Registration of food facilities with the U.S. Food and Drug Administration (FDA) has been a requirement for almost a decade. Since the passage of the Public Health Security and Bioterrorism Preparedness Response Act on June 12, 2002, facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States have been required to register with FDA in order to provide the agency with information on the origin and distribution of food and feed products, thereby aiding in the detection and quick response to actual or potential threats to the U.S. food supply.
Starting next week, however, all food facilities required to register with FDA must begin biennial re-registration to comply with the provisions of the Food Safety Modernization Act (FSMA). Signed into law on January 4, 2011, FSMA now requires that food facilities re-register every 2 years with FDA, during the period beginning on October 1 and ending on December 31 in even numbered years. The first registration renewal cycle under FSMA starts and Monday, October 1 and will continue until Monday, December 31, 2012. Even if a food facility is already registered with FDA, the facility is still obligated to renew registrations during the October 1-December 1 timeframe.
When registering, it is important for food facility representatives to remember that additional information is now required to accompany the registrations under FSMA. Specifically, registrations must contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the U.S. agent for the facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured, processed, packed, or held at registering facilities.
On a related note, under FSMA, the FDA is now, for the first time, explicitly granted the authority to suspend the registration of a food facility in certain circumstances involving food manufactured, processed, packed, received or held by a registered facility that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA did not previously have a process for suspending the registration of a food facility in such circumstances. If the FDA were to exercise this authority and suspend the registration of a food facility, that facility would be prohibited from introducing any food into the stream of commerce in the U.S., including importing or exporting food into the U.S.
Make sure to start submitting your registrations on Monday! To register, update, or renew a registration, food facilities must submit the paper Form 3537 by mail or fax or register online at www.fda.gov/furls. FDA encourages online registration as the least costly, quickest, and most efficient means for food facility registration.
SAVE THE DATE FOR THE ABA'S FOOD & SUPPLEMENTS FIRST ANNUAL WORKSHOP AT COCA-COLA IN ATLANTA THIS WINTER
Thursday, February 17, 2011 - Hosted by The Coca-Cola Company.
Please save the date for this first annual one-day CLE workshop sponsored by ABA’s Food and Supplements subcommittee that will include panels on the impact of federal statutory and regulatory reform on the food industry, state consumer laws and consumer class actions related to food packaging, labeling, and marketing, the evolving science of food safety and technology, ethical considerations in the labeling of bioactive foods, and in-house counsel's top predictions for the future of food regulation and litigation. Leslie M. Turner, General Counsel for Coca-Cola North America, will speak on "Protecting the Brand in the Food Industry" at our networking luncheon and a networking reception will follow the workshop.
Ricardo Carvajal from Hyman Phelps & McNamara and I will be moderating the panel on the impact of federal statutory and regulatory reform on the food industry.
More information and a full program agenda to come. Stay tuned.