• jeffreypkiplinger

Caught in a Trap

Updated: Feb 22

The FDA approved Epidiolex (Cannabidiol, CBD) as an ethical pharmaceutical, a Schedule V controlled substance. Cannabidiol is one of 113 known cannabinoid compounds in plants of the genus Cannabis.

In my opinion, the FDA granted approval at least partly to deflect criticism that it has not followed its charter under the 1906 Pure Food and Drug Act (under which FDA was created in 1927-30) and the 1938 Food Drug and Cosmetic Act. These laws require, in short, that a product sold as a medicine be reviewed for safety, efficacy, quality etc. by the agency. "Medicinal marijuana" received no such review. I'm convinced the agency was anxious to approve Epidiolex - with all due diligence complete, of course - for some therapeutic reason, just to say "Look, see - it really is a medicine!"

To do so they couldn't leave CBD on Schedule I, so they descheduled it. But in order to retain their vague justification for their historical position on marijuana (Cannabis sativa) they said that CBD extracted and purified from marijuana (Cannabis sativa) would remain on Schedule I, while CBD from hemp (Cannabis sativa) would be on Schedule V. Following so far? It gets worse.

Hemp has now been defined as Cannabis sativa that contains less than 0.3% tetrahydrocannabinol (THC, thought to be the primary psychoactive cannabinoid, although remember all the others are Schedule I compounds too, that is if they are not CDB except if isolated from marijuana not hemp) by dry weight. Now, it's possible to grow low-THC strains or cultivars of Cannabis sativa, so with the approval of Epidiolex on the horizon growers in 2016 began to plant a lot of hemp and extraction facilities started springing up. In 2017, products and foods containing CDB appeared everywhere. Literally. On my block in mid-2018 were coffee shops and ice cream shops (and of course bodegas and vape supply stores) selling products containing CBD. All that CBD was claimed to be 100% pure.

I'm an analytical chemist. There's little value in quality in the nutritional supplement industry - particularly in a rapidly expanding market. The FDA has exercised relatively lax control over this industry for some time, so that it generally acts only when problems arise post market. Suppliers at best believe the raw material CofA; only a few assay their own material or monitored its stability. I talked to cosmetic manufacturers who noticed off colors and rancid odors, poor shelf life, and particulates in "pure" CBD.

Now here's the trap. What happens when the same product is both a nutritional supplement and an ethically developed pharmaceutical? Well, a few too many people complain to state and local regulators and politicians get nervous. New York, Ohio, Maine and others cracked down and said "no unapproved product containing CBD may be sold".

As far as I can tell, most products were simply relabeled to say "hemp oil" or "hemp extract" instead of CBD. This is great for the maker or the coffee house - you don't have to claim you're adding "pure CBD" anymore! You can charge the same price as before, and wink at the customer who thinks they know what they're getting. Friends who were actually working on high quality, stable, potentially therapeutic CBD creams or other products can no longer differentiate themselves from the hundreds of creams available on Amazon.

By not following its founding mandate, FDA finds itself desperate to support medicinal claims for cannabinoids, while still maintaining a Nixon-era stance on the "lack of medicinal value" of all those Schedule I cannabinoids, and has forced regulators into a similarly conflicted position that actually reduces quality of consumer products.



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