Degnan Frederick H
King and Spalding, Washington, DC 20006-4795, USA.
Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S133-6; discussion S144-51. doi: 10.1086/523324.
Probiotics are living microorganisms that, when consumed, have the potential to confer a beneficial health effect. Unfortunately for purveyors of probiotic products, the system of regulation delineated in the Food, Drug, and Cosmetic Act is anything but "one size fits all." How a probiotic product is used or is intended to be used will govern the regulatory category or categories that the US Food and Drug Administration (FDA) will assign to the product. The extent and nature of the restraints and data-collection requirements that may be imposed on the marketing of a product hinge on how a product is categorized under the Act. More specifically, the categorization of a product governs the respective regulatory burdens of an industry sponsor and the FDA. Premarket systems, such as those for new drugs and biologics, place a heavy evidentiary burden on the sponsor of a product. Postmarket systems, such as those for dietary supplements, place, at least initially, a higher regulatory evidentiary burden on the FDA than on the product sponsor. This article explains regulatory categorizations under the Food, Drug, and Cosmetic Act and their effects regarding the federal regulation of probiotic products.
益生菌是一类活的微生物，食用后可能会对健康产生有益影响。对于益生菌产品供应商而言不幸的是，《食品、药品和化妆品法案》所规定的监管体系绝非“一刀切”。益生菌产品的使用方式或预期使用方式将决定美国食品药品监督管理局（FDA）对该产品的监管类别。对产品营销可能施加的限制程度和性质以及数据收集要求，取决于产品在该法案下的分类方式。更具体地说，产品的分类决定了行业赞助商和FDA各自的监管负担。上市前体系，如新药品和生物制品的体系，会给产品赞助商带来沉重的证据负担。上市后体系，如膳食补充剂的体系，至少在最初阶段，给FDA带来的监管证据负担要高于产品赞助商。本文解释了《食品、药品和化妆品法案》下的监管分类及其对益生菌产品联邦监管的影响。
