This is the second post in a two-part series. The first is available here.
Last week, the Food and Drug Administration (FDA) submitted a CBD enforcement policy to the White House. We do not yet have the text of that document but we anticipate that it will have a significant impact on hemp-derived CBD (Hemp CBD) products. In my last post, I summarized the FDA’s current enforcement policy and briefly discussed the FDA’s recently released guidance for drug manufacturers interested in cannabinoid research. An issue that came up in the FDA’s guidance for drug manufacturers was testing finished and intermediary products for cannabinoids.
Here’s how the FDA frames the issue of testing hemp products in the drug guidance document:
In general, the composition of a botanical raw material is calculated as the amount of the compound(s) of interest naturally present relative to the dry weight of botanical raw material prior to extraction or other manufacturing steps. However, this type of dry weight calculation has limited utility for intermediates such as solutions, extracts in solution (whether aqueous or nonaqueous), and for finished products. Therefore, 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.
Remember, this guidance is only intended to speak to drug manufacturers and even then it’s non-binding. But I think the FDA’s drug guidance could creep into its more general guidance. For example, the FDA provided the following guidance for determining delta-9 THC levels in liquid products:
For a solution-based material (intermediate, in-process material, or final drug product):
1. Determine the density of the liquid formulation and convert 1 mL of the formulation to mass units (mg).
2. Calculate water content (in mg) of each active and excipient component present in 1 mL of the formulation.
3. Sum the water content (in mg) for all components present in 1 mL of the liquid formulation and subtract this amount from the total mass of 1 mL (from step 1). This is the water-adjusted total mass of 1 mL of the formulation.
4. Calculate the mass, or mg amount, of delta-9 THC present in 1 mL of the liquid formulation.
5. Calculate the percentage delta-9 THC by dividing the mass of delta-9 THC from step 4 by the total water-adjusted mass in step 3 and multiplying by 100.
The FDA provides similar guidance for solid forms:
For a solid oral dosage form (e.g., tablet or capsule), this percentage is similarly calculated and would be the weight of delta-9 THC in the dosage unit divided by the total water-adjusted formulation weight multiplied by 100.
— For oral capsules, the mass of the capsule itself should not be included in the denominator weight. Include only the capsule fill.
— The water-adjusted formulation weight used in the calculation should reflect the removal (in mass units such as mg) of all water content present for each of the components, whether active or inactive, in the formulation.
A while back, I chastised the FDA for reporting on the fact that many Hemp CBD products sold on the market are listed with inaccurate levels of THC and CBD when the agency itself has the ability to implement industry-wide standards for labeling. To have accurate labels you need accurate testing and methodology. The FDA’s guidance for cannabinoid drug manufacturers touches on this issue by giving guidance on testing cannabinoids, specifically delta-9 THC, in solid and liquid form. I hope the agency will do the same when it issues broader CBD enforcement guidance.
Luckily, other federal agencies are also making moves in the testing world. Last week the National Institute for Standards and Technology (NIST) “launched a program to help laboratories accurately measure key chemical compounds in marijuana, hemp and other cannabis products including oils, edibles, tinctures and balms.” You can read NIST’s press release on the Cannabis Quality Assurance (CannaQAP) program here.
The NIST’s CannaQP testing program, once operational, will have an immediate impact on a problem that has plagued the Hemp CBD industry for years: inaccurate product labeling. Here is how NIST frames the issue:
The labels on most cannabis products list the concentration of at least two chemical compounds: tetrahydrocannabinol, or THC, the psychoactive ingredient that produces a high, and cannabidiol, or CBD, which is not intoxicating but is sought after for its many purported health benefits. However, most laboratories have limited experience making these measurements, which can sometimes be unreliable as a result.
The goal of the program, said NIST research chemist Brent Wilson, is to help labs produce consistent measurement results. “When you walk into a store or dispensary and see a label that says 10% CBD, you want to know that you can trust that number.”
Here’s how CannaQAP will work. In the first round of exercises, NIST will send hemp oil samples — all with the same, very carefully measured concentrations of THC, CBD and 15 other cannabinoid compounds — to participating labs. Those labs won’t be told the concentrations of those compounds but will measure them and send their results back to NIST, along with information about the methods they used to do the analysis.
After collecting responses, NIST will publish the measurements the labs obtained. That data will be anonymized so that the names of the individual labs are not revealed. However, the results will show how much variability there is between labs. Also, NIST will publish the correct measurements, so each lab will be able to see how accurate its measurements were and how it performed relative to its peers.
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NIST is also working on a hemp reference material — that is, a material that comes with known, accurate measurement values. Labs will be able to use that material to validate their measurement methods. One reason these measurements vary so much from lab to lab is that, currently, there are no reference materials for cannabis.
The CannaQAP will enable labs to better test for cannabinoids like THC and CBD. That will allow for accurate labeling of the CBD, along with other cannabinoids, in hemp products.
Hopefully, the CannaQAP and the eventual report from the FDA on CBD enforcement will bring clarity to the industry. We’ll keep monitoring but won’t hold our breath.