacture and distribution of official pharmaceuticals. The various elements in these industries are for the most part very well intentioned. They are disposed to do the right thing, and thus far they have voiced comparatively little opposition.
ACTIVITIES OF PROPRIETARY INDUSTRY
As might be expected, the great hue and cry is emanating from the proprietary remedy and cosmetic interests. It is these that mainly are to be held responsible for the highly organized and cunningly conceived propaganda now being so extensively disseminated. Doubtless there is by now not a newspaper or periodical publisher in the land who has not been circularized