For most consumers, it may come as a surprise to learn that many of the foods available at their local grocery store contain ingredients that have neither been evaluated nor approved by the U.S. Food and Drug Administration (FDA). This stunning radio silence from our nation’s foremost food safety regulatory agency is the result of a statutory loophole that has been utilized by the industry for decades — Generally Recognized as Safe (GRAS). In 1958, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) to establish new regulatory and procedural requirements for the use of novel food additives. In so doing, it defined a food additive as “any substance the intended use of which results or may reasonably be expected to result … in its becoming a component … of any food … if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety … to be safe.” In other words, a substance that would otherwise be considered a food additive is exempted from being defined as such if it is generally recognized as safe. This distinction becomes important in light of Section 348 of the FDCA, which requires all new food additives to obtain pre-market approval from FDA. The time and expense involved in gaining said approval make GRAS substances a more attractive option for many in the industry. Under the FDCA, a substance can be shown to be GRAS through (1) “common use in food” prior to 1958; or (2) “general[ ] recogni[tion] among experts qualified by scientific training and experience to evaluate the safety as having been adequately shown . . . to be safe under conditions of [its] intended use.” FDA regulations clarify that the opinions of those qualified experts must be based on “scientific procedures” approximately equivalent to those necessary to obtain pre-market approval for new food additives and that there be “common knowledge about the substance” among those within the scientific community knowledgeable about food safety. The regulations further state that such procedures “shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data and information.” Notably absent from both the language of the statute and subsequent regulations is any limitation on who may make GRAS determinations and any requirement that FDA be notified when such a determination has been made. Given the breadth of corporate authority to make GRAS determinations, regulation of GRAS substances has been problematic for FDA from the beginning. Initially, FDA created and maintained a list of substances known to be GRAS when used for a particular purpose. However, by FDA’s own admission, the GRAS list was incomplete and the rate of GRAS determinations made by manufacturers and others within the food industry made it impossible for FDA to list all GRAS substances. Subsequently, new scientific information led FDA to question the safety of certain substances listed on the GRAS list. In response to these concerns, FDA undertook a systematic review of GRAS substances to assess whether the underlying GRAS determinations comported with modern scientific standards. To facilitate this review, FDA codified criteria and procedures it could use to assess whether a substance was GRAS and created a mechanism whereby an interested party could petition review of a GRAS substance not currently under review. However, the voluntary petition process proved so burdensome that it deterred many companies from seeking affirmation of their GRAS determinations. As a result, in 1997, FDA transitioned to a voluntary notification program whereby an interested party may notify FDA of its own GRAS determination and provide FDA with the information necessary to assess whether that determination was sound. If the GRAS determination was satisfactory, FDA would respond with a letter stating that it had “no questions.” If FDA was not satisfied, it would respond with a letter seeking further information or supplemental scientific data. According to the Government Accountability Office (GAO), in the 10 years following the debut of the voluntary notification program, FDA received 274 notifications of GRAS determinations. In contrast, by 2010, there were approximately 1,000 industry-affirmed GRAS determinations. This shocking disparity engendered criticism from public and private organizations alike. In 2010, GAO published a report arguing that the voluntary notification program failed to ensure food safety because, among other things, FDA lacked even cursory information about an unknown number of industry-affirmed GRAS substances. FDA’s response to the GAO report makes clear that the agency would prefer to be informed of industry-affirmed GRAS determinations and have the opportunity to assess whether the underlying science is sufficiently robust. However, FDA maintains that it lacks the authority to compel manufacturers to provide the necessary information under the current statutory framework.
In 2011, the Food Safety Modernization Act (FSMA) was enacted to stem the rising tide of food safety-related concerns. Among other things, FSMA granted FDA newfound authority to address these concerns through regulatory actions aimed at prevention, inspections, and recalls. In order to prevent concerns related to food safety, FSMA requires food facilities to prepare written food safety plans that describe the methods used to identify potential hazards, establish preventive controls, assess the efficacy of those controls, and document corrective actions taken. Under the statute, a food facility includes “any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.” The owner, manager, or individual in charge of a food facility must “evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility … and provide assurances that such food is not adulterated … or misbranded.” Among the hazards that must be identified are natural toxins, pesticides, parasites, and unapproved food additives. A written hazard analysis must then be drafted and included in the facility’s food safety plan and made available upon the oral or written request of “a duly authorized representative of the Secretary.” A reevaluation of the potential hazards existing at a food facility must be completed at least once every three years.
In requiring food facilities to provide assurances to FDA that their food is not adulterated or misbranded, combined with the requirement that food facilities provide written hazard analyses documenting and describing how those hazards were identified and assessed, FSMA grants FDA the authority to compel food facilities to provide full documentation of self- or industry-affirmed GRAS determinations as part of their written food safety plans. Unapproved food additives are explicitly identified under the Act as a hazard that must be identified, evaluated, and addressed through preventive measures. In order to provide FDA with the statutorily mandated assurances that new ingredients are GRAS, and thus not unapproved food additives, food facilities must be able to provide FDA with proof of self- or industry-affirmed GRAS determinations, as well as the necessary documentation showing that those determinations comply with all FDA regulations. If a food facility is unable or unwilling to provide evidence of GRAS determinations that comply with the regulatory requirements, that facility has violated the requirements of FSMA, and FDA should take appropriate corrective action. This approach would allow manufacturers and others within the industry to continue self-affirmation of GRAS determinations, contingent upon their ability to provide documentation to that effect, and allow FDA to allocate its resources more efficiently by targeting food facilities that pose the greatest threat to public safety. FDA has called FSMA “the most sweeping reform of our food safety laws in more than 70 years.” Under the Act, FDA has the authority to compel food facilities to inform FDA of GRAS determinations and provide proof that generally recognized as safe means just that. FDA should seize this opportunity to inform itself and consumers about the true state of our food supply and finally capture the “Great White Whale” of food safety.