GRAS Paradigm for Pet Nutraceuticals

LAS VEGASWhile FDAs Center for Veterinary Medicine (CVM) has questioned the legality of including nutraceutical ingredients into pet foods, federal law does not appear to bar such inclusions, making the area a possible avenue for growth, according to George Burdock, Ph.D. In a presentation on Nov. 12 at SupplySide West, Burdock reviewed the current regulatory paradigm for nutraceuticals and dietary supplements, as it applies to products for companion animals, and noted there are changes in the wind.

In particular, Burdock focused on the use of GRAS (generally recognized as safe) ingredients, including the self-affirmation process, and the necessary additional steps suppliers may need to take to ensure the safety of those ingredients for animals. For example, it can be difficult to ascertain cross-species comparisons of safety data, making animal safety studies in the target species necessary. However, CVM is launching a pilot program in late 2009similar to the one in place for human GRAS ingredientsthat will encourage voluntary GRAS notifications on ingredients meant for use in products for companion animals, and further urge companies to schedule pre-submission meetings with the agency to ensure clarity of the submission.

Beyond the statement of determination and in-depth information about the identity of the substance, Burdock noted the information in the GRAS statement on utility provides an opportunity for claims. Particularly, intended uses can detail health-based claims, but not performance-based claims, which would make the substance a drug. Companies assembling GRAS documentation should also note use levels are species-specific.