Comments to FDA at Regulations.gov -- Pre-DSHEA Ingredients List

Filed 26 September 2017
Filing Receipt No. 1k1-8yw3-kmm1

In Re: Development of a List of           }
Pre-DSHEA Dietary Ingredients         }
Docket FDA-2017-N-4625 

Ralph Fucetola JD states as though under Oath:

1         1. This Statement is submitted as a Regulations.gov Comment to FDA docket 2017-N-4625 in advance of the Noticed Public Meeting of October 3, 2017.

2     I am a retired Attorney-at-Law and hold a Juris Doctor Degree. I practiced law from 1971 through 2006 in New Jersey and am a Notary Public.

3     In determining regulatory standards for producing a List of Pre-Dietary Supplement Health and Education Act (DSHEA) Dietary Ingredients (herein, the Pre-DSHEA List), the Food and Drug Administration should, among other factors, consider the relationship of the ingredient to the normal structure and function of the body.

4     Any substance or compound that was part of the food chain on the DSHEA “grandfather” date in 1994 (and not thereafter chemically changed) should be included by reference in any Pre-DSHEA List as such substances or compounds are “grandfathered” by the explicit terms of the Statute.

5     Such substances or compounds, at a minimum, should include all substances found naturally in mammalian, including human, bodies, including compounds produced by such bodies.

6     An example of a substance or compound actually produced by mammalian, including human, bodies and therefore part of the food chain to be considered “grandfathered” and part of any Pre-DSHEA List is Cannabidiol, or CBD.

7.     This substance or compound is also found in the hemp plant and other sources. It is not an intoxicant. It is a human neurotransmitter and a normal part of the cannabidiol neurotransmitter system in the human body.

8.     In 1995, while I was in practice as an Attorney-at-Law I was retained by the Life Extension Foundation to represent two of its members who had been arrested in New Jersey when importing DHEA (dehydroepiandrosterone) a hormone which is a normal part of the human body.

9.     It was believed by the New Jersey authorities that the DEA (Drug Enforcement Administration) had “scheduled” DHEA as a controlled substance. That belief was false. No such “scheduling” had occurred or could occur. Eventually the charges were dropped and an order was signed determining that DHEA was a normal part of the human body, not declared “contraband” by government authority. A copy of the Order closing the cases is posted here: http://www.lifespirit.org/dheaorder.JPG

10. It is my professional opinion that a substance or compound, native to mammalian, including human, bodies, and not being an intoxicant, is a Pre-DSHEA Dietary Ingredient and should be included in any such Pre-DSHEA List.

11. It is my professional opinion that Cannabidiol (CBD) is such a substance or compound.

I certify that the statements made by me in this Comment are true and accurate to the best of my knowledge and belief. I recognized that I am subject to punishment as for perjury if any are willfully false.

26 September 2017

Ralph Fucetola JD