FDA approval

MDI-diol-cured polyurethanes generally can receive FDA approval for use, provided no mercury catalysts are used. Polyurethanes made from most amine-cured TDI material will not meet the requirements for FDA approval. Trimetyleneglycol di-p-aminobenzote (Versalink 740M) of the diamine 

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The various FDA approved (ca 1992) feed additives for chicken, turkey, and swine, grouped according to their usage, are as follows ... 

The 1993 market for LPC-type products in the United States was for dried alfalfa meal for animal feed. This product is sold for both protein and carotenoid content. The USDA Pro-Xan product attempts to obtain improved xanthophyU contents for use in egg-laying rations in addition to protein contents. The limitations to commercial development of LPC products for human food use are high capital costs as compared with the low yields of protein, seasonal availabihty of raw materials, and the need in the United States for FDA approval of the products. 

Classification of the anabolic steroids is based on chemical stmctures and associated actions. A review of the biosynthesis and metabolism of the naturally occurring estrogens and androgens is available (1). Names, descriptions, approval dates, and recommended doses of the commercial products are found in References 1, 8, and 9. Although steroids may be orally active, the FDA approved mode of adrninistration is the subcutaneous implant. Effective dose is lower with implant rather than oral adrninistration. 

Typically, soHd stabilizers utilize natural saturated fatty acid ligands with chain lengths of Cg—C g. Ziac stearate [557-05-1/, ziac neodecanoate [27253-29-8] calcium stearate [1592-23-0] barium stearate [6865-35-6] and cadmium laurate [2605-44-9] are some examples. To complete the package, the soHd products also contain other soHd additives such as polyols, antioxidants, and lubricants. Liquid stabilizers can make use of metal soaps of oleic acid, tall oil acids, 2-ethyl-hexanoic acid, octylphenol, and nonylphenol. Barium bis(nonylphenate) [41157-58-8] ziac 2-ethyIhexanoate [136-53-8], cadmium 2-ethyIhexanoate [2420-98-6], and overbased barium tallate [68855-79-8] are normally used ia the Hquid formulations along with solubilizers such as plasticizers, phosphites, and/or epoxidized oils. The majority of the Hquid barium—cadmium formulations rely on barium nonylphenate as the source of that metal. There are even some mixed metal stabilizers suppHed as pastes. The U.S. FDA approved calcium—zinc stabilizers are good examples because they contain a mixture of calcium stearate and ziac stearate suspended ia epoxidized soya oil. Table 4 shows examples of typical mixed metal stabilizers. 

LLDPE by itself does not present any health-related hazard on account of its chemical inertness and low toxicity. Consequently, film, containers, and container Hds made from LLDPE are used on a large scale in food and dmg packaging. Some LLDPE grades produced with unsupported metallocene catalysts have an especially high purity due to high catalyst productivity and a low contamination level of resins with catalyst residue. FDA approved the use of film manufactured from these resins for food contact and for various medical appHcations (80). However, if LLDPE articles contain fillers, processing aids, or colorants, thek health factors must then be judged separately. 

In the United States, through the NDA review process, pharmaceutical companies that seek FDA approval for new dmg products are assessed user fees by FDA to gain faster approval, by virtue of the U.S. Prescription Dmg User Fee Act of 1992. These assessments are used to increase the new dmg review staff of the FDA, which has agreed to reduce the NDA review time to 12 months by 1997 (6). 

Various medical devices based on Terathane have been approved by the U.S. FDA, including those used within the body. Formulators are cautioned, however, that FDA approval is not given genericaHy for these devices it must be appHed for separately by each manufacturer for each device. Additional data on safety of PTMEG may be found in the material safety and data sheets provided by the manufacturers. 

There is a health benefit associated with hindering hydrogen bonding. Alkylphenols as a class are generally regarded as corrosive health hazards, but this corrosivity is eliminated when the hydroxyl group is flanked by bulky substituents in the ortho positions. In fact, hindered phenols as a class of compounds are utilized as antioxidants in plastics with FDA approval for indirect food contact. 

Sodium alumiaate is used ia the treatment of iadustrial and municipal water suppHes and the use of sodium alumiaate is approved ia the clarification of drinking water. The FDA approves the use of sodium alumiaate ia steam generation systems where the steam contacts food. One early use of sodium alumiaate was ia lime softening processes, where it iacreases the precipitation of ions contributing to hardness and improves suspended soHds removal from the treated water (17). Sodium alumiaate reacts with siHca to leave very low residual concentrations of siHca ia hot process water softeners. Sodium alumiaate is often used with other chemicals such as alum, ferric salts, clays, and polyelectrolytes, as a coagulant aid (18,19). 

Aluminum chlorohydrate [12359-72-7] Al2(OH) Gl 2H20 is a PAG product of specific composition, having r = 2.5. Aluminum chlorohydrate is used in antiperspirants regulated by the U.S. Food and Dmg Administration (FDA). Solutions sold for FDA-approved use are colorless in appearance, have 23—24% Al as AI2O2, and low levels of iron (<50 ppm), sulfate (<0.025 %), metals (Ga, Mg, Na <10 ppm), and heavy metals (as Pb <10 ppm). The pH of these solutions at 25°G is about 3.8—4.0. Typically, solutions at 25°G have specific gravities from 1.33 to 1.35 and viscosities from 40 to 60 mPa-s(=cps). Aluminum chlorohydrate [12042-91 -0] is also available in dry form with different particle-size distributions. 

In addition to being used for screening purposes for new dmg development, labeled dmgs and ligands are widely used by pharmaceutical companies for metabohc, bioavailabihty, and toxicological studies to support new dmg appHcations for FDA approval. 

Selective Serotonin Reuptake Inhibitors. In 1987, the FDA approved fluoxetine [54910-89-3] (42) for use in the treatment of major... 

Stannous chloride, an FDA-approved direct food additive with GRAS status, has also been extensively studied (59—62). In three FDA-sponsored studies, it was determined that stannous chloride is nonmutagenic in rats when administered orally up to 50 mg/kg to pregnant mice for ten consecutive days, stannous chloride has no discernible effect on nidation or on maternal or fetal survival and, when administered orally at 41.5 mg/kg to pregnant rabbits for 13 consecutive days, it produced no discernible effect on nidation or on maternal or fetal survival (63—65). 

Amantadine hydrochloride [665-66-7] (1-adamantanamine hydrochloride, 41), C qH N HQ., (93) is a good example of a narrow-spectmm agent active only against influenza A vims. It became the first antiviral dmg available for systemic use in the United States when it was approved by the FDA in 1966 for use against Asian influenza. In 1976, FDA approval was extended to the use of amantadine for the reHef of symptoms of all influenza A strains. Amantadine is marketed by Du Pont de Nemours Co., Inc. A stmcturaHy related dmg, rimantadine hydrochloride [1501 -84-4] C 2H2 N HQ, (a-methyl-l-adamantanemethylamine hydrochloride, 42), is widely used in Russia to treat influenza A vims (94). 

A series of sorbitol-based nonionic surfactants are used ia foods as water-ia-oil emulsifiers and defoamers. They are produced by reaction of fatty acids with sorbitol. During reaction, cycHc dehydration as well as esterification (primary hydroxyl group) occurs so that the hydrophilic portion is not only sorbitol but also its mono- and dianhydride. The product known as sorbitan monostearate [1338-41 -6] for example, is a mixture of partial stearic and palmitic acid esters (sorbitan monopalmitate [26266-57-9]) of sorbitol, 1,5-anhydro-D-glucitol [154-58-8] 1,4-sorbitan [27299-12-3] and isosorbide [652-67-5]. Sorbitan esters, such as the foregoing and also sorbitan monolaurate [1338-39-2] and sorbitan monooleate [1338-43-8], can be further modified by reaction with ethylene oxide to produce ethoxylated sorbitan esters, also nonionic detergents FDA approved for food use. 

To meet consumer demands, manufacturers are developing new nonnutritive sweeteners that more closely match the taste and mouthfeel of sucrose. There are several nonnutritive sweeteners currentiy pending FDA approval for use in soft drinks. They include sucralose [56038-13-2] aUtame [80863-62-3] encapsulated aspartame, cyclamates, and acesulfame-K [55589-62-3] also known as paUtinit. 

Because of the many choices of hydrophilic monomers, cross-linkers, and hydrophobic monomers, a large number of formulations have been developed and manufactured into hydrogel lenses. The water content of these hydrogel lenses ranges from about 38%, for HEMA-based lenses, to 80%, for poly(vinyl alcohol) and partially hydrolysed acrylonitrile lenses. Table 2 gives a representative Hst of FDA approved hydrogel materials available to the consumer in the early 1990s. 

In 1998 it was also announced that PEEK had obtained FDA approval for food contact applications. This raises the possibility of the material being used for such purposes as food containers, bearings and seals for processing equipment and as a coating for metals in non-stick cookware. 

Polyterpenes enjoy a number of FDA approvals. They are not only suitable for adhesives with indirect food contact, but also for use in both chewing gum and in films that will have direct food contact. Their higher price compared to petroleum-derived equivalents has resulted in a significant decline in usage over the past 10 years, except where FDA approvals dictate their usage. 

Approved indications FDA-approved in May, 2000, as lung sealant. FDA-approved in 1998 for skin closure of external lacerations and simple incisions. Avoid high tension. FDA-approved in December, 2001, as an adjunct in vascular surgical anastomoses. 

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