Operating a Business in the Hemp Industry
What a journey it has been. Launching/running a business is never an easy task. Operating one in a new industry (well, at least LEGALLY new) with conflicting rules and regulations between every “ABC” agency out there can be maddening at times. FDA, DEA, USDA, SBA, SCDA, SC DHEC, SC BOP - then throw in the local codes’ committees and law enforcement agencies – it is just crazy. I feel as if I am having to educate everyone and am forced to play referee between agencies whose rules are in direct conflict with one another.
Ascent Naturals is a Hemp Processor in South Carolina. While my partner, Sharon Peek, and I have over 55 combined years in FDA regulated industries, this is the first time as an extractor for either of us. Tablets, softgels, 2-piece hardshells, dispensing, blending, mixing, coating, sterilization, sterile filling, IV sets – those we understood. Extracting hemp was a new challenge.
The good news was that we had a very strong background in FDA regulated industries. We understood the rules for operating and being fully compliant to those FDA rules. 21 CFR Part 111 (“CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS”) was integral to our daily business lives since it was published in 2007. 21 CFR Part 117 (“CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD” – aka the Food Safety Modernization Act) became second nature to us.
This was the starting point for our design work on the Ascent Naturals manufacturing operations. We built the facility to be fully GMP compliant. We encourage visitors. We want our customers to see what we do and how we do it. We want them to understand the difference a GMP compliant facility means for the quality of the product that they purchase from us.
But (yes, there is always a “but”), the hemp extraction part required a lot of education. So, we hit the books and the trade show circuit. MJBizCon NEXT, Hemp Industry Daily Conference, CBDExpo(pick your region), Cannabis Conference, NoCo Hemp Expo, US Hemp Expo… we visited them all. We talked to other processors, farmers, equipment manufacturers, regulatory representatives - really anyone who would give us the time and answer our questions. And, honestly, everyone was helpful. This is a great industry to be a part of.
Then came visits to other processors and equipment manufacturers to gain a general understanding of the extraction technology available. It wasn’t just extraction equipment, but all the ancillary equipment required to be a processor. There’s distillation equipment, reactors, centrifuges, filtration, winterization, vacuum ovens, cryogenic equipment, chromatography (that is a blog post all by itself!)... All these processes and equipment, and more, are required to process hemp and refine its extracts.
We chose cryogenic ethanal extraction equipment as our primary process. It offered the best of all worlds. I’m stealing from the Extraction Services page here, but these are the benefits.
Extraction Efficiency: Our technology boasts an extraction efficiency of over 90%. We have tested our biomass before and after extraction to confirm this efficiency.
Cost Efficiency: Ethanol extraction is highly cost-efficient. For the same level of investment, ethanol has up to 20x the throughput capability of supercritical CO2 extraction.
Processing Efficiency: Unlike traditional ethanol extraction, cryogenic processing (-80˚ C) does not pull fats and lipids from the hemp plant, eliminating the need for a separate lengthy winterization process. Processing time is reduced, and yields improved, saving time and money.
Safety: Ethanol is much safer to handle than other hydrocarbons (i.e. butane) and does not need to operate at super-high pressures (like CO2).
Sustainability: Ethanol is recovered and reused to process additional hemp biomass.
Quality: Ethanol, (aka pure alcohol) has GRAS (Generally Recognized As Safe) status. That means it is safe to use in food (and drink) products.
We also developed White Label abilities so that we could work with new and established brands to manufacture and package the products that they sell. We created formulas for tinctures, topicals, and gummies. We worked with flavor houses to perfect the consumer experience. After all, what good is hemp/CBD product if the consumer does not use it because they do not like the way it tastes?
We test, test, and test again. It’s not just the engineer in us both, either. Yes, we do want to make sure we operate as efficiently as possible; however, we also want to ensure the products that we sell are the absolute best on the market. Our driving reason for entering this business was to help people. We believe strongly in the benefits that hemp and its derivatives offer people (and pets).
We have in-house testing capabilities to ensure our equipment and processes are operating properly and our products meet specifications. We send samples of all products, whether it is a concentrate like crude or distillate, or a finished good like a tincture or topical, to an accredited, third-party laboratory to verify the in-house results. We use those third-party testing results to generate our Certificates of Analysis (COAs). When we ship something, we know it meets your requirements and specifications.
So that is the nickel version or our story. Future posts will focus on hemp and its benefits. We will dive into detail on CBD and the rest of the cannabinoids and their benefits for people and pets. We will talk about the body’s endocannabinoid system and how hemp seems to have been designed specifically to work with the human body. If you have ideas on stories that you would like to see, please forward them for future posts. We are here to help, and education is just one part of that.
Thanks for taking the time to learn more about us. We hope you will come back for more.
Stay safe and healthy,
Co-Founder and CEO, Ascent Naturals