Springer James
The George Washington University Law School, USA.
Food Drug Law J. 2013;68(4):401-22, i-ii.
The Federal Food, Drug, and Cosmetic Act ("FDCA"), amended in 1990 by the Nutrition Education and Labeling Act ("NLEA"), established a national framework for the administration and promulgation of uniform food labeling standards. Specifically, the NLEA created affirmative obligations for the food--requiring detailed disclosure of food content and strict adherence to regulations governing the use of health and nutritional claims on food packaging. To accomplish these goals, Congress tasked the Food and Drug Administration ("FDA") with the sole responsibility of the enforcement of these new requirements. Under the statutory framework of the FDCA, the United States Supreme Court ("Court") has held that there is no private right of action, of which extended to the enforcement of NLEA standards. This interpretation has left individuals with no federal outlet for relief in the enforcement of federal food labeling standards. Adherence to this interpretation is especially concerning when the FDA currently faces exponential growth in administrative responsibilities while simultaneously experiencing employment reduction, a $206 million "Sequester," and a recent government-wide shutdown. As a result, the American people are left to depend on an Agency that is struggling with drastic resource reduction while being accountable for ever increasing enforcement responsibilities. To ensure consumer protection, this Article argues that Congress should amend the FDCA to include a citizen suit provision in order to provide individuals with a right of private action for the enforcement of NLEA standards. Borrowing from the successes realized under similar citizen suit provisions found in environmental legislation, this Article argues that a citizen suit provision is amendable to the FDCA and would relieve fiscal pressures, strengthen the current enforcement framework of the FDCA, encourage more robust enforcement by the FDA and states, and ensure uniform interpretation of NLEA standards.
《联邦食品、药品和化妆品法案》(“FDCA”)于1990年经《营养教育与标签法案》(“NLEA”)修订,确立了统一食品标签标准管理与颁布的国家框架。具体而言,NLEA规定了食品的肯定性义务——要求详细披露食品成分,并严格遵守食品包装上健康和营养声明使用的相关规定。为实现这些目标,国会赋予食品药品监督管理局(“FDA”)执行这些新要求的唯一责任。根据FDCA的法定框架,美国最高法院(“最高法院”)裁定不存在私人诉讼权,该权利并不延伸至NLEA标准的执行。这种解释使得个人在执行联邦食品标签标准时没有联邦救济途径。当FDA目前面临行政责任呈指数级增长,同时却在裁员、面临2.06亿美元的“自动减支”以及近期政府全面停摆的情况下,坚持这种解释尤其令人担忧。结果,美国民众只能依赖一个正努力应对大幅资源削减却要对不断增加的执法责任负责的机构。为确保消费者保护,本文认为国会应修订FDCA,纳入公民诉讼条款,以便为个人提供执行NLEA标准的私人诉讼权。借鉴环境立法中类似公民诉讼条款取得的成功经验,本文认为公民诉讼条款可适用于FDCA,将缓解财政压力,加强FDCA当前的执法框架,鼓励FDA和各州更有力地执法,并确保对NLEA标准的统一解释。