Docket Number & Title: 2006D-0480 - Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability
FR Type: Notice
Action: Availability.Guidance.Level 1
Comment Period End Date: 04/30/07
Summary: The Food and Drug Administration (FDA, we) is announcing the availability of a draft guidance for industry entitled "Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration." In recent years, the use of complementary and alternative medicine (CAM) products has increased in the United States, and we have seen increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug, and Cosmetic Act ("the Act") or Public Health Service Act ("PHS Act"). We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the Act or the PHS Act.