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.
A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.
Organic certification is a certification process for producers of organic food and other organic agricultural products, in the European Union more commonly known as ecological or biological products. In general, any business directly involved in food production can be certified, including seed suppliers, farmers, food processors, retailers and restaurants. A lesser known counterpart is certification for organic textiles that includes certification of textile products made from organically grown fibres.
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 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).
A nutraceutical or bioceutical is a pharmaceutical alternative which claims physiological benefits. In the US, nutraceuticals are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, under the authority of the Federal Food, Drug, and Cosmetic Act. The word "nutraceutical" is a portmanteau term, blending the words "nutrition" and "pharmaceutical".
Quality Assurance International (QAI) is a U.S.-based international organic certification company that is authorized by the United States Department of Agriculture (USDA) as "a USDA-accredited certifying agent that operates globally to certify organic operations to National Organic Program standards." It is a for-profit corporation, established in 1989, and headquartered in San Diego, California. It is one of the world's largest certifiers, operating in the United States, Canada, Latin America, European Union, and Japan. It is owned by public health and environmental organization NSF International.
GNC Holdings, LLC is a retail company based in Pittsburgh, Pennsylvania. It specializes in health and nutrition related products, including vitamins, supplements, minerals, herbs, sports nutrition, diet, and energy products.
Food policy is the area of public policy concerning how food is produced, processed, distributed, purchased, or provided. Food policies are designed to influence the operation of the food and agriculture system balanced with ensuring human health needs. This often includes decision-making around production and processing techniques, marketing, availability, utilization, and consumption of food, in the interest of meeting or furthering social objectives. Food policy can be promulgated on any level, from local to global, and by a government agency, business, or organization. Food policymakers engage in activities such as regulation of food-related industries, establishing eligibility standards for food assistance programs for the poor, ensuring safety of the food supply, food labeling, and even the qualifications of a product to be considered organic.
Pet food is animal feed intended for consumption by pets. Typically sold in pet stores and supermarkets, it is usually specific to the type of animal, such as dog food or cat food. Most meat used for animals is a byproduct of the human food industry, and is not regarded as "human grade".
The health freedom movement is a libertarian coalition that opposes regulation of health practices and advocates for increased access to "non-traditional" health care.
Dental laboratories manufacture or customize a variety of products to assist in the provision of oral health care by a licensed dentist. These products include crowns, bridges, dentures and other dental products. Dental lab technicians follow a prescription from a licensed dentist when manufacturing these items, which include prosthetic devices and therapeutic devices. The FDA regulates these products as medical devices and they are therefore subject to FDA's good manufacturing practice ("GMP") and quality system ("QS") requirements. In most cases, however, they are exempt from manufacturer registration requirements. Some of the most common restorations manufactured include crowns, bridges, dentures, and dental implants. Dental implants is one of the most advanced dental technologies in the field of dentistry.
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.
ConsumerLab.com, LLC. is a privately held American company registered in White Plains, NY. It is a publisher of test results on health, wellness, and nutrition products. Consumer Labs is not a laboratory, but contracts studies to outside laboratories. It purchases supplement products and other consumer goods directly from public storefronts and publishes reports based on the results. It primarily derives revenue from the sale of subscriptions to its online publications. Other sources of revenue include a proprietary certification program, licensing fees, contents re-publication license fees and advertising.
The Nutrition Labeling and Education Act (NLEA) is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W. Bush.
Unlike the National Organic Program in the United States, there is no legal definition of the word "natural" for food and consumer products. The Food and Drug Administration continues to follow the policy it set in 1993: "FDA has not established a formal definition for the term 'natural', however the agency has not objected to the use of the term on food labels provided it is used in a manner that is truthful and not misleading and the product does not contain added color, artificial flavors, or synthetic substances. Use of the term 'natural' is not permitted in the ingredient list, with the exception of the phrase 'natural flavorings'."
The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing of their health and medical claims.
The American Feed Industry Association (AFIA) is a not-for-profit organization that represents the feed industry in industry-wide events, national and state legislation, etc. Members of the AFIA include livestock feed manufacturers, ingredient suppliers, pet food manufacturers, supplier companies, regional and state associations, and international firms.
The Council for Responsible Nutrition (CRN) is a Washington D.C.-based trade association and lobbying group representing ingredient suppliers and manufacturers in the dietary supplement industry. CRN's current president and CEO is Steve M. Mister.
The Taiwan Quality Food Association (TQF Association) is a juridical association responsible for the management of the Taiwan Quality Food (TQF) Product Certification Scheme, which is in compliance with GHP, GMP and HACCP standards requirements, and also to provide guidelines and support for the food industry to voluntarily implement food safety management system. TQF Association's five main core functions are as follow:
- Harmonization of TQF certification with international food safety standards.
- Authorization of independent and impartial third-party certification bodies to assess compliance with TQF standards.
- Supervision and monitoring of certification bodies for the TQF Product Certification Scheme by an independent and impartial third-party accreditation body Taiwan Accreditation Foundation.
- Implement unannounced and unscheduled annual surveillance auditing.
- Promotion of a comprehensive upgrade on the professional competences of the food industry.
The Proxmire Amendments were a series of legislation that prohibits 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 analogs, 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, treating illness, helping 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.
