Fed Regist. 2017 Jan 9;82(5):2193-217.
The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
美国食品药品监督管理局（FDA）发布本最终规则，以描述供人类消费的烟草制成品或衍生产品在何种情况下将根据《联邦食品、药品和化妆品法案》（FD&C法案）作为药品、器械或组合产品受到监管。该行动旨在为受监管行业提供指导，并帮助避免消费者产生困惑。
