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Hemp legalization has solidified that products containing cannabidiol (CBD) aren’t going away. Last February, Stephen Hahn, Commissioner of the Food and Drug Administration (FDA), acknowledged that it was “a fool’s game” to attempt to pull hemp-derived CBD products off the market. This echoes the sentiment of former interim Commissioner, Scott Gottlieb, who’d stated that the…
Hemp legalization has solidified that products containing cannabidiol (CBD) aren’t going away. Last February, Stephen Hahn, Commissioner of the Food and Drug Administration (FDA), acknowledged that it was “a fool’s game” to attempt to pull hemp-derived CBD products off the market.
The chemical formula of cannabidiol (CBD), a cannabinoid that can be derived from industrial hemp.
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All of this makes the case for an FDA-approved pathway — essential to prevent the bank accounts of lawfully-operating businesses from being closed. Not to mention retailers’ refusal to stock CBD products and investors with deep pockets awaiting rules and regulations. Thus far, the FDA has been dilatory.
It’s important to examine the evolution of the CBD industry over the past several decades. In the 1980s, a number of West Coast folks saw CBD’s potential immediately after it had been isolated and reported by Dr. Rafael Mechoulam. Yet not until around 2008-2009 was the compound commercialized by the first CBD companies. The first movers were primarily located in San Diego, CA, and Denver, CO. These companies were contacting the Hoban Law Group (then Hoban & Feola, LLC) for legal opinions and a defined strategy for the production and distribution of CBD.
This was pre-2014 Farm Bill and lawful industrial hemp hadn’t yet been defined separately from illegal marijuana. The 2014 bill only legalized industrial hemp for research and development purposes, but the 2018 Farm Bill removed the R&D caveat.
CBD’s first movers were operating without federally-lawful domestic cultivation. Instead, these products were grown, harvested, and derived internationally, making the legal and regulatory strategy a great deal more intricate. Further, it involved interpretations and standards set forth by the 1994 Dietary Supplement Health and Education Act (DSHEA).
At the beginning, CBD oil was being imported into the US from China, but these products were quickly rendered unsuitable for distribution in America because of the presence of heavy metals and pesticides. Then oils were imported from a variety of European locations. This involved international trade, customs, uniform health and safety standards, fundamental legality questions, and dedicated legal positioning for widespread distribution.
Today, these pioneering companies are global leaders and I’m very proud that our firm, working with the early entrepreneurs, laid the foundation for this industry. Within a few years, Hoban Law Group’s CBD clientele grew from six to 20 to 100. Flash forward to the present when there are thousands of operators, thousands of brands, and countless international components — all more robust than ever. The U.S. and its regulatory agencies have never tried to shut the industry down, but the FDA recently sent out a number of warning letters to manufacturers. The message could not be clearer: do not make claims, but make products that are safe.
Most CBD products are regulated at the state level. This is true in Colorado, with the Hemp Foods Policy/Bill, which our firm helped establish and is the model for the FDA. When the DEA attempted to classify CBD as a Schedule I substance through its Drug code rule, it failed. The Hoban Law Group litigated this case and the court ruled that hemp and its derivatives were no longer controlled. Can you say resilience? The industry is here to stay…for the most part.
The CBD industry began as an offshoot of the marijuana extraction technology sweeping the nation in the early medical marijuana states. Individuals could lawfully grow hemp, purchase a piece of machinery for a nominal investment (compared to a decorticator for hemp textile processing), and derive cannabinoids in oil form – all with little oversight. The hemp-derivative sector was attractive to many who couldn’t qualify in the lawful marijuana market due to regulations and entry barriers.
This leaves many questions unanswered for a global market. What is the standard for this ingredient? How can it be sold? How will it be regulated? What’s the preferred form — Full spectrum, Broad Spectrum, or Isolate?
When concrete regulations come, we’ll see a “second wave” of CBD sweep across the planet, along with the unleashing of minor cannabinoids and cannabis terpenes. So get out your formulas. Perfect your brands. Position yourself for what’s next. But always, always, voluntarily follow the FDA tenets applicable to food and supplements, even if the FDA doesn’t expressly presently require this. If you don’t, you won’t be ready for the real gold rush.