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.
Food additives are substances added to food to preserve flavor or enhance taste, appearance, or other sensory qualities. Some additives have been used for centuries as part of an effort to preserve food, for example vinegar (pickling), salt (salting), smoke (smoking), sugar (crystallization), etc. This allows for longer-lasting foods such as bacon, sweets or wines. With the advent of ultra-processed foods in the second half of the twentieth century, many additives have been introduced, of both natural and artificial origin. Food additives also include substances that may be introduced to food indirectly in the manufacturing process, through packaging, or during storage or transport.
Stevia is a sweet sugar substitute extracted from the leaves of the plant species Stevia rebaudiana native to Paraguay and Brazil.
Butylated hydroxytoluene (BHT), also known as dibutylhydroxytoluene, is a lipophilic organic compound, chemically a derivative of phenol, that is useful for its antioxidant properties. BHT is widely used to prevent free radical-mediated oxidation in fluids and other materials, and the regulations overseen by the U.S. F.D.A.—which considers BHT to be "generally recognized as safe"—allow small amounts to be added to foods. Despite this, and the earlier determination by the National Cancer Institute that BHT was noncarcinogenic in an animal model, societal concerns over its broad use have been expressed. BHT has also been postulated as an antiviral drug, but as of December 2022, use of BHT as a drug is not supported by the scientific literature and it has not been approved by any drug regulatory agency for use as an antiviral.
Cyclamate is an artificial sweetener. It is 30–50 times sweeter than sucrose, making it the least potent of the commercially used artificial sweeteners. It is often used with other artificial sweeteners, especially saccharin; the mixture of 10 parts cyclamate to 1 part saccharin is common and masks the off-tastes of both sweeteners. It is less expensive than most sweeteners, including sucralose, and is stable under heating. Safety concerns led to it being banned in a few countries, though the European Union considers it safe.
Brominated vegetable oil (BVO) is a complex mixture of plant-derived triglycerides that have been reacted to contain atoms of the element bromine bonded to the molecules. Brominated vegetable oil is used primarily to help emulsify citrus-flavored soft drinks, preventing them from separating during distribution. Brominated vegetable oil has been used by the soft drink industry since 1931, generally at a level of about 8 ppm.
The Food Additives Amendment of 1958 is a 1958 amendment to the United States' Food, Drugs, and Cosmetic Act of 1938. It was a response to concerns about the safety of new food additives. The amendment established an exemption from the "food additive" definition and requirements for substances "generally recognized as safe" by scientific experts in the field, based on long history of use before 1958 or based on scientific studies. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive.
In food safety, the concept of substantial equivalence holds that the safety of a new food, particularly one that has been genetically modified (GM), may be assessed by comparing it with a similar traditional food that has proven safe in normal use over time. It was first formulated as a food safety policy in 1993, by the Organisation for Economic Co-operation and Development (OECD).
Cannabidiol (CBD) is a phytocannabinoid discovered in 1940. It is one of 113 identified cannabinoids in cannabis plants, along with tetrahydrocannabinol (THC), and accounts for up to 40% of the plant's extract. As of 2019, clinical research on CBD included studies related to anxiety, cognition, movement disorders, and pain, but there is insufficient high-quality evidence that cannabidiol is effective for these conditions. Nevertheless, CBD is a herbal dietary supplement promoted with unproven claims of particular therapeutic effects.
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.
D-Psicose (C6H12O6), also known as D-allulose, or simply allulose, is a low-calorie epimer of the monosaccharide sugar fructose, used by some major commercial food and beverage manufacturers as a low-calorie sweetener. First identified in wheat in the 1940s, allulose is naturally present in small quantities in certain foods.
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.
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.
Glutamate flavoring is the generic name for flavor-enhancing compounds based on glutamic acid and its salts (glutamates). These compounds provide an umami (savory) taste to food.
The Flavor and Extract Manufacturers Association (FEMA) is a food industry trade group based in the United States. FEMA was founded in 1909 by several flavor firms in response to the passage of the Pure Food and Drug Act of 1906. Founding members were McCormick & Company, Ulman Driefus & Company, Jones Brothers, Blanke Baer Chemical Company, Frank Tea & Spice Company, Foote & Jenkes, Sherer Gillett Company, and C.F. Sauer Company.
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.
A caffeinated alcoholic drink is a drink that contains both alcohol and a significant amount of caffeine. Caffeine, a stimulant, masks some of the depressant effects of alcohol. However, in 2010 and 2011, this type of drink faced criticism for posing health risks to its drinkers. In some places there is a ban on caffeinated alcoholic drinks.
Saccharin Study and Labeling Act of 1977 or Saccharin Study, Labeling and Advertising Act was a United States federal statute enacting requirements for a scientific observation regarding the impurities in, potential toxicity, and problematic carcinogenicity of a non-nutritive sweetener better known as saccharin. The Act of Congress invoked an immediate eighteen month moratorium prohibiting the Secretary of Health, Education, and Welfare from pursuing regulatory implications by limiting the production and use of saccharin. The Act codified a warning label requirement advocating the non-nutritive sweetener had been discovered to yield carcinogenicity in laboratory animals.
The Food Chemicals Codex (FCC) is a collection of internationally recognized standards for the purity and identity of food ingredients.
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.
