Recommends structure based on existing regulators
No more marijuana jokes. More properly, no more cannabis jokes; no more references to roach clips or Dazed and Confused or Pink Floyd. Truth is, cannabis is here; it will soon be a part of the American mainstream culturally and legally, and most important of all, it already is big business.
So, it’s time for our coverage of the topic to become a little more straitlaced.
The Story So Far
The long, slow march toward more comprehensive regulation and outright legalization of cannabis-derived products is an epic not easily condensed into a blog entry, but recent developments are worth noting. As we mentioned previously, much of the attention paid by the Food and Drug Administration (FDA) has dealt with cannabidiol (CBD) oil, the non-psychoactive cannabis ingredient that has emerged in a slew of products of late. CBD products combine the (beneficial?) trait of not getting anyone high with (unsubstantiated) health benefits as promoted by their manufacturers. The result is that CBD products are experiencing a surge in popularity with scads of attention from the Feds, even if that attention is, as of yet, inconclusive.
In early October, the National Cannabis Industry Association (the “Association”) tried to widen the scope of federal attention by advocating for a new, four-tiered structure to regulate all cannabis products.
Life in the Fast Lanes
The Association approach generally mirrors existing federal regulation by placing cannabis products under the watchful eye of the FDA. The classes of products would include pharmaceutical drugs, which would be highly regulated, including standard trials and testing; high-tetrahydrocannabinol (THC)-content products (products with more than 0.3% concentration of the psychoactive, or “fun,” chemical compound), to be regulated by state agencies and the U.S. Alcohol and Tobacco Trade Bureau, much like alcohol; CBD oils and other cannabis-derived products that contain little or no THC, to be regulated in the same fashion as diet supplements; and a final category – topical products with similarly low THC levels – to be regulated as cosmetics. You can read the plan, “Adapting a Regulatory Framework for the Emerging Cannabis Industry,” here.
What’s the upshot for marketers?
As a Schedule I drug under the Controlled Substances Act (CSA), much of the debate about how to regulate cannabis has concerned re-scheduling the drug at a “lower” level of scrutiny – schedule II or III – or removing it from the CSA altogether (descheduling). The Association promotes descheduling: “The first and most important step of a comprehensive regulatory system for cannabis would be for Congress to remove marijuana and its derivatives, including delta-9 tetrahydrocannabinol (THC), from the CSA, otherwise known as ‘descheduling.’ Descheduling is the only way for cannabis to be regulated in the manner proposed herein.”
Re-scheduling will keep the products under the FDA’s stringent drug approval process. Descheduling altogether without a federal regulatory framework would leave the market in legal limbo, but the Association promotes descheduling, while at the same time implementing a replacement framework. Neither would make marketing the products easier, for obvious reasons.
More important: The proposed plan will put marketers in familiar territory, where they can rely on a structure based on well-defined regulatory practices enjoyed by their alcohol-marketing brethren. It will also finally create a clear distinction between CBD and other cannabis products, which will put everyone in the booming CBD sector on firmer ground.