The FDA

1862 Bureau of Chemistry established as part of the US Department of Agriculture. 

1902 The Biologies Control Act is passed to ensure purity and safety of serums, vaccines, and 

1906 The original Food and Drugs Act is passed prohibiting misbranded and adulterated food and drugs. 

1912 Sherley Amendments prohibit labelling medicines with false therapeutic claims intended to defraud the purchaser. 

1927 The Bureau of Chemistry is re-organised with regulatory functions now residing in the Food, Drug and Insecticide Administration. 

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With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

The U.S. Food and Dmg 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. 

Acrylic polymers are considered to be nontoxic. In fact, the FDA allows certain acrylate polymers to be used in the packaging and handling of food. However, care must be exercised because additives or residual monomers present in various types of polymers can display toxicity. For example, some acryflc latex dispersions can be mild skin or eye irritants. This toxicity is usually ascribed to the surfactants in the latex and not to the polymer itself. 

The complexity of total replacement has slowed the rate of introduction of new materials, but most ingredient producers introduce a product which replaces one or two aspects of fat functionahty and has already been cleared for use in foods by the FDA. 

A number of products designated GRAS are being scmtini2ed by the FDA because of advertisements and claims made by producers or manufacturers of these products. Statements that indicate that feeding such products improve animal performance may require substantive data to support such claims in the future. 

FDA Quality Standards. Although standards for many dmgs and biologicals are included in the USP—NF, and for many food additives in the FCC, the FDA also estabhshes some specifications of its own. In the dmg field, specifications and testing methods for antibiotics and biologicals are set by the FDA. Also, specifications and testing methods are prescribed for colorants. Many food-additive petitions are granted with the requirement that certain specifications are met. 

A manufacturer of dmg chemicals is required to register with the FDA, and is subject to FDA inspection at least once every two years. Some manufacturers who make chemicals that incidentally are dmgs are impelled to drop the dmg designation from their labeling in order to avoid the exposure to inspection that registration entails. 

Cla.ssifica.tlon, In commerce, several classifications of flavoring and compounded flavorings are Hsted according to composition to allow the user to conform to state and federal food regulations and labeling requirements, as well as to show their proper appHcation. Both suppHer and purchaser are subject to the control of the FDA, USD A, and the Bureau of Alcohol, Tobacco, and Firearms (BATF). The latter regulates the alcohoHc content of flavors and the tax drawbacks on alcohol, ie, return of a portion of the tax paid on ethyl alcohol used in flavoring. 

The Food Chemicals Codex defines food-grade quaUty for the identity and purity of chemicals used in food products. In the United States, the FDA adopts many of the Food Chemicals Codex specifications as the legal basis for food-grade quaUty of flavor and food chemicals. 

The FDA appHes the Federal Food, Dmg and Cosmetic Act (3) to the spice iadustry and its products. The FDA has estabUshed a definition for spice which is somewhat general. It states, however, that vegetables such as onions, gadic, and celery are regarded as foods, not spices, even if dried. 

The FDA has pubhshed methods for the deterrnination of residual solvents in spice extracts such as oleoresins and has limited the concentrations of those specific solvents that are permitted. Chlorinated hydrocarbons and benzene have been almost completely removed from use as extracting solvents in the United States their use continues overseas where toxicity regulations are less stringent. The presence of pesticides or herbicides in spices is rigidly controHed by the FDA. 

PCTFE plastic is available in products that conform to ASTM 1430-89 Type 1 (Grades 1 and 2) and is suitable for processing into parts that meet MIL-P 46036 (Federal Specification LP-385C was canceled 1988). Standards for fabricated forms are available for compression molded heavy sections (AMS-3645 Class C), thin-walled tubing, rod, sheet, and molded shapes (AMS-3650). PCTFE plastics have been approved for use in contact with food by the FDA (55). 

Colorants. According to U.S. regulations, colorants are divided into two classes certified and exempt (see Colorants for foods, drugs, COSMETICS, AND MEDICAL DEVICES). Batch samples of certified colors must be sent to the FDA for analysis and confirmation that the colorants comply with estabhshed specifications. Color manufacturers pay a small fee for each batch of color that is analy2ed. The number of certified colors available to food technologists has declined. Several of the historical colorants were found to have carcinogenic effects. Table 1 shows the certified colors that are permissible for food use in the United States as of 1993. 

Saccharin. Sacchatin [81-07-2] C H NO S, which is approximately 300 times as sweet as sucrose ia coaceatratioas up to the equivaleat of a 10% sucrose solutioa, has beea used commercially as a nonnutritive sweeteaer siace before 1900, predomiaanfly ia carboaated soft drioks, tabletop sweeteaers, and dietetic foods marketed primarily to diabetics. In 1977, the FDA proposed a ban on sacchatin because of its association with bladder cancer ia laboratory animals. At the time, it was the only commercially available nonnutritive sweetener, and pubflc outcry led to a delay of the ban, which was officially withdrawn ia 1991. Instead, the FDA required that warning labels be placed on all foods that contained the iagredient. Although sacchatin is heat stable, the pubflc debate over its safety, as well as the fact that approximately one-third of the population perceives it to have a bitter aftertaste, has limited its use. 

In the United States, novel food ingredients or food ingredients produced by novel processes must be cleared by the FDA. In the case of meat and poultry, novel ingredients must also be cleared by the U.S. Department of Agriculture s Food Safety and Inspection Service (FSIS). 

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. 

The FDA first approved use of a polyether ionophore as a feed additive for catde ia 1975. Ionophores were first isolated from bacteria generally of the Streptomjces genus, but are produced commercially by bacterial fermentation (qv). Monensia [17090-79-8] and other ionophores are being fed to over 90% of feedlot cattle grown for beef (53) to enhance efficiency of gain improvements of 5—10% are common. Ionophores also are used as anticoccidial dmgs ia poultry production and have similar, but lesser, effects ia mminants (54). 

Health and Safety. The FDA affirmed (R-R, R -tartaric acid as a generally-recognized-as-safe (GRAS) food substance (88). 

One technology uses bovine somatotropin (bST) produced by recombinant technology (38). Somatotropin [9002-72-6] is a growth hormone. The bST-supplemented cows provide an increase in milk output per cow or an increased feed efficiency. Recombinant bST, also known as recombinant bovine growth hormone (rBGH) is the synthetic analogue of a natural hormone that increases milk production in cows (39). The use of recombinant technology was approved by the FDA in 1993. The Commission of the European Community has recommended that the moratorium on commercial use of BGH be delayed until the year 2000. 

The FDA has passed a rule (21 CFR 211.132) (3) requiring the use of tamper-evident packaging on all over-the-counter (OTC) dmgs and some cosmetics (qv), while ignoring other products they regulate (2). Table 1 offers examples of such packaging forms. 

When illegal residues have been found in monitoring studies conducted by the FDA or USD A, the reason has often been that no U.S. tolerance had been requested for that particular pesticide in that specific crop. For example, an imported crop would be deemed to be adulterated and would be seized at the port of entry into the United States if found to contain a pesticide residue in the absence of a tolerance in that crop. This is so even if tolerances have been set for the same pesticide in several crops grown in the United States and the pesticide had been used to control a pest that does not exist in the United States. Furthermore, an international maximum residue level (MRL) might already have been estabUshed for that pesticide—crop combination under the Codex system of standards for food of importance in international trade. The U.S. GAO issued two reports on food safety and pesticides in 1991 (89,90). 

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