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Revised FDA Import Alerts on Sept 14

September 15, 2011 |FDA and EPA

On September 14, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on Sept 13

September 14, 2011 |FDA and EPA

On September 13, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

FDA Establishes Dockets for Comments on Sodium Intake

September 14, 2011 |FDA and EPA

The Food and Drug Administration and the Food Safety and Inspection Service (FSIS) are requesting comments, data, and evidence by November 26, 2011, relevant to the dietary intake of sodium, as well as current and emerging approaches designed to promote sodium reduction. FDA and FSIS are particularly interested in research that will help both organizations understand current and emerging practices by industry in sodium reduction in foods; current consumer understanding of the role of sodium in hypertension and other chronic illnesses, sodium consumption practices; issues associated with the development of targets for sodium reduction, etc. FDA Constituent Update on this initiative available here.

FDA Extends Comment Period on Sunscreen Dosage Forms

September 14, 2011 |FDA and EPA

The Food and Drug Administration has extended the comment period on its June 2011 advance notice of proposed rulemaking (ANPR) requesting data and information on certain dosage forms of over-the-counter (OTC) sunscreen drug products marketed without approved applications. FDA requested the data to establish OTC monograph conditions, including dosage form specifications, for OTC sunscreen drug products in order to help resolve specific questions about the effectiveness and safety of OTC sunscreens in spray dosage forms.

FDA Warns Consumers of Botulism Risk in La Ruche Tapenade, Etc.

September 14, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration is warning consumers not to eat tapenade or spreadable dried tomato paste manufactured by the French food company La Ruche. French health authorities have reported an outbreak of botulism in France linked to the company’s products sold under the brand names “Les délices de Marie-Claire,” “Terre de Mistral” and Les Secrets d’Anaïs.” Eight adults are currently suffering from respiratory failure as a result of eating foods containing the neurotoxin produced by Clostridium botulinum. French authorities have ordered production halted at the company’s facility in France and have directed that all products sold under those brand names be recalled.

FDA Extends Comment Period on Draft Dietary Supplement Guidance

September 13, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration is extending the comment period on its draft guidance for industry on dietary supplement ingredient notifications and related issues which was issued on July 3, 2011. The draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and in preparing premarket safety notifications. It is a requirement of the Food Safety Modernization Act.

EPA Extends Comments Period on SNUR for 14 Glymes

September 12, 2011 by Elizabeth Parker|FDA and EPA

The Environmental Protection agency has extended the comment period to October 12, 2011 (from September 12) on its proposed rule concerning a proposed significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances and Control Act for 14 glymes. Twelve glymes (also known as dimethoxyethane) have industrial or consumer uses and two have no current uses. EPA has preliminarily determined that the manufacture, import, or processing of the 12 glymes for “any use in a consumer product” is a significant new use, as well as for “any use” of the other two glymes.

Revised FDA Import Alerts on Sept 9

September 12, 2011 |FDA and EPA

On September 9, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

Update on FDA's Letter for the Quick Release of Radiation-Emitting Electronic Products

September 12, 2011 by Marie Rapport|FDA and EPA

A recent U.S. Customs and Border Protection CSMS message describes the importance of adhering to a September 6, 2011 Food and Drug Administration "Letter to Industry" on the entry of medical and non-medical radiation emitting electronic products. CBP states that the proper submission of the required entry information and the submission of voluntary Affirmation of Compliance (AofC) codes, will make it more likely that a shipment is processed based on import system screening and not held for further FDA entry review.

Revised FDA Import Alerts on Sept 8

September 9, 2011 by Elizabeth Parker|FDA and EPA

On September 8, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of: