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CFS and USFDA agree to make GRAS nod system compliant with federal law
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Washington, DC
October 28 , 2014
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The Centre for Food Safety (CFS) announced a settlement agreement with
the United States Food and Drug Administration (USFDA) that required the
latter to bring its food additive approval process, known as Generally
Recognised as Safe (GRAS), into compliance with federal law.
For
more than 17 years, USFDA has operated under a proposed rule that
provides food manufacturers with a fast-track to get their food
additives on the market. Under the proposed rule, the regulator’s review
of substances falls far short of what is required to protect consumers
from potentially-unsafe food additives.
CFS sued the agency for
failing to follow federal rule-making requirements before putting this
fast-track process into place. “This is a major victory for consumers
and the public," stated Donna Solen, senior attorney, CFS.
“For
more than 17 years, USFDA has imposed a lax regulatory system on
consumers without affording them their right to participate in the
rule-making process. This is a violation of federal law that will come
to an end as a result of this settlement agreement,” she added.
The
settlement agreement, pending approval by the court, would require
USFDA to finalise the GRAS rule by August 2016. If the regulator fails
to meet this deadline, CFS can ask the court to order the agency to
fulfill its commitment and issue the rule. After the rule is finalised,
USFDA would be fully accountable for instituting a GRAS system that
adequately protects the public from harmful food additives.
“FDA
has finally agreed to live up to its obligation to finalise its proposed
regulation and provide the public with its right to participate in the
regulatory process,” said Solen, adding, “Having a final rule in place
would open the entire GRAS system to the scrutiny it deserves.”
In
1958, Congress passed a law requiring USFDA to conduct rigorous
pre-market reviews of food additives, and approve or reject them based
on scientific evidence. Common food ingredients like sugar and gelatin
were deemed GRAS, and thereby exempted from FDA review on the basis of a
history of safe use.
Manufacturers could also formally petition
USFDA to approve a food additive as GRAS based on published studies.
The regulator would then assess the evidence, decide whether or not the
additive was safe, and approve or reject it. It proposed the new rule in
1997, and it has completely supplanted the petition process.
Under
this never-finalised rule, manufacturers simply notify USFDA that a
substance is GRAS by submitting a GRAS exemption claim.
And as
the USFDA review is cursory, the agency refuses to confirm whether or
not the additive is generally recognised as safe. Instead, it relies on
manufacturers’ assertions about the safety of their products.
Despite
the fact that the regulator never fulfilled its legal obligation to
finalise the 1997 rule, it operated under this faulty rule.
“The
settlement vindicates the public’s right to participate in the
rule-making process, and a final rule gives the public the right to
challenge USFDA on its GRAS system. The safety of our food supply would
benefit as a result,” said Solen.
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