File Name: food drug and cosmetic act of 1938 .zip
- Emergency Use Authorization Toolkit
- Federal Food Drug and Cosmetic Act
- Food, Drug, and Cosmetic Law Research Guide
- U.S. Food and Drug Administration
Emergency Use Authorization Toolkit
Its regulatory authority covers most food products other than meat and poultry , human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumers, medical, and occupational use, cosmetics and animal feed.
The Pure Food and Drug Act of Act was enacted to prevent the manufacture, sale or transportation of adulterated or misbranded foods, drugs, medicines and liquors.
It vested enforcement power in the Bureau of Chemistry, of the U. Department of Agriculture. In July , the non-regulatory research functions of the bureau were transferred to a different segment of the department and the Bureau of Chemistry was renamed as the Food, Drug and Insecticide Administration.
Very few enforcement powers were provided in the Act to enforce the act. It vested this rulemaking authority in the Secretary of the Treasury, the Secretary of Agriculture and the Secretary of Commerce and Labor. The act authorized seizure of any article of food, drug or liquor in interstate commerce, or being warehoused after interstate transportation, that was found to be adulterated or misbranded.
A default of such payment was to constitute a lien against any future importation made by such owner. The Act was ridden with deficiencies in the enforcement powers that it provided for its enforcement. Another problem with the Act was that, while it required the listing of certain addictive substances on drug labels, it did not require enough additional information to make those statements meaningful to the average person.
An example of this is a case that the FDA investigated that involved a woman who had taken a headache medicine made of a coal-tar derivative. She had ingested a powder containing six grains of acetanilid, followed soon afterwards by a similar dose.
The average dose of acetanilid prescribed by physicians is three grains. Her death was instantaneous. Even for products that made false therapeutic claims that the FDA would have no difficulty proving that they were made with fraudulent intent, the manufacturers found a loophole by which they could escape FDA enforcement action.
Manufacturers would simply make the curative claims in advertising, rather than making them on the package. The Act authorized the Secretary of the Treasury, the Secretary of Agriculture and the Secretary of Commerce and Labor to make uniform rules and regulations for the enforcement of the Act.
A frustrated David F. Houston, Secretary of Agriculture, remarked in his first Annual Report,. Under the present conditions it is necessary in the individual prosecution to establish by evidence a standard for each individual article.
This procedure is very expensive, and sometimes its cost is out of proportion to its value. Moreover, it may result in lack of uniformity in different jurisdictions. With legal standards established, the control of foods would be more uniform and measurably less expensive. The lack of such standards is today one of the greatest difficulties in the administration of the food and drugs act. In Secretary Houston revived the Food Standards Committee to provide advisory criteria for what constituted economic adulteration forbidden by the Act.
First, it is such a tremendous undertaking that no Congress could manage it. Imitations of certain standard products sold under the name of the standard product were considered misbranded and thus proscribed by the Act.
The Act authorized the FDA to regulate food that was adulterated because it was filthy, decomposed or had in it any portion of an animal unfit for food. Since their jurisdiction began only when the finished product entered interstate commerce they were limited to examining samples taken from actual interstate shipments.
The Bureau of Dairy Industry was responsible for the sanitary inspection of these factories. The FDA did not have general inspection authority and it was thus difficult to administer the filth provisions of the Act. In , the Shrimp Amendment to the Act was passed, authorizing supervisory inspection of the seafood industry for all packers desiring the service. A therapeutic disaster in provided the force that led to the passage of a bill that had been in congress for five years.
Massengill Company. Whereas fraud was not a prerequisite for assessing penalties on violators, where fraud could be proved, higher penalties would be applied. Seized goods are proceeded against on libel of information and condemned in any district court of the U.
In the case of minor violations, the FDA can use its discretion to issue a written notice or. This applies if the FDA finds that any class of food in interstate commerce has been contaminated with micro-organisms during its manufacture, processing, or packing and that such contamination cannot be adequately determined after the articles have entered interstate commerce.
In this situation, the FDA is required to promulgate regulations providing for the issuance of permits to the manufacturers, processors, or packers of that class of food in the affected locality. The permit would set forth conditions governing the manufacture, processing, or packing of that class of food, for a temporary period of time, as may be necessary to protect the public health.
During this time, only permit-holders can manufacture, process or pack this class of food for introduction into interstate commerce. The permit can only be reinstated after a hearing and an inspection of the establishment, to assure that adequate measures have been taken to comply with and maintain the conditions of the permit. Denial of access for such an inspection is a ground for suspension of the permit, until such access is freely given by the operator.
A food with any amount of the poison below the tolerance established by the FDA is to be deemed safe, but any quantity of the poison exceeding such tolerance is to be deemed unsafe. A very important improvement in the FDCA was the elimination of the requirement to prove fraud in the prosecution of manufacturers that made false claims for drugs.
Even more significant was the provision requiring FDA approval of new drugs for safety before they are introduced into interstate commerce. This is a very important enforcement power, because it allows the FDA to revisit approved applications for new drugs after new technological advances show the approved drugs to be unsafe. Section c gives the FDA authority to inspect the records of any department or independent establishment in the executive branch of the Government.
Failure to permit such access is unlawful. They are also authorized to inspect any vehicle being used to transport or hold such articles in interstate commerce. Publicity is a very important and effective enforcement tool. If such samples are found to be adulterated, misbranded, or forbidden or restricted in sale in the country in which it was produced or from which it was exported, then the FDA is authorized to refuse such article admission.
The FDA could not only bring legal proceedings with higher penalties, it could seek injunctions, seize violative goods, establish legal standards for food, establish tolerance levels for poisons in food, exercise emergency permit control authority, pre-approve new drugs, suspend pre-approved drugs, inspect factories, refuse admission to violative imported goods, list approved coal-tar colors and certify each batch of such colors for use in food, drugs and cosmetics.
Congress provided for the certification of batches of drugs composed wholly or partly of insulin,  penicillin,  streptomycin,  chlortetracydine,  chloramphenicol  and bacitracin. The FDA could therefore put an end to the use of poisons it knew of, but did not have adequate resources to carry out research needed to assure that all food chemicals were safe. The Pesticide Amendment of gave the FDA the authority to promulgate regulations establishing tolerances for pesticide chemicals in or on raw agricultural commodities.
There was another therapeutic disaster in Europe between and Thousands of infants were born deformed to mothers who had taken thalidomide, a new sedative.
The inspection authorized extended to all things in the establishments being inspected, as well as records, files papers processes, controls and facilities. Economist Sam Peltzman of the University of Chicago conducted a study that concluded that the amendments had significantly reduced the introduction of effective new drugs from an average of Around , there was publicity involving the abuse of depressant and stimulant drugs in the U.
An official report stated that , pounds of barbiturates had been produced in This meant that there were thirty-three one-grain capsules for each person in the U. In January , President Johnson urged Congress to expedite "legislation to bring the production and distribution of barbiturates, amphetamines, and other psychotic drugs under more effective control. Prior to , there was a very inefficient and cumbersome system for the regulation of animal drugs.
Animal drugs were governed by one of or a combination of the new drug law, the antibiotic law and the food additive law. Technological advances had increased the number and complexity of medical devices. These advances improved medical care significantly. The Safe Medical Devices Act of was passed further improve the regulation of medical devices. There was another crisis in when one of the big infant formula manufacturers stopped adding salt to two of its soy products.
In , there was a tragic incident that involved the sudden deaths of seven people in Chicago that had ingested tylenol capsules that had been laced with cyanide.
The capsules had been placed in six different stores by an unknown person. The Act authorizes the FDA to provide recommendations upon request, for the non-clinical and clinical investigations that have to be conducted with an orphan drug before it is approved for the disease it is meant to treat. The process of approval of drugs for export was criticized for being too lengthy.
This Act created an administrative mechanism for adding countries onto the list. They are also required to report any information they receive indicating adverse reactions to such drugs. Congress made some findings that resulted in its passage of the Prescription Drug Marketing Act of According to Ed Scarbrough, Ph. It's price, taste and convenience.
The Nutrition Labeling and Education Act of gives the FDA the authority to require through regulations, that any of the required nutrition information be highlighted on the label, if it is deemed necessary to help consumers make informed dietary decisions.
It is also up to the FDA to designate the 20 varieties or more if necessary of vegetables, of fruit and of raw fish most frequently consumed, that have to observe the nutrition information guidelines.
The idea of charging applicants fees for reviewing their drug applications first came up in and then again in , both times being repudiated or failing to garner adequate support. Kessler, M. He impressed upon Congress the significance of user fees to the functioning of the FDA, and urged Congress to give the issue due consideration. Prior to , the FDA subjected dietary supplements to the same regulatory requirements as foods. In such proceedings, the U.
Due to a collaboration between the FDA, a coalition of animal industry groups, and manufacturers of animal drugs, Congress passed the Animal Drug Availability Act of to increase the number of animal drugs on the market.
They are also required to keep records that are subject to inspection by the FDA. FDAMA requires the FDA to approve a supplemental drug application for a major manufacturing change from the process previously approved, before the drug made with the change can be distributed. FDAMA authorizes the FDA to recognize and withdraw recognition of performance standards for medical devices that have been established by a nationally or internationally recognized standard development organization.
Congress passed the Medicine Equity and Drug Safety Act of in order to make accessible to Americans prescription drugs available in other countries at significantly lower prices than in the U.
In order to protect against bioterrorist threats to the food supply, the FDA is mandated to give high priority to increasing the number of inspections of food being imported, at the ports of entry into the U. Congress recognized that the resources the FDA allocated to reviewing medical device applications had been decreasing in recent years, and consequently, review was taking longer periods of time. In a case, the Supreme Court concluded that the FDCA does not create or imply a private right of action for individuals injured as a result of violations of the Act.
Injured individuals can still sue a violator for negligence in state courts. The Supreme Court in United States v. Cardiff  found that on its face, the FDCA only prohibited the refusal to permit entry and inspection if permission had previously been granted. Congress thus amended Section of the FDCA eliminating the provision requiring the FDA to obtain permission before entering at reasonable times to inspect facilities in which food, drugs, devices, or cosmetics are manufactured, processed, packed or held for introduction into interstate commerce, or held after such introduction.
Federal Food Drug and Cosmetic Act
Its regulatory authority covers most food products other than meat and poultry , human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumers, medical, and occupational use, cosmetics and animal feed. The Pure Food and Drug Act of Act was enacted to prevent the manufacture, sale or transportation of adulterated or misbranded foods, drugs, medicines and liquors. It vested enforcement power in the Bureau of Chemistry, of the U. Department of Agriculture. In July , the non-regulatory research functions of the bureau were transferred to a different segment of the department and the Bureau of Chemistry was renamed as the Food, Drug and Insecticide Administration. Very few enforcement powers were provided in the Act to enforce the act.
Food, Drug, and Cosmetic Law Research Guide
The U. House and Senate have adopted their own versions of reauthorizing legislation, both of which provide greater flexibility for HHS and FDA to approve the use of medical products in emergencies but differ in some specific provisions. Congress is likely to convene a conference committee to reconcile the differences between the bills.
Share this page. Follow Ballotpedia. This law, together with the Meat Inspection Act of , split federal food regulation between two agencies: the Bureau of Chemistry which would become the Food and Drug Administration was primarily responsible for enforcement of the Pure Food and Drug Act, and the Bureau of Animal Industry a division of the U.
U.S. Food and Drug Administration
GAO made a review to: 1 determine if modifications were needed to the Delaney Clause, and 2 present an overview of the social, scientific, and regulatory issues involving food additives that might cause cancer. The center of the controversy surrounding the Delaney Clause is the concept that no substance, in any amount, may be intentionally added to food if it has been shown to cause cancer. Tests to determine whether food additives cause cancer and statistical models to assess their risk to humans are available, but they have not yet been developed to the point where many experts totally accept their reliability.
Leonard M. Schechtman, Ph. The process is science based and has, over the years, achieved significant success in protecting human health. The authority by which the FDA provides pre- and postmarketing oversight of the products it regulates is established in the Federal Food, Drug, and Cosmetic Act, which has been amended extensively to broaden FDA's authority to include different products and product classes and to include oversight of safety and efficacy, greater stringency regarding reporting requirements, and enforcement processes. The structure of the agency, which comprises six regulatory components and a principal multidisciplinary research facility, is both practical and functional, providing regulatory oversight, regulatory guidance to industry, and fundamental and applied research. FDA's participation in different national and international scientific initiatives has helped bring focus to the prioritization, standardization, validation, and globalization of testing strategies and methodologies and the practical and widespread application of these initiatives to the regulation of consumer products.
For information on accessing the United States Code and researching U. These histories include photostatic PDF versions of the Public Law, all versions of enacted and related bills, Congressional Record excerpts, and committee hearings, reports, and documents. The database can be searched using the popular name of the law, the Public Law number, or the Statutes at Large citation. Georgetown Law Library Guides U. Search this Guide Search.
SUBCHAPTER I—SHORT TITLE. § Short title. This chapter may be cited as the Federal. Food, Drug, and Cosmetic Act. (June 25, , ch.