Regulation of food and dietary supplements by the U.S. Food and Drug Administration
Encyclopedia
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration 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...
("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, and to monitor claims made in the labeling about both the composition and the health
Health
Health is the level of functional or metabolic efficiency of a living being. In humans, it is the general condition of a person's mind, body and spirit, usually meaning to be free from illness, injury or pain...
benefits of foods.
Substances which the FDA regulates as food are subdivided into various categories, including foods, food additive
Food additive
Food additives are substances added to food to preserve flavor or enhance its taste and appearance.Some additives have been used for centuries; for example, preserving food by pickling , salting, as with bacon, preserving sweets or using sulfur dioxide as in some wines...
s, 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 gumChewing gumChewing gum is a type of gum traditionally made of chicle, a natural latex product, or synthetic rubber known as polyisobutylene. For economical and quality reasons, many modern chewing gums use rubber instead of chicle...
, and - articles used for components of any such article.
The first definition offered is self-referential
Self-reference
Self-reference occurs in natural or formal languages when a sentence or formula refers to itself. The reference may be expressed either directly—through some intermediate sentence or formula—or by means of some encoding...
, 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
United States Court of Appeals for the Seventh Circuit
The United States Court of Appeals for the Seventh Circuit is a federal court with appellate jurisdiction over the courts in the following districts:* Central District of Illinois* Northern District of Illinois...
found that starch
Starch
Starch or amylum is a carbohydrate consisting of a large number of glucose units joined together by glycosidic bonds. This polysaccharide is produced by all green plants as an energy store...
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:- ...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.
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" (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 warrantSearch warrant
A search warrant is a court order issued by a Magistrate, judge or Supreme Court Official that authorizes law enforcement officers to conduct a search of a person or location for evidence of a crime and to confiscate evidence if it is found....
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
Fourth Amendment to the United States Constitution
The Fourth Amendment to the United States Constitution is the part of the Bill of Rights which guards against unreasonable searches and seizures, along with requiring any warrant to be judicially sanctioned and supported by probable cause...
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
Expectation of privacy
In United States constitutional law the expectation of privacy is a legal test which is crucial in defining the scope of the applicability of the privacy protections of the Fourth Amendment to the United States Constitution...
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 aflatoxinAflatoxin
Aflatoxins are naturally occurring mycotoxins that are produced by many species of Aspergillus, a fungus, the most notable ones being Aspergillus flavus and Aspergillus parasiticus. Aflatoxins are toxic and among the most carcinogenic substances known...
, lead
Lead
Lead is a main-group element in the carbon group with the symbol Pb and atomic number 82. Lead is a soft, malleable poor metal. It is also counted as one of the heavy metals. Metallic lead has a bluish-white color after being freshly cut, but it soon tarnishes to a dull grayish color when exposed...
, and mercury
Mercury (element)
Mercury is a chemical element with the symbol Hg and atomic number 80. It is also known as quicksilver or hydrargyrum...
, 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
Advertising
Advertising is a form of communication used to persuade an audience to take some action with respect to products, ideas, or services. Most commonly, the desired result is to drive consumer behavior with respect to a commercial offering, although political and ideological advertising is also common...
, which instead falls under the authority of the Federal Trade Commission
Federal Trade Commission
The Federal Trade Commission is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act...
. 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 identityStandard of identity
Standard of identity for food are the mandatory, federally-set requirements that determine what a food product must contain to be marketed under a certain name in interstate commerce...
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
Cream cheese
Cream cheese is a soft, mild-tasting, white cheese with a high fat content. Traditionally, it is made from unskimmed milk enriched with additional cream....
, 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
Cool Whip
Cool Whip is a brand of imitation whipped cream named a whipped topping by its manufacturer. It is used in North America as a dessert topping and in some no-bake pie recipes. It was generally described as "non-dairy" as it contained no cream or milk and no lactose; however, it did contain the milk...
and Cheetos
Cheetos
Cheetos is a brand of cheese-flavored cornmeal snack made by Frito-Lay, a subsidiary of PepsiCo. Fritos creator Charles Elmer Doolin invented Cheetos in 1948, and began national distribution in the U.S. The initial success of Cheetos was a contributing factor to the merger between The Frito Company...
.
Health claims
There are two kinds of health claims that can be made about foods other than dietary supplements: structure/function claims and disease claims. Structure/function claims are claims that do not suggest that the food can diagnose, treat, or prevent any particular disease, but that it can, for example, maintain, regulate, or promote normal healthy bodily functions. Where such claims are made, foods are generally required to carry a disclaimerDisclaimer
A disclaimer is generally any statement intended to specify or delimit the scope of rights and obligations that may be exercised and enforced by parties in a legally recognized relationship...
on their label indicating that the claim has not been evaluated by the FDA.
Disease claims suggest that the food can help prevent specific diseases. Such claims are only permitted where the FDA finds that there is "significant scientific agreement", or where the claim has been approved by another federal health agency or the National Academy of Sciences
United States National Academy of Sciences
The National Academy of Sciences is a corporation in the United States whose members serve pro bono as "advisers to the nation on science, engineering, and medicine." As a national academy, new members of the organization are elected annually by current members, based on their distinguished and...
.
Food additives
Food additives are defined in the Act to be:- ...any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food...
The definition goes on to capture several broad categories of things not traditionally thought of as "food", including "any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food". The definition only applies if the substance in question is not "generally recognized as safe" by qualified experts, and also exempts substances that were in common use as food prior to January 1, 1958.
The Act sets forth certain exemptions for substances which are treated under different regulatory schemes, including pesticide chemicals and their residue, color additives, substances previously approved under other statutes, new animal drugs, and dietary supplements. The statute directs that food additives are generally to be presumed to be unsafe (and therefore prohibited) until they have been proven to be safe. However, the statute then sets out a regulatory scheme under which a person intending to use a heretofore unapproved food additive may petition for "the issuance of a regulation prescribing the conditions under which such additive may be safely used".
Delaney clause
The Delaney clauseDelaney clause
The Delaney Clause is a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938, named after Congressman James Delaney of New York.It said:...
, initially enacted in 1958, prohibits the FDA from approving food additives shown to cause cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
. At the time of the passage of the amendment, little was known about the carcinogen
Carcinogen
A carcinogen is any substance, radionuclide, or radiation that is an agent directly involved in causing cancer. This may be due to the ability to damage the genome or to the disruption of cellular metabolic processes...
ic propensities of a wide variety of additives. Following the enactment of this amendment, more and more substances were shown to be potentially carcinogenic, albeit in experiments wherein test animals were subjected to doses far in excess to the proportions which humans were likely to consume. In 1982, the FDA responded to this trend by adopting a rule that a food additive would not be denied approval under the Delaney clause unless the additive itself, and not just the constituent chemicals used to make it, was shown to cause cancer. This policy was later challenged in court following FDA approval of a food coloring manufactured with a compound known to be carcinogenic, after separate testing indicated that the food coloring itself did not cause cancer in test animals. The United States Court of Appeals for the Sixth Circuit
United States Court of Appeals for the Sixth Circuit
The United States Court of Appeals for the Sixth Circuit is a federal court with appellate jurisdiction over the district courts in the following districts:* Eastern District of Kentucky* Western District of Kentucky...
upheld the FDA's approval of the food coloring.
Added substances
Added substances are not separately defined in the act, but are understood to be different from food itself based on the definition of adulterated food, and a later section authorizing the FDA to set forth tolerance limits for "[a]ny poisonous or deleterious substance added to any food...". Such substances are prohibited, "except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice". Because added substances often can not be avoided in food, such as the presence of man-made pollutants in fish, the FDA is required to "promulgate regulations limiting the quantity therein or thereon to such extent as [is] necessary for the protection of public health". The action levels discussed above with respect to poisonous or deleterious substances address these added substances. Added substances differ from food additives, discussed above, in that the latter applies to things which are intentionally added to food, and therefore require FDA approval prior to being added to food.Dietary supplements
The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplementDietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
s as foods, rather than as drugs. Consequently, dietary supplements are defined as a kind of food under the statute, with the caveat that this does not exempt them from being treated as drugs in the way that other foods are exempted, if circumstances permit it.
Like other food substances, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs, and unlike drugs they do not require prior approval by the FDA; however, they are subject to the FDA regulations regarding adulteration and misbranding. The FDA can take action against dietary supplements only after they are proven to be unsafe. Dietary supplements may be deemed to be misbranded if they are marketed in a way that characterizes them as a drug, without having undergone the clinical trials to which new drugs are subjected. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products. They may not claim to treat, diagnose, cure, or prevent disease and must include a disclaimer on the label. Where a manufacturer makes a structure or function claim in connection with the sale of a dietary supplement, the manufacturer must notify the FDA within 30 days after it has introduced that product to the market.
Claims that either a food or dietary supplement acts to prevent a disease are permitted, so long as there is "significant scientific agreement" for the claim, or it has been approved in an "authoritative statement" by "a scientific body with official responsibility for the public health protection or research directly relating to human nutrition" such as the National Academy of Sciences
United States National Academy of Sciences
The National Academy of Sciences is a corporation in the United States whose members serve pro bono as "advisers to the nation on science, engineering, and medicine." As a national academy, new members of the organization are elected annually by current members, based on their distinguished and...
.
Prohibitions and treatment of violations
The Act expressly prohibits the "introduction, or delivery for introduction into interstate commerce of food... that is adulterated or misbranded", as well as the actual adulteration or misbranding of food. The Act further sets forth a broad range of powers that the FDA may exercise in order to prevent distribution of adulterated or misbranded food. In addition to the express powers set forth in the statute, the FDA exercises certain implied powers, such as the issuance of Warning LetterFDA Warning Letter
The United States Food and Drug Adminstration defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations...
s and recall orders.
The steps which the FDA may take in response to a violation include the following:
- Sending an "untitled letter" to the violator indicating the concern and requesting a response detailing how the concern will be addressed by the violator.
- Sending a Warning Letter to the violator specifically identifying the violation and requiring a response detailing how the violation will be addressed.
- Issuing a press release, holding a press conference, having notices posted, or taking similar action to alert the public to the violation. Use of publicityPublicityPublicity is the deliberate attempt to manage the public's perception of a subject. The subjects of publicity include people , goods and services, organizations of all kinds, and works of art or entertainment.From a marketing perspective, publicity is one component of promotion which is one...
is expressly authorized by the Act, and courts have held that the FDA need not give the alleged violator any notice or opportunity to be heard prior to the use of this measure. A party who feels that the FDA has wrongfully maligned its goods may file a lawsuitLawsuitA lawsuit or "suit in law" is a civil action brought in a court of law in which a plaintiff, a party who claims to have incurred loss as a result of a defendant's actions, demands a legal or equitable remedy. The defendant is required to respond to the plaintiff's complaint...
for defamation, but no such suit has ever succeeded. - Ordering the violator to recall the adulterated or misbranded products. The FDA has no formal authority to order a recall, but companies that receive such an order almost always comply with it to avoid invoking the FDA's more severe enforcement powers.
- Ordering the violator to disgorge its products from sales of products to third parties, and provide restitutionRestitutionThe law of restitution is the law of gains-based recovery. It is to be contrasted with the law of compensation, which is the law of loss-based recovery. Obligations to make restitution and obligations to pay compensation are each a type of legal response to events in the real world. When a court...
to those parties. The FDA also lacks statutory authority for this practice, but is able to coerce violators to disgorge profits through consent decrees. Courts have also found that they have the equitable power to order disgorgement and restitution as requested. - Petitioning a United States district courtUnited States district courtThe United States district courts are the general trial courts of the United States federal court system. Both civil and criminal cases are filed in the district court, which is a court of law, equity, and admiralty. There is a United States bankruptcy court associated with each United States...
s to issue an injunctionInjunctionAn injunction is an equitable remedy in the form of a court order that requires a party to do or refrain from doing certain acts. A party that fails to comply with an injunction faces criminal or civil penalties and may have to pay damages or accept sanctions...
against the violation, as permitted by the Act, and to order the seizure of foods which violate the Act. The FDA has an easier burden to obtain both preliminary and permanent injunctive relief that does a private litigant, because the FDA is always acting in the public interest, and the injury sought to be prevented - violation of the laws designed to protect the public from harmful or misleading products - is presumed to be irreparable. - Seizing the offending food without first obtaining a court order, if the FDA has probable cause to believe that a misbranded food is dangerous to health or is fraudulent in a way that would cause commercial injury to the consumer. Where this occurs, the owner of the food may later seek to recover the seized food by initiating a proceeding in the local United States district court.
- Seeking criminal penalties which may be imposed on violators, including imprisonment for up to a year and a fine of up to $1,000 for a first offense. Controversially, the president of a company that violates the Act may be found criminally liable for those violations even if he had no personal knowledge of the violations. Although the Act provides for civil penalties for certain violations relating to applications for approval of new drugs, it does not provide for civil penalties for violations involving food.
Where food is found to be adulterated, the FDA also has the option to offer the owner the opportunity to "recondition" the food - that is, to remove all traces and contamination, and submit that food for a reinspection by the FDA, at which time it may be approved for sale. Similarly, where food is found to be misbranded, the FDA has the option of offering the owner the opportunity to correct the labeling, and put the food back on the market with new labels that are not misleading.