The Conundrum Of Cannabis Regulations
Stagnant federal guidelines for non-psychoactive cannabis products are holding back the integration of cannabis into broader, established markets such as cosmetics. Behind the scenes, the cannabis industry has its own patchwork of guidelines. This patchwork further muddies the waters of the emerging CBD/cosmetics industry, which, even in its infancy, seems overly siloed. Lacking the broad experiences and understanding of standards already set forth by the well-established cosmetic and nutraceuticals industries, the cannabis industry doesn’t have the expertise to effectively communicate with cosmetic professionals.
The 2018 Farm Bill made legal for commerce non-psychoactive cannabinoid compounds (e.g., CBDA, CBD, CBGA, CBG) derived specifically from the hemp plant. While certain states may be slow to adopt their use in food commerce, their accepted use within topicals has grown but comes with an almost complete lack of safety enforcement and standards.
Having repeatedly heard the horror stories of so-called “CBD companies” selling pre-packed lotions, purchased in bulk, to which they simply “sprinkled-in” their homemade CBD oil before repackaging, Nextraction set out to flip the script on these shoddy business practices by bringing to market tech-based products with vastly superior transparency. By the time it officially launched in late 2021, Kriva had spent the prior two years focused on ingredient development and working closely with cosmetic giants Meiyume and Mana. The three companies partnered to build the first hemp topical supply chain backed by the cosmetic industry. The multi-year collaboration was formally launched with Kriva’s Wellness Lotion being introduced in recyclable, eco-friendly packaging, with all of the standard safety testing and efficacy the cosmetic industry and consumers have come to expect.
The hodgepodge of practices and regulations set forth by federal and state governments has created chaos and misinformation for non-psychoactive cannabis compounds in the broader cosmetic industry. This confusion is the biggest barrier to what is expected to be ubiquitous integration of these compounds for their overall, benign wellness attributes, as well as for their natural preservative characteristics.
While the 2018 Farm Bill makes non-psychoactive cannabis compounds legal in commerce, the Bill lacks a full explanation on rules enforcement. The Bill also leaves much of the hemp industry rule creation and enforcement to individual states, many of which are still working to become current with state-of-the-art industry knowledge. Unfortunately, most states have ignored the creation of regulations for topicals. Instead, they’ve focused on what they consider to be the larger regulatory thread, ingestion of hemp-based products through food and beverage.
The most well-defined federal regulations for non-psychoactive cannabis compounds in cosmetics come from the FDA’s authority to regulate, but not approve, cosmetic products (Title 21: Food and Drug, Chapter 9: Federal Food, Drug, and Cosmetics Act, “FDC Act,” Subchapter 6 Cosmetics). As with any actives used in the cosmetic space, if the effect of the active is mis-branded or causes adulteration within a topical, then the topical is no longer defined as a cosmetic and is, therefore, illegal.
This misbranding and adulteration drive home two key boundaries that are prevalent within the cannabis industry. The first is the requirement of section 361 (c) (within Title 21) that the preparation, packaging and storage of cosmetics must be performed in sanitary conditions. As noted, this purchase of already manufactured topicals and their post-bottling formulation and mixing is widely conducted in unsuitable environments, providing a fundamental example of the absence of standards such as Good Manufacturing Processes in the cannabis industry.
The second most defined point of regulation is specifically directed to one compound, Cannabidiol (CBD). The FDC Act states that cosmetics must be free from adulterations, specifying further that, “no poisonous or deleterious substance which may render the contents injurious to health” can be present. This regulatory requirement is proving to be a particularly vexing challenge for CBD products that are made from isolated cannabidiol. Why? FDA considers CBD to be a “drug” or “active pharmaceutical ingredient,” with identified adverse side effects (most notably liver damage and increased risk of infection) duly noted on the label of the FDA approved isolated CBD drug, Epidiolex. This regulatory jeopardy for isolated CBD may lead to its eventual downfall in consumer products, but leaves open the door for natural cannabinoids such as Cannabidiolic Acid (CBDA) and Cannabigerolic Acid (CBGA).
Overall, federal cosmetic regulations lack the definitive standards needed for cannabis topicals. Regulations that bring the best transparency and safety standards of the cannabis industry (e.g., potency, pesticide and residual solvent testing) to combine with those of the cosmetic industry (e.g., stability testin and bio-compatibility studies) would provide an ideal, solid regulatory footing for both industries to move forward with on safety and transparency.
As of September 2022, the patchwork of state regulations continues to be a barrier for non-psychoactive cannabis cosmetics. Since the 2018 Farm Bill ushered control to each individual state, a multitude of unique regulations around testing, manufacturing and labeling have been created. Generating even more confusion are the necessary requirements of licensing within each state and the allowances for selling into other states. Adding another layer of industry regulation, California now requires out-of-state companies to hold the state’s Industrial Hemp Product Registration (IHPR) in order to import non-psychoactive ingredients into the state for formulation.
Additionally, labeling challenges plague state regulators when it comes to cannabis cosmetics. A standard national testing panel policy and how to transparently present the information by distribution companies for easy consumer review is also left without clear regulatory guidance. A handful of hemp-based product companies are taking this transparency challenge and partnering with hemp traceability programs.
Originally, Kriva found it a challenge to locate a secure traceability system to meet its internal stringent requirements. Fortunately, in our investigations, we came across a block-chain backed transparency software company, TagOne. The SaaS-based platform allowed us to develop sophisticated transparency through QR code-enabled scans on all products. This tracking system allows each batch to have its own supply-chain transparency from seed to sale, including the cannabis industry’s most powerful document, the Certificate of Analysis (COA), showing Kriva’s products to have non-adulteration from common pesticides, heavy metals and other contaminants.
In addition to the legal regulations which affect the broader cosmetic space, there are also niche market guidelines that require additional certifications for safety. For instance, professional sports customers often require sports specific certifications such as those from National Sanitation Foundation (NSF) or from Informed Choice. While NSF has a robust cGMP program for cannabis companies and will certify ingestible products under its “NSF For Sport” scheme, topicals and cosmetics are not addressed. Informed Choice is said to be rolling out a cannabis topical sport certification by year-end, 2022.
Unethical operators have also done the cannabis industry no regulatory favor, what with their history of fabricated enforcements and empty product certifications. This is evident when hemp and THC-cannabis companies use quasi-official looking badges that tout misleading non-credentials such as “Solvent-free” or “THC-free.” While neither of these two proclamations is enforceable or certifiable by any governing regulatory body, the absence of transparent marketing in these types of instances must be addressed in evolving cosmetic cannabis product regulations.
So, where can non-psychoactive cannabinoids, such as CBDA, fit into the cosmetic space within the current patchwork of regulations and shortfall on enforcement? One would likely suppose that it falls first and foremost to thoughtful consumer education. Education on the right cannabinoid ingredients that are considered plant-based, non-psychoactive, extracted with clean technology, for example.
We must also allow the innovations and transparent, natural ingredients of the cannabis industry into the cosmetic industry through strong, continuing cross-industry partnerships and collaborations. The starting place for these collaborations is building transparent supply chains and educating consumers about non-psychoactive cannabinoid products.
Research surrounding non-psychoactive cannabis in cosmetics is proving to be the future of the industry, where actives such as CBDA and CBGA will become widely used, both for their health benefits as well as for their natural preservative characteristics. Only time will reveal how this collaboration between cosmetics and cannabis, combined with regulatory oversite, will push forward safer products with increased quality of life for consumers.
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Kriva understands the commitments athletes make in order to excel at the top levels of sport. Kriva takes the same approach to product development when it comes to safety, efficacy, and quality. Kriva develops cutting edge products with a commitment to the planet and to the athletes who live to excel on it. Kriva has focused on Cannabidiolic Acid (CBDA) since day one and is a leader in creating products that harness the power of acidic cannabinoids for human wellness. CBDA is the plant’s most naturally occurring cannabinoid and research demonstrates its strikingly higher bioavailability (absorption) and, thus, potency when compared to CBD. Kriva extracts natural CBDA from the plant using a water-based method that eliminates the risks of heavy metals and pesticide contamination common to traditional methods of extraction. All Kriva products come with digital access to a third-party Certificate of Analysis (COA) demonstrating potency and assurance of non-detectable levels of psychoactive cannabinoids (THC). |
About the Author
Nicole Foss MBA, MSN, RN is chief science officer and a founding shareholder of Nextraction, Inc. Initially working with veterans in medical cannabis, Foss has a combined 11 years of experience in the cannabis and hemp industries. Foss is also Nextraction’s director of consumer products and brands where she has been responsible for the launch of two in-house CBDA consumer brands, in addition to helping white label partners launch multiple brands. Her mission has been to help advance the hemp and cannabis industries through the employment of clean extraction technology and block-chain backed transparency. Foss is a registered nurse and holds master’s in business and in nursing and, as a technical expert on acidic cannabinoids, she is currently education chair and president-elect of the American Cannabis Nurses Association.
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