01.01.05
According to the American Herbal Products Association (AHPA), Silver Spring, MD, FDA has extended the comment period on its solicitation of information related to FDA’s pre-market notification program for new dietary ingredients (NDIs). A formal notice reopening the comment period for 60 days appeared in the Federal Register in early December. Comments are now due in early February. The agency is soliciting comments related to the type of information that should be included in a NDI submission and the legal status of an ingredient as a dietary ingredient and as a NDI. FDA is also seeking input as to whether it should define certain relevant terms (e.g., botanical, extract and tincture) or establish guidance to assist in submitting the required notifications for NDIs. (For more details regarding NDIs and claim substantiation, see this month’s Capitol Comments column, which starts on page 18, or refer to page 22 of the December issue.)
In other news, FDA has issued its final rule regarding record keeping under the Bioterrorism Act. This regulation calls for the establishment and maintenance of records to protect the food and animal feed supply in the U.S. Specifically, the rule implements section 306 of the Act, which requires persons who manufacture, process, pack, transport, distribute, receive, hold or import food to establish and maintain records identifying the immediate previous source of all food received and the immediate subsequent recipient of all food released.
In other news, FDA has issued its final rule regarding record keeping under the Bioterrorism Act. This regulation calls for the establishment and maintenance of records to protect the food and animal feed supply in the U.S. Specifically, the rule implements section 306 of the Act, which requires persons who manufacture, process, pack, transport, distribute, receive, hold or import food to establish and maintain records identifying the immediate previous source of all food received and the immediate subsequent recipient of all food released.