U. S. Food and Drug Administration

Food safety is a complex issue that has an impact on all segments of society, from the general public to government, industry, and academia. The second edition of the Bad Bug Book, published by the Center for Food Safety and Applied Nutrition, of the Food and Drug Administration (FDA), U. S. Department of Health and Human Services, provides current information about the major known agents that cause foodborne illness. The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference. Under the laws administered by FDA, a food is adulterated if it contains (1) a poisonous or otherwise harmful substance that is not an inherent natural constituent of the food itself, in an amount that poses a reasonable possibility of injury to health, or (2) a substance that is an inherent natural constituent of the food itself; is not the result of environmental, agricultural, industrial...

The purpose of this guide is to help small businesses - usually those with fewer than 500 employees - successfully navigate the realm of regulatory measures with which he U. S. Food and Drug Administration (FDA or the Agency) protects and promotes the health of the American public. Familiarity with FDA requirements is very important for a small firm that manufactures or plans to manufacture, sell, warehouse, transport, or import any of the thousands of FDA regulated products. To reach the U. S. interstate market, these products must comply with the applicable laws and the science-based public health rules developed and enforced by FDA. Although this obligation is routinely fulfilled by hundreds of thousands of American businesses, FDA is aware that for a small firm it can present a challenge. The Agency's responsibilities are defined in some 200 federal laws, and the resulting requirements, which can be complex, cover hundreds of pages in the Code of Federal Regulations. To find their way in this extensive domain of requirements, small and start-up businesses are likely to need expert assistance. The purpose of this guide is to help satisfy this need. Chapters I-IV provide an overview of FDA's responsibilities and operations and outline the main areas where small firms are most likely to come in contact with the Agency. Chapter V provides links to information that small businesses most frequently request from FDA's product centers and the Agency's Office of Regulatory Affairs. Chapter VI lists the Agency's offices and individuals who are ready to help small firms resolve their regulatory problems. This guide is designed to help make the small firms' contacts with FDA as efficient and productive as possible. We present this document as a blueprint that firms can follow to achieve their business aims while helping FDA accomplish its public health mission.

What you eat and drink can affect the way your medicines work. Use this guide to alert you to possible "food-drug interactions" and to help you learn what you can do to prevent them. In this guide, a food-drug interaction is a change in how a medicine works caused by food, caffeine, or alcohol. A food-drug interaction can: prevent a medicine from working the way it shouldcause a side effect from a medicine to get worse or bettercause a new side effectA medicine can also change the way your body uses a food. Any of these changes can be harmful. This guide covers interactions between some common prescription and over-the counter medicines and food, caffeine, and alcohol. These interactions come from medicine labels that FDA has approved. This guide uses the generic names of medicines, never brand names.