FFDCA

FFDCA, among other things, assured the safety of processed foods by establishing safe tolerance limits for pesticide residues in processed foods. The mles and interpretation of the mles were not always consistent between these two government offices. 

The FFDCA governs the establishment of pesticide tolerance for food and feed products. A tolerance is the maximum level of pesticide residues allowed in or on human food and animal feed. ... 

Test article (FDA) Any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the FFDCA or PHSA. 

The Federal Food, Drug and Cosmetic Act (FFDCA) places the responsibility for establishing the safety and efficacy of human and veterinary drugs and devices and the safety of food and color additives on the sponsor of the regulated product. The Public Health Service Act requires that a sponsor... 

The FDA s Bureau of Drugs requested a for-cause inspection of the manufacturer s laboratories to determine the cause and extent of the discrepancies. A for-cause inspection is one initiated at the request of an agency unit when there is reason to suspect a problem in an FDA-regulated product. The authority to make for-cause inspections is a general one imder the FFDCA, but one that had rarely been apphed to animal laboratories. 

The basic mechanism of enforcement was to be inspection of testing facihties by FDA field investigators. The FDA s authority to conduct inspections of facilities engaged in interstate commerce of regulated products is well estabhshed, and such inspections are the primary method of enforcement of the FFDCA. Under the proposal, studies performed by a testing facility that refused to permit inspection would not be accepted in support of an application for a research or marketing permit. 

The study examined the pertinent sections of the two relevant statutes, the FFDCA and PHSA, and their implementing regulations in the Code of Federal Regulations Title 21 (21 CFR). We searched the literature for relevant documents, especially for the type of pertinent reports that seldom get entered in the archival literature. 

Promulgation of the FFDCA in 1938, specifically the pre-market testing that it mandates, led to the publication of many studies that reported the metabolism,... 

As with the FFDCA, the FIFRA requires pesticide firms to conduct batteries of extensive testing to identify and characterize a candidate pesticide s bioavailability, distribution, metabolites, routes of excretion in experimental animals, and any adverse or toxic effects that the substance may cause, so that the safety of the pesticide can be assessed. In addition, in cases of pesticides intended to have food uses, extensive field trials must be conducted to characterize residues of the pesticide or metabolites thereof remaining on or in raw agricultural commodities. 

Prior to 1976, in total contrast to the extensive testing and other pre-market approval requirements established under the FFDCA for new substances intended to be marketed as drugs, and under the FIFRA for new substances intended to be marketed as pesticides, there were no pre-market statutory requirements for new industrial chemicals to protect human health and the environment from the risks posed by such substances. In the USA, chemical manufacturers could produce and market any new industrial chemical at will and without notifying the EPA. 

Just as similar requirements under the FFDCA caused the evolution of the medicinal chemist and changes in the way in which chemists are trained and approach drug design, and similar requirements under the FIFRA effectively caused changes in the way in which organic chemists are trained and approach the design of... 

For finished drug products, cGMP under 21 CFR, Parts 210 and 211, refers to the finished drug products. Section 501(a)(2)(B) of the FFDCA requires that all... 

Across the globe, countries employ their own legislative controls for food ingredients, but there are two main regions that exert great influence upon world opinion on this issue the European system controlled by the European Parliament with designated E-numbers for permitted food additives, and the system used in the United States where at the federal level the Federal Food, Drag and Cosmetic Act (FFDCA) lays down the framework for food safety. 

A petition or other request for establishment or modification of a tolerance, for an exemption for the need for a tolerance, or for other clearance under FFDCA section 408. 

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