Archive for the 'FDA' Category

Published by Ana on 08 Oct 2009

FDA :: NEW RULE TO REQUIRE FOOD FACILITIES TO REPORT POSSIBLY ADULTERATED FOOD IN ELECTRONIC FDA REGISTRY

September 11, 2009  

NEW RULE TO REQUIRE FOOD FACILITIES TO REPORT POSSIBLY ADULTERATED FOOD IN ELECTRONIC FDA REGISTRY

  Food facilities required to register with the Food and Drug Administration under the existing Bioterrorism Act (i.e., facilities located anywhere in the world that manufacture, process, package or hold food for consumption in the United States) must now submit a report to the FDA’s new electronic registry) within 24 hours if they find a reasonable probability that an article of food may cause severe health problems or death to a person or animal. This reporting requirement will apply to all foods and animal feed regulated by the FDA except infant formula and dietary supplements. Failure to timely submit the required report may lead to civil and criminal penalties. 

The following data elements must be included in any initial report to the FDA’s electronic registry.

1. the facility registration numbers of the responsible party
2. the date on which the article of food was determined to be a reportable food
3. a description of the article of food, including the quantity or amount
4. the extent and nature of the adulteration
5. the results of any investigation of the cause of the adulteration if it may have originated with the responsible party, when known
6. the disposition of the article of food, when known
7. the product information typically found on packaging, including product codes, use-by dates, and the names of manufacturers, packers or distributors sufficient to identify the article of food

No report will be required if the responsible party - the owner, operator or agent in charge of the registered food facility - found the problem before the food was shipped and corrected the problem or destroyed the food.

Although this rule came into effect Sept. 8, the FDA has now announced through an updated guidance document that it will refrain from enforcing the rule until Dec. 8 in circumstances where it determines that a responsible party has made a reasonable effort to comply and has otherwise acted to protect public health.

Sandler, Travis & Rosenberg, P.A., advises global food facilities and other regulated establishments and offers food facility registration and compliance services. For more information on the FDA’s electronic reporting requirements, ST&R’s food facility registration program and other FDA-related requirements governing the distribution and importation of food, cosmetics, devices or drugs, please contact Edgar Asebey or Lauren Perez in our Miami office at (305) 267-9200.

  

 

  You can also stay up-to-date on the latest developments on this issue by subscribing to ST&R’s WorldTrade\INTERACTIVE daily e-newsletter.

Sandler, Travis & Rosenberg, P.A., is a customs and international trade law firm concentrating in assisting clients with the global movement of goods, ideas and personnel and the setting of global trade policy. Our affiliated consulting company, Sandler & Travis Trade Advisory Services Inc., is a leading provider of trade-related management and consulting services to government and industry. For more information about ST&R and STTAS, please visit our Web site.

  

 

 

  Published by Sandler, Travis & Rosenberg, P.A.

NOTE: Information contained herein is of necessity a summary of complicated and fact-specific issues. It is not intended to convey legal advice, and receipt of it does not constitute or create an attorney-client relationship. Before you act on any information provided in this document, you should seek professional advice regarding its applicability to your specific circumstances.

© 2009, all rights reserved. [9/11/2009]

Receipt of this free publication is allowed under the House and Senate gift rules.
See Senate Rule XXXV 1.(c)(9) and 1.(c)(19); House Rule XXV 5.(a)(3)(I) and 5(a)(3)(R)(i).

  

 

 

  This message has been sent to you as an information service of Sandler, Travis & Rosenberg, P.A.

FDA

Published by Ana on 08 Oct 2009

FDA :: REPORTABLE FOOD REGISTRY

Please click here to view this message in your browser.

FDA Reportable Food Registry Launches September, 2009. Are you up to date?
Your facility was registered with the FDA Food Facility Registration database, as required by The Public Health Security and Bioterrorism Preparedness and Response Act of 2002. It is critical that all of the information on each facility in the Food Facility Registration database be current. Under FDA regulations, registration information is required to be updated within 60 days of a change.

Updated information is more important than ever. This fall, FDA will be launching a new system, the Reportable Food Registry, which will help the Agency manage and contain foodborne illness outbreaks more efficiently. The Food Facility Registration database and the Reportable Food Registry are designed to work together to enable close collaboration between FDA and the food industry. The contact information for the system must be up to date, so we are asking that you take a moment to update your registration information.

Updating your information is easy. You can do this by using Form 3537, available online at www.access.fda.gov. There is no fee for registration or updates to a registration.

If you have any questions, an online registration Help Desk is available on business days from 7:00 a.m. to 11:00 p.m. (EST). Call (800) 216-7331. Outside the U.S., call (301) 575-0156.

We encourage you to update your information as soon as possible. Thank you for working with us to improve the safety of the food supply.

   Update your information at www.access.fda.gov

FDA

Published by Ana on 27 Aug 2009

FDA :: REPORTABLE FOOD REGISTRY

FDA Reportable Food Registry Launches September, 2009. Are you up to date?
Your facility was registered with the FDA Food Facility Registration database, as required by The Public Health Security and Bioterrorism Preparedness and Response Act of 2002. It is critical that all of the information on each facility in the Food Facility Registration database be current. Under FDA regulations, registration information is required to be updated within 60 days of a change.

Updated information is more important than ever. This fall, FDA will be launching a new system, the Reportable Food Registry, which will help the Agency manage and contain foodborne illness outbreaks more efficiently. The Food Facility Registration database and the Reportable Food Registry are designed to work together to enable close collaboration between FDA and the food industry. The contact information for the system must be up to date, so we are asking that you take a moment to update your registration information.

Updating your information is easy. You can do this by using Form 3537, available online at www.access.fda.gov. There is no fee for registration or updates to a registration.

If you have any questions, an online registration Help Desk is available on business days from 7:00 a.m. to 11:00 p.m. (EST). Call (800) 216-7331. Outside the U.S., call (301) 575-0156.

We encourage you to update your information as soon as possible. Thank you for working with us to improve the safety of the food supply.

FDA

Published by Ana on 26 Aug 2009

FDA :: Import Alert listings on FDA Internet Site

Correction to message 09-000283

Date: August 7, 2009

To: Automated Broker Interface

The U.S. Food and Drug Administration (FDA) has become aware that some recent revisions to our Import Alerts are not being posted correctly on FDA’s internet website. After further investigation, there are data system difficulties preventing the trade community from viewing the most up-to-date versions of the import alerts. The appropriate parties within FDA are aware of the situation and are working expeditiously to remedy the problem, so we may have the most up-to-date import alerts available for viewing as soon as possible.

If an issue arises wherein there is uncertainty within the trade community as to whether or not a firm and/or product are subject to detention without physical examination as indicated by a particular import alert, please contact your local FDA office for further clarification. The following link provides contact information by region http://www.fda.gov/ICECI/Inspections/IOM/ucm124008.htm.

FDA

Published by Ana on 26 Aug 2009

FDA :: Import Alert Listings on FDA Internet Site

Fri, 07 Aug 2009 15:58:02 -0500

 

Automated Broker Interface

Title: Import Alert Listings on FDA Internet Site

Date: August 7, 2009

To: All brokers and importers

The U.S. Food and Drug Administration (FDA) has become aware that some recent revisions to our Import Alerts are not being posted correctly on FDA’s internet website. After further investigation, there are data system difficulties preventing the trade community from viewing the most up-to-date versions of the import alerts. The appropriate parties within FDA are aware of the situation and are working expeditiously to remedy the problem, so we may have the most up-to-date import alerts available for viewing as soon as possible.

If an issue arises wherein there is uncertainty within the trade community as to whether or not a firm and/or product are subject to detention without physical examination as indicated by a particular import alert, please contact your local FDA office for further clarification. The following link provides contact information by region:

http://www.fda.gov/ICECI/Inspections/IOM/ucm124008.htm

FDA

Published by Ana on 17 Apr 2009

FDA EXAMINATIONS :: FDA’s IMPORT PROGRAM / GENERAL PROCEDURES

During the month of April we have seen an upward trend on Food and Drug Administration [FDA] collection of random samples also known as “sampling.”

We are posting the General Procedures for your reference and review. We remind all customers that all fresh fruits and vegetables require release/submission to the Food and Drug Administration and therefore subject to random sampling. If selected for sampling, product sampled must be held intact at port of arrival until an OFFICIAL FDA RELEASE has been obtained.

FDA’s IMPORT PROGRAM / GENERAL PROCEDURES

To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative [Customs Broker], must file an entry notice and an entry bond with the U.S. Customs Service (Customs) pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs with whom FDA has an excellent working relationship. For specific information on U.S. Customs procedures, requirements, forms, etc., contact your local Customs office.

FDA is notified by Customs of the entry and makes a decision as to the article’s admissibility. If FDA does not wish to examine the entry, the product is allowed to proceed into United States commerce.

Generally, if FDA decides to examine an entry, an FDA representative will collect a sample from the shipment for laboratory evaluation. If the analysis indicates the product is in compliance, the shipment may be released into United States commerce. If there is a violation, the product will be refused admission. The FD&C Act, Section 801, directs FDA to refuse admission of any article that appears to be in violation of the Act.

When a sample of an article offered for import has been requested by FDA, the owner or consignee shall hold the shipment and not distribute it until further notice is received regarding the results of the examination of the sample. If it appears that the article is violative, FDA issues a Notice of Detention and Hearing to the owner or consignee of the article specifying a place and period of time whereby the individual may introduce testimony either verbally or in writing.

The importer is provided an opportunity to submit a petition to recondition the product to bring it into compliance. The owner or consignee may submit an application to FDA to relabel or perform other actions to bring the article into compliance or render the article other than a food, drug, device, or cosmetic. An application for authorization to relabel or perform other actions to bring the article into compliance shall contain a detailed proposal and specify the time and place where such operations will be carried out and the approximate time for completion as specified by regulation. All petitions to recondition a product are subject to FDA review and approval.

If the product is refused, the importer is required to either re-export or destroy the article under U.S. Customs or other approved supervision. If the refused product is not destroyed or re-exported, Customs issues a notice for redelivery to the importer of record. Failure to redeliver the refused product may result in Customs assessing liquidated damages against the importer’s bond

FDA