I've long-believed D9 in gummies was legal hemp so long as the extract came from hemp and the D9 did not exceed 0.3% on a dry-weight basis. In fact, I may have been the first client of Rod's to ask if I could do this in late 2019.
You've put this in doubt and I feel relieved that I do not offer any products of this nature.
However, if you have the time...
Does this debate not ultimately *boil down* to WIPHE?
The snippet Rod shared from the FDA: “recommends that sponsors, investigators, or applicants evaluating intermediates or finished products that contain cannabis or cannabis derived compounds base the calculation of delta-9 THC percentage on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.”
The FDA's language suggests that only water weight be deducted from the denominator for the purposes of determining % D9 content. Not that % D9 content should be measured as a % of cannabis extract used in the formula.
Perhaps it's different here though because of the CSA & Farm Bill, which I believe you are contending.
But then you are also essentially saying dilution is NOT the solution [to WIPHE]. Whether the diluent is hemp-derived or not. Because the CSA suggests these compounds are to be treated separately. The key operator being 'or' in 'material, compound, mixture, or preparation', so 'mixture' does not mean that we can mix a compliant hemp extract with a non-compliant extract and have a compliant one.
In which case, virtually all full-spectrum CBD products are illegal under the same argument you are making here. Even if they were diluted to compliance with other hemp-derived material like broad spectrum distillate, the non-hemp extract (under the CSA) was still a separate ingredient at some point in the process.
If it is in fact ok to dilute full spectrum CBD extract with MCT oil to get it to <0.3% D9 by dry-weight, as has been the consensus view from the beginning to my knowledge, then the dilution of mother liquor or converted D9 by gummy ingredients (other than water) must also be legal, too, right?
But if you contend that only isolates, broad spec distillates (non-diluted), and Delta-8 are legal as a final product or as an ingredient, then I must ask how your argument applies to crude oil as a material / compound in the process of making isolates, broad-spec distillates, and delta-8.
So now, perhaps only CBD flower is legal. But I suppose you will say that in making isolate, crude oil is stripped of non-compliant molecules, and it is not an ingredient.
The consensus has always been "if D9 does not represent more than 0.3% D9 of your final, consumer product, then your final, consumer product is legal." This is what has been communicated by agencies, and this is how the rules have been enforced. To my knowledge.
A full-spectrum CBD oil tested for legal compliance by an agency would be tested in the state that it has sold. I am not aware of any circumstance where they have gone beyond that to figure out if the inputs were all legal / compliant on their own.
Surely I am off-base here and should stop playing backseat-lawyer. Or maybe the rules / law is that grey.
Matt, excellent article.
I've long-believed D9 in gummies was legal hemp so long as the extract came from hemp and the D9 did not exceed 0.3% on a dry-weight basis. In fact, I may have been the first client of Rod's to ask if I could do this in late 2019.
You've put this in doubt and I feel relieved that I do not offer any products of this nature.
However, if you have the time...
Does this debate not ultimately *boil down* to WIPHE?
The snippet Rod shared from the FDA: “recommends that sponsors, investigators, or applicants evaluating intermediates or finished products that contain cannabis or cannabis derived compounds base the calculation of delta-9 THC percentage on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.”
The FDA's language suggests that only water weight be deducted from the denominator for the purposes of determining % D9 content. Not that % D9 content should be measured as a % of cannabis extract used in the formula.
Perhaps it's different here though because of the CSA & Farm Bill, which I believe you are contending.
But then you are also essentially saying dilution is NOT the solution [to WIPHE]. Whether the diluent is hemp-derived or not. Because the CSA suggests these compounds are to be treated separately. The key operator being 'or' in 'material, compound, mixture, or preparation', so 'mixture' does not mean that we can mix a compliant hemp extract with a non-compliant extract and have a compliant one.
In which case, virtually all full-spectrum CBD products are illegal under the same argument you are making here. Even if they were diluted to compliance with other hemp-derived material like broad spectrum distillate, the non-hemp extract (under the CSA) was still a separate ingredient at some point in the process.
If it is in fact ok to dilute full spectrum CBD extract with MCT oil to get it to <0.3% D9 by dry-weight, as has been the consensus view from the beginning to my knowledge, then the dilution of mother liquor or converted D9 by gummy ingredients (other than water) must also be legal, too, right?
But if you contend that only isolates, broad spec distillates (non-diluted), and Delta-8 are legal as a final product or as an ingredient, then I must ask how your argument applies to crude oil as a material / compound in the process of making isolates, broad-spec distillates, and delta-8.
So now, perhaps only CBD flower is legal. But I suppose you will say that in making isolate, crude oil is stripped of non-compliant molecules, and it is not an ingredient.
The consensus has always been "if D9 does not represent more than 0.3% D9 of your final, consumer product, then your final, consumer product is legal." This is what has been communicated by agencies, and this is how the rules have been enforced. To my knowledge.
A full-spectrum CBD oil tested for legal compliance by an agency would be tested in the state that it has sold. I am not aware of any circumstance where they have gone beyond that to figure out if the inputs were all legal / compliant on their own.
Surely I am off-base here and should stop playing backseat-lawyer. Or maybe the rules / law is that grey.