Food Additives and Generally Recognized As Safe

In 1958, Congress passed the Food Additives Amendment, which required manufacturers of new food additives to establish the safety of the additives before they could be introduced into the food supply. Now food ingredients are categorized as either “food additives” or “generally recognized as safe.” Food additives are defined as substances for which the intended use results or may reasonably be expected to result, directly or indirectly, in their becoming a component of food or otherwise affecting the characteristics of food.^[1] Food companies must obtain FDA approval before marketing a food with a food additive.^[2] The FDA generally issues a food additive regulation prescribing its approved use and thereafter the food additive will be deemed unsafe only if it does not conform to the terms of the regulation.^[3]

An ingredient is exempt from the definition of food additive if it is “generally recognized as safe,” or GRAS. A substance may be considered GRAS based on the views of “experts qualified by scientific training and experience to evaluate the safety of substances.”^[4] This may occur through two methods. First, for substances used in food prior to January 1, 1958, an ingredient could have been declared GRAS through experience based on common knowledge about the substance throughout the scientific community.^{[4] [4] [7]} Salt and pepper are examples of ingredients with GRAS status through this mechanism. Second, an ingredient can be declared GRAS through studies published in peer-reviewed journals, which may be corroborated by other data and information, the opinion of an ‘‘expert panel’’ convened for this purpose, or the recommendation of an authoritative body such as the National Academy of Sciences.^52,53

In 1969, President Richard Nixon convened a White House Conference on Food, Nutrition, and Health. Much of the conference focused on topics such as hunger, malnutrition, and nutrition education.^[8] However, in response to the FDA’s 1969 decision to remove various cyclamate salts (nonnutritive sweeteners) from the GRAS list after studies revealed bladder tumors in rats fed with them, President Nixon additionally directed the FDA to re-examine the safety of GRAS substances.^[9] The FDA announced that it would undertake a comprehensive study of GRAS substances in 1970 to evaluate the available safety information and determine whether each item should be confirmed as GRAS or be subject to a food additive regulation.^[9] The FDA created administrative procedures and convened the Select Committee on GRAS Substances to make independent scientific determinations.^[11] By 1982, the Select Committee had produced 151 detailed reports covering over 400 substances.^[11]

Thereafter, GRAS affirmation involved the FDA’s formal rulemaking procedure, which the agency found to be resource intensive. When a food company petitioned the FDA to confirm an ingredient should be GRAS based on its own determination that this was the case, the FDA had to engage in the following activities: (1) publish a notice in the Federal Register; (2) request comments on the petitioned request; (3) conduct a comprehensive review of the petitioner’s data and information and the comments received to determine whether the evidence established that the petitioned use of the substance is GRAS; (4) draft a detailed explanation of why the use is GRAS; and (5) publish that explanation in the Federal Register. In 1997, the FDA decided to permit food companies to self-declare an ingredient to be GRAS in order to avoid these steps and preserve its limited resources for other purposes.^[13] The FDA thus proposed a rule to avoid this formal process. Although the 1997 proposed rule was never finalized or subject to a complete notice and comment rulemaking at that time, the FDA has functioned under this determination since then.^[14]

Under the 1997 proposed rule program, the FDA permits companies to determine that a substance is GRAS and based on this conclusion, the company may market the food with the ingredient without first informing the FDA.^[15] Instead of formally petitioning the FDA for GRAS verification, the company need only file a ‘‘GRAS exemption claim’’ describing the substance, the applicable conditions of use, and the basis for the GRAS determination; however, it does not need to submit the information or data upon which the determination was made.^[16]

Several nonprofit groups sued the FDA in 2014, arguing that the GRAS exemption claim program is contrary to Congress’s intent in passing statutory requirements related to GRAS status, deprives the public of the right to have its comments considered as required by the Administrative Procedure Act, exposes the public to potentially hazardous substances, and raises concerns about the integrity of the process and the food industry’s determinations.^[17] The parties settled the lawsuit, with the FDA agreeing to finalize a GRAS rule by August 2016.^[18]

The FDA has the power to determine that a substance is not GRAS or no longer GRAS upon its own volition. The FDA must publish a notice in the Federal Register explaining its determination that a substance is not GRAS but rather is a food additive subject to regulatory oversight by the agency.^[19] In 2013, the FDA determined that partially hydrogenated oils, which are the primary dietary source of trans fat, are not GRAS.

In the 1990s, studies emerged to indicate that the consumption of trans fat increases the risk of coronary heart disease. Denmark banned trans fat in 2003, New York City’s Department of Health and Mental Hygiene banned its use in restaurant foods in 2006, and California followed suit in 2008.^[20] The FDA initially addressed concerns over partially hydrogenated oils by requiring the disclosure of the trans fat content of food on the Nutrition Facts Panel in 2006.^[21]

In 2013 the FDA issued a notice in the Federal Register, stating that it found that partially hydrogenated oils are “no longer GRAS under any condition of use in food and therefore are food additives.”^[22] The agency noted that partially hydrogenated oils have been used in food for many years based on the food industry’s self-determination that such use is GRAS.^[22] The agency thus sought comments on its conclusion that food manufacturers should no longer be permitted to sell partially hydrogenated oils, “either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.”^[22] The FDA received over 1,500 comments.^[25] In June 2015, the agency finalized its determination that partially hydrogenated oils are not GRAS for use in human food. The FDA gave food manufacturers three years to remove partially hydrogenated oils from their products but is permitting food companies to petition the agency to request an exemption for specific uses.

Caffeine is another substance with questionable GRAS status when added to food. See Box 5.1 for more information on caffeine and its GRAS designation.

• [1] 21 CFR 170.3.
• [2] 21 CFR 570.30.
• [3] Food and Drug Administration. Determining the Regulatory Status of a Food Ingredient.http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm228269.htm
• [4] 21 CFR 170.30
• [5] 21 CFR 170.30
• [6] 21 CFR 170.30
• [7] 18938 Federal Register. 1997162(74). Proposed Rules.
• [8] White House Conference on Food Nutrition and Health. Final Report. Remarks of thePresident at the Open Plenary Session on the White House Conference on Food Nutrition andHealth. Sheraton Park Hotel. December 2, 1969. www.nns.nih.gov/1969/full_report/White_House_Report2_S1a.pdf
• [9] 62 Federal Register 18938, 18939 (April 17, 1997).
• [10] 62 Federal Register 18938, 18939 (April 17, 1997).
• [11] Food and Drug Administration. History of the GRAS List and SCOGS Reviews. http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/ucm084142.htm
• [12] Food and Drug Administration. History of the GRAS List and SCOGS Reviews. http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/ucm084142.htm
• [13] 18938 Federal Register. 1997;62(74).Proposed Rules.
• [14] 18938 Federal Register. 1997;62(74)Proposed Rules.
• [15] U.S. Government Accountability Office. FDA Should Strengthen Its Oversightof Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). GAO-10246: Published: February 3, 2010. Publicly Released: March 5, 2010.
• [16] 18938 Federal Register. 1997^2(74). Proposed Rules.
• [17] Center for Food Safety v. Sebelius et al. Case No. 1:14-cv-267-RC. Complaint (D. DC March13, 2014). http://www.centerforfoodsafety.org/files/2014-3-13-dkt-8--pls--am-compl_76904.pdf
• [18] Center for Food Safety. Victory! CFS Wins First Step in Major Legal Battle to Protect Food Safety. October 20, 2014. http://www.centerforfoodsafety.org/press-releases/3550/ victory-cfs-wins-first-step-in-major-legal-battle-to-protect-food-safety#
• [19] 21 CFR 570.38.
• [20] K. D. Brownell, J. L. Pomeranz. The Trans Fat Ban—Food Regulation and Long-Term Health.New England Journal of Medicine. 2014;370:1773-1775.
• [21] 21 CFR 101.9(c)(2)(H).
• [22] 78 Federal Register 67169 (November 8, 2013).
• [23] 78 Federal Register 67169 (November 8, 2013).
• [24] 78 Federal Register 67169 (November 8, 2013).
• [25] Docket ID: FDA-2013-N-1317. Regulations.gov. http://www.regulations.gov/#!docketDetail;D =FDA-2013-N-1317