Food And Drug Law Cases And Material
Food And Drug Law Cases And Material
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the 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 (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), 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.
Food
Food is defined in the Act to be:
- articles used for food or drink for man or other animals,
- chewing gum, and
- articles used for components of any such article.
The first definition offered is self-referential, defining food in part as "articles used for food", leaving it to the FDA and the courts to determine what exactly constitutes food. This determination is particularly important because the definition of a "drug" under the act includes a section defining drugs as "articles ( other than food ) intended to affect the structure or any function of the body of man or other animals". Thus, the definition of food is important not only in determining what is covered by the regulatory regime for food, but in determining what is excluded from the regulatory regime for drugs. For example, in the 1983 case of Nutrilab, Inc. v. Schweiker , the United States Court of Appeals for the Seventh Circuit found that starch blockers, though derived from kidney beans, were drugs rather than food under the meaning of the Act. The starch blockers were sold as tablets, and "not consumed primarily for taste, aroma, or nutritive value". Products that are normally considered to be foods may also be regulated as drugs if the parties responsible for their manufacture or sale make claims as to their ability to treat diseases, although the FDA now permits advertising addressing the disease-fighting qualities in foods where those qualities have been endorsed by the scientific community.
The standards for food sold in the United States are set forth in Chapter IV of the Act. These standards set forth two main areas of food that violates the Act: adulterated food and misbranded food. These categories are independent of one another; food can be completely free of adulteration and otherwise healthy to consume, and still be in violation of the act if it is misbranded. Likewise, food that has completely accurate labels, including warnings about dangers that it may pose to health, may nevertheless be deemed adulterated.
Adulterated food
The Act sets forth several circumstances under which food will be deemed adulterated. The primary definition set forth is that food is adulterated if:
Added substances are treated separately by the FDA, meaning that the sale of an article or substance as food will generally be permitted if that article or substance is not ordinarily injurious to health.
Food is also deemed adulterated "if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food"; if it was "prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health"; if it was produced from "a diseased animal or of an animal which has died otherwise than by slaughter"; if it was packaged in a poisonous material; or if it was intentionally irradiated outside of irradiation guidelines set forth by the Act. These definitions are also independent, meaning that food that is "filthy" or has been "held under insanitary conditions" is still in violation of the Act and subject to condemnation even if the owner can demonstrate that it poses no actual threat to health. The phrase "otherwise unfit for food", although seeming to be a catch-all, has rarely been invoked. It would apply to a circumstance such as a seller offering wood chips as food, which might be safe to consume and prepared under sanitary conditions, but would be impossible to chew.
Inspections for adulteration
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" 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.
Action levels
The presence of some degree of contamination is inevitable in almost all food. Technically, the FDA could inspect all food under a microscope and prohibit the sale of every article containing any discernible trace of mold, insect fragments, rodent hairs, and the like - effectively barring the sale of all food. In order to avoid this outcome, the FDA sets "action levels", which specify minimum amounts of particular contaminants that must be found in a food sample before the FDA will take action with respect to that sample. The FDA maintains a listing of all current action levels on its website. The FDA also establishes action levels for man-made chemicals such as aflatoxin, lead, and mercury, and maintains these on its website.
Misbranded food
The primary basis under which food may be deemed misbranded under the Act is if "its labeling is false or misleading in any particular". Labeling is defined elsewhere in the Act, and includes:
...all labels and other written, printed, or graphic matter
- upon any article or any of its containers or wrappers, or
- accompanying such article
Under the second part of this definition, it has been held that a food substance sold in conjunction with a book or pamphlet which makes false claims about the benefits of that substance is misbranded. If books making false claims about a food are sold in conjunction with that food, the books themselves may also be seized and destroyed - even if the author had no intention of selling the book in conjunction with the food. However, if a store happens to be selling both a food and a book which makes false claims about that food, and is selling the items separately, then no misbranding occurs. This is so even if the book and the food are both produced by the same company, and even if the maker of the food encourages the seller to carry the book.
In terms of determining whether food is misbranded, the FDA only monitors labeling, and not advertising, which instead falls under the authority of the Federal Trade Commission. However, the FDA will review the advertising of a product to determine whether it is to be regulated as a food or as a drug, based on the claims that the manufacturer or seller makes about its properties.
Standards of identity
The FDA is authorized to issue a standard of identity for any food. This is a description of what, exactly, must be in that food in order for it to be identified under a certain name. For example, a court has upheld an FDA ruling that for a product to be sold as cream cheese, it must contain a specified minimum percentage of milk fat, and a maximum level of moisture. Incorrectly identifying a food by a name for which a standard of identity has been established is considered a form of misbranding. The FDA has set forth nearly 300 such standards. However, in recent decades, companies marketing new types of food items have diminished the importance of these standards by simply coining new names for foodstuffs that do not conform to an existing standard, with examples including Cool Whip and Cheetos.
Health claims
There are two
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