|Toilet Goods Association, Inc. v. Gardner|
|Argued January 16, 1967|
Decided May 22, 1967
|Full case name||Toilet Goods Association, Inc., et al. v. Gardner, Secretary of Health, Education, and Welfare, et al.|
|Citations||387 U.S. 158 ( more )|
87 S. Ct. 1520; 18 L. Ed. 2d 697
Toilet Goods Association, Inc. v. Gardner, 387 U.S. 158 (1967), was a case heard before the United States Supreme Court. It held that judicial review of a regulation's validity was inappropriate because the controversy was not ripe for adjudication. Since it was not clear whether or not an inspection would be ordered and the reasons had not been given by the Commissioner to justify his order, no primary conduct was affected and so no irremediable adverse consequences flowed from requiring a later challenge to the regulation by a manufacturer, who refused to allow inspection.
The Toilet Goods Association was an organization of cosmetic manufacturers accounting for 90% of annual American sales in the field.
The Commissioner of the Food and Drug Administration promulgated a rule that stated, in part:
"(a) When it appears to the Commissioner that a person has:"
"(4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and the formulae involved in the manufacture of the color additives and intermediates from which such color additives are derived; he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken."
Justice Harlan wrote, "In determining whether a challenge to an administrative regulation is ripe for review a twofold inquiry must be made: first to determine whether the issues tendered are appropriate for judicial resolution, and second to assess the hardship to the parties if judicial relief is denied at that stage."
The issues were appropriate for judicial resolution. The regulation states that the commissioner may order an inspection and that a permit may be refused.
There was no excessive hardship on the parties. Unlike in other cases, failure to comply with the rule resulted in, at most, a suspension of a certification. Fines, seizures of goods, and criminal liability were not present.
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
In United States law, ripeness refers to the readiness of a case for litigation; "a claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all." For example, if a law of ambiguous quality has been enacted but never applied, a case challenging that law lacks the ripeness necessary for a decision.
Food coloring, or color additive, is any dye, pigment or substance that imparts color when it is added to food or drink. They come in many forms consisting of liquids, powders, gels, and pastes. Food coloring is used both in commercial food production and in domestic cooking. Food colorants are also used in a variety of non-food applications including cosmetics, pharmaceuticals, home craft projects, and medical devices.
Tartrazine is a synthetic lemon yellow azo dye primarily used as a food coloring. It is also known as E number E102, C.I. 19140, FD&C Yellow 5, Acid Yellow 23, Food Yellow 4, and trisodium 1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-5-pyrazolone-3-carboxylate).
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act, (PHSBPRA) was signed by the President, the Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture (USDA).
Food safety is used as a scientific discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illnesses resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry to market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market to consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer.
Cosmetics ingredients come from a variety of sources but, unlike the ingredients of food, are often not considered by most consumers. Cosmetics often use vibrant colors that are derived from a wide variety of sources, ranging from crushed insects to rust.
Food contact materials are materials that are intended to be in contact with food. These can be things that are quite obvious like a glass or a can for soft drinks as well as machinery in a food factory or a coffee machine.
Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), was a case heard before the United States Supreme Court. Abbott Laboratories held that drug companies were not prohibited by the ripeness doctrine from challenging a U.S. Food and Drug Administration (FDA) regulation requiring a prescription drug's generic name to appear on all related printed materials. The government argued that the case was not ripe because the regulation had yet to be enforced; however, that argument failed as the Court found the issues to be fit for judicial resolution, and that the drug companies would experience substantial hardship if denied a pre-enforcement challenge to the statute. Prosecution for non-compliance was likely, civil and criminal penalties could be imposed, and the drug companies would suffer reputational damage if required to violate the regulation before challenging it in court.
Evergreening is any of various legal, business and technological strategies by which producers extend the lifetime of their patents that are about to expire, in order to retain royalties from them, by either taking out new patents, or by buying out, or frustrating competitors, for longer periods of time than would normally be permissible under the law.
The Highway Traffic Act (HTA) is legislation in Ontario, Canada, which regulates the licensing of vehicles, classification of traffic offences, administration of loads, classification of vehicles and other transport-related issues. First introduced in 1923 to deal with increasing accidents during the early years of motoring in Ontario, and replacing earlier legislation such as the Highway Travel Act, there have been amendments due to changes to driving conditions and new transportation trends. For example, in 2009, the Act was revised to ban the use of cell phones while driving.
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
The Organic Foods Production Act of 1990 (OFPA) authorizes a National Organic Program (NOP) to be administered by USDA's Agricultural Marketing Service (AMS). The program is based on federal regulations that define standard organic farming practices and on a National List of acceptable organic production inputs. Private and state certifiers visit producers, processors, and handlers to certify' that their operations abide by the standards. Once certified, these operations may affix a label on their product stating that it "Meets USDA Organic Requirements." It is illegal for anyone to use the word "organic" on a product if it does not meet the standards set in the law and regulations. The regulations under the OFPA are intended to set uniform minimum standards for organic production. However, states may adopt additional requirements after review and approval by USDA. AMS re-accredits certifying agents every 5 years, maintains federal oversight to assure truth in labeling, and provides assurance that imported organic products have been produced under standards that are equivalent to the U.S. standards.
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
Pesticide regulation in the United States is primarily a responsibility of the Environmental Protection Agency. In America it was not till the 1950s that pesticides were regulated in terms of their safety. The Pesticides Control Amendment (PCA) of 1954 was the first time Congress passed guidance regarding the establishment of safe limits for pesticide residues on food. It authorized the FDA to ban pesticides they determined to be unsafe if they were sprayed directly on food. The Food Additives Amendment, which included the Delaney Clause, prohibited the pesticide residues from any carcinogenic pesticides in processed food. In 1959 pesticides were required to be registered.
Camara v. Municipal Court, 387 U.S. 523 (1967), is a United States Supreme Court case that overruled a previous case and established the ability of a resident to deny entry to a building inspector without a warrant.
Radiation Control for Health and Safety Act of 1968 was an amendment to the Public Health Service Act mandating performance standards for electronic products suspectible of electromagnetic radiation or radiation emissions. The United States statute established provisions involving research and development programs for the studies of electromagnetic shielding, ionizing radiation, non-ionizing radiation, and exposure assessment to humans.
Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.