In an important ruling dismissing a proposed class action, the US District Court for the Southern District of Florida ruled that the US Food and Drug Administration’s (FDA’s) generally recognized as safe (GRAS) regulation preempts a Florida statute that criminalized adding grains of paradise to liquor. More specifically, the Court in Marrache v. Bacardi USA, Inc., 2020 US Dist. LEXIS 13668 (January 28, 2020), ruled that the Florida statute was preempted because it conflicts with the Federal Food, Drug and Cosmetic Act (FFDCA) and the FDA’s regulations (21 C.F.R. § 182.10) which establish that grains of paradise are GRAS. 2020 US LEXIS 13668, at *4.
FDA Publishes Final Rule for Protection Against Intentional Adulteration as Part of Food Safety Modernization Act
FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration. The rule will require domestic and foreign food facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) to address hazards that may be introduced with the intention to cause wide scale public health harm. More specifically, under this regulation, both domestic and foreign food facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities will now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.
FDA to Propose Rules to Address Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors
On Monday, July 29, 2013, U.S. Food and Drug Administration (FDA) will publish two proposed regulations to implement parts of the Food Safety Modernization Act (FSMA). The proposed rules will address: (A) Foreign Supplier Verification Programs (FSVP); and (B) the accreditation of third-party auditors. The comment period for these proposed rules runs 120 days, putting the comment deadline on or about November 26, 2013.
A. FSVP: In brief, the FSVP proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures equivalent to those domestically under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These processes and procedures include reasonably appropriate risk-based preventive controls, hazard analysis and risk-based preventive controls, and standards for produce safety. Moreover, controls should ensure the food is not adulterated or misbranded.
B. Accreditation of Third-Party Auditors: Under the accreditation rule, FDA will recognize accreditation bodies, which would in turn accredit third-party auditors to, among other things, conduct food safety audits and issue certifications for foreign facilities and food under specified programs. Importers will not generally be required to obtain certifications, but in certain circumstances FDA may use certifications from accredited auditors in determining whether to admit certain imported food into the United States that FDA has determined poses a food safety risk. FDA may also use accreditation to determine whether an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food.
These two new proposed rules are part of several FDA initiatives to implement the FSMA. Previously, FDA published proposed rules for produce safety and preventative controls for human food. The comment period for those two proposed rules ends on September 16, 2013.
In addition, FDA has three other regulations to propose in connection with FSMA: (1) preventative controls for animal feed; (2) protection against intentional adulteration; and (3) sanitary transportation of food.
By Court order, all of FDA’s FSMA rules must be proposed by November, 30, 2013, the comment period must end by March 31, 2014, and FDA must publish all final regulations no later than June 30, 2015.