IDFA filed comments last week on the Food and Drug Administration's draft guidance for the new Reportable Food Registry. IDFA expressed concern about the upcoming start date and urged FDA to delay reporting obligations.
The registry is intended to improve FDA's ability to ensure the safety of the domestic food supply. It requires a company to file a report through an FDA internet portal when there is reason to believe that an adulterated food, other than infant formula, will cause serious adverse health consequences or death to humans or animals.
The draft guidance covers who must submit reports; how, when and where reports may be submitted; what information the reports must include; and what steps must be taken to notify others in the supply chain of the adulterated food.
"IDFA commends FDA for obtaining input from regulated industries and scheduling public workshops to demonstrate the registry portal," the comments state. "IDFA is, however, concerned about the short time frame with which FDA intends to finalize the guidance and effectuate the obligation to begin using the registry portal by September 8, 2009."
IDFA urged FDA to delay registry reporting obligations until 60 days after the release of a revised industry guidance document.
The comments also raised the issues of confidentiality and erroneous reporting, as well as the need to clarify some language within the guidance. In each instance, IDFA offered a constructive remedy to the issues raised.
To read the comments, click here.