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Sandler, Travis & Rosenberg, P.A. > FDA Bioterrorism Programs >

News Release


FOR IMMEDIATE RELEASE
Contact: Lauren Perez, Senior Trade Advisor
Sandler, Travis & Rosenberg, P.A.
Telephone: (305) 267-9200 Ext. 120
Email: lperez@strtrade.com

SPANISH-LANGUAGE ASSISTANCE NOW AVAILABLE FOR FOOD INDUSTRY TO UNDERSTAND AND TIMELY COMPLY WITH NEW FDA BIOTERRORISM REGULATIONS


Miami, FL -- December 5, 2003 --- Sandler, Travis and Rosenberg, P.A. (ST&R) announced today that it has developed a Spanish-language program and Bioterrorism Helpline to help food facilities comply with new Food and Drug Administration (FDA) regulations that are in effect on December 12, 2003. By December 12, 2003, all food facilities throughout the World that manufacture, process, store, hold or pack food for U.S. consumption must be registered with the FDA and, if not located in the U.S., must designate a U.S. Agent. After that date, all such facilities must be registered with the FDA before commencing business. The Helpline can be reached at (305) 267-9200, extension 406, via Email: fda@strtrade.com or Fax: (305) 267-5155.

ST&R’s new program will ensure that businesses and individuals within the Spanish-speaking food industry learn the requirements of the new FDA rules and strategies for facilitating compliance within their internal business operations. In addition, ST&R will provide important and timely updates on the constantly evolving information about these regulations. The program includes the following services:

  • Registration of facilities with the FDA
  • Designation of a U.S. Agent
  • Advice, information and timely updates on FDA food regulations and enforcement
    • New guidance document issued December 1, 2003
    • Final recordkeeping and detention regulations
    • Final enforcement regulations
  • Timely submission of comments to the FDA
    • Comments on Prior Notice and Facility Registration are due December 24, 2003
    • Comments will be formally requested again in Spring 2004

Because registration is just the first step in the process of complying with these rapidly changing rules, a Spanish-language Helpline has also been established to ensure that businesses understand and are able to comply with the complex regulations both before and after December 12, 2003. The helpline will be provided through Sandler, Travis & Rosenberg, P.A. and will be staffed with a team of Spanish-language experienced professionals guaranteeing responses to all inquiries within one business day or less.

E-mail: fda@strtrade.com
Phone: (305) 267-9200 Ext. 406
Fax: (305) 267-5155