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Importing Food Into The United States: A Regulatory Guide

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A food product offered for import may be subject to regulation and enforcement by several different agencies within the U.S. government, depending upon the type of product. Understanding the legal and regulatory requirements that govern the importation of a given food product can help speed its entry into U.S. commerce. Importing Food Into The United States: A Regulatory Guide, can enable food companies and importers to understand the various applicable legal requirements and the federal agencies - FDA, USDA and CBP - responsible for their enforcement.

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U.S. Food Labeling Guide III

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There have been numerous changes in food labeling regulations that became effective Jan. 1, 2006. Namely new requirements for labeling of trans fats...new allergen labeling requirements, and new policies on qualified health claims. Are you aware that you and your firm can be impacted if you are not complying with the latest government regulations? This third edition of The Food Institute's best-selling U.S. Food Labeling Guide includes full explanations of these changes and how you should handle them. Food Institute counsel Olsson, Frank & Weeda, PC authored this publication in layman's terms, not in "legalese." The U.S. Food Labeling Guide continues to be the most comprehensive tool for labeling food products available (over 300 pages). Our prior editions are already used regularly by hundred of food manufacturers, consultants and label designers. This completely updated user-friendly guide simplifies the maze of complex legal requirements mandated by the government.

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Dietary Supplements: A Regulatory Guide

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Dietary supplements are regulated by the Food and Drug Administration (FDA) very differently in important respects from "conventional foods." Manufacturers of dietary supplements and the dietary ingredients that they contain must comply with far more specific current good manufacturing practice (CGMP) requirements, distinct labeling requirements, separate adverse event reporting requirements, and several requirements not applicable to conventional foods (e.g., new dietary ingredient (NDI) notification). Dietary supplements and dietary ingredients also are regulated under a safety standard that is different from the food additive/GRAS framework, and therefore may contain ingredients not permitted in conventional foods.

Any company in the business of manufacturing, distributing, or otherwise selling dietary supplements or dietary ingredients must be familiar with FDA's regulatory regime. In some cases, a particular product might be marketed as a dietary supplement or as a conventional food, and businesses need to know the advantages and disadvantages of each approach.

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Food Industry Bioterrorism Act Guide

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The Food Industry Bioterrorism Act Guide is designed to serve as a convenient reference source and guide to the Bioterrorism Act and federal regulations and policies implementing the Bioterrorism Act. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) is the greatest expansion in the Food and Drug Administration’s (FDA) food enforcement authorities since passage of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938. The Food Industry Bioterrorism Act Guide provides a comprehensive examination of the Bioterrorism Act, FDA’s implementing regulations, guidances, and similar documents. It is designed to assist U.S. and foreign food industry users in understanding not only the strict legal requirements, but also FDA’s findings, conclusions, and views as set forth in rulemaking preambles and other documents.

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OSHA Inspection Manual 3rd Edition

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Periodically, food industry establishments are subject to inspection by the federal Occupational Safety and Health Administration or its state counterparts causing internal confusion about what to expect and what to do! The results of an OSHA inspection can lead to civil fines, adverse publicity, abatement proceedings, and, in some cases, criminal proceedings. It is extremely important, therefore, to be familiar with OSHA's authority and its inspection procedures, and to deal effectively with OSHA compliance officers.

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Guide to Handling FDA Food Inspections

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The Guide To Handling FDA Food Inspections is intended to help you and your company deal with the Food and Drug Administration’s regulatory inspections of food processing operations as well as inspections of warehouses, shippers and retail establishments. It is essential that all such establishments understand their rights and responsibilities with respect to FDA inspections, and have in place a detailed plan to prepare for and respond to such inspections.

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Food Products Recall Manual

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Food recalls occur virtually everyday. Food products are recalled for a variety of reasons, ranging from the mundane to the serious. A manufacturer may choose, for business reasons, to retrieve product that is not selling well, does not meet quality specifications, has been the subject of consumer complaints or has minor labeling problems. At the other extreme, a manufacturer may be compelled to recall a food product that has been implicated in an outbreak of foodborne illness, contains undeclared allergens or contains metal fragments. Recalls are not pleasant experiences. Given the public's growing concern about food safety, a recall can quickly escalate into a local, national or even international news story. But, it need not be a cause for panic. Following responsible and sensible procedures, as outlined in this updated guide, can help contain the fallout.

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Retail Pharmacy Recall Manual

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This manual is designed to assist retail pharmacy companies in handling recalls and market withdrawals of the vast array of products carried by the typical full-line retail pharmacy, including prescription and over-the-counter drugs, controlled substances, medical devices, dietary supplements, cosmetics, infant formula, food, consumer products such as toys and cleaning products, and pesticides.

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Guide to Regulation of Food Ingredients and Food Packaging Materials

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Do your product formulations and packaging comply with federal law? In the U.S., the responsibility for assuring the safety of the food supply and particularly the safety of materials added to processed foods or used to package food is shared by FDA and USDA. All ingredients added to processed foods must either comply with these regulations or qualify for a legal exemption. Foods that contain ingredients that are not either compliant or exempt and foods packages using noncompliant materials are adulterated under federal law. The sale or distribution of adulterated food is a violation of federal law and may subject the processor to federal enforcement actions. This guide for the food processing industry offers a thorough understanding of FDA and USDA regulation of food ingredients and food contact materials. It will help food processors to determine if they are in compliance with federal requirements and how to obtain "approvals" for new ingredients.

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Food Law Anthology

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The Food Law Anthology is a 16-part reference volume containing the major food-related federal laws that are enforced by the U.S. Food and Drug Administration, the U.S. Department of Agriculture and the Federal Trade Commission. The Anthology covers various areas of food law, from the Federal Food, Drug, and Cosmetic Act to the Federal Meat Inspection Act. This collection provides an up-to-date reference to federal food statutes including the major changes made by the Bioterrorism Act of 2002. The Anthology also includes related federal statutes such as the Administrative Procedure Act and the Fair Labeling and Packaging Act. In addition to the comprehensive main table of contents, there is a detailed index preceding each act to enable you to find pertinent information easily.

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Investigations Operations Manual

The Investigations Operations Manual, or IOM, is the primary procedure manual for FDA personnel performing inspections and special investigations. This is the perfect companion to the Food Institute's FDA Inspection Guide, and is illustrated with corresponding screen shots taken from FACTS, FDA’s Field Accomplishments and Compliance Tracking System. This 2004 edition of the FDA Investigations Operations Manual gives standard investigation operating procedures followed by FDA insepctors explaining areas of responsibility

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