Importing Food Into The United States: A Regulatory
Guide
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
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
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
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
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
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
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
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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$166.00
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Guide to Regulation of Food Ingredients and Food Packaging
Materials
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
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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$72.00
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