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.
Cosmetics are composed of mixtures of chemical compounds derived from either natural sources or synthetically created ones. Cosmetics have various purposes, including personal and skin care. They can also be used to conceal blemishes and enhance natural features. Makeup can also add colour to a person's face, enhance a person's features or change the appearance of the face entirely to resemble a different person, creature, or object.
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) and strengths of final products.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
Ranbaxy Laboratories Limited was an Indian multinational pharmaceutical company that was incorporated in India in 1961 and remained an entity until 2014. The company went public in 1973. Ownership of Ranbaxy changed twice over the course of its history.
Anti-aging creams are predominantly moisturizer-based skin care products marketed with unproven claims of making the consumer look younger by reducing, masking or preventing signs of skin aging. Anti-aging supplements are ingestible products promoted to diminish the effects of aging, including vitamin supplements, powders, and teas.
Nutraceutical is a marketing term used to imply a pharmaceutical effect from a compound or food product that has not been scientifically confirmed or approved to have clinical benefits. In the United States, nutraceuticals are considered and regulated as a subset of foods by the Food and Drug Administration (FDA).
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.
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Natural skin care uses topical creams and lotions made of ingredients available in nature. Much of the recent literature reviews plant-derived ingredients, which may include herbs, roots, flowers and essential oils, but natural substances in skin care products include animal-derived products such as beeswax, and minerals. These substances may be combined with various carrier agents, preservatives, surfactants, humectants and emulsifiers.
Skin care or skincare is a range of practices that support skin integrity, enhance its appearance, and relieve skin conditions. They can include nutrition, avoidance of excessive sun exposure, and appropriate use of emollients. Practices that enhance appearance include the use of cosmetics, botulinum, exfoliation, fillers, laser resurfacing, microdermabrasion, peels, retinol therapy, and ultrasonic skin treatment. Skin care is a routine daily procedure in many settings, such as skin that is either too dry or too moist, and prevention of dermatitis and prevention of skin injuries.
Direct-to-consumer advertising (DTCA) refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. The term is synonymous primarily with the advertising of prescription medicines via mass media platforms—most commonly on television and in magazines, but also via online platforms.
The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.
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 revenues from them. Often the practice includes taking out new patents, or by buying out or frustrating competitors, for longer periods of time than would normally be permissible under the law. Robin Feldman, a law professor at UC Law SF and a leading researcher in intellectual property and patents, defines evergreening as "artificially extending the life of a patent or other exclusivity by obtaining additional protections to extend the monopoly period."
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
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 Food and Drug Administration is a federal agency of the United States, formed in 1930.
The Proxmire Amendments were a series of legislation that prohibited the Food and Drug Administration from monitoring and limiting the potency of vitamins and minerals found in dietary supplements. The Proxmire Amendment also made it so that food supplements could not be classified as drugs, making their sale possible without a prescription from a doctor. According to a study done, "dietary supplements fall into the following categories: vitamins, minerals, herbs or other botanicals, amino acids, animal-derived products, hormones and hormone analogues, enzymes, and concentrates, metabolites, constituents, or extracts of these." They can be used by anyone wishing to purchase them as much or as little as they desire. Dietary supplements can be used to increase productivity, treat illness, help mental health such as depression and anxiety, enhancing mental abilities, building muscle, or losing weight, among many other uses. William Proxmire, a Senator for Wisconsin, was instrumental in influencing the passing the Proxmire Amendment. The Proxmire Amendment is also known as The Rogers-Proxmire Amendment of 1976, and The Vitamins and Minerals Amendments. This amendment became section 411 of the Federal Food, Drug, and Cosmetic Act.
