U.S. Food and Drug Administration regulation

Virgin UHMWPE grades are in compliance with U.S. Food and Drug Administration regulations (13). 

The U.S. Food and Drug Administration regulates acetal resins intended for repeated contact with food. The FDA regulation for homopolymer is 21CFR 177.2480 and that for copolymer is 21CFR 177.2470. The U.S. Department of Agriculture regulates the use of acetal resins in contact with meat and poultry. 

The U.S. Food and Drug Administration regulates PVB resins used as indirect food additives (19,20). However, PVB resin is practically nontoxic by single-dose oral ingestion (LD50 > 10.0 g/kg for rats). Unformulated PVB and PVF resins have flash points above 370°C. The lower explosive limit for PVB dust in air is 20 g/m. Details on specific products are available with the manufacturer. 

BUSAN 40 is registered with the Environmental Protection Agency (EPA Reg. No. 1448-52) and is allowed for use in the manufacture of paper and paperboard under 21 CFR 176.300 of the U.S. Food and Drug Administration regulations. 

This pigment is recognized by the U.S. Food and Drug Administration (21 Code of Federal Regulations, Part 73) as a color additive exempted from certification (Subpart A, Foods, Section 73.35, Astaxanthin). Formulations containing astaxanthin include soft gelatin capsules containing 100 mg equivalents of total carotenoids, a skin care... 

The final consideration, but by no means a minor one, is the design and evaluation of contact lens care products, which are regulated by the U.S. Food and Drug Administration (FDA) as medical devices since... 

FDA. 1995. Substances prohibited from use in human food. Substances prohibited from indirect addition to human food through food-contact surfaces. U.S. Food and Drug Administration. Code of Federal Regulations. 21 CFR 189.240. 

Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Act No. 117 of October 16,1973 amended in 2009)], as well as their continued use by the U.S. Environmental Protection Agency (EPA) [Kavlock R, Dix D. J Toxicol Environ Health B Crit Rev 13(2-4) 197-217, 2010] and U.S. Food and Drug Administration (FDA) [U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) TSCA (1976) Toxic Substances Control Act. United States Publ. Law 94-469, 90 Stat 2003, USA],... 

Data are scarce in mammals that link zinc concentrations in tissues with environmental zinc perturbations. In harbor porpoises, impaired homeostasis reportedly occurs when zinc exceeds 100 mg/kg FW liver however, livers of many species of marine mammals routinely exceed this value (Wood and Van Vleet 1996). Elevated zinc concentrations, in mg Zn/kg DW tissue, were >120 in cattle liver, >180 in sheep kidney, and >250 in sheep liver (Table 9.9), but their significance is unclear. No international regulations or guidelines applicable to zinc are available (USPHS 1989). No U.S. Food and Drug Administration action level or other maximum acceptable concentration exists for zinc, and therefore no Final Residue Value can be calculated (USEPA 1987). This seems to be a high priority research need. 

Comprehensive federal laws, regulations, and guidelines help protect people who participate in research studies (called clinical trials). The U.S. Food and Drug Administration (FDA) regulates all gene therapy products in the United States and oversees research in this area. Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA. The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. 

The U.S. Environmental Protection Agency (US-EPA) is the federal agency responsible for regulating the level of contaminants in ambient air (Section 9.2.2.1), drinking water (Section 9.2.2.2), and soil (Section 9.2.2.3) while the U.S. Food and Drug Administration (US-FDA) is the federal agency responsible for regulating the level of contaminants in food (Section 9.2.2.4). 

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