Legal Commentary

Foods, Drugs and Public Health : New Safety Reporting Portal : Mandatory and Voluntary Reports

By Andis Kaulins

"On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched a new Web site for industry to report food safety problems or adverse events involving FDA-regulated foods (except for dietary supplements and infant formula), animal feeds, and animal drugs. Consumers can also use the site to report problems with pet foods and pet treats. The new site, called the Safety Reporting Portal (SRP), provides greater and easier access to online reporting."

• Safety Reporting Portal¹
• Safety Reporting Portal Frequently Asked Questions

"The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) and the National Institutes of Health (NIH).

Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all....

Who Should Submit a Safety Report?

Organizations and people in certain professional roles, such as the following, may be required by law to submit safety reports under some circumstances.

• Food Manufacturers, Processors, Packers, and Holders
• Researchers
• Drug Manufacturers

Others, including concerned citizens, health professionals, and public
health officials, may voluntarily submit reports if they encounter
safety issues with a product and/or unanticipated harmful
effects that they believe are related to a product.

Learn more about mandatory and voluntary reporting. "

Full post as published by LawPundit on May 25, 2010 (boomark / email).