Mechanisms - Food and Drug Administration (FDA)

Established year:


  • Monitoring compliance
  • Public dissemination of monitoring results
  • Applying sanctions to identified violations
  • Public dissemination of sanctions applied

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. The Food and Drug Administration is the oldest comprehensive consumer protection agency in the U. S. federal government. Since 1848 the federal government has used chemical analysis to monitor the safety of agricultural products -- a responsibility inherited by the Department of Agriculture in 1862 and by later by the FDA.  Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs--had been the driving force behind this law and headed its enforcement in the early years, providing basic elements of protection that consumers had never known before that time.  Since then, the FDA has changed along with social, economic, political and legal changes in the United States. Examining the history of these changes illuminates the evolving role that FDA has played in promoting public health and offers lessons to consider as we evaluate current regulatory challenges.


Partially Hydrogenated Oils 
FDA has determined that PHOs are not GRAS for any use in human food and therefore are food additives subject to the requirement of premarket approval under section 409 of the FD&C Act. A substance that will be added to food is subject to premarket approval by FDA unless it is generally recognized, among qualified experts, to be safe under the conditions of its intended use (GRAS is the acronym for generally recognized as safe).
Nutritional labeling, including Menu and Vending Machines Labeling Requirements
The Nutrition Labeling and Education Act of 1990 (NLEA) provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims (i.e., 'high fiber', 'low fat', etc.) and health claims be consistent with agency regulations.
Labeling Requirements - Misbranding
Front-of-Package Labeling Initiative
FDA intends to monitor and evaluate the various FOP labeling systems and their effect on consumers' food choices and perceptions. FDA recommends that manufacturers and distributors of food products that include FOP labeling ensure that the label statements are consistent with FDA laws and regulations. FDA will proceed with enforcement action against products that bear FOP labeling that are explicit or implied nutrient content claims and that are not consistent with current nutrient content claim requirements. FDA will also proceed with enforcement action where such FOP labeling or labeling systems are used in a manner that is false or misleading.

Revision log

Tue, 04/23/2019 - 21:21engesveenkBulk moderation state change.published