Why Cannabis Testing and Labeling Standardization Is Long Overdue

By Steven Schain

Imagine if beer’s testing and labeling requirements differed in every state in which the beverage is sold.

While legal in 38 states, each cannabis jurisdiction has its own, and often conflicting, testing and labeling laws. Thus, unlike virtually every other product sold in America, no two states’ cannabis items are identical and the respective potency and contaminant level testing and labeling standards greatly vary, impose enormous health and safety concerns, and create havoc for those growing, manufacturing, testing and selling cannabis.

With a California and Colorado testing lab and manufacturer recently defrocked for faking test results, equipment tampering and producing harmful “rogue intoxicant spiked” cannabis products, the need for national cannabis testing and labeling uniformity is urgent and may be solved by the American Society for Testing and Materials (ASTM).

Delta-9 THC’s Forms, Legality and Dosage

Comprised of three plants containing 480 compounds (including over 120 cannabinoids and 140 terpenes), cannabis’ most lucrative component is the intoxicant Tetrahydrocannabinol (THC).

Specifically, cannabis flower “bud glands” (i.e., trichomes) excrete an oily substance containing acidic form cannabinoids (ex., THCa), which, following heating, are decarboxylated to produce THC and other cannabinoids like cannabidol (CBD), cannabinol (CBN) and cannabigerol (CBG).

“Terpenes” are cannabis compound molecules composed of multiple isoprene units having pleasant fragrances (ex., α-pinene (pine needles, rosemary); myrcene (clove-like, earthy, fruity); limonene (citrus); and linalool (floral)) creating a particular strain’s flavor and scent.

Legally, marijuana is defined as “cannabis sativa L. containing less than 0.3% plant chemical Delta-9 THC” by the Controlled Substance Act, 21 U.S.C. Sections 801, Et. Seq (1970) (CSA) and regulations promulgated thereunder by the Drug Enforcement Agency (DEA). Listing it next to heroin as a Schedule I controlled substance having “a high potential for abuse” and for which there’s “no currently accepted medical use in treatment” and “a lack of accepted safety for use” “under medical supervision”, the CSA renders Marijuana 100% federally illegal. 21 U.S.C. at Section 812(b)(1). The CSA prohibits Marijuana’s cultivation, distribution, dispensation and possession and, pursuant to the U.S. Constitution’s supremacy clause, state laws conflicting with federal law are generally preempted and void. See U.S. Const., Art. VI, cl. 2; Wickard v. Filburn, 317 U.S. 111, 124 (1942)(”No form of state activity can constitutionally thwart the regulatory power granted by the commerce clause to Congress”). Those cultivating, processing, infusing, transporting or dispensing cannabis are deemed to be “plant-touching” Marijuana related businesses (MRBs) and subject to the CSA’s onerous penalties.

Despite federally illegality, Delta-9 THC cannabis is legal in 38 American states purchasable in two forms: “medical” (with a state-issued card to treat residents’ statutorily defined “covered medical condition”); or “adult-use” (by anyone over 21 from any state with a valid identification). Cannabis is consumed four ways: “flower” that is smoked; “oils” ingested by vaporizing; “concentrates” consumable after being heated to a high temperature; and “infused” products ranging from eye drops to “edibles.”

Cannabis products’ “dosage” is measured by milligrams (MGs) of Delta-9 THC ranging from: 1-2.5 MGs “Microdose”; 3-5 MGs “Low Dose”; 10-15 MGs “Moderate Dose”; 20-30 MGs “High Dose”; 50-100 MGs “Acute Dose” and 100-500 MGs “Macrodose.”

Because the CSA prevents cannabis from being sold outside of each respective legalized-Marijuana state and, thus, no “interstate cannabis commerce” can occur, state regulators like Colorado’s Marijuana Enforcement Division (MED), and not federal agencies like the Food and Drug Administration (FDA), issue licenses and regulate MRBs.

Rogue Intoxicants

Mirroring Delta-9 THC’s effects, Hemp-derived THC requires no license and imposes health. concerns regarding these untested and unregulated products’ safety and potency.

A fast-growing, sustainable, and inexpensively produced plant, Hemp is a variety of cannabis sativa L. containing less than 0.3% Delta-9 THC. The Agriculture Improvement Act of 2018 (2018 Farm Bill) both legalized hemp and its derivatives and removed plant cannabis sativa L. containing no more than 0.3% Delta-9 THC on a dry-weight basis from the CSA and DEA’s purview. 7 U.S.C. Section 1639o(1). Passed every five years and forming the federal government’s primary agricultural and food policy instrument, the Farm Bill permits importing, exporting and transporting hemp and hemp-derived products like any other crop, and tasks the Department of Agriculture (USDA) with promulgating hemp regulations, and charges states, territories and Indian tribes with submitting hemp-growing regulations plans to the USDA including “THC testing procedures.”

A cannabinoid of the THC “family” of compounds commonly derived from the cannabis plant, Delta-8 THC is a double bond isomer of Delta-9 THC. An isomer is a type of “chemical analog” comprising one of two or more compounds containing the identical number of atoms of the same elements but differing in structural arrangement and properties. There are 30 known THC isomers, and Delta-9 THC and Delta-8 THC differ regarding the single double bond’s location. Stated another way, while similar in molecular structure, Delta-8 THC is a different molecule than Delta-9 THC.

Delta-8 THC is derived either directly from the Hemp plant or converted from the CBD isolate. Because Hemp cultivars do not express Delta-8 THC in sufficient concentrations or quantities to be economically viable for commercial extraction purposes, and CBD is cheap and abundant, deriving Delta-8 THC by converting from CBD isolate is the faster, cheaper and more popular method.

Similar to Delta-8 THC, Delta-6 THC, Delta-10 THC and tetrahydrocannabivarion (THCV). (hereafter, collectively referred to as Rogue Intoxicants) are hemp-derived THC which are not federally illegal and often require no license, less regulated and cheaper than Delta-9 THC, and deployed by fishy MRBs to more cost-effectively enhance their product’s potency.

Cannabis Contaminant and Potency Testing

While varying by state, all legalized cannabis jurisdictions require testing and labeling for potency and contaminants including residual solvents, microbes, heavy metals and pesticides.

Potency. The primary cannabinoids of interest for potency testing are THC, CBD and CBN. Beyond a sheer measure of an item’s Delta-9 THC MGs (i.e., intoxicant level), CBN is an indicator of cannabis deterioration due to age or poor storage conditions. The two most common potency analysis methods are high-performance liquid chromatography (HPLC) with UV detection and gas chromatography (GC) with flame ionization detection (FID). While cheaper and simpler than HPLC, GC requires sample derivatization to quantitate both the free and acidic forms of THC and CBD.

Terpenes. Because they are nonpolar and structurally similar, terpenes present an analytical challenge. Mass spectrometry (MS) cannot distinguish terpenes that co-elute from a GC column because many have the same molecular weight and share fragment ions. Full evaporation technique (FET) is a terpene analyzation method in which a small amount of cannabis is placed in a 20-milliliter headspace vial and heated to volatilize the samples terpenes into the gas phase or headspace (HS).

Residual solvents. Along with supercritical carbon dioxide, ethanol, and water, solvents are used to extract THC from the cannabis plant. Because these volatile solvents (including butane, propane, isopropanol, or acetone) are harmful to consumer’s health, they should be absent from the final product. FET-HS-GC-FID can be used for both terpene and residual solvent analysis, however peak identification requires an MRB to accurately report which solvents were used in the extraction.

Pesticides. Aphids, spider mites, and mold thrive in the warm, moist indoor conditions used to grow cannabis and it is generally illegal for growers to use pesticides and fungicides to control them. State pesticides regulations vary with some regulators defining pesticide-positive samples as those containing 0.1 ppm of any pesticide. Because there are thousands of known pesticides, it is currently impossible to test for all. GC with an electron capture detector can detect chlorinated pesticides at the parts-per-trillion level, but the technique cannot detect nonchlorinated pesticides. GC in combination with tandem mass spectrometry (GC-MS/MS) can detect many pesticide classes.

Heavy metals. Entering Cannabis plants from contaminated soil, heavy metals like arsenic, mercury lead, cadmium, and chromium are detectable at trace amounts by inductively coupled plasma (ICP)-MS or ICP-optical emission spectrometry. Like techniques for pesticide analysis, methods for heavy metal analysis mirror those used by the food industry.

Microorganisms. During growth or storage, cannabis plants can become contaminated with microorganisms such as mold, mildew, bacteria, and yeast. Pathogenic bacteria such as Escherichia coli and Salmonella, as well as fungal toxins such as mycotoxins and aflatoxins, can cause severe illness, particularly in medical-cannabis-taking children or immunocompromised patients. Pathogenic bacteria can be swiftly tested using a quantitative polymerase chain reaction following which the sample is plated on standard media yielding a total yeast and mold count in about three days. Petri film techniques can also be used for microbiological analyses presently revealing a library of about 30 common species.

For example, before hitting Colorado dispensary shelves, all cannabis products must be tested for potency (THC, CBD and CBN), residual solvents (butane, hexane, heptane and BTX), and microorganisms (E. coli, Salmonella, yeast and mold). While testing for heavy metals and pesticides is not mandatory, Colorado’s MED has set limits for these contaminants that could be verified by random testing.

Rectifying Testing and Labeling Inconsistencies

Without the benefit of the FDA, DEA and USDA’s collaborative developing and validating of cannabis specific analytical methods, most jurisdictions and certified testing labs have launched their own proprietary methods which lack cross-validation and create inconsistencies imposing heath and informational challenges to consumers and operational obstacles to MRBs.

Until cannabis is removed from the CSA’s purview (and thereby activating the FDA, DEA and USDA’s regulatory jurisdiction), the best hope of creating testing and labeling uniformity is the ASTM.

Developing and publishing technical standards for a wide range of materials, products, systems and services, the ASTM has issued 13,000 standards in areas ranging from commercial spaceflight to pet products to supply chain digital information. The ASTM’s Committee D37 develops and maintains standards and guidance for cannabis and its products and processes addressing cultivation, quality assurance, laboratory considerations, devices, packaging and security. D37 is comprised of 16 subcommittees tasked with developing standards ranging from “Indoor and Outdoor Horticulture and Agriculture” to “Financial Services and Insurance.”

With its multidisciplinary approach, and 900 members sourced from 30 countries (including each of the 38 states with legalized cannabis programs), the ASTM’s Committee D37 is endeavoring to create uniform testing and labeling standards to both mature and developing cannabis jurisdictions.

Reprinted with permission from the August 26,2024 edition of  The Legal Intelligencer©2024 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited, contact 877-257-3382 or [email protected].

Steve Schain is counsel to national cannabis, hemp and hallucinogens law firm Smart-Counsel LLC, is admitted to practice in Pennsylvania and New Jersey, and represents entities, governments and individuals in litigation, regulation and compliance, license applications, and entity formation. Reach Schain at [email protected].