Managing Increasingly Complicated CBD Compliance Testing

If your lab doesn’t offer customized CBD compliance testing, your cost of doing business may soon increase. At best, you may need to use multiple labs. Worse: Unintentional contaminants may create even costlier problems such as recalls, class-action lawsuits or a warning letter from a governmental body. Here are three scenarios to consider:

  1. Inaccurate CBD levels. The most common problem with not using custom testing methods per product type is discovering that you have lower or higher cannabinoid levels because of interference from other ingredients you didn’t test for. You may think you’re selling a product with X-amount of CBD but it doesn’t have as much as it says on the label. Or, those ingredients could accidentally make your product ‘hot’ and therefore, not compliant. Neither is a good scenario.
  2. State-specific testing regulations. Currently, the FDA does not require testing beyond a THC measurement from any laboratory, regardless of experience. But individual states require testing for different pesticides and microbes such as Salmonella and E. coli. Having a lab such as Santé Laboratories, that is developing support for every state you distribute in is crucial. For example, Texas, Nevada and California all require different panels. If you distribute products nationally, this can quickly become an expensive problem unless you have a lab with your interests in mind that covers you for multiple states. Otherwise, you may need two or more labs to run test methodologies.
  3. Shelf stability. Shelf stability testing, for such labeling claims as “best buy” or “sell by” dates is not currently required of CBD companies here in the U.S. but the FDA will soon have a shelf stability ruling that will require shelf stability testing for every product. The UK already requires shelf stability testing for its Novel Food applications. Products sit in warehouses. They sit on shelves. Without shelf stability studies, you won’t know how time impacts your product’s appearance, its microbial content or if the CBD has broken down and you have 10 mg where you were reporting 100 mg. Manufacturers are scrambling because parallel or side-by-side shelf studies can take 12 months; accelerated studies still require 3 months. And the laboratories that they trust are faltering because they don’t have the validated methods to conduct these studies or the capacity.

 

Traditional recreational CBD labs vs. Santé Laboratories

There are significant distinctions between Santé Laboratories and traditional recreational marijuana labs. We are committed to investing in the best possible technology as well as the time for our analysts to validate our methods and ensure they are all ISO/IEC 17025:2017 accredited. Santé Laboratories uses the best testing methods to provide the best test results with the lowest levels of uncertainty, for everyone from farm to pharma.

Testing panel packages offered by traditional recreational CBD labs might include cannabinoids (THC, CBD, and usually others such as CBG); as well as heavy metals such as lead, arsenic, cadmium, and mercury. Another part of the panel would include pesticides which, depending on the quality of the lab, could range from 15-20 pesticides to several hundred on varying machine types. These labs might also offer microbial testing for E. coli, Salmonella, Enterobacteriaceae, and others.

Here is how Santé Laboratories differs:

  • We test for additional pesticides using both gas and liquid chromatography (LC-MS/MS and GC-MS/MS). Both methodologies should be used because some pesticides will be detected on one machine better than another. But some other labs can’t afford both machines and will only use liquid chromatography (LC-MS/MS), which ultimately cannot always pick up all the pesticides needed state to state, or provide the most accurate reading of those detected.
  • We offer an expanded panel of solvent testing. Extractors, processors, and manufacturers should be testing for residual solvents to ensure that you are not contaminating the products you make with high levels of potentially toxic solvents. Many labs can only test for about 15 solvents; Santé Laboratories offers testing for more than 50.
  • We offer a standardized drying method for farmers who are unable to do it on their own, which provides higher accuracy. Our method avoids drying too quickly, which can alter the cannabinoids and skew test results.
  • We offer label claim testing to compare the final product with what is on the label. Unlike some other labs, Santé Laboratories takes into account the way your product was processed. Before we put your sample on our machine, we accommodate for such things as variations during the extraction process or additional ingredients that could skew results.

And because Santé Laboratories is a CDMO, we can also create new in-house testing methods to treat your product uniquely and test it appropriately. That’s a huge advantage especially if there isn’t already a similar testing method available or if you are creating a new formulation.