The US Hemp Roundtable recently sent a letter to Senators Chuck Schumer, D-NY, Ron Wyden, D-OR and Cory Booker, D-NJ, to discuss issues with the Cannabis Administration and Opportunity Act (CAOA) that was introduced by the three. According to the letter, certain provisions now contained within the proposed legislation could decimate the industry if they become law.
A central issue is how to determine at what level THC can be considered a minor constituent and where it crosses the line to become an outright intoxicant.
The ‘industrial hemp’ definition
Existing federal legislation defines ‘industrial hemp,’ the source material for hemp/CBD dietary supplements and foods, as having less than 0.3% delta-9 THC by dry weight. Growers, botanists and agronomists have invested a significant amount of time and capital in recent years to develop cultivars and ways of growing them that can meet that standard. Despite this accrued experience, crops can and still do go ‘hot,’ i.e., express too much THC, which requires them to be destroyed.
Even with that effort, THC still shows up in CBD products on the shelf, especially in those that are labeled as ‘full spectrum.’ At one time, the trend in the industry was toward these kind of products, because it appeared that the US Food and Drug Administration was leaning toward viewing CBD isolate as a drug form.
Now it may be that the residual THC naturally contained within a full spectrum extract of industrial hemp could become an Achilles heel. The CAOA bill mandates that a product must have less than 1 mg of delta-9 THC per 100 grams to be considered non intoxicating.
How to define ‘intoxication’
Jonathan Miller, general counsel of the US Hemp Roundtable, said that particular provision appears to be somewhat arbitrary and could prove impossible for many manufacturers to meet.
“From what I understand, they just wanted it to be as close to zero as possible. There’s no science behind it,” Miller told NutraIngredients-USA.
The letter praised the formation of panel in Colorado to look into this question.
“We are unaware of any studies or scientific data that suggest a 1 mg THC/100 g limit is appropriate for hemp products. States that have endeavored to define intoxication have called for a much higher line of demarcation. But the most effective solution we have found is in Colorado, which recently created a commission of experts to develop standards grounded in science and industry experience,” the letter states.
Miller said the Colorado panel has only started to meet, so there are no results yet to point to. But that kind of collaborative approach, rather than drawing lines in the sand, it’s what’s called for on the federal level. Still, the group is not advocating for state-by-state solutions per se.
“Every state could come up with its own standards,” Miller said.
The letter includes proposed draft language for the creation for such a panel, which should include members from FDA, NIH, industry and academia. The draft language proposes a 120-day timeline for the issuance of a report.
In addition to the intoxication question, the letter also reiterates concerns which have been communicated to lawmakers previously, such as:
- Expanding protections to all non-intoxicating hemp derivatives and cannabinoids, rather than CBD only.
- Allowing companies to use all forms of safety evaluations permitted by law, rather than mandating the use of new dietary ingredient notifications (NDINs). (This would permit hemp firms to file self affirmed GRAS notices.)
- Providing a more comprehensive rulemaking process for determining potential daily serving limits for CBD to ensure ample stakeholder input.
- Opening an additional pathway for the sale of hemp extracts like CBD as food and beverage ingredients.
- Ensuring separate regulatory pathways for non-intoxicating hemp and intoxicating cannabis products.
Miller said the bill is unlikely to pass this year, but that it could be very influential in laying the groundwork for future legislation.
“We appreciate that the bill develops a pathway for the sale of CBD as a dietary supplement but we feel the regulatory regime is overly restrictive. CBD should be treated just like any other dietary ingredient,” Miller said.