Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act.
Learn More »The Bioterrorism Act was signed by President Bush on June 12, 2002 and authorized over $3 billion in funds for various federal agencies' efforts to guard against bioterrorist attack and other public health emergencies. Subtitle A of Title III of the Act sets forth four major provisions requiring FDA action. In response, most recently the FDA enacted final regulations, which were effective as of February 7, 2005, governing the establishment and maintenance of records to protect the U.S. human food and animal feed supply in the event of credible threats of serious adverse health consequences or death to humans or animals went into effect. The final regulations implemented §306 of the Bioterrorism Act, which directs the HHS Secretary to issue regulations requiring persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. These records will identify the immediate previous source of all food received, as well as the immediate subsequent recipient of all food released. These records allow the FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists, enabling the agency to get to the source of contamination. The Bioterrorism Act allows the FDA to bring civil and criminal actions against persons who fail to comply with this rule.
Prior to the final implementation in December, three other sections of the Bioterrorism Act were enacted over the last two years granting the FDA powers to protect the U.S. food supply. First, the FDA is authorized to detain an article of food for which there is credible evidence or information indicating such article presents a threat of serious adverse health consequences or death to humans or animals. Food subject to the administrative detention regulations include food and beverages for human and animal consumption. Second, food manufacturers are required to give prior notice of food, including animal feed, that is imported or offered for import into the United States. Prior notice must be submitted to the FDA electronically via either the Bureau of Customs and Border Protection Automated Broker Interface of the Automated Commercial System or the FDA Prior Notice System Interface. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Finally, all domestic and foreign food facilities were required, under the Bioterrorism Act, to register with the FDA by December 12, 2003. In the event of attack or outbreak of foodborne illness, registration should permit the FDA to quickly determine causes and promptly notify affected parties. The registration rules apply to all food and animal feed products, including dietary supplements, infant formulas, alcoholic beverages, and food additives, but not to farms, restaurants, non-profit establishments, fishing vessels, USDA-regulated slaughterhouses, and foreign facilities whose products undergo more than de minimus processing in the United States. Foreign facilities, which now need agents in the United States, may designate their agents to do the registration.
Ensuring food safety is a priority of the FDA and an important component of the war on terror. Therefore, it has become vitally important for the food industry to understand the intricacies and implications of the Bioterrorism Act.
For more information regarding this topic, see the Food, Drug and Cosmetics Law Reporter. The Reporter provides the full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act. Learn more.
Food, Drug and Cosmetics Law Reporter
Everything you need to know about Food and Drug Regulations.Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Learn More » |
Medical Devices ReporterAccess the full text plus expert analysis of all laws and regulations governing the classification, approval, manufacture, and marketing of all medical diagnostic, and radiological devices. Learn More » |