http://www.fda.gov/cvm/FDAVet2007VolXXIINo4.htm#7290USE THE MAIN FDA EMERGENCY REPORT NUMBER IF YOU HAVE PROBLEMS WITH PET FOOD.
REPORT EVERY ILLNESS OR DEATH RELATED TO PET FOOD TO THE FDA. THEY CAN'T IGNORE WHAT
HAS BEEN REPORTED FOREVER. MAKE SURE YOUR VETERINARIAN GETS THIS NUMBER:
From the CVM November 2007 Veterinary Newsletter:
Recently Enacted FDA Amendments Act Has Major Food Safety Components
by Walt D. Osborne, M.S., J.D., Assistant Editor
The FDA Amendments Act of 2007 (FDAAA) was signed into law by the President on September 27, 2007 (Public Law 110-085). Among its many provisions, the law reauthorizes and expands user fees for prescription human drugs and for medical devices. These programs are designed to ensure that FDA staff has the additional resources needed to conduct the complex and comprehensive reviews necessary to make new drugs and devices available to consumers. The new law also reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, both of which are designed to encourage more research into, and more development of, treatments for children.
Focus on food safety
Title X of the FDAAA imposes several requirements in the food safety arena. Many of these
apply to human and pet food and generally deal with processing and ingredient standards, improved communication during an ongoing recall, and
a mechanism for reporting food determined to be threatening to human or animal health. According to the new law, the impetus behind enactment of the FDAAA was to increase the public’s confidence in the safety of the food supply.
Of major concern has been the increased amount of imported food, which now accounts for 13 percent of the average American diet, including 9.5 percent of red meat, and 78.6 percent of fish and shellfish. Also cited in the legislation is the decrease since 2003 in the number of full-time FDA inspectors.
In order to
further enhance the safety of pet food, the new law directs that within 2 years the Secretary of Health and Human Services (HHS) is to promulgate new regulations to establish ingredient standards and definitions, processing standards, and updated standards for labeling to include nutritional and ingredient information.
Early warning system and effective communicationsThe new law also requires that, within 1 year, an early warning and surveillance system be established in order to identify any adulteration incidents affecting the pet food supply and also to alert the public about any outbreaks of illness associated with pet food. To do this, the law instructs the Secretary of HHS to consider the use of surveillance and monitoring mechanisms already in place to monitor human or animal health (e.g., FoodNet, PulseNet, and FDA’s Food Emergency Response Network).
FDA has already taken several steps to improve communication about a pet food recall, including posting information about the recall on FDA’s Internet Web site in a single location.
Reportable Food Registry
By September 27, 2008, FDA is also directed to establish a “Reportable Food Registry” to which instances of “reportable food” would be submitted by the Agency via an electronic portal, based on reports submitted by food facilities (i.e., manufacturers, processors, packers) that have registered pursuant to Section 415(a) of the Federal Food, Drug, and Cosmetic Act. For purposes of this requirement, “reportable food” means an article of food (other than infant formula) for which there is a reasonable probability that use of it will cause serious adverse health consequences or death to humans or animals.
Generally, any reports about such foods are to be submitted to the registry no later than 24 hours after a firm has determined that the food item poses possible serious adverse health effects. However, the law says that no report would be required if the party with which the adulteration originated detected the adulteration prior to any transfer of it to another person and either corrected the adulteration or destroyed the adulterated product.
Also, the new legislation authorizes persons submitting these reports to include a statement to the effect that the submitter “denies” that the report or notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or serious illness.
The new law delineates several follow-up actions after a report is submitted to the registry, and all responsible parties are instructed to
maintain records related to each report for 2 years. In addition, this law gives FDA 9 months to develop regulations and a guidance to
industry to implement the food registry. The guidance is to include specific information on how to submit the reports to the registry
via the electronic portal and how to provide the required notification to other persons in the supply chain about a suspect feed product
that poses a “reasonable probability” of causing serious adverse health consequences.
FDA Emergency NumbersThe Food and Drug Administration maintains a system of emergency phone numbers for complaints or concerns about any product FDA regulates.
The main number, which can be used to contact FDA headquarters, is 301-443-1240. Calls to that number go to FDA’s Office of Emergency Operations (OEO) during regular business hours, or to a Late Duty Officer volunteer at other times. All calls are returned.
Callers, in many cases, should consider contacting their local Complaint Coordinator (see below). The District of Columbia, Puerto Rico, the Virgin Islands, and each State has one (and California has two).
Dorothy Miller, OEO Director, said that the emergency numbers should be used only for FDA-regulated products, and not for medical emergencies. For medical emergencies, call 911.
MAIN FDA NUMBER (301) 443-1240Here are the numbers of Complaint Coordinators:
Alabama............................... (866) 289-3399
Alaska................................... (425) 483-4949
Arizona................................. (949) 608-3530
Arkansas.............................. (214) 253-5200, ext. 5233
California (Northern)............ (510) 337-6741
California (Southern)............ (949) 608-3530
Colorado............................... (303) 236-3044
Connecticut.......................... (781) 596-7700
Delaware.............................. (215) 597-9064
District of Columbia.............. (410) 779-5713
Florida................................... (866) 337-6272
Georgia................................. (404) 253-1161
Hawaii................................... (510) 337-6741
Idaho..................................... (425) 483-4949
Illinois.................................... (312) 353-7840
Indiana.................................. (313) 393-8100
Iowa...................................... (913) 752-2440
Kansas.................................. (913) 752-2440
Kentucky.............................. (513) 679-2700, ext. 124
Louisiana.............................. 866-289-3399
Maine.................................... (781) 596-7700
Maryland.............................. (410) 779-5713
Massachusetts..................... (781) 596-7700
Michigan............................... (313) 393-8100
Minnesota............................. (612) 758-7221
Mississippi............................ 866-289-3399
Missouri................................ (913) 752-2440
Montana............................... (425) 483-4949
Nebraska.............................. (913) 752-2440
Nevada................................. (510) 337-6741
New Hampshire................... (781) 596-7700
New Jersey.......................... (973) 331-4917
New Mexico......................... (303) 236-3044
New York............................. (718) 340-7000, ext 5588
North Carolina...................... (404) 253-1161
North Dakota........................ (612) 758-7221
Ohio...................................... (513) 679-2700, ext. 124
Oklahoma............................. (214) 253-5200, ext. 5233
Oregon................................. (425) 483-4949
Pennsylvania........................ (215) 597-9064
Rhode Island........................ (781) 596-7700
South Carolina...................... (404) 253-1161
South Dakota....................... (612) 758-7221
Tennessee............................ 866-289-3399
Texas.................................... (214) 253-5200, ext. 5233
Utah...................................... (303) 236-3044
Vermont................................ (781) 596-7700
Virginia.................................. (410) 779-5713
Washington........................... (425) 483-4949
West Virginia........................ (410) 779-5713
Wisconsin............................. (612) 758-7221
Wyoming.............................. (303) 236-3044
Puerto Rico and
U.S. Virgin Islands................ (800) 332-0127
