page_title: Regulation of food and dietary supplements by the U.S. Food and Drug Administration
section_title: Inspections for adulteration
hierarchical_section_title: Regulation of food and dietary supplements by the U.S. Food and Drug Administration / Food / Adulterated food / Inspections for adulteration
caption_attribution_description: English: FDA Inspector LCDR Teresa Fox (USPHS) gives an overview of the seafood inspection process to HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach at Phillips Foods and Seafood Restaurants’ processing facility in Baltimore, MD., from the Outreach Activities section of the website of U.S. Department of Health and Human Services.
context_page_description: The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration. Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
  Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances, and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.
context_section_description: The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held. In searching for contamination, the FDA typically uses organoleptic inspection methods - investigators trained to distinguish contamination and decomposition by sight and smell. Upon completion of such an inspection, the FDA will generate an "Establishment Inspection Report" (EIR) detailing any problems found. Where problems are found, the FDA will instruct the owner of the inspected facility how to proceed in resolving those problems. FDA inspectors may take photographs of an establishment unless they are expressly told not to do so, and the owner of the establishment must provide an employee to answer questions that arise during the inspection. If the owner of an establishment refuses to permit FDA inspectors to enter a covered establishment, or any part of one, then the FDA may obtain a search warrant to enter.
  Courts have held that, so long as the owner has not objected to the inspection and prevented the inspectors from entering, the FDA does not require a warrant to seize materials that are in violations of the Act. Furthermore, such materials may be used at trial against the owner without raising unreasonable search and seizure issues under the Fourth Amendment to the United States Constitution because the industry at issue has been found to be heavily regulated, meaning that the owner of such an establishment has no expectation of privacy with respect to premises of the type covered by the Act.
caption: An FDA Inspector gives an overview of the seafood inspection process to HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach at a Baltimore, Maryland processing facility owned by Phillips Foods, Inc. and Seafood Restaurants.
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