GRAS Hempseed Files

FDA

This PDF consolidates all the files FDA released regarding its acceptance of Generally Recognized As Safe (GRAS) exemption for hempseed, hemp protein powder, and hempseed oil as foods, submitted by Manitoba Harvest of Canada to the U.S. Food and Drug Administration (FDA) in 2018.

As it benefits the entire industry not just the dominant company filing for a GRAS exemption, it was one initiative the Hemp Food Association (founded 1998) was starting when a hemp fiber trade association crashed the hemp food market for years in a publicity stunt, almost taking Canadian hemp down with it.

All the congratulations go to Manitoba Harvest for biting the bullet and stepping up to do this critically-important task, and its attorney Marc C. Sanchez, Esq. Without a GRAS exemption, hempseed as food would still be considered an “adulterant” to FDA, not legal in foods despite being in human diets for millennia. Ironically, shelled hempseed was approved despite being developed only in 1996, after the DSHEA cut-off date; likely “substantial equivalence” to whole hempseed was the logic.

GRN-771 is hempseed, GRN-765 is hemp protein powder, and GRN-778 is hempseed oil. While not admitted or denied by FDA, the fact is that the millennia-long history of hempseed in the human diet delivered cannabinoids to us as well. Even modern hempseed oil contained as much as 117 ppm THC, enough for a 2-nano DWI in some states, as well as 20 times more CBD than THC. FDA knew that when approving these products, thus giving us an argument that cannabinoids traditionally found in hempseed oil are also exempt from GRAS registration per DSHEA 1994.

The file starts with the flawed and failed GRAS application in 1999 by the flawed and failed Consolidated Growers and Processors of Canada. This successful application was filed only in March 2018, being accepted by FDA in the December of that year, 2 hours after President Trump signed the 2018 Farm Bill legalizing hemp federally.

Files contained herein, in order:
GRASapplication_ucm265977.pdf 706kB
GRASnotice-hempseed-GRN765-web.pdf 19,408kB
GRN771-web2.pdf 19,490kB
GRAS-Notice-771-Part-1.pdf 4,496kB
GRAS-Notice-771-Part-2.pdf 15,238kB
GRAS-Notice-765-771-and-778-Amendment.pdf 360kB
GRAS-Notice-GRN-771-Agency-Response-Letter.pdf 497kB
GRAS-Notice-GRN-765-Agency-Response-Letter.pdf 278kB
GRAS-Notice-778.pdf 19,151kB
GRAS-Notice-GRN-778-Agency-Response-Letter.pdf 440kB

Of course, as these are public documents there are no warranties whatsoever as to the legality, suitability, ownership, purpose, or accuracy of this information. This information is provided on an “as is,” “as available” basis without warranties of any kind, express or implied. Void where prohibited. Specifications subject to change without notice. All patents, trademarks, service marks, and copyrights are the property of their respective owners. The Hemp Food Association makes no copyright claim whatsoever. This PDF is 1,170 pages total. Approx. 31 megs in size. FREE for HFA members, join today!

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