CV Sciences Inc (CVSI)

[Wolf-man jack]

How soon is soon? August 23? October 31? Imo Ahooooooo Wolf

US FDA contests Gras rule should be upheld

The US Food and Drug Administration (FDA) has defended its Generally Recognized as Safe (Gras) voluntary notification programme for food additives, saying it represents a reasonable interpretation of its statutory responsibilities and should be upheld.

The FDA’s position was set out in a 17 June cross-motion for summary judgement with respect to ongoing litigation over the agency’s ‘Gras rule’.

Under this scheme, food additives are permitted to be used without pre-market approval or notification to the agency, provided they meet the same safety standards of other approved substances.

In March, the plaintiffs in the case – the Environmental Defense Fund and the Center for Food Safety – argued that the process effectively permits industry to self-regulate its food contact substances. And it requested that the court vacate the rule and require the agency to develop new regulations compliant with the Federal Food Drug and Cosmetic Act of 1938 (FFDCA).

But in its response, the FDA said that the plaintiffs had "not identified any aspect of the rule that is arbitrary and capricious or not authorised by law".

Their arguments, it said, rely on the "erroneous premise" that the FDA has given manufacturers the ability to make conclusive determinations of Gras status. This, it said, "is simply not so".

"The Gras rule operates the way many important government requirements do: the government sets mandatory standards for private conduct, and parties are expected to meet those standards, risking serious sanctions if they fail to do so," it said.

The agency also dismissed as lacking merit the argument that the rule’s criteria do not constrain manufacturers’ Gras determinations and allow substances to come to market based on "hidden" information.

"The Gras rule should be upheld as a reasonable agency interpretation of a broad congressional delegation of authority," it concluded. And it pressed the court therefore to judge in its favour on all claims.

The lawsuit, Center for Food Safety et al v Price et al, is being heard in the US district court for the southern district of New York. Plaintiff responses are due by 23 August.



https://chemicalwatch.com/78921/us-fda-contests-gras-rule-should-be-upheld


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https://www.prnewswire.com/news-releases/eas-assists-food-and-hemp-firms-with-fda-gras-submissions-300862775.html