By Joel E. Roberson, Sara M. Klock and Jennifer M. Nowak
On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement announcing the agencies' joint regulatory framework for cell-cultured food products derived from livestock and poultry. The need for collaboration between the two agencies with regard to animal cell-cultured food technology – which the agencies have described as "the controlled growth of animal cells from livestock, poultry, fish or other animals, their subsequent differentiation into various cell types, and their collection and processing into food" – arises from the overlap of USDA's statutory mandate to regulate meat and poultry products and FDA's statutory responsibility for the safety of the national food supply, as well as FDA's experience in regulating cell-based technology.
This announcement follows a Federal Register Notice issued on Sept. 13, 2018 and a joint public meeting held on Oct. 23-24, 2018, by the two agencies, where FDA and USDA discussed the "potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry tissue" with stakeholders and the public. Under the framework, FDA will be primarily responsible for overseeing cell collection, cell banks, and cell growth and differentiation," while USDA will be primarily responsible for regulating the production and labeling of food products derived from these cells. The agencies anticipate that the transition of oversight from FDA to USDA will occur "during the cell harvest stage."
FDA and USDA are actively reviewing the details of the framework, including collaboration and information sharing. FDA and USDA do not anticipate enacting legislation to conduct their respective roles, as the agencies believe they "have the statutory authority necessary to appropriately regulate cell-cultured food products derived from livestock and poultry." In order to allow for consideration of the joint statement issued on Nov. 16, 2018 and stakeholder feedback from the public meeting held on Oct. 23-24, 2018, the agencies have extended the original public comment period associated with the public meeting by one month, until Dec. 26, 2018.
ADA Restaurant Websites Under ADA ScrutinyBy Philip J. Catanzano
In Haynes v. Dunkin' Donuts LLC, No. 18-10373, 2018 WL 3634720 (11th Cir. July 31, 2018), a blind plaintiff sued Dunkin' Donuts, alleging that its public-facing website, www.dunkindonuts.com, was not compatible with "his, or any, screen reading software." The parties agreed that Dunkin' Donuts is a "public accommodation," subject to Title III of the Americans with Disabilities Act (ADA), 42 U.S.C. §1218 et. seq. The plaintiff's legal theory was that, as a public accommodation, Dunkin' Donuts failed to maintain an accessible website. The district court dismissed the claim because the plaintiff had "failed to allege a nexus between the barriers to access that he faced on the website and his inability to access goods and services" in the physical stores. On appeal, the Eleventh Circuit reversed the district court and remanded for further proceedings, holding that the ADA's prohibition on discrimination was not limited to "tangible barriers" and "can extend to intangible barriers" like public-facing websites, too. While the district court focused on the plaintiff's ability to access the brick-and-mortar storefront for his coffee-drinking needs, the Eleventh Circuit highlighted the plaintiff's allegations that the website also helps people find store locations and purchase gift cards online, benefits that would seemingly be denied to blind people unable to navigate the inaccessible website. As restaurants move more of their services online, e.g., mobile ordering, online menus and store finder navigation tools, increased scrutiny can be expected from litigants and potentially the federal government.
ADA Class Action Premises Case RemandedBy Nathan A. Adams IV
