Regulation of food and dietary supplements by the U.S. Food and Drug Administration

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 enforced 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.

History of legislation

Pure Food and Drug Act

The Pure Food and Drug Act of 1906 was the first of a series of significant consumer protection laws enacted by the Federal Government in the twentieth century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by The United States Pharmacopeia or The National Formulary. The Jungle by Upton Sinclair was an inspirational piece that kept the public's attention on the important issue of unsanitary meat processing plants that later formed the Pure Food and Drug Act.

Federal Food, Drug, and Cosmetic Act

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a law first passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York.Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.CDER – Time Line. The act has been amended many times, most recently to add requirements about bioterrorism preparations.

The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.ASHP Website : News Article See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.

Food Additives Amendment of 1958

The Food Additives Amendment of 1958 is a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938. It was a response to concerns about the safety of new food additives. The amendment established the designation of "generally recognized as safe", which refers to chemicals or substances which can be used as food additives without further evaluation or testing just because they have been long used and there is broad acceptance of their use. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive.

Dietary Supplement Health and Education Act of 1994

The Dietary Supplement Health and Education Act of 1994 is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are mainly unregulated, without proof of effectiveness or safety needed to market a supplement, as well as dietary supplements being classified as foods instead of as drugs.

Food

Food is defined in the Act21 U.S.C. §321(f). 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.Peter Barton Hutt, Richard A. Merrill, Lewis A. Grossman, Food and Drug Law: Cases and Materials, Third Edition (2007). 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".21 U.S.C. §321(g)(1)(C). 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,Nutrilab, Inc. v. Schweiker, 713 F.2d 335 (7th Cir. 1983). 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.21 U.S.C. §401–417. 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: ...it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.21 U.S.C. §342(a)(1).

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";21 U.S.C. §342(a)(3). 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";21 U.S.C. §342(a)(4). if it was produced from "a diseased animal or of an animal which has died otherwise than by slaughter";21 U.S.C. §342(a)(5). if it was packaged in a poisonous material;21 U.S.C. §342(a)(6). or if it was intentionally irradiated outside of irradiation guidelines set forth by the Act.21 U.S.C. §342(a)(7). 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.21 U.S.C. §374. 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)FDA: "Investigations Operations Manual," 5.2.3.4 – Annotation of the FDA 483, last visited June 29, 2010. 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.FDA: The Food Defect Action Levels, last visited April 22, 2004. The FDA also establishes action levels for man-made chemicals such as aflatoxin, lead, and mercury, and maintains these on its website.FDA: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed, last visited April 22, 2004 .

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".21 U.S.C. §343(a)(1). Labeling is defined elsewhere in the Act,21 U.S.C. §321(m). and includes:

...all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers accompanying such article