FDA Publishes First Ever "No Questions" Letters in Response to CVM GRAS Notifications

Date: Mar 27, 2012

On March 15, 2012, the Food and Drug Administration (FDA)'s Center for Veterinary Medicine (CVM) published on its online Current Animal Food GRAS Notices Inventory its first ever "no questions" letters in response to Keller and Heckman's notifications for hydrophobic silica (AGRN 000-005), polyethylene glycol (400) dioleate (AGRN 000-006), and polysorbate 60 (AGRN 000-007). Partner Devon Wm. Hill, Associate Azim Chowdhury and Dr. William Reichert filed the notices on behalf of Emerald Carolina Chemicals, LLC. In each of its letters, CVM confirms that it has no questions regarding our conclusion that each of the substances are Generally Recognized as Safe (GRAS) when present as incidental additives in animal feed (at the specific parts per million levels indicated in the letters) as a result of their use as components of a processing aid used in the production of wet and dried distillers grains.

CVM initiated its pilot program for GRAS substances added to animal food in June 2010. Pursuant to the program, participants may voluntarily submit to the Agency notices of claims that a particular use of a substance in animal food is exempt from the statutory premarket approval requirements based on the notifier's determination that such use is GRAS. This program is CVM's implementation of the 1997 proposed rule to replace the petition process.

To date, these are the first notices to successfully complete CVM's GRAS review process, and represent an important step in FDA's implementation of its pilot program.