Quality Control in the Cannabis Industry: A Depressing Update

Back in 2019, I wrote about the need of the cannabis industry to adopt the pharmaceutical industry's quality control testing paradigm. Five years later, I am sad to report that little has changed. In this installment, I will revisit why it is important from a safety and monetary viewpoint, and review some technologies to accomplish this testing.

Why Do Industries Need Quality Control?

Simply put, anything that goes onto or into a human being can pose a health threat (1). This includes makeup, food, and medicine. History is rife with charlatans selling patent medicines that did not work and that poisoned consumers (2). Also, contaminated food can make people ill or kill them, and makeup can contain harmful ingredients that hurt the skin. For these reasons the United States (US) Federal Government in 1906 passed the Pure Food and Drug act and established the Food and Drug Administration (FDA). It is the purview of the FDA (3) to protect the health and safety of American consumers. Other countries have similar agencies.

The FDA’s standard for approving a drug for medicinal use is that it be “safe and effective.” Modern medicine has recorded many triumphs, including antibiotics, increasingly effective cancer treatments, and the eradication of smallpox from the planet (4). To ensure the safety and efficacy of medicines, the FDA requires companies to perform quality control testing. The pharmaceutical industry has been forced to adopt what is called a “cradle-to-grave” testing regime where testing is performed on all raw materials before they are used, and after every manufacturing process.

Why is this needed? First of all, raw material screening is needed because we have to make sure the material used in a medicine is what it says it is thus preventing unwanted or contaminated materials from getting into our products. Also, raw materials need to be screened for potentially harmful impurities. For example, at an aspirin tablet manufacturing facility the excipients, the inactive ingredients, need to be tested for identity and purity. Testing also needs to be performed after every manufacturing step to be sure that the process was carried out properly and that nothing in the process affected the safety or efficacy of the medicine being manufactured. Lastly, the final product needs to be tested before it goes out the door to ensure what is being sold to the consumer is the same as what the label states. Thus, we can break down the cradle-to-grave testing paradigm into these three steps as seen in Figure 1.

Cradle-to-grave testing is an important part of any industry's quality control program. Only with this type of testing can we make safe and effective medicines reproducibly.

Compliance Testing vs. In-House Testing

Compliance testing is testing that is required to be done by law, generally to protect the wallet, health, and safety of the consumer. Examples of this type of testing in the cannabis industry include potency testing, terpene analysis, pesticide screening, heavy metals determination, and biological contaminant analysis. Compliance testing is almost always performed by third-party cannabis analysis labs. The point here is that this testing is done at the end of the manufacturing process, and in many cases is the only testing that cannabis companies perform.

In-house testing is testing done by a business using their own samples and own lab to obtain data to make business decisions. In-house testing is the crux of any quality control program and is de rigueur in the pharmaceutical industry. This, of course, necessitates the procurement of lab space, analytical equipment, and trained scientists to perform the analyses. Not surprisingly, the cannabis industry has resisted doing this type of testing because of the cost. The following are my thoughts on how in-house testing should be implemented in the cannabis industry, and its importance.

What Would the Cradle-to-Grave Testing Paradigm Look Like in the Cannabis Industry?

The entire initial drive to legalize cannabis in the US was for its medicinal benefits. So, if these claims are to be believed then cannabis is a medicine. In this case, it should be tested like medicine, which has been the founding purpose of this column series. And in the US, who regulates the manufacture and sale of medicine? The FDA of course. At the moment, however, the FDA does not have regulatory control over our industry because at the federal level, any cannabis with more than 0.3% total tetrahydrocannabinol (THC) is illegal. Yet, there are many states in the US where cannabis is partially or totally legal. This has led to a regulatory nightmare of conflicting rules and regulations which has sapped money and effort from the industry just trying to stay out of jail! The stupidity of this situation is hopefully patently obvious, and in a rational universe the federal government needs to get over its “Reefer Madness” (5) mentality and regulate the cannabis industry like the pharmaceutical manufacturing industry that it is.

In the absence of any rational guidance from an overarching regulatory agency, what should we as an industry do to police ourselves to ensure the safety of our customers and the profitability of our businesses? Here is my proposal for how the pharmaceutical industry cradle-to-grave testing paradigm can be adapted to the cannabis industry.

Our challenge is that cannabis products come in many different forms and make their way into consumers' hands in different ways. Figure 2 shows some possible ways for how this may work.

An interesting aspect of cannabis products is that the raw material, cannabis buds, and processed cannabis products like tinctures, salves, food, and even makeup with cannabinoids added to it, are sold to consumers. The path from grower to dispensary is shown at the top of Figure 2. How and when should we test in this instance? At minimum, cannabis growers should be performing in-house testing, monitoring the potency of their crop so that it is harvested at the highest level to get the best price. Spectroscopic (6) and chromatographic (7) methods exist to do this. Before cannabis buds are sold to a dispensary, safety testing should be done. This should included testing for pesticides, heavy metals, and biological contaminants such as mold. Most states require this testing to, of course, protect the health and safety of consumers.

In general, dispensaries are not required to perform much testing, often times using the certificates of analysis (COAs) supplied to them by cannabis businesses as their only guide as to the safety and efficacy of the products they sell. This is a mistake. In a previous column (8), I argued for many reasons why dispensaries should be doing in-house testing. These reasons include:

• Ensuring customer safety
• Reducing liability if a product they sell causes harm
• Ensuring customers get what they pay for
• Making sure the dispensary receives the agreed upon products from cannabis suppliers
• Monitoring stock. My work has shown that THC and cannabidiol (CBD) lose potency with a half-life of several months (9)

So, for the sale of cannabis buds, growers, raw material suppliers, and dispensaries — the final, only consumer-facing link in the supply chain — should be performing in-house testing.

The bottom of Figure 2 illustrates a second way in which cannabis is used to supply products to the public. Cannabis plant material can be extracted with solvents to concentrate the cannabinoids of interest, the raw extract can be distilled to further concentrate the THC and other desirable molecules, and then these distillates can be formulated into final products such as tinctures, salves, or even incorporated into food and makeup. I will call these companies extractors, although “processors” works too.

Cannabis extractors should be performing cradle-to-grave testing just like a pharmaceutical company because they are manufacturing medicines! Extractors typically buy cannabis plant material from growers with the price based on potency, typically Total THC for cannabis or Total CBD for hemp. Extractors should have their own in-house potency testing ability to verify the potency of plant material before purchase to ensure they are not being ripped off. In my own business, Big Sur Scientific (6), I have had customers share horror stories about this. In one instance, a hemp extractor went to buy a large amount of plant material from a farmer. The farmer handed him a COA stating that the Total CBD content of the plant material was 14%. Fortunately, the extractor had purchased a portable potency analyzer (6) and found that the true potency of the plant material was only 9.3%. The farmer then sheepishly trotted out a COA stating that the true potency of the plant material was 9.3%. The extractor saved tens of thousands of dollars by not paying for CBD that wasn’t there, and the amount saved in that one transaction paid for the cost of the analyzer. I never want to hear again from anyone in this industry that in-house testing is too expensive.

The extraction process is complicated and expensive. The goal of any extraction process should be to maximize the amount of desired cannabinoids — again typically THC or CBD — in the extract. Many companies, upon completion of an extraction, stop the manufacturing process, send their samples off to a third-party lab, wait days or weeks for results, and then resume manufacturing with that batch. The extract is losing potency while it is sitting around waiting for your third-party lab to get around to analyzing it. The interruption to the manufacturing process means less material is produced per day, minimizing your profit. Worse yet, some extractors do not test their extracts at all. Thus, they will never know how to optimize their extractions and will be incapable of making any two batches of extract the same. This violates a fundamental principle of quality control. The case for testing distillates is similar. If you don’t test your distillate yourself, you will never be able to optimize and reproduce it. And yes, there exist in-house testing instruments that can determine potency and terpenes in plant material, extracts, and distillates (6). I have had more than one extractor customer tell me that in-house potency testing has helped them increase their yield by more than 20%, meaning the analyzer pays for itself in a matter of weeks or months.

Final products are what government regulations are currently focusing on, the aforementioned compliance testing. This is because final products are ultimately going to be consumed by human beings through oral or topical applications. Final product manufacturers should be doing in-house testing on their products before sending them out for compliance testing so there are no surprises. If you make a tincture, for example, and the label says it contains 5% CBD, and the compliance lab comes back and says it contains 1% CBD, you will probably be faced with scrapping this entire batch. By performing their own potency testing, final product manufacturers can ensure their label claims are correct and avoid this disaster.

The State of In-House Testing in the Cannabis Industry

In a word, dismal. The purpose of my writing my first article on this topic 5 years ago (1) was to try to get this industry to adapt the cradle-to-grave testing paradigm. It has fallen on deaf ears. Even now I hear cannabis businesses telling me that there is no need for in-house testing, or that they can’t afford it. This is poppycock. If you care about your customers, you will perform in-house testing. If you care about your bottom line, you will perform in-house testing.

I blame the lack of in-house testing in the cannabis industry on two things. First, no government agency has forced the industry to institute quality control measures the way the FDA does for the pharmaceutical industry. The rest, frankly, is just greed and ignorance. It scares the devil out of me that we have people making and selling cannabis medicines who have no scientific background and no experience in making and selling medicines. In what other industry would we put up with this? The answer is none. And the cost argument is now moot given what I have just explained.

Come on, cannabis industry, get your act together and do the right thing. Do the profitable thing, and set up an in-house quality control program.

Conclusions

I reviewed the need for quality control programs in industry, and how the cradle-to-grave testing paradigm used by the pharmaceutical industry works. I discussed what this paradigm would look like in the cannabis industry, and then lamented the lack of in-house testing in the cannabis industry.

References

1. Smith, B., Cannabis Is Medicine . . . Test It like Medicine, Cannabis Science and Technology, 2019, 2(4), 12-14.
2. Patent medicine https://en.wikipedia.org/wiki/Patent_medicine.
3. Food and Drug Administration https://en.wikipedia.org/wiki/Food_and_Drug_Administration.
4. Smallpox https://en.wikipedia.org/wiki/Smallpox.
5. Reefer madness https://en.wikipedia.org/wiki/Reefer_Madness.
6. Big Sur Scientific. https://bigsurscientific.com/.
7. Giese, M.W.; Lewis, M.A.; Giese, L.; and Smith, K.M., Journal of AOAC International, 2015, 98(6), 1503.
8. Smith, B.C., Hemp Testing Insanity IV: Problems with the USDA’s Hemp Sampling Rules, Cannabis Science and Technology, 2021, 4(4), 10-12.
9. Smith, B., Determination of Cannabis Oil Potency Degradation Rate and Mechanism by Infrared Spectroscopy, Terpenes and Testing, 2017, pg. 48.

About the Columnist

Brian C. Smith, PhD, is Founder, CEO, and Chief Technical Officer of Big Sur Scientific. He is the inventor of the BSS series of patented mid-infrared based cannabis analyzers. Dr. Smith has done pioneering research and published numerous peer-reviewed papers on the application of mid-infrared spectroscopy to cannabis analysis, and sits on the editorial board of Cannabis Science and Technology. He has worked as a laboratory director for a cannabis extractor, as an analytical chemist for Waters Associates and PerkinElmer, and as an analytical instrument salesperson. He has more than 30 years of experience in chemical analysis and has written three books on the subject. Dr. Smith earned his PhD on physical chemistry from Dartmouth College. Direct correspondence to: brian@bigsurscientific.com.

How to Cite this Article

Smith, B., Quality Control in the Cannabis Industry: A Depressing Update, Cannabis Science and Technology, 2024, 7(6), 6-9.