Since Industrial Hemp became federally legal in the United States in 2014, this industry has never been given the ability to grow without constant regulatory intrusion. And to date, this issue has only gotten worse. For hemp alone, it is the opinion of Apothio’s Leadership that there has always been a “regulatory trap” within key U.S. Federal Agencies, namely, the USDA, DEA, and FDA. This is pretty simple to figure out; just follow who has the most money.
In 2014, when the USDA began clearing a way for the American Farmer to legally grow hemp, the DEA continued to protect its “legal territory” regarding Industrial Hemp. Even though, hemp is genetically separate and apart from marijuana or now called cannabis, the DEA falsely claimed that hemp and marijuana are the same and that Hemp will be a vehicle to sell cannabis. Thankfully Senator Mitch McConnell had the DEA Commissioner removed in 2015 for a more progressive DEA Commissioner, so the DEA openly rescinded its position against Industrial Hemp in 2016, admitting in writing that the USDA superseded the DEA in all matters regarding Industrial Hemp. However, under the Trump Administration and Attorney General Barr, the DEA raised its ugly head again, stating in its 2019/2020 Interim Final Rules against hemp that any extraction of legal hemp biomass would become a felony as soon as the THC content exceeded 0.3% THC. We suspect the DEA will now back down against Industrial Hemp since the U.S. now has President Biden managing all things hemp and cannabis, and without Attorney General Barr.
The most devastating activity against the U.S. Industrial Hemp market has been the FDA’s low key, pernicious attack against Hemp derived CBD. The FDA has far more money than the USDA. The American Farmer cannot outspend the Health Insurance and Pharmaceutical Industry. So far, the FDA has only approved ONE cannabis-derived drug. This drug is owned and manufactured by a joint venture company that is held by GlaxoSmithKline, Merck, Eli Lilly, Bayer and Monsanto. Will the American Farmer ever be able to “out lobby” Big Pharma, Big Ag and the Insurance Industry? No. Thus, all markets for the U.S. Industrial Hemp industry have been muted. When the Drug Industry is ready to sell CBD and other Hemp derived cannabinoids, then the FDA will approve hemp derived CBD as a “food ingredient”, then hemp will have an open sales market in the U.S. worth billions.
Canada is a completely different story. Canada is not beholden to the drug companies, and Canada sees good science-based cannabis and hemp production as a tax revenue generator that can help millions of Canadians, as well as the billions of other humans and animals that will purchase Canadian made cannabis and hemp products. This is pure genius on Canada’s part, as the Canadians are managing their decisions with objective, qualified data, instead of who can pay the political lobbyists the most money.
So, as the regulatory market in the United States dwarfed the dreams of a fruitful Industrial Hemp regulatory and business climate, Apothio looked abroad for a business friendly environment fit for scalable international export markets that would allow us to see out our vision for a “genetics first” approach to whole plant hemp extracts that address specific symptoms.
This journey starts with patenting our unique library of proprietary genetics, which will be done at the DNA Lab of the Innovation Center for Advanced Manufacturing and Prototyping in Ontario, Canada.
These novel cultivars will be grown in off-grid indoor modular farms developed by EnerDynamic Hybrid Technologies, allowing us to eliminate the variability in biochemical outcomes that would otherwise be associated with farming outdoors. Hemp is a highly adaptive plant, whose chemical signatures are an epigenetic blueprint that reflects the soil type and seasonal weather patterns.
Without standardizing the “nurture” variable behind our cultivation program, the “nature” of the plant will never yield the same results. Our ability to standardize the biochemical outcomes of our production unlocks a massive opportunity for us to pioneer whole plant extracts.
Without these preliminary steps, the end result of our cultivation efforts are akin to a vintage, which cannot be replicated. This creates an environment in which isolated cannabinoids are our only option towards standardization, which compromises the integrity and effectiveness of the final product. Our cultivation pilot of 30,000 square feet of indoor growing facilities will become the blueprint for infinitely scalable cultivation of whole plant extract with standardized outcomes, anywhere in the world.
2021 will be the first year of cultivation of our patented novel varieties of industrial hemp in standardized shipping containers, which will allow us to begin clinical trials for opiate replacement therapy, and a wide variety of other symptoms. This massive milestone will enable us to make claims on the consumer, pharmaceutical, and nutraceutical products that our we, and our partner brands, will be able to make. Without the ability to do this, the entire industry is stuck attempting to sell a product that is reputed to do something , without being able to tell the consumer actually know what it does due to regulatory restrictions. It leaves the industry selling a one size fits all solution, in a consumer that demands a product this is customized to their needs.
The Canadian market has been incredibly welcoming to the Apothio team, we could not be more excited to take our next step into actualizing this vision, and believe that we have put together a world class team to make it happen.