CHAPTER III

THE QUALITY AND PURITY OF VEGETABLE DRUGS FROM THE STANDPOINT OF THE PURE DRUGS ACT

I. THE PURE DRUGS LAWS

Through the efforts of a few public-spirited men backed by the American public we now have a national pure food and drugs law. This law went into effect June 30, 1906. There is no single legislative act of recent times which equals this in importance. With this law as a guide the several states have enacted similar laws. In addition to this we have city ordinances which likewise have more or less supervision as regards the quality and purity of foods and drugs. If the letter of the law or laws were followed we should have nothing but foods and drugs of absolute purity and of the highest quality but in spite of all legal restrictions, adulteration continues to be practiced. In fact as the prohibitory measures become more and more stringent the methods of those who sophisticate and misrepresent become more and more subtle. The chief benefit of the law is that it makes it possible to punish offenders. Mere legislative enactment will not stamp out the pernicious methods of the sophisticators; for the lawbreakers existed before the law and it is they who made it necessary to formulate a law to hold them in check.

Under the pure food and drug laws, federal and state laboratories have been established in which much good work has been done. Offenders have been fined and otherwise punished as provided by the law. But after all, the chief work thus far has been of an educational nature. Rulings and decisions by the Department of Agriculture have been issued from time to time which serve as guides of conduct and give information of the highest importance. Numerous papers of instruction and lay constructions of the law have been published in the pharmaceutical journals. Findings and notices of judgment have been reported, etc., all of which is intended to teach and advise those concerned in such a way as to make it easier for them to conform to the requirements of the law. Many technical offenders have been let off with a warning when it became evident that the offense was due to ignorance of the law rather than criminal intent.

Until the advent of the pure drug laws, adulteration and substitution of crude and powdered drugs was sufficiently common to make the expected physiological or therapeutic effect of drugs most uncertain and to create doubt in the mind of the physician. This lead physicians away from the use of drug store preparations and induced them to use the preparations of the large manufacturing houses, the proprietaries and even patent remedies. Large manufacturing houses have the necessary equipment to assay, test and standardize the drugs and preparations manufactured. Many of the proprietaries are carefully tested physiologically and thereapeutically before being placed on the market. It is, therefore, not surprising that the physician should prefer these preparations of guaranteed origin and composition and activity to the preparations put up by a druggist who has perhaps. never studied the science of pharmacy and who is wholly incapable of testing the drugs which he handles. When competent pharmacists shall have gained the confidence of physicians then the business and profession of pharmacy will receive better recognition.

With the progress in science, the former crude methods of sophistication have been largely abandoned. Wooden nutmegs, coffee beans of pressed clay and starch, imitation eggs, cabbage leaf and corn silk tobaccos, etc., are things of the past. Spices appear to be most peculiarly suited to the work of the sophisticators. Black pepper, capsicum and mustard are very frequently adulterated. Wheat flour with curcuma is a most common adulterant of mustard. Wheat flour and cornmeal are added to capsicum. Ground cinnamon, nutmeg, pepper, allspice, and other spices are often of very inferior quality though no foreign substances are added. Teas and ground coffee are likely to be adulterated. The former may have exhausted tea leaves, the leaves of old plants, the leaves of Japanese tea (Thea japonicum), foreign leaves, etc., the latter may contain chicory and other roots, coffee shells, nut shells, figs, prunes, cereals, etc.

The sweepings, trimmings and refuse of vegetable drugs are mixed with powdered drugs where these additions are less likely to be detected. Other forms of adulteration will be described in another chapter. Under the law any importer may bring into the United States such articles as Bombay mace, clove stems, pyrethrum stems, olive pits, cocoanut shells, peanut shells, senna siftings, senna with stems, buchu with stems, cubeb with stems, mallow leaves, licorice trimmings, inferior gum tragacanth, all manner of substandard and adulterated and wholly inferior drugs labeled "for technical use only," etc., etc. If these articles are correctly declared at the port they cannot be refused entry, no matter how certain it may be that said articles will

subsequently appear in interstate and intrastate commerce as adulterants, even bearing the U. S. P. or other high standard label. These articles above named have been found on the Pacific Coast, distributed as follows: Bombay mace, sold as true mace or mixed with true mace; clove stems as a common adulterant of cloves; powdered pyrethrum stems sold as high grade Dalmation and Persian insect powder; ground olive pits and cocoa shells as the adulterants of black pepper, of nut galls, of cloves, of allspice, etc., ground peanut shells in spices, senna siftings, senna with stems, buchu with stems and cubeb with stems, etc., bearing the U. S. P. label. Mallow leaves are added to Origanum and other leaf spices and to the herbaceous drugs. To such an extent is marjoram adulterated that some spice dealers have decided to take this article off the market rather than take the risk of marketing an adulterated article.

Sections 6, 7 and 8 of the federal food and drugs act reads as follows: SEC. 6. That the term "drug" as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals.

SEC. 7.-That for the purpose of this Act an article shall be deemed adulterated:

In the case of drugs:

First. If, when a drug is sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, it differs from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation: Provided, That no drug defined in the United States Pharmacopoeia or National Formulary shall be deemed to be adulterated under this provision if the standard of strength, quality, or purity be plainly stated upon the bottle, box, or other container thereof although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary.

Second. If its strength or purity fall below the professed standard or quality under which it is sold.

SEC. 8.-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 contained 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 or produced.

That for the purposes of this Act an article shall also be deemed to be misbranded:

In case of drugs:

First. If it be an imitation of or offered for sale under the name of another article.

Second. If the contents of the package as originally put up shall have been removed, in whole or in part, and other contents shall have been placed in such

package, or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein.

In August, 1912, Congress adopted a measure which is a most important addition to the act of June 30, 1906, and which reads as follows:

"An article shall be deemed misbranded if its package or label shall bear or contain any statement, design or device regarding the curative or therapeutic effects of such article or any of the ingredients therein, which is false and fraudulent."

This law is especially directed against proprietary remedies and socalled patent remedies. In addition to the Service and Regulatory Announcements of the Bureau, the Department of Agriculture has from time to time issued rulings and interpretations of the food and drugs act which should be consulted by those interested. The Department has also issued legal definitions or standardized descriptions of food articles, drugs and spices, which have been quite generally adopted as standards by the several states in the administration of the state food and drugs laws.

The Federal Pure Food and Drugs act is administered by the Bureau of Chemistry of the Department of Agriculture, Washington, D. C Appointment to any. position in the Bureau is under the United States civil service rules and regulations; and the educational and special training requirements for this department of the government service are unusually high. Those in the laboratory division must, as a rule, hold university degrees, or the educational equivalent thereof, must have done graduate work, and must have specialized along the lines of the work to be done. Examinations for vacancies to be filled, are held from time to time, throughout the United States, and to which all citizens are eligible, provided they can meet the educational and other requirements.

The United States Treasury Department coöperates with the Department of Agriculture in the enforcement of the pure food and drugs act, but this coöperation is rather loose. The treasury department is primarily interested in the proper fixing of the tariff and revenue schedules, and the work done in the analytical laboratories of this department pertains to questions of tariff rates, rather than purity and quality.

There is also a certain coöperation between the Bureau of Chemistry and the Bureau of Animal Industry, the latter giving the major attention to animal food products, meat inspection, etc. Even here the coöperation is not as close nor as harmonious as it should be.

Since the adoption of the federal pure food and drugs act, every state in the union has adopted a similar act, usually a close copy of the federal act, and administered by some state commission, bureau, or department. The state administration is not uniform. In one state the law is administered by the Board of Health, in another by the Dairying Commission, in another by the Veterinary Commission, in another the work is divided, the pure food law under the Board of Health, while the drugs law is under the Board of Pharmacy. Some states administer the law excellently, while others administer it very laxly or indifferently. Some states have an equipment which cannot be excelled, while in other states the equipment is wholly inadequate. The cooperation between state and federal authorities is, as a rule, quite close.

The following is an outline of the Bureau of Chemistry machinery which is operative in enforcing the Pure Food and Drugs Act of June 30, 1906, and all amendments thereto.

Chief and Assistant Chief of the Bureau, at Washington.

Two Chief Chemists, one for foods and one for drugs, at Washington.

Chief of the Micro-Chemical Laboratory, at Washington.

Chief Chemist in charge of the Main or Check Laboratory, at Washington, with a corps of assistants.

Analytical Laboratories, at the larger ports and commercial centers. in the United States. Each laboratory has a chief of the laboratory or station chief.

Analysts, mostly chemists, with an occasional microanalyst and bacteriologist.

Chief Inspector, at Washington.

Corps of Inspectors. These are assigned to the various laboratories. and their work was formerly directed by the chief of inspectors in Washington.

United States District Attorneys and assistants, in different judicial districts, who direct the court proceeding against violators of the law.

Pharmacognosists and other Specialists, usually attached to one of the sub-laboratories or station laboratories.

The inspectors are empowered to secure samples of drugs and medicamenta presented for entry at any port or such as are intended for interstate commerce. Federal inspectors have no jurisdiction over articles intended for intrastate commerce only. Three samples of each article are taken, all duly sealed, numbered (Inspector's serial number-I. S. No.) and recorded. One sample is left with the firm