V. SUGGESTIONS TO FOREIGN EXPORTERS AND UNITED STATES APPENDIX: Statutory definitions of certain terms in the Federal Food, Drug, and Text of import provisions of the Food, Drug, and Cosmetic Act. Information from other United States Agencies Directory. 45 46 48 49 50 51 Introduction A spice supplier in a foreign country sought to reestablish trade with the United States. To his dismay his first shipments were rejected by the United States pure food authorities at port of entry. Something was said about filth and insanitary conditions. A foreign manufacturer of a medicinal preparation learned, too late to save the expense of shipment to the United States, that it was barred from entry because it was a "new drug." A foreign cosmetic manufacturer, planning to begin postwar business with American importers, heard rumors that the United States Government imposes restrictions on the dyes that may be used in such products. These exporters desired to establish a legitimate trade with this country. They were handicapped because they had not fully informed themselves of the requirements of the United States Federal Food, Drug, and Cosmetic Act of 1938. The spice exporter did not fully appreciate that this act classes a food as adulterated not only if it consists in whole or in part of a filthy, decomposed, or putrid substance, but if it has been prepared, held, or packed under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. The drug manufacturer was unacquainted with that provision of the act which classes as a "new drug" any drug not generally recognized among experts as safe for use under the conditions prescribed, recommended, or suggested in the labeling. The cosmetic manufacturer did not know that any coal-tar dye used in his products must not only be eligible for certification for cosmetic use, but must be from a batch certified by the Food and Drug Administration. A great many different articles may fall within the statutory definitions of the terms "food," "drug," "device," and "cosmetic," the commodities which are covered by the Food, Drug, and Cosmetic Act. Feed and medicines for animals are included, as well as articles for human use. Of the 16 schedules, or broad classifications, of articles in the United States Tariff Act of 1930, at least 6 (1, 5, 7, 8, 9, and 16) include articles that may classify themselves as articles coming within the scope of the Food, Drug, and Cosmetic Act. It is the purpose of this publication to convey information on the Federal Food, Drug, and Cosmetic Act that will be helpful to foreign manufacturers and exporters and to United States importers who may not be fully familiar with the requirements of this United States law. While lack of full understanding of its provisions by foreign exporters may make import control at times appear burdensome, the object and |