The U.S. Food and Drug Administration has filed a motion to dismiss a lawsuit against them regarding a proposed rule on substances generally recognized as safe (GRAS). The 46-page motion, dated May 14, 2014, was filed with the U.S. District Court for the District of Columbia. The Center for Food Safety (CFS) suit filed in February calls on the agency to vacate its never-finalized rule from 1997, which replaces the traditional petitioning process for a manufacturer seeking GRAS status for an additive, with a “procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS.” “Although Plaintiff notes that years have passed since the issuance of the proposal and acknowledges, as it must, that FDA has not actually ‘promulgate[d] a final rule,'” FDA states in the memorandum. The arguments for dismissal FDA puts forward are that CFS has not identified any member “who has actually suffered this clearly speculative injury” and that “the proposed rule does not cause the alleged injuries from consumption of food substances.” In addition, the agency argues that the rule is not “final agency action” and therefore is “not subject to judicial review.” The document also states that FDA plans to clear the final rule by July 2016.
The News Desk team at Food Safety News covers breaking developments, regulatory updates, recalls, and key topics shaping food safety today. These articles are produced collaboratively by our editorial staff.
A judge in South Africa has criticized the conduct of two health agencies and told them to pay costs in a case related to the Tiger Brands Listeria incident.
The
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or
A leading academic has warned that any plans for UK regulators to help industry grow could end up repeating past mistakes and impacting public health.
As part of modernization plans,
The FDA has issued final guidance for manufacturers of infant formula and laboratories conducting testing on infant formula.
The guidance was developed to help manufacturers and laboratories in the design,
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or
Synear Foods USA LLC, a Chatsworth, Calif. establishment, is recalling 71,603 pounds of frozen not-ready-to-eat (NRTE) pork and crab soup dumpling products due to misbranding and undeclared allergens, the
The a2 Milk Company (“a2MC”) has recalled three specific batches of its imported a2 Platinum Premium USA label infant formula 0-12 months because of the presence of cereulide. The product
JXK Enterprises Inc. is recalling Boner Bears Chocolate, Lot #BB21125, after being notified that FDA laboratory analysis confirmed the presence of sildenafil, an active ingredient in the FDA-approved prescription drug
