consumption. We have not been able to give that class of products the attention which its importance to the American consumer would justify.

INVESTIGATION OF FLAVORS AND SPICES

Mr. CANNON. I note that you are asking for an increase of $7,840 for flavors and spices.

Mr. CAMPBELL. That is right.

Our principal concern on this has been to maintain control at the ports of imported spice seeds.

There is a total importation of perhaps 100,000,000 pounds. Of this pepper constitutes about 35,000,000 pounds.

Originally the principal adulteration of pepper was through the use of ground olive pits. Now exhausted peppers and pepper shells are the principal means of adulteration, together with the incorporation of common dirt and sand.

Out of 3,344,000 pounds of pepper examined last year, 408,000 pounds or 12.2 percent were detained. That shows the importance of giving greater attention to even that product.

Mr. THURSTON. Twelve percent of the pepper that you inspected was found to be adulterated?

Mr. CAMPBELL. Twelve and two-tenths percent of the pepper that we examined was found to be adulterated and was not permitted to come into the country. But the amount that we examined was only 3% million pounds out of a total of 35% million pounds.

The other spices include caraway, nutmeg, cardamon, mustard seed, poppy, and the like, some of which you will find on rolls and bread. Of that class we examined 27 million pounds, and we effected the detention of 41⁄2 million pounds or a total of 17.5 percent.

The basis of detention of that material was the evidences of extensive rodent infestation. The product when harvested is put in shocks in the field. Mice will nest in them. The adulteration is due to improper cleaning. We detained it and insisted upon it being properly cleaned.

We have done nothing at all under flavoring extracts. There are some 600 manufacturers in the country.

One manufacturer brought to our office this past year a bushel basket of food flavors which were misbranded, and which did not comply with the standards under the Food and Drugs Act.

We had given no attention to that in the belief that after all it was an unimportant item of our diet, that the objections were purely economic, and that we could not withdraw people from the consideration of the more important health and sanitary problems.

THURSDAY, JANUARY 23, 1936.

INSPECTION OF PHARMACEUTICALS

Mr. CANNON. We will continue the hearing on the estimates for the Food and Drug Administration.

Mr. CAMPBELL. Mr. Chairman, I understood you granted me last night sufficient time to continue with a brief statement on drugs, and with that understanding I will pass over the various projects on

food products, and will take up, with your permission, pharmaceuticals, to let the committee know, in a sketchy way, at least, the scope of the work on such drugs. I will undertake to make this statement extremely brief.

Pharmaceutical products represent the vast field of drugs upon which physicians rely in the issuance of their prescriptions and use in emergencies. They include products like aspirin, nitroglycerine, and products like belladonna, ether, and digitalis.

The law makes the United States Pharmacopoeia and the National Formulary legal standard texts for these drug products.

The United States Pharmacopoeia lists 500 different products. We have been able to give attention during the past year to 224 of those products. Our work on that project represented a collection of 2,051 samples. We found 412 of those samples, or 20 percent of them, illegal, in violation of the law.

The National Formulary lists 689 products, and we gave attention last year to 74 of those, collecting 241 samples, 81 of which, or 32.7 percent, were found to be in violation of the law.

When prescriptions for the administration of these drugs are issued by physicians, a physician has no opportunity to make an examination of the product or to know whether it is in compliance with the legal standard or not. He is dependent upon the manufacturer; and the suffering sick public, of course, are dependent upon him.

The exercise of that sort of manufacturing control which will guarantee that the proper proportion or percentage of active ingredients exists, that they are of the potency which the legal test requires, is a costly matter, and many manufacturers, unfortunately, do not exercise the supervision and effective control that should be exercised. It represents for us a continuous amount of work which, in our opinion, is of the utmost importance.

It is for a better supervision of the traffic in such articles that we are asking for an increase of $81,340 in this project, and to take care of a condition that we found prevailing extensively last year in the marketing of salvage drugs.

A total of 55 firms throughout the United States were engaged in the marketing of these salvage stocks of drugs. Some of these drugs had been compounded prior to the time the Food and Drugs Act was passed. They had been collected from dead stocks on the shelves of retailers and wholesalers and had undergone in almost every instance such deterioration as to make them wholly unfit for the therapeutic purposes for which they were originally intended. We were able, in the State of Texas alone, to effect the destruction of a total of 28 tons of that class of material last year.

I have said nothing so far about our work in connection with the enforcement of the Shirley amendment. If I may say a brief word on that, I have here illustrations of some of the products that we have dealt with, and that will conclude the statement I have to make.

FLUORINE IN DICALCIUM PHOSPHATE

But first, I present to you a package of dicalcium phosphate. This is, as you probably know, administered extensively now, particularly to growing children, where there is, for one reason or another, a deficiency in calcium for bone and tooth building.

47432-36-46

Calcium and phosphorus, as you know, are essential to proper bone construction. This product is prepared by one of the most prominent drug manufacturers in the country. Our examination of it showed that it contained 2,000 parts per million of fluorine.

Investigations have been concluded, some under the direction of the Bureau of Chemistry and Soils of the Department of Agriculture, which show that the intake of that amount of fluorine will adversely affect the bones and teeth, particularly of children. In some sections of the country where imperfect bone structure was disclosed by mottled teeth, it was, by thorough and appropriate research, definitely determined to be due to the fluorine found in the water supply. The preparation of this product is from a mineral known as apatite which contains phosphate, calcium, and fluorine.

The product was not sufficiently purified before being put on the market, and if administered according to direction, it would give to the child or the person taking it four times the amount of fluorine that has been established by research as a safe tolerance.

PHARMACEUTICALS FOR INTRAVENOUS INJECTIONS

In addition to the regular, standard products in the United States pharmacopoeia and the Formulary, there is a large group of pharmaceuticals for intravenous injections. These are put out in these small, sealed flasks, or ampules, sufficient for a single administration. It is of the utmost importance that such drugs when introduced directly into the blood stream be not only what they purport to be and have the strength which they are represented to possess, but that they also be sterile.

A representative of the College of Physicians and Surgeons came to my office last week and urged that we give more attention to these products and insure their sterility, because surgeons very generally were complaining about the consequences of infection of their patients through administering such products.

The supervision of traffic in such articles, which, by the way, are being produced in progressively increased amounts, as well as the traffic in such articles as sutures, to guarantee their sterility, falls under the terms of this act, as a duty which we are required to face and to deal with.

TUBERCULOSIS "REMEDIES"

Here is a product [indicating] on which prosecution was instituted under the so-called Shirley amendment to the act, on the ground that it contained false and fraudulent therapeutic claims. It was called Brewster's G. D., manufactured by the Brewster Laboratories in Nashville, Tenn. It is labeled and sold for treatment of tuberculosis of the lungs. Its composition is kerosene, turpentine, and cottonseed oil. It cost, including the cost of bottling and packing, about 8 cents per bottle and sells for $2 per bottle.

We are required, Mr. Chairman, in the collection of evidence to maintain cases of this character, to show not only that the statements on the labels of such packages are false, but we must also show that they are fraudulent; that is, that the manufacturer knew them to be false.

You can appreciate the difficulty in doing that.

We found patients using that product extensively for the treatment of tuberculosis, part of the directions for the administering of which calls for the closing of windows and doors and the retention of the patient in a warm atmosphere.

We lost that case, the trial of which cost us something like $12,000. It lasted for several days. We lost it because of our inability to show knowledge on the part of the manufacturer.

The act also covers food and drug products intended for consumption by and administration to animals as well as human beings.

VETERINARY PREPARATIONS

Veterinary articles take up a portion of the expense incurred by us under this project. Here is an article put out by a firm in Richmond, Va., for the cure of contagious abortion in cattle. It is bicarbonate of soda, with a very slight amount of permanganate in it, merely enough to color the water when the product is dissolved. That sold for from eight to twelve dollars per package, and cost to manufacture it possibly not more than 5 cents per package.

In the first case we tried, based on this article, we were fortunate in being able to procure outstanding veterinarians not only in our own Department, but State veterinarians, and those practicing in different parts of the country, to testify that it would have no effect whatever in the treatment of contagious abortion. The trial resulted in a hung jury. The subsequent trial, however, resulted in a verdict for the Government. The court put the manufacturer on probation, with a suspension of the sentence.

This brief statement, like the preceding ones I made yesterday, Mr. Chairman, is intended, with the utmost sincerity on our part, to give to the committee some conception, however sketchy, of the obligations and the duties which are ours. I have made it with the desire to be helpful to the committee in passing intelligently upon the merit or demerit of our request for an increase in our appropriation. I do not intend to trespass upon your time any longer, because I wish to observe both the spirit and the letter of the promise I made to you yesterday. That, together with what I said this morning, will conclude what I have to say to you.

May I make one exception to that, in the belief that Judge Tarver will be interested?

WARM SPRINGS CRYSTAL COMPOUND

Here is a product labeled "Warm Springs Crystal Compound." When the commercial enterprise of marketing it first started the product was prepared in Atlanta. The composition of it is sodium sulphate or Glauber's salts. The label on it is "Warm Springs Crystal Compound, Warm Springs Crystal Company, Warm Springs, Georgia.' A small place at Warm Springs was rented to which this chemical was shipped, prepared, and put in packages of this character [indicating], and sent out through the country.

Its distribution was effected by the sale of territory to agents. The agent who had been selected for the State of Oklahoma was a woman. She conferred with certain prominent druggists about the prospect of this as a profitable undertaking. They told her she could even sell

sand at a profit if labeled as emanating from Warm Springs, Ga., in almost any amount in which she could acquire it.

We proceeded against the people engaged in this traffic, and, because of the greater severity of the penalty, we proceeded under the criminal code on a charge of conspiracy to violate the Food and Drugs Act, rather than under the Food and Drugs Act itself. The trial resulted in a conviction of those people. They were sentenced to terms in the penitentiary. The case was appealed, and I received yesterday the decision of the circuit court of appeals affirming the conviction in the lower court.

Mr. TARVER. Where were the cases tried and the convictions had? Mr. CAMPBELL. At Macon.

ENFORCEMENT OF THE FILLED MILK ACT

Mr. CANNON. You are asking for an appropriation of $10,000 for the enforcement of the Filled Milk Act.

Mr. CAMPBELL. A statement is submitted for inclusion in the hearing, Mr. Chairman, in defense of this item:

A new item of $10,000 is recommended for the enforcement of the Filled Milk Act.— Public, No. 350, Seventy-fourth Congress, approved August 27, 1935, amended the Filled Milk Act of March 4, 1923, by authorizing the Department of Agriculture to administer its provisions. The law has not heretofore been enforced, since the Department of Justice has no laboratory facilities for the analysis of samples necessary to prove violations of the act, and no other department of the Government has authority to make such analyses. This appropriation will cover the cost of collecting and analyzing samples of filled milk and, if necessary, of presenting the necessary inspectional and analytical evidence in court for a limited number of cases. It is only possible to do this with the amount estimated because laboratory facilities provided for the enforcement of other regulatory laws can be utilized for filled-milk work.

Work done under this appropriation.-This appropriation provides for the enforcement of the Filled Milk Act. The act prohibits the shipment in interstate or foreign commerce of so-called filled milk, which is made by the removing butterfat and the substitution of other fats.

Mr. CAMPBELL. That is a minor item. That law heretofore has been enforced by the Department of Justice. They requested it to be transferred to the Department of Agriculture. I have no particular point to make in regard to that. We are asking for $10,000 in the belief that it will take that much, or perhaps more, for its administration.

Mr. CANNON. Has there been a corresponding decrease in the appropriation provided for the Department of Justice for that purpose?

Mr. CAMPBELL. I do not think they had any appropriation.

Mr. CANNON. Did they enforce the act? Was the act enforced? Mr. CAMPBELL. I am inclined to think not. I think the transfer of this act is the result of the industry's insistence upon some plan of administration.

Mr. CANNON. But the act has been administered, has it not? If the Department of Justice was able to administer it without funds, do you not think the Department of Agriculture could be as efficient? Mr. CAMPBELL. We could perhaps administer it in the same way the Department of Justice did, without funds.

Mr. CANNON. What abuses have shown the need of an appropriation for enforcement of the act? Has the administration of the law