In comments submitted to the FDA this week, the GMA drew attention to several industry-wide concerns regarding the FDA's implementation of its food import requirements.
Under the Bioterrorism Act of 2002, food and beverage companies are required to submit prior notice before importing foods -including dietary supplements and ingredients - for human consumption.
"When the FDA issued the interim final rule for prior notice, it wisely established an 'educational' phase to allow companies to become familiar with how the system works while maintaining a free flow of trade," said Susan Stout, GMA vice president of federal affairs. "However, the educational portion of the system has been sadly lacking, and there is no basis to conclude that the prior notice system will work as intended once the educational phase ends and full enforcement begins."
According to FDA estimates, as many as 50,000 prior notices per week are incomplete, but FDA has not notified importers why. Companies, therefore, have no basis to determine whether their efforts to comply with the regulation have been successful.
"We suggest that the FDA extends the education phase and provides feedback to companies regarding incomplete prior notices," Stout added.
The GMA also recommended that the FDA takes other steps to improve the interim final rule, including decoupling the requirement that all prior notices include facility registration numbers for items such as sample products that are not intended to be sold. This would allow companies to continue this routine practice without potentially having to move R&D facilities outside of the US.
FDA issued the interim final rule for prior notice in December 2003 and full enforcement is expected to begin on 13 August.