美国FDA 指导原则 行业膳食补充剂指南草案新的膳食成分通知和相关问题PDF 英文原版.pdfVIP

Contains Nonbinding Recommendations Draft-Not for Implementation Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry Draft Guidance This guidance is being distributed for comment purposes only. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2011-D-0376, which is listed in the notice of availability that publishes in the Federal Register . For questions regarding this draft document, contact the Food and Drug Administration, Office of Dietary Supplement Programs, 5001 Campus Drive (HFS-810), College Park, MD 20740, Toll Free (855) 543-3784, or 240-402-2375. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition August 2016 Replaces draft guidance issued July 2011 Contains Nonbinding Recommendations Draft-Not for Implementation Table of Contents I.