Is Your CBD Pharmaceutical-Grade?

by Dionne Dyches

Cannabidiol (CBD) products seem to be everywhere and are saturating the health and wellness market every day. With so many options, how do you know if you are buying the best or a second-rate CBD product? The best way to know what you are getting is to focus on the key factors that go into a Good Manufacturing Practices (GMP) certified, pharmaceutical-grade CBD product like Curatio’s and why it’s critical to do your research.

Key Factors to Consider

Varieties of CBD: not all are created equal — These days, you can procure CBD in multiple vehicles of consumption (including oil, capsule, spray, lozenge, cream and others) as well as a variety of types of extracts, such as full-spectrum, broad-spectrum and CBD isolate. Full-spectrum is the most robust and effective type of CBD oil available. In addition to CBD it also includes a diversity of other cannabinoids (with trace amounts of THC) and loaded with terpenes, flavonoids and fatty acids. Broad spectrum CBD oil is achieved through a distillation and THC remediation process. The remediation process not only removes the THC, but unfortunately also removes the secondary cannabinoids. CBD isolate, a flavorless powder that is the result of CBD extract into crystalline form, contains no THC, terpenes or phytocannabinoids. CBD isolate is only the CBD molecule. Its accessibility and low price-point make it attractive for both consumers and CBD brands alike, but its lack of terpenes and phytocannabinoids — as well as loose regulations on the solvents and processes by which the isolate is distilled — may increase the chances that some CBD isolates are either not efficacious or perhaps even illegitimate. Full-spectrum CBD, on the other hand, preserves both terpenes and phytocannabinoids, which synergize with CBD itself in what is known as the entourage effect. Many full-spectrum CBD brands are able to create a production infrastructure that allows for stringent testing and protocols that mimic the standard pharmaceutical process, yielding pharmaceutical-grade products. Curatio tests every product three times — twice at the active ingredient and once at final product. (provide link)

Source and extraction of the hemp — Legal CBD products derive from hemp and contain only 0.3% or less of THC by dry weight and is non-psychoactive. The hemp strain, location its grown and methods of extraction will determine the cannabinoid profile, the effect and quality of the product.  Although there are many different extraction methods, including supercritical carbon dioxide extraction, or the use of ethanol as a solvent, it’s important to look beyond the mere process and understand the nuanced details of production. Many brands may cut corners to reduce costs and use processes that yield a product that doesn’t deliver the same effect as a product that is rigorously and meticulously assessed for quality from start to finish. 

Pharmaceutical grade potency, delivery and dependability  — The active ingredient is a critical component of  an efficacious pharmaceutical product. A full-spectrum product is the foundation, but it doesn’t stop there — the diversity and ratio of the cannabinoids, terpenes, and fatty acids are critical to achieving true potency. But you can’t experience the benefits of the active ingredient without a delivery system that actually gets the product into the bloodstream (if it’s an oral product) or into the muscle, connective tissue and joints (if it’s a topical product). On the other hand, when it comes to skin and beauty products, the delivery system doesn’t need to go past the dermis layer, since the area of interest is just the skin. 

Nano-delivery, the process of miniaturizing the active ingredient to get it to the target location(s), is the best way of ensuring that a person can experience the benefits of a CBD product. If the active ingredient is not the right size, then it can’t reach the target. Non-nano topical products, for instance, do not travel past the dermis barrier. Curatio understood these issues from the start and invested a lot of research into developing the most potent active ingredient and delivery system to get the product to the target site. They also recognized that patients who rely on CBD depend on a consistent product, leading to a proprietary hemp strain that is consistent from batch to batch. 

Good manufacturing practices — Good manufacturing practice (GMP) is a set of regulations established by the Food and Drug Administration (FDA) which, by force of law, requires certain manufacturers to ensure that there is a consistent process and standard for producing their products — through all phases of the production — resulting in reliable quality standards. GMP regulations seek to protect consumers from purchasing faulty or downright dangerous products. In short, GMP mitigates risk associated with pharmaceutical production by ensuring that detailed processes and procedures are followed and documented proof that these steps were taken, every time. GMP also covers the materials used, the production site, any associate equipment as well as the staff.

In accordance with GMP, every ingredient used in Curatio’s products is tested before it is combined into  a finished product. This is significant because there are currently no regulated acceptable levels of substances (such as lead) that can be used to manufacture CBD. As such, some CBD makers could include higher levels of lead or other harmful substances as they deem necessary. Curatio’s rigorous compliance with GMP alleviates the concerns with product quality — from the beginning to the end of the production cycle.  Curatio is GMP from seed to shelf, including farming, drying, extraction, nano processing, finish product manufacturing, all the way through fulfillment. All facility’s in the chain-of-custody are FDA registered, which means it is randomly reviewed without notice. 

Testing requirements — Always demand a COA, which shows the purity and potency of a product. Testing of CBD products can be a misleading topic for consumers. Even though testing should be mandatory, there are requirements or standards to ensure consistency, and results can be significantly different across brands. Consumers must beware because CBD manufacturers in many instances set their own safety and quality standards that are not approved or enforced by any regulatory body. Curatio, however, tests its products three times, despite not being required to do so. This product testing is critical to ensuring that these products are safe and distinguishes their products from the marketplace. All of their products are manufactured at a GMP facility, which means they practice food grade and pharmaceutical quality standards to ensure product purity, potency and safety.

Verification — For your own protection, it’s important to seek out the information you need to verify whether your CBD is pharmaceutical grade. Check the product website and call or email to ask all of the questions you want to know. If the brand is not transparent about their process and the ingredients used, refrain from trusting that product for your own protection. Curatio has created a full product line of medical-grade products, providing certainty of the quality of their products.

According to one study, 26 percent of CBD products had lower levels of CBD than the label indicated, or didn’t contain CBD at all. In instances where the dosage is key to medical treatment, this inconsistency is particularly important. Their pharmaceutical-grade practices means consistency and reliability in the way their products are developed.  

Choosing Pharmaceutical-Grade CBD

Consumers should gather information on the CBD products they buy. Researching where and how the hemp is grown and then extracted, evaluating the manufacturers that produce the CBD and assessing whether the products have been tested for potency and safety,  will inspire more confidence in the purchase. All of these steps are critical to deciding how to choose CBD oil that meets rigorous standards like Curatio products. In addition to seeing the Certificate of Analysis for each of their products (including cannabinoid and terpene profile), you can also read through the lab results of tests measuring potency, microbial contaminants, residual solvents, heavy metals and pesticides. Ultimately, you will be able to navigate this growing CBD market, armed with the right information that’s best for your health needs.

Dionne Dyches, MS, is a communications professional and writer and specializing in the healthcare, hospital and pharmaceuticals industry. Her niche includes internal communications, crisis communications, corporate communications, market research, management and business development.

References:

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818782/
  2. https://savedelete.com/health-fitness/how-to-choose-the-best-pharmaceutical-grade-cbd-oil-to-suit-you/268576/
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  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818782/ 
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  9. https://cdn.shopify.com/s/files/1/0253/1780/2089/files/Potency_Lab_Result.pdf?3207 
  10. https://cdn.shopify.com/s/files/1/0253/1780/2089/files/Residual_Solvents.pdf?3204
  11. https://cdn.shopify.com/s/files/1/0253/1780/2089/files/Heavy_Metals.pdf?3207
  12. https://cdn.shopify.com/s/files/1/0253/1780/2089/files/Pesticide.pdf?3208
  13. https://ispe.org/initiatives/regulatory-resources/gmp
  14. https://www.forbes.com/sites/sarabrittanysomerset/2019/07/30/cbn-is-another-cannabis-compound-with-beneficial-properties/#426e4be01d9b
  15. https://thesleepdoctor.com/2018/10/03/is-cbn-the-next-big-thing-in-cannabis-therapy-for-sleep-mood-and-health/

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