Monday, March 27, 2023
In business, the process of making facts or information known to the public is called disclosure. ‘Valuable Disclosures’ are the most important admissions a company can share with a consumer, and often become the most important part of their decision-making process. When it comes to consumer products, clarity around the manufacturing process is of utmost importance, so consumers can understand and feel supported in making an educated purchasing decision.
In an unregulated CBD industry where there’s tons of misinformation, companies who offer the most insight into their process give customers a sense of trust and transparency. When applying this Valuable Disclosures concept, consumers are informed about the most beneficial and useful information they need to know when purchasing a CBD product. At the very least, CBD companies should provide the following three disclosures: Clinical and safety study results, extensive product labeling (including linked certificates of analysis), and manufacturing processes. These are crucial when it comes to purchasing safe CBD products on the market.
Clinical & Safety Study Results
Before buying a CBD product, it’s important that the company has conducted clinical safety and toxicity studies on the CBD ingredient itself. These toxicity studies determine the level that a particular ingredient becomes toxic to the body and establishes an amount that a certain substance will produce adverse effects. Without these types of studies, consumers don’t know what constitutes a “safe” dose for these CBD products.
Toxicology reports inform potential problems with products ahead of time, ensure they’re safe to use, and demonstrate the manufacturer’s responsibility by investing in these types of studies. Performing toxicity studies on CBD products before they’re brought to market ensures the awareness of any unwanted outcomes, and allows these unwanted effects to be addressed before they can impact consumers.
Above all, clinical and safety studies allow manufacturers to arrive at an Acceptable Daily Intake (ADI) for their CBD ingredient. The ADI for a particular CBD ingredient informs consumers on the amount that is “safe” to consume daily. These clinical and safety studies are seen as the basis for the GRAS (generally recognized as safe) notification program and the NDIN (new dietary ingredient notification) application, although the FDA recently concluded that there will be a new regulatory pathway for CBD products.
Extensive Product Labeling
Additional valuable disclosures for CBD products should be found on the product label itself. Disclosing whether synthetic or natural compounds are used, the type of cannabinoid extract that’s in the product, how much total THC is in the CBD product, and displaying a QR code that links to certified third-party lab results are crucial practices often skipped during the CBD labeling process. Transparency when it comes to everything inside your CBD is of utmost importance when labeling these products, so consumers know exactly what they are purchasing.
Synthetic Product Disclosure
We’ve touched on the dangers of synthetic compounds in a previous article, and recently worked closely with the Colorado SB 22-205 Task Force to make rule recommendations concerning intoxicating hemp products. One label recommendation was to “…promulgate regulations for labeling Industrial Hemp Products which distinguish those products which contain synthetic/synthesized cannabinoids from those which only contain naturally occurring cannabinoids”. Due to our body’s chemistry and our biology, it’s crucial for the manufacturer to inform consumers whether or not synthetic compounds are being used in their CBD products. Washington currently has bill SB 5367 in place with similar synthetic labeling requirements, stating labels must include “…the amount of any synthetically derived CBD in the product sold or provided to the ultimate user”.
Raw Material Disclosure
Disclosing the type of raw starting material utilized for final CBD products is critical for the consumer and should be displayed on the label itself. It’s important for customers to know exactly what they’re buying and consuming, and whether the product is an isolate, broad-spectrum, or full-spectrum CBD extract. CDPHE regulation 6 CCR 1010-21 requires manufacturers to display, within the ingredient list, whether the product contains isolated cannabinoids or full or broad spectrum hemp extracts. Full spectrum products include the psychoactive cannabinoid THC and can be detrimental for consumers who are drug tested for their jobs, making this disclosure very important.
THC Content Disclosure
Since full spectrum CBD extracts include levels of THC, it’s vital that the amount of total THC in the CBD product is displayed on the product label. Some consumers prefer CBD products without THC, possibly to avoid its psychoactive side effects or to pass a drug test. Numerous states are even taking action to pass bills that limit the total amount of THC per serving and package, in hemp products. Similar to the label recommendations regarding THC content proposed in the new Washington bill SB 5367, the Colorado SB 22-205 Task Force “…recommends that CDPHE promulgate regulations requiring a notice statement (versus a warning statement) that such product includes THC and other Potentially Intoxicating Compounds”. Disclosing the total amount of THC along with CBD on a product’s label can assist consumers with their decision-making process.
Certificate of Analysis Disclosure
Possibly the most crucial disclosure when it comes to product labeling is a QR code on the CBD product label that links to a certified third-party lab’s Certificate of Analysis (COA). A COA is a lab report on the chemical make-up (e.g., contents) of a product, displaying the cannabinoid, terpene, and contaminant profile of CBD products. The first thing you want to check on a COA is that the company who performed the lab test is not the same company who is selling the product, avoiding bias in the report. Labeling alone is not reliable, especially when products are sold online to customers who do not fully understand the ins and outs of the industry. COA’s are used to verify that the contents of the CBD product are matched to how it is advertised on the label.
Reliable Manufacturing Processes and Systems
Another Valuable Disclosure for the CBD industry is transparency behind the manufacturing processes and systems that are utilized when formulating CBD products. Operating a consistent and reliable manufacturing facility for cannabinoids is key to a quality CBD product. Making sure the manufacturing facility where these products are made is cGMP 21CFR111 compliant, allows for trust that these products are produced in a safe and quality manner. Having quality management systems with digital document control, manufacturing execution systems with full traceability from raw material to finished product, and laboratory information management systems, are the bare minimum processes that a CBD manufacturer should employ.
Cannabinoid manufacturing facilities should retain specific permits, licenses, and certifications. We are ISO 9001:2015 certified and have a certified food manufacturer license from the Colorado Department of Public Health and Environment (CDPHE). We have Environmental Protection Agency (EPA) permits including solvent usage and hazard waste disposal. Our in-house analytical laboratory is also ISO 17025 certified. Additionally, we hold food safety to the highest standards, therefore our facility is kosher certified, with allergen-free, non-gmo, and gluten free official statements. Kazmira’s facility can manufacture plant-derived cannabinoid formulations with unmatched quality, safety & efficacy, every time.
The Importance of Valuable Disclosures
In an industry that is quickly expanding with limited regulation, it is important that consumers know exactly what they are purchasing. A CBD company’s reputation is only as good as the value their disclosures provide to their customers. When browsing for a CBD product, be cautious if the company doesn’t have clinical safety studies completed. If the product label is not thorough and doesn’t include a QR code that links to a third-party COA, this is a cause for concern. Above all, the manufacturing facility where these products are formulated should have all the proper and up to date licenses, permits, and certifications that are required by their state. Undoubtedly, without these Valuable Disclosures, it’s difficult to know whether the CBD product you’re purchasing, and consuming, is truly safe.