Pure Food and Drug Act

“ 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. The term “food,” as used herein, shall include all articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compound. ”

“ An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes. ”

“ If it consists in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter. ”

“ But we are all the more convinced that we must give effect to congressional intent in view of the well-accepted principle that remedial legislation such as the Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the Act's overriding purpose to protect the public health, and specifically, § 507's purpose to ensure that antibiotic products marketed serve the public with 'efficacy' and 'safety.' Cf. ”

“ Consequently the people accepted with amazing credulity the startling claims to miraculous cures of various pills and potions as set forth under glaring headlines in the daily papers. The publicity of the last few years has hurt the traffic seriously, but it still has a great hold upon the ignorant and credulous part of the population, and there is still a very large number of these preparations upon the market. Many persons think that the Pure Food Law guarantees every drug preparation now sold to be perfectly safe for use. ”

“ Lack of opportunity alone, of knowledge of what to take and how to procure it, has saved many a person under severe physical or mental strain from recklessly resorting to drugs. Since the passage of the Pure Food and Drugs Act, which was intended to protect the public by requiring the express statement of any dangerous ingredients in a compound, the sale of preparations containing habit-forming drugs has preceptibly increased. ”

“ Americans now have greater protection against harmful, unclean, or misrepresented foods, drugs, or cosmetics through a strengthened Food and Drug Administration and by new legislation which requires that food additives be proved safe for human consumption before use. ”

“ In connection with its mandate to promote health and reduce the risk of harm, the Food and Drug Administration routinely makes decisions about whether and how products may be marketed in the United States. ”

“ Half a century ago, in 1938, the Federal Food, Drug, and Cosmetic Act was signed into law by President Franklin Delano Roosevelt. This legislation was the start of modern food and drug regulation. That this year is the 50th anniversary of that legislation reminds each of us to be grateful for our American legacy of concern for protecting the public health. ”

“ The pharmacist has felt his hampered position for some time, but now that the Pure Food and Drugs Act has become effective, we are face to face with the issue. With the United States Pharmacopœia and the National Formulary as the legal standards he will now be held responsible for the identity and quality of the drugs which he sells. ”

“ Retail pharmacists should, and if they desire to maintain their standing in the community they must, favor pure food and drug legislation that is designed to protect the public. By themselves taking an active interest in the securing of legislation along these lines they could readily prevent the enactment of ill-advised measures that would tend to hamper or restrict them in the pursuance of their business. ”

“ Attention is directed to the fact that by publishing the guarantee under the pure food laws the company presumes to disperse all doubt and criticism, assuming that the majority of physicians will be satisfied with the guarantee as it stands. Inasmuch as the preparation contains acetanilid and antipyrin, however, the manufacturers are disregarding that part of the Food and Drugs Act which requires that the name of the parent substance—​in this case acetanilid and antipyrin—​be put in parenthesis. ”

“ But, after the period of concentration came on, it was found as a matter of fact that food and drugs were extensively sold of inferior quality and even dangerous character under false names. After a prolonged contest, the pure food and drug laws were enacted by Congress and by the several states. The manufacturers of food and drugs denounced these regulatory measures as an interference with private business. It seems odd to us now that any one should consider it a right to sell a food or a drug under a false name. ”

“ The term 'human drug product' means the active ingredient of a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient. ”

“ Even assuming no present dispute among medical authorities, we cannot ignore that it has become commonplace for a drug or food additive to be universally regarded as harmless on one day and to be condemned as perilous on the next. ”

“ The public interest in protecting consumers throughout the Nation from misbranded drugs requires prompt action by the agency charged with responsibility for administration of the federal food and drug laws. ”

“ Congress certainly did not intend that a poisonous or deleterious ingredient which made a proprietary food an enemy to the public health should be treated as a 'valuable constituent,' or to induce the continued use of such injurious ingredients by making their elimination an adulteration, subject to the penalties of the statute. ”

“ For many drugs and chemicals not in the Pharmacopoeia there is no standard of purity that can be used under the Adulteration of Food and Drugs Act, and for these, as well as for the commercial quality of those drugs and essential oils which are also in the Pharmacopoeia, a legal standard of commercial purity is much needed. ”

“ The profit is uncertain, often impossible, until the laws of the state and of the nation command that every article of commerce shall be sold under its own name and upon its individual merits.
In the enforcement of the state laws, in the committee hearings concerning the proposed national law, the dominant questions have been, and, in the event of the passage of the national law, will be, artificial colors, antiseptics, standards and labeling. And at the present time the adulteration and misbranding of drugs and liquors occupy a prominent place in the pure food issue. ”

“ The only way to effectively protect the public health from the dangers of unsubstantiated modified risk tobacco products is to empower the Food and Drug Administration to require that products that tobacco manufacturers sold or distributed for risk reduction be reviewed in advance of marketing, and to require that the evidence relied on to support claims be fully verified. ”

“ Food and Drugs Act are a matter of scandalous history. What, then, would be the difficulties in passing a Federal bill to restrict the sale of patent medicines containing habit-forming drugs? It is of course to the interest of every druggist to create a lasting demand for his article. There is obviously not so much profit in a medicine that cures as in one that becomes indispensable. Hence arises the great inducement, from the druggist’s point of view, in soothing-syrups and the like. ”

“ Additional special rule.—Beginning 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco. ”

“ The Federal Trade Commission was created to protect consumers from unfair or deceptive acts or practices, and to regulate unfair methods of competition. Its focus is on those marketplace practices that deceive or mislead consumers, and those that give some competitors an unfair advantage. Its mission is to regulate activities in the marketplace. Neither the Federal Trade Commission nor any other Federal agency except the Food and Drug Administration possesses the scientific expertise needed to implement effectively all provisions of the Family Smoking Prevention and Tobacco Control Act. ”

“ It is well known that in many kinds of foods in their natural state some quantity of poisonous or deleterious ingredients exist. How far these substances may be deleterious to health when the food articles containing them are consumed may be a subject of dispute between the scientists, but the bill reported does not in any way consider that question. If, however, poisonous or deleterious substances are added by man to the food product, then the bill declares the article to be adulterated, and forbids interstate traffic.'
This statement throws light upon the intention of Congress. ”

“ The Food and Drug Administration is a regulatory agency with the scientific expertise to identify harmful substances in products to which consumers are exposed, to design standards to limit exposure to those substances, to evaluate scientific studies supporting claims about the safety of products, and to evaluate the impact of labels, labeling, and advertising on consumer behavior in order to reduce the risk of harm and promote understanding of the impact of the product on health. ”

“ It is just as important to prohibit the sale to the housewife of a compound containing boric acid, to be used by her to preserve fruits and vegetables put up by her for family use, as it is to prohibit the sale of fruits and vegetables after such an ingredient has been added. We think the reasonable construction of the act to be that the prohibition against boric acid is not limited to foods to which it is an added ingredient, but extends to compounds sold as a food preservative which contain boric acid. ”

“ To protect our consumers from the careless and the unscrupulous, I shall recommend improvements in the Food and Drug laws—strengthening inspection and standards, halting unsafe and worthless products, preventing misleading labels, and cracking down on the illicit sale of habit-forming drugs. ”

“ The first meeting of this Association was held at Manila, the second at Hongkong. The third will take place at Saigon.
The results of a rigid enforcement of the “Pure Food and Drugs Act” are worthy of more than passing notice. Such enforcement has been comparatively easy as the officials concerned are not hampered by politics. The Philippines were at one time a dumping-ground for products that could not be sold elsewhere, but it is now possible for Filipinos to obtain wholesome preserved foods and unadulterated drugs, except in very remote places where none of any sort are available. ”

“ That is the mission of our Food and Drug Administration and it is a mission shared by our Department of Agriculture, and a variety of other agencies and offices at just about every level of government.
The men and women who inspect our foods and test the safety of our medicines are chemists and physicians, veterinarians and pharmacists. It is because of the work they do each and every day that the United States is one of the safest places in the world to buy groceries at a supermarket or pills at a drugstore. ”

“ When objects of commerce get within the sphere of State legislation the States may exercise its independent judgment and prohibit what Congress did not see fit to forbid. When they get within that sphere is determined, as we have said, by the old long-established criteria. The Food and Drugs Act does not interfere with State regulation of selling at retail. ”

“ In twenty years evidence has steadily accumulated of the danger to the public health from the general consumption of foods which have been stripped of elements essential to the maintenance of health. The Filled Milk Act was adopted by Congress after committee hearings, in the course of which eminent scientists and health experts testified. An extensive investigation was made of the commerce in milk compounds in which vegetable oils have been substituted for natural milk fat, and of the effect upon the public health of the use of such compounds as a food substitute for milk. ”

“ The druggist has been permitted to import and manufacture as freely as he pleased, and to sell under restrictions which were insufficient to prevent promotion of drug habits; the physician has never been required to make accounting for prescription of or the administration of these dangerous substances, and his medical training, both in college and in hospital, has left him in the dark concerning the danger point in their administration.
“This proposed New York State legislation has been drawn with careful eye to the establishment, here in the Empire State, of a model law for other States. ”

“ A Party shall, if in its opinion the prevailing conditions in its country render it the most appropriate means of protecting the public health and welfare, prohibit the production, manufacture, export and import of, trade in, possession or use of any such drug except for amounts which may be necessary for medical and scientific research only, including clinical trials therewith to be conducted under or subject to the direct supervision and control of the Party. ”