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Industry associations, testing labs, suppliers, and finished product manufacturers are exercising due diligence, each in their own way, to self-regulate and promote responsible behavior, claims, and best practices in an immature hemp and CBD market.
The 2018 Farm Bill removed hemp and hemp-derived cannabidiol (CBD) from the U.S. Drug Enforcement Administration’s Schedule I drug list, but even so, there’s still much uncertainty around how the resulting CBD marketplace will be regulated and to what extent existing rules and best practices will be enforced. In the meantime, responsible parties aren’t waiting for standards to come from above. A growing faction of industry associations, testing labs, suppliers, and finished product manufacturers are exercising due diligence, each in their own way, to self-regulate and promote responsible behavior, claims, and best practices in an immature hemp and CBD market. Here’s a snapshot of their progress.
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Testing Your Own Ingredient
Because the current CBD market is already full of diverse claims-including claims of superior bioavailability, specialized extraction processes, and various ranges of cannabinoid content-it’s safe to say that not every CBD extract is the same.
“What the CBD industry can’t do is market heavily on the fact that their CBD is unique, better, or different-and at the same time not be willing to gather the requisite data on safety and benefits,” says Duffy MacKay, ND, CV Sciences’ (San Diego, CA) senior vice president of scientific and regulatory affairs.
Though many CBD companies are going to market without rigorous safety data on their own unique products, CV Sciences is doing the hard work. Last year, the company contracted AIBMR Life Sciences (Seattle, WA) to conduct a toxicological assessment of its PlusCBD brand of hemp-derived CBD oil. Following this toxicological assessment, CV Sciences achieved the first Generally Recognized as Safe (GRAS) self-determination for a CBD hemp oil extract.
To this day, the company continues to track safety data on its products by utilizing a third party that collects and analyzes all product complaints and adverse events with the aid of medical doctors on staff and a system called Nutravigilance. CV Sciences says it has already submitted a year’s worth of data, combined with data from other CBD firms, to FDA as part of the public comments that hemp-advocacy group U.S. Hemp Roundtable (Lexington, KY) submitted to FDA this summer in response to the agency’s call for public comments on the issue of CBD regulation. CV Sciences says that this collective data suggests that hemp-derived CBD products are “extremely safe and well tolerated.”
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Independent Lab Testing
In another effort to increase confidence and improve decision making in the hemp products market, independent testing labs are developing methods to, first and foremost, detect the presence of delta-9-tetrahydrocannabinol (THC) in hemp products. THC is the psychoactive compound in cannabis. Under the 2018 Farm Bill, industrial hemp-which would be the hemp used in hemp foods and health products-cannot have a THC concentration higher than 0.3% on a dry weight basis.
Seeing a need to create integrity through analytical testing, cannabis certification bodies are forming. Perhaps largest in scope is the recently formed International Cannabinoid Analysis Program (ICAP), a joint venture between the contract research organization Nutrasource (Guelph, ON, Canada) and independent botanical testing lab Alkemist Labs (Garden Grove, CA). As an international program rather than a strictly U.S. one, ICAP’s THC threshold is set at 0.2% THC so that it falls under the THC cap for the U.S. but also EU regulations.
The need for standardized analytical testing grows greater each day as more products flood the CBD market. The need for analytical labs that know how to properly handle cannabis also grows. “There are, at this point, a handful of peer-reviewed and validated methods available to all labs,” says Alkemist Labs CEO Elan Sudberg. “They produce slightly different results. That’s confusing and problematic if labs don’t know how to resolve those discrepancies.”
The first ICAP certifications were scheduled to be awarded this September.
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Industry associations are taking it upon themselves to create best practices for self-regulation of the hemp and CBD industries in ways that reach all the way from the farms that grow hemp to the manufacturers of branded, finished products.
Seeing an immediate need to embrace the new CBD market, dietary supplement association the Council for Responsible Nutrition (CRN; Washington, DC) began opening up its membership to CBD food and dietary supplement companies in April. Besides requiring that each CBD manufacturer’s products be derived from hemp and contain no more than 0.3% THC (the U.S. limit), the standards CRN demands of its CBD members are largely in line with those normally required of CRN member companies. They must use facilities that adhere to current Good Manufacturing Practices (cGMPs), abide by food safety regulations such as adverse event reporting, not make illegal disease claims on products, and back any lawful claims on products with scientific substantiation. The list goes on, but it’s largely in line with dietary supplement regulations in general.
For standards unique to hemp and CBD extraction, specialized organizations are emerging. The U.S. Hemp Authority (Lexington, KY) is a new certifying body situated in one of the fastest-growing states for U.S. hemp production. Led by experts from across the hemp and natural products industry, it already has more than 20 certified companies-including growers, manufacturers, and brands-that are adopting core principles for all things hemp. Examples of these particular hemp industry standards include best practices for pre- and post-harvest sampling, cannabinoid testing, contaminant testing, and hemp drying and curing. Interested parties are encouraged to check out the full U.S. Hemp Authority Guidance on the certifier’s website for a wealth of beneficial hemp industry guidance soon to be updated in a 2.0 version.
For companies seeking safe and vetted sources of hemp materials and CBD extracts, the Hemp Exchange is a useful new service designed to verify hemp farms, processors, and manufacturers for accurate representation and product traceability. Member companies are routinely audited for accurate business information, unaltered Certificates of Analysis, and product integrity. The goal of the project is to provide a safe and reliable hemp marketplace free of the issues that currently penetrate the hemp market but that are also part of the global ingredient trade in general.
“First and foremost, there are several brokers in the industry today who are less than honest and often intentionally misrepresent themselves as well as products they have,” says Hemp Exchange CEO Chris Fontes. “Often times, the broker will claim they are the processor or the farmer, or they will claim they are the exclusive broker for said processor or farmer when, in fact, they don’t have any real relationship to the processor or farmer at all. In fact, they often will attempt to sell product they have never seen, touched, and have no access to.”
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Vertical Supply Chain
If you have the capability of taking full control of your own CBD sourcing, here’s some inspiration that it can be done.
Gaia Herbs is a leading herbal supplement brand that grows many of its own ingredients on a 350-acre farm in North Carolina. The company now has two full-spectrum hemp extracts for sale, but they had to outsource the raw-material farming of their hemp because it was illegal to grow hemp in North Carolina-until the passage of the U.S. Farm Bill in 2018. Stacey Gillespie, Gaia Herbs director of product strategy, says, “There were definitely challenges to find a hemp oil supplier that could meet all of our rigorous standards-including their overall growing conditions, facility conditions, a commitment to regenerative agriculture, their environmentally and socially responsible business practices, their harvesting philosophy (harvesting at the peak time of phytochemical activity according to nature versus a set production schedule), and also their community resource protection practices.”
Since the passage of the Farm Bill, Gaia Herbs has received its own license to grow hemp in North Carolina and is now actively exploring the possibility of farming its own hemp. With its farm being certified organic, Gaia Herbs hopes to eventually have its own certified-organic hemp, which would be a rarity in the current hemp supply chain.
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