Most November modelling we see is built entirely around the 0.4 milligram cap. There is a separate exclusion in the same section that turns on how a product is sold rather than what is in it, and it catches a business model that a lot of the industry has been quietly running.
The clause
Section 781 of Public Law 119-37 excludes from the definition of hemp:
“any intermediate hemp-derived cannabinoid products which are marketed or sold as a final product or directly to an end consumer for personal or household use”
Note what it does not say. It does not specify a milligram threshold. It does not turn on which cannabinoid is present. It turns on presentation and channel.
Why this exists
Intermediate products are the bulk material in the middle of a supply chain: distillate, isolate, concentrated fractions. In a conventional structure these move business to business, get formulated into a finished product, and reach a consumer as something with a label, a dose and a responsible manufacturer behind it.
A substantial parallel trade grew up moving that material straight to end users, skipping the finished-product stage and the accountability that comes with it. The clause closes it.
Who this affects, specifically
Three models are directly in scope.
Anyone selling bulk distillate or isolate through a consumer-facing storefront. The material is intermediate, the channel is direct to consumer, and both halves of the clause are satisfied.
Anyone selling intermediate material presented as though it were finished, for example bulk material packaged in retail-style presentation with usage suggestions attached.
Anyone operating a hybrid where a nominally business-to-business catalogue is in practice open to individual buyers. The clause reaches products “marketed or sold” that way, so an unenforced trade-only policy is unlikely to be much protection.
Why milligram compliance does not rescue it
This is the point most often missed. A product can sit comfortably under the 0.4 mg combined cap and still fall outside the hemp definition under this clause, because the objection is structural rather than quantitative.
Equally, an intermediate product moving properly business to business, into a manufacturer who formulates it into a compliant finished good, is not touched by this clause at all. The clause is about where the material goes, not about what it is.
What to check in your own operation
Whether any part of your catalogue is intermediate material available to individual buyers. Whether your account opening process actually verifies business status or merely asks. Whether your marketing for bulk lines addresses formulators or consumers, since the clause covers how something is marketed. And whether any pack presentation of intermediate material could reasonably be read as a final product.
If you sell through distributors, this extends to how they resell. A compliant sale into a distributor who then retails the material direct to consumers is a supply chain question worth having in writing, and it belongs in the same conversation as how your supply agreements are structured.
The wider point about this statute
Section 781 was not drafted only as a potency limit. It contains a threshold test, a combined finished-product cap, two clauses about how cannabinoids are produced, and this clause about how products are sold. A compliance review that checks only the milligram figure will pass products that four other clauses fail.
The full sequence for that review is in our November 12 compliance brief.
About this brief
Written 22 July 2026 and checked against the statute and the Federal Register rather than against secondary coverage. This is a summary for commercial planning, not legal advice. Where the answer depends on your product format, your state or your licence position, take the specific question to your own counsel.


