Cosmetic Act

In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act, which served to  

The Food Additives Amendment was added in 1958, requiring manufacturers of new food additives to establish safety. The Delaney proviso prohibited the approval of any food additive shown to induce cancer in humans or animals, and the FDA published the first list of substances, including herbs and spices, as Generally Recognized As Safe (GRAS) in the Federal Register. The list contained nearly 200 substances. This list is now compiled under Title 21 of the Code of Federal Regulations. 

---

Action to compile standards for food-grade chemicals did not take place until after the enactment of the Food Additives Amendment to the Food, Dmg, and Cosmetic Act in 1958 (13). This amendment stated that substances added to foods should be of food-grade quaUty, but it contained no criteria by which such quahty could be determined (see also Colorants forfood, drugs, cosmetics, and medicaldevices). The Food Protection Committee of the National Academy of Sciences—National Research Council (NAS—NRC) therefore undertook the project of producing a Food Chemicals Codex. 

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. 

Cranberry juice, too acidic to be consumed as a 100% juice drink, has been sold since 1929 as cranberry juice cocktail. Juice extraction usually involves pressing the juice from thawed cranberries in a tapered screw press, which affords a 60—64% juice yield. The juice is diluted with two volumes of water and sugar is added to raise the °Brix to 15 to produce a juice cocktail. Under the Federal Food, Dmg and Cosmetic Act, cranberry juice cocktail must contain not less than 25% single-strength cranberry juice with soluble soHds content of 14—16 °Brix, vitamin C content of 30—60 mg/177 mL (6 02), and... 

Hair Coloring Regulation Issues. In the United States the classification of color additives is complex. Under the Federal Food, Dmg and Cosmetic Act, all cosmetic colors must be the subject of an approved color additive petition to the Food and Dmg Administration there is an exception for coal-tar colorants used to color hair. Based on the composition of these colorants, FDA can require a certification on each manufactured batch of colorant to assure conformance with the approved specifications. In the early 1990s FDA has required certification only for synthetically derived coal-tar type colors. Many of the approved color additives, both certified and noncertified, are restricted ia their potential use. These restrictions can be found ia the color additive regulations ia the Code of Federal Regulations at 21 CFR 73 and 74. 

Dmg and Cosmetics Act and the Fair Packaging and Labeling Act. Each of these Acts imposes slightly different conditions and labeling requirements for the products under their jurisdiction. 

The Food, Dmg and Cosmetics Act defines a cosmetic as a substance intended to be mbbed, poured, sprinkled, or sprayed on, introduced into, or otherwise appHed to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. A dmg is defined as an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals, and articles intended to affect the stmcture or any function of the body of humans or other animals. 

The Fair Packaging and Labeling Act, which uses the same definitions for dmgs and cosmetics as the Food, Dmg and Cosmetic Act, only has jurisdiction over retail products sold to the consumer for use at home. This condition exempts free samples and professional use products not sold to a consumer for personal use. 

Labeling Regulations. The Food, Dmg and Cosmetics Act requires that the cosmetic product be safe under conditions of use and that labeling is not false or misleading. Under this Act, the labeling of a cosmetic product must contain the name and address of the manufacturer, packer, or distributor the net contents and any appropriate warnings. This information must appear on the label of the product, both inner and outer containers. 

FDA has pubHshed two final rules for hair products as of this writing (69). Any over-the-counter (OTC) dmg product labeled or promoted for external use as a hair grower or for hair loss prevention is regarded as a new dmg and must be the subject of an approved new dmg appHcation (NDA). Products making these claims without an NDA are considered to be ia violation of the Federal Food, Dmg and Cosmetic Act and are also mislabeled. 

Federal Food, Drug and Cosmetic Act, Section 601 (e), U.S. Government Printing Office, Washiagton, D.C. Ibid, Section 601 (a). 

Pesticides are more closely regulated than other chemicals because pesticides are intentiaHy appHed in the environment, often repeatedly at relatively high rates. In the United States, pesticides are regulated under the federal Insecticide, fungicide and Rodenticide Act (EIERA), and residues from uses of pesticides in food or feed crops are regulated under Sections 408 and 409 of the federal food, Dmg and Cosmetics Act (EEDCA). 

In 1962, amendments to the U.S. Federal Food, Dmg and Cosmetic Act (Kefauver-Harris amendments) promulgated regulations concerning the requirements for premarketing approval by the FDA. This legislation estabUshed requirements of proof of both safety and therapeutic efficacy and strict control of human clinical testing, for example, which have extended the time and cost to market a new dmg. Thus, whereas approximately 40 new dmgs were marketed annually from 1948 to 1962, this number had fallen to 12 by 1966. 

Considerable interest has been shown ia poly(ethylene oxide) for diverse appHcations ia food, drug, and cosmetic products. Such uses fall within the scope of the Federal Food, Dmg, and Cosmetic Act. The U.S. FDA has recognized and approved the use of poly(ethylene oxide) for specific food and food packaging uses. USP/NF-grades of Polyox water-soluble resins (Union Carbide Corp.) are available for pharmaceutical appHcations. 

Sutures are regulated by the EDA as medical devices iatended for human use. The Eederal Eood, Dmg, and Cosmetic Act of 1938 has been amended many times, ia particular by the Medical Device Amendments of 1976. Devices have been under the jurisdiction of the EDA siace 1938. Section 513 of the Act requires the EDA to classify medical devices (sutures) ia one of three categories as follows. 

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

Health and Safety Factors. The LD q of anhydrous sodium thiosulfate for mice is 7.5 0.752 g/kg (40). Because of low toxicity, it can be safely used iu veterinary medicine. Sodium thiosulfate pentahydrate is affirmed as a GRAS indirect and direct human food ingredient under the Federal Food, Dmg, and Cosmetic Act (41) (see Food additives). 

Polyoxyethylated castor oil containing 42 moles of ethylene oxide may be used under the Federal Food, E)mg, and Cosmetic Act as an emulsifier in nitrocellulose coatings for paper and paperboard intended for use in contact with fatty foods at a maximum level of 8 wt % of the coating soHd (130). 

Specifications and Standards Test Methods. Ethylcellulose is cleared foi many apphcations in food and food contact under the Eedeial Eood, Dmg, and Cosmetic Act, as amended. Examples include binder in dry vitamin preparations for animal feed, coatings and inks for paper and paperboard products used in food packaging, and closures with sealing gaskets for food containers (44). Methods of analyses ate given in ASTM D914-72 (19), NationalFonmila XIV, and Food Chemicals Codex II. 

In the United States, chocolate and cocoa are standardized by the U.S. Food and Dmg Administration under the Federal Food, Dmg, and Cosmetic Act. The current definitions and standards resulted from prolonged discussions between the U.S. chocolate industry and the Food and Dmg Administration (FDA). The definitions and standards originally pubUshed in the of December 6, 1944, have been revised only slightly. 

In 1938 a new law, the Federal Food, Dmg, and Cosmetic Act of 1938 (18), which instituted several new and important practices, was enacted. Fkst, it clearly stated that, henceforth, the use of any uncertified coal-tar color in any food, dmg, or cosmetic shipped in interstate commerce was stricdy forbidden. This restriction appHed regardless of the inherent toxicity of the colorant. In effect, the colorants that could be used were limited, certification became mandatory, and governmental control was extended to the coloring of dmgs and cosmetics. Next, it created three categories of coal-tar colors ... 

No coloi additive oi product containing one can be used in the aiea of the eye, in surgical sutures, or in injections, unless so stated. Also, no colorant can be used to color foods for which standards of identity have been promulgated under Section 401 of the Federal Food, Dmg, and Cosmetic Act, unless the use of added color is authorized by the standard. Colorants without restrictions can be used for coloring foods generally, in amounts consistent with good manufacturing practice. 

Use Restrictions. There are numerous restrictions on the use of color additives. They caimot, for example, be employed to deceive the pubHc by adding weight or bulk to a product or by hiding quaUty. In addition, special permission is needed to use colorants or products containing them in the area of the eyes, in injections, in surgical sutures, and in foods for which standards of identity have been promulgated under Section 401 of the Eederal Eood, Dmg, and Cosmetic Act. 

The legal status of dairy substitutes varies widely among countries. In the United States, the FDA has held that filled products should be nutritionally equivalent to the products they resemble. In the case of imitation milks, the FDA proposed regulations for nutritional equivalency (31). A section of the Food, Dmg and Cosmetic Act defines misbranded foods, and the FDA has set up standards of identity for foods under this part of the law (32) which includes standards for imitation milks, cheese, and creams (32). 

A primary responsibility of the Food and Drug Administration (FDA) is the enforcement of the Federal Food, Dmg, and Cosmetic Act of 1938 and its various amendments, eg. May, 1976, in which dental materials, instmments, and equipment are included. Premarketing clearance requirements apply for estabhshing the safety and effectiveness of new products. There is a close Haison between the FDA and the ADA standards and certification programs. 

The measurement of filth elements by microanalysis is a valuable adjunct in the enforcement of the Food, Drug, and Cosmetic Act and serves as an efficient means of evaluating conditions of cleanliness, decency, and sanitation in food-producing plants. This, of course, is in addition to the value of microanalytical methods in the determination of the fitness of foods as they reach the consumer. The techniques available, together with proficiency of manipulation, repeated references to authentic materials, and sound judgment in the interpretation of results, provide effective enforcement weapons in the constant war to prevent the production and interstate distribution of products which are unfit for the table of the American consumer. 

Many laws have been enacted over the last century that affect drug distribution and administration. Those included here are the Pure Food and Drug Act Harrison Narcotic Act Pure Food, Drug, and Cosmetic Act and the Comprehensive Drug Abuse Prevention and Control Act. These laws control the use of the three categories of drugs in the United States (prescription, nonprescription, and controlled substances). 

The Food, Drug and Cosmetic Act is passed. This requires drugs to be shown to be safe before marketing, and authorises inspections of facilities. 

---