The Food and Drug Administration (FDA) is the United States oldest consumer protection agency.

This federal agency was previously named the Food, Drug, and Insecticide Administration, Bureau of Chemistry, and Division of Chemistry. The Department of Health and Human Services is the parent agency of the FDA. Nine agencies fall under the umbrella of the FDA. Formed in 1906 from other governmental agencies by the Pure Food and Drug Act, which prohibited interstate commerce in contaminated and mis-branded food and drugs. Initially the FDA intended to protect consumers from being abused by food and drug sellers by ensuring the safety and purity of food and drugs. Later, the agencys responsibility included protecting consumers from abusing drugs they purchase. Today, the FDA regulates the safety and efficacy of biologics, human and veterinary drugs, and medical devices; safety, wholesomeness, and sanitation of foods; and the safety of cosmetics and radiation-emitting electronic products. FDA has the task of advancing public health by approving new products and methods that result in safer, more effective, and cheaper drugs. In addition, the agency ensures that all regulated products are unadulterated and represented to the public accurately and informatively. FDA regulates the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for protection against counterterrorism and naturally emerging public health threats that endanger Americas food supply. However, advertising, alcohol, consumer products, drugs of abuse (illegal street drugs), health insurance, meat and poultry, pesticides, restaurants and grocery stores, and water are not regulated by the FDA. Since the Pure Food and Drug Act (PFDA) of 1906, more than 200 laws were enacted to protect consumers and public health. FDA rules and regulations ensure the saftey and efficacy of regulated products. In 1938, approval of Federal Food, Drug, and Cosmetics Act (FD&C Act) replaced the PFDA and enabled the FDA to regulate the safety of cosmetics and enforce the law through search and seizure and prosecution.2 The Kefauver-Harris Admendments of 1962 required manufactures to prove drug efficacy. In addition, the Medical device Amendments of 1976 required safety and effectiveness safeguards for medical devices.3 The Freedom of Information Act (FOIA) requires public access to On January 04, 2011 the Food Safety Modernization Act (FSMA) became law; it ensures safety of Americas food supply by requiring steps to prevent food contamination.4 Enforcing the law is an important responsibility of the FDA. FDA enforces the Freedom of Information Act (FOIA) which gives the public access to United States government records. 5 Chapter one of the Code of Federal Regulations (CFR) is also enforced by the FDA; it pertains to the Food, Drug, and Cosmetic Act regulations. CFR is a collection of general and permanent government rules.6 Standards are essential for FDA to evaluate the safety and effectiveness of products. FDA enforces laws when manufactures fail to meet criteria based on standardized activities that include: development of performance characteristics, testing methodology, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling, or other technical or policy criteria.7 Manufacturers of human pharmaceuticals must follow rules and regulations in CFR Title 21 Food and Drug: part 200 through part 300. For example, rules and regulations for current Good Manufacturing Practices (cGMP) are found in part 210 of CFR title 21 and they are applicable to manufacturing practices

in manufacturing, processing, packing, or holding of drugs. The section specifies the status, applications, and definitions of the GMPs; they are mandatory. Biologics GMPs for human blood and blood products are found in CFR title 21 part 606. However, requirements for human cells, tissues, and cellular and tissue-based products are regulated by current Good Tissue Practices (cGTPs), which protects against transmission of communicable diseases, including bacterial or fungal contamination during processing.10 Quality of medical devices is based on regulations of International Organization for Standardization (ISO) that are similar to cGMPs. ISO is a standardized acronym used by all countries to mean equal. One hundred sixty-three private and public agencies collaborate in ISOs to meet business requirements and to provide the greater needs of the public. Standards are necessary for the FDA to ensure desirable characteristics of regulated products and services including quality, safety, reliability, efficiency, and interchangeability at affordable costs.11 Manufacturers violate regulations by failing to meet mandated standards in development and manufacturing products and services. FDA can issue warnings to companies that violate rules and regulations such as cGMPs. Gulf Pharmaceutical Industries (2/23/12) and Laboratories Jaloma S.A. de C.V. (3/9/12) are two companies that received warning letters in 2012 from the FDAs Office of manufacturing and Product Quality.12 Gulf Pharmaceutical Industries was cited for adulterated products due to cGMP violations that require manufactures to take specific steps to prevent contaminantion. The warning letter stated the specific CFR code violated, a request for corrective actions and supporting documentation, and a specific deadline to respond to the letter. In addition, the FDA warned the company that their products will be not be accepted into the United States until there is proof of cGMP compliance and corrective actions are implemented. Laboratories Jaloma S.A. de C.V. had a similar warning letter for noncompliance to standards and cGMPs. The company had insufficent standards or equipment to perform required testing and they failed to obtain testing through an independent lab. In addition, Laboratories Jaloma failed to properly identify and label each active ingredient in the product.12

Works Cited http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_drug_administration/index. html 1

http://www.personalcarecouncil.org/1938-fdc-act 2 http://www.fda.gov/RegulatoryInformation/Legislation/default.htm 3 http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/Signif icantAmendmentstotheFDCAct/ucm244718.htm 4 http://www.gwu.edu/~nsarchiv/nsa/foia.html5 http://www.archives.gov/federal-register/cfr/ 6 http://www.fda.gov/RegulatoryInformation/Standards/default.htm 7 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx? sid=70b2295d9382a38221cd69e826125452&c=ecfr&tpl=/ecfrbrowse/Title21/21tab_ 02.tpl 8 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm 9 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=606
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http://www.iso.org/iso/about/discover-iso_what-standards-do.htm 11 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementAc tivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ ucm289143.htm 12