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From Health Law Daily, September 14, 2018

FDA final rule posed risk of harm to members of public

By Matt Pavich, J.D.

A rule allowing manufacturers to self-certify their products and to bypass the FDA’s food additive process posed potential harm to members of two advocacy groups because those members were, and would continue to be, exposed to potential dangerous products, a federal district court in New York has ruled. The court found that the groups had standing to oppose a Final rule (81 FR 54960) promulgated by the FDA (Center for Food Safety v. Price, September 12, 2018, Broderick, V.).

Background. Under the 1958 Amendment to the federal Food, Drug, and Cosmetic Act (FDC Act), the FDA must review and approve the proposed use for food additives before they may be used in food. However, substances generally recognized as safe (GRAS) are not considered additives and manufacturers can bypass the approval process before adding them. In 1997, the FDA proposed the GRAS rule, under which manufacturers can make GRAS determinations without FDA input or approval and without judicial review. The FDA published the Final rule in 2016 (see GRAS classification requires scientific considerations; FDA implements notification process, August 17, 2016). Various advocacy groups sought to vacate the rule. The government moved to dismiss for lack of standing.

Diversion of resources. The groups needed to show that they had suffered an injury in fact in order to have standing. The groups alleged that their mission was to protect the public from unsafe foods and the rule caused them to prioritize resources because they lacked safety data on the GRAS substances. The court rejected the argument, finding that the alleged harm was not sufficiently distinct from their general mission and noted that finding otherwise would contravene the principal that mere interest in a problem does not confer standing.

Informational harm. The court also ruled that the groups had not suffered harm due to a failure to obtain information that must be made public pursuant to a statute. The groups argued that the GRAS ruled denied them information that the FDC Act guaranteed would be publicly disclosed. The court, however, found that the FDC Act requires information to be disclosed about additives, not GRAS substances.

Harm to members. The court did find that two of the groups showed that their members would be harmed by the rule. Those groups alleged that their members had, and would continue to be exposed to potentially dangerous substances because the GRAS rule eliminated FDA oversight and judicial review. They identified numerous substances that manufacturers had identified as GRAS and used, despite safety concerns, and other substances that they expected would be introduced. Despite the government’s contention, these potential injuries did not need to be avoidable in order to give rise to an injury for standing purposes. Furthermore, the groups contended that their members lacked the information, thanks to the GRAS rule, that would allow them to avoid potentially dangerous substances, as the rule allowed manufacturers not to identify the chemicals they have self-certified as GRAS. The court found that the rule could indirectly harm the members and that the harm could be redressed if the FDA were to fulfill its obligations. The court therefore found the two groups had standing and denied the motion to dismiss as to them. It granted the motion as to the remaining three groups.

The case is No. 17-CV-3833.

Attorneys: Alexis Charlotte Andiman (Earthjustice) for Center for Food Safety and Environmental Defense Fund. Michael James Byars, U.S. Attorney's Office, for Tom Price.

Companies: Center for Food Safety; Breast Cancer Prevention Partners; Center for Science in the Public Interest; Environmental Defense Fund; Environmental Working Group

MainStory: TopStory CaseDecisions FDCActNews FoodNews FoodSafetyNews FoodStandardsNews LabelingNews SafetyNews NewYorkNews

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