2017: Hemp Flower Products Pre-DSHEA

Hempseed and other hemp flower products have been in the human and animal diet for many millennia. There is much documentation of that, evidence from around the world including the U.S.

Therefore when in 2017 FDA announced it was soliciting comments for which food ingredients should be on the official list as existing before October 1994, I saw the opportunity present our case. Ingredients introduced after that date would require FDA notification and possibly much more testing and validation.

I submitted an 18-page fact-filled document arguing for all hemp flower products being on the list, including flowers and the compounds found therein such as CBD (and thus logically, THC). Seed and seed oil became GRAS about a year later, but CBD and hemp flower are still sitting in limbo.

FDA could take advantage of this elegant approach to regulating CBD and include hemp flower products in the official list of ingredients existing before DSHEA. It could overcome Food and Drug Act, DSHEA, Exclusionary Rule, New Dietary Ingredient, Generally Recognized As Safe, Investigative New Drug, and Orphan Drug Status objections, depending on product, form, marketing, content, and other factors.

Comments of Richard Rose to FDA’s Request for Comments on the ‘Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients’ and the reasons Hemp Flower Products should be considered an ingredient existing before the passage of DSHEA” can be downloaded at: https://downloads.regulations.gov/FDA-2017-N-4625-0024/attachment_1.pdf.

The Docket FDA-2017-N-4625 with 37 comments can be seen at: https://www.regulations.gov/docket/FDA-2017-N-4625.

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