The Food and Drug Administration has announced that due to scheduled maintenance, users of certain systems and their subcomponents, including the Food Facility Registration system and the Prior Notice System Interface (PNSI), may experience intermittent time outs on May 21, 2011 between 3:00 a.m. and 1:00 p.m. ET.
On May 13, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On May 12, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration has requested a permanent injunction in the case against American Mercantile Corp. and Ingredients Corporation of America of Memphis, and Damon S. Arney, their owner and president. The companies receive, process, manufacture, prepare, pack, label, hold, and distribute a wide variety of food products and ingredients, including spices, herbs, and sauces. The complaint charges that they violate the Federal Food, Drug, and Cosmetic Act by preparing, packing and holding food under insanitary conditions where it may have become contaminated with filth.
The Food and Drug Administration has updated its Frequently Asked Questions document on the Food Safety Modernization Act (FSMA) to provide more information on Dockets, Guidance, Laws, and Regulations.
On May 11, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency has issued a final rule, effective May 11, 2011, which amends the Toxic Substances Control Act section 8(a) Inventory Update Reporting (IUR) regulations to suspend the next submission period (June 1, 2011 to September 30, 2011) within which manufacturers and importers must report IUR data on the manufacturing, processing, and use of the chemical substances to EPA.1
On May 17, 2011, the Food and Drug Administration will hold a webinar on foreign inspections. During the webinar, FDA's Deputy Director of the Division of Foreign Field Investigations will give an overview and answer questions about FDA's Global Inspection program.
The Office of Management and Budget states that it has extended its review of a FDA final rule and proposed rule on over-the-counter sunscreen products. In its July 30, 2010 final rule submission to OMB, the Food and Drug Administration states that the OTC drug review establishes conditions under which such drugs are generally recognized as safe (GRAS) and effective and not misbranded. After a final rule is issued, only OTC drugs meeting the conditions of the rule, or having an approved new drug application, may be legally marketed. The first action addresses active ingredients reviewed under Time and Extent Applications. The second action addresses other effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The last action addresses combination products containing sunscreen and insect repellent ingredients. Also on July 30, 2010, the FDA has submitted a proposed rule to OMB titled: "Revised Safety and Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use.'"
The Environmental Protection Agency is proposing to revoke a significant new use rule (SNUR) issued under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for a chemical substance identified generically as substituted ethoxyethylamine phosphonate, which was the subject of premanufacture notice (PMN) P-95-1950.