Regulatory Focus™ > News Articles > FDA Developing New Standardized Form for GRAS Submissions, Seeks Comment

FDA Developing New Standardized Form for GRAS Submissions, Seeks Comment

Posted 18 January 2012 | By Alexander Gaffney, RAC 

A Federal Registerposting today by the US Food and Drug Administration (FDA) is soliciting comments on the food additive Notification Procedure for Substances Generally Recognized as Safe (GRAS) and its new Form FDA 3667.

In particular, FDA invites comments on whether information sought by FDA is necessary, onerous, adequate or efficient.

FDA currently regulates food additives through a premarket approval system. Exemptions from this system may be sought by companies if they believe-and qualified experts determine that-the additive is GRAS.

In 1997, FDA sought to standardize the submission of GRAS information by proposing a voluntary procedure whereby manufacturers would apply for an exemption to premarket approval requirements. The proposed format would include a detailed summary of the data and information supporting the GRAS application, and this information would be made public by FDA. This proposed rule was shelved by FDA until 28 December 2011, when the agency made a call for comments.

FDA's Center for Food Safety and Applied Nutrition (CFSAN) has recently developed Form FDA 3667, Generally Recognized as Safe (GRAS) Notice, which may be submitted to FDA via the Electronic Submission Gateway (ESG) or in paper form. FDA's Center for Veterinary Medicine (CVM) is also involved with the development of the GRAS pilot process.

The information sought by Form FDA 3667 includes summary information about the GRAS submission, information about the notifier, general administrative information, intended use of the additive, identity of the additive and any other information about the additive that might be useful to FDA.

Comments on Form FDA 3667 are due by 19 March 2012.


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