Cannabis: Will FDA say it's OK?
Man’s love-hate relationship with drugs is a complicated beast. Depending on perspective, drugs are seen as harmless fun or relaxation, medically necessary, or a ticket to a wrecked life and overflowing prisons.
Personal opinions aside, the characterization of “drugs” — and this may surprise you — has more to do with social history than harmful effect.
Remember, cocaine was once widely available, including in the 20th century as an over-the-counter headache remedy (and an ingredient in Coca Cola). Opium was freely prescribed and easy to get in the 19th century. Meth was approved by the FDA in 1944 to treat many medical conditions, and MDMA/Ecstasy was still legal in the U.S. in 1984. Even coffee was banned as a “Satanic” stimulant in the 16th century, until Pope Clement VII lifted it (he loved the stuff).
A 2010 British study by the Independent Scientific Committee on Drugs ranked 20 legal and illegal drugs on 16 measures of harm to the user and to broader society. The worst? Alcohol, by far. The least harmful of the 20? LSD. Marijuana ranked in the lower half, and 250 percent less harmful than alcohol.
Many a sob story features alcohol. Prohibition’s advocates pointed to car accidents, marital and family problems, violence. Yet most of us partake, and alcohol-related crime in the U.S. seemed worse when it wasn’t federally controlled. Perhaps the countries where it’s still illegal would disagree.
Like alcohol, marijuana (and industrial hemp) have had an on-and-off relationship with legality. And at the state level at least, the trend is back on.
As Idaho prepares for yet another attempt at a medical marijuana initiative (note the proposal is for limited, doctor-prescribed purposes only), Kootenai County Sheriff Ben Wolfinger made an interesting comment in Wednesday’s Press. While consistently opposed to legalizing marijuana, he indicated he’d reconsider it for medical use if the FDA was involved.
Which got me wondering: With so many states legalizing marijuana not only medically, but in some cases recreationally, why hasn’t the FDA weighed in? Here’s what I learned:
1. They’re constricted. The FDA can only review and regulate what they’re asked to. That means a specific product by a specific applicant. Part of the problem with cannabis and its derivative products such as CBD oils is that the chemistry, strength and effects can vary widely, with literally thousands of possibilities. To date, they’ve approved four, prescription-only products.
2. CBD is all over the place. One of those four is Epidiolex, a purified form of CBD (with no THC which causes the “high”) to treat seizures. Otherwise, none of the CBD products out there is yet FDA-approved.
A 2017 National Institutes of Health study, “Labeling Accuracy of Cannabidiol Extracts Sold Online,” concluded only a minority of CBD products — 30 percent — are accurate in their potency or purity claims. Finding an effective, safe CBD oil product — which are non-high producing and users believe help common conditions such as anxiety and muscle cramps — is a challenge. Without regulation or reliable labeling, the purity, safety, and strength is impossible to determine.
3. The FDA is willing but wants more research first. That means carefully controlled, clinical trials to help them evaluate specific cannabis-related drug applications. The agency has received public complaints of adverse reactions to some of the products out there. An FDA.gov article on the issue states:
“The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis.”
Wherever Idaho ends up with the medical pot debate, it would seem beneficial to the public if an independent, government body could weigh in on this, as well as many other less controversial but effectively inconsistent “natural” botanical products out there. Waiting for manufacturers to go through the expense and time required for testing and approval may not be soon enough, if the prevalence and risks of currently unregulated use is anything to go by.
It’s kind of frustrating, because the need for FDA involvement is clear if the pace of states taking the reins is any indication. Citizens can petition the FDA, but only about drugs already regulated by them.
For more information about the FDA’s stance on cannabis, see: Bit.ly/2rZ9SSm.
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Sholeh Patrick is a columnist for the Hagadone News Network. Contact her at Sholeh@cdapress.com.