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, caffeine 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.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies 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 United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States 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. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. 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.
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment. It is administered and regulated by the United States Environmental Protection Agency (EPA) and the appropriate environmental agencies of the respective states. FIFRA has undergone several important amendments since its inception. A significant revision in 1972 by the Federal Environmental Pesticide Control Act (FEPCA) and several others have expanded EPA's present authority to oversee the sales and use of pesticides with emphasis on the preservation of human health and protection of the environment by "(1) strengthening the registration process by shifting the burden of proof to the chemical manufacturer, (2) enforcing compliance against banned and unregistered products, and (3) promulgating the regulatory framework missing from the original law".
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005, is a controversial tort liability shield intended to protect pharmaceutical manufacturers from financial risk in the event of a declared public health emergency. The part of PREPA that actually affords such protection is now codified at 42 U.S.C. § 247d-6d. The act specifically affords to drug makers immunity from actions related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS). PREPA provides $3.8 billion for pandemic influenza preparedness to protect public health in the case of a pandemic disease outbreak.
Altria Group v. Good, 555 U.S. 70 (2008), was a United States Supreme Court case in which the Court held that a state law prohibiting deceptive tobacco advertising was not preempted by a federal law regulating cigarette advertising.
Tobacco politics refers to the politics surrounding the use and distribution of tobacco, likewise with regulations.
Hazard statements form part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). They are intended to form a set of standardized phrases about the hazards of chemical substances and mixtures that can be translated into different languages. As such, they serve the same purpose as the well-known R-phrases, which they are intended to replace.
Hazard pictograms form part of the international Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Two sets of pictograms are included within the GHS: one for the labelling of containers and for workplace hazard warnings, and a second for use during the transport of dangerous goods. Either one or the other is chosen, depending on the target audience, but the two are not used together for the same hazard. The two sets of pictograms use the same symbols for the same hazards, although certain symbols are not required for transport pictograms. Transport pictograms come in a wider variety of colors and may contain additional information such as a subcategory number.
The Family Smoking Prevention and Tobacco Control Act, is a federal statute in the United States that was signed into law by President Barack Obama on June 22, 2009. The Act gives the Food and Drug Administration the power to regulate the tobacco industry. A signature element of the law imposes new warnings and labels on tobacco packaging and their advertisements, with the goal of discouraging minors and young adults from smoking. The Act also bans flavored cigarettes, places limits on the advertising of tobacco products to minors and requires tobacco companies to seek FDA approval for new tobacco products.
Adulteration is a legal offense and when the food fails to meet the legal standards set by the government, it is said to have been Adulterated Food. One form of adulteration is the addition of another substance to a food item in order to increase the quantity of the food item in raw form or prepared form, which results in the loss of the actual quality of the food item. These substances may be either available food items or non-food items. Among meat and meat products some of the items used to adulterate are water or ice, carcasses, or carcasses of animals other than the animal meant to be consumed. In the case of seafood, adulteration may refer to species substitution (mislabeling), which replaces the species identified on the product label with another species, or undisclosed processing methods, in which treatments such as additives, excessive glazing, or short-weighting are not disclosed to the consumer.
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
ANSI Z535 are American-developed standards designed to improve the identification of potential hazards to workers and/or property. The identifications are called Hazardous Communication (HazCom). ANSI Z535 sets the design and application standards for all HazCom used across North America and globally, in most industrialized nations. ANSI Z535 standards integrate with international ISO 3864 standards, ensuring the widest compliance, globally, with export/import laws. ANSI Z535 standardized HazCom may appear on workplace walls, industrial machines, at industrial access points, on electrical controls, inside product user guides, and on export documentation.
Regulation of tobacco by the U.S. Food and Drug Administration began in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act by the United States Congress. With this statute, the Food and Drug Administration (FDA) was given the ability to regulate tobacco products.
The Food and Drug Administration is a federal agency of the United States, formed in 1930.
Women's Voices for the Earth (WVE) is a feminist, women-led, North American environmental organization that specializes in research and advocacy regarding toxic chemicals used in products that disproportionately impact women's health, including cosmetics, menstrual care products, professional salon and cleaning products. WVE is a non-profit organization whose mission is to amplify women's voices to eliminate toxics that harm communities and health. With its inclusive vision of environmental work WVE has become a hub for visionary feminist environmentalism that recognizes the systemic connections between health, class, race, and the environment. Addressing the inter-connectivity of these various channels of exposure to toxic chemicals has been key to WVE's approach which is multi-scalar: targeting consumer behaviors, corporate practices, and government policies.
Tobacco policy in Armenia is the attempt by the Armenian authorities to regulate smoking in Armenia. Tobacco laws and regulations are controlled by the Ministry of Health of Armenia. Armenian men tend to be the most common tobacco users, as 42.5% of men over the age of 15 smoke.
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.
A safety sign is a sign designed to warn of hazards, indicate mandatory actions or required use of personal protective equipment, prohibit actions or objects, identify the location of firefighting or safety equipment, or marking of exit routes.
