GRAS (Generally Recognized as Safe)

GRAS lists a list of ingredients established by the FDA that had long been in use and were believed safe.

The Generally Recognized as Safe list was established in 1958 by Congress. Those substances that were being added to food over a long time, which under conditions of their intended use were generally recognized as safe by qualified scientists, would be exempt from premarket clearance.

After questions were raised about the safety of some GRAS ingredients, FDA initiated a review of these ingredients in 1972.

FDA utilized the scientific expertise of an independent organization, the Federation of American Societies for Experimental Biology, to assist in the evaluation, which spanned a decade.

Substances on the GRAS list are not officially considered food additives, so they are exempt from the legal requirement of proving their safety.

However, GRAS substances are continually reevaluated, and as new methods for testing are developed, some substances are removed from the GRAS list.

GRAS status requires consensus, but not unanimity, among epxo9erts qualified by scientific training and experience.

Under the FD&C Act, GRAS determination must be made ‘among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures’.
GRAS (Generally Recognized as Safe)

History of US Food and Drug Administration

The origins of the Food and Drug Administration can be traced back to 1862, when President Lincoln appointed chemist Charles M. Wetherill to head the Chemical Division in the new US Department of Agriculture.

In 1883, Harvey W. Wiley became the chief of the division as it grew into the Bureau of Chemistry in 1901. He focused his attention and efforts on chemically altered foods and food additives and their impact on health, which he believed was a greater public health threat than fraudulent or misbranded drugs.

The bureau modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The act was a response to revelations of false claims for adulterated and dangerous patent medicines.

In 1927 Congress authorized the formation of the Food, Drug and Insecticide Administration from the regulatory wing of the Bureau of Chemistry; the name of the agency was shortened to the Food and Drug Administration (FDA) in 1930.

Pesticide residues began to be problem in the 1920s. In 1938, the stronger Food, Drug and Cosmetic Act – still the nation’s governing statue – replaced the 1906.

In 1940 FDA moved from Department of Agriculture to the Federal Security Agency then to the Departments of Health, and Welfare and Health and Human Services.
History of US Food and Drug Administration

History of Food Safety

History of Food Safety
Before manufacturing traditional, farming practices and preserving techniques were used to ensure safe food.

During industrial revolution, food began to be processed and packaged. Lacking regulation, manufacturers were free to add whatever they liked to their products. Sweeping from the floor were included in pepper, lead salts were added to candy and cheese, textile inks were used as coloring agents, bricks dust was added to cocoa, and copper salts were added to peas and pickles.

In the 1880s, women started organizing groups to protest the conditions at slaughterhouses in New York City and adulterated foods in other parts of the country.

In 1883, Harvey W. Wiley, chief chemist of the U.S Agricultural Department’s Bureau of Chemistry, began experimenting with food and drug adulteration.

Meanwhile, Upton Sinclair spent several weeks in a meat packing plant investigating labor conditions and turned his discoveries into a book, The Jungle, published in 1906. Although the focus of that book was the conditions immigrants experienced in the early twentieth century, there were graphic descriptions of the filth and poor hygiene in packing plants. It caught the public attention.

People began complaining to Congress and to President Theodore Roosevelt. Pressure was also mounting from foreign governments that wanted some assures that food imported from United States was pure and wholesome.

Two acts were passed in 1906, the Pure Food and Drug Act and the Beef Inspection Act, to improve food safety conditions.

In 1927, U.S Food, Drug and Insecticide Administration (shortened to Food and Drug Administration) or FDA was created to enforce the Pure Food and Drug act.


The Pure food Act was later superseded in 1938 by Pure Food, Drug and Cosmetics Act. This act prohibited any food or drug that is dangerous to health to be sold in interstate commerce.

In 1958, concern over cancer led to the adoption of the Delaney Amendments, which expanded the FDA’s regulatory powers to set limits on pesticides and additives. Manufacturers had to prove that additives and pesticides were safe before they could be used.

The Fair Packaging and Labeling Act of 1966 standardized the labels of products and required that labels provide honest information.

The next major act was the Food Quality Protection Act of 1996. It set new regulations requiring implementation of Hazard Analysis and Critical Control points (HACCPs) for most food processor.

The Food quality Protection Act also changed the way acceptable pesticide levels are calculated. Now total exposure for all sources must be calculated.
History of Food Safety