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Revised FDA Import Alerts on Sept 26
September 28, 2011 by Barbara Chaves|FDA and EPA

On September 26, 2011, the Food and Drug Administration posted a revised version of the following Import Alert on the detention without physical examination of:

FDA Update on Aligning PGA "Trusted Trader" Programs, Document Imaging
September 27, 2011 by Barbara Chaves|FDA and EPA

A Food and Drug Administration official who spoke at the September 2011 annual NCBFAA1 Government Affairs Conference gave an update on the Border Interagency Executive Council's efforts to (i) align participating government agency (PGA) “trusted trader” programs; and (ii) share information and images via the Document Image System (DIS).

Revised FDA Import Alerts on Sept 23
September 26, 2011 by Barbara Chaves|FDA and EPA

On September 23, 2011, the Food and Drug Administration posted a revised version of the following Import Alert on the detention without physical examination of:

FDA Says OTC Asthma Inhalers with CFC Banned After Dec 31
September 26, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration states that users of epinephrine inhalers with chlorofluorocarbon (CFC)-containing epinephrine should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after December 31, 2011. Primatene Mist, marketed by Armstrong Pharmaceutical Inc, is the only such FDA-approved over-the-counter inhaler of this type. According to FDA, this action is in accordance with the Montreal Protocol on Substances that Deplete the Ozone Layer and the phase-out date was announced in November 2008.

FDA Final Rule Makes Technical Amendments for Food Additives, GRAS, Etc.
September 26, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration has issued a final rule to make technical amendments to its regulations regarding environmental impact considerations, food additives, and generally recognized as safe (GRAS) substances to correct minor errors in the Code of Federal Regulations (CFR). FDA says that this action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations. The rule is effective 7 days after September 26, 2011.

Revised FDA Import Alerts on Sept 22
September 23, 2011 by Elizabeth Parker|FDA and EPA

On September 22, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

FDA Issues Biennial Report on Food Emergency Response Network
September 23, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration has posted its biennial report to Congress on the Food Emergency Response Network (FERN), which is an integrated, secure laboratory system for Federal, State, and local government agencies engaged in food safety and defense activities. It integrates many food-testing laboratories into a network that is able to detect, identify, respond to, and aid in the recovery from emergencies involving biological, chemical, or radiological contamination of food. The biennial report on FERN's progress is a requirement of the Food Safety Modernization Act.

Revised FDA Import Alerts on Sept 21
September 22, 2011 by Elizabeth Parker|FDA and EPA

On September 21, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

FDA Issues Guidance on Salmonella in Pistachio Products
September 22, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration is announcing the availability of a guidance entitled “Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient.” This level 1 guidance clarifies for manufacturers who produce foods containing a pistachio-derived product as an ingredient that there is a risk that Salmonella species may be present in the incoming pistachio-derived product, and recommends measures to address that risk. Pistachio-derived products include roasted in-shell pistachios and shelled pistachios (also called kernels) that are roasted or raw.