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CFS and USFDA agree to make GRAS nod system compliant with federal law
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Wednesday, 22 October, 2014, 08 : 00 AM [IST]
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Washington, DC
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fiogf49gjkf0d 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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