On May 3, 2013, the U.S. Food and Drug Administration (FDA) announced that it is currently investigating the safety of added caffeine in foods, particularly in response to a recent trend of caffeinated products. The FDA is primarily concerned with the consumption of caffeine by children and adolescents, and in turn, caffeine in food products marketed to these age groups. You can read the FDA’s article here.
According to the article, the FDA will address the health effects of caffeine, especially for those at risk from excess consumption. It will also look at the appropriate products for added caffeine and might eventually decide to limit the amount of caffeine in foods, particularly those that are marketed to children and adolescents. One concern with caffeine in foods is that caffeine is being added in excess of its traditional use levels, which raises the question of whether these higher levels are safe. The FDA currently lists 400 milligrams of caffeine, or 4 or 5 cups of coffee a day, as a safe level for healthy adults.
Caffeine is explicitly approved as an additive by the FDA only in cola-type beverages. This does not preclude the use of caffeine in other foods at safe levels, however. Pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act (FDCA), a substance that is intentionally added to a conventional food, which is consumed for taste, aroma, or nutritive value, is considered unsafe unless its use has been pre-approved by the FDA or it is generally recognized as safe (GRAS) by qualified experts. This means that manufacturers can add an ingredient, such as caffeine, to a conventional food if they make the determination that it is GRAS for its intended use.
Additionally, many manufacturers market caffeinated products as dietary supplements rather than conventional foods. Under the Dietary Supplement Health and Education Act (DSHEA), a dietary supplement is a product taken by mouth that contains a dietary ingredient and is intended to supplement the diet. The regulations for added ingredients in dietary supplements are different than those for conventional foods. Dietary ingredients marketed prior to 1994, such as caffeine, intended for use in a dietary supplement are presumed safe, for example. This means that they do not require premarket approval or a GRAS determination.
In all, the FDA is authorized to take enforcement actions against any products that it considers to be unsafe. In 2010, for example, the Agency withdrew certain caffeinated alcoholic beverages from the market due to health-related risks. If you have any questions about the FDA regulation of caffeine in foods or need the assistance of a FDA regulatory attorney, please contact us at: firstname.lastname@example.org.