Federal Food, Drug, and Cosmetic Act

“ GAO Study.—Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall submit a study to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate addressing the effectiveness and overall impact of exclusivity under section 505G of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) , and section 586C of such Act (21 U.S.C. 360fff–3) , including the impact of such exclusivity on consumer access. ”

“ We fully recognize the important public interest served by assuring prompt and unimpeded administration of the Pure Food, Drug, and Cosmetic Act, but we do not find the Government's argument convincing. First, in this particular case, a pre-enforcement challenge by nearly all prescription drug manufacturers is calculated to speed enforcement. If the Government prevails, a large part of the industry is bound by the decree; if the Government loses, it can more quickly revise its regulation. ”

“ 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. ”

“ Further to paragraph 7, each Party shall, when regulating cosmetic products, take into account that cosmetic products are generally expected to pose less potential risk to human health or safety than medical devices or pharmaceutical products. ”

“ I do not think Congress meant the phrase to be so disastrously limited. For the 'doing of any other act with respect to, a food, drug, device, or cosmetic' is prohibited by § 301 (k) only 'if such act * * * results in such article being misbranded.' And the statute provides, not a single common definition of misbranding for foods, drugs and cosmetics, but separate and differing sections on misbranded foods, misbranded drugs and devices, and misbranded cosmetics. ”

“ 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. ”

“ Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That it shall be unlawful for any person to manufacture within any Territory or the District of Columbia any article of food or drug which is adulterated or misbranded, within the meaning of this Act ”

“ 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. ”

“ 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. ”

“ 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. ”

“ As a result of the findings of the governmental chemists, there was enacted in 1906, the Food and Drug Act, which aims to raise the standard of food purity, by prescribing the conditions under which foods may be manufactured and sold. The law compels the maker of artificially colored or preserved food products to correctly label his goods. The national law was the instigation of state laws, which have further helped to insure a supply of pure food products. ”

“ The scope of the offense which Congress defined is not to be judicially narrowed as applied to drugs by envisioning extreme possible applications of its different misbranding provisions which relate to food, cosmetics, and the like. There will be opportunity enough to consider such contingencies should they ever arise. ”

“ 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. ”

“ There are many such men in the ‘patent medicine’ world. The only way in which the public may properly be protected against being defrauded in such cases is for the federal Food and Drugs Act to have its scope extended to cover all advertising of the products coming under the purview of the act.”— (From The Journal A. M. A., March 17, 1917.) ”

“ 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. ”

“ 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. ”

“ Congress should also give the FDA greater authority to halt imports of fruits, vegetables, and other food products that are produced under safety conditions that simply do not match our own strict standards. ”

“ The measures and education programs in this legislation will enable the FDA to gather solid data about the dangers some dietary supplements pose. With this information in hand, the FDA can make sensible, informed decisions and policies about dietary supplements. Consumers can have greater assurance than they currently have about the safety of the products on the market. We cannot continue to stand on the sidelines and let this insidious public health threat go unchecked. The health and well being of our young people and loved ones are at risk. ”

“ 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 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. ”

“ 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. ”

“ This is because DSHEA shifted the burden of proof from dietary supplement manufacturers to the FDA. Consumers have no way of learning about reported side effects and the FDA does not possess the authority to require such reports. As a result, American consumers have been unwitting victims of a multibillion-dollar industry! ”

“ 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. ”