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

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.

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.

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.

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.

For example, in the 1983 case of Nutrilab, Inc. v. Schweiker,[8] 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.

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.

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";[11] 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";[12] if it was produced from "a diseased animal or of an animal which has died otherwise than by slaughter";[13] if it was packaged in a poisonous material;[14] or if it was intentionally irradiated outside of irradiation guidelines set forth by the Act.

[15] 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.

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.

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.

[23] 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.

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.

[33] The Delaney clause, initially enacted in 1958, prohibits the FDA from approving food additives shown to cause cancer.

[6] 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.

The United States Court of Appeals for the Sixth Circuit upheld the FDA's approval of the food coloring.

[38] 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".

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.

[46] 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.