GRAS Notice (GRN) No. 661 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm ORIGINAL SUBMISSION 749 46th Square Vero Beach, FL 32968, USA ~ont ~ssottates Telephone: 772-299-0746 & 3Jnt. Facsimile: 772-299-5381 E-mail:
[email protected] GRIV OOOfobi August 1, 2016 Office of Food Additive Safety (HFS-255) Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740-3835 Subject: GRAS Notification for Fucoidan Concentrate from Fucus vesiculosus Dear Sir/Madam: Pursuant to proposed 21 CFR 170.36 (62 FR 18960; April 17, 1997), Marinova Pty. Ltd. (Marinova), Australia, through Soni & Associates Inc. as its agent, hereby provides notice of a claim that the food ingredient Fucoidan concentrate derived from Fucus vesiculosus described in the enclosed notification document is exempt from the premarket approval requirement of the Federal Food, Drug, and Cosmetic Act because it has been determined to be Generally Recognized As Safe (GRAS), based on scientific procedures. As required, please fmd enclosed three copies of the notification. If you have any questions or require additional information, please feel free to contact me by phone at 772-299-0746 or by email at
[email protected]. Sincerely, Madhu G. Soni, Ph.D., FATS Enclosure: Three copies ofthe GRAS notice www .son iassociates.net 749 46th Square Vero Beach, FL 32968, USA Telephone: 772-299-0746 ~ont & ~ssoctates J!nc. Facsimile: 772-299-5381 E-mail:
[email protected] I. Claim of GRAS Status A. Claim of Exemption from the Requirement for Premarket Approval Requirements Pursuant to Proposed 21 CFR § 170.36(c)(l) Marinova Pty.