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the FDA continues to move forward with reviewing and enforcing past
and new legislation over the food and dietary supplement industry,
questions still remain in the air about issues such as the regulation’s
content, who is governing the process and its timeline, and so forth.
In another effort to enhance food safety and respond to previous and
recent scandals where products were pulled off the shelves due to
adulteration, the FDA has set forth yet another “tracking system”
that lacks obliged officiates to do the job. The Reportable Food Registry
(RFR) will require FDA-regulated manufacturers, distributors (infant
formula is exempt) and all companies registered with the FDA under
the Bioterrorism Act of 2002 (including non-U.S. firms) to report
information to the RFR about possible product contamination.
The congressional purpose of the RFR is listed as:
“to provide a reliable mechanism to track patterns of adulteration
in food [which] would support efforts by the FDA to target limited
inspection resources to protect the public health” (Pub. L.
110-085, section 1005 (a) (4)).
Once the RFR system is up and running, the FDA
will require a “responsible party” to submit the necessary
information via an FDA internet portal. Many questions remain on
the surface – what constitutes a “responsible party”?
Will he or she be chosen by the FDA or the firm which this individual
works for? Will there be an official inspection process set up to
be performed periodically? Needless to say, the FDA’s plan
to implement the RFR by September 8, 2009 will be met with stiff
interrogation by its subjects on yet another governmental effort
to control the food and dietary supplement industry.
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